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TDMS Study 05006-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                   BENZALDEHYDE                                     DATE: 09/03/94       
EXPERIMENT: 05006 TEST: 05                                                                                     TIME: 09:00:50       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1CP9565101          ROUTE: GAVAGE                                                                      NTP C#: 56133        
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 000100527       
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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: 05                                                                                     TIME: 09:00:50      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1CP9565101          ROUTE: GAVAGE                                                                      NTP C#: 56133       
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 000100527      
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                   BENZALDEHYDE                                     DATE: 09/03/94       
EXPERIMENT: 05006 TEST: 05                                                                                     TIME: 09:00:50       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1CP9565101          ROUTE: GAVAGE                                                                      NTP C#: 56133        
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 000100527       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF BENZALDEHYDE
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Clitoral/Preputial Gland      Carcinoma or Adenoma
                             Pancreas                      Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Skin                          Keratoacanthoma
                                                           Papilloma
                                                           Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Testes                        Adenoma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Mesothelioma Benign, Malignant, NOS
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Islets, Pancreatic            Adenoma
                                                           Carcinoma or Adenoma
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Carcinoma or Adenoma
                             Thyroid Gland: C-Cell         Carcinoma or Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Carcinoma
                                                           Carcinoma or Adenoma
 
              ====================================================================================================
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE   1
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       1/50 (2%)      |     0/50 (0%)       2/50 (4%)       2/50 (4%)      |
|ADJUSTED (b)           |      2.2%            3.4%            2.9%          |      0.0%            4.2%            6.4%          |
|TERMINAL (d)           |     0/37 (0%)       1/29 (3%)       0/21 (0%)      |     0/33 (0%)       0/33 (0%)       1/29 (3%)      |
|FIRST INCIDENCE (DAYS) |      593             729 (T)         573           |      ---             542             692           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.532         P=0.736         P=0.685        |     P=0.148         P=0.252         P=0.208        |
|INCIDENTAL TUMOR       |     P=0.626N        P=0.687         P=0.702N       |     P=0.170         P=0.240         P=0.199        |
|LOGISTIC REGRESSION    |     P=0.584N        P=0.754N        P=0.699N       |     P=0.206         P=0.132         P=0.207        |
|COCHRAN-ARMITAGE       |     P=0.640                                        |     P=0.176                                        |
|FISHER EXACT           |                     P=0.753N        P=0.753N       |                     P=0.247         P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    17/49 (35%)     19/50 (38%)     14/49 (29%)     |     5/49 (10%)      3/49 (6%)       3/47 (6%)      |
|ADJUSTED (b)           |     44.5%           50.4%           50.3%          |     13.5%            9.1%           10.7%          |
|TERMINAL (d)           |    15/36 (42%)     11/29 (38%)      8/21 (38%)     |     2/33 (6%)       3/33 (9%)       3/28 (11%)     |
|FIRST INCIDENCE (DAYS) |      696             564             558           |      695             730 (T)         730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.164         P=0.193         P=0.208        |     P=0.366N        P=0.369N        P=0.455N       |
|INCIDENTAL TUMOR       |     P=0.481         P=0.570N        P=0.504        |     P=0.396N        P=0.332N        P=0.515N       |
|LOGISTIC REGRESSION    |     P=0.403         P=0.433         P=0.439        |     P=0.382N        P=0.348N        P=0.474N       |
|COCHRAN-ARMITAGE       |     P=0.297N                                       |     P=0.302N                                       |
|FISHER EXACT           |                     P=0.447         P=0.332N       |                     P=0.357N        P=0.381N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE   2
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       5/50 (10%)      5/49 (10%)     |     2/49 (4%)       0/49 (0%)       2/47 (4%)      |
|ADJUSTED (b)           |      5.6%           16.3%           18.2%          |      5.0%            0.0%            6.3%          |
|TERMINAL (d)           |     2/36 (6%)       4/29 (14%)      2/21 (10%)     |     1/33 (3%)       0/33 (0%)       1/28 (4%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         714             499           |      364             ---             652           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.051         P=0.142         P=0.080        |     P=0.575         P=0.240N        P=0.637        |
|INCIDENTAL TUMOR       |     P=0.121         P=0.202         P=0.219        |     P=0.508N        P=0.500N        P=0.644N       |
|LOGISTIC REGRESSION    |     P=0.097         P=0.177         P=0.149        |     P=0.555N        P=0.338N        P=0.667N       |
|COCHRAN-ARMITAGE       |     P=0.178                                        |     P=0.609                                        |
|FISHER EXACT           |                     P=0.226         P=0.218        |                     P=0.247N        P=0.676        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    19/49 (39%)     23/50 (46%)     19/49 (39%)     |     7/49 (14%)      3/49 (6%)       5/47 (11%)     |
|ADJUSTED (b)           |     49.8%           61.5%           62.1%          |     18.0%            9.1%           16.7%          |
|TERMINAL (d)           |    17/36 (47%)     15/29 (52%)     10/21 (48%)     |     3/33 (9%)       3/33 (9%)       4/28 (14%)     |
|FIRST INCIDENCE (DAYS) |      696             564             499           |      364             730 (T)         652           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.031 *       P=0.085         P=0.046 *      |     P=0.409N        P=0.171N        P=0.499N       |
|INCIDENTAL TUMOR       |     P=0.195         P=0.376         P=0.260        |     P=0.347N        P=0.223N        P=0.472N       |
|LOGISTIC REGRESSION    |     P=0.140         P=0.277         P=0.172        |     P=0.386N        P=0.164N        P=0.468N       |
|COCHRAN-ARMITAGE       |     P=0.541N                                       |     P=0.333N                                       |
|FISHER EXACT           |                     P=0.300         P=0.582N       |                     P=0.159N        P=0.410N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE   3
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       3/50 (6%)       3/50 (6%)      |     1/45 (2%)       3/50 (6%)       1/48 (2%)      |
|ADJUSTED (b)           |      2.2%            9.6%           12.4%          |      3.6%            9.1%            3.7%          |
|TERMINAL (d)           |     0/37 (0%)       2/29 (7%)       2/21 (10%)     |     1/28 (4%)       3/33 (9%)       1/27 (4%)      |
|FIRST INCIDENCE (DAYS) |      588             714             593           |      730 (T)         730 (T)         730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.104         P=0.252         P=0.163        |     P=0.602         P=0.365         P=0.754        |
|INCIDENTAL TUMOR       |     P=0.185         P=0.324         P=0.253        |     P=0.602         P=0.365         P=0.754        |
|LOGISTIC REGRESSION    |     P=0.185         P=0.307         P=0.282        |     P=0.602         P=0.365         P=0.754        |
|COCHRAN-ARMITAGE       |     P=0.239                                        |     P=0.588N                                       |
|FISHER EXACT           |                     P=0.309         P=0.309        |                     P=0.349         P=0.736N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       4/50 (8%)       4/50 (8%)      |     1/45 (2%)       0/50 (0%)       1/48 (2%)      |
|ADJUSTED (b)           |      2.0%           10.2%           11.9%          |      2.6%            0.0%            3.7%          |
|TERMINAL (d)           |     0/37 (0%)       1/29 (3%)       1/21 (5%)      |     0/28 (0%)       0/33 (0%)       1/27 (4%)      |
|FIRST INCIDENCE (DAYS) |      507             495             427           |      698             ---             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.072         P=0.161         P=0.109        |     P=0.645         P=0.516N        P=0.734        |
|INCIDENTAL TUMOR       |     P=0.389         P=0.074         P=0.372        |     P=0.644         P=0.479N        P=0.729        |
|LOGISTIC REGRESSION    |     P=0.327         P=0.095         P=0.364        |     P=0.658         P=0.477N        P=0.746        |
|COCHRAN-ARMITAGE       |     P=0.146                                        |     P=0.658N                                       |
|FISHER EXACT           |                     P=0.181         P=0.181        |                     P=0.474N        P=0.736N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE   4
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       6/50 (12%)      7/50 (14%)     |     2/45 (4%)       3/50 (6%)       2/48 (4%)      |
|ADJUSTED (b)           |      4.2%           16.6%           23.2%          |      6.1%            9.1%            7.4%          |
|TERMINAL (d)           |     0/37 (0%)       3/29 (10%)      3/21 (14%)     |     1/28 (4%)       3/33 (9%)       2/27 (7%)      |
|FIRST INCIDENCE (DAYS) |      507             495             427           |      698             730 (T)         730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.017 *       P=0.109         P=0.028 *      |     P=0.571         P=0.552         P=0.666        |
|INCIDENTAL TUMOR       |     P=0.141         P=0.047 *       P=0.137        |     P=0.569         P=0.569         P=0.662        |
|LOGISTIC REGRESSION    |     P=0.127         P=0.151         P=0.138        |     P=0.560         P=0.562         P=0.664        |
|COCHRAN-ARMITAGE       |     P=0.067                                        |     P=0.567N                                       |
|FISHER EXACT           |                     P=0.134         P=0.080        |                     P=0.550         P=0.667N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/49 (8%)       8/48 (17%)      1/48 (2%)      |     1/48 (2%)       2/2 (100%)      0/50 (0%)      |
|ADJUSTED (b)           |     11.1%           23.5%            4.8%          |      2.8%            0.0%            0.0%          |
|TERMINAL (d)           |     4/36 (11%)      4/29 (14%)      1/21 (5%)      |     0/32 (0%)       0/0             0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         692             729 (T)       |      711             682             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.456N        P=0.105         P=0.371N       |     P=0.409N        P=0.496         P=0.536N       |
|INCIDENTAL TUMOR       |     P=0.272N        P=0.285         P=0.371N       |     P=0.415N        P=0.070         P=0.527N       |
|LOGISTIC REGRESSION    |     P=0.371N        P=0.147         P=0.371N       |     P=0.403N        P<0.001 **      P=0.519N       |
|COCHRAN-ARMITAGE       |     P=0.195N                                       |     P=0.370N                                       |
|FISHER EXACT           |                     P=0.168         P=0.187N       |                     P=0.002 **      P=0.490N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE   5
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/49 (10%)      9/48 (19%)      2/48 (4%)      |     1/48 (2%)       2/2 (100%)      0/50 (0%)      |
|ADJUSTED (b)           |     13.9%           26.6%            8.0%          |      2.8%            0.0%            0.0%          |
|TERMINAL (d)           |     5/36 (14%)      5/29 (17%)      1/21 (5%)      |     0/32 (0%)       0/0             0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         692             680           |      711             682             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.520N        P=0.108         P=0.460N       |     P=0.409N        P=0.496         P=0.536N       |
|INCIDENTAL TUMOR       |     P=0.313N        P=0.276         P=0.379N       |     P=0.415N        P=0.070         P=0.527N       |
|LOGISTIC REGRESSION    |     P=0.417N        P=0.155         P=0.387N       |     P=0.403N        P<0.001 **      P=0.519N       |
|COCHRAN-ARMITAGE       |     P=0.219N                                       |     P=0.370N                                       |
|FISHER EXACT           |                     P=0.182         P=0.226N       |                     P=0.002 **      P=0.490N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       1/50 (2%)      |     5/50 (10%)      0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      5.4%            0.0%            4.8%          |     14.6%            0.0%            2.9%          |
|TERMINAL (d)           |     2/37 (5%)       0/29 (0%)       1/21 (5%)      |     4/33 (12%)      0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             729 (T)       |      715             ---             676           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.516N        P=0.293N        P=0.694N       |     P=0.050N*       P=0.035N*       P=0.143N       |
|INCIDENTAL TUMOR       |     P=0.516N        P=0.293N        P=0.694N       |     P=0.049N*       P=0.032N*       P=0.147N       |
|LOGISTIC REGRESSION    |     P=0.516N        P=0.293N        P=0.694N       |     P=0.048N*       P=0.033N*       P=0.140N       |
|COCHRAN-ARMITAGE       |     P=0.361N                                       |     P=0.037N*                                      |
|FISHER EXACT           |                     P=0.247N        P=0.500N       |                     P=0.028N*       P=0.102N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE   6
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |     5/50 (10%)      0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      5.4%            3.4%            4.8%          |     14.6%            0.0%            2.9%          |
|TERMINAL (d)           |     2/37 (5%)       1/29 (3%)       1/21 (5%)      |     4/33 (12%)      0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |      715             ---             676           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.560N        P=0.585N        P=0.694N       |     P=0.050N*       P=0.035N*       P=0.143N       |
|INCIDENTAL TUMOR       |     P=0.560N        P=0.585N        P=0.694N       |     P=0.049N*       P=0.032N*       P=0.147N       |
|LOGISTIC REGRESSION    |     P=0.560N        P=0.585N        P=0.694N       |     P=0.048N*       P=0.033N*       P=0.140N       |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |     P=0.037N*                                      |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.028N*       P=0.102N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |     5/50 (10%)      0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      5.4%            3.4%            4.8%          |     14.6%            0.0%            2.9%          |
|TERMINAL (d)           |     2/37 (5%)       1/29 (3%)       1/21 (5%)      |     4/33 (12%)      0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |      715             ---             676           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.560N        P=0.585N        P=0.694N       |     P=0.050N*       P=0.035N*       P=0.143N       |
|INCIDENTAL TUMOR       |     P=0.560N        P=0.585N        P=0.694N       |     P=0.049N*       P=0.032N*       P=0.147N       |
|LOGISTIC REGRESSION    |     P=0.560N        P=0.585N        P=0.694N       |     P=0.048N*       P=0.033N*       P=0.140N       |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |     P=0.037N*                                      |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.028N*       P=0.102N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE   7
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      4.9%            3.4%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/37 (3%)       1/29 (3%)       0/21 (0%)      |     0/33 (0%)       0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      593             729 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.226N        P=0.554N        P=0.343N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.191N        P=0.602N        P=0.265N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.150N        P=0.496N        P=0.234N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.142N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      4.9%            6.9%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/37 (3%)       2/29 (7%)       0/21 (0%)      |     0/33 (0%)       0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      593             729 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.296N        P=0.629         P=0.343N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.256N        P=0.588         P=0.265N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.208N        P=0.695N        P=0.234N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.176N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.691N        P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE   8
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            2.4%            0.0%          |      2.9%            4.6%            0.0%          |
|TERMINAL (d)           |     0/37 (0%)       0/29 (0%)       0/21 (0%)      |     0/33 (0%)       0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             676             ---           |      715             620             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.691         P=0.500           (e)          |     P=0.408N        P=0.499         P=0.538N       |
|INCIDENTAL TUMOR       |     P=0.706N        P=0.761           (e)          |     P=0.378N        P=0.525         P=0.550N       |
|LOGISTIC REGRESSION    |     P=0.733         P=0.505           (e)          |     P=0.350N        P=0.481         P=0.530N       |
|COCHRAN-ARMITAGE       |     P=0.730N                                       |     P=0.360N                                       |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.500         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      2.7%            0.0%            0.0%          |      3.0%            0.0%            6.9%          |
|TERMINAL (d)           |     1/37 (3%)       0/29 (0%)       0/21 (0%)      |     1/33 (3%)       0/33 (0%)       2/29 (7%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             ---           |      730 (T)         ---             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.346N        P=0.549N        P=0.613N       |     P=0.325         P=0.500N        P=0.455        |
|INCIDENTAL TUMOR       |     P=0.346N        P=0.549N        P=0.613N       |     P=0.325         P=0.500N        P=0.455        |
|LOGISTIC REGRESSION    |     P=0.346N        P=0.549N        P=0.613N       |     P=0.325         P=0.500N        P=0.455        |
|COCHRAN-ARMITAGE       |     P=0.270N                                       |     P=0.360                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.500N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE   9
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |     2/50 (4%)       2/50 (4%)       2/50 (4%)      |
|ADJUSTED (b)           |      2.7%            2.4%            0.0%          |      5.8%            4.6%            6.9%          |
|TERMINAL (d)           |     1/37 (3%)       0/29 (0%)       0/21 (0%)      |     1/33 (3%)       0/33 (0%)       2/29 (7%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         676             ---           |      715             620             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.426N        P=0.734         P=0.613N       |     P=0.540         P=0.691         P=0.641        |
|INCIDENTAL TUMOR       |     P=0.326N        P=0.664N        P=0.613N       |     P=0.561         P=0.675N        P=0.635        |
|LOGISTIC REGRESSION    |     P=0.377N        P=0.762         P=0.613N       |     P=0.564         P=0.689         P=0.635        |
|COCHRAN-ARMITAGE       |     P=0.332N                                       |     P=0.601                                        |
|FISHER EXACT           |                     P=0.753N        P=0.500N       |                     P=0.691N        P=0.691N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       2/50 (4%)       1/50 (2%)      |    28/50 (56%)     28/50 (56%)     22/50 (44%)     |
|ADJUSTED (b)           |      7.9%            5.6%            4.8%          |     71.4%           64.5%           62.1%          |
|TERMINAL (d)           |     2/37 (5%)       1/29 (3%)       1/21 (5%)      |    22/33 (67%)     18/33 (55%)     16/29 (55%)     |
|FIRST INCIDENCE (DAYS) |      726             632             729 (T)       |      520             495             485           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.403N        P=0.578N        P=0.524N       |     P=0.356N        P=0.568N        P=0.378N       |
|INCIDENTAL TUMOR       |     P=0.296N        P=0.497N        P=0.394N       |     P=0.294N        P=0.538N        P=0.320N       |
|LOGISTIC REGRESSION    |     P=0.316N        P=0.503N        P=0.509N       |     P=0.304N        P=0.552N        P=0.353N       |
|COCHRAN-ARMITAGE       |     P=0.222N                                       |     P=0.135N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.309N       |                     P=0.580N        P=0.159N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  10
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       3/50 (6%)       1/50 (2%)      |    29/50 (58%)     30/50 (60%)     22/50 (44%)     |
|ADJUSTED (b)           |      7.9%            7.9%            4.8%          |     72.2%           66.1%           62.1%          |
|TERMINAL (d)           |     2/37 (5%)       1/29 (3%)       1/21 (5%)      |    22/33 (67%)     18/33 (55%)     16/29 (55%)     |
|FIRST INCIDENCE (DAYS) |      726             632             729 (T)       |      520             495             485           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.431N        P=0.592         P=0.524N       |     P=0.307N        P=0.501         P=0.316N       |
|INCIDENTAL TUMOR       |     P=0.280N        P=0.571N        P=0.394N       |     P=0.231N        P=0.551         P=0.258N       |
|LOGISTIC REGRESSION    |     P=0.331N        P=0.661         P=0.509N       |     P=0.235N        P=0.528         P=0.282N       |
|COCHRAN-ARMITAGE       |     P=0.238N                                       |     P=0.096N                                       |
|FISHER EXACT           |                     P=0.661N        P=0.309N       |                     P=0.500         P=0.115N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       3/50 (6%)       1/50 (2%)      |    29/50 (58%)     30/50 (60%)     22/50 (44%)     |
|ADJUSTED (b)           |     10.5%            7.9%            4.8%          |     72.2%           66.1%           62.1%          |
|TERMINAL (d)           |     3/37 (8%)       1/29 (3%)       1/21 (5%)      |    22/33 (67%)     18/33 (55%)     16/29 (55%)     |
|FIRST INCIDENCE (DAYS) |      726             632             729 (T)       |      520             495             485           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.297N        P=0.585N        P=0.386N       |     P=0.307N        P=0.501         P=0.316N       |
|INCIDENTAL TUMOR       |     P=0.177N        P=0.423N        P=0.279N       |     P=0.231N        P=0.551         P=0.258N       |
|LOGISTIC REGRESSION    |     P=0.208N        P=0.503N        P=0.373N       |     P=0.235N        P=0.528         P=0.282N       |
|COCHRAN-ARMITAGE       |     P=0.133N                                       |     P=0.096N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.181N       |                     P=0.500         P=0.115N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  11
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       2/49 (4%)       7/48 (15%)     |     0/48 (0%)       0/2 (0%)        1/50 (2%)      |
|ADJUSTED (b)           |      8.3%            6.2%           31.2%          |      0.0%            0.0%            3.4%          |
|TERMINAL (d)           |     3/36 (8%)       1/29 (3%)       6/21 (29%)     |     0/32 (0%)       0/0             1/29 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         711             697           |      ---             ---             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.018 *       P=0.590N        P=0.026 *      |     P=0.291           (e)           P=0.480        |
|INCIDENTAL TUMOR       |     P=0.026 *       P=0.476N        P=0.038 *      |     P=0.291           (e)           P=0.480        |
|LOGISTIC REGRESSION    |     P=0.024 *       P=0.532N        P=0.038 *      |     P=0.291           (e)           P=0.480        |
|COCHRAN-ARMITAGE       |     P=0.093                                        |     P=0.313                                        |
|FISHER EXACT           |                     P=0.500N        P=0.150        |                       (e)           P=0.510        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/49 (31%)     22/50 (44%)     11/49 (22%)     |    23/49 (47%)     31/49 (63%)     15/49 (31%)     |
|ADJUSTED (b)           |     35.7%           57.0%           40.1%          |     59.4%           71.4%           46.7%          |
|TERMINAL (d)           |    10/36 (28%)     13/29 (45%)      6/21 (29%)     |    17/32 (53%)     20/32 (63%)     12/29 (41%)     |
|FIRST INCIDENCE (DAYS) |      585             561             506           |      463             495             676           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.259         P=0.045 *       P=0.399        |     P=0.180N        P=0.115         P=0.164N       |
|INCIDENTAL TUMOR       |     P=0.350N        P=0.175         P=0.327N       |     P=0.132N        P=0.095         P=0.131N       |
|LOGISTIC REGRESSION    |     P=0.473N        P=0.117         P=0.450N       |     P=0.132N        P=0.081         P=0.146N       |
|COCHRAN-ARMITAGE       |     P=0.225N                                       |     P=0.064N                                       |
|FISHER EXACT           |                     P=0.121         P=0.246N       |                     P=0.077         P=0.073N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  12
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       0/50 (0%)       3/49 (6%)      |     3/49 (6%)       2/49 (4%)       1/49 (2%)      |
|ADJUSTED (b)           |      7.8%            0.0%           11.5%          |      8.5%            5.7%            2.4%          |
|TERMINAL (d)           |     2/36 (6%)       0/29 (0%)       1/21 (5%)      |     2/32 (6%)       1/32 (3%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      610             ---             680           |      674             697             554           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.426         P=0.143N        P=0.446        |     P=0.266N        P=0.507N        P=0.355N       |
|INCIDENTAL TUMOR       |     P=0.582         P=0.176N        P=0.665N       |     P=0.248N        P=0.481N        P=0.327N       |
|LOGISTIC REGRESSION    |     P=0.534         P=0.116N        P=0.505N       |     P=0.229N        P=0.495N        P=0.308N       |
|COCHRAN-ARMITAGE       |     P=0.601                                        |     P=0.222N                                       |
|FISHER EXACT           |                     P=0.117N        P=0.661N       |                     P=0.500N        P=0.309N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    18/49 (37%)     22/50 (44%)     14/49 (29%)     |    26/49 (53%)     33/49 (67%)     16/49 (33%)     |
|ADJUSTED (b)           |     42.0%           57.0%           48.0%          |     65.7%           74.5%           48.0%          |
|TERMINAL (d)           |    12/36 (33%)     13/29 (45%)      7/21 (33%)     |    19/32 (59%)     21/32 (66%)     12/29 (41%)     |
|FIRST INCIDENCE (DAYS) |      585             561             506           |      463             495             554           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.217         P=0.128         P=0.308        |     P=0.114N        P=0.155         P=0.101N       |
|INCIDENTAL TUMOR       |     P=0.363N        P=0.358         P=0.332N       |     P=0.067N        P=0.135         P=0.067N       |
|LOGISTIC REGRESSION    |     P=0.504N        P=0.292         P=0.509N       |     P=0.065N        P=0.115         P=0.074N       |
|COCHRAN-ARMITAGE       |     P=0.231N                                       |     P=0.027N*                                      |
|FISHER EXACT           |                     P=0.298         P=0.259N       |                     P=0.108         P=0.033N*      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  13
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            6.9%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/37 (0%)       2/29 (7%)       0/21 (0%)      |     0/33 (0%)       0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.548         P=0.186           (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.548         P=0.186           (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.548         P=0.186           (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.668N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.247           (e)          |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       4/50 (8%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.7%            0.0%           17.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/37 (3%)       0/29 (0%)       3/21 (14%)     |     0/33 (0%)       0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             593           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.028 *       P=0.549N        P=0.061        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.040 *       P=0.549N        P=0.081        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.047 *       P=0.549N        P=0.104        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.082                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.181        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  14
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Papilloma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       3/50 (6%)      |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            2.5%           11.1%          |      0.0%            0.0%            6.1%          |
|TERMINAL (d)           |     0/37 (0%)       0/29 (0%)       1/21 (5%)      |     0/33 (0%)       0/33 (0%)       1/29 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             682             427           |      ---             ---             629           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.028 *       P=0.495         P=0.059        |     P=0.082           (e)           P=0.212        |
|INCIDENTAL TUMOR       |     P=0.095         P=0.761         P=0.184        |     P=0.103           (e)           P=0.249        |
|LOGISTIC REGRESSION    |     P=0.067         P=0.503         P=0.127        |     P=0.089           (e)           P=0.222        |
|COCHRAN-ARMITAGE       |     P=0.060                                        |     P=0.095                                        |
|FISHER EXACT           |                     P=0.500         P=0.121        |                       (e)           P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       3/50 (6%)       7/50 (14%)     |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      2.7%            9.2%           26.8%          |      0.0%            0.0%            6.1%          |
|TERMINAL (d)           |     1/37 (3%)       2/29 (7%)       4/21 (19%)     |     0/33 (0%)       0/33 (0%)       1/29 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         682             427           |      ---             ---             629           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.002 **      P=0.242         P=0.005 **     |     P=0.082           (e)           P=0.212        |
|INCIDENTAL TUMOR       |     P=0.010 **      P=0.338         P=0.020 *      |     P=0.103           (e)           P=0.249        |
|LOGISTIC REGRESSION    |     P=0.009 **      P=0.299         P=0.018 *      |     P=0.089           (e)           P=0.222        |
|COCHRAN-ARMITAGE       |     P=0.017 *                                      |     P=0.095                                        |
|FISHER EXACT           |                     P=0.309         P=0.030 *      |                       (e)           P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  15
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      3/50 (6%)       3/50 (6%)      |     0/50 (0%)       3/50 (6%)       0/50 (0%)      |
|ADJUSTED (b)           |     13.2%            9.2%           12.9%          |      0.0%            8.7%            0.0%          |
|TERMINAL (d)           |     4/37 (11%)      2/29 (7%)       2/21 (10%)     |     0/33 (0%)       2/33 (6%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      726             676             697           |      ---             702             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.562N        P=0.477N        P=0.628        |     P=0.602         P=0.121           (e)          |
|INCIDENTAL TUMOR       |     P=0.423N        P=0.290N        P=0.498N       |     P=0.598         P=0.129           (e)          |
|LOGISTIC REGRESSION    |     P=0.476N        P=0.375N        P=0.602N       |     P=0.600         P=0.120           (e)          |
|COCHRAN-ARMITAGE       |     P=0.283N                                       |     P=0.639N                                       |
|FISHER EXACT           |                     P=0.357N        P=0.357N       |                     P=0.121           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      4.7%            3.4%            7.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/37 (0%)       1/29 (3%)       0/21 (0%)      |     0/33 (0%)       0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      585             729 (T)         680           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.451         P=0.558N        P=0.535        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.532N        P=0.437N        P=0.468N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.574         P=0.494N        P=0.666        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.610                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.691N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  16
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Myxosarcoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            4.5%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/37 (0%)       0/29 (0%)       0/21 (0%)      |     0/33 (0%)       0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             235             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.624         P=0.234           (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.278N        P=0.761           (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.360N        P=0.359           (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.668N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.247           (e)          |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      5/50 (10%)      4/50 (8%)      |     0/50 (0%)       3/50 (6%)       0/50 (0%)      |
|ADJUSTED (b)           |     15.0%           14.7%           15.9%          |      0.0%            8.7%            0.0%          |
|TERMINAL (d)           |     4/37 (11%)      3/29 (10%)      2/21 (10%)     |     0/33 (0%)       2/33 (6%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      585             676             680           |      ---             702             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.510         P=0.621N        P=0.569        |     P=0.602         P=0.121           (e)          |
|INCIDENTAL TUMOR       |     P=0.401N        P=0.409N        P=0.432N       |     P=0.598         P=0.129           (e)          |
|LOGISTIC REGRESSION    |     P=0.475N        P=0.504N        P=0.561N       |     P=0.600         P=0.120           (e)          |
|COCHRAN-ARMITAGE       |     P=0.309N                                       |     P=0.639N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.370N       |                     P=0.121           (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  17
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      4.7%            5.9%            7.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/37 (0%)       1/29 (3%)       0/21 (0%)      |     0/33 (0%)       0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      585             682             680           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.429         P=0.644         P=0.535        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.496N        P=0.536N        P=0.468N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.561         P=0.690N        P=0.666        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.601                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.691N        P=0.691N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            0.0%            6.9%          |
|TERMINAL (d)           |     0/37 (0%)       0/29 (0%)       0/21 (0%)      |     0/33 (0%)       0/33 (0%)       2/29 (7%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             ---             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.081           (e)           P=0.210        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.081           (e)           P=0.210        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.081           (e)           P=0.210        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.095                                        |
|FISHER EXACT           |                       (e)             (e)          |                       (e)           P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  18
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    46/50 (92%)     47/50 (94%)     31/49 (63%)     |                                                    |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |                                                    |
|TERMINAL (d)           |    37/37 (100%)    29/29 (100%)    21/21 (100%)    |                                                    |
|FIRST INCIDENCE (DAYS) |      507             495             558           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.135         P=0.045 *       P=0.187        |                                                    |
|INCIDENTAL TUMOR       |     P=0.068N        P=0.304         P=0.132N       |                                                    |
|LOGISTIC REGRESSION    |     P=0.109N        P=0.480         P=0.198N       |                                                    |
|COCHRAN-ARMITAGE       |     P<0.001N**                                     |                                                    |
|FISHER EXACT           |                     P=0.500         P<0.001N**     |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       8/50 (16%)      7/49 (14%)     |     2/50 (4%)       1/4 (25%)       3/50 (6%)      |
|ADJUSTED (b)           |     10.8%           23.1%           29.0%          |      6.1%           33.3%            9.4%          |
|TERMINAL (d)           |     4/37 (11%)      4/29 (14%)      5/21 (24%)     |     2/33 (6%)       1/3 (33%)       2/29 (7%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         692             605           |      730 (T)         730 (T)         629           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.041 *       P=0.103         P=0.055        |     P=0.354         P=0.295         P=0.442        |
|INCIDENTAL TUMOR       |     P=0.094         P=0.293         P=0.088        |     P=0.383         P=0.295         P=0.473        |
|LOGISTIC REGRESSION    |     P=0.071         P=0.160         P=0.097        |     P=0.347         P=0.295         P=0.438        |
|COCHRAN-ARMITAGE       |     P=0.214                                        |     P=0.415                                        |
|FISHER EXACT           |                     P=0.178         P=0.251        |                     P=0.210         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  19
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       1/49 (2%)      |     0/50 (0%)       1/4 (25%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.6%            6.5%            2.6%          |      0.0%           33.3%            0.0%          |
|TERMINAL (d)           |     0/37 (0%)       1/29 (3%)       0/21 (0%)      |     0/33 (0%)       1/3 (33%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      726             719             506           |      ---             730 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.462         P=0.419         P=0.668        |     P=0.674         P=0.066           (e)          |
|INCIDENTAL TUMOR       |     P=0.480N        P=0.740N        P=0.552N       |     P=0.674         P=0.066           (e)          |
|LOGISTIC REGRESSION    |     P=0.616         P=0.477         P=0.742N       |     P=0.674         P=0.066           (e)          |
|COCHRAN-ARMITAGE       |     P=0.616                                        |     P=0.696N                                       |
|FISHER EXACT           |                     P=0.500         P=0.747        |                     P=0.074           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)     10/50 (20%)      8/49 (16%)     |     2/50 (4%)       2/4 (50%)       3/50 (6%)      |
|ADJUSTED (b)           |     13.2%           28.5%           30.8%          |      6.1%           66.7%            9.4%          |
|TERMINAL (d)           |     4/37 (11%)      5/29 (17%)      5/21 (24%)     |     2/33 (6%)       2/3 (67%)       2/29 (7%)      |
|FIRST INCIDENCE (DAYS) |      726             692             506           |      730 (T)         730 (T)         629           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.039 *       P=0.067         P=0.057        |     P=0.354         P=0.014 *       P=0.442        |
|INCIDENTAL TUMOR       |     P=0.147         P=0.310         P=0.159        |     P=0.381         P=0.014 *       P=0.473        |
|LOGISTIC REGRESSION    |     P=0.087         P=0.112         P=0.127        |     P=0.344         P=0.014 *       P=0.438        |
|COCHRAN-ARMITAGE       |     P=0.230                                        |     P=0.421                                        |
|FISHER EXACT           |                     P=0.131         P=0.264        |                     P=0.024 *       P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  20
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       1/49 (2%)      |     0/50 (0%)       0/4 (0%)        1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            5.9%            4.8%          |      0.0%            0.0%            3.4%          |
|TERMINAL (d)           |     0/37 (0%)       1/29 (3%)       1/21 (5%)      |     0/33 (0%)       0/3 (0%)        1/29 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             682             729 (T)       |      ---             ---             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.233         P=0.211         P=0.387        |     P=0.282           (e)           P=0.474        |
|INCIDENTAL TUMOR       |     P=0.289         P=0.336         P=0.387        |     P=0.282           (e)           P=0.474        |
|LOGISTIC REGRESSION    |     P=0.272         P=0.236         P=0.387        |     P=0.282           (e)           P=0.474        |
|COCHRAN-ARMITAGE       |     P=0.355                                        |     P=0.304                                        |
|FISHER EXACT           |                     P=0.247         P=0.495        |                       (e)           P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/49 (0%)      |     0/50 (0%)       2/4 (50%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%           34.9%            2.7%          |
|TERMINAL (d)           |     0/37 (0%)       0/29 (0%)       0/21 (0%)      |     0/33 (0%)       1/3 (33%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             652             629           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.332         P=0.055         P=0.475        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.369         P<0.001 **      P=0.545        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.374         P<0.001 **      P=0.523        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.383                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.004 **      P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  21
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       1/49 (2%)      |     0/50 (0%)       2/4 (50%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            5.9%            4.8%          |      0.0%           34.9%            6.1%          |
|TERMINAL (d)           |     0/37 (0%)       1/29 (3%)       1/21 (5%)      |     0/33 (0%)       1/3 (33%)       1/29 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             682             729 (T)       |      ---             652             629           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.233         P=0.211         P=0.387        |     P=0.168         P=0.055         P=0.212        |
|INCIDENTAL TUMOR       |     P=0.289         P=0.336         P=0.387        |     P=0.202         P<0.001 **      P=0.249        |
|LOGISTIC REGRESSION    |     P=0.272         P=0.236         P=0.387        |     P=0.196         P<0.001 **      P=0.222        |
|COCHRAN-ARMITAGE       |     P=0.355                                        |     P=0.218                                        |
|FISHER EXACT           |                     P=0.247         P=0.495        |                     P=0.004 **      P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |    12/50 (24%)      8/50 (16%)     14/50 (28%)     |
|ADJUSTED (b)           |                                                    |     29.6%           20.6%           46.4%          |
|TERMINAL (d)           |                                                    |     7/33 (21%)      4/33 (12%)     13/29 (45%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      364             491             659           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.241         P=0.241N        P=0.271        |
|INCIDENTAL TUMOR       |                                                    |     P=0.295         P=0.279N        P=0.333        |
|LOGISTIC REGRESSION    |                                                    |     P=0.306         P=0.263N        P=0.322        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.360                                        |
|FISHER EXACT           |                                                    |                     P=0.227N        P=0.410        |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  22
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |    13/50 (26%)      8/50 (16%)     14/50 (28%)     |
|ADJUSTED (b)           |                                                    |     31.3%           20.6%           46.4%          |
|TERMINAL (d)           |                                                    |     7/33 (21%)      4/33 (12%)     13/29 (45%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      364             491             659           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.317         P=0.183N        P=0.346        |
|INCIDENTAL TUMOR       |                                                    |     P=0.379         P=0.198N        P=0.413        |
|LOGISTIC REGRESSION    |                                                    |     P=0.397         P=0.190N        P=0.409        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.453                                        |
|FISHER EXACT           |                                                    |                     P=0.163N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.0%            0.0%            8.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/37 (0%)       0/29 (0%)       0/21 (0%)      |     0/33 (0%)       0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      479             ---             712           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.260         P=0.504N        P=0.363        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.582         P=0.718N        P=0.706N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.409         P=0.350N        P=0.535        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.360                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  23
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/50 (20%)     17/50 (34%)     16/50 (32%)     |    15/50 (30%)     20/50 (40%)     18/50 (36%)     |
|ADJUSTED (b)           |     24.6%           50.6%           56.7%          |     37.3%           53.3%           50.9%          |
|TERMINAL (d)           |     7/37 (19%)     13/29 (45%)     10/21 (48%)     |     9/33 (27%)     16/33 (48%)     12/29 (41%)     |
|FIRST INCIDENCE (DAYS) |      508             632             373           |      534             613             520           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.003 **      P=0.026 *       P=0.006 **     |     P=0.163         P=0.217         P=0.194        |
|INCIDENTAL TUMOR       |     P=0.028 *       P=0.072         P=0.058        |     P=0.168         P=0.222         P=0.187        |
|LOGISTIC REGRESSION    |     P=0.023 *       P=0.081         P=0.041 *      |     P=0.163         P=0.211         P=0.205        |
|COCHRAN-ARMITAGE       |     P=0.112                                        |     P=0.301                                        |
|FISHER EXACT           |                     P=0.088         P=0.127        |                     P=0.201         P=0.335        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     2/50 (4%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            7.0%          |      5.1%            0.0%            2.8%          |
|TERMINAL (d)           |     0/37 (0%)       0/29 (0%)       0/21 (0%)      |     1/33 (3%)       0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             680           |      578             ---             652           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.060           (e)           P=0.163        |     P=0.402N        P=0.237N        P=0.555N       |
|INCIDENTAL TUMOR       |     P=0.091           (e)           P=0.397        |     P=0.372N        P=0.240N        P=0.518N       |
|LOGISTIC REGRESSION    |     P=0.073           (e)           P=0.189        |     P=0.331N        P=0.254N        P=0.490N       |
|COCHRAN-ARMITAGE       |     P=0.095                                        |     P=0.361N                                       |
|FISHER EXACT           |                       (e)           P=0.247        |                     P=0.247N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  24
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      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)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     2/50 (4%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            7.0%          |      5.1%            0.0%            2.8%          |
|TERMINAL (d)           |     0/37 (0%)       0/29 (0%)       0/21 (0%)      |     1/33 (3%)       0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             680           |      578             ---             652           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.060           (e)           P=0.163        |     P=0.402N        P=0.237N        P=0.555N       |
|INCIDENTAL TUMOR       |     P=0.091           (e)           P=0.397        |     P=0.372N        P=0.240N        P=0.518N       |
|LOGISTIC REGRESSION    |     P=0.073           (e)           P=0.189        |     P=0.331N        P=0.254N        P=0.490N       |
|COCHRAN-ARMITAGE       |     P=0.095                                        |     P=0.361N                                       |
|FISHER EXACT           |                       (e)           P=0.247        |                     P=0.247N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       5/50 (10%)      2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%           15.9%            7.3%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/37 (0%)       4/29 (14%)      1/21 (5%)      |     0/33 (0%)       0/33 (0%)       0/29 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             676             558           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.104         P=0.020 *       P=0.156        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.146         P=0.032 *       P=0.206        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.167         P=0.031 *       P=0.233        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.239                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.028 *       P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  25
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    48/50 (96%)     49/50 (98%)     38/50 (76%)     |    42/50 (84%)     46/50 (92%)     37/50 (74%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     91.2%           92.0%           97.3%          |
|TERMINAL (d)           |    37/37 (100%)    29/29 (100%)    21/21 (100%)    |    29/33 (88%)     29/33 (88%)     28/29 (97%)     |
|FIRST INCIDENCE (DAYS) |      507             495             427           |      364             491             485           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.018 *       P=0.054         P=0.024 *      |     P=0.490         P=0.317         P=0.545        |
|INCIDENTAL TUMOR       |     P=0.181N        P=0.409         P=0.314N       |     P=0.412N        P=0.168         P=0.463N       |
|LOGISTIC REGRESSION    |     P=0.486N        P=0.374         P=0.629N       |     P=0.472N        P=0.173         P=0.561N       |
|COCHRAN-ARMITAGE       |     P<0.001N**                                     |     P=0.113N                                       |
|FISHER EXACT           |                     P=0.500         P=0.004N**     |                     P=0.178         P=0.163N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    24/50 (48%)     34/50 (68%)     33/50 (66%)     |    25/50 (50%)     27/50 (54%)     24/50 (48%)     |
|ADJUSTED (b)           |     51.6%           80.3%           86.4%          |     56.1%           63.6%           62.6%          |
|TERMINAL (d)           |    15/37 (41%)     21/29 (72%)     16/21 (76%)     |    14/33 (42%)     18/33 (55%)     15/29 (52%)     |
|FIRST INCIDENCE (DAYS) |      479             235             373           |      364             583             520           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.012 *       P<0.001 **     |     P=0.361         P=0.433         P=0.396        |
|INCIDENTAL TUMOR       |     P=0.024 *       P=0.025 *       P=0.037 *      |     P=0.456         P=0.395         P=0.492        |
|LOGISTIC REGRESSION    |     P=0.012 *       P=0.034 *       P=0.013 *      |     P=0.447         P=0.422         P=0.498        |
|COCHRAN-ARMITAGE       |     P=0.041 *                                      |     P=0.460N                                       |
|FISHER EXACT           |                     P=0.034 *       P=0.053        |                     P=0.421         P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05006 TEST: 05                                                 PAGE  26
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZALDEHYDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         200.            400.          |      VEHICLE         200.            400.          |
|                       |      CONTROL         MG/KG           MG/KG         |      CONTROL         MG/KG           MG/KG         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    50/50 (100%)    50/50 (100%)    42/50 (84%)     |    46/50 (92%)     48/50 (96%)     43/50 (86%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     93.8%           96.0%          100.0%          |
|TERMINAL (d)           |    37/37 (100%)    29/29 (100%)    21/21 (100%)    |    30/33 (91%)     31/33 (94%)     29/29 (100%)    |
|FIRST INCIDENCE (DAYS) |      479             235             373           |      364             491             485           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.009 **      P=0.088         P=0.012 *      |     P=0.318         P=0.440         P=0.350        |
|INCIDENTAL TUMOR       |     P=0.052N          (e)           P=0.249N       |     P=0.411         P=0.329         P=0.506        |
|LOGISTIC REGRESSION    |     P=0.087N          (e)           P=0.860N       |     P=0.372         P=0.339         P=0.419        |
|COCHRAN-ARMITAGE       |     P<0.001N**                                     |     P=0.187N                                       |
|FISHER EXACT           |                     P=1.000N        P=0.003N**     |                     P=0.339         P=0.262N       |
|=================================================================================================================================|
 
 (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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