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TDMS Study 05053-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                     BROMOFORM                                       DATE: 09/08/94       
EXPERIMENT: 05053 TEST: 01                                                                                     TIME: 01:16:50       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES2803301          ROUTE: GAVAGE                                                                      NTP C#: 55130        
PATHOLOGIST: K. MURTHY_____                                                                                    CAS: 75-25-2         
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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: Mason                                                     BROMOFORM                                       DATE: 09/08/94      
EXPERIMENT: 05053 TEST: 01                                                                                     TIME: 01:16:50      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES2803301          ROUTE: GAVAGE                                                                      NTP C#: 55130       
PATHOLOGIST: K. MURTHY_____                                                                                    CAS: 75-25-2        
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                     BROMOFORM                                       DATE: 09/08/94       
EXPERIMENT: 05053 TEST: 01                                                                                     TIME: 01:16:50       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES2803301          ROUTE: GAVAGE                                                                      NTP C#: 55130        
PATHOLOGIST: K. MURTHY_____                                                                                    CAS: 75-25-2         
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                           IN THE ANALYSIS OF THE STUDY OF BROMOFORM
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                             Clitoral/Preputial Gland      Carcinoma
                                                           Carcinoma or Adenoma
                             Intestine Large               Polyp Adenomatous
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Skin: Subcutaneous Tissue     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             Testes                        Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                     BROMOFORM                                       DATE: 09/08/94       
EXPERIMENT: 05053 TEST: 01                                                                                     TIME: 01:16:50       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES2803301          ROUTE: GAVAGE                                                                      NTP C#: 55130        
PATHOLOGIST: K. MURTHY_____                                                                                    CAS: 75-25-2         
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                           IN THE ANALYSIS OF THE STUDY OF BROMOFORM
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Clitoral/Preputial Gland      Adenoma
                             Intestine Large               Polyp Adenomatous
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Uterus                        Polyp Stromal
                                                           Sarcoma Stromal or Polyp Stromal
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE   1
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    16/48 (33%)     11/50 (22%)      8/50 (16%)     |     2/50 (4%)       0/18 (0%)       3/50 (6%)      |
|ADJUSTED (b)           |     45.1%           30.0%           49.2%          |      5.9%            0.0%           10.0%          |
|TERMINAL (d)           |    13/32 (41%)      6/30 (20%)      4/11 (36%)     |     2/34 (6%)       0/1 (0%)        2/28 (7%)      |
|FIRST INCIDENCE (DAYS) |      611             621             643           |      735 (T)         ---             721           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.510         P=0.209N        P=0.415        |     P=0.332         P=0.972N        P=0.422        |
|INCIDENTAL TUMOR       |     P=0.093N        P=0.082N        P=0.281N       |     P=0.358         P=0.972N        P=0.448        |
|LOGISTIC REGRESSION    |     P=0.132N        P=0.111N        P=0.245N       |     P=0.367         P=0.972N        P=0.458        |
|COCHRAN-ARMITAGE       |     P=0.029N*                                      |     P=0.402                                        |
|FISHER EXACT           |                     P=0.152N        P=0.039N*      |                     P=0.538N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/41 (10%)      3/38 (8%)       0/34 (0%)      |     0/34 (0%)       1/9 (11%)       2/39 (5%)      |
|ADJUSTED (b)           |     13.3%           11.6%            0.0%          |      0.0%          100.0%            8.7%          |
|TERMINAL (d)           |     4/30 (13%)      2/21 (10%)      0/10 (0%)      |     0/24 (0%)       1/1 (100%)      2/23 (9%)      |
|FIRST INCIDENCE (DAYS) |      734 (T)         632             ---           |      ---             735 (T)         735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.219N        P=0.655N        P=0.274N       |     P=0.176         P=0.009 **      P=0.228        |
|INCIDENTAL TUMOR       |     P=0.187N        P=0.647         P=0.274N       |     P=0.176         P=0.009 **      P=0.228        |
|LOGISTIC REGRESSION    |     P=0.118N        P=0.574N        P=0.274N       |     P=0.176         P=0.009 **      P=0.228        |
|COCHRAN-ARMITAGE       |     P=0.070N                                       |     P=0.205                                        |
|FISHER EXACT           |                     P=0.543N        P=0.083N       |                     P=0.209         P=0.282        |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE   2
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/41 (15%)      2/38 (5%)       1/34 (3%)      |     1/34 (3%)       1/9 (11%)       0/39 (0%)      |
|ADJUSTED (b)           |     18.4%            7.5%            7.7%          |      2.2%            2.9%            0.0%          |
|TERMINAL (d)           |     5/30 (17%)      1/21 (5%)       0/10 (0%)      |     0/24 (0%)       0/1 (0%)        0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      377             680             716           |      630             638             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.181N        P=0.235N        P=0.336N       |     P=0.364N        P=0.694         P=0.523N       |
|INCIDENTAL TUMOR       |     P=0.067N        P=0.206N        P=0.174N       |     P=0.217N        P=0.565N        P=0.398N       |
|LOGISTIC REGRESSION    |     P=0.043N*       P=0.160N        P=0.083N       |     P=0.272N        P=0.757         P=0.420N       |
|COCHRAN-ARMITAGE       |     P=0.046N*                                      |     P=0.318N                                       |
|FISHER EXACT           |                     P=0.158N        P=0.088N       |                     P=0.379         P=0.466N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/41 (24%)      5/38 (13%)      1/34 (3%)      |     1/34 (3%)       2/9 (22%)       2/39 (5%)      |
|ADJUSTED (b)           |     31.4%           18.7%            7.7%          |      2.2%          100.0%            8.7%          |
|TERMINAL (d)           |     9/30 (30%)      3/21 (14%)      0/10 (0%)      |     0/24 (0%)       1/1 (100%)      2/23 (9%)      |
|FIRST INCIDENCE (DAYS) |      377             632             716           |      630             638             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.077N        P=0.288N        P=0.134N       |     P=0.377         P=0.203         P=0.477        |
|INCIDENTAL TUMOR       |     P=0.025N*       P=0.271N        P=0.061N       |     P=0.439         P=0.463         P=0.549        |
|LOGISTIC REGRESSION    |     P=0.008N**      P=0.163N        P=0.014N*      |     P=0.462         P=0.143         P=0.553        |
|COCHRAN-ARMITAGE       |     P=0.006N**                                     |     P=0.462                                        |
|FISHER EXACT           |                     P=0.163N        P=0.008N**     |                     P=0.106         P=0.552        |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE   3
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            8.3%          |      0.0%            0.0%            7.1%          |
|TERMINAL (d)           |     0/34 (0%)       0/30 (0%)       0/11 (0%)      |     0/34 (0%)       0/28 (0%)       2/28 (7%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             723           |      ---             ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.137           (e)           P=0.293        |     P=0.080           (e)           P=0.196        |
|INCIDENTAL TUMOR       |     P=0.424           (e)           P=0.788        |     P=0.080           (e)           P=0.196        |
|LOGISTIC REGRESSION    |     P=0.174           (e)           P=0.363        |     P=0.080           (e)           P=0.196        |
|COCHRAN-ARMITAGE       |     P=0.269                                        |     P=0.095                                        |
|FISHER EXACT           |                       (e)           P=0.500        |                       (e)           P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large                                                                                                                  |
|     Polyp Adenomatous                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       1/50 (2%)       6/50 (12%)     |
|ADJUSTED (b)           |      0.0%            0.0%           11.4%          |      0.0%            3.6%           17.6%          |
|TERMINAL (d)           |     0/34 (0%)       0/30 (0%)       1/11 (9%)      |     0/34 (0%)       1/28 (4%)       3/28 (11%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             527           |      ---             735 (T)         637           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.042 *         (e)           P=0.118        |     P=0.004 **      P=0.461         P=0.013 *      |
|INCIDENTAL TUMOR       |     P=0.045 *         (e)           P=0.095        |     P=0.005 **      P=0.461         P=0.017 *      |
|LOGISTIC REGRESSION    |     P=0.101           (e)           P=0.230        |     P=0.004 **      P=0.461         P=0.015 *      |
|COCHRAN-ARMITAGE       |     P=0.095                                        |     P=0.005 **                                     |
|FISHER EXACT           |                       (e)           P=0.247        |                     P=0.500         P=0.013 *      |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE   4
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/48 (8%)       3/50 (6%)       1/50 (2%)      |     2/48 (4%)       0/49 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     12.5%            9.3%            5.3%          |      6.1%            0.0%            0.0%          |
|TERMINAL (d)           |     4/32 (13%)      2/30 (7%)       0/11 (0%)      |     2/33 (6%)       0/28 (0%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      734 (T)         679             670           |      735 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.428N        P=0.530N        P=0.554N       |     P=0.116N        P=0.275N        P=0.275N       |
|INCIDENTAL TUMOR       |     P=0.216N        P=0.440N        P=0.359N       |     P=0.116N        P=0.275N        P=0.275N       |
|LOGISTIC REGRESSION    |     P=0.251N        P=0.464N        P=0.373N       |     P=0.116N        P=0.275N        P=0.275N       |
|COCHRAN-ARMITAGE       |     P=0.122N                                       |     P=0.091N                                       |
|FISHER EXACT           |                     P=0.477N        P=0.168N       |                     P=0.242N        P=0.237N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       4/49 (8%)       2/50 (4%)      |
|ADJUSTED (b)           |     11.0%            5.8%            0.0%          |      0.0%           13.8%            7.1%          |
|TERMINAL (d)           |     3/34 (9%)       1/30 (3%)       0/11 (0%)      |     0/34 (0%)       3/28 (11%)      2/28 (7%)      |
|FIRST INCIDENCE (DAYS) |      610             659             ---           |      ---             722             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.122N        P=0.362N        P=0.220N       |     P=0.173         P=0.043 *       P=0.196        |
|INCIDENTAL TUMOR       |     P=0.048N*       P=0.275N        P=0.144N       |     P=0.192         P=0.033 *       P=0.196        |
|LOGISTIC REGRESSION    |     P=0.054N        P=0.320N        P=0.109N       |     P=0.197         P=0.038 *       P=0.196        |
|COCHRAN-ARMITAGE       |     P=0.037N*                                      |     P=0.223                                        |
|FISHER EXACT           |                     P=0.339N        P=0.059N       |                     P=0.056         P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE   5
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      2/50 (4%)       1/50 (2%)      |     0/50 (0%)       4/49 (8%)       2/50 (4%)      |
|ADJUSTED (b)           |     13.5%            5.8%            3.1%          |      0.0%           13.8%            7.1%          |
|TERMINAL (d)           |     3/34 (9%)       1/30 (3%)       0/11 (0%)      |     0/34 (0%)       3/28 (11%)      2/28 (7%)      |
|FIRST INCIDENCE (DAYS) |      610             659             636           |      ---             722             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.194N        P=0.239N        P=0.343N       |     P=0.173         P=0.043 *       P=0.196        |
|INCIDENTAL TUMOR       |     P=0.039N*       P=0.113N        P=0.088N       |     P=0.192         P=0.033 *       P=0.196        |
|LOGISTIC REGRESSION    |     P=0.082N        P=0.204N        P=0.161N       |     P=0.197         P=0.038 *       P=0.196        |
|COCHRAN-ARMITAGE       |     P=0.060N                                       |     P=0.223                                        |
|FISHER EXACT           |                     P=0.218N        P=0.102N       |                     P=0.056         P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      2/50 (4%)       1/50 (2%)      |     0/50 (0%)       4/49 (8%)       2/50 (4%)      |
|ADJUSTED (b)           |     13.5%            5.8%            3.1%          |      0.0%           13.8%            7.1%          |
|TERMINAL (d)           |     3/34 (9%)       1/30 (3%)       0/11 (0%)      |     0/34 (0%)       3/28 (11%)      2/28 (7%)      |
|FIRST INCIDENCE (DAYS) |      610             659             636           |      ---             722             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.194N        P=0.239N        P=0.343N       |     P=0.173         P=0.043 *       P=0.196        |
|INCIDENTAL TUMOR       |     P=0.039N*       P=0.113N        P=0.088N       |     P=0.192         P=0.033 *       P=0.196        |
|LOGISTIC REGRESSION    |     P=0.082N        P=0.204N        P=0.161N       |     P=0.197         P=0.038 *       P=0.196        |
|COCHRAN-ARMITAGE       |     P=0.060N                                       |     P=0.223                                        |
|FISHER EXACT           |                     P=0.218N        P=0.102N       |                     P=0.056         P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE   6
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |     2/50 (4%)       1/32 (3%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            2.1%            9.1%          |      5.6%            2.8%            3.6%          |
|TERMINAL (d)           |     0/34 (0%)       0/30 (0%)       1/11 (9%)      |     1/34 (3%)       0/15 (0%)       1/28 (4%)      |
|FIRST INCIDENCE (DAYS) |      ---             600             734 (T)       |      691             625             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.212         P=0.531         P=0.276        |     P=0.436N        P=0.651N        P=0.548N       |
|INCIDENTAL TUMOR       |     P=0.309         P=0.531         P=0.276        |     P=0.401N        P=0.739N        P=0.522N       |
|LOGISTIC REGRESSION    |     P=0.310         P=0.448         P=0.276        |     P=0.403N        P=0.691N        P=0.529N       |
|COCHRAN-ARMITAGE       |     P=0.331                                        |     P=0.385N                                       |
|FISHER EXACT           |                     P=0.500         P=0.500        |                     P=0.664N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       2/50 (4%)      |     2/50 (4%)       1/32 (3%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            2.1%           11.5%          |      5.6%            2.8%            7.1%          |
|TERMINAL (d)           |     0/34 (0%)       0/30 (0%)       1/11 (9%)      |     1/34 (3%)       0/15 (0%)       2/28 (7%)      |
|FIRST INCIDENCE (DAYS) |      ---             600             591           |      691             625             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.077         P=0.531         P=0.118        |     P=0.541         P=0.651N        P=0.638        |
|INCIDENTAL TUMOR       |     P=0.170         P=0.531         P=0.183        |     P=0.573         P=0.739N        P=0.660        |
|LOGISTIC REGRESSION    |     P=0.144         P=0.448         P=0.202        |     P=0.577         P=0.691N        P=0.665        |
|COCHRAN-ARMITAGE       |     P=0.142                                        |     P=0.603                                        |
|FISHER EXACT           |                     P=0.500         P=0.247        |                     P=0.664N        P=0.691N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE   7
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      1/50 (2%)       0/50 (0%)      |    22/50 (44%)     17/50 (34%)      6/50 (12%)     |
|ADJUSTED (b)           |     14.7%            3.3%            0.0%          |     50.9%           51.0%           18.2%          |
|TERMINAL (d)           |     5/34 (15%)      1/30 (3%)       0/11 (0%)      |    14/34 (41%)     12/28 (43%)      4/28 (14%)     |
|FIRST INCIDENCE (DAYS) |      734 (T)         734 (T)         ---           |      537             618             543           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.057N        P=0.132N        P=0.215N       |     P=0.004N**      P=0.509N        P=0.004N**     |
|INCIDENTAL TUMOR       |     P=0.057N        P=0.132N        P=0.215N       |     P<0.001N**      P=0.329N        P<0.001N**     |
|LOGISTIC REGRESSION    |     P=0.057N        P=0.132N        P=0.215N       |     P<0.001N**      P=0.369N        P<0.001N**     |
|COCHRAN-ARMITAGE       |     P=0.011N*                                      |     P<0.001N**                                     |
|FISHER EXACT           |                     P=0.102N        P=0.028N*      |                     P=0.206N        P<0.001N**     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      1/50 (2%)       0/50 (0%)      |    23/50 (46%)     17/50 (34%)      6/50 (12%)     |
|ADJUSTED (b)           |     14.7%            3.3%            0.0%          |     53.3%           51.0%           18.2%          |
|TERMINAL (d)           |     5/34 (15%)      1/30 (3%)       0/11 (0%)      |    15/34 (44%)     12/28 (43%)      4/28 (14%)     |
|FIRST INCIDENCE (DAYS) |      734 (T)         734 (T)         ---           |      537             618             543           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.057N        P=0.132N        P=0.215N       |     P=0.003N**      P=0.441N        P=0.002N**     |
|INCIDENTAL TUMOR       |     P=0.057N        P=0.132N        P=0.215N       |     P<0.001N**      P=0.265N        P<0.001N**     |
|LOGISTIC REGRESSION    |     P=0.057N        P=0.132N        P=0.215N       |     P<0.001N**      P=0.303N        P<0.001N**     |
|COCHRAN-ARMITAGE       |     P=0.011N*                                      |     P<0.001N**                                     |
|FISHER EXACT           |                     P=0.102N        P=0.028N*      |                     P=0.154N        P<0.001N**     |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE   8
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       3/50 (6%)       1/50 (2%)      |     1/48 (2%)       0/49 (0%)       3/50 (6%)      |
|ADJUSTED (b)           |      2.9%           10.0%            5.0%          |      3.0%            0.0%            9.7%          |
|TERMINAL (d)           |     1/34 (3%)       3/30 (10%)      0/11 (0%)      |     1/33 (3%)       0/28 (0%)       2/28 (7%)      |
|FIRST INCIDENCE (DAYS) |      734 (T)         734 (T)         666           |      735 (T)         ---             665           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.285         P=0.261         P=0.563        |     P=0.151         P=0.533N        P=0.257        |
|INCIDENTAL TUMOR       |     P=0.409         P=0.261         P=0.777N       |     P=0.177         P=0.533N        P=0.290        |
|LOGISTIC REGRESSION    |     P=0.417         P=0.261         P=0.691        |     P=0.173         P=0.533N        P=0.293        |
|COCHRAN-ARMITAGE       |     P=0.610N                                       |     P=0.185                                        |
|FISHER EXACT           |                     P=0.309         P=0.753N       |                     P=0.495N        P=0.324        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       3/50 (6%)       1/50 (2%)      |     1/48 (2%)       1/49 (2%)       3/50 (6%)      |
|ADJUSTED (b)           |      2.9%           10.0%            5.0%          |      3.0%            3.6%            9.7%          |
|TERMINAL (d)           |     1/34 (3%)       3/30 (10%)      0/11 (0%)      |     1/33 (3%)       1/28 (4%)       2/28 (7%)      |
|FIRST INCIDENCE (DAYS) |      734 (T)         734 (T)         666           |      735 (T)         735 (T)         665           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.285         P=0.261         P=0.563        |     P=0.169         P=0.725         P=0.257        |
|INCIDENTAL TUMOR       |     P=0.409         P=0.261         P=0.777N       |     P=0.193         P=0.725         P=0.290        |
|LOGISTIC REGRESSION    |     P=0.417         P=0.261         P=0.691        |     P=0.197         P=0.725         P=0.293        |
|COCHRAN-ARMITAGE       |     P=0.610N                                       |     P=0.212                                        |
|FISHER EXACT           |                     P=0.309         P=0.753N       |                     P=0.747N        P=0.324        |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE   9
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/50 (24%)     12/48 (25%)      2/45 (4%)      |    29/48 (60%)     12/46 (26%)     16/48 (33%)     |
|ADJUSTED (b)           |     31.8%           31.9%           11.8%          |     66.6%           38.1%           46.9%          |
|TERMINAL (d)           |     9/34 (26%)      6/28 (21%)      1/11 (9%)      |    19/33 (58%)      8/26 (31%)     10/27 (37%)     |
|FIRST INCIDENCE (DAYS) |      586             537             616           |      610             538             582           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.149N        P=0.508         P=0.130N       |     P=0.043N*       P=0.019N*       P=0.067N       |
|INCIDENTAL TUMOR       |     P=0.034N*       P=0.543         P=0.044N*      |     P=0.008N**      P=0.003N**      P=0.013N*      |
|LOGISTIC REGRESSION    |     P=0.024N*       P=0.567         P=0.028N*      |     P=0.008N**      P=0.003N**      P=0.012N*      |
|COCHRAN-ARMITAGE       |     P=0.011N*                                      |     P=0.005N**                                     |
|FISHER EXACT           |                     P=0.547         P=0.007N**     |                     P<0.001N**      P=0.007N**     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basosquamous Tumor Benign                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.9%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/34 (6%)       0/30 (0%)       0/11 (0%)      |     0/34 (0%)       0/28 (0%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      734 (T)         ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.187N        P=0.266N        P=0.507N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.187N        P=0.266N        P=0.507N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.187N        P=0.266N        P=0.507N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.095N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.247N        P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE  10
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.4%            3.3%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/34 (3%)       1/30 (3%)       0/11 (0%)      |     0/34 (0%)       0/28 (0%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      611             734 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.257N        P=0.513N        P=0.383N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.185N        P=0.511N        P=0.249N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.167N        P=0.493N        P=0.269N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.142N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       4/50 (8%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     10.8%           13.3%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     3/34 (9%)       4/30 (13%)      0/11 (0%)      |     0/34 (0%)       0/28 (0%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      514             734 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.253N        P=0.589         P=0.214N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.282N        P=0.477         P=0.235N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.103N        P=0.620N        P=0.084N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.060N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.643N        P=0.059N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE  11
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      5/50 (10%)      0/50 (0%)      |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |     13.4%           15.6%            0.0%          |      2.9%            3.2%            0.0%          |
|TERMINAL (d)           |     3/34 (9%)       4/30 (13%)      0/11 (0%)      |     1/34 (3%)       0/28 (0%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      514             659             ---           |      735 (T)         687             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.195N        P=0.582         P=0.158N       |     P=0.359N        P=0.719         P=0.539N       |
|INCIDENTAL TUMOR       |     P=0.097N        P=0.637         P=0.066N       |     P=0.336N        P=0.673         P=0.539N       |
|LOGISTIC REGRESSION    |     P=0.061N        P=0.609N        P=0.049N*      |     P=0.350N        P=0.729         P=0.539N       |
|COCHRAN-ARMITAGE       |     P=0.036N*                                      |     P=0.331N                                       |
|FISHER EXACT           |                     P=0.630N        P=0.028N*      |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    46/50 (92%)     45/50 (90%)     37/50 (74%)     |                                                    |
|ADJUSTED (b)           |    100.0%           97.8%          100.0%          |                                                    |
|TERMINAL (d)           |    34/34 (100%)    29/30 (97%)     11/11 (100%)    |                                                    |
|FIRST INCIDENCE (DAYS) |      429             537             499           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.432         P<0.001 **     |                                                    |
|INCIDENTAL TUMOR       |     P=0.529N        P=0.379N        P=0.555N       |                                                    |
|LOGISTIC REGRESSION    |     P=0.234N        P=0.134N        P=0.251N       |                                                    |
|COCHRAN-ARMITAGE       |     P=0.008N**                                     |                                                    |
|FISHER EXACT           |                     P=0.500N        P=0.016N*      |                                                    |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE  12
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       1/49 (2%)       3/47 (6%)      |     4/50 (8%)       3/47 (6%)       2/49 (4%)      |
|ADJUSTED (b)           |      5.7%            3.3%           13.2%          |     11.8%            8.3%            7.1%          |
|TERMINAL (d)           |     1/34 (3%)       1/30 (3%)       0/9 (0%)       |     4/34 (12%)      1/27 (4%)       2/28 (7%)      |
|FIRST INCIDENCE (DAYS) |      688             734 (T)         603           |      735 (T)         577             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.152         P=0.532N        P=0.209        |     P=0.348N        P=0.613N        P=0.429N       |
|INCIDENTAL TUMOR       |     P=0.548         P=0.392N        P=0.576N       |     P=0.331N        P=0.512N        P=0.429N       |
|LOGISTIC REGRESSION    |     P=0.303         P=0.488N        P=0.383        |     P=0.292N        P=0.553N        P=0.429N       |
|COCHRAN-ARMITAGE       |     P=0.383                                        |     P=0.274N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.480        |                     P=0.535N        P=0.349N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       1/49 (2%)       4/47 (9%)      |     5/50 (10%)      3/47 (6%)       2/49 (4%)      |
|ADJUSTED (b)           |      5.7%            3.3%           16.5%          |     14.7%            8.3%            7.1%          |
|TERMINAL (d)           |     1/34 (3%)       1/30 (3%)       0/9 (0%)       |     5/34 (15%)      1/27 (4%)       2/28 (7%)      |
|FIRST INCIDENCE (DAYS) |      688             734 (T)         603           |      735 (T)         577             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.065         P=0.532N        P=0.107        |     P=0.230N        P=0.479N        P=0.298N       |
|INCIDENTAL TUMOR       |     P=0.392         P=0.392N        P=0.689N       |     P=0.214N        P=0.381N        P=0.298N       |
|LOGISTIC REGRESSION    |     P=0.166         P=0.488N        P=0.233        |     P=0.185N        P=0.421N        P=0.298N       |
|COCHRAN-ARMITAGE       |     P=0.224                                        |     P=0.167N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.319        |                     P=0.393N        P=0.226N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE  13
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/49 (0%)       0/47 (0%)      |     1/50 (2%)       1/47 (2%)       2/49 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      2.9%            3.7%            6.3%          |
|TERMINAL (d)           |     0/34 (0%)       0/30 (0%)       0/9 (0%)       |     1/34 (3%)       1/27 (4%)       1/28 (4%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      735 (T)         735 (T)         713           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.338         P=0.710         P=0.458        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.356         P=0.710         P=0.478        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.354         P=0.710         P=0.470        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.373                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.737         P=0.492        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       3/49 (6%)       2/47 (4%)      |     1/50 (2%)       1/47 (2%)       1/49 (2%)      |
|ADJUSTED (b)           |      0.0%            9.7%            6.5%          |      2.9%            3.7%            2.8%          |
|TERMINAL (d)           |     0/34 (0%)       2/30 (7%)       0/9 (0%)       |     1/34 (3%)       1/27 (4%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             721             600           |      735 (T)         735 (T)         713           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.054         P=0.103         P=0.188        |     P=0.603         P=0.710         P=0.742        |
|INCIDENTAL TUMOR       |     P=0.222         P=0.169         P=0.418        |     P=0.619         P=0.710         P=0.761N       |
|LOGISTIC REGRESSION    |     P=0.134         P=0.114         P=0.229        |     P=0.612         P=0.710         P=0.744        |
|COCHRAN-ARMITAGE       |     P=0.190                                        |     P=0.633                                        |
|FISHER EXACT           |                     P=0.121         P=0.237        |                     P=0.737         P=0.747        |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE  14
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       3/49 (6%)       2/47 (4%)      |     2/50 (4%)       2/47 (4%)       3/49 (6%)      |
|ADJUSTED (b)           |      0.0%            9.7%            6.5%          |      5.9%            7.4%            8.9%          |
|TERMINAL (d)           |     0/34 (0%)       2/30 (7%)       0/9 (0%)       |     2/34 (6%)       2/27 (7%)       1/28 (4%)      |
|FIRST INCIDENCE (DAYS) |      ---             721             600           |      735 (T)         735 (T)         713           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.054         P=0.103         P=0.188        |     P=0.353         P=0.610         P=0.453        |
|INCIDENTAL TUMOR       |     P=0.222         P=0.169         P=0.418        |     P=0.379         P=0.610         P=0.483        |
|LOGISTIC REGRESSION    |     P=0.134         P=0.114         P=0.229        |     P=0.371         P=0.610         P=0.461        |
|COCHRAN-ARMITAGE       |     P=0.190                                        |     P=0.398                                        |
|FISHER EXACT           |                     P=0.121         P=0.237        |                     P=0.668         P=0.490        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |    10/50 (20%)      9/50 (18%)      2/50 (4%)      |
|ADJUSTED (b)           |                                                    |     26.4%           26.1%            6.2%          |
|TERMINAL (d)           |                                                    |     7/34 (21%)      5/28 (18%)      1/28 (4%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      630             538             665           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.040N*       P=0.519         P=0.033N*      |
|INCIDENTAL TUMOR       |                                                    |     P=0.020N*       P=0.594N        P=0.023N*      |
|LOGISTIC REGRESSION    |                                                    |     P=0.020N*       P=0.591N        P=0.020N*      |
|COCHRAN-ARMITAGE       |                                                    |     P=0.015N*                                      |
|FISHER EXACT           |                                                    |                     P=0.500N        P=0.014N*      |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE  15
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |    11/50 (22%)      9/50 (18%)      2/50 (4%)      |
|ADJUSTED (b)           |                                                    |     27.9%           26.1%            6.2%          |
|TERMINAL (d)           |                                                    |     7/34 (21%)      5/28 (18%)      1/28 (4%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      537             538             665           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.024N*       P=0.582N        P=0.021N*      |
|INCIDENTAL TUMOR       |                                                    |     P=0.008N**      P=0.460N        P=0.009N**     |
|LOGISTIC REGRESSION    |                                                    |     P=0.010N**      P=0.458N        P=0.009N**     |
|COCHRAN-ARMITAGE       |                                                    |     P=0.008N**                                     |
|FISHER EXACT           |                                                    |                     P=0.402N        P=0.007N**     |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.9%            5.7%            2.6%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/34 (3%)       1/30 (3%)       0/11 (0%)      |     0/34 (0%)       0/28 (0%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      734 (T)         649             527           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.428         P=0.483         P=0.631        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.520         P=0.608         P=0.588        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.614         P=0.515         P=0.770N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.622N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500         P=0.753N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE  16
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/50 (28%)      9/50 (18%)      5/50 (10%)     |     9/50 (18%)     13/50 (26%)      6/50 (12%)     |
|ADJUSTED (b)           |     34.8%           20.4%           27.8%          |     22.8%           32.3%           17.5%          |
|TERMINAL (d)           |     9/34 (26%)      1/30 (3%)       2/11 (18%)     |     5/34 (15%)      3/28 (11%)      3/28 (11%)     |
|FIRST INCIDENCE (DAYS) |      483             600             600           |      642             576             483           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.190N        P=0.193N        P=0.364N       |     P=0.386N        P=0.122         P=0.390N       |
|INCIDENTAL TUMOR       |     P=0.007N**      P=0.108N        P=0.087N       |     P=0.237N        P=0.179         P=0.266N       |
|LOGISTIC REGRESSION    |     P=0.004N**      P=0.086N        P=0.048N*      |     P=0.257N        P=0.172         P=0.293N       |
|COCHRAN-ARMITAGE       |     P=0.015N*                                      |     P=0.261N                                       |
|FISHER EXACT           |                     P=0.171N        P=0.020N*      |                     P=0.235         P=0.288N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            2.4%          |      5.9%            0.0%            0.0%          |
|TERMINAL (d)           |     0/34 (0%)       0/30 (0%)       0/11 (0%)      |     2/34 (6%)       0/28 (0%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             393           |      735 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.246           (e)           P=0.469        |     P=0.120N        P=0.282N        P=0.282N       |
|INCIDENTAL TUMOR       |     P=0.233           (e)           P=0.419        |     P=0.120N        P=0.282N        P=0.282N       |
|LOGISTIC REGRESSION    |     P=0.430           (e)           P=0.666        |     P=0.120N        P=0.282N        P=0.282N       |
|COCHRAN-ARMITAGE       |     P=0.269                                        |     P=0.095N                                       |
|FISHER EXACT           |                       (e)           P=0.500        |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE  17
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            2.4%          |      5.9%            0.0%            0.0%          |
|TERMINAL (d)           |     0/34 (0%)       0/30 (0%)       0/11 (0%)      |     2/34 (6%)       0/28 (0%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             393           |      735 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.246           (e)           P=0.469        |     P=0.120N        P=0.282N        P=0.282N       |
|INCIDENTAL TUMOR       |     P=0.233           (e)           P=0.419        |     P=0.120N        P=0.282N        P=0.282N       |
|LOGISTIC REGRESSION    |     P=0.430           (e)           P=0.666        |     P=0.120N        P=0.282N        P=0.282N       |
|COCHRAN-ARMITAGE       |     P=0.269                                        |     P=0.095N                                       |
|FISHER EXACT           |                       (e)           P=0.500        |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       4/50 (8%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.9%            3.3%           14.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/34 (6%)       1/30 (3%)       0/11 (0%)      |     0/34 (0%)       0/28 (0%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      734 (T)         734 (T)         356           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.076         P=0.544N        P=0.121        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.339         P=0.544N        P=0.528        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.247         P=0.544N        P=0.337        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.238                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.339        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE  18
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    46/50 (92%)     47/50 (94%)     38/50 (76%)     |    41/50 (82%)     28/50 (56%)     33/50 (66%)     |
|ADJUSTED (b)           |    100.0%           97.9%          100.0%          |     87.1%           72.8%           80.0%          |
|TERMINAL (d)           |    34/34 (100%)    29/30 (97%)     11/11 (100%)    |    28/34 (82%)     18/28 (64%)     20/28 (71%)     |
|FIRST INCIDENCE (DAYS) |      429             537             499           |      537             538             543           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.304         P<0.001 **     |     P=0.372N        P=0.199N        P=0.413N       |
|INCIDENTAL TUMOR       |     P=0.549         P=0.636N        P=0.592        |     P=0.104N        P=0.032N*       P=0.122N       |
|LOGISTIC REGRESSION    |     P=0.341N        P=0.417N        P=0.420N       |     P=0.113N        P=0.032N*       P=0.131N       |
|COCHRAN-ARMITAGE       |     P=0.012N*                                      |     P=0.054N                                       |
|FISHER EXACT           |                     P=0.500         P=0.027N*      |                     P=0.004N**      P=0.055N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    25/50 (50%)     21/50 (42%)     14/50 (28%)     |    17/50 (34%)     18/50 (36%)     10/50 (20%)     |
|ADJUSTED (b)           |     55.3%           46.2%           52.1%          |     40.4%           44.1%           27.4%          |
|TERMINAL (d)           |    14/34 (41%)      7/30 (23%)      2/11 (18%)     |    10/34 (29%)      6/28 (21%)      5/28 (18%)     |
|FIRST INCIDENCE (DAYS) |      377             337             356           |      537             576             319           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.515         P=0.339N        P=0.478        |     P=0.202N        P=0.255         P=0.193N       |
|INCIDENTAL TUMOR       |     P<0.001N**      P=0.072N        P=0.009N**     |     P=0.064N        P=0.411         P=0.052N       |
|LOGISTIC REGRESSION    |     P=0.005N**      P=0.241N        P=0.013N*      |     P=0.069N        P=0.459         P=0.062N       |
|COCHRAN-ARMITAGE       |     P=0.016N*                                      |     P=0.078N                                       |
|FISHER EXACT           |                     P=0.274N        P=0.020N*      |                     P=0.500         P=0.088N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05053 TEST: 01                                                 PAGE  19
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.1 G/KG        0.2 G/KG      |      VEHICLE         0.1 G/KG        0.2 G/KG      |
|                       |      46 VM           46 LM           46 HM         |      46 VF           46 LF           46 HF         |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    49/50 (98%)     49/50 (98%)     42/50 (84%)     |    47/50 (94%)     37/50 (74%)     38/50 (76%)     |
|ADJUSTED (b)           |    100.0%           98.0%          100.0%          |     94.0%           86.0%           86.0%          |
|TERMINAL (d)           |    34/34 (100%)    29/30 (97%)     11/11 (100%)    |    31/34 (91%)     22/28 (79%)     22/28 (79%)     |
|FIRST INCIDENCE (DAYS) |      377             337             356           |      537             538             319           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.389         P<0.001 **     |     P=0.376N        P=0.479N        P=0.401N       |
|INCIDENTAL TUMOR       |     P=0.405N        P=0.747N        P=0.909        |     P=0.026N*       P=0.083N        P=0.020N*      |
|LOGISTIC REGRESSION    |     P=0.196N        P=0.612N        P=0.926N       |     P=0.031N*       P=0.073N        P=0.023N*      |
|COCHRAN-ARMITAGE       |     P=0.005N**                                     |     P=0.015N*                                      |
|FISHER EXACT           |                     P=0.753N        P=0.015N*      |                     P=0.006N**      P=0.011N*      |
|=================================================================================================================================|
 
 (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).