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TR 371 Mouse Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: IRDC                                                       TOLUENE                                        DATE: 09/18/94       
EXPERIMENT: 05701 TEST: 03                                                                                     TIME: 15:06:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: 0570101               ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 07272B       
PATHOLOGIST: J. SAGARTZ                                                                                        CAS: 108883          
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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: IRDC                                                       TOLUENE                                        DATE: 09/18/94      
EXPERIMENT: 05701 TEST: 03                                                                                     TIME: 15:06:29      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: 0570101               ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 07272B      
PATHOLOGIST: J. SAGARTZ                                                                                        CAS: 108883         
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: IRDC                                                       TOLUENE                                        DATE: 09/18/94       
EXPERIMENT: 05701 TEST: 03                                                                                     TIME: 15:06:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: 0570101               ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 07272B       
PATHOLOGIST: J. SAGARTZ                                                                                        CAS: 108883          
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                            IN THE ANALYSIS OF THE STUDY OF TOLUENE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Spleen                        Hemangiosarcoma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Lung                          Alveolar/Bronchiolar Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                             All Organs                    Hemangiosarcoma
                                                           Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE   1
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma NOS                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/58 (0%)    0/58 (0%)    0/59 (0%)  |  1/49 (2%)    1/50 (2%)    1/49 (2%)    2/47 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   3.3%         3.0%         4.2%         6.0%      |
|TERMINAL (d)           |  0/17 (0%)    0/22 (0%)    0/16 (0%)    0/19 (0%)  |  1/30 (3%)    1/33 (3%)    1/24 (4%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   729 (T)      729 (T)      729 (T)      715       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.342      P=0.741N     P=0.712      P=0.518    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.316      P=0.741N     P=0.712      P=0.437    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.331      P=0.741N     P=0.712      P=0.488    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.326                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.747N     P=0.753N     P=0.484    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/58 (0%)    0/58 (0%)    0/59 (0%)  |  1/49 (2%)    2/50 (4%)    1/49 (2%)    2/47 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   3.3%         5.4%         4.2%         6.0%      |
|TERMINAL (d)           |  0/17 (0%)    0/22 (0%)    0/16 (0%)    0/19 (0%)  |  1/30 (3%)    1/33 (3%)    1/24 (4%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   729 (T)      599          729 (T)      715       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.467      P=0.514      P=0.712      P=0.518    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.483      P=0.377      P=0.712      P=0.437    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.458      P=0.502      P=0.712      P=0.488    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.459                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.508      P=0.753N     P=0.484    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE   2
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    3/60 (5%)    0/60 (0%)    2/60 (3%)  |  0/50 (0%)    2/50 (4%)    1/50 (2%)    1/47 (2%)  |
|ADJUSTED (b)           |   0.0%         8.1%         0.0%         8.2%      |   0.0%         6.1%         4.2%         3.1%      |
|TERMINAL (d)           |  0/17 (0%)    0/22 (0%)    0/16 (0%)    1/19 (5%)  |  0/30 (0%)    2/33 (6%)    1/24 (4%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          400          ---          633       |   ---          729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.491      P=0.152        (e)        P=0.275    |  P=0.569      P=0.259      P=0.455      P=0.513    |
|INCIDENTAL TUMOR       |  P=0.375      P=0.123        (e)        P=0.213    |  P=0.569      P=0.259      P=0.455      P=0.513    |
|LOGISTIC REGRESSION    |  P=0.472      P=0.107        (e)        P=0.253    |  P=0.569      P=0.259      P=0.455      P=0.513    |
|COCHRAN-ARMITAGE       |  P=0.477                                           |  P=0.558                                           |
|FISHER EXACT           |               P=0.122        (e)        P=0.248    |               P=0.247      P=0.500      P=0.485    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    3/60 (5%)    1/60 (2%)    2/60 (3%)  |  0/50 (0%)    2/50 (4%)    2/50 (4%)    2/47 (4%)  |
|ADJUSTED (b)           |   0.0%         8.1%         4.2%         8.2%      |   0.0%         6.1%         8.3%         6.3%      |
|TERMINAL (d)           |  0/17 (0%)    0/22 (0%)    0/16 (0%)    1/19 (5%)  |  0/30 (0%)    2/33 (6%)    2/24 (8%)    2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |   ---          400          639          633       |   ---          729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.459      P=0.152      P=0.500      P=0.275    |  P=0.280      P=0.259      P=0.190      P=0.252    |
|INCIDENTAL TUMOR       |  P=0.319      P=0.123      P=0.461      P=0.213    |  P=0.280      P=0.259      P=0.190      P=0.252    |
|LOGISTIC REGRESSION    |  P=0.431      P=0.107      P=0.485      P=0.253    |  P=0.280      P=0.259      P=0.190      P=0.252    |
|COCHRAN-ARMITAGE       |  P=0.437                                           |  P=0.260                                           |
|FISHER EXACT           |               P=0.122      P=0.500      P=0.248    |               P=0.247      P=0.247      P=0.232    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE   3
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    0/60 (0%)    1/59 (2%)  |  1/49 (2%)    0/50 (0%)    0/50 (0%)    0/47 (0%)  |
|ADJUSTED (b)           |   8.2%         0.0%         0.0%         3.2%      |   2.6%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/17 (6%)    0/22 (0%)    0/16 (0%)    0/19 (0%)  |  0/30 (0%)    0/33 (0%)    0/24 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   543          ---          ---          638       |   681          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.525N     P=0.199N     P=0.261N     P=0.458N   |  P=0.367N     P=0.505N     P=0.539N     P=0.516N   |
|INCIDENTAL TUMOR       |  P=0.591N     P=0.231N     P=0.240N     P=0.567N   |  P=0.386N     P=0.571N     P=0.448N     P=0.638N   |
|LOGISTIC REGRESSION    |  P=0.540N     P=0.223N     P=0.253N     P=0.498N   |  P=0.357N     P=0.498N     P=0.497N     P=0.510N   |
|COCHRAN-ARMITAGE       |  P=0.534N                                          |  P=0.357N                                          |
|FISHER EXACT           |               P=0.248N     P=0.248N     P=0.506N   |               P=0.495N     P=0.495N     P=0.510N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/60 (12%)  10/60 (17%)   9/60 (15%)  11/59 (19%) |  3/49 (6%)    7/50 (14%)   6/50 (12%)   7/47 (15%) |
|ADJUSTED (b)           |  24.1%        33.2%        34.4%        34.3%      |  10.0%        19.7%        22.5%        20.0%      |
|TERMINAL (d)           |  2/17 (12%)   5/22 (23%)   4/16 (25%)   3/19 (16%) |  3/30 (10%)   5/33 (15%)   5/24 (21%)   5/32 (16%) |
|FIRST INCIDENCE (DAYS) |   446          501          319          297       |   729 (T)      683          509          520       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.246      P=0.475      P=0.332      P=0.305    |  P=0.235      P=0.190      P=0.153      P=0.181    |
|INCIDENTAL TUMOR       |  P=0.237      P=0.334      P=0.379      P=0.178    |  P=0.180      P=0.160      P=0.163      P=0.152    |
|LOGISTIC REGRESSION    |  P=0.226      P=0.347      P=0.377      P=0.212    |  P=0.208      P=0.147      P=0.225      P=0.136    |
|COCHRAN-ARMITAGE       |  P=0.241                                           |  P=0.210                                           |
|FISHER EXACT           |               P=0.301      P=0.395      P=0.210    |               P=0.167      P=0.254      P=0.142    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE   4
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/60 (22%)   8/60 (13%)   9/60 (15%)   8/59 (14%) |  4/49 (8%)    2/50 (4%)    2/50 (4%)    7/47 (15%) |
|ADJUSTED (b)           |  44.5%        27.1%        32.7%        27.1%      |  11.1%         5.0%         6.3%        19.4%      |
|TERMINAL (d)           |  4/17 (24%)   4/22 (18%)   2/16 (13%)   2/19 (11%) |  2/30 (7%)    0/33 (0%)    1/24 (4%)    4/32 (13%) |
|FIRST INCIDENCE (DAYS) |   436          526          425          366       |   631          477          578          589       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.263N     P=0.088N     P=0.315N     P=0.138N   |  P=0.090      P=0.337N     P=0.407N     P=0.264    |
|INCIDENTAL TUMOR       |  P=0.231N     P=0.117N     P=0.292N     P=0.160N   |  P=0.101      P=0.468N     P=0.229N     P=0.234    |
|LOGISTIC REGRESSION    |  P=0.261N     P=0.119N     P=0.293N     P=0.165N   |  P=0.078      P=0.336N     P=0.328N     P=0.232    |
|COCHRAN-ARMITAGE       |  P=0.242N                                          |  P=0.078                                           |
|FISHER EXACT           |               P=0.168N     P=0.240N     P=0.179N   |               P=0.329N     P=0.329N     P=0.238    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/60 (32%)  17/60 (28%)  18/60 (30%)  19/59 (32%) |  7/49 (14%)   9/50 (18%)   8/50 (16%)  13/47 (28%) |
|ADJUSTED (b)           |  57.9%        51.0%        57.9%        53.2%      |  20.6%        23.7%        28.3%        34.5%      |
|TERMINAL (d)           |  6/17 (35%)   8/22 (36%)   6/16 (38%)   5/19 (26%) |  5/30 (17%)   5/33 (15%)   6/24 (25%)   8/32 (25%) |
|FIRST INCIDENCE (DAYS) |   436          501          319          297       |   631          477          509          520       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.432      P=0.210N     P=0.537      P=0.457N   |  P=0.093      P=0.435      P=0.358      P=0.124    |
|INCIDENTAL TUMOR       |  P=0.449      P=0.335N     P=0.563N     P=0.548    |  P=0.077      P=0.308      P=0.491      P=0.090    |
|LOGISTIC REGRESSION    |  P=0.400      P=0.326N     P=0.573N     P=0.566    |  P=0.070      P=0.390      P=0.503      P=0.081    |
|COCHRAN-ARMITAGE       |  P=0.438                                           |  P=0.072                                           |
|FISHER EXACT           |               P=0.421N     P=0.500N     P=0.553    |               P=0.410      P=0.517      P=0.086    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE   5
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/60 (32%)  17/60 (28%)  18/60 (30%)  19/59 (32%) |  7/49 (14%)   9/50 (18%)   8/50 (16%)  13/47 (28%) |
|ADJUSTED (b)           |  57.9%        51.0%        57.9%        53.2%      |  20.6%        23.7%        28.3%        34.5%      |
|TERMINAL (d)           |  6/17 (35%)   8/22 (36%)   6/16 (38%)   5/19 (26%) |  5/30 (17%)   5/33 (15%)   6/24 (25%)   8/32 (25%) |
|FIRST INCIDENCE (DAYS) |   436          501          319          297       |   631          477          509          520       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.432      P=0.210N     P=0.537      P=0.457N   |  P=0.093      P=0.435      P=0.358      P=0.124    |
|INCIDENTAL TUMOR       |  P=0.449      P=0.335N     P=0.563N     P=0.548    |  P=0.077      P=0.308      P=0.491      P=0.090    |
|LOGISTIC REGRESSION    |  P=0.400      P=0.326N     P=0.573N     P=0.566    |  P=0.070      P=0.390      P=0.503      P=0.081    |
|COCHRAN-ARMITAGE       |  P=0.438                                           |  P=0.072                                           |
|FISHER EXACT           |               P=0.421N     P=0.500N     P=0.553    |               P=0.410      P=0.517      P=0.086    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/60 (13%)   1/60 (2%)    2/60 (3%)    8/60 (13%) |  5/50 (10%)   0/50 (0%)    3/50 (6%)    4/47 (9%)  |
|ADJUSTED (b)           |  32.9%         4.5%         8.4%        26.2%      |  14.8%         0.0%        10.3%        11.7%      |
|TERMINAL (d)           |  3/17 (18%)   1/22 (5%)    1/16 (6%)    3/19 (16%) |  3/30 (10%)   0/33 (0%)    1/24 (4%)    3/32 (9%)  |
|FIRST INCIDENCE (DAYS) |   613          729 (T)      450          366       |   681          ---          702          598       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.228      P=0.010N**   P=0.068N     P=0.516N   |  P=0.354      P=0.031N*    P=0.477N     P=0.489N   |
|INCIDENTAL TUMOR       |  P=0.179      P=0.011N*    P=0.068N     P=0.565    |  P=0.314      P=0.040N*    P=0.343N     P=0.581N   |
|LOGISTIC REGRESSION    |  P=0.210      P=0.010N**   P=0.062N     P=0.591N   |  P=0.335      P=0.036N*    P=0.409N     P=0.545N   |
|COCHRAN-ARMITAGE       |  P=0.224                                           |  P=0.334                                           |
|FISHER EXACT           |               P=0.016N*    P=0.047N*    P=0.605N   |               P=0.028N*    P=0.357N     P=0.540N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE   6
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |  0/50 (0%)    3/50 (6%)    1/50 (2%)    3/47 (6%)  |
|ADJUSTED (b)           |   8.5%         4.5%         0.0%         3.0%      |   0.0%         8.6%         4.2%         7.8%      |
|TERMINAL (d)           |  0/17 (0%)    1/22 (5%)    0/16 (0%)    0/19 (0%)  |  0/30 (0%)    2/33 (6%)    1/24 (4%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   618          729 (T)      ---          587       |   ---          686          729 (T)      523       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.385N     P=0.429N     P=0.252N     P=0.472N   |  P=0.228      P=0.134      P=0.455      P=0.118    |
|INCIDENTAL TUMOR       |  P=0.381N     P=0.483N     P=0.261N     P=0.514N   |  P=0.202      P=0.112      P=0.455      P=0.115    |
|LOGISTIC REGRESSION    |  P=0.381N     P=0.451N     P=0.257N     P=0.492N   |  P=0.210      P=0.114      P=0.455      P=0.114    |
|COCHRAN-ARMITAGE       |  P=0.374N                                          |  P=0.211                                           |
|FISHER EXACT           |               P=0.500N     P=0.248N     P=0.500N   |               P=0.121      P=0.500      P=0.110    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/60 (15%)   1/60 (2%)    2/60 (3%)    9/60 (15%) |  5/50 (10%)   3/50 (6%)    4/50 (8%)    7/47 (15%) |
|ADJUSTED (b)           |  36.4%         4.5%         8.4%        28.4%      |  14.8%         8.6%        14.2%        18.9%      |
|TERMINAL (d)           |  3/17 (18%)   1/22 (5%)    1/16 (6%)    3/19 (16%) |  3/30 (10%)   2/33 (6%)    2/24 (8%)    4/32 (13%) |
|FIRST INCIDENCE (DAYS) |   613          729 (T)      450          366       |   681          686          702          523       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.205      P=0.005N**   P=0.042N*    P=0.508N   |  P=0.182      P=0.331N     P=0.627N     P=0.386    |
|INCIDENTAL TUMOR       |  P=0.167      P=0.006N**   P=0.040N*    P=0.574    |  P=0.141      P=0.396N     P=0.505N     P=0.305    |
|LOGISTIC REGRESSION    |  P=0.187      P=0.005N**   P=0.037N*    P=0.584N   |  P=0.156      P=0.375N     P=0.567N     P=0.330    |
|COCHRAN-ARMITAGE       |  P=0.200                                           |  P=0.157                                           |
|FISHER EXACT           |               P=0.008N**   P=0.027N*    P=0.601N   |               P=0.357N     P=0.500N     P=0.336    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE   7
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  2/50 (4%)    0/50 (0%)    2/50 (4%)    1/47 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   6.3%         0.0%         6.1%         3.1%      |
|TERMINAL (d)           |  0/17 (0%)    0/22 (0%)    0/16 (0%)    0/19 (0%)  |  1/30 (3%)    0/33 (0%)    0/24 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   716          ---          659          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.598      P=0.226N     P=0.620      P=0.485N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.545      P=0.267N     P=0.646N     P=0.563N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.594      P=0.242N     P=0.681      P=0.512N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.594                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.247N     P=0.691N     P=0.523N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/59 (0%)    2/58 (3%)    1/58 (2%)    0/56 (0%)  | 12/49 (24%)  19/48 (40%)  21/49 (43%)  15/46 (33%) |
|ADJUSTED (b)           |   0.0%         7.5%         6.7%         0.0%      |  36.9%        51.0%        58.0%        46.9%      |
|TERMINAL (d)           |  0/17 (0%)    1/22 (5%)    1/15 (7%)    0/18 (0%)  | 10/30 (33%)  15/33 (45%)  10/24 (42%)  15/32 (47%) |
|FIRST INCIDENCE (DAYS) |   ---          633          729 (T)      ---       |   653          653          398          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.365N     P=0.297      P=0.475        (e)      |  P=0.410      P=0.146      P=0.014 *    P=0.382    |
|INCIDENTAL TUMOR       |  P=0.408N     P=0.275      P=0.475        (e)      |  P=0.325      P=0.091      P=0.038 *    P=0.325    |
|LOGISTIC REGRESSION    |  P=0.367N     P=0.266      P=0.475        (e)      |  P=0.344      P=0.066      P=0.033 *    P=0.278    |
|COCHRAN-ARMITAGE       |  P=0.367N                                          |  P=0.367                                           |
|FISHER EXACT           |               P=0.244      P=0.496        (e)      |               P=0.084      P=0.043 *    P=0.258    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE   8
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/50 (0%)    0/50 (0%)    2/50 (4%)    1/47 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         8.0%         2.9%      |
|TERMINAL (d)           |  0/17 (0%)    0/22 (0%)    0/16 (0%)    0/19 (0%)  |  0/30 (0%)    0/33 (0%)    1/24 (4%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          725          715       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.213        (e)        P=0.196      P=0.506    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.147        (e)        P=0.242      P=0.362    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.200        (e)        P=0.194      P=0.487    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.194                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.247      P=0.485    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    3/59 (5%)  |  1/50 (2%)    1/50 (2%)    0/49 (0%)    2/47 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         6.3%        15.8%      |   3.3%         3.0%         0.0%         5.6%      |
|TERMINAL (d)           |  0/17 (0%)    0/22 (0%)    1/16 (6%)    3/19 (16%) |  1/30 (3%)    1/33 (3%)    0/24 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      729 (T)   |   729 (T)      729 (T)      ---          598       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.016 *      (e)        P=0.488      P=0.137    |  P=0.367      P=0.741N     P=0.545N     P=0.501    |
|INCIDENTAL TUMOR       |  P=0.016 *      (e)        P=0.488      P=0.137    |  P=0.396      P=0.741N     P=0.545N     P=0.489    |
|LOGISTIC REGRESSION    |  P=0.016 *      (e)        P=0.488      P=0.137    |  P=0.354      P=0.741N     P=0.545N     P=0.475    |
|COCHRAN-ARMITAGE       |  P=0.017 *                                         |  P=0.354                                           |
|FISHER EXACT           |                 (e)        P=0.500      P=0.119    |               P=0.753N     P=0.505N     P=0.477    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE   9
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |  3/50 (6%)    1/50 (2%)    1/50 (2%)    3/47 (6%)  |
|ADJUSTED (b)           |   5.9%         4.5%         5.0%         0.0%      |  10.0%         3.0%         4.2%         9.4%      |
|TERMINAL (d)           |  1/17 (6%)    1/22 (5%)    0/16 (0%)    0/19 (0%)  |  3/30 (10%)   1/33 (3%)    1/24 (4%)    3/32 (9%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      689          ---       |   729 (T)      729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.301N     P=0.704N     P=0.748      P=0.478N   |  P=0.439      P=0.271N     P=0.387N     P=0.634N   |
|INCIDENTAL TUMOR       |  P=0.257N     P=0.704N     P=0.754      P=0.478N   |  P=0.439      P=0.271N     P=0.387N     P=0.634N   |
|LOGISTIC REGRESSION    |  P=0.295N     P=0.704N     P=0.748      P=0.478N   |  P=0.439      P=0.271N     P=0.387N     P=0.634N   |
|COCHRAN-ARMITAGE       |  P=0.303N                                          |  P=0.418                                           |
|FISHER EXACT           |               P=0.752N     P=0.752N     P=0.500N   |               P=0.309N     P=0.309N     P=0.631    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    0/60 (0%)    0/59 (0%)  |  0/50 (0%)    0/50 (0%)    4/50 (8%)    0/47 (0%)  |
|ADJUSTED (b)           |   5.9%         7.3%         0.0%         0.0%      |   0.0%         0.0%        12.0%         0.0%      |
|TERMINAL (d)           |  1/17 (6%)    1/22 (5%)    0/16 (0%)    0/19 (0%)  |  0/30 (0%)    0/33 (0%)    1/24 (4%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      611          ---          ---       |   ---          ---          629          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.143N     P=0.577      P=0.512N     P=0.478N   |  P=0.405        (e)        P=0.050 *      (e)      |
|INCIDENTAL TUMOR       |  P=0.157N     P=0.573      P=0.512N     P=0.478N   |  P=0.388        (e)        P=0.090        (e)      |
|LOGISTIC REGRESSION    |  P=0.137N     P=0.551      P=0.512N     P=0.478N   |  P=0.404        (e)        P=0.063        (e)      |
|COCHRAN-ARMITAGE       |  P=0.136N                                          |  P=0.404                                           |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.504N   |                 (e)        P=0.059        (e)      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE  10
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    0/60 (0%)    0/59 (0%)  |  1/50 (2%)    0/50 (0%)    4/50 (8%)    0/47 (0%)  |
|ADJUSTED (b)           |   5.9%         7.3%         0.0%         0.0%      |   3.3%         0.0%        12.0%         0.0%      |
|TERMINAL (d)           |  1/17 (6%)    1/22 (5%)    0/16 (0%)    0/19 (0%)  |  1/30 (3%)    0/33 (0%)    1/24 (4%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      611          ---          ---       |   729 (T)      ---          629          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.143N     P=0.577      P=0.512N     P=0.478N   |  P=0.592      P=0.481N     P=0.140      P=0.487N   |
|INCIDENTAL TUMOR       |  P=0.157N     P=0.573      P=0.512N     P=0.478N   |  P=0.592      P=0.481N     P=0.214      P=0.487N   |
|LOGISTIC REGRESSION    |  P=0.137N     P=0.551      P=0.512N     P=0.478N   |  P=0.593      P=0.481N     P=0.178      P=0.487N   |
|COCHRAN-ARMITAGE       |  P=0.136N                                          |  P=0.594                                           |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.504N   |               P=0.500N     P=0.181      P=0.515N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  3/50 (6%)    2/50 (4%)    1/50 (2%)    2/47 (4%)  |
|ADJUSTED (b)           |                                                    |  10.0%         5.9%         3.8%         6.3%      |
|TERMINAL (d)           |                                                    |  3/30 (10%)   1/33 (3%)    0/24 (0%)    2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   729 (T)      722          713          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.422N     P=0.457N     P=0.393N     P=0.470N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.451N     P=0.497N     P=0.342N     P=0.470N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.429N     P=0.490N     P=0.369N     P=0.470N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.435N                                          |
|FISHER EXACT           |                                                    |               P=0.500N     P=0.309N     P=0.530N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE  11
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |  2/50 (4%)    1/50 (2%)    0/50 (0%)    2/47 (4%)  |
|ADJUSTED (b)           |   0.0%         2.8%         4.2%         0.0%      |   6.7%         3.0%         0.0%         5.8%      |
|TERMINAL (d)           |  0/17 (0%)    0/22 (0%)    0/16 (0%)    0/19 (0%)  |  2/30 (7%)    1/33 (3%)    0/24 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          607          639          ---       |   729 (T)      729 (T)      ---          696       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.529N     P=0.530      P=0.500        (e)      |  P=0.563      P=0.467N     P=0.288N     P=0.676N   |
|INCIDENTAL TUMOR       |  P=0.631N     P=0.522      P=0.461        (e)      |  P=0.541      P=0.467N     P=0.288N     P=0.653    |
|LOGISTIC REGRESSION    |  P=0.541N     P=0.502      P=0.485        (e)      |  P=0.550      P=0.467N     P=0.288N     P=0.676    |
|COCHRAN-ARMITAGE       |  P=0.536N                                          |  P=0.548                                           |
|FISHER EXACT           |               P=0.500      P=0.500        (e)      |               P=0.500N     P=0.247N     P=0.668    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    1/60 (2%)    5/60 (8%)  |  2/50 (4%)    2/50 (4%)    1/50 (2%)    6/47 (13%) |
|ADJUSTED (b)           |   8.2%         0.0%         6.3%        23.6%      |   5.8%         6.1%         3.3%        17.0%      |
|TERMINAL (d)           |  1/17 (6%)    0/22 (0%)    1/16 (6%)    4/19 (21%) |  1/30 (3%)    2/33 (6%)    0/24 (0%)    4/32 (13%) |
|FIRST INCIDENCE (DAYS) |   543          ---          729 (T)      638       |   681          729 (T)      708          598       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.030 *    P=0.199N     P=0.530N     P=0.264    |  P=0.054      P=0.670N     P=0.569N     P=0.142    |
|INCIDENTAL TUMOR       |  P=0.022 *    P=0.231N     P=0.507N     P=0.211    |  P=0.041 *    P=0.688      P=0.465N     P=0.090    |
|LOGISTIC REGRESSION    |  P=0.032 *    P=0.223N     P=0.531N     P=0.250    |  P=0.044 *    P=0.684      P=0.519N     P=0.112    |
|COCHRAN-ARMITAGE       |  P=0.031 *                                         |  P=0.043 *                                         |
|FISHER EXACT           |               P=0.248N     P=0.500N     P=0.219    |               P=0.691N     P=0.500N     P=0.115    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE  12
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    1/60 (2%)    2/60 (3%)    5/60 (8%)  |  4/50 (8%)    3/50 (6%)    1/50 (2%)    8/47 (17%) |
|ADJUSTED (b)           |   8.2%         2.8%        10.2%        23.6%      |  12.3%         9.1%         3.3%        22.2%      |
|TERMINAL (d)           |  1/17 (6%)    0/22 (0%)    1/16 (6%)    4/19 (21%) |  3/30 (10%)   3/33 (9%)    0/24 (0%)    5/32 (16%) |
|FIRST INCIDENCE (DAYS) |   543          607          639          638       |   681          729 (T)      708          598       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.066      P=0.440N     P=0.670      P=0.264    |  P=0.078      P=0.457N     P=0.251N     P=0.194    |
|INCIDENTAL TUMOR       |  P=0.040 *    P=0.480N     P=0.670      P=0.211    |  P=0.058      P=0.483N     P=0.188N     P=0.116    |
|LOGISTIC REGRESSION    |  P=0.064      P=0.484N     P=0.664      P=0.250    |  P=0.063      P=0.514N     P=0.208N     P=0.143    |
|COCHRAN-ARMITAGE       |  P=0.065                                           |  P=0.062                                           |
|FISHER EXACT           |               P=0.500N     P=0.691N     P=0.219    |               P=0.500N     P=0.181N     P=0.149    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  0/50 (0%)    0/50 (0%)    2/50 (4%)    1/47 (2%)  |
|ADJUSTED (b)           |   2.5%         0.0%         0.0%         3.8%      |   0.0%         0.0%         8.3%         2.9%      |
|TERMINAL (d)           |  0/17 (0%)    0/22 (0%)    0/16 (0%)    0/19 (0%)  |  0/30 (0%)    0/33 (0%)    2/24 (8%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   543          ---          ---          691       |   ---          ---          729 (T)      709       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.541      P=0.477N     P=0.527N     P=0.737N   |  P=0.211        (e)        P=0.190      P=0.494    |
|INCIDENTAL TUMOR       |  P=0.601      P=0.539N     P=0.489N     P=0.731N   |  P=0.181        (e)        P=0.190      P=0.362    |
|LOGISTIC REGRESSION    |  P=0.531      P=0.519N     P=0.491N     P=0.761N   |  P=0.199        (e)        P=0.190      P=0.486    |
|COCHRAN-ARMITAGE       |  P=0.536                                           |  P=0.194                                           |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.752N   |                 (e)        P=0.247      P=0.485    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE  13
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/60 (10%)  10/60 (17%)   8/60 (13%)   5/60 (8%)  | 22/50 (44%)  10/50 (20%)  19/50 (38%)  12/47 (26%) |
|ADJUSTED (b)           |  29.0%        36.4%        41.2%        24.1%      |  60.5%        26.6%        51.9%        35.0%      |
|TERMINAL (d)           |  4/17 (24%)   6/22 (27%)   6/16 (38%)   4/19 (21%) | 16/30 (53%)   6/33 (18%)   8/24 (33%)  10/32 (31%) |
|FIRST INCIDENCE (DAYS) |   543          556          319          691       |   624          599          398          670       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.259N     P=0.373      P=0.335      P=0.420N   |  P=0.228N     P=0.007N**   P=0.510      P=0.023N*  |
|INCIDENTAL TUMOR       |  P=0.193N     P=0.283      P=0.371      P=0.385N   |  P=0.228N     P=0.024N*    P=0.328N     P=0.046N*  |
|LOGISTIC REGRESSION    |  P=0.241N     P=0.303      P=0.311      P=0.410N   |  P=0.227N     P=0.010N*    P=0.377N     P=0.039N*  |
|COCHRAN-ARMITAGE       |  P=0.249N                                          |  P=0.231N                                          |
|FISHER EXACT           |               P=0.211      P=0.389      P=0.500N   |               P=0.009N**   P=0.342N     P=0.045N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)   10/60 (17%)   8/60 (13%)   4/60 (7%)  | 22/50 (44%)  10/50 (20%)  17/50 (34%)  11/47 (23%) |
|ADJUSTED (b)           |  27.2%        36.4%        41.2%        21.1%      |  60.5%        26.6%        45.9%        33.1%      |
|TERMINAL (d)           |  4/17 (24%)   6/22 (27%)   6/16 (38%)   4/19 (21%) | 16/30 (53%)   6/33 (18%)   6/24 (25%)  10/32 (31%) |
|FIRST INCIDENCE (DAYS) |   701          556          319          729 (T)   |   624          599          398          670       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.218N     P=0.262      P=0.230      P=0.425N   |  P=0.147N     P=0.007N**   P=0.473N     P=0.012N*  |
|INCIDENTAL TUMOR       |  P=0.169N     P=0.195      P=0.252      P=0.393N   |  P=0.135N     P=0.024N*    P=0.181N     P=0.023N*  |
|LOGISTIC REGRESSION    |  P=0.172N     P=0.205      P=0.258      P=0.393N   |  P=0.138N     P=0.010N*    P=0.227N     P=0.022N*  |
|COCHRAN-ARMITAGE       |  P=0.211N                                          |  P=0.142N                                          |
|FISHER EXACT           |               P=0.135      P=0.279      P=0.500N   |               P=0.009N**   P=0.206N     P=0.027N*  |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE  14
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/60 (27%)  18/60 (30%)  14/60 (23%)  19/60 (32%) | 19/50 (38%)  28/50 (56%)  29/50 (58%)  29/47 (62%) |
|ADJUSTED (b)           |  57.0%        50.5%        55.2%        55.8%      |  56.9%        70.0%        74.9%        78.2%      |
|TERMINAL (d)           |  7/17 (41%)   7/22 (32%)   7/16 (44%)   7/19 (37%) | 16/30 (53%)  21/33 (64%)  15/24 (63%)  24/32 (75%) |
|FIRST INCIDENCE (DAYS) |   446          400          319          297       |   653          534          398          520       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.385      P=0.471N     P=0.514N     P=0.487    |  P=0.069      P=0.105      P=0.007 **   P=0.048 *  |
|INCIDENTAL TUMOR       |  P=0.326      P=0.540      P=0.481N     P=0.317    |  P=0.018 *    P=0.052      P=0.022 *    P=0.014 *  |
|LOGISTIC REGRESSION    |  P=0.348      P=0.531      P=0.514N     P=0.360    |  P=0.025 *    P=0.025 *    P=0.025 *    P=0.009 ** |
|COCHRAN-ARMITAGE       |  P=0.392                                           |  P=0.033 *                                         |
|FISHER EXACT           |               P=0.420      P=0.417N     P=0.344    |               P=0.054      P=0.036 *    P=0.016 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 21/60 (35%)  16/60 (27%)  17/60 (28%)  17/60 (28%) | 26/50 (52%)  17/50 (34%)  27/50 (54%)  27/47 (57%) |
|ADJUSTED (b)           |  69.4%        52.7%        63.8%        60.1%      |  66.2%        40.9%        66.8%        64.3%      |
|TERMINAL (d)           |  9/17 (53%)   9/22 (41%)   8/16 (50%)   9/19 (47%) | 17/30 (57%)   9/33 (27%)  11/24 (46%)  17/32 (53%) |
|FIRST INCIDENCE (DAYS) |   436          526          319          366       |   624          477          398          523       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.386N     P=0.074N     P=0.377N     P=0.183N   |  P=0.139      P=0.055N     P=0.213      P=0.537    |
|INCIDENTAL TUMOR       |  P=0.309N     P=0.110N     P=0.336N     P=0.204N   |  P=0.048 *    P=0.118N     P=0.580      P=0.233    |
|LOGISTIC REGRESSION    |  P=0.388N     P=0.098N     P=0.392N     P=0.211N   |  P=0.083      P=0.091N     P=0.459      P=0.335    |
|COCHRAN-ARMITAGE       |  P=0.353N                                          |  P=0.070                                           |
|FISHER EXACT           |               P=0.215N     P=0.278N     P=0.278N   |               P=0.053N     P=0.500      P=0.369    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05701 TEST: 03                                                 PAGE  15
                                   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TOLUENE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        120 PPM      600 PPM      1200 PPM  |   0 PPM        120 PPM      600 PPM      1200 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 29/60 (48%)  29/60 (48%)  26/60 (43%)  33/60 (55%) | 33/50 (66%)  36/50 (72%)  42/50 (84%)  38/47 (81%) |
|ADJUSTED (b)           |  83.4%        74.5%        87.9%        85.8%      |  80.3%        83.7%        93.3%        88.4%      |
|TERMINAL (d)           | 12/17 (71%)  13/22 (59%)  13/16 (81%)  14/19 (74%) | 22/30 (73%)  26/33 (79%)  21/24 (88%)  27/32 (84%) |
|FIRST INCIDENCE (DAYS) |   436          400          319          297       |   624          477          398          520       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.269      P=0.229N     P=0.507N     P=0.505    |  P=0.151      P=0.507      P=0.009 **   P=0.296    |
|INCIDENTAL TUMOR       |  P=0.217      P=0.386N     P=0.457N     P=0.320    |  P=0.018 *    P=0.149      P=0.027 *    P=0.028 *  |
|LOGISTIC REGRESSION    |  P=0.181      P=0.380N     P=0.533N     P=0.307    |  P=0.038 *    P=0.130      P=0.017 *    P=0.040 *  |
|COCHRAN-ARMITAGE       |  P=0.272                                           |  P=0.040 *                                         |
|FISHER EXACT           |               P=0.572N     P=0.357N     P=0.292    |               P=0.333      P=0.032 *    P=0.077    |
|=================================================================================================================================|
 
 (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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