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TDMS Study 05109-11 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                      TRIETHANOLAMINE                                    DATE: 05/19/95       
EXPERIMENT: 05109 TEST: 11                                                                                     TIME: 23:42:26       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85226                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61621D       
PATHOLOGIST: J. TOFF                                                                                           CAS: 102-71-6        
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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: Battelle Columbus                                      TRIETHANOLAMINE                                    DATE: 05/19/95       
EXPERIMENT: 05109 TEST: 11                                                                                     TIME: 23:42:26       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85226                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61621D       
PATHOLOGIST: J. TOFF                                                                                           CAS: 102-71-6        


                                                    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 Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Clitoral/Preputial 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: Battelle Columbus                                      TRIETHANOLAMINE                                    DATE: 05/19/95       
EXPERIMENT: 05109 TEST: 11                                                                                     TIME: 23:42:26       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85226                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61621D       
PATHOLOGIST: J. TOFF                                                                                           CAS: 102-71-6        


                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                        IN THE ANALYSIS OF THE STUDY OF TRIETHANOLAMINE
              ====================================================================================================
                                                           MALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Adrenal Medulla               Pheochromocytoma Benign
                                            Pheochromocytoma: Benign, Complex, Malignant, NOS
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
              Skin                          Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal
                                             Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma
                                            Keratoacanthoma
                                            Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
                                            Squamous Cell Papilloma, Papilloma, or Keratoacanthoma
              Testes                        Adenoma
              All Organs                    Benign Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
                                                           FEMALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Thyroid Gland: C-Cell         Adenoma
                                            Carcinoma or Adenoma
              Uterus                        Polyp Stromal
              ====================================================================================================
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE   1
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    8/60 (13%)   5/59 (8%)    3/60 (5%)  |  0/60 (0%)    2/60 (3%)    0/60 (0%)    1/59 (2%)  |
|ADJUSTED (b)           |  11.8%        44.9%        18.3%        11.8%      |   0.0%         6.3%         0.0%         2.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  1/21 (5%)    4/11 (36%)   2/18 (11%)   1/19 (5%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   702          573          456 (I)      558       |   ---          708          ---          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.375N     P=0.025 *    P=0.337      P=0.592    |  P=0.467      P=0.247        (e)        P=0.500    |
|INCIDENTAL TUMOR       |  P=0.395N     P=0.070      P=0.350      P=0.654    |  P=0.489      P=0.179        (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P=0.374N     P=0.065      P=0.345      P=0.635    |  P=0.535      P=0.237        (e)        P=0.614    |
|COCHRAN-ARMITAGE       |  P=0.359N                                          |  P=0.535                                           |
|FISHER EXACT           |               P=0.102      P=0.349      P=0.660N   |               P=0.248        (e)        P=0.496    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    8/60 (13%)   6/59 (10%)   3/60 (5%)  |  0/60 (0%)    2/60 (3%)    0/60 (0%)    1/59 (2%)  |
|ADJUSTED (b)           |  11.8%        44.9%        20.4%        11.8%      |   0.0%         6.3%         0.0%         2.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  1/21 (5%)    4/11 (36%)   2/18 (11%)   1/19 (5%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   702          573          456 (I)      558       |   ---          708          ---          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.397N     P=0.025 *    P=0.230      P=0.592    |  P=0.467      P=0.247        (e)        P=0.500    |
|INCIDENTAL TUMOR       |  P=0.423N     P=0.070      P=0.244      P=0.654    |  P=0.489      P=0.179        (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P=0.392N     P=0.065      P=0.233      P=0.635    |  P=0.535      P=0.237        (e)        P=0.614    |
|COCHRAN-ARMITAGE       |  P=0.378N                                          |  P=0.535                                           |
|FISHER EXACT           |               P=0.102      P=0.237      P=0.660N   |               P=0.248        (e)        P=0.496    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE   2
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/58 (2%)    1/60 (2%)  |  2/58 (3%)    6/59 (10%)   2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         1.7%         3.0%      |   8.0%        17.3%         8.0%         7.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    0/18 (0%)    0/19 (0%)  |  2/25 (8%)    3/29 (10%)   2/25 (8%)    1/18 (6%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          353          642       |   729 (T)      579          729 (T)      389       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.247        (e)        P=0.500      P=0.500    |  P=0.511N     P=0.170      P=0.697      P=0.597    |
|INCIDENTAL TUMOR       |  P=0.103        (e)        P=0.638      P=0.464    |  P=0.417N     P=0.138      P=0.697      P=0.701N   |
|LOGISTIC REGRESSION    |  P=0.202        (e)        P=0.382      P=0.497    |  P=0.425N     P=0.139      P=0.697      P=0.670    |
|COCHRAN-ARMITAGE       |  P=0.236                                           |  P=0.329N                                          |
|FISHER EXACT           |                 (e)        P=0.492      P=0.500    |               P=0.141      P=0.678N     P=0.678N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    0/58 (0%)    0/60 (0%)  |  2/58 (3%)    0/59 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.8%         5.9%         0.0%         0.0%      |   5.8%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    0/18 (0%)    0/19 (0%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   705          719          ---          ---       |   593          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.246N     P=0.696      P=0.500N     P=0.543N   |  P=0.137N     P=0.237N     P=0.236N     P=0.320N   |
|INCIDENTAL TUMOR       |  P=0.235N     P=0.693N     P=0.500N     P=0.483N   |  P=0.115N     P=0.295N     P=0.245N     P=0.248N   |
|LOGISTIC REGRESSION    |  P=0.243N     P=0.720      P=0.508N     P=0.517N   |  P=0.117N     P=0.234N     P=0.231N     P=0.260N   |
|COCHRAN-ARMITAGE       |  P=0.237N                                          |  P=0.112N                                          |
|FISHER EXACT           |               P=0.752N     P=0.508N     P=0.500N   |               P=0.244N     P=0.239N     P=0.239N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE   3
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    1/58 (2%)    1/60 (2%)  |  4/58 (7%)    6/59 (10%)   2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |   3.8%         5.9%         1.7%         3.0%      |  13.3%        17.3%         8.0%         7.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    0/18 (0%)    0/19 (0%)  |  2/25 (8%)    3/29 (10%)   2/25 (8%)    1/18 (6%)  |
|FIRST INCIDENCE (DAYS) |   705          719          353          642       |   593          579          729 (T)      389       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.628      P=0.696      P=0.760      P=0.737    |  P=0.276N     P=0.421      P=0.336N     P=0.479N   |
|INCIDENTAL TUMOR       |  P=0.559      P=0.693N     P=0.686N     P=0.750    |  P=0.190N     P=0.343      P=0.342N     P=0.340N   |
|LOGISTIC REGRESSION    |  P=0.632      P=0.720      P=0.744      P=0.752    |  P=0.201N     P=0.379      P=0.325N     P=0.377N   |
|COCHRAN-ARMITAGE       |  P=0.632                                           |  P=0.142N                                          |
|FISHER EXACT           |               P=0.752N     P=0.744      P=0.752N   |               P=0.382      P=0.324N     P=0.324N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    3/59 (5%)    5/60 (8%)  |  0/60 (0%)    2/60 (3%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   4.8%        17.1%        14.5%        23.1%      |   0.0%         6.6%         0.0%         6.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  1/21 (5%)    1/11 (9%)    2/18 (11%)   4/19 (21%) |  0/25 (0%)    1/29 (3%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      667          710          563       |   ---          715          ---          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.088      P=0.167      P=0.275      P=0.080    |  P=0.173      P=0.264        (e)        P=0.193    |
|INCIDENTAL TUMOR       |  P=0.084      P=0.244      P=0.272      P=0.077    |  P=0.189      P=0.226        (e)        P=0.200    |
|LOGISTIC REGRESSION    |  P=0.070      P=0.241      P=0.300      P=0.083    |  P=0.222      P=0.240        (e)        P=0.259    |
|COCHRAN-ARMITAGE       |  P=0.081                                           |  P=0.248                                           |
|FISHER EXACT           |               P=0.309      P=0.303      P=0.103    |               P=0.248        (e)        P=0.248    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE   4
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    3/59 (5%)    5/60 (8%)  |  0/60 (0%)    2/60 (3%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |   4.8%        17.1%        14.5%        23.1%      |   0.0%         6.6%         4.0%         6.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  1/21 (5%)    1/11 (9%)    2/18 (11%)   4/19 (21%) |  0/25 (0%)    1/29 (3%)    1/25 (4%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      667          710          563       |   ---          715          729 (T)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.088      P=0.167      P=0.275      P=0.080    |  P=0.161      P=0.264      P=0.500      P=0.193    |
|INCIDENTAL TUMOR       |  P=0.084      P=0.244      P=0.272      P=0.077    |  P=0.174      P=0.226      P=0.500      P=0.200    |
|LOGISTIC REGRESSION    |  P=0.070      P=0.241      P=0.300      P=0.083    |  P=0.201      P=0.240      P=0.500      P=0.259    |
|COCHRAN-ARMITAGE       |  P=0.081                                           |  P=0.246                                           |
|FISHER EXACT           |               P=0.309      P=0.303      P=0.103    |               P=0.248      P=0.500      P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    4/59 (7%)    2/60 (3%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         5.6%        15.2%        10.5%      |   4.0%         2.9%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    1/18 (6%)    2/19 (11%) |  1/25 (4%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          718          649          729 (T)   |   729 (T)      678          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.179      P=0.460      P=0.060      P=0.215    |  P=0.287N     P=0.741N     P=0.500N     P=0.566N   |
|INCIDENTAL TUMOR       |  P=0.169      P=0.562      P=0.063      P=0.215    |  P=0.281N     P=0.749      P=0.500N     P=0.566N   |
|LOGISTIC REGRESSION    |  P=0.154      P=0.454      P=0.060      P=0.215    |  P=0.273N     P=0.762      P=0.500N     P=0.566N   |
|COCHRAN-ARMITAGE       |  P=0.165                                           |  P=0.236N                                          |
|FISHER EXACT           |               P=0.500      P=0.057      P=0.248    |               P=0.752N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE   5
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    0/60 (0%)    0/59 (0%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   8.9%         0.0%         0.0%         5.3%      |   0.0%         0.0%         0.0%         4.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    0/18 (0%)    1/19 (5%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   550          ---          ---          729 (T)   |   ---          ---          ---          700       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.256N     P=0.160N     P=0.129N     P=0.343N   |  P=0.142        (e)          (e)        P=0.416    |
|INCIDENTAL TUMOR       |  P=0.276N     P=0.064N     P=0.107N     P=0.340N   |  P=0.163        (e)          (e)        P=0.427    |
|LOGISTIC REGRESSION    |  P=0.252N     P=0.124N     P=0.124N     P=0.316N   |  P=0.158        (e)          (e)        P=0.439    |
|COCHRAN-ARMITAGE       |  P=0.249N                                          |  P=0.199                                           |
|FISHER EXACT           |               P=0.122N     P=0.125N     P=0.309N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    0/60 (0%)    1/59 (2%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   8.9%         0.0%         4.5%         5.3%      |   0.0%         0.0%         0.0%         4.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    0/18 (0%)    1/19 (5%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   550          ---          722          729 (T)   |   ---          ---          ---          700       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.304N     P=0.160N     P=0.316N     P=0.343N   |  P=0.142        (e)          (e)        P=0.416    |
|INCIDENTAL TUMOR       |  P=0.326N     P=0.064N     P=0.275N     P=0.340N   |  P=0.163        (e)          (e)        P=0.427    |
|LOGISTIC REGRESSION    |  P=0.304N     P=0.124N     P=0.312N     P=0.316N   |  P=0.158        (e)          (e)        P=0.439    |
|COCHRAN-ARMITAGE       |  P=0.297N                                          |  P=0.199                                           |
|FISHER EXACT           |               P=0.122N     P=0.316N     P=0.309N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE   6
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    0/60 (0%)    1/59 (2%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   8.9%         0.0%         4.5%         5.3%      |   0.0%         0.0%         0.0%         4.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    0/18 (0%)    1/19 (5%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   550          ---          722          729 (T)   |   ---          ---          ---          700       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.304N     P=0.160N     P=0.316N     P=0.343N   |  P=0.142        (e)          (e)        P=0.416    |
|INCIDENTAL TUMOR       |  P=0.326N     P=0.064N     P=0.275N     P=0.340N   |  P=0.163        (e)          (e)        P=0.427    |
|LOGISTIC REGRESSION    |  P=0.304N     P=0.124N     P=0.312N     P=0.316N   |  P=0.158        (e)          (e)        P=0.439    |
|COCHRAN-ARMITAGE       |  P=0.297N                                          |  P=0.199                                           |
|FISHER EXACT           |               P=0.122N     P=0.316N     P=0.309N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    0/59 (0%)    0/60 (0%)  |  0/60 (0%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.8%         8.3%         0.0%         0.0%      |   0.0%         6.9%         4.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/21 (5%)    0/11 (0%)    0/18 (0%)    0/19 (0%)  |  0/25 (0%)    2/29 (7%)    1/25 (4%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      727          ---          ---       |   ---          729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.244N     P=0.615      P=0.531N     P=0.520N   |  P=0.556N     P=0.271      P=0.500        (e)      |
|INCIDENTAL TUMOR       |  P=0.237N     P=0.730      P=0.531N     P=0.520N   |  P=0.556N     P=0.271      P=0.500        (e)      |
|LOGISTIC REGRESSION    |  P=0.239N     P=0.676      P=0.531N     P=0.520N   |  P=0.556N     P=0.271      P=0.500        (e)      |
|COCHRAN-ARMITAGE       |  P=0.236N                                          |  P=0.461N                                          |
|FISHER EXACT           |               P=0.752N     P=0.504N     P=0.500N   |               P=0.248      P=0.500        (e)      |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE   7
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    0/59 (0%)    0/60 (0%)  | 13/60 (22%)  13/60 (22%)  10/60 (17%)   8/60 (13%) |
|ADJUSTED (b)           |   4.8%         0.0%         0.0%         0.0%      |  40.8%        44.8%        28.4%        32.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/21 (5%)    0/11 (0%)    0/18 (0%)    0/19 (0%)  |  7/25 (28%)  13/29 (45%)   3/25 (12%)   4/18 (22%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   636          729 (T)      619          459       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.308N     P=0.629N     P=0.531N     P=0.520N   |  P=0.383N     P=0.451N     P=0.335N     P=0.460N   |
|INCIDENTAL TUMOR       |  P=0.308N     P=0.629N     P=0.531N     P=0.520N   |  P=0.274N     P=0.530N     P=0.362N     P=0.327N   |
|LOGISTIC REGRESSION    |  P=0.308N     P=0.629N     P=0.531N     P=0.520N   |  P=0.300N     P=0.583N     P=0.327N     P=0.380N   |
|COCHRAN-ARMITAGE       |  P=0.306N                                          |  P=0.107N                                          |
|FISHER EXACT           |               P=0.500N     P=0.504N     P=0.500N   |               P=0.588N     P=0.322N     P=0.168N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    0/59 (0%)    0/60 (0%)  | 13/60 (22%)  13/60 (22%)  11/60 (18%)   8/60 (13%) |
|ADJUSTED (b)           |   4.8%         0.0%         0.0%         0.0%      |  40.8%        44.8%        31.7%        32.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/21 (5%)    0/11 (0%)    0/18 (0%)    0/19 (0%)  |  7/25 (28%)  13/29 (45%)   4/25 (16%)   4/18 (22%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   636          729 (T)      619          459       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.308N     P=0.629N     P=0.531N     P=0.520N   |  P=0.404N     P=0.451N     P=0.418N     P=0.460N   |
|INCIDENTAL TUMOR       |  P=0.308N     P=0.629N     P=0.531N     P=0.520N   |  P=0.293N     P=0.530N     P=0.459N     P=0.327N   |
|LOGISTIC REGRESSION    |  P=0.308N     P=0.629N     P=0.531N     P=0.520N   |  P=0.321N     P=0.583N     P=0.420N     P=0.380N   |
|COCHRAN-ARMITAGE       |  P=0.306N                                          |  P=0.115N                                          |
|FISHER EXACT           |               P=0.500N     P=0.504N     P=0.500N   |               P=0.588N     P=0.410N     P=0.168N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE   8
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    1/60 (2%)    0/59 (0%)    0/60 (0%)  | 13/60 (22%)  13/60 (22%)  11/60 (18%)   8/60 (13%) |
|ADJUSTED (b)           |   9.5%         8.3%         0.0%         0.0%      |  40.8%        44.8%        31.7%        32.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/21 (10%)   0/11 (0%)    0/18 (0%)    0/19 (0%)  |  7/25 (28%)  13/29 (45%)   4/25 (16%)   4/18 (22%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      727          ---          ---       |   636          729 (T)      619          459       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.109N     P=0.713N     P=0.272N     P=0.259N   |  P=0.404N     P=0.451N     P=0.418N     P=0.460N   |
|INCIDENTAL TUMOR       |  P=0.104N     P=0.612N     P=0.272N     P=0.259N   |  P=0.293N     P=0.530N     P=0.459N     P=0.327N   |
|LOGISTIC REGRESSION    |  P=0.103N     P=0.655N     P=0.272N     P=0.259N   |  P=0.321N     P=0.583N     P=0.420N     P=0.380N   |
|COCHRAN-ARMITAGE       |  P=0.102N                                          |  P=0.115N                                          |
|FISHER EXACT           |               P=0.500N     P=0.252N     P=0.248N   |               P=0.588N     P=0.410N     P=0.168N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 38/60 (63%)  41/60 (68%)  37/58 (64%)  43/60 (72%) | 33/60 (55%)  27/60 (45%)  32/60 (53%)  27/60 (45%) |
|ADJUSTED (b)           |  87.6%        89.0%        84.0%        95.3%      |  81.2%        66.7%        75.4%        80.0%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   3/10 (30%)   5/10 (50%)   2/10 (20%) |  0/10 (0%)    1/10 (10%)   2/10 (20%)   4/10 (40%) |
|TERMINAL (d)           | 16/21 (76%)   7/11 (64%)  11/17 (65%)  17/19 (89%) | 18/25 (72%)  16/29 (55%)  15/25 (60%)  12/18 (67%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      416          379          404       |   390          457 (I)      457 (I)      429       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.296      P=0.050 *    P=0.447      P=0.149    |  P=0.194      P=0.112N     P=0.502N     P=0.359    |
|INCIDENTAL TUMOR       |  P=0.192      P=0.436      P=0.530      P=0.169    |  P=0.455      P=0.130N     P=0.524N     P=0.477N   |
|LOGISTIC REGRESSION    |  P=0.170      P=0.323      P=0.533      P=0.131    |  P=0.437      P=0.174N     P=0.528N     P=0.517N   |
|COCHRAN-ARMITAGE       |  P=0.227                                           |  P=0.236N                                          |
|FISHER EXACT           |               P=0.350      P=0.556      P=0.218    |               P=0.181N     P=0.500N     P=0.181N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE   9
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,                                                       |
|     malignant or NOS), or Trichoepithelioma                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    0/59 (0%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.8%        13.3%         0.0%         5.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/21 (5%)    0/11 (0%)    0/18 (0%)    1/19 (5%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      724          ---          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.497N     P=0.339      P=0.531N     P=0.741    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.494N     P=0.499      P=0.531N     P=0.741    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.508N     P=0.628N     P=0.531N     P=0.741    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.501N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500      P=0.504N     P=0.752N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal                                                       |
|     Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/60 (13%)   2/60 (3%)    2/59 (3%)    3/60 (5%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  30.2%        13.3%        11.1%        15.8%      |   4.0%         3.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/21 (24%)   0/11 (0%)    2/18 (11%)   3/19 (16%) |  1/25 (4%)    1/29 (3%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   550          724          729 (T)      729 (T)   |   729 (T)      729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.094N     P=0.171N     P=0.070N     P=0.129N   |  P=0.282N     P=0.729N     P=0.500N     P=0.566N   |
|INCIDENTAL TUMOR       |  P=0.096N     P=0.070N     P=0.061N     P=0.130N   |  P=0.282N     P=0.729N     P=0.500N     P=0.566N   |
|LOGISTIC REGRESSION    |  P=0.100N     P=0.070N     P=0.049N*    P=0.122N   |  P=0.282N     P=0.729N     P=0.500N     P=0.566N   |
|COCHRAN-ARMITAGE       |  P=0.096N                                          |  P=0.236N                                          |
|FISHER EXACT           |               P=0.047N*    P=0.050N     P=0.102N   |               P=0.752N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE  10
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    2/60 (3%)    2/59 (3%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   6.9%         4.7%         8.2%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    1/18 (6%)    0/19 (0%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   586          456 (I)      617          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.176N     P=0.624      P=0.655      P=0.274N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.191N     P=0.590N     P=0.685N     P=0.250N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.165N     P=0.693N     P=0.688      P=0.244N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.165N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.691N     P=0.684      P=0.248N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    2/60 (3%)    3/59 (5%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  14.0%         4.7%         9.8%         7.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/21 (5%)    0/11 (0%)    1/18 (6%)    1/19 (5%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   586          456 (I)      431          502       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.325N     P=0.468N     P=0.551N     P=0.381N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.313N     P=0.271N     P=0.516N     P=0.331N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.321N     P=0.342N     P=0.510N     P=0.349N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.321N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.340N     P=0.509N     P=0.340N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE  11
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    1/59 (2%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   7.6%         0.0%         1.8%         7.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/21 (5%)    0/11 (0%)    0/18 (0%)    1/19 (5%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   642          ---          431          502       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.481      P=0.339N     P=0.531N     P=0.673    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.537      P=0.258N     P=0.534N     P=0.678N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.469      P=0.262N     P=0.507N     P=0.686    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.469                                           |    (e)                                             |
|FISHER EXACT           |               P=0.248N     P=0.506N     P=0.691N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    0/60 (0%)    2/59 (3%)    2/60 (3%)  |  0/60 (0%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  21.7%         0.0%        11.1%        10.5%      |   0.0%         3.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/21 (19%)   0/11 (0%)    2/18 (11%)   2/19 (11%) |  0/25 (0%)    1/29 (3%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   670          ---          729 (T)      729 (T)   |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.252N     P=0.100N     P=0.273N     P=0.257N   |  P=0.627N     P=0.530        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.248N     P=0.079N     P=0.262N     P=0.242N   |  P=0.627N     P=0.530        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.273N     P=0.052N     P=0.213N     P=0.256N   |  P=0.627N     P=0.530        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.265N                                          |  P=0.567N                                          |
|FISHER EXACT           |               P=0.029N*    P=0.226N     P=0.219N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE  12
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Neurofibrosarcoma or Schwannoma (malignant or NOS)                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    0/59 (0%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         7.6%         0.0%         0.0%      |   3.4%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    0/18 (0%)    0/19 (0%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          635          ---          ---       |   718          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.407N     P=0.199        (e)          (e)      |  P=0.346N     P=0.493N     P=0.493N     P=0.584N   |
|INCIDENTAL TUMOR       |  P=0.435N     P=0.321        (e)          (e)      |  P=0.340N     P=0.552N     P=0.516N     P=0.573N   |
|LOGISTIC REGRESSION    |  P=0.409N     P=0.228        (e)          (e)      |  P=0.342N     P=0.499N     P=0.501N     P=0.576N   |
|COCHRAN-ARMITAGE       |  P=0.406N                                          |  P=0.306N                                          |
|FISHER EXACT           |               P=0.248        (e)          (e)      |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Neurofibrosarcoma, Neurofibroma, or Schwannoma (benign, malignant or NOS)                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    0/59 (0%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         7.6%         0.0%         0.0%      |   3.4%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    0/18 (0%)    0/19 (0%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          635          ---          ---       |   718          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.407N     P=0.199        (e)          (e)      |  P=0.346N     P=0.493N     P=0.493N     P=0.584N   |
|INCIDENTAL TUMOR       |  P=0.435N     P=0.321        (e)          (e)      |  P=0.340N     P=0.552N     P=0.516N     P=0.573N   |
|LOGISTIC REGRESSION    |  P=0.409N     P=0.228        (e)          (e)      |  P=0.342N     P=0.499N     P=0.501N     P=0.576N   |
|COCHRAN-ARMITAGE       |  P=0.406N                                          |  P=0.306N                                          |
|FISHER EXACT           |               P=0.248        (e)          (e)      |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE  13
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    0/59 (0%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.8%         0.0%         0.0%         7.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/21 (5%)    0/11 (0%)    0/18 (0%)    1/19 (5%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          502       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.261      P=0.629N     P=0.531N     P=0.474    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.309      P=0.629N     P=0.531N     P=0.544    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.243      P=0.629N     P=0.531N     P=0.490    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.246                                           |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.504N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    0/60 (0%)    1/59 (2%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   9.7%         0.0%         5.6%         0.0%      |   4.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/21 (5%)    0/11 (0%)    1/18 (6%)    0/19 (0%)  |  1/25 (4%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   550          ---          729 (T)      ---       |   729 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.091N     P=0.180N     P=0.343N     P=0.134N   |  P=0.342N     P=0.470N     P=0.500N     P=0.566N   |
|INCIDENTAL TUMOR       |  P=0.098N     P=0.104N     P=0.318N     P=0.149N   |  P=0.342N     P=0.470N     P=0.500N     P=0.566N   |
|LOGISTIC REGRESSION    |  P=0.089N     P=0.125N     P=0.313N     P=0.124N   |  P=0.342N     P=0.470N     P=0.500N     P=0.566N   |
|COCHRAN-ARMITAGE       |  P=0.087N                                          |  P=0.306N                                          |
|FISHER EXACT           |               P=0.122N     P=0.316N     P=0.122N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE  14
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/60 (12%)   0/60 (0%)    2/59 (3%)    2/60 (3%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  25.8%         0.0%        11.1%        10.5%      |   4.0%         3.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/21 (19%)   0/11 (0%)    2/18 (11%)   2/19 (11%) |  1/25 (4%)    1/29 (3%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   550          ---          729 (T)      729 (T)   |   729 (T)      729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.094N     P=0.035N*    P=0.113N     P=0.105N   |  P=0.282N     P=0.729N     P=0.500N     P=0.566N   |
|INCIDENTAL TUMOR       |  P=0.100N     P=0.016N*    P=0.099N     P=0.105N   |  P=0.282N     P=0.729N     P=0.500N     P=0.566N   |
|LOGISTIC REGRESSION    |  P=0.101N     P=0.013N*    P=0.084N     P=0.096N   |  P=0.282N     P=0.729N     P=0.500N     P=0.566N   |
|COCHRAN-ARMITAGE       |  P=0.097N                                          |  P=0.236N                                          |
|FISHER EXACT           |               P=0.006N**   P=0.085N     P=0.081N   |               P=0.752N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/60 (12%)   0/60 (0%)    2/59 (3%)    2/60 (3%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  25.8%         0.0%        11.1%        10.5%      |   4.0%         3.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/21 (19%)   0/11 (0%)    2/18 (11%)   2/19 (11%) |  1/25 (4%)    1/29 (3%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   550          ---          729 (T)      729 (T)   |   729 (T)      729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.094N     P=0.035N*    P=0.113N     P=0.105N   |  P=0.282N     P=0.729N     P=0.500N     P=0.566N   |
|INCIDENTAL TUMOR       |  P=0.100N     P=0.016N*    P=0.099N     P=0.105N   |  P=0.282N     P=0.729N     P=0.500N     P=0.566N   |
|LOGISTIC REGRESSION    |  P=0.101N     P=0.013N*    P=0.084N     P=0.096N   |  P=0.282N     P=0.729N     P=0.500N     P=0.566N   |
|COCHRAN-ARMITAGE       |  P=0.097N                                          |  P=0.236N                                          |
|FISHER EXACT           |               P=0.006N**   P=0.085N     P=0.081N   |               P=0.752N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE  15
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 34/60 (57%)  40/60 (67%)  37/59 (63%)  29/60 (48%) |                                                    |
|ADJUSTED (b)           |  86.1%       100.0%        87.0%        77.8%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   7/10 (70%)   4/10 (40%)   4/10 (40%) |                                                    |
|TERMINAL (d)           | 16/21 (76%)  11/11 (100%) 13/18 (72%)  12/19 (63%) |                                                    |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      353          456 (I)   |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.162N     P=0.006 **   P=0.254      P=0.420N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.149N     P=0.067      P=0.293      P=0.310N   |                                                    |
|LOGISTIC REGRESSION    |  P=0.115N     P=0.093      P=0.282      P=0.272N   |                                                    |
|COCHRAN-ARMITAGE       |  P=0.110N                                          |                                                    |
|FISHER EXACT           |               P=0.174      P=0.314      P=0.232N   |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/60 (12%)   4/60 (7%)    8/59 (14%)   6/60 (10%) |  1/60 (2%)    2/60 (3%)    2/60 (3%)    5/59 (8%)  |
|ADJUSTED (b)           |  27.1%        17.3%        24.8%        20.1%      |   4.0%         6.9%         8.0%        20.5%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/21 (24%)   1/11 (9%)    2/18 (11%)   2/19 (11%) |  1/25 (4%)    2/29 (7%)    2/25 (8%)    3/18 (17%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      573          456 (I)      459       |   729 (T)      729 (T)      729 (T)      429       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.547      P=0.508N     P=0.436      P=0.552N   |  P=0.015 *    P=0.552      P=0.500      P=0.053    |
|INCIDENTAL TUMOR       |  P=0.494      P=0.386N     P=0.467      P=0.534N   |  P=0.026 *    P=0.552      P=0.500      P=0.091    |
|LOGISTIC REGRESSION    |  P=0.534      P=0.294N     P=0.484      P=0.520N   |  P=0.022 *    P=0.552      P=0.500      P=0.069    |
|COCHRAN-ARMITAGE       |  P=0.541                                           |  P=0.048 *                                         |
|FISHER EXACT           |               P=0.264N     P=0.486      P=0.500N   |               P=0.500      P=0.500      P=0.100    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE  16
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/60 (12%)   5/60 (8%)    9/59 (15%)   6/60 (10%) |  1/60 (2%)    2/60 (3%)    2/60 (3%)    6/59 (10%) |
|ADJUSTED (b)           |  27.1%        19.3%        28.2%        20.1%      |   4.0%         6.9%         8.0%        25.8%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/21 (24%)   1/11 (9%)    2/18 (11%)   2/19 (11%) |  1/25 (4%)    2/29 (7%)    2/25 (8%)    4/18 (22%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      558          456 (I)      459       |   729 (T)      729 (T)      729 (T)      429       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.533N     P=0.617      P=0.339      P=0.552N   |  P=0.004 **   P=0.552      P=0.500      P=0.024 *  |
|INCIDENTAL TUMOR       |  P=0.512      P=0.490N     P=0.368      P=0.534N   |  P=0.008 **   P=0.552      P=0.500      P=0.043 *  |
|LOGISTIC REGRESSION    |  P=0.551N     P=0.409N     P=0.377      P=0.520N   |  P=0.007 **   P=0.552      P=0.500      P=0.032 *  |
|COCHRAN-ARMITAGE       |  P=0.543N                                          |  P=0.020 *                                         |
|FISHER EXACT           |               P=0.381N     P=0.381      P=0.500N   |               P=0.500      P=0.500      P=0.054    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/59 (2%)    0/60 (0%)  |  2/60 (3%)    1/60 (2%)    2/60 (3%)    2/59 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.8%         0.0%      |   6.2%         2.2%         5.7%         4.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    0/18 (0%)    0/19 (0%)  |  1/25 (4%)    0/29 (0%)    1/25 (4%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          617          ---       |   582          562          457 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.691        (e)        P=0.500        (e)      |  P=0.446      P=0.488N     P=0.690      P=0.620    |
|INCIDENTAL TUMOR       |  P=0.667        (e)        P=0.516        (e)      |  P=0.568      P=0.550N     P=0.681      P=0.623N   |
|LOGISTIC REGRESSION    |  P=0.694        (e)        P=0.497        (e)      |  P=0.596      P=0.500N     P=0.693N     P=0.660N   |
|COCHRAN-ARMITAGE       |  P=0.694                                           |  P=0.519                                           |
|FISHER EXACT           |                 (e)        P=0.496        (e)      |               P=0.500N     P=0.691N     P=0.684    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE  17
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    1/59 (2%)    0/60 (0%)  |  3/60 (5%)    2/60 (3%)    2/60 (3%)    2/59 (3%)  |
|ADJUSTED (b)           |   0.0%         4.3%         2.8%         0.0%      |  10.1%         5.5%         5.7%         4.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    0/18 (0%)    0/19 (0%)  |  2/25 (8%)    0/29 (0%)    1/25 (4%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          684          617          ---       |   582          562          457 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.599N     P=0.468      P=0.500        (e)      |  P=0.539N     P=0.465N     P=0.502N     P=0.600N   |
|INCIDENTAL TUMOR       |  P=0.634N     P=0.562      P=0.516        (e)      |  P=0.431N     P=0.549N     P=0.512N     P=0.457N   |
|LOGISTIC REGRESSION    |  P=0.598N     P=0.478      P=0.497        (e)      |  P=0.414N     P=0.501N     P=0.501N     P=0.499N   |
|COCHRAN-ARMITAGE       |  P=0.595N                                          |  P=0.439N                                          |
|FISHER EXACT           |               P=0.500      P=0.496        (e)      |               P=0.500N     P=0.500N     P=0.508N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  4/60 (7%)    2/60 (3%)    8/60 (13%)   7/60 (12%) |
|ADJUSTED (b)           |                                                    |   9.3%         5.1%        30.2%        20.6%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  2/10 (20%)   1/10 (10%)   0/10 (0%)    2/10 (20%) |
|TERMINAL (d)           |                                                    |  1/25 (4%)    1/29 (3%)    7/25 (28%)   2/18 (11%) |
|FIRST INCIDENCE (DAYS) |                                                    |   457 (I)      457 (I)      700          353       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.039 *    P=0.316N     P=0.180      P=0.186    |
|INCIDENTAL TUMOR       |                                                    |  P=0.104      P=0.336N     P=0.172      P=0.400    |
|LOGISTIC REGRESSION    |                                                    |  P=0.107      P=0.337N     P=0.176      P=0.403    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.101                                           |
|FISHER EXACT           |                                                    |               P=0.340N     P=0.181      P=0.264    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE  18
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    1/59 (2%)    1/60 (2%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         7.2%         3.4%         2.7%      |   1.7%         2.3%         0.0%         2.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    0/18 (0%)    0/19 (0%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          558          652          572       |   457 (I)      576          ---          556       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.478      P=0.212      P=0.480      P=0.480    |  P=0.655N     P=0.760      P=0.500N     P=0.736    |
|INCIDENTAL TUMOR       |  P=0.450      P=0.321      P=0.517      P=0.464    |  P=0.578N     P=0.729      P=0.500N     P=0.747N   |
|LOGISTIC REGRESSION    |  P=0.499      P=0.235      P=0.496      P=0.498    |  P=0.510N     P=0.759      P=0.455N     P=0.687N   |
|COCHRAN-ARMITAGE       |  P=0.499                                           |  P=0.616N                                          |
|FISHER EXACT           |               P=0.248      P=0.496      P=0.500    |               P=0.752N     P=0.500N     P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/60 (42%)  16/60 (27%)  21/59 (36%)  22/60 (37%) | 13/60 (22%)  14/60 (23%)  13/60 (22%)  16/60 (27%) |
|ADJUSTED (b)           |  72.7%        57.6%        64.3%        77.4%      |  39.7%        39.6%        36.2%        53.9%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 13/21 (62%)   2/11 (18%)   8/18 (44%)  13/19 (68%) |  7/25 (28%)   9/29 (31%)   5/25 (20%)   6/18 (33%) |
|FIRST INCIDENCE (DAYS) |   452          558          500          424       |   636          443          484          439       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.496N     P=0.424N     P=0.425N     P=0.514N   |  P=0.055      P=0.569N     P=0.581      P=0.080    |
|INCIDENTAL TUMOR       |  P=0.515N     P=0.061N     P=0.363N     P=0.390N   |  P=0.169      P=0.508      P=0.579      P=0.157    |
|LOGISTIC REGRESSION    |  P=0.524      P=0.087N     P=0.313N     P=0.439N   |  P=0.121      P=0.492      P=0.577      P=0.112    |
|COCHRAN-ARMITAGE       |  P=0.503N                                          |  P=0.303                                           |
|FISHER EXACT           |               P=0.062N     P=0.312N     P=0.354N   |               P=0.500      P=0.588N     P=0.335    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE  19
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    0/60 (0%)    2/59 (3%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.3%         0.0%         5.1%         4.2%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    1/10 (10%)   1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/21 (0%)    0/11 (0%)    0/18 (0%)    0/19 (0%)  |  0/25 (0%)    0/29 (0%)    0/25 (0%)    0/18 (0%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          456 (I)      456 (I)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.583N     P=0.153N     P=0.506N     P=0.522N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.595      P=0.085N     P=0.477N     P=0.525N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.589N     P=0.120N     P=0.513N     P=0.508N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.578N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.122N     P=0.508N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 49/60 (82%)  58/60 (97%)  56/59 (95%)  53/60 (88%) | 45/60 (75%)  39/60 (65%)  42/60 (70%)  37/60 (62%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  95.6%        90.4%        93.2%        88.9%      |
|INTERIM SACRIFICE 1 (c)|  5/10 (50%)   9/10 (90%)   9/10 (90%)   5/10 (50%) |  2/10 (20%)   2/10 (20%)   3/10 (30%)   7/10 (70%) |
|TERMINAL (d)           | 21/21 (100%) 11/11 (100%) 18/18 (100%) 19/19 (100%)| 23/25 (92%)  25/29 (86%)  22/25 (88%)  14/18 (78%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      416          353          404       |   390          457 (I)      457 (I)      353       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.415      P=0.002 **   P=0.104      P=0.167    |  P=0.168      P=0.089N     P=0.386N     P=0.338    |
|INCIDENTAL TUMOR       |  P=0.226      P=0.005 **   P=0.010 **   P=0.148    |  P=0.492N     P=0.086N     P=0.367N     P=0.248N   |
|LOGISTIC REGRESSION    |  P=0.249      P=0.002 **   P=0.006 **   P=0.095    |  P=0.522N     P=0.135N     P=0.355N     P=0.310N   |
|COCHRAN-ARMITAGE       |  P=0.317                                           |  P=0.108N                                          |
|FISHER EXACT           |               P=0.008 **   P=0.023 *    P=0.222    |               P=0.160N     P=0.342N     P=0.085N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE  20
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      32 MG/KG     63 MG/KG     125       |   0 MG/KG      63 MG/KG     125          250       |
|                       |                                          MG/KG     |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 27/60 (45%)  24/60 (40%)  27/59 (46%)  26/60 (43%) | 17/60 (28%)  17/60 (28%)  13/60 (22%)  18/60 (30%) |
|ADJUSTED (b)           |  77.1%        68.9%        72.2%        82.4%      |  47.4%        45.8%        36.2%        56.4%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 14/21 (67%)   2/11 (18%)   9/18 (50%)  14/19 (74%) |  8/25 (32%)  10/29 (34%)   5/25 (20%)   6/18 (33%) |
|FIRST INCIDENCE (DAYS) |   452          467          379          424       |   457 (I)      443          484          439       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.525      P=0.270      P=0.428      P=0.467    |  P=0.126      P=0.469N     P=0.280N     P=0.148    |
|INCIDENTAL TUMOR       |  P=0.525N     P=0.292N     P=0.466      P=0.518N   |  P=0.347      P=0.557      P=0.276N     P=0.321    |
|LOGISTIC REGRESSION    |  P=0.487      P=0.451N     P=0.530      P=0.563    |  P=0.272      P=0.574      P=0.270N     P=0.285    |
|COCHRAN-ARMITAGE       |  P=0.531                                           |  P=0.490                                           |
|FISHER EXACT           |               P=0.356N     P=0.540      P=0.500N   |               P=0.580N     P=0.264N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 53/60 (88%)  58/60 (97%)  57/59 (97%)  55/60 (92%) | 50/60 (83%)  44/60 (73%)  47/60 (78%)  44/60 (73%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  98.0%        93.5%        95.9%        95.2%      |
|INTERIM SACRIFICE 1 (c)|  6/10 (60%)   9/10 (90%)   9/10 (90%)   5/10 (50%) |  3/10 (30%)   2/10 (20%)   3/10 (30%)   7/10 (70%) |
|TERMINAL (d)           | 21/21 (100%) 11/11 (100%) 18/18 (100%) 19/19 (100%)| 24/25 (96%)  26/29 (90%)  23/25 (92%)  16/18 (89%) |
|FIRST INCIDENCE (DAYS) |   452          416          353          404       |   390          443          457 (I)      353       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.467      P=0.010 *    P=0.199      P=0.247    |  P=0.072      P=0.101N     P=0.396N     P=0.180    |
|INCIDENTAL TUMOR       |  P=0.409      P=0.097      P=0.041 *    P=0.414    |  P=0.479      P=0.065N     P=0.313N     P=0.390N   |
|LOGISTIC REGRESSION    |  P=0.399      P=0.043 *    P=0.027 *    P=0.277    |  P=0.355      P=0.100N     P=0.328N     P=0.507N   |
|COCHRAN-ARMITAGE       |  P=0.432                                           |  P=0.182N                                          |
|FISHER EXACT           |               P=0.081      P=0.085      P=0.381    |               P=0.134N     P=0.322N     P=0.134N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 11                                                 PAGE  21
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
                                                                           
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   456
          Female interim sacrifices(days): 457
 (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).