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TDMS Study 05162-09 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08
LAB: Battelle Columbus                                       DIETHANOLAMINE                                    DATE: 06/19/97

EXPERIMENT: 05162 TEST: 09                                                                                     TIME: 12:11:40
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55174D
PATHOLOGIST: RYAN, M.                                                                                          CAS: 111-42-2
                

Rats(FISCHER344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.

                                                 ----------------
                                                 Adrenal Gland
                                                 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                                       DIETHANOLAMINE                                    DATE: 06/19/97     
EXPERIMENT: 05162 TEST: 09                                                                                     TIME: 12:11:40     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:              
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55174D     
PATHOLOGIST: RYAN, M.                                                                                          CAS: 111-42-2      



SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF             DIETHANOLAMINE
===============================================================

Male Rats
------------
Organ                                 Morphology
-----                                 ----------
Pituitary Gland: Pars Distalis or UnspeAdenomaSite
                                       Carcinoma or Adenoma
Testes                                 Adenoma
All Organs                             Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                       Benign Tumors
                                       Malignant Tumors
                                       Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ                                  Morphology
-----                                  ----------
Clitoral/Preputial Gland               Adenoma
Mammary Gland                          Fibroadenoma
                                       Fibroma, Fibroadenoma or Adenoma
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma
===============================================================
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 1
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)        -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         4.8%         0.0%        |0.0%         2.3%         0.0%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    1/29 (3%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          ---          663          ---         |---          730 (T)      ---          703          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.584      (e)          P=0.252      (e)         |P=0.392      P=0.530      (e)          P=0.515      |
|POLY 3             |     P=0.603      (e)          P=0.257      (e)         |P=0.405      P=0.516      (e)          P=0.499      |
|POLY 1.5           |     P=0.598      (e)          P=0.250      (e)         |P=0.404      P=0.509      (e)          P=0.499      |
|POLY 6             |     P=0.626      (e)          P=0.270      (e)         |P=0.408      P=0.527      (e)          P=0.500      |
|LOGISTIC REGRESSION|     P=0.596      (e)          P=0.235      (e)         |P=0.394      P=0.530      (e)          P=0.499      |
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |P=0.405      P=0.500      (e)          P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     9/50 (18%)   7/50 (14%)   7/50 (14%)   12/50 (24%) |0/49 (0%)    1/50 (2%)    2/49 (4%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     22.3%        18.5%        16.3%        29.6%       |0.0%         2.3%         4.8%         5.0%         |
|TERMINAL (d)       |     2/14 (14%)   2/10 (20%)   2/21 (10%)   5/22 (23%)  |0/25 (0%)    1/29 (3%)    1/29 (3%)    2/24 (8%)    |
|FIRST INCIDENCE    |     561          463          533          533         |---          730 (T)      665          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.488      P=0.596      P=0.223N     P=0.529     |P=0.139      P=0.530      P=0.279      P=0.228      |
|POLY 3             |     P=0.214      P=0.447N     P=0.340N     P=0.309     |P=0.154      P=0.520      P=0.250      P=0.239      |
|POLY 1.5           |     P=0.205      P=0.407N     P=0.354N     P=0.313     |P=0.158      P=0.513      P=0.243      P=0.239      |
|POLY 6             |     P=0.241      P=0.526N     P=0.318N     P=0.317     |P=0.151      P=0.530      P=0.261      P=0.239      |
|LOGISTIC REGRESSION|     P=0.210      P=0.412N     P=0.369N     P=0.316     |P=0.146      P=0.530      P=0.247      P=0.228      |
|COCH-ARM / FISHERS |     P=0.198      P=0.393N     P=0.393N     P=0.312     |P=0.163      P=0.505      P=0.247      P=0.253      |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 2
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     10/50 (20%)  7/50 (14%)   7/50 (14%)   12/50 (24%) |0/49 (0%)    1/50 (2%)    2/49 (4%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     24.8%        18.5%        16.3%        29.6%       |0.0%         2.3%         4.8%         5.0%         |
|TERMINAL (d)       |     2/14 (14%)   2/10 (20%)   2/21 (10%)   5/22 (23%)  |0/25 (0%)    1/29 (3%)    1/29 (3%)    2/24 (8%)    |
|FIRST INCIDENCE    |     561          463          533          533         |---          730 (T)      665          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.510N     P=0.516N     P=0.151N     P=0.542N    |P=0.139      P=0.530      P=0.279      P=0.228      |
|POLY 3             |     P=0.289      P=0.346N     P=0.247N     P=0.404     |P=0.154      P=0.520      P=0.250      P=0.239      |
|POLY 1.5           |     P=0.277      P=0.309N     P=0.261N     P=0.408     |P=0.158      P=0.513      P=0.243      P=0.239      |
|POLY 6             |     P=0.323      P=0.423N     P=0.227N     P=0.415     |P=0.151      P=0.530      P=0.261      P=0.239      |
|LOGISTIC REGRESSION|     P=0.283      P=0.321N     P=0.270N     P=0.411     |P=0.146      P=0.530      P=0.247      P=0.228      |
|COCH-ARM / FISHERS |     P=0.267      P=0.298N     P=0.298N     P=0.405     |P=0.163      P=0.505      P=0.247      P=0.253      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     5.1%         2.7%         0.0%         0.0%        |0.0%         0.0%         0.0%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     302          463          ---          ---         |---          ---          ---          728          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.091N     P=0.525N     P=0.198N     P=0.222N    |P=0.185      (e)          (e)          P=0.492      |
|POLY 3             |     P=0.096N     P=0.523N     P=0.225N     P=0.241N    |P=0.193      (e)          (e)          P=0.498      |
|POLY 1.5           |     P=0.098N     P=0.508N     P=0.229N     P=0.240N    |P=0.195      (e)          (e)          P=0.498      |
|POLY 6             |     P=0.092N     P=0.550N     P=0.218N     P=0.238N    |P=0.191      (e)          (e)          P=0.499      |
|LOGISTIC REGRESSION|     P=0.145N     P=0.668N     P=0.355N     P=0.273N    |P=0.184      (e)          (e)          P=0.500      |
|COCH-ARM / FISHERS |     P=0.101N     P=0.500N     P=0.247N     P=0.247N    |P=0.199      (e)          (e)          P=0.500      |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 3
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    1/49 (2%)    4/50 (8%)   |4/50 (8%)    6/50 (12%)   2/49 (4%)    0/47 (0%)    |
|POLY-3 ADJUSTED (b)|     2.6%         2.7%         2.5%         10.3%       |10.0%        13.5%        4.8%         0.0%         |
|TERMINAL (d)       |     1/14 (7%)    0/10 (0%)    1/20 (5%)    3/22 (14%)  |4/25 (16%)   3/29 (10%)   1/29 (3%)    0/22 (0%)    |
|FIRST INCIDENCE    |     729 (T)      688          729 (T)      701         |730 (T)      544          561          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.176      P=0.689      P=0.682N     P=0.320     |P=0.026N*    P=0.480      P=0.278N     P=0.077N     |
|POLY 3             |     P=0.071      P=0.749      P=0.749N     P=0.180     |P=0.025N*    P=0.432      P=0.316N     P=0.068N     |
|POLY 1.5           |     P=0.069      P=0.758      P=0.754N     P=0.180     |P=0.025N*    P=0.403      P=0.332N     P=0.069N     |
|POLY 6             |     P=0.077      P=0.733      P=0.740N     P=0.186     |P=0.024N*    P=0.475      P=0.291N     P=0.067N     |
|LOGISTIC REGRESSION|     P=0.114      P=0.709      P=0.682N     P=0.258     |P=0.026N*    P=0.436      P=0.316N     (e)          |
|COCH-ARM / FISHERS |     P=0.068      P=0.753N     P=0.747      P=0.181     |P=0.026N*    P=0.370      P=0.349N     P=0.066N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    1/50 (2%)    1/50 (2%)    2/50 (4%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     7.8%         2.7%         2.4%         5.1%        |0.0%         2.3%         2.4%         0.0%         |
|TERMINAL (d)       |     2/14 (14%)   0/10 (0%)    1/21 (5%)    1/22 (5%)   |0/25 (0%)    1/29 (3%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     687          638          729 (T)      653         |---          730 (T)      648          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.330N     P=0.423N     P=0.186N     P=0.382N    |P=0.615N     P=0.530      P=0.521      (e)          |
|POLY 3             |     P=0.456N     P=0.324N     P=0.278N     P=0.495N    |P=0.596N     P=0.516      P=0.512      (e)          |
|POLY 1.5           |     P=0.466N     P=0.310N     P=0.287N     P=0.496N    |P=0.596N     P=0.509      P=0.505      (e)          |
|POLY 6             |     P=0.436N     P=0.351N     P=0.264N     P=0.484N    |P=0.593N     P=0.527      P=0.522      (e)          |
|LOGISTIC REGRESSION|     P=0.437N     P=0.364N     P=0.210N     P=0.478N    |P=0.600N     P=0.530      P=0.497      (e)          |
|COCH-ARM / FISHERS |     P=0.474N     P=0.309N     P=0.309N     P=0.500N    |P=0.595N     P=0.500      P=0.500      (e)          |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 4
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     5.2%         2.7%         2.4%         0.0%        |0.0%         0.0%         0.0%         2.5%         |
|TERMINAL (d)       |     2/14 (14%)   0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |     729 (T)      688          663          ---         |---          ---          ---          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.099N     P=0.611N     P=0.400N     P=0.144N    |P=0.182      (e)          (e)          P=0.492      |
|POLY 3             |     P=0.146N     P=0.519N     P=0.471N     P=0.235N    |P=0.193      (e)          (e)          P=0.498      |
|POLY 1.5           |     P=0.150N     P=0.505N     P=0.481N     P=0.235N    |P=0.195      (e)          (e)          P=0.498      |
|POLY 6             |     P=0.137N     P=0.545N     P=0.453N     P=0.229N    |P=0.191      (e)          (e)          P=0.499      |
|LOGISTIC REGRESSION|     P=0.132N     P=0.598N     P=0.448N     (e)         |(e)          (e)          (e)          P=0.492      |
|COCH-ARM / FISHERS |     P=0.153N     P=0.500N     P=0.500N     P=0.247N    |P=0.199      (e)          (e)          P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/50 (10%)   2/50 (4%)    2/50 (4%)    2/50 (4%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     12.9%        5.4%         4.8%         5.1%        |0.0%         2.3%         2.4%         2.5%         |
|TERMINAL (d)       |     4/14 (29%)   0/10 (0%)    1/21 (5%)    1/22 (5%)   |0/25 (0%)    1/29 (3%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |     687          638          663          653         |---          730 (T)      648          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.089N     P=0.359N     P=0.104N     P=0.107N    |P=0.360      P=0.530      P=0.521      P=0.492      |
|POLY 3             |     P=0.170N     P=0.233N     P=0.183N     P=0.209N    |P=0.376      P=0.516      P=0.512      P=0.498      |
|POLY 1.5           |     P=0.179N     P=0.219N     P=0.194N     P=0.212N    |P=0.379      P=0.509      P=0.505      P=0.498      |
|POLY 6             |     P=0.152N     P=0.261N     P=0.165N     P=0.197N    |P=0.375      P=0.527      P=0.522      P=0.499      |
|LOGISTIC REGRESSION|     P=0.152N     P=0.309N     P=0.137N     P=0.176N    |P=0.374      P=0.530      P=0.497      P=0.492      |
|COCH-ARM / FISHERS |     P=0.186N     P=0.218N     P=0.218N     P=0.218N    |P=0.384      P=0.500      P=0.500      P=0.500      |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 5
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    1/50 (2%)   |1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         5.5%         0.0%         2.5%        |2.5%         2.3%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |1/25 (4%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          673          ---          465         |730 (T)      724          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.576      P=0.166      (e)          P=0.500     |P=0.240N     P=0.728N     P=0.470N     P=0.508N     |
|POLY 3             |     P=0.548      P=0.225      (e)          P=0.505     |P=0.235N     P=0.743N     P=0.490N     P=0.502N     |
|POLY 1.5           |     P=0.546      P=0.234      (e)          P=0.504     |P=0.236N     P=0.751N     P=0.495N     P=0.502N     |
|POLY 6             |     P=0.553      P=0.210      (e)          P=0.511     |P=0.233N     P=0.730N     P=0.481N     P=0.501N     |
|LOGISTIC REGRESSION|     P=0.525      P=0.214      (e)          P=0.441     |P=0.234N     P=0.719N     (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.539      P=0.247      (e)          P=0.500     |P=0.236N     P=0.753N     P=0.500N     P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    1/50 (2%)   |1/50 (2%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         5.5%         0.0%         2.5%        |2.5%         2.3%         0.0%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |1/25 (4%)    0/29 (0%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |     ---          673          ---          465         |730 (T)      724          ---          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.576      P=0.166      (e)          P=0.500     |P=0.638N     P=0.728N     P=0.470N     P=0.754      |
|POLY 3             |     P=0.548      P=0.225      (e)          P=0.505     |P=0.616N     P=0.743N     P=0.490N     P=0.759      |
|POLY 1.5           |     P=0.546      P=0.234      (e)          P=0.504     |P=0.616N     P=0.751N     P=0.495N     P=0.759      |
|POLY 6             |     P=0.553      P=0.210      (e)          P=0.511     |P=0.615N     P=0.730N     P=0.481N     P=0.761      |
|LOGISTIC REGRESSION|     P=0.525      P=0.214      (e)          P=0.441     |P=0.633N     P=0.719N     (e)          P=0.754      |
|COCH-ARM / FISHERS |     P=0.539      P=0.247      (e)          P=0.500     |P=0.616N     P=0.753N     P=0.500N     P=0.753N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 6
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           |
|     or Hepatoblastoma                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    1/50 (2%)   |1/50 (2%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         5.5%         0.0%         2.5%        |2.5%         2.3%         0.0%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |1/25 (4%)    0/29 (0%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |     ---          673          ---          465         |730 (T)      724          ---          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.576      P=0.166      (e)          P=0.500     |P=0.638N     P=0.728N     P=0.470N     P=0.754      |
|POLY 3             |     P=0.548      P=0.225      (e)          P=0.505     |P=0.616N     P=0.743N     P=0.490N     P=0.759      |
|POLY 1.5           |     P=0.546      P=0.234      (e)          P=0.504     |P=0.616N     P=0.751N     P=0.495N     P=0.759      |
|POLY 6             |     P=0.553      P=0.210      (e)          P=0.511     |P=0.615N     P=0.730N     P=0.481N     P=0.761      |
|LOGISTIC REGRESSION|     P=0.525      P=0.214      (e)          P=0.441     |P=0.633N     P=0.719N     (e)          P=0.754      |
|COCH-ARM / FISHERS |     P=0.539      P=0.247      (e)          P=0.500     |P=0.616N     P=0.753N     P=0.500N     P=0.753N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         2.6%        |4.9%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    1/22 (5%)   |1/25 (4%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          729 (T)     |460          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.274      (e)          (e)          P=0.590     |P=0.116N     P=0.223N     P=0.228N     P=0.247N     |
|POLY 3             |     P=0.203      (e)          (e)          P=0.502     |P=0.116N     P=0.223N     P=0.230N     P=0.243N     |
|POLY 1.5           |     P=0.201      (e)          (e)          P=0.501     |P=0.115N     P=0.230N     P=0.234N     P=0.241N     |
|POLY 6             |     P=0.211      (e)          (e)          P=0.506     |P=0.118N     P=0.213N     P=0.221N     P=0.243N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.590     |P=0.105N     P=0.254N     P=0.226N     P=0.215N     |
|COCH-ARM / FISHERS |     P=0.198      (e)          (e)          P=0.500     |P=0.115N     P=0.247N     P=0.247N     P=0.247N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 7
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)   |2/50 (4%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.7%         0.0%         2.6%        |4.9%         0.0%         2.3%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    1/22 (5%)   |1/25 (4%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          702          ---          729 (T)     |460          ---          634          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.507      P=0.433      (e)          P=0.590     |P=0.194N     P=0.223N     P=0.476N     P=0.247N     |
|POLY 3             |     P=0.409      P=0.489      (e)          P=0.502     |P=0.197N     P=0.223N     P=0.486N     P=0.243N     |
|POLY 1.5           |     P=0.408      P=0.497      (e)          P=0.501     |P=0.193N     P=0.230N     P=0.494N     P=0.241N     |
|POLY 6             |     P=0.413      P=0.474      (e)          P=0.506     |P=0.202N     P=0.213N     P=0.470N     P=0.243N     |
|LOGISTIC REGRESSION|     P=0.455      P=0.458      (e)          P=0.590     |P=0.173N     P=0.254N     P=0.496N     P=0.215N     |
|COCH-ARM / FISHERS |     P=0.405      P=0.500      (e)          P=0.500     |P=0.188N     P=0.247N     P=0.500N     P=0.247N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |14/50 (28%)  8/50 (16%)   9/50 (18%)   5/50 (10%)   |
|POLY-3 ADJUSTED (b)|     2.6%         0.0%         0.0%         0.0%        |33.9%        18.2%        20.8%        12.6%        |
|TERMINAL (d)       |     1/14 (7%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |9/25 (36%)   5/29 (17%)   5/29 (17%)   4/24 (17%)   |
|FIRST INCIDENCE    |     729 (T)      ---          ---          ---         |648          638          606          728          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.236N     P=0.567N     P=0.419N     P=0.410N    |P=0.031N*    P=0.051N     P=0.095N     P=0.025N*    |
|POLY 3             |     P=0.297N     P=0.512N     P=0.484N     P=0.498N    |P=0.027N*    P=0.075N     P=0.130N     P=0.019N*    |
|POLY 1.5           |     P=0.302N     P=0.503N     P=0.489N     P=0.499N    |P=0.025N*    P=0.091N     P=0.150N     P=0.019N*    |
|POLY 6             |     P=0.290N     P=0.528N     P=0.476N     P=0.494N    |P=0.030N*    P=0.058N     P=0.104N     P=0.020N*    |
|LOGISTIC REGRESSION|     P=0.236N     (e)          (e)          (e)         |P=0.024N*    P=0.057N     P=0.121N     P=0.016N*    |
|COCH-ARM / FISHERS |     P=0.306N     P=0.500N     P=0.500N     P=0.500N    |P=0.023N*    P=0.114N     P=0.171N     P=0.020N*    |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 8
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)   |14/50 (28%)  9/50 (18%)   9/50 (18%)   5/50 (10%)   |
|POLY-3 ADJUSTED (b)|     2.6%         0.0%         0.0%         2.6%        |33.9%        20.1%        20.8%        12.6%        |
|TERMINAL (d)       |     1/14 (7%)    0/10 (0%)    0/21 (0%)    1/22 (5%)   |9/25 (36%)   5/29 (17%)   5/29 (17%)   4/24 (17%)   |
|FIRST INCIDENCE    |     729 (T)      ---          ---          729 (T)     |648          492          606          728          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.650N     P=0.567N     P=0.419N     P=0.659N    |P=0.027N*    P=0.085N     P=0.095N     P=0.025N*    |
|POLY 3             |     P=0.606      P=0.512N     P=0.484N     P=0.760N    |P=0.024N*    P=0.112N     P=0.130N     P=0.019N*    |
|POLY 1.5           |     P=0.599      P=0.503N     P=0.489N     P=0.759N    |P=0.022N*    P=0.136N     P=0.150N     P=0.019N*    |
|POLY 6             |     P=0.621      P=0.528N     P=0.476N     P=0.755N    |P=0.027N*    P=0.086N     P=0.104N     P=0.020N*    |
|LOGISTIC REGRESSION|     P=0.650N     (e)          (e)          P=0.659N    |P=0.021N*    P=0.118N     P=0.121N     P=0.016N*    |
|COCH-ARM / FISHERS |     P=0.595      P=0.500N     P=0.500N     P=0.753N    |P=0.020N*    P=0.171N     P=0.171N     P=0.020N*    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    1/50 (2%)    1/50 (2%)   |14/50 (28%)  9/50 (18%)   10/50 (20%)  6/50 (12%)   |
|POLY-3 ADJUSTED (b)|     2.6%         0.0%         2.4%         2.6%        |33.9%        20.1%        23.0%        15.1%        |
|TERMINAL (d)       |     1/14 (7%)    0/10 (0%)    1/21 (5%)    1/22 (5%)   |9/25 (36%)   5/29 (17%)   5/29 (17%)   5/24 (21%)   |
|FIRST INCIDENCE    |     729 (T)      ---          729 (T)      729 (T)     |648          492          606          728          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.612N     P=0.567N     P=0.670N     P=0.659N    |P=0.058N     P=0.085N     P=0.140N     P=0.046N*    |
|POLY 3             |     P=0.552      P=0.512N     P=0.743N     P=0.760N    |P=0.053N     P=0.112N     P=0.187N     P=0.040N*    |
|POLY 1.5           |     P=0.544      P=0.503N     P=0.749N     P=0.759N    |P=0.048N*    P=0.136N     P=0.214N     P=0.039N*    |
|POLY 6             |     P=0.573      P=0.528N     P=0.734N     P=0.755N    |P=0.060N     P=0.086N     P=0.151N     P=0.041N*    |
|LOGISTIC REGRESSION|     P=0.612N     (e)          P=0.670N     P=0.659N    |P=0.046N*    P=0.118N     P=0.184N     P=0.033N*    |
|COCH-ARM / FISHERS |     P=0.539      P=0.500N     P=0.753N     P=0.753N    |P=0.043N*    P=0.171N     P=0.241N     P=0.039N*    |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 9
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     2.6%         5.4%         0.0%         0.0%        |0.0%         2.3%         0.0%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    1/29 (3%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |     702          666          ---          ---         |---          730 (T)      ---          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.167N     P=0.374      P=0.416N     P=0.457N    |P=0.386      P=0.530      (e)          P=0.492      |
|POLY 3             |     P=0.185N     P=0.483      P=0.485N     P=0.499N    |P=0.404      P=0.516      (e)          P=0.498      |
|POLY 1.5           |     P=0.185N     P=0.496      P=0.490N     P=0.499N    |P=0.404      P=0.509      (e)          P=0.498      |
|POLY 6             |     P=0.184N     P=0.459      P=0.477N     P=0.495N    |P=0.407      P=0.527      (e)          P=0.499      |
|LOGISTIC REGRESSION|     P=0.182N     P=0.473      P=0.476N     P=0.492N    |(e)          P=0.530      (e)          P=0.492      |
|COCH-ARM / FISHERS |     P=0.188N     P=0.500      P=0.500N     P=0.500N    |P=0.405      P=0.500      (e)          P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     32/50 (64%)  39/50 (78%)  39/50 (78%)  32/49 (65%) |27/49 (55%)  31/50 (62%)  31/50 (62%)  34/50 (68%)  |
|POLY-3 ADJUSTED (b)|     72.5%        83.1%        79.9%        70.6%       |61.7%        66.5%        68.6%        72.4%        |
|TERMINAL (d)       |     10/14 (71%)  8/10 (80%)   15/21 (71%)  12/21 (57%) |15/25 (60%)  19/29 (66%)  19/29 (66%)  16/24 (67%)  |
|FIRST INCIDENCE    |     479          463          471          431         |460          492          579          430          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.066N     P=0.025 *    P=0.404N     P=0.249N    |P=0.097      P=0.519N     P=0.558N     P=0.155      |
|POLY 3             |     P=0.308N     P=0.146      P=0.265      P=0.516N    |P=0.158      P=0.395      P=0.314      P=0.184      |
|POLY 1.5           |     P=0.364N     P=0.135      P=0.195      P=0.559N    |P=0.139      P=0.352      P=0.297      P=0.156      |
|POLY 6             |     P=0.220N     P=0.163      P=0.377      P=0.437N    |P=0.192      P=0.457      P=0.362      P=0.231      |
|LOGISTIC REGRESSION|     P=0.447N     P=0.088      P=0.130      P=0.537     |P=0.102      P=0.387      P=0.366      P=0.129      |
|COCH-ARM / FISHERS |     P=0.462N     P=0.093      P=0.093      P=0.530     |P=0.125      P=0.311      P=0.311      P=0.133      |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 10
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/49 (0%)   |2/49 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.8%         0.0%         0.0%        |5.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/21 (0%)   |1/25 (4%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          722          ---          ---         |632          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.482N     P=0.471      (e)          (e)         |P=0.116N     P=0.210N     P=0.215N     P=0.250N     |
|POLY 3             |     P=0.571N     P=0.488      (e)          (e)         |P=0.115N     P=0.217N     P=0.224N     P=0.237N     |
|POLY 1.5           |     P=0.568N     P=0.497      (e)          (e)         |P=0.113N     P=0.224N     P=0.229N     P=0.236N     |
|POLY 6             |     P=0.579N     P=0.473      (e)          (e)         |P=0.117N     P=0.209N     P=0.216N     P=0.238N     |
|LOGISTIC REGRESSION|     P=0.518N     P=0.443      (e)          (e)         |P=0.113N     P=0.230N     P=0.231N     P=0.235N     |
|COCH-ARM / FISHERS |     P=0.571N     P=0.500      (e)          (e)         |P=0.113N     P=0.242N     P=0.242N     P=0.242N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     32/50 (64%)  40/50 (80%)  39/50 (78%)  32/49 (65%) |29/49 (59%)  31/50 (62%)  31/50 (62%)  34/50 (68%)  |
|POLY-3 ADJUSTED (b)|     72.5%        85.2%        79.9%        70.6%       |65.7%        66.5%        68.6%        72.4%        |
|TERMINAL (d)       |     10/14 (71%)  8/10 (80%)   15/21 (71%)  12/21 (57%) |16/25 (64%)  19/29 (66%)  19/29 (66%)  16/24 (67%)  |
|FIRST INCIDENCE    |     479          463          471          431         |460          492          579          430          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.059N     P=0.018 *    P=0.404N     P=0.249N    |P=0.153      P=0.381N     P=0.420N     P=0.239      |
|POLY 3             |     P=0.272N     P=0.089      P=0.265      P=0.516N    |P=0.252      P=0.559      P=0.471      P=0.315      |
|POLY 1.5           |     P=0.329N     P=0.085      P=0.195      P=0.559N    |P=0.229      P=0.515      P=0.454      P=0.278      |
|POLY 6             |     P=0.187N     P=0.096      P=0.377      P=0.437N    |P=0.289      P=0.575N     P=0.516      P=0.369      |
|LOGISTIC REGRESSION|     P=0.415N     P=0.055      P=0.130      P=0.537     |P=0.177      P=0.554      P=0.533      P=0.235      |
|COCH-ARM / FISHERS |     P=0.431N     P=0.059      P=0.093      P=0.530     |P=0.209      P=0.468      P=0.468      P=0.241      |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 11
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor                                                                       |
|     (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     5.2%         8.2%         4.8%         0.0%        |0.0%         4.6%         2.3%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    1/10 (10%)   2/21 (10%)   0/22 (0%)   |0/25 (0%)    2/29 (7%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     702          610          729 (T)      ---         |---          730 (T)      490          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.066N     P=0.368      P=0.538N     P=0.192N    |P=0.476N     P=0.271      P=0.500      (e)          |
|POLY 3             |     P=0.129N     P=0.477      P=0.668N     P=0.236N    |P=0.458N     P=0.255      P=0.513      (e)          |
|POLY 1.5           |     P=0.131N     P=0.495      P=0.676N     P=0.236N    |P=0.461N     P=0.247      P=0.507      (e)          |
|POLY 6             |     P=0.122N     P=0.444      P=0.655N     P=0.232N    |P=0.451N     P=0.268      P=0.524      (e)          |
|LOGISTIC REGRESSION|     P=0.112N     P=0.442      P=0.614N     P=0.228N    |P=0.453N     P=0.271      P=0.591      (e)          |
|COCH-ARM / FISHERS |     P=0.134N     P=0.500      P=0.691N     P=0.247N    |P=0.462N     P=0.247      P=0.500      (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        |
|     or Fibrous Histiocytoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    1/50 (2%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         5.4%         0.0%         2.6%        |2.5%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |1/25 (4%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          542          ---          709         |730 (T)      ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.622      P=0.218      (e)          P=0.573     |P=0.308N     P=0.470N     P=0.470N     P=0.508N     |
|POLY 3             |     P=0.543      P=0.227      (e)          P=0.502     |P=0.309N     P=0.484N     P=0.490N     P=0.502N     |
|POLY 1.5           |     P=0.543      P=0.235      (e)          P=0.501     |P=0.308N     P=0.491N     P=0.495N     P=0.502N     |
|POLY 6             |     P=0.547      P=0.212      (e)          P=0.507     |P=0.312N     P=0.473N     P=0.481N     P=0.501N     |
|LOGISTIC REGRESSION|     P=0.539      P=0.235      (e)          P=0.514     |P=0.308N     (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.539      P=0.247      (e)          P=0.500     |P=0.305N     P=0.500N     P=0.500N     P=0.500N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 12
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     5.2%         5.4%         0.0%         0.0%        |0.0%         0.0%         2.3%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     702          610          ---          ---         |---          ---          490          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.058N     P=0.589      P=0.151N     P=0.192N    |P=0.691      (e)          P=0.500      (e)          |
|POLY 3             |     P=0.082N     P=0.677      P=0.221N     P=0.236N    |P=0.677      (e)          P=0.513      (e)          |
|POLY 1.5           |     P=0.083N     P=0.690      P=0.226N     P=0.236N    |P=0.684      (e)          P=0.507      (e)          |
|POLY 6             |     P=0.079N     P=0.652      P=0.213N     P=0.232N    |P=0.669      (e)          P=0.524      (e)          |
|LOGISTIC REGRESSION|     P=0.082N     P=0.672      P=0.210N     P=0.228N    |P=0.734      (e)          P=0.591      (e)          |
|COCH-ARM / FISHERS |     P=0.086N     P=0.691N     P=0.247N     P=0.247N    |P=0.695      (e)          P=0.500      (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    2/50 (4%)   |0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         2.4%         5.0%        |0.0%         4.6%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    2/29 (7%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          ---          710          577         |---          730 (T)      ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.085      (e)          P=0.592      P=0.222     |P=0.418N     P=0.271      (e)          (e)          |
|POLY 3             |     P=0.076      (e)          P=0.516      P=0.243     |P=0.393N     P=0.255      (e)          (e)          |
|POLY 1.5           |     P=0.073      (e)          P=0.511      P=0.241     |P=0.399N     P=0.247      (e)          (e)          |
|POLY 6             |     P=0.085      (e)          P=0.525      P=0.251     |P=0.381N     P=0.268      (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.070      (e)          P=0.534      P=0.230     |(e)          P=0.271      (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.070      (e)          P=0.500      P=0.247     |P=0.406N     P=0.247      (e)          (e)          |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 13
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           |
|     Carcinoma or Keratoacanthoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     5.2%         8.2%         4.8%         0.0%        |0.0%         2.3%         2.3%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    1/10 (10%)   2/21 (10%)   0/22 (0%)   |0/25 (0%)    1/29 (3%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     702          610          729 (T)      ---         |---          730 (T)      490          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.066N     P=0.368      P=0.538N     P=0.192N    |P=0.608N     P=0.530      P=0.500      (e)          |
|POLY 3             |     P=0.129N     P=0.477      P=0.668N     P=0.236N    |P=0.595N     P=0.516      P=0.513      (e)          |
|POLY 1.5           |     P=0.131N     P=0.495      P=0.676N     P=0.236N    |P=0.596N     P=0.509      P=0.507      (e)          |
|POLY 6             |     P=0.122N     P=0.444      P=0.655N     P=0.232N    |P=0.593N     P=0.527      P=0.524      (e)          |
|LOGISTIC REGRESSION|     P=0.112N     P=0.442      P=0.614N     P=0.228N    |P=0.575N     P=0.530      P=0.591      (e)          |
|COCH-ARM / FISHERS |     P=0.134N     P=0.500      P=0.691N     P=0.247N    |P=0.595N     P=0.500      P=0.500      (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     5.2%         8.2%         2.4%         0.0%        |0.0%         2.3%         2.3%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    1/10 (10%)   1/21 (5%)    0/22 (0%)   |0/25 (0%)    1/29 (3%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     702          610          729 (T)      ---         |---          730 (T)      490          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.055N     P=0.368      P=0.357N     P=0.192N    |P=0.608N     P=0.530      P=0.500      (e)          |
|POLY 3             |     P=0.099N     P=0.477      P=0.475N     P=0.236N    |P=0.595N     P=0.516      P=0.513      (e)          |
|POLY 1.5           |     P=0.101N     P=0.495      P=0.482N     P=0.236N    |P=0.596N     P=0.509      P=0.507      (e)          |
|POLY 6             |     P=0.095N     P=0.444      P=0.462N     P=0.232N    |P=0.593N     P=0.527      P=0.524      (e)          |
|LOGISTIC REGRESSION|     P=0.090N     P=0.442      P=0.437N     P=0.228N    |P=0.575N     P=0.530      P=0.591      (e)          |
|COCH-ARM / FISHERS |     P=0.104N     P=0.500      P=0.500N     P=0.247N    |P=0.595N     P=0.500      P=0.500      (e)          |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 14
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Sebaceous Gland                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     5.1%         0.0%         2.4%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     610          ---          694          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.168N     P=0.298N     P=0.439N     P=0.249N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.177N     P=0.253N     P=0.477N     P=0.238N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.184N     P=0.242N     P=0.484N     P=0.237N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.165N     P=0.276N     P=0.466N     P=0.236N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.188N     P=0.238N     P=0.505N     P=0.238N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.188N     P=0.247N     P=0.500N     P=0.247N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     32/50 (64%)  19/50 (38%)  28/50 (56%)  26/50 (52%) |                                                    |
|POLY-3 ADJUSTED (b)|     74.4%        48.6%        63.6%        62.4%       |                                                    |
|TERMINAL (d)       |     11/14 (79%)  8/10 (80%)   18/21 (86%)  17/22 (77%) |                                                    |
|FIRST INCIDENCE    |     561          542          499          465         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.010N*    P=0.234N     P=0.021N*    P=0.019N*   |                                                    |
|POLY 3             |     P=0.306N     P=0.007N**   P=0.180N     P=0.153N    |                                                    |
|POLY 1.5           |     P=0.326N     P=0.005N**   P=0.191N     P=0.139N    |                                                    |
|POLY 6             |     P=0.274N     P=0.022N*    P=0.184N     P=0.183N    |                                                    |
|LOGISTIC REGRESSION|     P=0.261N     P=0.019N*    P=0.123N     P=0.139N    |                                                    |
|COCH-ARM / FISHERS |     P=0.360N     P=0.008N**   P=0.270N     P=0.156N    |                                                    |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 15
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     6/50 (12%)   2/50 (4%)    5/50 (10%)   7/49 (14%)  |8/50 (16%)   9/50 (18%)   6/50 (12%)   5/50 (10%)   |
|POLY-3 ADJUSTED (b)|     15.2%        5.5%         11.9%        17.8%       |19.7%        20.5%        13.8%        12.4%        |
|TERMINAL (d)       |     2/14 (14%)   1/10 (10%)   3/21 (14%)   2/22 (9%)   |6/25 (24%)   7/29 (24%)   3/29 (10%)   4/24 (17%)   |
|FIRST INCIDENCE    |     595          625          568          465         |638          597          490          515          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.514      P=0.258N     P=0.303N     P=0.554N    |P=0.199N     P=0.577N     P=0.295N     P=0.294N     |
|POLY 3             |     P=0.281      P=0.154N     P=0.452N     P=0.500     |P=0.173N     P=0.573      P=0.334N     P=0.275N     |
|POLY 1.5           |     P=0.265      P=0.139N     P=0.466N     P=0.496     |P=0.172N     P=0.539      P=0.361N     P=0.277N     |
|POLY 6             |     P=0.318      P=0.186N     P=0.431N     P=0.516     |P=0.173N     P=0.598N     P=0.296N     P=0.270N     |
|LOGISTIC REGRESSION|     P=0.259      P=0.162N     P=0.449N     P=0.486     |P=0.179N     P=0.580N     P=0.353N     P=0.276N     |
|COCH-ARM / FISHERS |     P=0.250      P=0.134N     P=0.500N     P=0.484     |P=0.168N     P=0.500      P=0.387N     P=0.277N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/49 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.7%         0.0%         0.0%        |0.0%         2.3%         0.0%         4.9%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    1/29 (3%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |     ---          625          ---          ---         |---          730 (T)      ---          465          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.563N     P=0.472      (e)          (e)         |P=0.127      P=0.530      (e)          P=0.235      |
|POLY 3             |     P=0.570N     P=0.490      (e)          (e)         |P=0.140      P=0.516      (e)          P=0.239      |
|POLY 1.5           |     P=0.568N     P=0.498      (e)          (e)         |P=0.139      P=0.509      (e)          P=0.238      |
|POLY 6             |     P=0.576N     P=0.476      (e)          (e)         |P=0.141      P=0.527      (e)          P=0.241      |
|LOGISTIC REGRESSION|     P=0.574N     P=0.496      (e)          (e)         |P=0.149      P=0.530      (e)          P=0.254      |
|COCH-ARM / FISHERS |     P=0.571N     P=0.500      (e)          (e)         |P=0.140      P=0.500      (e)          P=0.247      |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 16
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     6/50 (12%)   2/50 (4%)    5/50 (10%)   7/49 (14%)  |8/50 (16%)   10/50 (20%)  6/50 (12%)   7/50 (14%)   |
|POLY-3 ADJUSTED (b)|     15.2%        5.5%         11.9%        17.8%       |19.7%        22.7%        13.8%        17.0%        |
|TERMINAL (d)       |     2/14 (14%)   1/10 (10%)   3/21 (14%)   2/22 (9%)   |6/25 (24%)   8/29 (28%)   3/29 (10%)   5/24 (21%)   |
|FIRST INCIDENCE    |     595          625          568          465         |638          597          490          465          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.514      P=0.258N     P=0.303N     P=0.554N    |P=0.386N     P=0.536      P=0.295N     P=0.524N     |
|POLY 3             |     P=0.281      P=0.154N     P=0.452N     P=0.500     |P=0.331N     P=0.470      P=0.334N     P=0.488N     |
|POLY 1.5           |     P=0.265      P=0.139N     P=0.466N     P=0.496     |P=0.333N     P=0.436      P=0.361N     P=0.495N     |
|POLY 6             |     P=0.318      P=0.186N     P=0.431N     P=0.516     |P=0.326N     P=0.518      P=0.296N     P=0.479N     |
|LOGISTIC REGRESSION|     P=0.259      P=0.162N     P=0.449N     P=0.486     |P=0.352N     P=0.541      P=0.353N     P=0.507N     |
|COCH-ARM / FISHERS |     P=0.250      P=0.134N     P=0.500N     P=0.484     |P=0.334N     P=0.398      P=0.387N     P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    0/50 (0%)    0/49 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.6%         5.5%         0.0%         0.0%        |0.0%         2.3%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    1/29 (3%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     694          670          ---          ---         |---          730 (T)      ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.155N     P=0.388      P=0.428N     P=0.468N    |P=0.582N     P=0.530      (e)          (e)          |
|POLY 3             |     P=0.188N     P=0.482      P=0.485N     P=0.504N    |P=0.556N     P=0.516      (e)          (e)          |
|POLY 1.5           |     P=0.188N     P=0.495      P=0.490N     P=0.504N    |P=0.562N     P=0.509      (e)          (e)          |
|POLY 6             |     P=0.187N     P=0.457      P=0.477N     P=0.502N    |P=0.547N     P=0.527      (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.184N     P=0.466      P=0.483N     P=0.501N    |(e)          P=0.530      (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.191N     P=0.500      P=0.500N     P=0.505N    |P=0.568N     P=0.500      (e)          (e)          |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 17
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    0/50 (0%)    0/49 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     5.2%         5.5%         0.0%         0.0%        |0.0%         2.3%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    1/29 (3%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     673          670          ---          ---         |---          730 (T)      ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.068N     P=0.565      P=0.186N     P=0.226N    |P=0.582N     P=0.530      (e)          (e)          |
|POLY 3             |     P=0.084N     P=0.674      P=0.222N     P=0.242N    |P=0.556N     P=0.516      (e)          (e)          |
|POLY 1.5           |     P=0.085N     P=0.689      P=0.226N     P=0.242N    |P=0.562N     P=0.509      (e)          (e)          |
|POLY 6             |     P=0.082N     P=0.647      P=0.214N     P=0.240N    |P=0.547N     P=0.527      (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.083N     P=0.668      P=0.225N     P=0.241N    |(e)          P=0.530      (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.088N     P=0.691N     P=0.247N     P=0.253N    |P=0.568N     P=0.500      (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |3/50 (6%)    1/50 (2%)    1/50 (2%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|                                                        |7.5%         2.3%         2.3%         4.9%         |
|TERMINAL (d)       |                                                        |3/25 (12%)   1/29 (3%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |                                                        |730 (T)      730 (T)      365          395          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.494N     P=0.252N     P=0.269N     P=0.515N     |
|POLY 3             |                                                        |P=0.482N     P=0.276N     P=0.279N     P=0.495N     |
|POLY 1.5           |                                                        |P=0.478N     P=0.290N     P=0.292N     P=0.498N     |
|POLY 6             |                                                        |P=0.487N     P=0.258N     P=0.262N     P=0.489N     |
|LOGISTIC REGRESSION|                                                        |P=0.448N     P=0.252N     P=0.310N     P=0.499N     |
|COCH-ARM / FISHERS |                                                        |P=0.474N     P=0.309N     P=0.309N     P=0.500N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 18
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |4/50 (8%)    1/50 (2%)    2/50 (4%)    3/50 (6%)    |
|POLY-3 ADJUSTED (b)|                                                        |10.0%        2.3%         4.6%         7.4%         |
|TERMINAL (d)       |                                                        |4/25 (16%)   1/29 (3%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |                                                        |730 (T)      730 (T)      365          395          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.568N     P=0.134N     P=0.286N     P=0.513N     |
|POLY 3             |                                                        |P=0.555N     P=0.154N     P=0.304N     P=0.492N     |
|POLY 1.5           |                                                        |P=0.550N     P=0.166N     P=0.320N     P=0.497N     |
|POLY 6             |                                                        |P=0.562N     P=0.139N     P=0.281N     P=0.484N     |
|LOGISTIC REGRESSION|                                                        |P=0.531N     P=0.134N     P=0.340N     P=0.503N     |
|COCH-ARM / FISHERS |                                                        |P=0.543N     P=0.181N     P=0.339N     P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    1/50 (2%)    1/50 (2%)   |2/50 (4%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         5.4%         2.4%         2.5%        |4.8%         0.0%         2.4%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    1/29 (3%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          541          702          533         |522          ---          730 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.518      P=0.239      P=0.584      P=0.500     |P=0.196N     P=0.233N     P=0.480N     P=0.252N     |
|POLY 3             |     P=0.512      P=0.230      P=0.516      P=0.505     |P=0.197N     P=0.225N     P=0.492N     P=0.245N     |
|POLY 1.5           |     P=0.508      P=0.237      P=0.511      P=0.503     |P=0.193N     P=0.231N     P=0.497N     P=0.242N     |
|POLY 6             |     P=0.526      P=0.217      P=0.525      P=0.511     |P=0.202N     P=0.217N     P=0.482N     P=0.247N     |
|LOGISTIC REGRESSION|     P=0.473      P=0.186      P=0.524      P=0.471     |P=0.174N     P=0.239N     P=0.497N     P=0.190N     |
|COCH-ARM / FISHERS |     P=0.500      P=0.247      P=0.500      P=0.500     |P=0.188N     P=0.247N     P=0.500N     P=0.247N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 19
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           |
|     Undifferentiated                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     23/50 (46%)  14/50 (28%)  13/50 (26%)  18/50 (36%) |11/50 (22%)  13/50 (26%)  10/50 (20%)  13/50 (26%)  |
|POLY-3 ADJUSTED (b)|     52.4%        35.5%        29.5%        41.7%       |25.6%        28.6%        22.6%        30.8%        |
|TERMINAL (d)       |     6/14 (43%)   3/10 (30%)   4/21 (19%)   4/22 (18%)  |3/25 (12%)   3/29 (10%)   3/29 (10%)   7/24 (29%)   |
|FIRST INCIDENCE    |     394          554          499          379         |438          556          579          565          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.091N     P=0.293N     P=0.010N*    P=0.130N    |P=0.371      P=0.578N     P=0.405N     P=0.385      |
|POLY 3             |     P=0.223N     P=0.083N     P=0.021N*    P=0.211N    |P=0.383      P=0.467      P=0.468N     P=0.383      |
|POLY 1.5           |     P=0.243N     P=0.057N     P=0.021N*    P=0.203N    |P=0.396      P=0.437      P=0.488N     P=0.389      |
|POLY 6             |     P=0.188N     P=0.149N     P=0.021N*    P=0.210N    |P=0.374      P=0.514      P=0.431N     P=0.382      |
|LOGISTIC REGRESSION|     P=0.270N     P=0.051N     P=0.031N*    P=0.207N    |P=0.426      P=0.383      P=0.515N     P=0.410      |
|COCH-ARM / FISHERS |     P=0.272N     P=0.048N*    P=0.030N*    P=0.208N    |P=0.422      P=0.408      P=0.500N     P=0.408      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     5.1%         2.8%         2.4%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    1/10 (10%)   0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     653          729 (T)      715          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.103N     P=0.609N     P=0.402N     P=0.237N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.146N     P=0.524N     P=0.476N     P=0.237N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.150N     P=0.507N     P=0.483N     P=0.237N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.138N     P=0.556N     P=0.464N     P=0.234N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.136N     P=0.551N     P=0.478N     P=0.236N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.153N     P=0.500N     P=0.500N     P=0.247N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 20
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     5.1%         2.7%         0.0%         0.0%        |0.0%         0.0%         0.0%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     302          463          ---          ---         |---          ---          ---          728          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.091N     P=0.525N     P=0.198N     P=0.222N    |P=0.185      (e)          (e)          P=0.492      |
|POLY 3             |     P=0.096N     P=0.523N     P=0.225N     P=0.241N    |P=0.193      (e)          (e)          P=0.498      |
|POLY 1.5           |     P=0.098N     P=0.508N     P=0.229N     P=0.240N    |P=0.195      (e)          (e)          P=0.498      |
|POLY 6             |     P=0.092N     P=0.550N     P=0.218N     P=0.238N    |P=0.191      (e)          (e)          P=0.499      |
|LOGISTIC REGRESSION|     P=0.145N     P=0.668N     P=0.355N     P=0.273N    |P=0.184      (e)          (e)          P=0.500      |
|COCH-ARM / FISHERS |     P=0.101N     P=0.500N     P=0.247N     P=0.247N    |P=0.199      (e)          (e)          P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma or Osteoma                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     5.1%         2.7%         0.0%         0.0%        |0.0%         0.0%         0.0%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     302          463          ---          ---         |---          ---          ---          728          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.091N     P=0.525N     P=0.198N     P=0.222N    |P=0.185      (e)          (e)          P=0.492      |
|POLY 3             |     P=0.096N     P=0.523N     P=0.225N     P=0.241N    |P=0.193      (e)          (e)          P=0.498      |
|POLY 1.5           |     P=0.098N     P=0.508N     P=0.229N     P=0.240N    |P=0.195      (e)          (e)          P=0.498      |
|POLY 6             |     P=0.092N     P=0.550N     P=0.218N     P=0.238N    |P=0.191      (e)          (e)          P=0.499      |
|LOGISTIC REGRESSION|     P=0.145N     P=0.668N     P=0.355N     P=0.273N    |P=0.184      (e)          (e)          P=0.500      |
|COCH-ARM / FISHERS |     P=0.101N     P=0.500N     P=0.247N     P=0.247N    |P=0.199      (e)          (e)          P=0.500      |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 21
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     47/50 (94%)  46/50 (92%)  48/50 (96%)  45/50 (90%) |38/50 (76%)  39/50 (78%)  40/50 (80%)  41/50 (82%)  |
|POLY-3 ADJUSTED (b)|     99.5%        95.9%        97.2%        95.2%       |84.2%        82.6%        83.8%        84.4%        |
|TERMINAL (d)       |     14/14 (100%) 10/10 (100%) 20/21 (95%)  21/22 (96%) |24/25 (96%)  24/29 (83%)  23/29 (79%)  19/24 (79%)  |
|FIRST INCIDENCE    |     479          463          471          431         |460          492          365          395          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.018N*    P=0.115      P=0.079N     P=0.083N    |P=0.213      P=0.231N     P=0.351N     P=0.329      |
|POLY 3             |     P=0.188N     P=0.241N     P=0.459N     P=0.206N    |P=0.513      P=0.534N     P=0.598N     P=0.610      |
|POLY 1.5           |     P=0.204N     P=0.242N     P=0.546N     P=0.196N    |P=0.399      P=0.600      P=0.517      P=0.473      |
|POLY 6             |     P=0.186N     P=0.467N     P=0.466N     P=0.285N    |P=0.478N     P=0.398N     P=0.422N     P=0.479N     |
|LOGISTIC REGRESSION|     P=0.306N     P=0.185N     P=0.489N     P=0.282N    |P=0.213      P=0.493N     P=0.455      P=0.287      |
|COCH-ARM / FISHERS |     P=0.320N     P=0.500N     P=0.500      P=0.357N    |P=0.259      P=0.500      P=0.405      P=0.312      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     32/50 (64%)  23/50 (46%)  19/50 (38%)  22/50 (44%) |17/50 (34%)  16/50 (32%)  15/50 (30%)  22/50 (44%)  |
|POLY-3 ADJUSTED (b)|     68.2%        53.3%        42.1%        48.8%       |38.3%        35.3%        32.8%        49.9%        |
|TERMINAL (d)       |     8/14 (57%)   3/10 (30%)   6/21 (29%)   5/22 (23%)  |6/25 (24%)   6/29 (21%)   4/29 (14%)   11/24 (46%)  |
|FIRST INCIDENCE    |     101          463          499          379         |438          556          434          465          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.014N*    P=0.407N     P=0.003N**   P=0.032N*   |P=0.134      P=0.318N     P=0.315N     P=0.212      |
|POLY 3             |     P=0.034N*    P=0.096N     P=0.007N**   P=0.041N*   |P=0.126      P=0.469N     P=0.373N     P=0.181      |
|POLY 1.5           |     P=0.039N*    P=0.071N     P=0.007N**   P=0.039N*   |P=0.132      P=0.487N     P=0.398N     P=0.189      |
|POLY 6             |     P=0.026N*    P=0.151N     P=0.008N**   P=0.039N*   |P=0.121      P=0.438N     P=0.332N     P=0.178      |
|LOGISTIC REGRESSION|     P=0.046N*    P=0.046N*    P=0.013N*    P=0.035N*   |P=0.153      P=0.520N     P=0.442N     P=0.209      |
|COCH-ARM / FISHERS |     P=0.042N*    P=0.054N     P=0.008N**   P=0.035N*   |P=0.146      P=0.500N     P=0.415N     P=0.206      |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 09                                            Page 22
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     50/50 (100%) 49/50 (98%)  49/50 (98%)  47/50 (94%) |46/50 (92%)  42/50 (84%)  43/50 (86%)  45/50 (90%)  |
|POLY-3 ADJUSTED (b)|     100.0%       99.3%        98.0%        96.4%       |95.3%        87.5%        87.6%        90.8%        |
|TERMINAL (d)       |     14/14 (100%) 10/10 (100%) 20/21 (95%)  21/22 (96%) |24/25 (96%)  24/29 (83%)  23/29 (79%)  21/24 (88%)  |
|FIRST INCIDENCE    |     101          463          471          379         |438          492          365          395          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.015N*    P=0.122      P=0.052N     P=0.074N    |P=0.377      P=0.070N     P=0.136N     P=0.551      |
|POLY 3             |     P=0.107N     P=0.972N     P=0.500N     P=0.264N    |P=0.372N     P=0.138N     P=0.147N     P=0.304N     |
|POLY 1.5           |     P=0.088N     P=0.760N     P=0.500N     P=0.204N    |P=0.441N     P=0.159N     P=0.198N     P=0.382N     |
|POLY 6             |     P=0.127N     P=1.000N     P=0.500N     P=0.328N    |P=0.316N     P=0.114N     P=0.096N     P=0.235N     |
|LOGISTIC REGRESSION|     P=0.047N*    P=0.420N     (e)          P=0.098N    |P=0.537      P=0.112N     P=0.249N     P=0.505N     |
|COCH-ARM / FISHERS |     P=0.054N     P=0.500N     P=0.500N     P=0.121N    |P=0.558N     P=0.178N     P=0.262N     P=0.500N     |
|=================================================================================================================================|

(a)  Number of tumor-bearing animals /  number of animals examined at site.
(b)  Poly-3 adjusted lifetime tumor incidence.
(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.
Logistic regression is an alternative
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers 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).