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TDMS Study 05004-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                      FURAN                                         DATE: 09/03/94       
EXPERIMENT: 05004 TEST: 03                                                                                     TIME: 00:14:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01CP9565101          ROUTE: GAVAGE                                                                      NTP C#: 56202        
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 110-00-9        
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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                                      FURAN                                         DATE: 09/03/94      
EXPERIMENT: 05004 TEST: 03                                                                                     TIME: 00:14:45      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01CP9565101          ROUTE: GAVAGE                                                                      NTP C#: 56202       
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 110-00-9       
 
 
 
 
 
                                                    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                                      FURAN                                         DATE: 09/03/94       
EXPERIMENT: 05004 TEST: 03                                                                                     TIME: 00:14:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01CP9565101          ROUTE: GAVAGE                                                                      NTP C#: 56202        
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 110-00-9        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                             IN THE ANALYSIS OF THE STUDY OF FURAN
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Islets, Pancreatic            Adenoma
                                                           Carcinoma or Adenoma
                             Liver                         Cholangiocarcinoma
                                                           Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Skin                          Keratoacanthoma
                             Skin: Subcutaneous Tissue     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             Spleen                        Sarcoma
                             Testes                        Adenoma
                             Thyroid Gland: C-Cell         Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                      FURAN                                         DATE: 09/03/94       
EXPERIMENT: 05004 TEST: 03                                                                                     TIME: 00:14:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01CP9565101          ROUTE: GAVAGE                                                                      NTP C#: 56202        
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 110-00-9        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                             IN THE ANALYSIS OF THE STUDY OF FURAN
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Cholangiocarcinoma
                                                           Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Mammary Gland                 Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             Urinary Bladder               Papilloma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE   1
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)   4/47 (9%)    9/48 (19%)  10/49 (20%) |  2/50 (4%)    3/49 (6%)    1/50 (2%)    3/49 (6%)  |
|ADJUSTED (b)           |  24.2%        14.3%        31.0%        45.1%      |   5.4%         9.4%         3.6%        14.1%      |
|TERMINAL (d)           |  8/33 (24%)   4/28 (14%)   6/25 (24%)   5/15 (33%) |  1/34 (3%)    3/32 (9%)    1/28 (4%)    2/19 (11%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      633          624       |   687          729 (T)      729 (T)      696       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.009 **   P=0.259N     P=0.281      P=0.036 *  |  P=0.250      P=0.471      P=0.557N     P=0.285    |
|INCIDENTAL TUMOR       |  P=0.061      P=0.259N     P=0.324      P=0.144    |  P=0.305      P=0.446      P=0.545N     P=0.362    |
|LOGISTIC REGRESSION    |  P=0.058      P=0.259N     P=0.335      P=0.155    |  P=0.302      P=0.467      P=0.539N     P=0.344    |
|COCHRAN-ARMITAGE       |  P=0.184                                           |  P=0.471                                           |
|FISHER EXACT           |               P=0.210N     P=0.463      P=0.379    |               P=0.490      P=0.500N     P=0.490    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/47 (0%)    3/48 (6%)    0/49 (0%)  |  0/50 (0%)    1/49 (2%)    0/50 (0%)    2/49 (4%)  |
|ADJUSTED (b)           |   2.4%         0.0%        10.0%         0.0%      |   0.0%         3.1%         0.0%         5.1%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    2/25 (8%)    0/15 (0%)  |  0/34 (0%)    1/32 (3%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   629          ---          520          ---       |   ---          729 (T)      ---          532       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.616N     P=0.515N     P=0.251      P=0.520N   |  P=0.094      P=0.488        (e)        P=0.199    |
|INCIDENTAL TUMOR       |  P=0.497N     P=0.557N     P=0.394      P=0.419N   |  P=0.208      P=0.488        (e)        P=0.460    |
|LOGISTIC REGRESSION    |  P=0.502N     P=0.511N     P=0.289      P=0.504N   |  P=0.186      P=0.488        (e)        P=0.334    |
|COCHRAN-ARMITAGE       |  P=0.502N                                          |  P=0.137                                           |
|FISHER EXACT           |               P=0.515N     P=0.293      P=0.505N   |               P=0.495        (e)        P=0.242    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE   2
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/50 (18%)   4/47 (9%)   11/48 (23%)  10/49 (20%) |  3/50 (6%)    4/49 (8%)    1/50 (2%)    5/49 (10%) |
|ADJUSTED (b)           |  26.1%        14.3%        36.1%        45.1%      |   7.9%        12.5%         3.6%        18.5%      |
|TERMINAL (d)           |  8/33 (24%)   4/28 (14%)   7/25 (28%)   5/15 (33%) |  1/34 (3%)    4/32 (13%)   1/28 (4%)    2/19 (11%) |
|FIRST INCIDENCE (DAYS) |   629          729 (T)      520          624       |   687          729 (T)      729 (T)      532       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.016 *    P=0.182N     P=0.203      P=0.070    |  P=0.135      P=0.466      P=0.360N     P=0.172    |
|INCIDENTAL TUMOR       |  P=0.106      P=0.190N     P=0.302      P=0.244    |  P=0.257      P=0.422      P=0.340N     P=0.376    |
|LOGISTIC REGRESSION    |  P=0.129      P=0.162N     P=0.294      P=0.284    |  P=0.246      P=0.463      P=0.335N     P=0.316    |
|COCHRAN-ARMITAGE       |  P=0.239                                           |  P=0.324                                           |
|FISHER EXACT           |               P=0.142N     P=0.362      P=0.480    |               P=0.489      P=0.309N     P=0.346    |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |  0/50 (0%)    2/50 (4%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.1%         0.0%      |   0.0%         5.1%         0.0%         2.2%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    0/26 (0%)    0/16 (0%)  |  0/34 (0%)    1/32 (3%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          394          ---       |   ---          364          ---          457       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.702        (e)        P=0.504        (e)      |  P=0.480      P=0.233        (e)        P=0.483    |
|INCIDENTAL TUMOR       |  P=0.713N       (e)        P=0.638        (e)      |  P=0.520N     P=0.488        (e)        P=0.638    |
|LOGISTIC REGRESSION    |  P=0.673        (e)        P=0.505        (e)      |  P=0.500N     P=0.361        (e)        P=0.743    |
|COCHRAN-ARMITAGE       |  P=0.694                                           |  P=0.539                                           |
|FISHER EXACT           |                 (e)        P=0.500        (e)      |               P=0.247        (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE   3
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    2/50 (4%)    4/46 (9%)    4/48 (8%)  |  3/43 (7%)    7/48 (15%)   5/50 (10%)   2/47 (4%)  |
|ADJUSTED (b)           |   3.1%         7.1%        14.1%        15.0%      |   9.1%        21.3%        15.1%        10.1%      |
|TERMINAL (d)           |  1/32 (3%)    2/28 (7%)    2/24 (8%)    1/15 (7%)  |  2/29 (7%)    6/31 (19%)   3/28 (11%)   1/18 (6%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      633          575       |   659          639          561          716       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.030 *    P=0.453      P=0.120      P=0.087    |  P=0.511N     P=0.174      P=0.321      P=0.659    |
|INCIDENTAL TUMOR       |  P=0.117      P=0.453      P=0.172      P=0.222    |  P=0.342N     P=0.199      P=0.415      P=0.593N   |
|LOGISTIC REGRESSION    |  P=0.092      P=0.453      P=0.146      P=0.166    |  P=0.337N     P=0.178      P=0.429      P=0.607N   |
|COCHRAN-ARMITAGE       |  P=0.106                                           |  P=0.222N                                          |
|FISHER EXACT           |               P=0.508      P=0.162      P=0.175    |               P=0.207      P=0.445      P=0.457N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    4/50 (8%)    0/46 (0%)    0/48 (0%)  |  0/43 (0%)    0/48 (0%)    2/50 (4%)    1/47 (2%)  |
|ADJUSTED (b)           |   0.0%        11.8%         0.0%         0.0%      |   0.0%         0.0%         5.5%         5.6%      |
|TERMINAL (d)           |  0/32 (0%)    1/28 (4%)    0/24 (0%)    0/15 (0%)  |  0/29 (0%)    0/31 (0%)    1/28 (4%)    1/18 (6%)  |
|FIRST INCIDENCE (DAYS) |   ---          660          ---          ---       |   ---          ---          388          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.316N     P=0.056        (e)          (e)      |  P=0.170        (e)        P=0.236      P=0.405    |
|INCIDENTAL TUMOR       |  P=0.119N     P=0.077        (e)          (e)      |  P=0.239        (e)        P=0.331      P=0.405    |
|LOGISTIC REGRESSION    |  P=0.263N     P=0.059        (e)          (e)      |  P=0.331        (e)        P=0.413      P=0.405    |
|COCHRAN-ARMITAGE       |  P=0.256N                                          |  P=0.256                                           |
|FISHER EXACT           |               P=0.061        (e)          (e)      |                 (e)        P=0.286      P=0.522    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE   4
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    6/50 (12%)   4/46 (9%)    4/48 (8%)  |  3/43 (7%)    7/48 (15%)   7/50 (14%)   3/47 (6%)  |
|ADJUSTED (b)           |   3.1%        18.4%        14.1%        15.0%      |   9.1%        21.3%        20.1%        15.3%      |
|TERMINAL (d)           |  1/32 (3%)    3/28 (11%)   2/24 (8%)    1/15 (7%)  |  2/29 (7%)    6/31 (19%)   4/28 (14%)   2/18 (11%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      660          633          575       |   659          639          388          716       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.125      P=0.047 *    P=0.120      P=0.087    |  P=0.403      P=0.174      P=0.141      P=0.440    |
|INCIDENTAL TUMOR       |  P=0.432      P=0.061      P=0.172      P=0.222    |  P=0.531N     P=0.199      P=0.235      P=0.545    |
|LOGISTIC REGRESSION    |  P=0.267      P=0.049 *    P=0.146      P=0.166    |  P=0.478N     P=0.178      P=0.266      P=0.542    |
|COCHRAN-ARMITAGE       |  P=0.290                                           |  P=0.389N                                          |
|FISHER EXACT           |               P=0.059      P=0.162      P=0.175    |               P=0.207      P=0.227      P=0.618N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   2/50 (4%)    1/50 (2%)    1/49 (2%)  |  1/49 (2%)    0/49 (0%)    0/49 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |  18.2%         6.9%         3.8%         2.5%      |   2.9%         0.0%         0.0%         5.0%      |
|TERMINAL (d)           |  6/33 (18%)   1/28 (4%)    1/26 (4%)    0/15 (0%)  |  1/34 (3%)    0/31 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      702          729 (T)      609       |   729 (T)      ---          ---          718       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.107N     P=0.192N     P=0.101N     P=0.235N   |  P=0.485      P=0.518N     P=0.539N     P=0.632    |
|INCIDENTAL TUMOR       |  P=0.062N     P=0.172N     P=0.101N     P=0.204N   |  P=0.572      P=0.518N     P=0.539N     P=0.723    |
|LOGISTIC REGRESSION    |  P=0.048N*    P=0.179N     P=0.101N     P=0.095N   |  P=0.514      P=0.518N     P=0.539N     P=0.665    |
|COCHRAN-ARMITAGE       |  P=0.032N*                                         |  P=0.599                                           |
|FISHER EXACT           |               P=0.134N     P=0.056N     P=0.059N   |               P=0.500N     P=0.500N     P=0.747N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE   5
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/50 (14%)   2/50 (4%)    1/50 (2%)    1/49 (2%)  |  1/49 (2%)    0/49 (0%)    0/49 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |  20.6%         6.9%         3.8%         2.5%      |   2.9%         0.0%         0.0%         5.0%      |
|TERMINAL (d)           |  6/33 (18%)   1/28 (4%)    1/26 (4%)    0/15 (0%)  |  1/34 (3%)    0/31 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   716          702          729 (T)      609       |   729 (T)      ---          ---          718       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.066N     P=0.129N     P=0.065N     P=0.175N   |  P=0.485      P=0.518N     P=0.539N     P=0.632    |
|INCIDENTAL TUMOR       |  P=0.023N*    P=0.098N     P=0.060N     P=0.085N   |  P=0.572      P=0.518N     P=0.539N     P=0.723    |
|LOGISTIC REGRESSION    |  P=0.026N*    P=0.112N     P=0.053N     P=0.058N   |  P=0.514      P=0.518N     P=0.539N     P=0.665    |
|COCHRAN-ARMITAGE       |  P=0.017N*                                         |  P=0.599                                           |
|FISHER EXACT           |               P=0.080N     P=0.030N*    P=0.032N*  |               P=0.500N     P=0.500N     P=0.747N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Cholangiocarcinoma                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)   43/50 (86%)  48/50 (96%)  49/50 (98%) |  0/50 (0%)   49/50 (98%)  50/50 (100%) 48/50 (96%) |
|ADJUSTED (b)           |   0.0%       100.0%       100.0%       100.0%      |   0.0%       100.0%       100.0%       100.0%      |
|TERMINAL (d)           |  0/33 (0%)   28/28 (100%) 26/26 (100%) 16/16 (100%)|  0/34 (0%)   32/32 (100%) 28/28 (100%) 19/19 (100%)|
|FIRST INCIDENCE (DAYS) |   ---          470          254          421       |   ---          436          388          143       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P<0.001 **   P<0.001 **   P<0.001 ** |               P<0.001 **   P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE   6
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    4/50 (8%)   18/50 (36%)  27/50 (54%) |  0/50 (0%)    2/50 (4%)    4/50 (8%)    7/50 (14%) |
|ADJUSTED (b)           |   2.6%        14.3%        56.9%        74.0%      |   0.0%         6.0%        13.3%        33.8%      |
|TERMINAL (d)           |  0/33 (0%)    4/28 (14%)  13/26 (50%)   8/16 (50%) |  0/34 (0%)    1/32 (3%)    3/28 (11%)   6/19 (32%) |
|FIRST INCIDENCE (DAYS) |   660          729 (T)      613          490       |   ---          697          688          644       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.142      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.230      P=0.045 *    P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.156      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.195      P=0.047 *    P=0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.149      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.224      P=0.048 *    P=0.002 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.003 **                                        |
|FISHER EXACT           |               P=0.181      P<0.001 **   P<0.001 ** |               P=0.247      P=0.059      P=0.006 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    6/50 (12%)  18/50 (36%) |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         3.6%        22.0%        58.5%      |   0.0%         0.0%         0.0%         3.4%      |
|TERMINAL (d)           |  0/33 (0%)    1/28 (4%)    5/26 (19%)   5/16 (31%) |  0/34 (0%)    0/32 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      703          624       |   ---          ---          ---          664       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.467      P=0.008 **   P<0.001 ** |  P=0.156        (e)          (e)        P=0.426    |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.467      P=0.009 **   P<0.001 ** |  P=0.231        (e)          (e)        P=0.519    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.467      P=0.009 **   P<0.001 ** |  P=0.197        (e)          (e)        P=0.502    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.198                                           |
|FISHER EXACT           |               P=0.500      P=0.013 *    P<0.001 ** |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE   7
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    5/50 (10%)  22/50 (44%)  35/50 (70%) |  0/50 (0%)    2/50 (4%)    4/50 (8%)    8/50 (16%) |
|ADJUSTED (b)           |   2.6%        17.9%        68.0%        84.5%      |   0.0%         6.0%        13.3%        36.1%      |
|TERMINAL (d)           |  0/33 (0%)    5/28 (18%)  16/26 (62%)  10/16 (63%) |  0/34 (0%)    1/32 (3%)    3/28 (11%)   6/19 (32%) |
|FIRST INCIDENCE (DAYS) |   660          729 (T)      613          490       |   ---          697          688          644       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.075      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.230      P=0.045 *    P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.083      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.195      P=0.047 *    P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.079      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.224      P=0.048 *    P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.102      P<0.001 **   P<0.001 ** |               P=0.247      P=0.059      P=0.003 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    5/50 (10%)  22/50 (44%)  35/50 (70%) |  0/50 (0%)    2/50 (4%)    4/50 (8%)    8/50 (16%) |
|ADJUSTED (b)           |   2.6%        17.9%        68.0%        84.5%      |   0.0%         6.0%        13.3%        36.1%      |
|TERMINAL (d)           |  0/33 (0%)    5/28 (18%)  16/26 (62%)  10/16 (63%) |  0/34 (0%)    1/32 (3%)    3/28 (11%)   6/19 (32%) |
|FIRST INCIDENCE (DAYS) |   660          729 (T)      613          490       |   ---          697          688          644       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.075      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.230      P=0.045 *    P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.083      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.195      P=0.047 *    P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.079      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.224      P=0.048 *    P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.102      P<0.001 **   P<0.001 ** |               P=0.247      P=0.059      P=0.003 ** |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE   8
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         7.3%         0.0%      |   2.9%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    1/26 (4%)    0/16 (0%)  |  1/34 (3%)    0/32 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          707          ---       |   729 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.466        (e)        P=0.194        (e)      |  P=0.370N     P=0.512N     P=0.539N     P=0.616N   |
|INCIDENTAL TUMOR       |  P=0.653        (e)        P=0.214        (e)      |  P=0.370N     P=0.512N     P=0.539N     P=0.616N   |
|LOGISTIC REGRESSION    |  P=0.544        (e)        P=0.210        (e)      |  P=0.370N     P=0.512N     P=0.539N     P=0.616N   |
|COCHRAN-ARMITAGE       |  P=0.594                                           |  P=0.305N                                          |
|FISHER EXACT           |                 (e)        P=0.247        (e)      |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    2/50 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         5.9%         2.4%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    0/26 (0%)    0/16 (0%)  |  0/34 (0%)    0/32 (0%)    1/28 (4%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          627          549       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.177        (e)        P=0.211      P=0.473    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.355        (e)        P=0.303      P=0.757    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.290        (e)        P=0.241      P=0.631    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.245                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.247      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE   9
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |  1/50 (2%)    3/50 (6%)    3/50 (6%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         2.4%         0.0%         0.0%      |   2.9%         8.7%         8.9%         4.8%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    0/26 (0%)    0/16 (0%)  |  1/34 (3%)    2/32 (6%)    1/28 (4%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          539          ---          ---       |   729 (T)      659          541          716       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.566N     P=0.486        (e)          (e)      |  P=0.502      P=0.282      P=0.257      P=0.638    |
|INCIDENTAL TUMOR       |  P=0.452N     P=0.682        (e)          (e)      |  P=0.541N     P=0.260      P=0.316      P=0.710    |
|LOGISTIC REGRESSION    |  P=0.580N     P=0.522        (e)          (e)      |  P=0.564N     P=0.285      P=0.312      P=0.665    |
|COCHRAN-ARMITAGE       |  P=0.567N                                          |  P=0.500N                                          |
|FISHER EXACT           |               P=0.500        (e)          (e)      |               P=0.309      P=0.309      P=0.753N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |  1/50 (2%)    3/50 (6%)    5/50 (10%)   2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         2.4%         0.0%         0.0%      |   2.9%         8.7%        14.4%         7.1%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    0/26 (0%)    0/16 (0%)  |  1/34 (3%)    2/32 (6%)    2/28 (7%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          539          ---          ---       |   729 (T)      659          541          549       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.566N     P=0.486        (e)          (e)      |  P=0.240      P=0.282      P=0.078      P=0.364    |
|INCIDENTAL TUMOR       |  P=0.452N     P=0.682        (e)          (e)      |  P=0.472      P=0.260      P=0.133      P=0.583    |
|LOGISTIC REGRESSION    |  P=0.580N     P=0.522        (e)          (e)      |  P=0.416      P=0.285      P=0.106      P=0.502    |
|COCHRAN-ARMITAGE       |  P=0.567N                                          |  P=0.437                                           |
|FISHER EXACT           |               P=0.500        (e)          (e)      |               P=0.309      P=0.102      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  10
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    3/50 (6%)    1/50 (2%)    1/50 (2%)  | 15/50 (30%)  17/50 (34%)  18/50 (36%)  14/50 (28%) |
|ADJUSTED (b)           |  11.6%        10.7%         3.8%         3.4%      |  39.2%        42.5%        51.6%        48.9%      |
|TERMINAL (d)           |  3/33 (9%)    3/28 (11%)   1/26 (4%)    0/16 (0%)  | 11/34 (32%)  10/32 (31%)  12/28 (43%)   6/19 (32%) |
|FIRST INCIDENCE (DAYS) |   680          729 (T)      729 (T)      688       |   665          541          549          521       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.219N     P=0.586N     P=0.252N     P=0.355N   |  P=0.112      P=0.351      P=0.171      P=0.148    |
|INCIDENTAL TUMOR       |  P=0.129N     P=0.557N     P=0.242N     P=0.163N   |  P=0.461      P=0.313      P=0.256      P=0.416    |
|LOGISTIC REGRESSION    |  P=0.141N     P=0.568N     P=0.216N     P=0.233N   |  P=0.417      P=0.370      P=0.231      P=0.395    |
|COCHRAN-ARMITAGE       |  P=0.092N                                          |  P=0.419N                                          |
|FISHER EXACT           |               P=0.500N     P=0.181N     P=0.181N   |               P=0.415      P=0.335      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    3/50 (6%)    1/50 (2%)    1/50 (2%)  | 15/50 (30%)  17/50 (34%)  20/50 (40%)  15/50 (30%) |
|ADJUSTED (b)           |  11.6%        10.7%         3.8%         3.4%      |  39.2%        42.5%        55.7%        50.2%      |
|TERMINAL (d)           |  3/33 (9%)    3/28 (11%)   1/26 (4%)    0/16 (0%)  | 11/34 (32%)  10/32 (31%)  13/28 (46%)   6/19 (32%) |
|FIRST INCIDENCE (DAYS) |   680          729 (T)      729 (T)      688       |   665          541          549          521       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.219N     P=0.586N     P=0.252N     P=0.355N   |  P=0.065      P=0.351      P=0.089      P=0.107    |
|INCIDENTAL TUMOR       |  P=0.129N     P=0.557N     P=0.242N     P=0.163N   |  P=0.383      P=0.313      P=0.156      P=0.379    |
|LOGISTIC REGRESSION    |  P=0.141N     P=0.568N     P=0.216N     P=0.233N   |  P=0.325      P=0.370      P=0.125      P=0.347    |
|COCHRAN-ARMITAGE       |  P=0.092N                                          |  P=0.531N                                          |
|FISHER EXACT           |               P=0.500N     P=0.181N     P=0.181N   |               P=0.415      P=0.201      P=0.586N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  11
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    4/50 (8%)    1/50 (2%)    1/50 (2%)  | 15/50 (30%)  18/50 (36%)  23/50 (46%)  15/50 (30%) |
|ADJUSTED (b)           |  11.6%        12.9%         3.8%         3.4%      |  39.2%        44.0%        61.0%        50.2%      |
|TERMINAL (d)           |  3/33 (9%)    3/28 (11%)   1/26 (4%)    0/16 (0%)  | 11/34 (32%)  10/32 (31%)  14/28 (50%)   6/19 (32%) |
|FIRST INCIDENCE (DAYS) |   680          539          729 (T)      688       |   665          541          541          521       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.184N     P=0.560      P=0.252N     P=0.355N   |  P=0.061      P=0.282      P=0.029 *    P=0.107    |
|INCIDENTAL TUMOR       |  P=0.091N     P=0.636N     P=0.242N     P=0.163N   |  P=0.399      P=0.229      P=0.058      P=0.379    |
|LOGISTIC REGRESSION    |  P=0.089N     P=0.606      P=0.216N     P=0.233N   |  P=0.334      P=0.297      P=0.042 *    P=0.347    |
|COCHRAN-ARMITAGE       |  P=0.077N                                          |  P=0.530N                                          |
|FISHER EXACT           |               P=0.643N     P=0.181N     P=0.181N   |               P=0.335      P=0.074      P=0.586N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Malignant                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |                                                    |   0.0%         6.3%         0.0%         0.0%      |
|TERMINAL (d)           |                                                    |  0/34 (0%)    2/32 (6%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.520N     P=0.225        (e)          (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.520N     P=0.225        (e)          (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.520N     P=0.225        (e)          (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.405N                                          |
|FISHER EXACT           |                                                    |               P=0.247        (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  12
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   9/50 (18%)  10/50 (20%)   6/49 (12%) |  0/50 (0%)    0/49 (0%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |  17.0%        29.8%        33.9%        35.3%      |   0.0%         0.0%         3.2%         0.0%      |
|TERMINAL (d)           |  4/33 (12%)   7/28 (25%)   7/26 (27%)   5/15 (33%) |  0/34 (0%)    0/31 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   680          668          665          665       |   ---          ---          703          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.142      P=0.191      P=0.105      P=0.196    |  P=0.639        (e)        P=0.476        (e)      |
|INCIDENTAL TUMOR       |  P=0.444      P=0.246      P=0.111      P=0.382    |  P=0.713        (e)        P=0.500        (e)      |
|LOGISTIC REGRESSION    |  P=0.378      P=0.212      P=0.142      P=0.401    |  P=0.671        (e)        P=0.486        (e)      |
|COCHRAN-ARMITAGE       |  P=0.506N                                          |  P=0.694                                           |
|FISHER EXACT           |               P=0.288      P=0.207      P=0.606    |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   9/50 (18%)  11/50 (22%)   6/49 (12%) |  0/50 (0%)    0/49 (0%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |  17.0%        29.8%        37.4%        35.3%      |   0.0%         0.0%         3.2%         0.0%      |
|TERMINAL (d)           |  4/33 (12%)   7/28 (25%)   8/26 (31%)   5/15 (33%) |  0/34 (0%)    0/31 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   680          668          665          665       |   ---          ---          703          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.125      P=0.191      P=0.064      P=0.196    |  P=0.639        (e)        P=0.476        (e)      |
|INCIDENTAL TUMOR       |  P=0.410      P=0.246      P=0.067      P=0.382    |  P=0.713        (e)        P=0.500        (e)      |
|LOGISTIC REGRESSION    |  P=0.353      P=0.212      P=0.088      P=0.401    |  P=0.671        (e)        P=0.486        (e)      |
|COCHRAN-ARMITAGE       |  P=0.519N                                          |  P=0.694                                           |
|FISHER EXACT           |               P=0.288      P=0.143      P=0.606    |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  13
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/49 (22%)  11/50 (22%)  17/49 (35%)  11/49 (22%) | 28/50 (56%)  26/50 (52%)  25/49 (51%)  20/49 (41%) |
|ADJUSTED (b)           |  30.4%        31.3%        45.2%        43.5%      |  61.6%        66.1%        68.7%        69.4%      |
|TERMINAL (d)           |  8/33 (24%)   5/28 (18%)   7/26 (27%)   5/16 (31%) | 17/34 (50%)  19/32 (59%)  16/27 (59%)  11/19 (58%) |
|FIRST INCIDENCE (DAYS) |   659          629          394          421       |   470          436          541          549       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.107      P=0.455      P=0.064      P=0.139    |  P=0.266      P=0.546N     P=0.441      P=0.365    |
|INCIDENTAL TUMOR       |  P=0.378N     P=0.580      P=0.148      P=0.598    |  P=0.273N     P=0.535N     P=0.423N     P=0.211N   |
|LOGISTIC REGRESSION    |  P=0.446      P=0.519      P=0.110      P=0.528    |  P=0.264N     P=0.449N     P=0.473N     P=0.241N   |
|COCHRAN-ARMITAGE       |  P=0.469                                           |  P=0.075N                                          |
|FISHER EXACT           |               P=0.574N     P=0.132      P=0.595N   |               P=0.421N     P=0.384N     P=0.095N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/49 (22%)  11/50 (22%)  17/49 (35%)  12/49 (24%) | 28/50 (56%)  26/50 (52%)  25/49 (51%)  20/49 (41%) |
|ADJUSTED (b)           |  30.4%        31.3%        45.2%        45.9%      |  61.6%        66.1%        68.7%        69.4%      |
|TERMINAL (d)           |  8/33 (24%)   5/28 (18%)   7/26 (27%)   5/16 (31%) | 17/34 (50%)  19/32 (59%)  16/27 (59%)  11/19 (58%) |
|FIRST INCIDENCE (DAYS) |   659          629          394          421       |   470          436          541          549       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.069      P=0.455      P=0.064      P=0.092    |  P=0.266      P=0.546N     P=0.441      P=0.365    |
|INCIDENTAL TUMOR       |  P=0.449N     P=0.580      P=0.148      P=0.544    |  P=0.273N     P=0.535N     P=0.423N     P=0.211N   |
|LOGISTIC REGRESSION    |  P=0.349      P=0.519      P=0.110      P=0.428    |  P=0.264N     P=0.449N     P=0.473N     P=0.241N   |
|COCHRAN-ARMITAGE       |  P=0.372                                           |  P=0.075N                                          |
|FISHER EXACT           |               P=0.574N     P=0.132      P=0.500    |               P=0.421N     P=0.384N     P=0.095N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  14
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    3/50 (6%)    5/50 (10%)   2/50 (4%)  |  0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         9.4%        18.0%         6.1%      |   0.0%         0.0%         3.6%         0.0%      |
|TERMINAL (d)           |  0/33 (0%)    1/28 (4%)    4/26 (15%)   0/16 (0%)  |  0/34 (0%)    0/32 (0%)    1/28 (4%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          660          678          665       |   ---          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.137      P=0.104      P=0.019 *    P=0.214    |  P=0.629        (e)        P=0.461        (e)      |
|INCIDENTAL TUMOR       |  P=0.425      P=0.138      P=0.020 *    P=0.500    |  P=0.629        (e)        P=0.461        (e)      |
|LOGISTIC REGRESSION    |  P=0.251      P=0.108      P=0.023 *    P=0.233    |  P=0.629        (e)        P=0.461        (e)      |
|COCHRAN-ARMITAGE       |  P=0.291                                           |  P=0.694                                           |
|FISHER EXACT           |               P=0.121      P=0.028 *    P=0.247    |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    3/50 (6%)    0/50 (0%)    1/50 (2%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.0%         9.3%         0.0%         3.1%      |   0.0%         3.1%         0.0%         0.0%      |
|TERMINAL (d)           |  1/33 (3%)    2/28 (7%)    0/26 (0%)    0/16 (0%)  |  0/34 (0%)    1/32 (3%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      421          ---          667       |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.539N     P=0.262      P=0.548N     P=0.668    |  P=0.656N     P=0.488        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.400N     P=0.335      P=0.548N     P=0.746N   |  P=0.656N     P=0.488        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.409N     P=0.298      P=0.548N     P=0.746    |  P=0.656N     P=0.488        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.409N                                          |  P=0.567N                                          |
|FISHER EXACT           |               P=0.309      P=0.500N     P=0.753N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  15
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    2/50 (4%)    0/50 (0%)    1/50 (2%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.0%         5.8%         0.0%         3.1%      |   0.0%         3.1%         0.0%         0.0%      |
|TERMINAL (d)           |  1/33 (3%)    1/28 (4%)    0/26 (0%)    0/16 (0%)  |  0/34 (0%)    1/32 (3%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      421          ---          667       |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.598N     P=0.459      P=0.548N     P=0.668    |  P=0.656N     P=0.488        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.444N     P=0.563      P=0.548N     P=0.746N   |  P=0.656N     P=0.488        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.500N     P=0.504      P=0.548N     P=0.746    |  P=0.656N     P=0.488        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.500N                                          |  P=0.567N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.753N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    7/50 (14%)   5/50 (10%)   4/50 (8%)  |  0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   6.1%        21.3%        18.0%        12.8%      |   0.0%         3.1%         3.6%         0.0%      |
|TERMINAL (d)           |  2/33 (6%)    4/28 (14%)   4/26 (15%)   0/16 (0%)  |  0/34 (0%)    1/32 (3%)    1/28 (4%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      421          678          665       |   ---          729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.207      P=0.057      P=0.137      P=0.196    |  P=0.680      P=0.488      P=0.461        (e)      |
|INCIDENTAL TUMOR       |  P=0.556N     P=0.090      P=0.142      P=0.558    |  P=0.680      P=0.488      P=0.461        (e)      |
|LOGISTIC REGRESSION    |  P=0.438      P=0.069      P=0.159      P=0.303    |  P=0.680      P=0.488      P=0.461        (e)      |
|COCHRAN-ARMITAGE       |  P=0.467                                           |  P=0.595N                                          |
|FISHER EXACT           |               P=0.080      P=0.218      P=0.339    |               P=0.500      P=0.500        (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  16
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    3/50 (6%)    4/50 (8%)    3/50 (6%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         9.4%        12.0%        11.7%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/33 (0%)    2/28 (7%)    1/26 (4%)    1/16 (6%)  |  0/34 (0%)    0/32 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          525          541          591       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.078      P=0.102      P=0.051      P=0.073    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.273      P=0.149      P=0.074      P=0.153    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.161      P=0.115      P=0.062      P=0.118    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.162                                           |    (e)                                             |
|FISHER EXACT           |               P=0.121      P=0.059      P=0.121    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.2%         0.0%         7.7%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    2/26 (8%)    0/16 (0%)  |  0/34 (0%)    0/32 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   464          ---          729 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.576N     P=0.509N     P=0.445      P=0.504N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.505N     P=0.318N     P=0.523      P=0.282N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.461N     P=0.459N     P=0.501      P=0.527N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.461N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  17
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    3/50 (6%)    6/50 (12%)   3/50 (6%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.2%         9.4%        19.1%        11.7%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/33 (0%)    2/28 (7%)    3/26 (12%)   1/16 (6%)  |  0/34 (0%)    0/32 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   464          525          541          591       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.125      P=0.271      P=0.043 *    P=0.227    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.364      P=0.433      P=0.068      P=0.468    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.264      P=0.313      P=0.058      P=0.304    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.264                                           |    (e)                                             |
|FISHER EXACT           |               P=0.309      P=0.056      P=0.309    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         8.6%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    0/26 (0%)    1/16 (6%)  |  0/34 (0%)    0/32 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          609       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.027 *      (e)          (e)        P=0.156    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.032 *      (e)          (e)        P=0.199    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.046 *      (e)          (e)        P=0.234    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.046 *                                         |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  18
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 45/50 (90%)  38/50 (76%)  40/50 (80%)  45/50 (90%) |                                                    |
|ADJUSTED (b)           | 100.0%       100.0%        97.5%       100.0%      |                                                    |
|TERMINAL (d)           | 33/33 (100%) 28/28 (100%) 25/26 (96%)  16/16 (100%)|                                                    |
|FIRST INCIDENCE (DAYS) |   407          587          520          448       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.504N     P=0.331      P<0.001 ** |                                                    |
|INCIDENTAL TUMOR       |  P=0.263      P=0.091N     P=0.117N     P=0.625N   |                                                    |
|LOGISTIC REGRESSION    |  P=0.329      P=0.031N*    P=0.054N     P=0.526N   |                                                    |
|COCHRAN-ARMITAGE       |  P=0.348                                           |                                                    |
|FISHER EXACT           |               P=0.054N     P=0.131N     P=0.630N   |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/48 (13%)   6/50 (12%)   1/50 (2%)    4/48 (8%)  |  8/50 (16%)   4/50 (8%)    5/50 (10%)   2/49 (4%)  |
|ADJUSTED (b)           |  15.6%        18.9%         3.1%        24.4%      |  22.5%        12.5%        17.9%         9.6%      |
|TERMINAL (d)           |  3/33 (9%)    4/28 (14%)   0/26 (0%)    3/15 (20%) |  7/34 (21%)   4/32 (13%)   5/28 (18%)   1/19 (5%)  |
|FIRST INCIDENCE (DAYS) |   464          660          678          707       |   666          729 (T)      729 (T)      701       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.474N     P=0.530      P=0.091N     P=0.542    |  P=0.199N     P=0.208N     P=0.407N     P=0.213N   |
|INCIDENTAL TUMOR       |  P=0.180N     P=0.583N     P=0.030N*    P=0.411N   |  P=0.168N     P=0.219N     P=0.399N     P=0.162N   |
|LOGISTIC REGRESSION    |  P=0.234N     P=0.607      P=0.052N     P=0.395N   |  P=0.148N     P=0.212N     P=0.373N     P=0.143N   |
|COCHRAN-ARMITAGE       |  P=0.209N                                          |  P=0.050N                                          |
|FISHER EXACT           |               P=0.591N     P=0.050N*    P=0.370N   |               P=0.178N     P=0.277N     P=0.049N*  |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  19
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/48 (2%)    1/50 (2%)    2/50 (4%)    0/48 (0%)  |  1/50 (2%)    1/50 (2%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   3.0%         3.1%         7.4%         0.0%      |   2.9%         2.2%         0.0%         0.0%      |
|TERMINAL (d)           |  1/33 (3%)    0/28 (0%)    1/26 (4%)    0/15 (0%)  |  1/34 (3%)    0/32 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      680          725          ---       |   729 (T)      575          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.526N     P=0.729      P=0.422      P=0.657N   |  P=0.287N     P=0.751      P=0.539N     P=0.616N   |
|INCIDENTAL TUMOR       |  P=0.291N     P=0.752N     P=0.445      P=0.657N   |  P=0.195N     P=0.679N     P=0.539N     P=0.616N   |
|LOGISTIC REGRESSION    |  P=0.436N     P=0.749      P=0.432      P=0.657N   |  P=0.210N     P=0.739N     P=0.539N     P=0.616N   |
|COCHRAN-ARMITAGE       |  P=0.368N                                          |  P=0.238N                                          |
|FISHER EXACT           |               P=0.742N     P=0.515      P=0.500N   |               P=0.753N     P=0.500N     P=0.505N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/48 (13%)   7/50 (14%)   3/50 (6%)    4/48 (8%)  |  9/50 (18%)   5/50 (10%)   5/50 (10%)   2/49 (4%)  |
|ADJUSTED (b)           |  15.6%        21.5%        10.3%        24.4%      |  25.4%        14.4%        17.9%         9.6%      |
|TERMINAL (d)           |  3/33 (9%)    4/28 (14%)   1/26 (4%)    3/15 (20%) |  8/34 (24%)   4/32 (13%)   5/28 (18%)   1/19 (5%)  |
|FIRST INCIDENCE (DAYS) |   464          660          678          707       |   666          575          729 (T)      701       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.512N     P=0.409      P=0.334N     P=0.542    |  P=0.122N     P=0.228N     P=0.309N     P=0.157N   |
|INCIDENTAL TUMOR       |  P=0.146N     P=0.554      P=0.179N     P=0.411N   |  P=0.085N     P=0.202N     P=0.303N     P=0.117N   |
|LOGISTIC REGRESSION    |  P=0.247N     P=0.483      P=0.233N     P=0.395N   |  P=0.070N     P=0.225N     P=0.278N     P=0.100N   |
|COCHRAN-ARMITAGE       |  P=0.215N                                          |  P=0.025N*                                         |
|FISHER EXACT           |               P=0.532      P=0.223N     P=0.370N   |               P=0.194N     P=0.194N     P=0.028N*  |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  20
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder                                                                                                                  |
|     Papilloma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/49 (0%)    0/50 (0%)    0/49 (0%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%        15.8%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    0/26 (0%)    0/16 (0%)  |  0/34 (0%)    0/32 (0%)    0/27 (0%)    3/19 (16%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.002 **     (e)          (e)        P=0.040 *  |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.002 **     (e)          (e)        P=0.040 *  |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.002 **     (e)          (e)        P=0.040 *  |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.012 *                                         |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)          (e)        P=0.125    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    1/50 (2%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |                                                    |   0.0%         3.1%         0.0%         7.5%      |
|TERMINAL (d)           |                                                    |  0/34 (0%)    1/32 (3%)    0/28 (0%)    1/19 (5%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          729 (T)      ---          532       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.078      P=0.488        (e)        P=0.165    |
|INCIDENTAL TUMOR       |                                                    |  P=0.116      P=0.488        (e)        P=0.240    |
|LOGISTIC REGRESSION    |                                                    |  P=0.141      P=0.488        (e)        P=0.266    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.140                                           |
|FISHER EXACT           |                                                    |               P=0.500        (e)        P=0.247    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  21
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 10/50 (20%)  12/50 (24%)  14/50 (28%)   9/50 (18%) |
|ADJUSTED (b)           |                                                    |  24.6%        36.1%        36.8%        30.0%      |
|TERMINAL (d)           |                                                    |  5/34 (15%)  11/32 (34%)   6/28 (21%)   3/19 (16%) |
|FIRST INCIDENCE (DAYS) |                                                    |   528          667          557          457       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.211      P=0.344      P=0.157      P=0.318    |
|INCIDENTAL TUMOR       |                                                    |  P=0.480N     P=0.283      P=0.297      P=0.457N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.540N     P=0.356      P=0.237      P=0.526N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.421N                                          |
|FISHER EXACT           |                                                    |               P=0.405      P=0.241      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 10/50 (20%)  13/50 (26%)  14/50 (28%)   9/50 (18%) |
|ADJUSTED (b)           |                                                    |  24.6%        37.7%        36.8%        30.0%      |
|TERMINAL (d)           |                                                    |  5/34 (15%)  11/32 (34%)   6/28 (21%)   3/19 (16%) |
|FIRST INCIDENCE (DAYS) |                                                    |   528          639          557          457       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.233      P=0.266      P=0.157      P=0.318    |
|INCIDENTAL TUMOR       |                                                    |  P=0.418N     P=0.241      P=0.297      P=0.457N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.499N     P=0.278      P=0.237      P=0.526N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.388N                                          |
|FISHER EXACT           |                                                    |               P=0.318      P=0.241      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  22
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Vagina                                                                                                                           |
|     Polyp                                                                                                                       |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |                                                    |   5.9%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |                                                    |  2/34 (6%)    0/32 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   729 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.160N     P=0.252N     P=0.282N     P=0.373N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.160N     P=0.252N     P=0.282N     P=0.373N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.160N     P=0.252N     P=0.282N     P=0.373N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.115N                                          |
|FISHER EXACT           |                                                    |               P=0.247N     P=0.247N     P=0.247N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)  11/50 (22%)  17/50 (34%)  25/50 (50%) |  8/50 (16%)   9/50 (18%)  17/50 (34%)  21/50 (42%) |
|ADJUSTED (b)           |  21.0%        31.7%        46.5%        70.6%      |  18.6%        24.1%        45.4%        59.9%      |
|TERMINAL (d)           |  4/33 (12%)   6/28 (21%)   8/26 (31%)   8/16 (50%) |  1/34 (3%)    5/32 (16%)   9/28 (32%)   7/19 (37%) |
|FIRST INCIDENCE (DAYS) |   645          384          520          421       |   556          602          557          238       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.227      P=0.016 *    P<0.001 ** |  P<0.001 **   P=0.441      P=0.022 *    P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.002 **   P=0.385      P=0.046 *    P=0.005 ** |  P=0.003 **   P=0.521      P=0.050 *    P=0.020 *  |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.267      P=0.027 *    P<0.001 ** |  P<0.001 **   P=0.527      P=0.027 *    P=0.008 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.306      P=0.032 *    P<0.001 ** |               P=0.500      P=0.032 *    P=0.004 ** |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  23
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/50 (2%)    3/50 (6%)    3/50 (6%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.0%         3.6%         7.2%        10.5%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/33 (3%)    1/28 (4%)    0/26 (0%)    1/16 (6%)  |  0/34 (0%)    0/32 (0%)    0/28 (0%)    0/19 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      556          490       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.104      P=0.725      P=0.279      P=0.190    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.177      P=0.725      P=0.538      P=0.296    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.163      P=0.725      P=0.307      P=0.306    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.164                                           |    (e)                                             |
|FISHER EXACT           |               P=0.753N     P=0.309      P=0.309    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 46/50 (92%)  42/50 (84%)  46/50 (92%)  47/50 (94%) | 42/50 (84%)  41/50 (82%)  41/50 (82%)  37/50 (74%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  85.7%        93.1%        95.2%        92.4%      |
|TERMINAL (d)           | 33/33 (100%) 28/28 (100%) 26/26 (100%) 16/16 (100%)| 27/34 (79%)  29/32 (91%)  26/28 (93%)  16/19 (84%) |
|FIRST INCIDENCE (DAYS) |   407          421          394          421       |   470          436          462          457       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.414      P=0.094      P<0.001 ** |  P=0.012 *    P=0.462      P=0.221      P=0.034 *  |
|INCIDENTAL TUMOR       |  P=0.624      P=0.288N     P=0.638N     P=0.500N   |  P=0.536N     P=0.466      P=0.557N     P=0.476N   |
|LOGISTIC REGRESSION    |  P=0.609      P=0.200N     P=0.691N     P=0.417N   |  P=0.549N     P=0.609      P=0.561      P=0.549N   |
|COCHRAN-ARMITAGE       |  P=0.244                                           |  P=0.120N                                          |
|FISHER EXACT           |               P=0.178N     P=0.643N     P=0.500    |               P=0.500N     P=0.500N     P=0.163N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  24
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |   VEHICLE      2. MG/KG     4. MG/KG     8. MG/KG  |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/50 (28%)  44/50 (88%)  48/50 (96%)  49/50 (98%) | 16/50 (32%)  50/50 (100%) 50/50 (100%) 50/50 (100%)|
|ADJUSTED (b)           |  33.5%       100.0%       100.0%       100.0%      |  35.9%       100.0%       100.0%       100.0%      |
|TERMINAL (d)           |  6/33 (18%)  28/28 (100%) 26/26 (100%) 16/16 (100%)|  6/34 (18%)  32/32 (100%) 28/28 (100%) 19/19 (100%)|
|FIRST INCIDENCE (DAYS) |   464          384          254          421       |   556          364          388          143       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P<0.001 **   P<0.001 **   P<0.001 ** |               P<0.001 **   P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 46/50 (92%)  45/50 (90%)  48/50 (96%)  49/50 (98%) | 45/50 (90%)  50/50 (100%) 50/50 (100%) 50/50 (100%)|
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  91.8%       100.0%       100.0%       100.0%      |
|TERMINAL (d)           | 33/33 (100%) 28/28 (100%) 26/26 (100%) 16/16 (100%)| 30/34 (88%)  32/32 (100%) 28/28 (100%) 19/19 (100%)|
|FIRST INCIDENCE (DAYS) |   407          384          254          421       |   470          364          388          143       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.221      P=0.053      P<0.001 ** |  P<0.001 **   P=0.129      P=0.036 *    P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.555        (e)        P=0.443        (e)      |  P=0.012 *    P=0.039 *    P=0.037 *    P=0.063    |
|LOGISTIC REGRESSION    |  P=0.241        (e)        P=0.268        (e)      |  P=0.010 **   P=0.033 *    P=0.034 *    P=0.043 *  |
|COCHRAN-ARMITAGE       |  P=0.079                                           |  P=0.009 **                                        |
|FISHER EXACT           |               P=0.500N     P=0.339      P=0.181    |               P=0.028 *    P=0.028 *    P=0.028 *  |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05004 TEST: 03                                                 PAGE  25
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- FURAN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).

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