National Toxicology Program

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Statistical Analysis Of Primary Tumors

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08
LAB: Battelle Columbus                            OLEIC ACID DIETHANOLAMINE CONDENSATE                         DATE: 08/13/97

EXPERIMENT: 91014 TEST: 03                                                                                     TIME: 12:17:19
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:
CONT: NO1-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: C91014
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 93-83-4
                

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

                                                 ----------------
                                                 Adrenal Gland
                                                 Adrenal Medulla
                                                 Bone Marrow
                                                 Brain
                                                 Clitoral Gland
                                                 Clitoral/Preputial Gland
                                                 Epididymis
                                                 Heart
                                                 Islets, Pancreatic
                                                 Kidney
                                                 Liver
                                                 Lung
                                                 Nose
                                                 Ovary
                                                 Pancreas
                                                 Parathyroid Gland
                                                 Pituitary Gland
                                                 Preputial Gland
                                                 Prostate
                                                 Salivary Glands
                                                 Spleen
                                                 Testes
                                                 Thymus
                                                 Thyroid Gland
                                                 Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08   
LAB: Battelle Columbus                            OLEIC ACID DIETHANOLAMINE CONDENSATE                         DATE: 08/13/97     
EXPERIMENT: 91014 TEST: 03                                                                                     TIME: 12:17:19     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:              
CONT: NO1-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: C91014     
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 93-83-4       



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

Male Rats
------------
Organ                                 Morphology
-----                                 ----------
Adrenal Medulla                        Pheochromocytoma Benign
                                       Pheochromocytoma: Benign, Complex, Malignant, NOS
Mammary Gland                          Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Testes                                 Adenoma
Thyroid Gland: Follicular Cell         Carcinoma or Adenoma
===============================================================
Female Rats
------------
Organ                                  Morphology
-----                                  ----------
Clitoral/Preputial Gland               Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
                                       Adenoma
All Organs                             Benign Tumors
===============================================================
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 1
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)        -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        12/50 (24%)      6/50 (12%)       6/49 (12%)    |  2/50 (4%)        0/50 (0%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        33.9%            17.3%            16.2%         |  5.7%             0.0%             3.5%            |
|TERMINAL (d)       |        2/8 (25%)        3/10 (30%)       4/14 (29%)    |  1/15 (7%)        0/18 (0%)        1/14 (7%)       |
|FIRST INCIDENCE    |        618              580              661           |  695              ---              728 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.011N*        P=0.092N         P=0.013N*     |  P=0.382N         P=0.215N         P=0.535N        |
|POLY 3             |        P=0.044N*        P=0.085N         P=0.063N      |  P=0.395N         P=0.239N         P=0.566N        |
|POLY 1.5           |        P=0.054N         P=0.090N         P=0.078N      |  P=0.386N         P=0.242N         P=0.547N        |
|POLY 6             |        P=0.034N*        P=0.085N         P=0.050N      |  P=0.398N         P=0.232N         P=0.578N        |
|LOGISTIC REGRESSION|        P=0.020N*        P=0.081N         P=0.025N*     |  P=0.398N         P=0.220N         P=0.558N        |
|COCH-ARM / FISHERS |        P=0.072N         P=0.096N         P=0.104N      |  P=0.360N         P=0.247N         P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        12/50 (24%)      6/50 (12%)       7/49 (14%)    |  2/50 (4%)        0/50 (0%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        33.9%            17.3%            18.7%         |  5.7%             0.0%             3.5%            |
|TERMINAL (d)       |        2/8 (25%)        3/10 (30%)       4/14 (29%)    |  1/15 (7%)        0/18 (0%)        1/14 (7%)       |
|FIRST INCIDENCE    |        618              580              647           |  695              ---              728 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.022N*        P=0.092N         P=0.027N*     |  P=0.382N         P=0.215N         P=0.535N        |
|POLY 3             |        P=0.080N         P=0.085N         P=0.106N      |  P=0.395N         P=0.239N         P=0.566N        |
|POLY 1.5           |        P=0.096N         P=0.090N         P=0.128N      |  P=0.386N         P=0.242N         P=0.547N        |
|POLY 6             |        P=0.062N         P=0.085N         P=0.084N      |  P=0.398N         P=0.232N         P=0.578N        |
|LOGISTIC REGRESSION|        P=0.041N*        P=0.081N         P=0.051N      |  P=0.398N         P=0.220N         P=0.558N        |
|COCH-ARM / FISHERS |        P=0.122N         P=0.096N         P=0.166N      |  P=0.360N         P=0.247N         P=0.500N        |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 2
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        1/50 (2%)     |  10/49 (20%)      3/47 (6%)        4/50 (8%)       |
|POLY-3 ADJUSTED (b)|        0.0%             3.0%             2.7%          |  27.6%            9.4%             13.6%           |
|TERMINAL (d)       |        0/8 (0%)         1/10 (10%)       1/14 (7%)     |  4/15 (27%)       1/17 (6%)        1/14 (7%)       |
|FIRST INCIDENCE    |        ---              728 (T)          728 (T)       |  524              685              526             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.456          P=0.545          P=0.612       |  P=0.066N         P=0.032N*        P=0.131N        |
|POLY 3             |        P=0.371          P=0.502          P=0.522       |  P=0.066N         P=0.050N         P=0.138N        |
|POLY 1.5           |        P=0.354          P=0.500          P=0.513       |  P=0.056N         P=0.049N*        P=0.111N        |
|POLY 6             |        P=0.397          P=0.503          P=0.537       |  P=0.073N         P=0.048N*        P=0.162N        |
|LOGISTIC REGRESSION|        (e)              P=0.545          P=0.612       |  P=0.068N         P=0.045N*        P=0.121N        |
|COCH-ARM / FISHERS |        P=0.331          P=0.500          P=0.500       |  P=0.039N*        P=0.042N*        P=0.068N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        2/50 (4%)     |  10/49 (20%)      4/47 (9%)        5/50 (10%)      |
|POLY-3 ADJUSTED (b)|        0.0%             3.0%             5.3%          |  27.6%            12.5%            17.0%           |
|TERMINAL (d)       |        0/8 (0%)         1/10 (10%)       1/14 (7%)     |  4/15 (27%)       2/17 (12%)       2/14 (14%)      |
|FIRST INCIDENCE    |        ---              728 (T)          526           |  524              685              526             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.217          P=0.545          P=0.314       |  P=0.129N         P=0.062N         P=0.206N        |
|POLY 3             |        P=0.169          P=0.502          P=0.266       |  P=0.143N         P=0.102N         P=0.232N        |
|POLY 1.5           |        P=0.157          P=0.500          P=0.253       |  P=0.121N         P=0.099N         P=0.191N        |
|POLY 6             |        P=0.190          P=0.503          P=0.286       |  P=0.160N         P=0.100N         P=0.269N        |
|LOGISTIC REGRESSION|        P=0.159          P=0.545          P=0.226       |  P=0.142N         P=0.088N         P=0.208N        |
|COCH-ARM / FISHERS |        P=0.142          P=0.500          P=0.247       |  P=0.083N         P=0.086N         P=0.122N        |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 3
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        3/50 (6%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        3.0%             0.0%             8.0%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        0/8 (0%)         0/10 (0%)        1/14 (7%)     |  0/15 (0%)        0/18 (0%)        0/14 (0%)       |
|FIRST INCIDENCE    |        614              ---              647           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.255          P=0.520N         P=0.418       |  (e)              (e)              (e)             |
|POLY 3             |        P=0.192          P=0.501N         P=0.344       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.184          P=0.501N         P=0.328       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.206          P=0.502N         P=0.373       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.209          P=0.500N         P=0.352       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.176          P=0.500N         P=0.309       |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        1/50 (2%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        6.0%             3.0%             2.7%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        1/8 (13%)        0/10 (0%)        1/14 (7%)     |  0/15 (0%)        0/18 (0%)        0/14 (0%)       |
|FIRST INCIDENCE    |        707              674              728 (T)       |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.227N         P=0.460N         P=0.306N      |  (e)              (e)              (e)             |
|POLY 3             |        P=0.353N         P=0.496N         P=0.462N      |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.365N         P=0.499N         P=0.478N      |  (e)              (e)              (e)             |
|POLY 6             |        P=0.335N         P=0.491N         P=0.436N      |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.264N         P=0.483N         P=0.322N      |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.378N         P=0.500N         P=0.500N      |  (e)              (e)              (e)             |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 4
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        3/50 (6%)        1/50 (2%)        4/50 (8%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        8.9%             3.0%             10.7%         |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        1/8 (13%)        0/10 (0%)        2/14 (14%)    |  0/15 (0%)        0/18 (0%)        0/14 (0%)       |
|FIRST INCIDENCE    |        614              674              647           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.565N         P=0.287N         P=0.591N      |  (e)              (e)              (e)             |
|POLY 3             |        P=0.453          P=0.303N         P=0.560       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.435          P=0.305N         P=0.534       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.484          P=0.300N         P=0.600       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.526          P=0.296N         P=0.631       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.412          P=0.309N         P=0.500       |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        0/50 (0%)     |  1/50 (2%)        1/50 (2%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        0.0%             6.0%             0.0%          |  2.9%             2.9%             3.5%            |
|TERMINAL (d)       |        0/8 (0%)         2/10 (20%)       0/14 (0%)     |  0/15 (0%)        1/18 (6%)        0/14 (0%)       |
|FIRST INCIDENCE    |        ---              728 (T)          ---           |  610              728 (T)          709             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.544N         P=0.284          (e)           |  P=0.606          P=0.744N         P=0.721         |
|POLY 3             |        P=0.631N         P=0.237          (e)           |  P=0.603          P=0.757          P=0.716         |
|POLY 1.5           |        P=0.647N         P=0.237          (e)           |  P=0.612          P=0.755          P=0.730         |
|POLY 6             |        P=0.604N         P=0.237          (e)           |  P=0.600          P=0.762          P=0.708         |
|LOGISTIC REGRESSION|        (e)              P=0.284          (e)           |  P=0.591          P=0.761          P=0.727         |
|COCH-ARM / FISHERS |        P=0.669          P=0.247          (e)           |  P=0.640          P=0.753N         P=0.753N        |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 5
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        0/50 (0%)     |  1/50 (2%)        0/50 (0%)        3/50 (6%)       |
|POLY-3 ADJUSTED (b)|        3.0%             0.0%             0.0%          |  2.9%             0.0%             10.4%           |
|TERMINAL (d)       |        1/8 (13%)        0/10 (0%)        0/14 (0%)     |  1/15 (7%)        0/18 (0%)        2/14 (14%)      |
|FIRST INCIDENCE    |        728 (T)          ---              ---           |  728 (T)          ---              692             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.197N         P=0.455N         P=0.388N      |  P=0.147          P=0.464N         P=0.268         |
|POLY 3             |        P=0.272N         P=0.498N         P=0.478N      |  P=0.166          P=0.502N         P=0.241         |
|POLY 1.5           |        P=0.271N         P=0.500N         P=0.487N      |  P=0.167          P=0.504N         P=0.259         |
|POLY 6             |        P=0.272N         P=0.497N         P=0.463N      |  P=0.167          P=0.496N         P=0.232         |
|LOGISTIC REGRESSION|        P=0.197N         (e)              (e)           |  P=0.134          (e)              P=0.246         |
|COCH-ARM / FISHERS |        P=0.269N         P=0.500N         P=0.500N      |  P=0.176          P=0.500N         P=0.309         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        0/50 (0%)     |  1/50 (2%)        1/50 (2%)        3/50 (6%)       |
|POLY-3 ADJUSTED (b)|        3.0%             0.0%             0.0%          |  2.9%             2.9%             10.4%           |
|TERMINAL (d)       |        1/8 (13%)        0/10 (0%)        0/14 (0%)     |  1/15 (7%)        1/18 (6%)        2/14 (14%)      |
|FIRST INCIDENCE    |        728 (T)          ---              ---           |  728 (T)          728 (T)          692             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.197N         P=0.455N         P=0.388N      |  P=0.168          P=0.722N         P=0.268         |
|POLY 3             |        P=0.272N         P=0.498N         P=0.478N      |  P=0.175          P=0.759          P=0.241         |
|POLY 1.5           |        P=0.271N         P=0.500N         P=0.487N      |  P=0.181          P=0.756          P=0.259         |
|POLY 6             |        P=0.272N         P=0.497N         P=0.463N      |  P=0.173          P=0.758N         P=0.232         |
|LOGISTIC REGRESSION|        P=0.197N         (e)              (e)           |  P=0.155          P=0.722N         P=0.246         |
|COCH-ARM / FISHERS |        P=0.269N         P=0.500N         P=0.500N      |  P=0.202          P=0.753N         P=0.309         |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 6
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        3/50 (6%)        0/50 (0%)        1/50 (2%)     |  9/50 (18%)       10/50 (20%)      6/50 (12%)      |
|POLY-3 ADJUSTED (b)|        8.9%             0.0%             2.7%          |  24.7%            27.8%            20.6%           |
|TERMINAL (d)       |        2/8 (25%)        0/10 (0%)        0/14 (0%)     |  4/15 (27%)       4/18 (22%)       4/14 (29%)      |
|FIRST INCIDENCE    |        618              ---              723           |  497              579              637             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.091N         P=0.099N         P=0.153N      |  P=0.363N         P=0.588          P=0.388N        |
|POLY 3             |        P=0.165N         P=0.117N         P=0.268N      |  P=0.444N         P=0.487          P=0.461N        |
|POLY 1.5           |        P=0.170N         P=0.118N         P=0.284N      |  P=0.379N         P=0.476          P=0.401N        |
|POLY 6             |        P=0.156N         P=0.115N         P=0.245N      |  P=0.490N         P=0.525          P=0.511N        |
|LOGISTIC REGRESSION|        P=0.118N         P=0.113N         P=0.205N      |  P=0.402N         P=0.494          P=0.448N        |
|COCH-ARM / FISHERS |        P=0.176N         P=0.121N         P=0.309N      |  P=0.251N         P=0.500          P=0.288N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        3/50 (6%)        0/50 (0%)        1/50 (2%)     |  9/50 (18%)       11/50 (22%)      6/50 (12%)      |
|POLY-3 ADJUSTED (b)|        8.9%             0.0%             2.7%          |  24.7%            30.6%            20.6%           |
|TERMINAL (d)       |        2/8 (25%)        0/10 (0%)        0/14 (0%)     |  4/15 (27%)       5/18 (28%)       4/14 (29%)      |
|FIRST INCIDENCE    |        618              ---              723           |  497              579              637             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.091N         P=0.099N         P=0.153N      |  P=0.367N         P=0.501          P=0.388N        |
|POLY 3             |        P=0.165N         P=0.117N         P=0.268N      |  P=0.462N         P=0.381          P=0.461N        |
|POLY 1.5           |        P=0.170N         P=0.118N         P=0.284N      |  P=0.392N         P=0.374          P=0.401N        |
|POLY 6             |        P=0.156N         P=0.115N         P=0.245N      |  P=0.513N         P=0.416          P=0.511N        |
|LOGISTIC REGRESSION|        P=0.118N         P=0.113N         P=0.205N      |  P=0.412N         P=0.394          P=0.448N        |
|COCH-ARM / FISHERS |        P=0.176N         P=0.121N         P=0.309N      |  P=0.254N         P=0.402          P=0.288N        |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 7
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        4/50 (8%)        0/50 (0%)        1/50 (2%)     |  10/50 (20%)      11/50 (22%)      8/50 (16%)      |
|POLY-3 ADJUSTED (b)|        11.9%            0.0%             2.7%          |  27.5%            30.6%            27.3%           |
|TERMINAL (d)       |        3/8 (38%)        0/10 (0%)        0/14 (0%)     |  5/15 (33%)       5/18 (28%)       5/14 (36%)      |
|FIRST INCIDENCE    |        618              ---              723           |  497              579              637             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.030N*        P=0.042N*        P=0.062N      |  P=0.483N         P=0.584N         P=0.516N        |
|POLY 3             |        P=0.072N         P=0.058N         P=0.146N      |  P=0.546          P=0.485          P=0.607N        |
|POLY 1.5           |        P=0.075N         P=0.059N         P=0.160N      |  P=0.505N         P=0.475          P=0.538N        |
|POLY 6             |        P=0.065N         P=0.056N         P=0.127N      |  P=0.508          P=0.527          P=0.569         |
|LOGISTIC REGRESSION|        P=0.042N*        P=0.053N         P=0.089N      |  P=0.549N         P=0.498          P=0.602N        |
|COCH-ARM / FISHERS |        P=0.082N         P=0.059N         P=0.181N      |  P=0.352N         P=0.500          P=0.398N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        38/50 (76%)      38/50 (76%)      40/49 (82%)   |  29/50 (58%)      20/50 (40%)      19/50 (38%)     |
|POLY-3 ADJUSTED (b)|        83.6%            82.8%            86.7%         |  70.7%            55.7%            56.6%           |
|TERMINAL (d)       |        6/8 (75%)        8/10 (80%)       12/14 (86%)   |  10/15 (67%)      11/18 (61%)      7/14 (50%)      |
|FIRST INCIDENCE    |        440              224              482           |  462              622              501             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.136N         P=0.481N         P=0.134N      |  P=0.136N         P=0.038N*        P=0.205N        |
|POLY 3             |        P=0.385          P=0.579N         P=0.447       |  P=0.093N         P=0.109N         P=0.134N        |
|POLY 1.5           |        P=0.357          P=0.578N         P=0.410       |  P=0.065N         P=0.084N         P=0.091N        |
|POLY 6             |        P=0.408          P=0.589N         P=0.482       |  P=0.117N         P=0.146N         P=0.167N        |
|LOGISTIC REGRESSION|        P=0.343          P=0.593          P=0.413       |  P=0.118N         P=0.040N*        P=0.140N        |
|COCH-ARM / FISHERS |        P=0.291          P=0.592N         P=0.331       |  P=0.028N*        P=0.055N         P=0.036N*       |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 8
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        0/50 (0%)     |  0/50 (0%)        1/50 (2%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        5.9%             3.0%             0.0%          |  0.0%             2.9%             0.0%            |
|TERMINAL (d)       |        1/8 (13%)        0/10 (0%)        0/14 (0%)     |  0/15 (0%)        0/18 (0%)        0/14 (0%)       |
|FIRST INCIDENCE    |        603              659              ---           |  ---              702              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.098N         P=0.471N         P=0.174N      |  P=0.731          P=0.542          (e)             |
|POLY 3             |        P=0.129N         P=0.499N         P=0.215N      |  P=0.698          P=0.498          (e)             |
|POLY 1.5           |        P=0.135N         P=0.500N         P=0.224N      |  P=0.707          P=0.496          (e)             |
|POLY 6             |        P=0.120N         P=0.497N         P=0.201N      |  P=0.694          P=0.506          (e)             |
|LOGISTIC REGRESSION|        P=0.124N         P=0.496N         P=0.211N      |  P=0.709          P=0.508          (e)             |
|COCH-ARM / FISHERS |        P=0.142N         P=0.500N         P=0.247N      |  P=0.731          P=0.500          (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        |
|     or Fibrous Histiocytoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        3/50 (6%)        2/50 (4%)     |  0/50 (0%)        1/50 (2%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        5.9%             8.8%             5.3%          |  0.0%             2.9%             0.0%            |
|TERMINAL (d)       |        1/8 (13%)        1/10 (10%)       0/14 (0%)     |  0/15 (0%)        0/18 (0%)        0/14 (0%)       |
|FIRST INCIDENCE    |        603              659              674           |  ---              702              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.419N         P=0.537          P=0.563N      |  P=0.731          P=0.542          (e)             |
|POLY 3             |        P=0.544N         P=0.504          P=0.656N      |  P=0.698          P=0.498          (e)             |
|POLY 1.5           |        P=0.565N         P=0.501          P=0.672N      |  P=0.707          P=0.496          (e)             |
|POLY 6             |        P=0.507N         P=0.510          P=0.628N      |  P=0.694          P=0.506          (e)             |
|LOGISTIC REGRESSION|        P=0.517N         P=0.508          P=0.649N      |  P=0.709          P=0.508          (e)             |
|COCH-ARM / FISHERS |        P=0.594          P=0.500          P=0.691N      |  P=0.731          P=0.500          (e)             |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 9
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        2/50 (4%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             5.9%             5.3%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        0/8 (0%)         1/10 (10%)       0/14 (0%)     |  0/15 (0%)        0/18 (0%)        0/14 (0%)       |
|FIRST INCIDENCE    |        ---              674              674           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.295          P=0.257          P=0.330       |  (e)              (e)              (e)             |
|POLY 3             |        P=0.215          P=0.239          P=0.264       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.197          P=0.238          P=0.252       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.247          P=0.241          P=0.285       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.229          P=0.245          P=0.269       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.176          P=0.247          P=0.247       |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/50 (4%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             5.3%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        0/8 (0%)         0/10 (0%)        0/14 (0%)     |  0/15 (0%)        0/18 (0%)        0/14 (0%)       |
|FIRST INCIDENCE    |        ---              ---              535           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.134          (e)              P=0.313       |  (e)              (e)              (e)             |
|POLY 3             |        P=0.107          (e)              P=0.266       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.101          (e)              P=0.253       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.117          (e)              P=0.288       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.089          (e)              P=0.218       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.095          (e)              P=0.247       |  (e)              (e)              (e)             |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 10
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        24/50 (48%)      30/50 (60%)      37/50 (74%)   |                                                    |
|POLY-3 ADJUSTED (b)|        62.8%            72.6%            83.0%         |                                                    |
|TERMINAL (d)       |        8/8 (100%)       9/10 (90%)       13/14 (93%)   |                                                    |
|FIRST INCIDENCE    |        440              440              526           |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.403          P=0.317          P=0.447       |                                                    |
|POLY 3             |        P=0.011 *        P=0.212          P=0.015 *     |                                                    |
|POLY 1.5           |        P=0.007 **       P=0.177          P=0.009 **    |                                                    |
|POLY 6             |        P=0.029 *        P=0.289          P=0.041 *     |                                                    |
|LOGISTIC REGRESSION|        P=0.015 *        P=0.151          P=0.021 *     |                                                    |
|COCH-ARM / FISHERS |        P=0.005 **       P=0.158          P=0.007 **    |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        5/50 (10%)       7/50 (14%)    |  4/50 (8%)        4/50 (8%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        5.9%             14.1%            18.6%         |  11.4%            11.4%            6.7%            |
|TERMINAL (d)       |        0/8 (0%)         0/10 (0%)        3/14 (21%)    |  2/15 (13%)       2/18 (11%)       1/14 (7%)       |
|FIRST INCIDENCE    |        638              554              638           |  679              544              355             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.171          P=0.197          P=0.241       |  P=0.330N         P=0.587N         P=0.394N        |
|POLY 3             |        P=0.081          P=0.232          P=0.103       |  P=0.361N         P=0.645N         P=0.415N        |
|POLY 1.5           |        P=0.072          P=0.223          P=0.092       |  P=0.336N         P=0.637          P=0.392N        |
|POLY 6             |        P=0.098          P=0.248          P=0.121       |  P=0.372N         P=0.624N         P=0.427N        |
|LOGISTIC REGRESSION|        P=0.091          P=0.217          P=0.151       |  P=0.339N         P=0.641N         P=0.406N        |
|COCH-ARM / FISHERS |        P=0.061          P=0.218          P=0.080       |  P=0.274N         P=0.643N         P=0.339N        |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 11
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        1/50 (2%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        6.0%             3.0%             2.7%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        1/8 (13%)        1/10 (10%)       0/14 (0%)     |  0/15 (0%)        0/18 (0%)        0/14 (0%)       |
|FIRST INCIDENCE    |        694              728 (T)          638           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.260N         P=0.448N         P=0.379N      |  (e)              (e)              (e)             |
|POLY 3             |        P=0.351N         P=0.498N         P=0.459N      |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.364N         P=0.500N         P=0.477N      |  (e)              (e)              (e)             |
|POLY 6             |        P=0.330N         P=0.498N         P=0.431N      |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.292N         P=0.460N         P=0.427N      |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.378N         P=0.500N         P=0.500N      |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        3/50 (6%)        6/50 (12%)       8/50 (16%)    |  4/50 (8%)        4/50 (8%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        8.9%             17.0%            21.1%         |  11.4%            11.4%            6.7%            |
|TERMINAL (d)       |        1/8 (13%)        1/10 (10%)       3/14 (21%)    |  2/15 (13%)       2/18 (11%)       1/14 (7%)       |
|FIRST INCIDENCE    |        638              554              638           |  679              544              355             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.229          P=0.248          P=0.299       |  P=0.330N         P=0.587N         P=0.394N        |
|POLY 3             |        P=0.108          P=0.261          P=0.133       |  P=0.361N         P=0.645N         P=0.415N        |
|POLY 1.5           |        P=0.094          P=0.250          P=0.118       |  P=0.336N         P=0.637          P=0.392N        |
|POLY 6             |        P=0.136          P=0.281          P=0.162       |  P=0.372N         P=0.624N         P=0.427N        |
|LOGISTIC REGRESSION|        P=0.125          P=0.245          P=0.187       |  P=0.339N         P=0.641N         P=0.406N        |
|COCH-ARM / FISHERS |        P=0.078          P=0.243          P=0.100       |  P=0.274N         P=0.643N         P=0.339N        |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 12
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        4/50 (8%)        1/50 (2%)     |  0/50 (0%)        1/50 (2%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             11.6%            2.7%          |  0.0%             2.9%             0.0%            |
|TERMINAL (d)       |        0/8 (0%)         1/10 (10%)       1/14 (7%)     |  0/15 (0%)        0/18 (0%)        0/14 (0%)       |
|FIRST INCIDENCE    |        ---              580              728 (T)       |  ---              693              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.521          P=0.071          P=0.612       |  P=0.708          P=0.509          (e)             |
|POLY 3             |        P=0.464          P=0.063          P=0.522       |  P=0.698          P=0.498          (e)             |
|POLY 1.5           |        P=0.432          P=0.061          P=0.513       |  P=0.707          P=0.496          (e)             |
|POLY 6             |        P=0.518          P=0.066          P=0.537       |  P=0.694          P=0.506          (e)             |
|LOGISTIC REGRESSION|        P=0.439          P=0.063          P=0.612       |  P=0.708          P=0.504          (e)             |
|COCH-ARM / FISHERS |        P=0.390          P=0.059          P=0.500       |  P=0.731          P=0.500          (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        1/50 (2%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             5.9%             2.7%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        0/8 (0%)         1/10 (10%)       1/14 (7%)     |  0/15 (0%)        0/18 (0%)        0/14 (0%)       |
|FIRST INCIDENCE    |        ---              607              728 (T)       |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.472          P=0.264          P=0.612       |  (e)              (e)              (e)             |
|POLY 3             |        P=0.413          P=0.240          P=0.522       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.390          P=0.238          P=0.513       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.450          P=0.243          P=0.537       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.423          P=0.240          P=0.612       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.360          P=0.247          P=0.500       |  (e)              (e)              (e)             |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 13
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        6/50 (12%)       2/50 (4%)     |  0/50 (0%)        1/50 (2%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             17.2%            5.4%          |  0.0%             2.9%             0.0%            |
|TERMINAL (d)       |        0/8 (0%)         2/10 (20%)       2/14 (14%)    |  0/15 (0%)        0/18 (0%)        0/14 (0%)       |
|FIRST INCIDENCE    |        ---              580              728 (T)       |  ---              693              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.412          P=0.023 *        P=0.366       |  P=0.708          P=0.509          (e)             |
|POLY 3             |        P=0.324          P=0.016 *        P=0.262       |  P=0.698          P=0.498          (e)             |
|POLY 1.5           |        P=0.290          P=0.016 *        P=0.251       |  P=0.707          P=0.496          (e)             |
|POLY 6             |        P=0.383          P=0.017 *        P=0.279       |  P=0.694          P=0.506          (e)             |
|LOGISTIC REGRESSION|        P=0.318          P=0.018 *        P=0.366       |  P=0.708          P=0.504          (e)             |
|COCH-ARM / FISHERS |        P=0.252          P=0.013 *        P=0.247       |  P=0.731          P=0.500          (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  1/50 (2%)        2/50 (4%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|                                                        |  2.9%             5.8%             6.8%            |
|TERMINAL (d)       |                                                        |  0/15 (0%)        2/18 (11%)       1/14 (7%)       |
|FIRST INCIDENCE    |                                                        |  614              728 (T)          419             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.339          P=0.542          P=0.434         |
|POLY 3             |                                                        |  P=0.337          P=0.492          P=0.441         |
|POLY 1.5           |                                                        |  P=0.351          P=0.490          P=0.457         |
|POLY 6             |                                                        |  P=0.330          P=0.500          P=0.432         |
|LOGISTIC REGRESSION|                                                        |  P=0.348          P=0.505          P=0.512         |
|COCH-ARM / FISHERS |                                                        |  P=0.390          P=0.500          P=0.500         |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 14
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           |
|     Undifferentiated                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        14/50 (28%)      13/50 (26%)      13/50 (26%)   |  5/50 (10%)       9/50 (18%)       8/50 (16%)      |
|POLY-3 ADJUSTED (b)|        37.7%            35.5%            32.6%         |  14.2%            25.0%            25.6%           |
|TERMINAL (d)       |        5/8 (63%)        5/10 (50%)       3/14 (21%)    |  2/15 (13%)       3/18 (17%)       2/14 (14%)      |
|FIRST INCIDENCE    |        293              483              580           |  635              547              169             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.152N         P=0.406N         P=0.193N      |  P=0.172          P=0.264          P=0.218         |
|POLY 3             |        P=0.359N         P=0.519N         P=0.407N      |  P=0.153          P=0.194          P=0.191         |
|POLY 1.5           |        P=0.405N         P=0.516N         P=0.451N      |  P=0.174          P=0.184          P=0.213         |
|POLY 6             |        P=0.282N         P=0.526N         P=0.333N      |  P=0.153          P=0.225          P=0.188         |
|LOGISTIC REGRESSION|        P=0.367N         P=0.495N         P=0.430N      |  P=0.152          P=0.189          P=0.198         |
|COCH-ARM / FISHERS |        P=0.455N         P=0.500N         P=0.500N      |  P=0.240          P=0.194          P=0.277         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        1/50 (2%)        3/50 (6%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        6.0%             2.9%             8.0%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        1/8 (13%)        0/10 (0%)        2/14 (14%)    |  0/15 (0%)        0/18 (0%)        0/14 (0%)       |
|FIRST INCIDENCE    |        623              603              628           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.541          P=0.483N         P=0.679       |  (e)              (e)              (e)             |
|POLY 3             |        P=0.439          P=0.496N         P=0.550       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.422          P=0.499N         P=0.529       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.467          P=0.493N         P=0.584       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.462          P=0.498N         P=0.596       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.399          P=0.500N         P=0.500       |  (e)              (e)              (e)             |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 15
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        47/50 (94%)      47/50 (94%)      49/50 (98%)   |  38/50 (76%)      28/50 (56%)      26/50 (52%)     |
|POLY-3 ADJUSTED (b)|        98.1%            97.4%            98.6%         |  86.5%            74.5%            72.3%           |
|TERMINAL (d)       |        8/8 (100%)       10/10 (100%)     14/14 (100%)  |  13/15 (87%)      15/18 (83%)      10/14 (71%)     |
|FIRST INCIDENCE    |        440              224              482           |  462              544              355             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.092N         P=0.472N         P=0.094N      |  P=0.130N         P=0.030N*        P=0.192N        |
|POLY 3             |        P=0.600          P=0.738N         P=0.794       |  P=0.045N*        P=0.101N         P=0.067N        |
|POLY 1.5           |        P=0.432          P=0.688N         P=0.586       |  P=0.024N*        P=0.058N         P=0.034N*       |
|POLY 6             |        P=0.776N         P=0.882N         P=0.955N      |  P=0.086N         P=0.195N         P=0.127N        |
|LOGISTIC REGRESSION|        P=0.384          P=0.641          P=0.571       |  P=0.069N         P=0.019N*        P=0.072N        |
|COCH-ARM / FISHERS |        P=0.238          P=0.661N         P=0.309       |  P=0.009N**       P=0.028N*        P=0.011N*       |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        21/50 (42%)      18/50 (36%)      22/50 (44%)   |  12/50 (24%)      15/50 (30%)      12/50 (24%)     |
|POLY-3 ADJUSTED (b)|        53.1%            47.7%            52.0%         |  31.7%            40.7%            38.3%           |
|TERMINAL (d)       |        6/8 (75%)        7/10 (70%)       5/14 (36%)    |  4/15 (27%)       6/18 (33%)       5/14 (36%)      |
|FIRST INCIDENCE    |        293              483              526           |  429              541              169             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.195N         P=0.271N         P=0.230N      |  P=0.390          P=0.437          P=0.436         |
|POLY 3             |        P=0.514N         P=0.396N         P=0.551N      |  P=0.309          P=0.280          P=0.374         |
|POLY 1.5           |        P=0.519          P=0.380N         P=0.566       |  P=0.383          P=0.282          P=0.447         |
|POLY 6             |        P=0.396N         P=0.417N         P=0.439N      |  P=0.267          P=0.306          P=0.326         |
|LOGISTIC REGRESSION|        P=0.534N         P=0.335N         P=0.546       |  P=0.364          P=0.306          P=0.442         |
|COCH-ARM / FISHERS |        P=0.459          P=0.341N         P=0.500       |  P=0.545          P=0.326          P=0.592N        |
|=================================================================================================================================|
       Date:  08/13/97                           EXPERIMENT: 91014 TEST: 03                                            Page 16
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -   OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          50 MG/KG         100MG/KG      |  0 MG/KG          50 MG/KG         100MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |        #                #                #             |  #                #                #               |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        49/50 (98%)      48/50 (96%)      50/50 (100%)  |  40/50 (80%)      34/50 (68%)      32/50 (64%)     |
|POLY-3 ADJUSTED (b)|        99.5%            98.8%            100.0%        |  88.5%            86.8%            85.4%           |
|TERMINAL (d)       |        8/8 (100%)       10/10 (100%)     14/14 (100%)  |  13/15 (87%)      17/18 (94%)      13/14 (93%)     |
|FIRST INCIDENCE    |        293              224              482           |  429              541              169             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.075N         P=0.430N         P=0.078N      |  P=0.362N         P=0.111N         P=0.428N        |
|POLY 3             |        P=0.694          P=0.894N         P=0.997       |  P=0.386N         P=0.548N         P=0.462N        |
|POLY 1.5           |        P=0.488          P=0.712N         P=0.822       |  P=0.177N         P=0.332N         P=0.225N        |
|POLY 6             |        P=0.987          P=1.000N         P=1.000       |  P=0.525          P=0.581          P=0.620         |
|LOGISTIC REGRESSION|        P=0.508          P=0.561N         P=0.706       |  P=0.328N         P=0.143N         P=0.302N        |
|COCH-ARM / FISHERS |        P=0.360          P=0.500N         P=0.500       |  P=0.050N         P=0.127N         P=0.059N        |
|=================================================================================================================================|

(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.