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TDMS Study 55323-04 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08
LAB: Battelle Columbus                            LAURIC ACID DIETHANOLAMINE CONDENSATE                        DATE: 08/01/97

EXPERIMENT: 55323 TEST: 04                                                                                     TIME: 09:03:03
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:
CONT: NO1-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: 55323B
PATHOLOGIST: M. RYAN                                                                                           CAS: 120-40-1
            

Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.

                                                 ----------------
                                                 Adrenal Gland
                                                 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                            LAURIC ACID DIETHANOLAMINE CONDENSATE                        DATE: 08/01/97     
EXPERIMENT: 55323 TEST: 04                                                                                     TIME: 09:03:03     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:              
CONT: NO1-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: 55323B     
PATHOLOGIST: M. RYAN                                                                                           CAS: 120-40-1      



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

Male Mice
------------
Organ                                 Morphology
-----                                 ----------
All Organs                             Hemangiosarcoma
                                       Hemangiosarcoma or Hemangioma
                                       Benign Tumors
===============================================================
Female Mice
------------
Organ                                  Morphology
-----                                  ----------
Liver                                  Hepatocellular Adenoma
                                       Hepatocellular Carcinoma
                                       Hepatocellular Carcinoma or Hepatoblastoma
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Skin                                   Fibrosarcoma
Thyroid Gland: Follicular Cell         Adenoma
All Organs                             Malignant and Benign Tumors
===============================================================
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 1
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)        -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        7/50 (14%)       1/50 (2%)     |  1/50 (2%)        0/49 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        4.5%             15.7%            2.2%          |  2.2%             0.0%             0.0%            |
|TERMINAL (d)       |        2/40 (5%)        7/37 (19%)       1/41 (2%)     |  1/37 (3%)        0/40 (0%)        0/29 (0%)       |
|FIRST INCIDENCE    |        735 (T)          735 (T)          735 (T)       |  736 (T)          ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.408N         P=0.062          P=0.491N      |  P=0.294N         P=0.484N         P=0.549N        |
|POLY 3             |        P=0.409N         P=0.077          P=0.495N      |  P=0.288N         P=0.495N         P=0.520N        |
|POLY 1.5           |        P=0.411N         P=0.077          P=0.496N      |  P=0.282N         P=0.499N         P=0.513N        |
|POLY 6             |        P=0.404N         P=0.077          P=0.494N      |  P=0.295N         P=0.491N         P=0.529N        |
|LOGISTIC REGRESSION|        P=0.408N         P=0.062          P=0.491N      |  P=0.294N         (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.421N         P=0.080          P=0.500N      |  P=0.270N         P=0.505N         P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        0/49 (0%)     |  1/50 (2%)        0/49 (0%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        0.0%             2.2%             0.0%          |  2.2%             0.0%             4.9%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        0/41 (0%)     |  0/37 (0%)        0/40 (0%)        2/29 (7%)       |
|FIRST INCIDENCE    |        ---              462              ---           |  638              ---              736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.727N         P=0.500          (e)           |  P=0.302          P=0.482N         P=0.423         |
|POLY 3             |        P=0.729N         P=0.502          (e)           |  P=0.358          P=0.497N         P=0.462         |
|POLY 1.5           |        P=0.730N         P=0.501          (e)           |  P=0.358          P=0.500N         P=0.475         |
|POLY 6             |        P=0.727N         P=0.503          (e)           |  P=0.359          P=0.494N         P=0.445         |
|LOGISTIC REGRESSION|        P=0.719          P=0.582          (e)           |  P=0.350          P=0.562N         P=0.477         |
|COCH-ARM / FISHERS |        P=0.728          P=0.500          (e)           |  P=0.361          P=0.505N         P=0.500         |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 2
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        0/49 (0%)     |  1/50 (2%)        0/49 (0%)        3/50 (6%)       |
|POLY-3 ADJUSTED (b)|        0.0%             4.4%             0.0%          |  2.2%             0.0%             7.3%            |
|TERMINAL (d)       |        0/40 (0%)        1/37 (3%)        0/41 (0%)     |  0/37 (0%)        0/40 (0%)        2/29 (7%)       |
|FIRST INCIDENCE    |        ---              462              ---           |  638              ---              539             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.661N         P=0.231          (e)           |  P=0.136          P=0.482N         P=0.242         |
|POLY 3             |        P=0.665N         P=0.240          (e)           |  P=0.172          P=0.497N         P=0.272         |
|POLY 1.5           |        P=0.668N         P=0.238          (e)           |  P=0.172          P=0.500N         P=0.283         |
|POLY 6             |        P=0.661N         P=0.241          (e)           |  P=0.172          P=0.494N         P=0.258         |
|LOGISTIC REGRESSION|        P=0.643          P=0.257          (e)           |  P=0.209          P=0.562N         P=0.332         |
|COCH-ARM / FISHERS |        P=0.665          P=0.247          (e)           |  P=0.177          P=0.505N         P=0.309         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        2/50 (4%)        3/50 (6%)     |  1/50 (2%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        2.2%             4.4%             6.6%          |  2.2%             0.0%             0.0%            |
|TERMINAL (d)       |        1/40 (3%)        1/37 (3%)        3/41 (7%)     |  1/37 (3%)        0/40 (0%)        0/29 (0%)       |
|FIRST INCIDENCE    |        735 (T)          638              735 (T)       |  736 (T)          ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.234          P=0.485          P=0.314       |  P=0.294N         P=0.484N         P=0.549N        |
|POLY 3             |        P=0.227          P=0.501          P=0.310       |  P=0.287N         P=0.495N         P=0.520N        |
|POLY 1.5           |        P=0.227          P=0.499          P=0.309       |  P=0.282N         P=0.498N         P=0.513N        |
|POLY 6             |        P=0.229          P=0.503          P=0.312       |  P=0.294N         P=0.491N         P=0.529N        |
|LOGISTIC REGRESSION|        P=0.226          P=0.499          P=0.314       |  P=0.294N         (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.222          P=0.500          P=0.309       |  P=0.269N         P=0.500N         P=0.500N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 3
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        2/50 (4%)        3/50 (6%)     |  2/50 (4%)        1/50 (2%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        2.2%             4.4%             6.6%          |  4.5%             2.2%             2.5%            |
|TERMINAL (d)       |        1/40 (3%)        1/37 (3%)        3/41 (7%)     |  2/37 (5%)        1/40 (3%)        1/29 (3%)       |
|FIRST INCIDENCE    |        735 (T)          638              735 (T)       |  736 (T)          736 (T)          736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.234          P=0.485          P=0.314       |  P=0.449N         P=0.473N         P=0.585N        |
|POLY 3             |        P=0.227          P=0.501          P=0.310       |  P=0.412N         P=0.492N         P=0.536N        |
|POLY 1.5           |        P=0.227          P=0.499          P=0.309       |  P=0.401N         P=0.497N         P=0.524N        |
|POLY 6             |        P=0.229          P=0.503          P=0.312       |  P=0.424N         P=0.485N         P=0.550N        |
|LOGISTIC REGRESSION|        P=0.226          P=0.499          P=0.314       |  P=0.449N         P=0.473N         P=0.585N        |
|COCH-ARM / FISHERS |        P=0.222          P=0.500          P=0.309       |  P=0.378N         P=0.500N         P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        1/50 (2%)     |  1/50 (2%)        1/49 (2%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             4.5%             2.2%          |  2.2%             2.2%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        1/37 (3%)        1/41 (2%)     |  1/37 (3%)        1/40 (3%)        0/29 (0%)       |
|FIRST INCIDENCE    |        ---              719              735 (T)       |  736 (T)          736 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.372          P=0.226          P=0.505       |  P=0.376N         P=0.744N         P=0.549N        |
|POLY 3             |        P=0.367          P=0.236          P=0.503       |  P=0.369N         P=0.755N         P=0.520N        |
|POLY 1.5           |        P=0.366          P=0.236          P=0.502       |  P=0.357N         P=0.759N         P=0.513N        |
|POLY 6             |        P=0.369          P=0.237          P=0.504       |  P=0.384N         P=0.751N         P=0.529N        |
|LOGISTIC REGRESSION|        P=0.367          P=0.236          P=0.505       |  P=0.376N         P=0.744N         (e)             |
|COCH-ARM / FISHERS |        P=0.360          P=0.247          P=0.500       |  P=0.332N         P=0.747          P=0.500N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 4
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        2/50 (4%)        1/50 (2%)     |  1/50 (2%)        1/49 (2%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        2.2%             4.5%             2.2%          |  2.2%             2.2%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        1/37 (3%)        1/41 (2%)     |  1/37 (3%)        1/40 (3%)        0/29 (0%)       |
|FIRST INCIDENCE    |        584              719              735 (T)       |  736 (T)          736 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.615N         P=0.485          P=0.758       |  P=0.376N         P=0.744N         P=0.549N        |
|POLY 3             |        P=0.620N         P=0.495          P=0.760N      |  P=0.369N         P=0.755N         P=0.520N        |
|POLY 1.5           |        P=0.620N         P=0.496          P=0.760N      |  P=0.357N         P=0.759N         P=0.513N        |
|POLY 6             |        P=0.621N         P=0.493          P=0.760N      |  P=0.384N         P=0.751N         P=0.529N        |
|LOGISTIC REGRESSION|        P=0.620          P=0.504          P=0.751       |  P=0.376N         P=0.744N         (e)             |
|COCH-ARM / FISHERS |        P=0.622          P=0.500          P=0.753N      |  P=0.332N         P=0.747          P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        7/50 (14%)       2/50 (4%)        3/50 (6%)     |  2/50 (4%)        1/49 (2%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        15.2%            4.5%             6.4%          |  4.4%             2.2%             0.0%            |
|TERMINAL (d)       |        4/40 (10%)       1/37 (3%)        1/41 (2%)     |  1/37 (3%)        1/40 (3%)        0/29 (0%)       |
|FIRST INCIDENCE    |        562              706              519           |  671              736 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.104N         P=0.098N         P=0.165N      |  P=0.172N         P=0.479N         P=0.289N        |
|POLY 3             |        P=0.094N         P=0.085N         P=0.152N      |  P=0.166N         P=0.494N         P=0.262N        |
|POLY 1.5           |        P=0.095N         P=0.083N         P=0.153N      |  P=0.158N         P=0.499N         P=0.253N        |
|POLY 6             |        P=0.094N         P=0.088N         P=0.151N      |  P=0.176N         P=0.488N         P=0.273N        |
|LOGISTIC REGRESSION|        P=0.103N         P=0.081N         P=0.175N      |  P=0.152N         P=0.502N         P=0.250N        |
|COCH-ARM / FISHERS |        P=0.099N         P=0.080N         P=0.159N      |  P=0.143N         P=0.508N         P=0.247N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 5
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        19/50 (38%)      26/50 (52%)      25/50 (50%)   |  23/50 (46%)      32/49 (65%)      29/50 (58%)     |
|POLY-3 ADJUSTED (b)|        42.1%            55.8%            54.3%         |  49.5%            68.8%            65.8%           |
|TERMINAL (d)       |        18/40 (45%)      20/37 (54%)      24/41 (59%)   |  19/37 (51%)      30/40 (75%)      19/29 (66%)     |
|FIRST INCIDENCE    |        670              528              554           |  542              651              517             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.165          P=0.073          P=0.173       |  P=0.012 *        P=0.113          P=0.027 *       |
|POLY 3             |        P=0.145          P=0.133          P=0.166       |  P=0.059          P=0.041 *        P=0.081         |
|POLY 1.5           |        P=0.143          P=0.119          P=0.164       |  P=0.075          P=0.040 *        P=0.099         |
|POLY 6             |        P=0.149          P=0.153          P=0.171       |  P=0.049 *        P=0.042 *        P=0.070         |
|LOGISTIC REGRESSION|        P=0.140          P=0.105          P=0.164       |  P=0.045 *        P=0.067          P=0.077         |
|COCH-ARM / FISHERS |        P=0.135          P=0.114          P=0.157       |  P=0.134          P=0.041 *        P=0.158         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        11/50 (22%)      8/50 (16%)       12/50 (24%)   |  10/50 (20%)      13/49 (27%)      16/50 (32%)     |
|POLY-3 ADJUSTED (b)|        23.3%            17.7%            24.6%         |  21.6%            27.9%            38.2%           |
|TERMINAL (d)       |        7/40 (18%)       6/37 (16%)       6/41 (15%)    |  6/37 (16%)       10/40 (25%)      11/29 (38%)     |
|FIRST INCIDENCE    |        353              626              444           |  542              638              615             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.470          P=0.356N         P=0.513       |  P=0.035 *        P=0.399          P=0.048 *       |
|POLY 3             |        P=0.484          P=0.342N         P=0.537       |  P=0.059          P=0.324          P=0.068         |
|POLY 1.5           |        P=0.471          P=0.332N         P=0.523       |  P=0.072          P=0.314          P=0.085         |
|POLY 6             |        P=0.500          P=0.352N         P=0.555       |  P=0.048 *        P=0.335          P=0.054         |
|LOGISTIC REGRESSION|        P=0.425          P=0.299N         P=0.463       |  P=0.071          P=0.291          P=0.086         |
|COCH-ARM / FISHERS |        P=0.451          P=0.306N         P=0.500       |  P=0.105          P=0.298          P=0.127         |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 6
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        11/50 (22%)      8/50 (16%)       12/50 (24%)   |  10/50 (20%)      13/49 (27%)      17/50 (34%)     |
|POLY-3 ADJUSTED (b)|        23.3%            17.7%            24.6%         |  21.6%            27.9%            40.6%           |
|TERMINAL (d)       |        7/40 (18%)       6/37 (16%)       6/41 (15%)    |  6/37 (16%)       10/40 (25%)      12/29 (41%)     |
|FIRST INCIDENCE    |        353              626              444           |  542              638              615             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.470          P=0.356N         P=0.513       |  P=0.021 *        P=0.399          P=0.030 *       |
|POLY 3             |        P=0.484          P=0.342N         P=0.537       |  P=0.036 *        P=0.324          P=0.042 *       |
|POLY 1.5           |        P=0.471          P=0.332N         P=0.523       |  P=0.045 *        P=0.314          P=0.054         |
|POLY 6             |        P=0.500          P=0.352N         P=0.555       |  P=0.029 *        P=0.335          P=0.032 *       |
|LOGISTIC REGRESSION|        P=0.425          P=0.299N         P=0.463       |  P=0.044 *        P=0.291          P=0.055         |
|COCH-ARM / FISHERS |        P=0.451          P=0.306N         P=0.500       |  P=0.071          P=0.298          P=0.088         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        28/50 (56%)      29/50 (58%)      32/50 (64%)   |  28/50 (56%)      40/49 (82%)      36/50 (72%)     |
|POLY-3 ADJUSTED (b)|        59.1%            62.1%            65.6%         |  59.3%            84.7%            80.3%           |
|TERMINAL (d)       |        23/40 (58%)      22/37 (60%)      26/41 (63%)   |  22/37 (60%)      35/40 (88%)      24/29 (83%)     |
|FIRST INCIDENCE    |        353              528              444           |  542              638              517             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.306          P=0.377          P=0.332       |  P=0.002 **       P=0.049 *        P=0.007 **      |
|POLY 3             |        P=0.288          P=0.467          P=0.326       |  P=0.009 **       P=0.004 **       P=0.019 *       |
|POLY 1.5           |        P=0.269          P=0.466          P=0.306       |  P=0.014 *        P=0.004 **       P=0.029 *       |
|POLY 6             |        P=0.313          P=0.475          P=0.352       |  P=0.006 **       P=0.004 **       P=0.014 *       |
|LOGISTIC REGRESSION|        P=0.246          P=0.490          P=0.270       |  P=0.009 **       P=0.010 *        P=0.023 *       |
|COCH-ARM / FISHERS |        P=0.238          P=0.500          P=0.270       |  P=0.051          P=0.005 **       P=0.072         |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 7
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           |
|     or Hepatoblastoma                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        28/50 (56%)      29/50 (58%)      32/50 (64%)   |  28/50 (56%)      40/49 (82%)      36/50 (72%)     |
|POLY-3 ADJUSTED (b)|        59.1%            62.1%            65.6%         |  59.3%            84.7%            80.3%           |
|TERMINAL (d)       |        23/40 (58%)      22/37 (60%)      26/41 (63%)   |  22/37 (60%)      35/40 (88%)      24/29 (83%)     |
|FIRST INCIDENCE    |        353              528              444           |  542              638              517             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.306          P=0.377          P=0.332       |  P=0.002 **       P=0.049 *        P=0.007 **      |
|POLY 3             |        P=0.288          P=0.467          P=0.326       |  P=0.009 **       P=0.004 **       P=0.019 *       |
|POLY 1.5           |        P=0.269          P=0.466          P=0.306       |  P=0.014 *        P=0.004 **       P=0.029 *       |
|POLY 6             |        P=0.313          P=0.475          P=0.352       |  P=0.006 **       P=0.004 **       P=0.014 *       |
|LOGISTIC REGRESSION|        P=0.246          P=0.490          P=0.270       |  P=0.009 **       P=0.010 *        P=0.023 *       |
|COCH-ARM / FISHERS |        P=0.238          P=0.500          P=0.270       |  P=0.051          P=0.005 **       P=0.072         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        6/50 (12%)       6/50 (12%)       10/50 (20%)   |  1/50 (2%)        2/49 (4%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        13.3%            13.4%            21.6%         |  2.2%             4.4%             2.5%            |
|TERMINAL (d)       |        5/40 (13%)       6/37 (16%)       7/41 (17%)    |  1/37 (3%)        2/40 (5%)        1/29 (3%)       |
|FIRST INCIDENCE    |        646              735 (T)          573           |  736 (T)          736 (T)          736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.180          P=0.570          P=0.228       |  P=0.551          P=0.527          P=0.707         |
|POLY 3             |        P=0.172          P=0.613          P=0.221       |  P=0.588          P=0.508          P=0.737         |
|POLY 1.5           |        P=0.169          P=0.614          P=0.216       |  P=0.599          P=0.502          P=0.745         |
|POLY 6             |        P=0.178          P=0.609          P=0.228       |  P=0.575          P=0.515          P=0.728         |
|LOGISTIC REGRESSION|        P=0.167          P=0.618          P=0.211       |  P=0.551          P=0.527          P=0.707         |
|COCH-ARM / FISHERS |        P=0.161          P=0.620N         P=0.207       |  P=0.621          P=0.492          P=0.753N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 8
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        8/50 (16%)       8/50 (16%)       6/50 (12%)    |  7/50 (14%)       3/49 (6%)        3/50 (6%)       |
|POLY-3 ADJUSTED (b)|        17.7%            17.8%            13.2%         |  15.6%            6.5%             7.4%            |
|TERMINAL (d)       |        7/40 (18%)       6/37 (16%)       6/41 (15%)    |  7/37 (19%)       3/40 (8%)        3/29 (10%)      |
|FIRST INCIDENCE    |        616              668              735 (T)       |  736 (T)          736 (T)          736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.322N         P=0.551          P=0.372N      |  P=0.172N         P=0.127N         P=0.270N        |
|POLY 3             |        P=0.332N         P=0.603          P=0.383N      |  P=0.132N         P=0.147N         P=0.201N        |
|POLY 1.5           |        P=0.332N         P=0.602          P=0.383N      |  P=0.124N         P=0.155N         P=0.186N        |
|POLY 6             |        P=0.332N         P=0.603          P=0.383N      |  P=0.142N         P=0.139N         P=0.221N        |
|LOGISTIC REGRESSION|        P=0.322N         P=0.605          P=0.372N      |  P=0.172N         P=0.127N         P=0.270N        |
|COCH-ARM / FISHERS |        P=0.336N         P=0.607N         P=0.387N      |  P=0.107N         P=0.167N         P=0.159N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        14/50 (28%)      14/50 (28%)      16/50 (32%)   |  8/50 (16%)       5/49 (10%)       4/50 (8%)       |
|POLY-3 ADJUSTED (b)|        30.7%            31.1%            34.5%         |  17.8%            10.9%            9.9%            |
|TERMINAL (d)       |        12/40 (30%)      12/37 (32%)      13/41 (32%)   |  8/37 (22%)       5/40 (13%)       4/29 (14%)      |
|FIRST INCIDENCE    |        616              668              573           |  736 (T)          736 (T)          736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.403          P=0.505          P=0.442       |  P=0.229N         P=0.224N         P=0.311N        |
|POLY 3             |        P=0.389          P=0.573          P=0.433       |  P=0.174N         P=0.260N         P=0.229N        |
|POLY 1.5           |        P=0.385          P=0.576          P=0.428       |  P=0.161N         P=0.272N         P=0.211N        |
|POLY 6             |        P=0.396          P=0.567          P=0.440       |  P=0.190N         P=0.246N         P=0.252N        |
|LOGISTIC REGRESSION|        P=0.386          P=0.585          P=0.428       |  P=0.229N         P=0.224N         P=0.311N        |
|COCH-ARM / FISHERS |        P=0.371          P=0.588N         P=0.414       |  P=0.135N         P=0.290N         P=0.178N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 9
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  4/50 (8%)        1/49 (2%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|                                                        |  8.9%             2.2%             4.9%            |
|TERMINAL (d)       |                                                        |  4/37 (11%)       1/40 (3%)        2/29 (7%)       |
|FIRST INCIDENCE    |                                                        |  736 (T)          736 (T)          736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.315N         P=0.156N         P=0.454N        |
|POLY 3             |                                                        |  P=0.266N         P=0.172N         P=0.385N        |
|POLY 1.5           |                                                        |  P=0.258N         P=0.177N         P=0.369N        |
|POLY 6             |                                                        |  P=0.275N         P=0.165N         P=0.405N        |
|LOGISTIC REGRESSION|                                                        |  P=0.315N         P=0.156N         P=0.454N        |
|COCH-ARM / FISHERS |                                                        |  P=0.239N         P=0.187N         P=0.339N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  1/50 (2%)        2/49 (4%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|                                                        |  2.2%             4.4%             2.5%            |
|TERMINAL (d)       |                                                        |  1/37 (3%)        2/40 (5%)        1/29 (3%)       |
|FIRST INCIDENCE    |                                                        |  736 (T)          736 (T)          736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.551          P=0.527          P=0.707         |
|POLY 3             |                                                        |  P=0.588          P=0.508          P=0.737         |
|POLY 1.5           |                                                        |  P=0.599          P=0.502          P=0.745         |
|POLY 6             |                                                        |  P=0.575          P=0.515          P=0.728         |
|LOGISTIC REGRESSION|                                                        |  P=0.551          P=0.527          P=0.707         |
|COCH-ARM / FISHERS |                                                        |  P=0.621          P=0.492          P=0.753N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 10
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor: Benign, Malignant, NOS                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  1/50 (2%)        3/49 (6%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|                                                        |  2.2%             6.5%             2.5%            |
|TERMINAL (d)       |                                                        |  1/37 (3%)        3/40 (8%)        1/29 (3%)       |
|FIRST INCIDENCE    |                                                        |  736 (T)          736 (T)          736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.528          P=0.333          P=0.707         |
|POLY 3             |                                                        |  P=0.564          P=0.314          P=0.737         |
|POLY 1.5           |                                                        |  P=0.579          P=0.308          P=0.745         |
|POLY 6             |                                                        |  P=0.546          P=0.321          P=0.728         |
|LOGISTIC REGRESSION|                                                        |  P=0.528          P=0.333          P=0.707         |
|COCH-ARM / FISHERS |                                                        |  P=0.609          P=0.301          P=0.753N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/48 (0%)        1/49 (2%)        0/50 (0%)     |  10/47 (21%)      9/49 (18%)       7/50 (14%)      |
|POLY-3 ADJUSTED (b)|        0.0%             2.3%             0.0%          |  23.8%            19.5%            17.0%           |
|TERMINAL (d)       |        0/38 (0%)        1/36 (3%)        0/41 (0%)     |  9/34 (27%)       8/40 (20%)       5/29 (17%)      |
|FIRST INCIDENCE    |        ---              735 (T)          ---           |  719              651              583             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.716N         P=0.489          (e)           |  P=0.366N         P=0.354N         P=0.428N        |
|POLY 3             |        P=0.721N         P=0.504          (e)           |  P=0.263N         P=0.405N         P=0.305N        |
|POLY 1.5           |        P=0.722N         P=0.503          (e)           |  P=0.247N         P=0.428N         P=0.288N        |
|POLY 6             |        P=0.720N         P=0.504          (e)           |  P=0.278N         P=0.378N         P=0.324N        |
|LOGISTIC REGRESSION|        (e)              P=0.489          (e)           |  P=0.292N         P=0.372N         P=0.347N        |
|COCH-ARM / FISHERS |        P=0.725N         P=0.505          (e)           |  P=0.210N         P=0.459N         P=0.250N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 11
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)     |  0/50 (0%)        0/50 (0%)        3/50 (6%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  0.0%             0.0%             7.3%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        0/41 (0%)     |  0/37 (0%)        0/40 (0%)        1/29 (3%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  ---              ---              625             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.025 *        (e)              P=0.093         |
|POLY 3             |        (e)              (e)              (e)           |  P=0.035 *        (e)              P=0.104         |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.035 *        (e)              P=0.108         |
|POLY 6             |        (e)              (e)              (e)           |  P=0.035 *        (e)              P=0.099         |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.040 *        (e)              P=0.125         |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.037 *        (e)              P=0.121         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        2/50 (4%)     |  2/50 (4%)        0/49 (0%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        4.4%             0.0%             4.4%          |  4.4%             0.0%             2.5%            |
|TERMINAL (d)       |        1/40 (3%)        0/37 (0%)        2/41 (5%)     |  0/37 (0%)        0/40 (0%)        1/29 (3%)       |
|FIRST INCIDENCE    |        670              ---              735 (T)       |  629              ---              736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.612N         P=0.248N         P=0.684N      |  P=0.413N         P=0.230N         P=0.573N        |
|POLY 3             |        P=0.621N         P=0.239N         P=0.691N      |  P=0.382N         P=0.235N         P=0.540N        |
|POLY 1.5           |        P=0.621N         P=0.239N         P=0.691N      |  P=0.375N         P=0.238N         P=0.526N        |
|POLY 6             |        P=0.621N         P=0.240N         P=0.691N      |  P=0.390N         P=0.233N         P=0.558N        |
|LOGISTIC REGRESSION|        P=0.618N         P=0.238N         P=0.691N      |  P=0.337N         P=0.288N         P=0.490N        |
|COCH-ARM / FISHERS |        P=0.622          P=0.247N         P=0.691N      |  P=0.361N         P=0.253N         P=0.500N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 12
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        4/50 (8%)        2/50 (4%)     |  4/50 (8%)        3/49 (6%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        2.2%             9.0%             4.3%          |  8.8%             6.5%             0.0%            |
|TERMINAL (d)       |        1/40 (3%)        4/37 (11%)       1/41 (2%)     |  3/37 (8%)        2/40 (5%)        0/29 (0%)       |
|FIRST INCIDENCE    |        735 (T)          735 (T)          519           |  562              668              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.417          P=0.156          P=0.506       |  P=0.071N         P=0.466N         P=0.094N        |
|POLY 3             |        P=0.424          P=0.177          P=0.510       |  P=0.066N         P=0.491N         P=0.076N        |
|POLY 1.5           |        P=0.418          P=0.177          P=0.507       |  P=0.060N         P=0.499N         P=0.070N        |
|POLY 6             |        P=0.431          P=0.177          P=0.513       |  P=0.075N         P=0.481N         P=0.084N        |
|LOGISTIC REGRESSION|        P=0.408          P=0.156          P=0.481       |  P=0.049N*        P=0.530N         P=0.063N        |
|COCH-ARM / FISHERS |        P=0.406          P=0.181          P=0.500       |  P=0.049N*        P=0.511N         P=0.059N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  2/50 (4%)        1/50 (2%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                                                        |  4.5%             2.2%             0.0%            |
|TERMINAL (d)       |                                                        |  2/37 (5%)        1/40 (3%)        0/29 (0%)       |
|FIRST INCIDENCE    |                                                        |  736 (T)          736 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.172N         P=0.473N         P=0.293N        |
|POLY 3             |                                                        |  P=0.164N         P=0.492N         P=0.261N        |
|POLY 1.5           |                                                        |  P=0.156N         P=0.497N         P=0.253N        |
|POLY 6             |                                                        |  P=0.173N         P=0.485N         P=0.271N        |
|LOGISTIC REGRESSION|                                                        |  P=0.172N         P=0.473N         (e)             |
|COCH-ARM / FISHERS |                                                        |  P=0.142N         P=0.500N         P=0.247N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 13
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        8/50 (16%)       2/50 (4%)        5/50 (10%)    |  3/50 (6%)        2/50 (4%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        17.4%            4.5%             10.7%         |  6.6%             4.4%             4.9%            |
|TERMINAL (d)       |        5/40 (13%)       1/37 (3%)        3/41 (7%)     |  1/37 (3%)        2/40 (5%)        1/29 (3%)       |
|FIRST INCIDENCE    |        562              706              519           |  629              736 (T)          523             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.205N         P=0.061N         P=0.277N      |  P=0.491N         P=0.471N         P=0.586N        |
|POLY 3             |        P=0.195N         P=0.049N*        P=0.266N      |  P=0.450N         P=0.495N         P=0.546N        |
|POLY 1.5           |        P=0.197N         P=0.048N*        P=0.268N      |  P=0.436N         P=0.499N         P=0.530N        |
|POLY 6             |        P=0.195N         P=0.052N         P=0.265N      |  P=0.468N         P=0.491N         P=0.566N        |
|LOGISTIC REGRESSION|        P=0.207N         P=0.048N*        P=0.291N      |  P=0.385N         P=0.501N         P=0.455N        |
|COCH-ARM / FISHERS |        P=0.202N         P=0.046N*        P=0.277N      |  P=0.406N         P=0.500N         P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        9/50 (18%)       2/50 (4%)        5/50 (10%)    |  3/50 (6%)        2/50 (4%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        19.6%            4.5%             10.7%         |  6.6%             4.4%             4.9%            |
|TERMINAL (d)       |        6/40 (15%)       1/37 (3%)        3/41 (7%)     |  1/37 (3%)        2/40 (5%)        1/29 (3%)       |
|FIRST INCIDENCE    |        562              706              519           |  629              736 (T)          523             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.132N         P=0.038N*        P=0.197N      |  P=0.491N         P=0.471N         P=0.586N        |
|POLY 3             |        P=0.121N         P=0.028N*        P=0.184N      |  P=0.450N         P=0.495N         P=0.546N        |
|POLY 1.5           |        P=0.123N         P=0.027N*        P=0.186N      |  P=0.436N         P=0.499N         P=0.530N        |
|POLY 6             |        P=0.121N         P=0.029N*        P=0.183N      |  P=0.468N         P=0.491N         P=0.566N        |
|LOGISTIC REGRESSION|        P=0.131N         P=0.028N*        P=0.204N      |  P=0.385N         P=0.501N         P=0.455N        |
|COCH-ARM / FISHERS |        P=0.128N         P=0.026N*        P=0.194N      |  P=0.406N         P=0.500N         P=0.500N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 14
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)     |  0/50 (0%)        0/50 (0%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  0.0%             0.0%             4.9%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        0/41 (0%)     |  0/37 (0%)        0/40 (0%)        0/29 (0%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  ---              ---              596             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.078          (e)              P=0.207         |
|POLY 3             |        (e)              (e)              (e)           |  P=0.094          (e)              P=0.217         |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.094          (e)              P=0.224         |
|POLY 6             |        (e)              (e)              (e)           |  P=0.095          (e)              P=0.210         |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.104          (e)              P=0.251         |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.095          (e)              P=0.247         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        4/50 (8%)        3/50 (6%)        2/50 (4%)     |  9/50 (18%)       5/50 (10%)       11/50 (22%)     |
|POLY-3 ADJUSTED (b)|        8.7%             6.5%             4.4%          |  19.6%            10.8%            25.9%           |
|TERMINAL (d)       |        2/40 (5%)        1/37 (3%)        2/41 (5%)     |  5/37 (14%)       4/40 (10%)       6/29 (21%)      |
|FIRST INCIDENCE    |        344              164              735 (T)       |  562              668              457             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.263N         P=0.517N         P=0.332N      |  P=0.208          P=0.168N         P=0.244         |
|POLY 3             |        P=0.271N         P=0.502N         P=0.343N      |  P=0.297          P=0.188N         P=0.328         |
|POLY 1.5           |        P=0.268N         P=0.501N         P=0.341N      |  P=0.310          P=0.193N         P=0.351         |
|POLY 6             |        P=0.272N         P=0.503N         P=0.345N      |  P=0.282          P=0.182N         P=0.302         |
|LOGISTIC REGRESSION|        P=0.294N         P=0.450N         P=0.364N      |  P=0.336          P=0.192N         P=0.393         |
|COCH-ARM / FISHERS |        P=0.264N         P=0.500N         P=0.339N      |  P=0.344          P=0.194N         P=0.402         |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 15
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        4/50 (8%)        3/50 (6%)        2/50 (4%)     |  9/50 (18%)       5/50 (10%)       9/50 (18%)      |
|POLY-3 ADJUSTED (b)|        8.7%             6.5%             4.4%          |  19.6%            10.8%            21.4%           |
|TERMINAL (d)       |        2/40 (5%)        1/37 (3%)        2/41 (5%)     |  5/37 (14%)       4/40 (10%)       6/29 (21%)      |
|FIRST INCIDENCE    |        344              164              735 (T)       |  562              668              457             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.263N         P=0.517N         P=0.332N      |  P=0.392          P=0.168N         P=0.421         |
|POLY 3             |        P=0.271N         P=0.502N         P=0.343N      |  P=0.500          P=0.188N         P=0.523         |
|POLY 1.5           |        P=0.268N         P=0.501N         P=0.341N      |  P=0.518          P=0.193N         P=0.550         |
|POLY 6             |        P=0.272N         P=0.503N         P=0.345N      |  P=0.480          P=0.182N         P=0.489         |
|LOGISTIC REGRESSION|        P=0.294N         P=0.450N         P=0.364N      |  P=0.540          P=0.192N         P=0.588         |
|COCH-ARM / FISHERS |        P=0.264N         P=0.500N         P=0.339N      |  P=0.555          P=0.194N         P=0.602N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        27/50 (54%)      36/50 (72%)      35/50 (70%)   |  34/50 (68%)      37/50 (74%)      35/50 (70%)     |
|POLY-3 ADJUSTED (b)|        59.5%            75.4%            73.6%         |  72.5%            79.1%            78.0%           |
|TERMINAL (d)       |        25/40 (63%)      28/37 (76%)      30/41 (73%)   |  28/37 (76%)      34/40 (85%)      22/29 (76%)     |
|FIRST INCIDENCE    |        646              462              519           |  542              651              517             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.098          P=0.026 *        P=0.104       |  P=0.057          P=0.557          P=0.091         |
|POLY 3             |        P=0.085          P=0.071          P=0.103       |  P=0.299          P=0.300          P=0.352         |
|POLY 1.5           |        P=0.072          P=0.055          P=0.090       |  P=0.332          P=0.297          P=0.383         |
|POLY 6             |        P=0.104          P=0.094          P=0.123       |  P=0.289          P=0.316          P=0.342         |
|LOGISTIC REGRESSION|        P=0.059          P=0.040 *        P=0.074       |  P=0.184          P=0.420          P=0.256         |
|COCH-ARM / FISHERS |        P=0.058          P=0.048 *        P=0.074       |  P=0.456          P=0.330          P=0.500         |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 16
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        29/50 (58%)      23/50 (46%)      22/50 (44%)   |  30/50 (60%)      22/50 (44%)      31/50 (62%)     |
|POLY-3 ADJUSTED (b)|        58.0%            48.4%            44.0%         |  62.3%            46.9%            67.5%           |
|TERMINAL (d)       |        19/40 (48%)      15/37 (41%)      14/41 (34%)   |  20/37 (54%)      18/40 (45%)      17/29 (59%)     |
|FIRST INCIDENCE    |        344              164              444           |  542              638              457             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.128N         P=0.272N         P=0.151N      |  P=0.153          P=0.062N         P=0.164         |
|POLY 3             |        P=0.095N         P=0.227N         P=0.115N      |  P=0.360          P=0.094N         P=0.376         |
|POLY 1.5           |        P=0.096N         P=0.200N         P=0.115N      |  P=0.384          P=0.090N         P=0.406         |
|POLY 6             |        P=0.095N         P=0.257N         P=0.116N      |  P=0.337          P=0.101N         P=0.347         |
|LOGISTIC REGRESSION|        P=0.099N         P=0.148N         P=0.135N      |  P=0.391          P=0.076N         P=0.439         |
|COCH-ARM / FISHERS |        P=0.097N         P=0.158N         P=0.115N      |  P=0.460          P=0.080N         P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        45/50 (90%)      44/50 (88%)      42/50 (84%)   |  44/50 (88%)      43/50 (86%)      45/50 (90%)     |
|POLY-3 ADJUSTED (b)|        90.0%            89.5%            84.0%         |  90.3%            90.6%            94.8%           |
|TERMINAL (d)       |        35/40 (88%)      32/37 (87%)      33/41 (81%)   |  33/37 (89%)      37/40 (93%)      27/29 (93%)     |
|FIRST INCIDENCE    |        344              164              444           |  542              638              457             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.271N         P=0.459          P=0.304N      |  P=0.035 *        P=0.252N         P=0.057         |
|POLY 3             |        P=0.222N         P=0.596N         P=0.277N      |  P=0.257          P=0.625          P=0.317         |
|POLY 1.5           |        P=0.223N         P=0.567N         P=0.277N      |  P=0.282          P=0.615N         P=0.339         |
|POLY 6             |        P=0.222N         P=0.613N         P=0.277N      |  P=0.253          P=0.591          P=0.317         |
|LOGISTIC REGRESSION|        P=0.232N         P=0.498N         (e)           |  P=0.163          P=0.451N         P=0.238         |
|COCH-ARM / FISHERS |        P=0.226N         P=0.500N         P=0.277N      |  P=0.439          P=0.500N         P=0.500         |
|=================================================================================================================================|

(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).