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TDMS Study 05006-06 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                   BENZALDEHYDE                                     DATE: 09/03/94       
EXPERIMENT: 05006 TEST: 06                                                                                     TIME: 10:32:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1CP9565101          ROUTE: GAVAGE                                                                      NTP C#: 56133        
PATHOLOGIST: H. GILES                        S.EUSTIS                                                          CAS: 100-52-7        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                   BENZALDEHYDE                                     DATE: 09/03/94      
EXPERIMENT: 05006 TEST: 06                                                                                     TIME: 10:32:45      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1CP9565101          ROUTE: GAVAGE                                                                      NTP C#: 56133       
PATHOLOGIST: H. GILES                        S.EUSTIS                                                          CAS: 100-52-7       
 
 
 
 
 
                                                    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                                   BENZALDEHYDE                                     DATE: 09/03/94       
EXPERIMENT: 05006 TEST: 06                                                                                     TIME: 10:32:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1CP9565101          ROUTE: GAVAGE                                                                      NTP C#: 56133        
PATHOLOGIST: H. GILES                        S.EUSTIS                                                          CAS: 100-52-7        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF BENZALDEHYDE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Stomach, Forestomach          Squamous Cell Carcinoma or Papilloma Squamous
                                                           Squamous Cell Papilloma
 
              ====================================================================================================
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE   1
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/0 (0%)        2/50 (4%)      |     1/50 (2%)       0/0 (0%)        0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.5%          |      3.3%            0.0%            0.0%          |
|TERMINAL (d)           |     0/32 (0%)       0/0             2/31 (6%)      |     1/30 (3%)       0/0             0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             736 (T)       |      729 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.138           (e)           P=0.231        |     P=0.282N          (e)           P=0.469N       |
|INCIDENTAL TUMOR       |     P=0.138           (e)           P=0.231        |     P=0.282N          (e)           P=0.469N       |
|LOGISTIC REGRESSION    |     P=0.138           (e)           P=0.231        |     P=0.282N          (e)           P=0.469N       |
|COCHRAN-ARMITAGE       |     P=0.142                                        |     P=0.308N                                       |
|FISHER EXACT           |                       (e)           P=0.247        |                     P=1.000N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       0/0 (0%)        2/50 (4%)      |     1/50 (2%)       0/0 (0%)        0/50 (0%)      |
|ADJUSTED (b)           |      4.7%            0.0%            6.5%          |      3.3%            0.0%            0.0%          |
|TERMINAL (d)           |     0/32 (0%)       0/0             2/31 (6%)      |     1/30 (3%)       0/0             0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      576             ---             736 (T)       |      729 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.590         P=0.251N        P=0.671        |     P=0.282N          (e)           P=0.469N       |
|INCIDENTAL TUMOR       |     P=0.572N          (e)           P=0.670N       |     P=0.282N          (e)           P=0.469N       |
|LOGISTIC REGRESSION    |     P=0.572N          (e)           P=0.670N       |     P=0.282N          (e)           P=0.469N       |
|COCHRAN-ARMITAGE       |     P=0.593N                                       |     P=0.308N                                       |
|FISHER EXACT           |                     P=1.000N        P=0.684N       |                     P=1.000N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE   2
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       2/50 (4%)      |     1/50 (2%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      5.4%            6.1%            6.2%          |      3.3%            2.2%            2.9%          |
|TERMINAL (d)           |     1/32 (3%)       2/33 (6%)       1/31 (3%)      |     1/30 (3%)       0/27 (0%)       1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |      576             736 (T)         717           |      729 (T)         473             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.586         P=0.690N        P=0.678        |     P=0.609N        P=0.744         P=0.727N       |
|INCIDENTAL TUMOR       |     P=0.593         P=0.682         P=0.689        |     P=0.633N        P=0.734         P=0.727N       |
|LOGISTIC REGRESSION    |     P=0.600         P=0.693N        P=0.693N       |     P=0.630         P=0.763N        P=0.727N       |
|COCHRAN-ARMITAGE       |     P=0.601                                        |     P=0.640                                        |
|FISHER EXACT           |                     P=0.691N        P=0.691N       |                     P=0.753N        P=0.753N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       2/50 (4%)       2/50 (4%)      |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      8.2%            6.1%            6.2%          |      6.7%            2.2%            2.9%          |
|TERMINAL (d)           |     1/32 (3%)       2/33 (6%)       1/31 (3%)      |     2/30 (7%)       0/27 (0%)       1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |      576             736 (T)         717           |      729 (T)         473             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.422N        P=0.493N        P=0.517N       |     P=0.346N        P=0.529N        P=0.446N       |
|INCIDENTAL TUMOR       |     P=0.424N        P=0.542N        P=0.517N       |     P=0.366N        P=0.540N        P=0.446N       |
|LOGISTIC REGRESSION    |     P=0.408N        P=0.497N        P=0.498N       |     P=0.379N        P=0.499N        P=0.446N       |
|COCHRAN-ARMITAGE       |     P=0.406N                                       |     P=0.378N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE   3
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/50 (16%)      6/18 (33%)     14/50 (28%)     |     1/50 (2%)       2/8 (25%)       4/49 (8%)      |
|ADJUSTED (b)           |     22.2%           43.2%           39.9%          |      3.3%           35.2%           11.4%          |
|TERMINAL (d)           |     5/32 (16%)      5/12 (42%)     11/31 (35%)     |     1/30 (3%)       1/3 (33%)       4/35 (11%)     |
|FIRST INCIDENCE (DAYS) |      576             697             293           |      729 (T)         641             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.079         P=0.315         P=0.102        |     P=0.204         P=0.101         P=0.227        |
|INCIDENTAL TUMOR       |     P=0.083         P=0.108         P=0.102        |     P=0.180         P=0.085         P=0.227        |
|LOGISTIC REGRESSION    |     P=0.097         P=0.128         P=0.116        |     P=0.188         P=0.028 *       P=0.227        |
|COCHRAN-ARMITAGE       |     P=0.098                                        |     P=0.149                                        |
|FISHER EXACT           |                     P=0.113         P=0.114        |                     P=0.047 *       P=0.175        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/50 (24%)      6/18 (33%)      7/50 (14%)     |     1/50 (2%)       2/8 (25%)       1/49 (2%)      |
|ADJUSTED (b)           |     29.4%           30.2%           17.0%          |      2.9%           66.7%            2.9%          |
|TERMINAL (d)           |     5/32 (16%)      3/12 (25%)      2/31 (6%)      |     0/30 (0%)       2/3 (67%)       1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |      448             527             471           |      667             729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.160N        P=0.374N        P=0.199N       |     P=0.550N        P=0.097         P=0.728N       |
|INCIDENTAL TUMOR       |     P=0.064N        P=0.443         P=0.084N       |     P=0.575N        P=0.014 *       P=0.758        |
|LOGISTIC REGRESSION    |     P=0.044N*       P=0.321         P=0.053N       |     P=0.570N        P=0.024 *       P=0.756N       |
|COCHRAN-ARMITAGE       |     P=0.136N                                       |     P=0.598                                        |
|FISHER EXACT           |                     P=0.317         P=0.154N       |                     P=0.047 *       P=0.747        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE   4
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    19/50 (38%)     12/18 (67%)     20/50 (40%)     |     2/50 (4%)       4/8 (50%)       5/49 (10%)     |
|ADJUSTED (b)           |     45.6%           69.8%           50.8%          |      6.1%          100.0%           14.3%          |
|TERMINAL (d)           |    10/32 (31%)      8/12 (67%)     13/31 (42%)     |     1/30 (3%)       3/3 (100%)      5/35 (14%)     |
|FIRST INCIDENCE (DAYS) |      448             527             293           |      667             641             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.410         P=0.477         P=0.448        |     P=0.279         P=0.008 **      P=0.282        |
|INCIDENTAL TUMOR       |     P=0.505         P=0.057         P=0.542        |     P=0.245         P<0.001 **      P=0.261        |
|LOGISTIC REGRESSION    |     P=0.474         P=0.045 *       P=0.514        |     P=0.251         P<0.001 **      P=0.261        |
|COCHRAN-ARMITAGE       |     P=0.459                                        |     P=0.195                                        |
|FISHER EXACT           |                     P=0.034 *       P=0.500        |                     P=0.002 **      P=0.210        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    19/50 (38%)     12/18 (67%)     20/50 (40%)     |     2/50 (4%)       4/8 (50%)       5/49 (10%)     |
|ADJUSTED (b)           |     45.6%           69.8%           50.8%          |      6.1%          100.0%           14.3%          |
|TERMINAL (d)           |    10/32 (31%)      8/12 (67%)     13/31 (42%)     |     1/30 (3%)       3/3 (100%)      5/35 (14%)     |
|FIRST INCIDENCE (DAYS) |      448             527             293           |      667             641             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.410         P=0.477         P=0.448        |     P=0.279         P=0.008 **      P=0.282        |
|INCIDENTAL TUMOR       |     P=0.505         P=0.057         P=0.542        |     P=0.245         P<0.001 **      P=0.261        |
|LOGISTIC REGRESSION    |     P=0.474         P=0.045 *       P=0.514        |     P=0.251         P<0.001 **      P=0.261        |
|COCHRAN-ARMITAGE       |     P=0.459                                        |     P=0.195                                        |
|FISHER EXACT           |                     P=0.034 *       P=0.500        |                     P=0.002 **      P=0.210        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE   5
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      2/14 (14%)      1/50 (2%)      |     0/50 (0%)       1/4 (25%)       0/50 (0%)      |
|ADJUSTED (b)           |     17.0%           16.7%            3.2%          |      0.0%          100.0%            0.0%          |
|TERMINAL (d)           |     4/32 (13%)      1/7 (14%)       1/31 (3%)      |     0/30 (0%)       1/1 (100%)      0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      451             717             736 (T)       |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.047N*       P=0.525N        P=0.064N       |     P=0.666N        P=0.004 **        (e)          |
|INCIDENTAL TUMOR       |     P=0.045N*       P=0.499         P=0.051N       |     P=0.666N        P=0.004 **        (e)          |
|LOGISTIC REGRESSION    |     P=0.047N*       P=0.572         P=0.057N       |     P=0.666N        P=0.004 **        (e)          |
|COCHRAN-ARMITAGE       |     P=0.048N*                                      |     P=0.696N                                       |
|FISHER EXACT           |                     P=0.563         P=0.056N       |                     P=0.074           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       2/14 (14%)      5/50 (10%)     |     0/50 (0%)       0/4 (0%)        0/50 (0%)      |
|ADJUSTED (b)           |      9.1%           16.5%           14.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/32 (6%)       1/7 (14%)       3/31 (10%)     |     0/30 (0%)       0/1 (0%)        0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      734             697             640           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.274         P=0.522         P=0.339        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.274         P=0.342         P=0.338        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.287         P=0.282         P=0.346        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.298                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.299         P=0.357        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE   6
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/50 (16%)      4/14 (29%)      6/50 (12%)     |     0/50 (0%)       1/4 (25%)       0/50 (0%)      |
|ADJUSTED (b)           |     22.4%           32.4%           17.5%          |      0.0%          100.0%            0.0%          |
|TERMINAL (d)           |     5/32 (16%)      2/7 (29%)       4/31 (13%)     |     0/30 (0%)       1/1 (100%)      0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      451             697             640           |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.363N        P=0.581         P=0.412N       |     P=0.666N        P=0.004 **        (e)          |
|INCIDENTAL TUMOR       |     P=0.346N        P=0.191         P=0.382N       |     P=0.666N        P=0.004 **        (e)          |
|LOGISTIC REGRESSION    |     P=0.343N        P=0.219         P=0.385N       |     P=0.666N        P=0.004 **        (e)          |
|COCHRAN-ARMITAGE       |     P=0.341N                                       |     P=0.696N                                       |
|FISHER EXACT           |                     P=0.241         P=0.387N       |                     P=0.074           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     2/50 (4%)       2/50 (4%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      5.2%            6.9%            5.3%          |
|TERMINAL (d)           |     0/32 (0%)       0/33 (0%)       0/31 (0%)      |     0/30 (0%)       1/27 (4%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      504             711             688           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.542N        P=0.671         P=0.649N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.555         P=0.666N        P=0.625        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.596N        P=0.695         P=0.684        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.601                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.691N        P=0.691N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE   7
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/44 (2%)       0/0 (0%)        1/47 (2%)      |     5/47 (11%)      1/3 (33%)       2/48 (4%)      |
|ADJUSTED (b)           |      2.2%            0.0%            3.3%          |     17.2%           50.0%            5.6%          |
|TERMINAL (d)           |     0/29 (0%)       0/0             1/30 (3%)      |     5/29 (17%)      1/2 (50%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      451             ---             736 (T)       |      729 (T)         729 (T)         718           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.642N        P=0.496N        P=0.752N       |     P=0.117N        P=0.419         P=0.156N       |
|INCIDENTAL TUMOR       |     P=0.580N          (e)           P=0.712N       |     P=0.127N        P=0.419         P=0.165N       |
|LOGISTIC REGRESSION    |     P=0.580N          (e)           P=0.712N       |     P=0.115N        P=0.419         P=0.151N       |
|COCHRAN-ARMITAGE       |     P=0.622N                                       |     P=0.167N                                       |
|FISHER EXACT           |                     P=1.000N        P=0.736N       |                     P=0.324         P=0.209N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       3/50 (6%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.3%            3.0%            7.9%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/32 (6%)       1/33 (3%)       1/31 (3%)      |     0/30 (0%)       0/27 (0%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      736 (T)         736 (T)         529           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.390         P=0.489N        P=0.489        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.420         P=0.489N        P=0.538        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.403         P=0.489N        P=0.504        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.400                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE   8
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       3/50 (6%)       4/50 (8%)      |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      7.9%            9.1%           10.2%          |      0.0%            3.7%            0.0%          |
|TERMINAL (d)           |     1/32 (3%)       3/33 (9%)       1/31 (3%)      |     0/30 (0%)       1/27 (4%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      609             736 (T)         529           |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.406         P=0.659N        P=0.483        |     P=0.702N        P=0.479           (e)          |
|INCIDENTAL TUMOR       |     P=0.488         P=0.639         P=0.617        |     P=0.702N        P=0.479           (e)          |
|LOGISTIC REGRESSION    |     P=0.424         P=0.661N        P=0.495        |     P=0.702N        P=0.479           (e)          |
|COCHRAN-ARMITAGE       |     P=0.421                                        |     P=0.730N                                       |
|FISHER EXACT           |                     P=0.661N        P=0.500        |                     P=0.500           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      5/50 (10%)      7/50 (14%)     |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |     13.8%           14.6%           18.5%          |      2.9%            3.7%            0.0%          |
|TERMINAL (d)           |     3/32 (9%)       4/33 (12%)      3/31 (10%)     |     0/30 (0%)       1/27 (4%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      609             700             529           |      672             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.302         P=0.619N        P=0.362        |     P=0.303N        P=0.742         P=0.468N       |
|INCIDENTAL TUMOR       |     P=0.349         P=0.594         P=0.451        |     P=0.329N        P=0.741N        P=0.536N       |
|LOGISTIC REGRESSION    |     P=0.323         P=0.629N        P=0.384        |     P=0.320N        P=0.758         P=0.500N       |
|COCHRAN-ARMITAGE       |     P=0.318                                        |     P=0.332N                                       |
|FISHER EXACT           |                     P=0.630N        P=0.380        |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE   9
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       4/50 (8%)       5/50 (10%)     |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      7.9%           11.6%           13.2%          |      2.9%            3.7%            0.0%          |
|TERMINAL (d)           |     1/32 (3%)       3/33 (9%)       2/31 (6%)      |     0/30 (0%)       1/27 (4%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      609             700             529           |      672             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.278         P=0.504         P=0.344        |     P=0.303N        P=0.742         P=0.468N       |
|INCIDENTAL TUMOR       |     P=0.338         P=0.449         P=0.459        |     P=0.329N        P=0.741N        P=0.536N       |
|LOGISTIC REGRESSION    |     P=0.294         P=0.504         P=0.355        |     P=0.320N        P=0.758         P=0.500N       |
|COCHRAN-ARMITAGE       |     P=0.290                                        |     P=0.332N                                       |
|FISHER EXACT           |                     P=0.500         P=0.357        |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       5/50 (10%)     |     0/50 (0%)       5/50 (10%)      5/50 (10%)     |
|ADJUSTED (b)           |      3.1%            5.3%           16.1%          |      0.0%           15.6%           13.4%          |
|TERMINAL (d)           |     1/32 (3%)       1/33 (3%)       5/31 (16%)     |     0/30 (0%)       3/27 (11%)      4/35 (11%)     |
|FIRST INCIDENCE (DAYS) |      736 (T)         541             736 (T)       |      ---             591             526           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.054         P=0.504         P=0.094        |     P=0.057         P=0.030 *       P=0.047 *      |
|INCIDENTAL TUMOR       |     P=0.063         P=0.585         P=0.094        |     P=0.036 *       P=0.038 *       P=0.040 *      |
|LOGISTIC REGRESSION    |     P=0.057         P=0.502         P=0.094        |     P=0.039 *       P=0.032 *       P=0.035 *      |
|COCHRAN-ARMITAGE       |     P=0.060                                        |     P=0.036 *                                      |
|FISHER EXACT           |                     P=0.500         P=0.102        |                     P=0.028 *       P=0.028 *      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE  10
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       5/50 (10%)     |     0/50 (0%)       5/50 (10%)      4/50 (8%)      |
|ADJUSTED (b)           |      3.1%            5.3%           16.1%          |      0.0%           15.6%           10.6%          |
|TERMINAL (d)           |     1/32 (3%)       1/33 (3%)       5/31 (16%)     |     0/30 (0%)       3/27 (11%)      3/35 (9%)      |
|FIRST INCIDENCE (DAYS) |      736 (T)         541             736 (T)       |      ---             591             526           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.054         P=0.504         P=0.094        |     P=0.101         P=0.030 *       P=0.082        |
|INCIDENTAL TUMOR       |     P=0.063         P=0.585         P=0.094        |     P=0.068         P=0.038 *       P=0.069        |
|LOGISTIC REGRESSION    |     P=0.057         P=0.502         P=0.094        |     P=0.074         P=0.032 *       P=0.063        |
|COCHRAN-ARMITAGE       |     P=0.060                                        |     P=0.070                                        |
|FISHER EXACT           |                     P=0.500         P=0.102        |                     P=0.028 *       P=0.059        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       0/0 (0%)        1/49 (2%)      |     1/49 (2%)       0/0 (0%)        1/49 (2%)      |
|ADJUSTED (b)           |      5.3%            0.0%            3.2%          |      3.3%            0.0%            2.9%          |
|TERMINAL (d)           |     1/32 (3%)       0/0             1/31 (3%)      |     1/30 (3%)       0/0             1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |      451             ---             736 (T)       |      729 (T)         ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.383N        P=0.496N        P=0.502N       |     P=0.598N          (e)           P=0.727N       |
|INCIDENTAL TUMOR       |     P=0.318N          (e)           P=0.429N       |     P=0.598N          (e)           P=0.727N       |
|LOGISTIC REGRESSION    |     P=0.318N          (e)           P=0.429N       |     P=0.598N          (e)           P=0.727N       |
|COCHRAN-ARMITAGE       |     P=0.385N                                       |     P=0.640                                        |
|FISHER EXACT           |                     P=1.000N        P=0.500N       |                     P=1.000N        P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE  11
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/0 (0%)        2/49 (4%)      |     0/49 (0%)       0/0 (0%)        0/49 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.5%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/32 (0%)       0/0             2/31 (6%)      |     0/30 (0%)       0/0             0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             736 (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=0.142                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       0/0 (0%)        3/49 (6%)      |     1/49 (2%)       0/0 (0%)        1/49 (2%)      |
|ADJUSTED (b)           |      5.3%            0.0%            9.7%          |      3.3%            0.0%            2.9%          |
|TERMINAL (d)           |     1/32 (3%)       0/0             3/31 (10%)     |     1/30 (3%)       0/0             1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |      451             ---             736 (T)       |      729 (T)         ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.398         P=0.496N        P=0.492        |     P=0.598N          (e)           P=0.727N       |
|INCIDENTAL TUMOR       |     P=0.458           (e)           P=0.550        |     P=0.598N          (e)           P=0.727N       |
|LOGISTIC REGRESSION    |     P=0.458           (e)           P=0.550        |     P=0.598N          (e)           P=0.727N       |
|COCHRAN-ARMITAGE       |     P=0.409                                        |     P=0.640                                        |
|FISHER EXACT           |                     P=1.000N        P=0.500        |                     P=1.000N        P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE  12
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |                                                    |      0.0%            6.1%            0.0%          |
|TERMINAL (d)           |                                                    |     0/30 (0%)       1/27 (4%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             591             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.640N        P=0.231           (e)          |
|INCIDENTAL TUMOR       |                                                    |     P=0.649         P=0.264           (e)          |
|LOGISTIC REGRESSION    |                                                    |     P=0.668         P=0.238           (e)          |
|COCHRAN-ARMITAGE       |                                                    |     P=0.668N                                       |
|FISHER EXACT           |                                                    |                     P=0.247           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |                                                    |      3.3%            6.1%            2.9%          |
|TERMINAL (d)           |                                                    |     1/30 (3%)       1/27 (4%)       1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      729 (T)         591             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.575N        P=0.478         P=0.727N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.615N        P=0.514         P=0.727N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.607N        P=0.497         P=0.727N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.622N                                       |
|FISHER EXACT           |                                                    |                     P=0.500         P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE  13
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      2.3%            2.9%            5.9%          |      3.3%            0.0%            5.7%          |
|TERMINAL (d)           |     0/32 (0%)       0/33 (0%)       1/31 (3%)      |     1/30 (3%)       0/27 (0%)       2/35 (6%)      |
|FIRST INCIDENCE (DAYS) |      556             727             659           |      729 (T)         ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.365         P=0.758         P=0.484        |     P=0.407         P=0.521N        P=0.554        |
|INCIDENTAL TUMOR       |     P=0.369         P=0.697         P=0.500        |     P=0.407         P=0.521N        P=0.554        |
|LOGISTIC REGRESSION    |     P=0.381         P=0.762         P=0.499        |     P=0.407         P=0.521N        P=0.554        |
|COCHRAN-ARMITAGE       |     P=0.379                                        |     P=0.360                                        |
|FISHER EXACT           |                     P=0.753N        P=0.500        |                     P=0.500N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       2/50 (4%)      |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      4.5%            2.9%            5.9%          |      3.3%            0.0%            5.7%          |
|TERMINAL (d)           |     0/32 (0%)       0/33 (0%)       1/31 (3%)      |     1/30 (3%)       0/27 (0%)       2/35 (6%)      |
|FIRST INCIDENCE (DAYS) |      556             727             659           |      729 (T)         ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.588         P=0.507N        P=0.671        |     P=0.407         P=0.521N        P=0.554        |
|INCIDENTAL TUMOR       |     P=0.605N        P=0.594N        P=0.680N       |     P=0.407         P=0.521N        P=0.554        |
|LOGISTIC REGRESSION    |     P=0.610         P=0.504N        P=0.690        |     P=0.407         P=0.521N        P=0.554        |
|COCHRAN-ARMITAGE       |     P=0.610N                                       |     P=0.360                                        |
|FISHER EXACT           |                     P=0.500N        P=0.691N       |                     P=0.500N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE  14
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            2.9%            0.0%          |      6.5%            0.0%            0.0%          |
|TERMINAL (d)           |     0/32 (0%)       0/33 (0%)       0/31 (0%)      |     1/30 (3%)       0/27 (0%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             727             ---           |      714             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.723         P=0.506           (e)          |     P=0.088N        P=0.263N        P=0.207N       |
|INCIDENTAL TUMOR       |     P=0.700         P=0.433           (e)          |     P=0.092N        P=0.219N        P=0.242N       |
|LOGISTIC REGRESSION    |     P=0.726         P=0.501           (e)          |     P=0.086N        P=0.247N        P=0.210N       |
|COCHRAN-ARMITAGE       |     P=0.730                                        |     P=0.096N                                       |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       3/50 (6%)       5/50 (10%)     |    15/50 (30%)      9/50 (18%)     15/50 (30%)     |
|ADJUSTED (b)           |      2.7%            8.6%           15.2%          |     41.9%           27.5%           37.2%          |
|TERMINAL (d)           |     0/32 (0%)       1/33 (3%)       3/31 (10%)     |    10/30 (33%)      5/27 (19%)     10/35 (29%)     |
|FIRST INCIDENCE (DAYS) |      675             717             717           |      568             612             618           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.068         P=0.321         P=0.102        |     P=0.387N        P=0.182N        P=0.413N       |
|INCIDENTAL TUMOR       |     P=0.048 *       P=0.210         P=0.079        |     P=0.545         P=0.085N        P=0.563        |
|LOGISTIC REGRESSION    |     P=0.063         P=0.306         P=0.095        |     P=0.537         P=0.127N        P=0.560        |
|COCHRAN-ARMITAGE       |     P=0.070                                        |     P=0.545                                        |
|FISHER EXACT           |                     P=0.309         P=0.102        |                     P=0.121N        P=0.586N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE  15
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       5/50 (10%)     |    13/50 (26%)      9/50 (18%)     15/50 (30%)     |
|ADJUSTED (b)           |      2.7%            5.8%           15.2%          |     36.9%           27.5%           37.2%          |
|TERMINAL (d)           |     0/32 (0%)       1/33 (3%)       3/31 (10%)     |     9/30 (30%)      5/27 (19%)     10/35 (29%)     |
|FIRST INCIDENCE (DAYS) |      675             717             717           |      568             612             618           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.058         P=0.513         P=0.102        |     P=0.522         P=0.307N        P=0.577        |
|INCIDENTAL TUMOR       |     P=0.045 *       P=0.424         P=0.079        |     P=0.355         P=0.185N        P=0.377        |
|LOGISTIC REGRESSION    |     P=0.054         P=0.502         P=0.095        |     P=0.341         P=0.245N        P=0.366        |
|COCHRAN-ARMITAGE       |     P=0.060                                        |     P=0.364                                        |
|FISHER EXACT           |                     P=0.500         P=0.102        |                     P=0.235N        P=0.412        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    21/50 (42%)     13/50 (26%)     28/50 (56%)     |    12/50 (24%)     10/50 (20%)     10/50 (20%)     |
|ADJUSTED (b)           |     53.1%           35.6%           71.0%          |     38.0%           29.7%           26.7%          |
|TERMINAL (d)           |    14/32 (44%)     10/33 (30%)     20/31 (65%)     |    11/30 (37%)      6/27 (22%)      8/35 (23%)     |
|FIRST INCIDENCE (DAYS) |      451             541             293           |      504             473             526           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.087         P=0.071N        P=0.110        |     P=0.239N        P=0.495N        P=0.265N       |
|INCIDENTAL TUMOR       |     P=0.097         P=0.072N        P=0.122        |     P=0.302N        P=0.454N        P=0.303N       |
|LOGISTIC REGRESSION    |     P=0.095         P=0.063N        P=0.121        |     P=0.309N        P=0.419N        P=0.329N       |
|COCHRAN-ARMITAGE       |     P=0.094                                        |     P=0.357N                                       |
|FISHER EXACT           |                     P=0.069N        P=0.115        |                     P=0.405N        P=0.405N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE  16
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         300.            600.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    20/50 (40%)     17/50 (34%)     25/50 (50%)     |    21/50 (42%)     16/50 (32%)     21/50 (42%)     |
|ADJUSTED (b)           |     45.9%           41.2%           56.3%          |     51.9%           47.2%           50.0%          |
|TERMINAL (d)           |     9/32 (28%)      9/33 (27%)     12/31 (39%)     |    11/30 (37%)     10/27 (37%)     14/35 (40%)     |
|FIRST INCIDENCE (DAYS) |      448             527             471           |      504             591             618           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.187         P=0.344N        P=0.218        |     P=0.342N        P=0.313N        P=0.372N       |
|INCIDENTAL TUMOR       |     P=0.189         P=0.453N        P=0.257        |     P=0.530         P=0.130N        P=0.519        |
|LOGISTIC REGRESSION    |     P=0.283         P=0.312N        P=0.354        |     P=0.520         P=0.165N        P=0.503        |
|COCHRAN-ARMITAGE       |     P=0.181                                        |     P=0.541                                        |
|FISHER EXACT           |                     P=0.339N        P=0.211        |                     P=0.204N        P=0.580N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    36/50 (72%)     26/50 (52%)     40/50 (80%)     |    29/50 (58%)     23/50 (46%)     27/50 (54%)     |
|ADJUSTED (b)           |     78.3%           61.7%           86.8%          |     72.1%           62.6%           62.8%          |
|TERMINAL (d)           |    22/32 (69%)     17/33 (52%)     25/31 (81%)     |    19/30 (63%)     14/27 (52%)     19/35 (54%)     |
|FIRST INCIDENCE (DAYS) |      448             527             293           |      504             473             526           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.229         P=0.061N        P=0.252        |     P=0.186N        P=0.302N        P=0.201N       |
|INCIDENTAL TUMOR       |     P=0.247         P=0.031N*       P=0.290        |     P=0.350N        P=0.105N        P=0.407N       |
|LOGISTIC REGRESSION    |     P=0.347         P=0.022N*       P=0.289        |     P=0.368N        P=0.166N        P=0.426N       |
|COCHRAN-ARMITAGE       |     P=0.228                                        |     P=0.382N                                       |
|FISHER EXACT           |                     P=0.032N*       P=0.241        |                     P=0.158N        P=0.420N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 06                                                 PAGE  17
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZALDEHYDE
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE 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).

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