National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/10632

Statistical Analysis of Primary Tumors

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08
LAB: Battelle Columbus                            OLEIC ACID DIETHANOLAMINE CONDENSATE                         DATE: 09/30/97

EXPERIMENT: 91014 TEST: 04                                                                                     TIME: 08:20:48
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:
CONT: N01-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: C91014
PATHOLOGIST: SELLS, D.                                                                                         CAS: 93-83-4
            

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                            OLEIC ACID DIETHANOLAMINE CONDENSATE                         DATE: 09/30/97     
EXPERIMENT: 91014 TEST: 04                                                                                     TIME: 08:20:48     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:              
CONT: N01-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: C91014     
PATHOLOGIST: SELLS, D.                                                                                         CAS: 93-83-4       



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

Male Mice
------------
Organ                                 Morphology
-----                                 ----------
All Organs                             Hemangioma
                                       Malignant Lymphoma And Histiocytic Sarcoma
                                       Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type
===============================================================
Female Mice
------------
Organ                                  Morphology
-----                                  ----------
Pituitary Gland: Pars Distalis or Unspecified Site
                                       Adenoma
All Organs                             Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type
                                       Malignant and Benign Tumors
===============================================================
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 1
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)        -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/49 (4%)        0/50 (0%)        0/50 (0%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        4.4%             0.0%             0.0%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        2/41 (5%)        0/35 (0%)        0/34 (0%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          ---              ---           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.118N         P=0.274N         P=0.280N      |  (e)              (e)              (e)             |
|POLY 3             |        P=0.100N         P=0.241N         P=0.253N      |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.097N         P=0.238N         P=0.245N      |  (e)              (e)              (e)             |
|POLY 6             |        P=0.104N         P=0.246N         P=0.264N      |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.118N         (e)              (e)           |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.093N         P=0.242N         P=0.242N      |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        0/50 (0%)        0/50 (0%)     |  2/50 (4%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  4.6%             0.0%             0.0%            |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        0/34 (0%)     |  2/34 (6%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  730 (T)          ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.098N         P=0.266N         P=0.232N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.094N         P=0.240N         P=0.236N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.094N         P=0.238N         P=0.236N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.094N         P=0.245N         P=0.235N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.098N         (e)              (e)             |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.095N         P=0.247N         P=0.247N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 2
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        0/50 (0%)        2/50 (4%)     |  1/50 (2%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             4.7%          |  2.3%             0.0%             0.0%            |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        2/34 (6%)     |  1/34 (3%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              ---              729 (T)       |  730 (T)          ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.080          (e)              P=0.198       |  P=0.271N         P=0.525N         P=0.494N        |
|POLY 3             |        P=0.095          (e)              P=0.222       |  P=0.270N         P=0.503N         P=0.499N        |
|POLY 1.5           |        P=0.095          (e)              P=0.230       |  P=0.270N         P=0.501N         P=0.499N        |
|POLY 6             |        P=0.095          (e)              P=0.213       |  P=0.270N         P=0.507N         P=0.498N        |
|LOGISTIC REGRESSION|        (e)              (e)              P=0.198       |  P=0.271N         (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.097          (e)              P=0.253       |  P=0.269N         P=0.500N         P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        4/50 (8%)     |  3/50 (6%)        1/50 (2%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        4.4%             2.2%             9.3%          |  6.8%             2.3%             0.0%            |
|TERMINAL (d)       |        2/41 (5%)        1/35 (3%)        2/34 (6%)     |  2/34 (6%)        1/30 (3%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          729 (T)          638           |  621              730 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.186          P=0.555N         P=0.264       |  P=0.062N         P=0.338N         P=0.120N        |
|POLY 3             |        P=0.227          P=0.506N         P=0.311       |  P=0.060N         P=0.314N         P=0.119N        |
|POLY 1.5           |        P=0.233          P=0.502N         P=0.325       |  P=0.060N         P=0.309N         P=0.119N        |
|POLY 6             |        P=0.219          P=0.514N         P=0.295       |  P=0.060N         P=0.324N         P=0.119N        |
|LOGISTIC REGRESSION|        P=0.217          P=0.555N         P=0.313       |  P=0.060N         P=0.308N         P=0.120N        |
|COCH-ARM / FISHERS |        P=0.238          P=0.500N         P=0.339       |  P=0.060N         P=0.309N         P=0.121N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 3
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        4/50 (8%)     |  3/50 (6%)        2/50 (4%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        4.4%             2.2%             9.3%          |  6.8%             4.7%             0.0%            |
|TERMINAL (d)       |        2/41 (5%)        1/35 (3%)        2/34 (6%)     |  2/34 (6%)        2/30 (7%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          729 (T)          638           |  621              730 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.186          P=0.555N         P=0.264       |  P=0.083N         P=0.543N         P=0.120N        |
|POLY 3             |        P=0.227          P=0.506N         P=0.311       |  P=0.082N         P=0.511N         P=0.119N        |
|POLY 1.5           |        P=0.233          P=0.502N         P=0.325       |  P=0.081N         P=0.504N         P=0.119N        |
|POLY 6             |        P=0.219          P=0.514N         P=0.295       |  P=0.082N         P=0.524N         P=0.119N        |
|LOGISTIC REGRESSION|        P=0.217          P=0.555N         P=0.313       |  P=0.082N         P=0.508N         P=0.120N        |
|COCH-ARM / FISHERS |        P=0.238          P=0.500N         P=0.339       |  P=0.082N         P=0.500N         P=0.121N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        0/50 (0%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        4.4%             0.0%             0.0%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        2/41 (5%)        0/35 (0%)        0/34 (0%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          ---              ---           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.118N         P=0.274N         P=0.280N      |  (e)              (e)              (e)             |
|POLY 3             |        P=0.101N         P=0.241N         P=0.253N      |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.097N         P=0.238N         P=0.245N      |  (e)              (e)              (e)             |
|POLY 6             |        P=0.105N         P=0.246N         P=0.264N      |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.118N         (e)              (e)           |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.095N         P=0.247N         P=0.247N      |  (e)              (e)              (e)             |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 4
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Site Unspecified                                                                                                |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        0/50 (0%)        0/50 (0%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        4.4%             0.0%             0.0%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        2/41 (5%)        0/35 (0%)        0/34 (0%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          ---              ---           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.118N         P=0.274N         P=0.280N      |  (e)              (e)              (e)             |
|POLY 3             |        P=0.101N         P=0.241N         P=0.253N      |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.097N         P=0.238N         P=0.245N      |  (e)              (e)              (e)             |
|POLY 6             |        P=0.105N         P=0.246N         P=0.264N      |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.118N         (e)              (e)           |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.095N         P=0.247N         P=0.247N      |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        2/50 (4%)        2/50 (4%)     |  1/49 (2%)        0/50 (0%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        0.0%             4.5%             4.7%          |  2.3%             0.0%             2.3%            |
|TERMINAL (d)       |        0/41 (0%)        2/35 (6%)        2/34 (6%)     |  1/34 (3%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              729 (T)          729 (T)       |  730 (T)          ---              692             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.140          P=0.204          P=0.198       |  P=0.655N         P=0.525N         P=0.751N        |
|POLY 3             |        P=0.160          P=0.233          P=0.222       |  P=0.664N         P=0.500N         P=0.756N        |
|POLY 1.5           |        P=0.168          P=0.236          P=0.230       |  P=0.664N         P=0.497N         P=0.755N        |
|POLY 6             |        P=0.151          P=0.228          P=0.213       |  P=0.663N         P=0.505N         P=0.755N        |
|LOGISTIC REGRESSION|        (e)              P=0.204          P=0.198       |  P=0.664N         (e)              P=0.758N        |
|COCH-ARM / FISHERS |        P=0.180          P=0.253          P=0.253       |  P=0.665N         P=0.495N         P=0.747N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 5
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        2/50 (4%)        2/50 (4%)     |  1/49 (2%)        1/50 (2%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        0.0%             4.5%             4.7%          |  2.3%             2.3%             2.3%            |
|TERMINAL (d)       |        0/41 (0%)        2/35 (6%)        2/34 (6%)     |  1/34 (3%)        1/30 (3%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              729 (T)          729 (T)       |  730 (T)          730 (T)          692             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.140          P=0.204          P=0.198       |  P=0.626N         P=0.734          P=0.751N        |
|POLY 3             |        P=0.160          P=0.233          P=0.222       |  P=0.633N         P=0.761N         P=0.756N        |
|POLY 1.5           |        P=0.168          P=0.236          P=0.230       |  P=0.632N         P=0.757N         P=0.755N        |
|POLY 6             |        P=0.151          P=0.228          P=0.213       |  P=0.632N         P=0.756          P=0.755N        |
|LOGISTIC REGRESSION|        (e)              P=0.204          P=0.198       |  P=0.633N         P=0.734          P=0.758N        |
|COCH-ARM / FISHERS |        P=0.180          P=0.253          P=0.253       |  P=0.634N         P=0.747N         P=0.747N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/49 (2%)        4/50 (8%)        2/50 (4%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        2.2%             8.9%             4.6%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        1/41 (2%)        4/35 (11%)       1/34 (3%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          729 (T)          468           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.341          P=0.135          P=0.459       |  (e)              (e)              (e)             |
|POLY 3             |        P=0.377          P=0.173          P=0.482       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.392          P=0.177          P=0.492       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.356          P=0.166          P=0.468       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.416          P=0.135          P=0.572       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.415          P=0.187          P=0.508       |  (e)              (e)              (e)             |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 6
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        22/49 (45%)      22/50 (44%)      22/50 (44%)   |  26/50 (52%)      30/50 (60%)      28/50 (56%)     |
|POLY-3 ADJUSTED (b)|        46.7%            48.6%            49.2%         |  57.7%            65.5%            63.1%           |
|TERMINAL (d)       |        20/41 (49%)      19/35 (54%)      17/34 (50%)   |  20/34 (59%)      21/30 (70%)      24/35 (69%)     |
|FIRST INCIDENCE    |        456              660              356           |  578              501              659             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.251          P=0.330          P=0.301       |  P=0.443          P=0.143          P=0.476         |
|POLY 3             |        P=0.448          P=0.511          P=0.490       |  P=0.332          P=0.286          P=0.376         |
|POLY 1.5           |        P=0.501          P=0.545          P=0.541       |  P=0.359          P=0.287          P=0.401         |
|POLY 6             |        P=0.386          P=0.467          P=0.429       |  P=0.309          P=0.272          P=0.356         |
|LOGISTIC REGRESSION|        P=0.469          P=0.563          P=0.566       |  P=0.376          P=0.247          P=0.423         |
|COCH-ARM / FISHERS |        P=0.505N         P=0.545N         P=0.545N      |  P=0.381          P=0.273          P=0.421         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        9/49 (18%)       9/50 (18%)       13/50 (26%)   |  5/50 (10%)       10/50 (20%)      7/50 (14%)      |
|POLY-3 ADJUSTED (b)|        19.0%            19.6%            29.2%         |  11.3%            22.5%            15.9%           |
|TERMINAL (d)       |        4/41 (10%)       4/35 (11%)       7/34 (21%)    |  3/34 (9%)        4/30 (13%)       4/35 (11%)      |
|FIRST INCIDENCE    |        452              547              537           |  562              585              659             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.122          P=0.514          P=0.148       |  P=0.362          P=0.112          P=0.400         |
|POLY 3             |        P=0.155          P=0.575          P=0.185       |  P=0.331          P=0.130          P=0.376         |
|POLY 1.5           |        P=0.174          P=0.590          P=0.209       |  P=0.335          P=0.131          P=0.379         |
|POLY 6             |        P=0.136          P=0.553          P=0.161       |  P=0.332          P=0.127          P=0.378         |
|LOGISTIC REGRESSION|        P=0.237          P=0.546N         P=0.305       |  P=0.338          P=0.131          P=0.381         |
|COCH-ARM / FISHERS |        P=0.208          P=0.584N         P=0.251       |  P=0.336          P=0.131          P=0.380         |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 7
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        9/49 (18%)       9/50 (18%)       13/50 (26%)   |  6/50 (12%)       10/50 (20%)      7/50 (14%)      |
|POLY-3 ADJUSTED (b)|        19.0%            19.6%            29.2%         |  13.4%            22.5%            15.9%           |
|TERMINAL (d)       |        4/41 (10%)       4/35 (11%)       7/34 (21%)    |  3/34 (9%)        4/30 (13%)       4/35 (11%)      |
|FIRST INCIDENCE    |        452              547              537           |  562              585              659             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.122          P=0.514          P=0.148       |  P=0.465          P=0.180          P=0.516         |
|POLY 3             |        P=0.155          P=0.575          P=0.185       |  P=0.430          P=0.200          P=0.489         |
|POLY 1.5           |        P=0.174          P=0.590          P=0.209       |  P=0.438          P=0.205          P=0.495         |
|POLY 6             |        P=0.136          P=0.553          P=0.161       |  P=0.426          P=0.193          P=0.486         |
|LOGISTIC REGRESSION|        P=0.237          P=0.546N         P=0.305       |  P=0.446          P=0.207          P=0.502         |
|COCH-ARM / FISHERS |        P=0.208          P=0.584N         P=0.251       |  P=0.445          P=0.207          P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        29/49 (59%)      27/50 (54%)      30/50 (60%)   |  28/50 (56%)      35/50 (70%)      29/50 (58%)     |
|POLY-3 ADJUSTED (b)|        59.3%            58.4%            65.2%         |  61.4%            74.3%            65.2%           |
|TERMINAL (d)       |        22/41 (54%)      21/35 (60%)      21/34 (62%)   |  21/34 (62%)      22/30 (73%)      24/35 (69%)     |
|FIRST INCIDENCE    |        452              547              356           |  562              501              659             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.174          P=0.455          P=0.206       |  P=0.518          P=0.063          P=0.553         |
|POLY 3             |        P=0.321          P=0.545N         P=0.352       |  P=0.385          P=0.126          P=0.438         |
|POLY 1.5           |        P=0.391          P=0.488N         P=0.426       |  P=0.423          P=0.118          P=0.471         |
|POLY 6             |        P=0.253          P=0.556          P=0.282       |  P=0.353          P=0.135          P=0.410         |
|LOGISTIC REGRESSION|        P=0.458          P=0.388N         P=0.561       |  P=0.459          P=0.097          P=0.504         |
|COCH-ARM / FISHERS |        P=0.506          P=0.376N         P=0.548       |  P=0.459          P=0.107          P=0.500         |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 8
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           |
|     or Hepatoblastoma                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        29/49 (59%)      27/50 (54%)      30/50 (60%)   |  28/50 (56%)      35/50 (70%)      29/50 (58%)     |
|POLY-3 ADJUSTED (b)|        59.3%            58.4%            65.2%         |  61.4%            74.3%            65.2%           |
|TERMINAL (d)       |        22/41 (54%)      21/35 (60%)      21/34 (62%)   |  21/34 (62%)      22/30 (73%)      24/35 (69%)     |
|FIRST INCIDENCE    |        452              547              356           |  562              501              659             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.174          P=0.455          P=0.206       |  P=0.518          P=0.063          P=0.553         |
|POLY 3             |        P=0.321          P=0.545N         P=0.352       |  P=0.385          P=0.126          P=0.438         |
|POLY 1.5           |        P=0.391          P=0.488N         P=0.426       |  P=0.423          P=0.118          P=0.471         |
|POLY 6             |        P=0.253          P=0.556          P=0.282       |  P=0.353          P=0.135          P=0.410         |
|LOGISTIC REGRESSION|        P=0.458          P=0.388N         P=0.561       |  P=0.459          P=0.097          P=0.504         |
|COCH-ARM / FISHERS |        P=0.506          P=0.376N         P=0.548       |  P=0.459          P=0.107          P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocholangiocarcinoma                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        2/50 (4%)        1/50 (2%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             4.4%             2.3%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        0/34 (0%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              686              572           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.326          P=0.227          P=0.496       |  (e)              (e)              (e)             |
|POLY 3             |        P=0.341          P=0.235          P=0.489       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.351          P=0.237          P=0.495       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.328          P=0.231          P=0.481       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.395          P=0.244          P=0.592       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.366          P=0.253          P=0.505       |  (e)              (e)              (e)             |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 9
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        7/49 (14%)       8/50 (16%)       5/50 (10%)    |  1/50 (2%)        1/50 (2%)        4/50 (8%)       |
|POLY-3 ADJUSTED (b)|        15.1%            17.7%            11.5%         |  2.3%             2.3%             9.2%            |
|TERMINAL (d)       |        6/41 (15%)       6/35 (17%)       4/34 (12%)    |  0/34 (0%)        1/30 (3%)        4/35 (11%)      |
|FIRST INCIDENCE    |        452              621              416           |  615              730 (T)          730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.456N         P=0.390          P=0.493N      |  P=0.110          P=0.749          P=0.187         |
|POLY 3             |        P=0.386N         P=0.479          P=0.426N      |  P=0.099          P=0.755          P=0.176         |
|POLY 1.5           |        P=0.356N         P=0.491          P=0.401N      |  P=0.100          P=0.758          P=0.178         |
|POLY 6             |        P=0.425N         P=0.462          P=0.459N      |  P=0.098          P=0.749          P=0.175         |
|LOGISTIC REGRESSION|        P=0.316N         P=0.511          P=0.328N      |  P=0.102          P=0.762          P=0.180         |
|COCH-ARM / FISHERS |        P=0.315N         P=0.517          P=0.365N      |  P=0.101          P=0.753N         P=0.181         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        7/49 (14%)       10/50 (20%)      9/50 (18%)    |  3/50 (6%)        2/50 (4%)        3/50 (6%)       |
|POLY-3 ADJUSTED (b)|        15.4%            21.8%            21.1%         |  6.8%             4.6%             6.9%            |
|TERMINAL (d)       |        7/41 (17%)       7/35 (20%)       8/34 (24%)    |  2/34 (6%)        1/30 (3%)        2/35 (6%)       |
|FIRST INCIDENCE    |        729 (T)          547              691           |  578              585              723             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.212          P=0.204          P=0.244       |  P=0.575N         P=0.526N         P=0.649N        |
|POLY 3             |        P=0.289          P=0.300          P=0.337       |  P=0.585          P=0.507N         P=0.659         |
|POLY 1.5           |        P=0.318          P=0.303          P=0.366       |  P=0.587          P=0.502N         P=0.661         |
|POLY 6             |        P=0.255          P=0.292          P=0.303       |  P=0.585          P=0.517N         P=0.659         |
|LOGISTIC REGRESSION|        P=0.274          P=0.292          P=0.255       |  P=0.587N         P=0.500N         P=0.662N        |
|COCH-ARM / FISHERS |        P=0.363          P=0.314          P=0.410       |  P=0.588          P=0.500N         P=0.661N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 10
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        12/49 (24%)      18/50 (36%)      13/50 (26%)   |  4/50 (8%)        3/50 (6%)        7/50 (14%)      |
|POLY-3 ADJUSTED (b)|        25.9%            38.9%            29.9%         |  9.0%             6.9%             16.0%           |
|TERMINAL (d)       |        11/41 (27%)      13/35 (37%)      11/34 (32%)   |  2/34 (6%)        2/30 (7%)        6/35 (17%)      |
|FIRST INCIDENCE    |        452              547              416           |  578              585              723             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.260          P=0.070          P=0.308       |  P=0.212          P=0.530N         P=0.278         |
|POLY 3             |        P=0.365          P=0.130          P=0.427       |  P=0.187          P=0.514N         P=0.250         |
|POLY 1.5           |        P=0.412          P=0.135          P=0.466       |  P=0.192          P=0.505N         P=0.257         |
|POLY 6             |        P=0.310          P=0.123          P=0.378       |  P=0.183          P=0.529N         P=0.245         |
|LOGISTIC REGRESSION|        P=0.423          P=0.141          P=0.471       |  P=0.196          P=0.500N         P=0.263         |
|COCH-ARM / FISHERS |        P=0.481          P=0.152          P=0.523       |  P=0.195          P=0.500N         P=0.262         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  3/50 (6%)        2/50 (4%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                                                        |  6.7%             4.7%             0.0%            |
|TERMINAL (d)       |                                                        |  1/34 (3%)        1/30 (3%)        0/35 (0%)       |
|FIRST INCIDENCE    |                                                        |  150              711              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.086N         P=0.532N         P=0.124N        |
|POLY 3             |                                                        |  P=0.087N         P=0.522N         P=0.124N        |
|POLY 1.5           |                                                        |  P=0.085N         P=0.513N         P=0.123N        |
|POLY 6             |                                                        |  P=0.087N         P=0.535N         P=0.125N        |
|LOGISTIC REGRESSION|                                                        |  P=0.093N         P=0.525N         P=0.142N        |
|COCH-ARM / FISHERS |                                                        |  P=0.082N         P=0.500N         P=0.121N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 11
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Teratoma Benign                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  0/50 (0%)        2/50 (4%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                                                        |  0.0%             4.6%             0.0%            |
|TERMINAL (d)       |                                                        |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |                                                        |  ---              662              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.663N         P=0.225          (e)             |
|POLY 3             |                                                        |  P=0.668N         P=0.236          (e)             |
|POLY 1.5           |                                                        |  P=0.668N         P=0.237          (e)             |
|POLY 6             |                                                        |  P=0.667N         P=0.233          (e)             |
|LOGISTIC REGRESSION|                                                        |  P=0.667          P=0.237          (e)             |
|COCH-ARM / FISHERS |                                                        |  P=0.669          P=0.247          (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        0/47 (0%)        0/50 (0%)     |  9/50 (18%)       6/50 (12%)       3/50 (6%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  20.6%            13.8%            6.9%            |
|TERMINAL (d)       |        0/41 (0%)        0/33 (0%)        0/34 (0%)     |  8/34 (24%)       4/30 (13%)       3/35 (9%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  660              616              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.044N*        P=0.363N         P=0.055N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.043N*        P=0.288N         P=0.058N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.043N*        P=0.285N         P=0.058N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.042N*        P=0.296N         P=0.058N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.044N*        P=0.302N         P=0.056N        |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.045N*        P=0.288N         P=0.061N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 12
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        0/47 (0%)        0/50 (0%)     |  0/50 (0%)        3/50 (6%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  0.0%             6.9%             2.3%            |
|TERMINAL (d)       |        0/41 (0%)        0/33 (0%)        0/34 (0%)     |  0/34 (0%)        2/30 (7%)        1/35 (3%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  ---              604              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.389          P=0.111          P=0.506         |
|POLY 3             |        (e)              (e)              (e)           |  P=0.379          P=0.117          P=0.501         |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.380          P=0.119          P=0.501         |
|POLY 6             |        (e)              (e)              (e)           |  P=0.382          P=0.114          P=0.502         |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.379          P=0.120          P=0.506         |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.378          P=0.121          P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        1/50 (2%)     |  2/50 (4%)        3/50 (6%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             2.3%          |  4.6%             6.9%             4.6%            |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        0/34 (0%)     |  1/34 (3%)        0/30 (0%)        2/35 (6%)       |
|FIRST INCIDENCE    |        ---              ---              549           |  675              585              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.266          (e)              P=0.496       |  P=0.584N         P=0.476          P=0.688N        |
|POLY 3             |        P=0.272          (e)              P=0.489       |  P=0.593          P=0.500          P=0.693         |
|POLY 1.5           |        P=0.271          (e)              P=0.495       |  P=0.592N         P=0.502          P=0.693N        |
|POLY 6             |        P=0.274          (e)              P=0.481       |  P=0.593          P=0.495          P=0.694         |
|LOGISTIC REGRESSION|        P=0.239          (e)              P=0.469       |  P=0.593N         P=0.500          P=0.693N        |
|COCH-ARM / FISHERS |        P=0.269          (e)              P=0.500       |  P=0.594          P=0.500          P=0.691N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 13
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        3/49 (6%)        5/50 (10%)       2/50 (4%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        6.6%             11.1%            4.6%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        3/41 (7%)        4/35 (11%)       1/34 (3%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          697              468           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.510N         P=0.281          P=0.566N      |  (e)              (e)              (e)             |
|POLY 3             |        P=0.460N         P=0.348          P=0.524N      |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.439N         P=0.355          P=0.510N      |  (e)              (e)              (e)             |
|POLY 6             |        P=0.488N         P=0.337          P=0.542N      |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.423N         P=0.319          P=0.462N      |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.410N         P=0.369          P=0.490N      |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        3/50 (6%)        0/50 (0%)     |  4/50 (8%)        2/50 (4%)        4/50 (8%)       |
|POLY-3 ADJUSTED (b)|        0.0%             6.6%             0.0%          |  9.2%             4.7%             9.2%            |
|TERMINAL (d)       |        0/41 (0%)        2/35 (6%)        0/34 (0%)     |  4/34 (12%)       2/30 (7%)        4/35 (11%)      |
|FIRST INCIDENCE    |        ---              628              ---           |  730 (T)          730 (T)          730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.595          P=0.104          (e)           |  P=0.563N         P=0.395N         P=0.629N        |
|POLY 3             |        P=0.608          P=0.117          (e)           |  P=0.578N         P=0.344N         P=0.642N        |
|POLY 1.5           |        P=0.625          P=0.119          (e)           |  P=0.578N         P=0.339N         P=0.641N        |
|POLY 6             |        P=0.585          P=0.114          (e)           |  P=0.577N         P=0.354N         P=0.640N        |
|LOGISTIC REGRESSION|        P=0.637          P=0.120          (e)           |  P=0.563N         P=0.395N         P=0.629N        |
|COCH-ARM / FISHERS |        P=0.640          P=0.121          (e)           |  P=0.579          P=0.339N         P=0.643N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 14
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        0/50 (0%)     |  3/50 (6%)        2/50 (4%)        4/50 (8%)       |
|POLY-3 ADJUSTED (b)|        0.0%             4.4%             0.0%          |  6.9%             4.7%             9.2%            |
|TERMINAL (d)       |        0/41 (0%)        1/35 (3%)        0/34 (0%)     |  3/34 (9%)        2/30 (7%)        4/35 (11%)      |
|FIRST INCIDENCE    |        ---              628              ---           |  730 (T)          730 (T)          730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.637          P=0.220          (e)           |  P=0.432          P=0.558N         P=0.516         |
|POLY 3             |        P=0.645          P=0.235          (e)           |  P=0.418          P=0.507N         P=0.502         |
|POLY 1.5           |        P=0.658          P=0.237          (e)           |  P=0.419          P=0.502N         P=0.502         |
|POLY 6             |        P=0.629          P=0.231          (e)           |  P=0.420          P=0.517N         P=0.504         |
|LOGISTIC REGRESSION|        P=0.667N         P=0.237          (e)           |  P=0.432          P=0.558N         P=0.516         |
|COCH-ARM / FISHERS |        P=0.669          P=0.247          (e)           |  P=0.417          P=0.500N         P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/49 (4%)        0/50 (0%)        1/50 (2%)     |  2/50 (4%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        4.4%             0.0%             2.3%          |  4.6%             0.0%             0.0%            |
|TERMINAL (d)       |        2/41 (5%)        0/35 (0%)        0/34 (0%)     |  1/34 (3%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          ---              606           |  615              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.402N         P=0.274N         P=0.551N      |  P=0.098N         P=0.251N         P=0.239N        |
|POLY 3             |        P=0.371N         P=0.241N         P=0.521N      |  P=0.095N         P=0.243N         P=0.238N        |
|POLY 1.5           |        P=0.365N         P=0.238N         P=0.509N      |  P=0.095N         P=0.239N         P=0.237N        |
|POLY 6             |        P=0.379N         P=0.246N         P=0.534N      |  P=0.095N         P=0.249N         P=0.239N        |
|LOGISTIC REGRESSION|        P=0.349N         (e)              P=0.486N      |  P=0.096N         P=0.238N         P=0.239N        |
|COCH-ARM / FISHERS |        P=0.355N         P=0.242N         P=0.492N      |  P=0.095N         P=0.247N         P=0.247N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 15
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        3/49 (6%)        0/50 (0%)        1/50 (2%)     |  2/50 (4%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        6.6%             0.0%             2.3%          |  4.6%             0.0%             0.0%            |
|TERMINAL (d)       |        3/41 (7%)        0/35 (0%)        0/34 (0%)     |  1/34 (3%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          ---              606           |  615              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.215N         P=0.150N         P=0.364N      |  P=0.098N         P=0.251N         P=0.239N        |
|POLY 3             |        P=0.182N         P=0.122N         P=0.327N      |  P=0.095N         P=0.243N         P=0.238N        |
|POLY 1.5           |        P=0.177N         P=0.120N         P=0.315N      |  P=0.095N         P=0.239N         P=0.237N        |
|POLY 6             |        P=0.188N         P=0.126N         P=0.341N      |  P=0.095N         P=0.249N         P=0.239N        |
|LOGISTIC REGRESSION|        P=0.174N         (e)              P=0.303N      |  P=0.096N         P=0.238N         P=0.239N        |
|COCH-ARM / FISHERS |        P=0.171N         P=0.117N         P=0.301N      |  P=0.095N         P=0.247N         P=0.247N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  0/50 (0%)        2/50 (4%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                                                        |  0.0%             4.7%             0.0%            |
|TERMINAL (d)       |                                                        |  0/34 (0%)        2/30 (7%)        0/35 (0%)       |
|FIRST INCIDENCE    |                                                        |  ---              730 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.659N         P=0.211          (e)             |
|POLY 3             |                                                        |  P=0.668N         P=0.233          (e)             |
|POLY 1.5           |                                                        |  P=0.668N         P=0.236          (e)             |
|POLY 6             |                                                        |  P=0.667N         P=0.228          (e)             |
|LOGISTIC REGRESSION|                                                        |  (e)              P=0.211          (e)             |
|COCH-ARM / FISHERS |                                                        |  P=0.669          P=0.247          (e)             |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 16
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  1/50 (2%)        2/50 (4%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                                                        |  2.3%             4.6%             0.0%            |
|TERMINAL (d)       |                                                        |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |                                                        |  621              641              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.360N         P=0.493          P=0.500N        |
|POLY 3             |                                                        |  P=0.363N         P=0.495          P=0.501N        |
|POLY 1.5           |                                                        |  P=0.361N         P=0.499          P=0.500N        |
|POLY 6             |                                                        |  P=0.364N         P=0.488          P=0.501N        |
|LOGISTIC REGRESSION|                                                        |  P=0.366N         P=0.498          P=0.513N        |
|COCH-ARM / FISHERS |                                                        |  P=0.360N         P=0.500          P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  2/50 (4%)        2/50 (4%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|                                                        |  4.6%             4.6%             0.0%            |
|TERMINAL (d)       |                                                        |  1/34 (3%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |                                                        |  621              641              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.178N         P=0.675          P=0.237N        |
|POLY 3             |                                                        |  P=0.178N         P=0.689          P=0.238N        |
|POLY 1.5           |                                                        |  P=0.176N         P=0.692          P=0.237N        |
|POLY 6             |                                                        |  P=0.178N         P=0.682          P=0.238N        |
|LOGISTIC REGRESSION|                                                        |  P=0.177N         P=0.695          P=0.238N        |
|COCH-ARM / FISHERS |                                                        |  P=0.176N         P=0.691N         P=0.247N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 17
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        4/50 (8%)     |  1/50 (2%)        3/50 (6%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        0.0%             2.2%             9.3%          |  2.3%             7.0%             4.6%            |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        2/34 (6%)     |  1/34 (3%)        2/30 (7%)        2/35 (6%)       |
|FIRST INCIDENCE    |        ---              709              638           |  730 (T)          659              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.019 *        P=0.485          P=0.048 *     |  P=0.413          P=0.272          P=0.510         |
|POLY 3             |        P=0.022 *        P=0.497          P=0.053       |  P=0.401          P=0.302          P=0.501         |
|POLY 1.5           |        P=0.023 *        P=0.499          P=0.057       |  P=0.402          P=0.305          P=0.501         |
|POLY 6             |        P=0.021 *        P=0.493          P=0.049 *     |  P=0.403          P=0.295          P=0.503         |
|LOGISTIC REGRESSION|        P=0.024 *        P=0.499          P=0.059       |  P=0.404          P=0.294          P=0.510         |
|COCH-ARM / FISHERS |        P=0.026 *        P=0.500          P=0.059       |  P=0.399          P=0.309          P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        4/50 (8%)        7/50 (14%)       4/50 (8%)     |  1/50 (2%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        8.8%             15.6%            9.2%          |  2.3%             0.0%             0.0%            |
|TERMINAL (d)       |        4/41 (10%)       6/35 (17%)       3/34 (9%)     |  1/34 (3%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          697              468           |  730 (T)          ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.450          P=0.184          P=0.552       |  P=0.271N         P=0.525N         P=0.494N        |
|POLY 3             |        P=0.527          P=0.252          P=0.615       |  P=0.270N         P=0.503N         P=0.499N        |
|POLY 1.5           |        P=0.550          P=0.259          P=0.631       |  P=0.270N         P=0.501N         P=0.499N        |
|POLY 6             |        P=0.497          P=0.241          P=0.592       |  P=0.270N         P=0.507N         P=0.498N        |
|LOGISTIC REGRESSION|        P=0.532          P=0.216          P=0.636       |  P=0.271N         (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.566          P=0.262          P=0.643N      |  P=0.269N         P=0.500N         P=0.500N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 18
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        4/50 (8%)        8/50 (16%)       8/50 (16%)    |  2/50 (4%)        3/50 (6%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        8.8%             17.8%            18.3%         |  4.6%             7.0%             4.6%            |
|TERMINAL (d)       |        4/41 (10%)       6/35 (17%)       5/34 (15%)    |  2/34 (6%)        2/30 (7%)        2/35 (6%)       |
|FIRST INCIDENCE    |        729 (T)          697              468           |  730 (T)          659              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.091          P=0.120          P=0.116       |  P=0.579N         P=0.452          P=0.685N        |
|POLY 3             |        P=0.130          P=0.170          P=0.156       |  P=0.592N         P=0.496          P=0.693N        |
|POLY 1.5           |        P=0.142          P=0.176          P=0.168       |  P=0.591N         P=0.499          P=0.692N        |
|POLY 6             |        P=0.115          P=0.161          P=0.141       |  P=0.590N         P=0.488          P=0.692N        |
|LOGISTIC REGRESSION|        P=0.129          P=0.146          P=0.168       |  P=0.588N         P=0.483          P=0.685N        |
|COCH-ARM / FISHERS |        P=0.152          P=0.178          P=0.178       |  P=0.594          P=0.500          P=0.691N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        0/50 (0%)     |  3/50 (6%)        2/50 (4%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        0.0%             2.2%             0.0%          |  6.7%             4.7%             2.3%            |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        0/34 (0%)     |  1/34 (3%)        2/30 (7%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              567              ---           |  435              730 (T)          552             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.729          P=0.509          (e)           |  P=0.226N         P=0.534N         P=0.312N        |
|POLY 3             |        P=0.718          P=0.499          (e)           |  P=0.229N         P=0.523N         P=0.312N        |
|POLY 1.5           |        P=0.724          P=0.500          (e)           |  P=0.227N         P=0.512N         P=0.309N        |
|POLY 6             |        P=0.710          P=0.496          (e)           |  P=0.228N         P=0.538N         P=0.311N        |
|LOGISTIC REGRESSION|        P=0.715          P=0.480          (e)           |  P=0.241N         P=0.512N         P=0.348N        |
|COCH-ARM / FISHERS |        P=0.731          P=0.500          (e)           |  P=0.222N         P=0.500N         P=0.309N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 19
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        7/50 (14%)       2/50 (4%)     |  6/50 (12%)       11/50 (22%)      12/50 (24%)     |
|POLY-3 ADJUSTED (b)|        2.2%             14.8%            4.6%          |  13.2%            25.3%            26.6%           |
|TERMINAL (d)       |        0/41 (0%)        1/35 (3%)        1/34 (3%)     |  2/34 (6%)        8/30 (27%)       7/35 (20%)      |
|FIRST INCIDENCE    |        695              176              356           |  435              646              552             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.368          P=0.033 *        P=0.457       |  P=0.106          P=0.113          P=0.120         |
|POLY 3             |        P=0.380          P=0.034 *        P=0.482       |  P=0.073          P=0.115          P=0.088         |
|POLY 1.5           |        P=0.404          P=0.034 *        P=0.493       |  P=0.076          P=0.127          P=0.091         |
|POLY 6             |        P=0.347          P=0.034 *        P=0.467       |  P=0.074          P=0.100          P=0.089         |
|LOGISTIC REGRESSION|        P=0.407          P=0.024 *        P=0.482       |  P=0.082          P=0.143          P=0.092         |
|COCH-ARM / FISHERS |        P=0.421          P=0.030 *        P=0.500       |  P=0.082          P=0.143          P=0.096         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        6/50 (12%)       2/50 (4%)     |  3/50 (6%)        9/50 (18%)       11/50 (22%)     |
|POLY-3 ADJUSTED (b)|        2.2%             12.8%            4.6%          |  6.8%             20.7%            24.7%           |
|TERMINAL (d)       |        0/41 (0%)        1/35 (3%)        1/34 (3%)     |  1/34 (3%)        6/30 (20%)       7/35 (20%)      |
|FIRST INCIDENCE    |        695              176              356           |  603              646              604             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.362          P=0.056          P=0.457       |  P=0.028 *        P=0.048 *        P=0.030 *       |
|POLY 3             |        P=0.380          P=0.060          P=0.482       |  P=0.017 *        P=0.054          P=0.020 *       |
|POLY 1.5           |        P=0.402          P=0.060          P=0.493       |  P=0.018 *        P=0.058          P=0.020 *       |
|POLY 6             |        P=0.350          P=0.058          P=0.467       |  P=0.018 *        P=0.049 *        P=0.020 *       |
|LOGISTIC REGRESSION|        P=0.399          P=0.047 *        P=0.482       |  P=0.019 *        P=0.059          P=0.022 *       |
|COCH-ARM / FISHERS |        P=0.417          P=0.056          P=0.500       |  P=0.019 *        P=0.061          P=0.020 *       |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 20
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        28/50 (56%)      30/50 (60%)      32/50 (64%)   |  37/50 (74%)      40/50 (80%)      31/50 (62%)     |
|POLY-3 ADJUSTED (b)|        58.6%            64.4%            69.3%         |  79.7%            85.2%            69.7%           |
|TERMINAL (d)       |        25/41 (61%)      23/35 (66%)      24/34 (71%)   |  29/34 (85%)      26/30 (87%)      26/35 (74%)     |
|FIRST INCIDENCE    |        452              547              356           |  150              501              659             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.055          P=0.175          P=0.068       |  P=0.114N         P=0.144          P=0.116N        |
|POLY 3             |        P=0.160          P=0.354          P=0.188       |  P=0.146N         P=0.325          P=0.182N        |
|POLY 1.5           |        P=0.202          P=0.383          P=0.233       |  P=0.131N         P=0.305          P=0.166N        |
|POLY 6             |        P=0.122          P=0.328          P=0.146       |  P=0.157N         P=0.359          P=0.195N        |
|LOGISTIC REGRESSION|        P=0.202          P=0.414          P=0.248       |  P=0.093N         P=0.307          P=0.125N        |
|COCH-ARM / FISHERS |        P=0.237          P=0.420          P=0.270       |  P=0.110N         P=0.318          P=0.142N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        24/50 (48%)      29/50 (58%)      25/50 (50%)   |  22/50 (44%)      24/50 (48%)      21/50 (42%)     |
|POLY-3 ADJUSTED (b)|        49.7%            58.9%            52.8%         |  46.1%            53.2%            45.8%           |
|TERMINAL (d)       |        17/41 (42%)      15/35 (43%)      15/34 (44%)   |  12/34 (35%)      14/30 (47%)      12/35 (34%)     |
|FIRST INCIDENCE    |        452              176              356           |  435              585              552             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.231          P=0.136          P=0.263       |  P=0.437N         P=0.304          P=0.474N        |
|POLY 3             |        P=0.417          P=0.240          P=0.461       |  P=0.538N         P=0.315          P=0.571N        |
|POLY 1.5           |        P=0.452          P=0.240          P=0.493       |  P=0.506N         P=0.360          P=0.542N        |
|POLY 6             |        P=0.374          P=0.241          P=0.420       |  P=0.532          P=0.268          P=0.582         |
|LOGISTIC REGRESSION|        P=0.491          P=0.212          P=0.516       |  P=0.456N         P=0.420          P=0.501N        |
|COCH-ARM / FISHERS |        P=0.460          P=0.212          P=0.500       |  P=0.460N         P=0.421          P=0.500N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 21
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        42/50 (84%)      43/50 (86%)      44/50 (88%)   |  46/50 (92%)      45/50 (90%)      36/50 (72%)     |
|POLY-3 ADJUSTED (b)|        85.7%            87.4%            89.2%         |  92.1%            93.2%            78.5%           |
|TERMINAL (d)       |        34/41 (83%)      29/35 (83%)      29/34 (85%)   |  31/34 (91%)      27/30 (90%)      27/35 (77%)     |
|FIRST INCIDENCE    |        452              176              356           |  150              501              552             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.073          P=0.175          P=0.085       |  P=0.042N*        P=0.370          P=0.044N*       |
|POLY 3             |        P=0.353          P=0.520          P=0.411       |  P=0.028N*        P=0.565          P=0.047N*       |
|POLY 1.5           |        P=0.378          P=0.544          P=0.436       |  P=0.012N*        P=0.618          P=0.024N*       |
|POLY 6             |        P=0.332          P=0.504          P=0.389       |  P=0.057N         P=0.540          P=0.082N        |
|LOGISTIC REGRESSION|        P=0.323          P=0.505          P=0.374       |  P=0.003N**       P=0.493N         P=0.008N**      |
|COCH-ARM / FISHERS |        P=0.333          P=0.500          P=0.387       |  P=0.004N**       P=0.500N         P=0.009N**      |
|=================================================================================================================================|

(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).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.