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TDMS Study 55323-04 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10
LAB: Battelle Columbus                            LAURIC ACID DIETHANOLAMINE CONDENSATE                        DATE: 08/01/97

EXPERIMENT: 55323 TEST: 04                                                                                     TIME: 15:08:30
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:
CONT: NO1-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: 55323B
PATHOLOGIST: M. RYAN                                                                                           CAS: 120-40-1
            

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

                                                 ----------------
                                                 Adrenal Gland
                                                 Adrenal Medulla
                                                 Bone Marrow
                                                 Brain
                                                 Clitoral Gland
                                                 Clitoral/Preputial Gland
                                                 Epididymis
                                                 Heart
                                                 Islets, Pancreatic
                                                 Kidney
                                                 Liver
                                                 Lung
                                                 Nose
                                                 Ovary
                                                 Pancreas
                                                 Parathyroid Gland
                                                 Pituitary Gland
                                                 Preputial Gland
                                                 Prostate
                                                 Salivary Glands
                                                 Spleen
                                                 Testes
                                                 Thymus
                                                 Thyroid Gland
                                                 Urinary Bladder
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10   
LAB: Battelle Columbus                            LAURIC ACID DIETHANOLAMINE CONDENSATE                        DATE: 08/01/97     
EXPERIMENT: 55323 TEST: 04                                                                                     TIME: 15:08:30     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:              
CONT: NO1-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: 55323B     
PATHOLOGIST: M. RYAN                                                                                           CAS: 120-40-1      



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

Male Mice
------------
Organ                                 Morphology
-----                                 ----------
Adrenal Cortex                         Hyperplasia Focal
Islets, Pancreatic                     Hyperplasia
Liver                                  Clear Cell Focus
Skin: Epidermis, Skin, Site of ApplicatHyperplasia
Skin: Sebaceous Gland, Skin, Site of ApHyperplasia
Skin: Skin, Site of Application        Hyperkeratosis
                                       Inflammation Chronic
                                       Parakeratosis
Thyroid Gland: Follicle                Hyperplasia Focal
===============================================================
Female Mice
------------
Organ                                  Morphology
-----                                  ----------
Islets, Pancreatic                     Hyperplasia
Kidney                                 Nephropathy
Liver                                  Eosinophilic Focus
Skin: Epidermis, Skin, Site of ApplicatHyperplasia
Skin: Sebaceous Gland, Skin, Site of ApHyperplasia
Skin: Skin, Site of Application        Hyperkeratosis
                                       Inflammation Chronic
                                       Parakeratosis
                                       Ulcer
Spleen                                 Hyperplasia Lymphoid
Stomach, Forestomach                   Ulcer
Uterus: Endometrium                    Hyperplasia Cystic
===============================================================
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 1

Statistical Analysis of Non-neoplastic Lesions in        Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        29/50 (58%)      17/50 (34%)      24/50 (48%)   |  1/50 (2%)        4/49 (8%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        62.9%            38.0%            52.4%         |  2.2%             8.7%             0.0%            |
|TERMINAL (d)       |        26/40 (65%)      16/37 (43%)      23/41 (56%)   |  1/37 (3%)        4/40 (10%)       0/29 (0%)       |
|FIRST INCIDENCE    |        562              719              643           |  736 (T)          736 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.149N         P=0.027N*        P=0.173N      |  P=0.472N         P=0.203          P=0.549N        |
|POLY 3             |        P=0.174N         P=0.012N*        P=0.207N      |  P=0.461N         P=0.186          P=0.520N        |
|POLY 1.5           |        P=0.172N         P=0.012N*        P=0.203N      |  P=0.436N         P=0.181          P=0.513N        |
|POLY 6             |        P=0.178N         P=0.014N*        P=0.213N      |  P=0.491N         P=0.192          P=0.529N        |
|LOGISTIC REGRESSION|        P=0.150N         P=0.010N*        P=0.178N      |  P=0.472N         P=0.203          (e)             |
|COCH-ARM / FISHERS |        P=0.184N         P=0.013N*        P=0.212N      |  P=0.391N         P=0.175          P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/49 (4%)     |  2/50 (4%)        2/49 (4%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             4.4%          |  4.5%             4.3%             4.9%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        2/41 (5%)     |  2/37 (5%)        1/40 (3%)        1/29 (3%)       |
|FIRST INCIDENCE    |        ---              ---              735 (T)       |  736 (T)          651              646             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.102          (e)              P=0.244       |  P=0.522          P=0.662N         P=0.614         |
|POLY 3             |        P=0.094          (e)              P=0.238       |  P=0.570          P=0.683N         P=0.660         |
|POLY 1.5           |        P=0.094          (e)              P=0.237       |  P=0.579          P=0.690N         P=0.671         |
|POLY 6             |        P=0.095          (e)              P=0.241       |  P=0.561          P=0.674N         P=0.647         |
|LOGISTIC REGRESSION|        (e)              (e)              P=0.244       |  P=0.582          P=0.694          P=0.658         |
|COCH-ARM / FISHERS |        P=0.093          (e)              P=0.242       |  P=0.600          P=0.684          P=0.691N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 2
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Fibrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)     |  1/50 (2%)        3/49 (6%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  2.2%             6.5%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        0/41 (0%)     |  1/37 (3%)        3/40 (8%)        0/29 (0%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  736 (T)          736 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.449N         P=0.333          P=0.549N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.439N         P=0.314          P=0.520N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.418N         P=0.308          P=0.513N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.466N         P=0.321          P=0.529N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.449N         P=0.333          (e)             |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.379N         P=0.301          P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Myocardium                                                                                                                |
|     Degeneration                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        5/50 (10%)       3/50 (6%)        8/50 (16%)    |  5/50 (10%)       10/49 (20%)      5/50 (10%)      |
|POLY-3 ADJUSTED (b)|        11.1%            6.6%             17.3%         |  11.0%            21.7%            12.2%           |
|TERMINAL (d)       |        4/40 (10%)       0/37 (0%)        7/41 (17%)    |  3/37 (8%)        9/40 (23%)       4/29 (14%)      |
|FIRST INCIDENCE    |        670              638              444           |  602              668              625             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.231          P=0.377N         P=0.296       |  P=0.392          P=0.171          P=0.491         |
|POLY 3             |        P=0.218          P=0.353N         P=0.292       |  P=0.461          P=0.136          P=0.563         |
|POLY 1.5           |        P=0.216          P=0.357N         P=0.288       |  P=0.494          P=0.131          P=0.586         |
|POLY 6             |        P=0.220          P=0.348N         P=0.295       |  P=0.424          P=0.144          P=0.536         |
|LOGISTIC REGRESSION|        P=0.209          P=0.357N         P=0.279       |  P=0.471          P=0.139          P=0.574         |
|COCH-ARM / FISHERS |        P=0.209          P=0.357N         P=0.277       |  P=0.558          P=0.122          P=0.630N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 3
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small, Duodenum                                                                                                        |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/49 (0%)     |  2/50 (4%)        0/49 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  4.4%             0.0%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        0/41 (0%)     |  1/37 (3%)        0/40 (0%)        0/29 (0%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  638              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.110N         P=0.222N         P=0.287N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.105N         P=0.234N         P=0.262N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.101N         P=0.237N         P=0.254N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.108N         P=0.230N         P=0.274N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.089N         P=0.259N         P=0.235N        |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.096N         P=0.253N         P=0.247N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        27/50 (54%)      28/50 (56%)      12/50 (24%)   |  2/50 (4%)        9/49 (18%)       6/50 (12%)      |
|POLY-3 ADJUSTED (b)|        59.2%            60.2%            25.3%         |  4.5%             19.6%            14.4%           |
|TERMINAL (d)       |        25/40 (63%)      23/37 (62%)      9/41 (22%)    |  2/37 (5%)        9/40 (23%)       3/29 (10%)      |
|FIRST INCIDENCE    |        562              415              444           |  736 (T)          736 (T)          539             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.002N**       P=0.357          P=0.002N**    |  P=0.064          P=0.036 *        P=0.084         |
|POLY 3             |        P<0.001N**       P=0.543          P<0.001N**    |  P=0.098          P=0.027 *        P=0.109         |
|POLY 1.5           |        P<0.001N**       P=0.520          P<0.001N**    |  P=0.108          P=0.026 *        P=0.116         |
|POLY 6             |        P<0.001N**       P=0.565          P<0.001N**    |  P=0.089          P=0.029 *        P=0.101         |
|LOGISTIC REGRESSION|        P<0.001N**       P=0.491          P=0.002N**    |  P=0.096          P=0.036 *        P=0.122         |
|COCH-ARM / FISHERS |        P=0.002N**       P=0.500          P=0.002N**    |  P=0.135          P=0.023 *        P=0.134         |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 4
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Nephropathy                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        28/50 (56%)      31/50 (62%)      33/50 (66%)   |  19/50 (38%)      30/49 (61%)      16/50 (32%)     |
|POLY-3 ADJUSTED (b)|        60.7%            69.4%            72.6%         |  42.4%            63.5%            39.0%           |
|TERMINAL (d)       |        26/40 (65%)      31/37 (84%)      32/41 (78%)   |  19/37 (51%)      27/40 (68%)      14/29 (48%)     |
|FIRST INCIDENCE    |        353              735 (T)          730           |  736 (T)          481              650             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.183          P=0.153          P=0.230       |  P=0.388          P=0.041 *        P=0.486         |
|POLY 3             |        P=0.124          P=0.250          P=0.153       |  P=0.479N         P=0.029 *        P=0.462N        |
|POLY 1.5           |        P=0.144          P=0.276          P=0.173       |  P=0.421N         P=0.023 *        P=0.420N        |
|POLY 6             |        P=0.108          P=0.220          P=0.138       |  P=0.541N         P=0.040 *        P=0.509N        |
|LOGISTIC REGRESSION|        P=0.177          P=0.328          P=0.208       |  P=0.523          P=0.030 *        P=0.570         |
|COCH-ARM / FISHERS |        P=0.178          P=0.342          P=0.206       |  P=0.307N         P=0.017 *        P=0.338N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        2/50 (4%)        0/50 (0%)     |  0/50 (0%)        0/49 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        4.4%             4.5%             0.0%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        1/40 (3%)        1/37 (3%)        0/41 (0%)     |  0/37 (0%)        0/40 (0%)        0/29 (0%)       |
|FIRST INCIDENCE    |        636              719              ---           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.176N         P=0.676          P=0.237N      |  (e)              (e)              (e)             |
|POLY 3             |        P=0.175N         P=0.690          P=0.236N      |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.175N         P=0.690          P=0.236N      |  (e)              (e)              (e)             |
|POLY 6             |        P=0.175N         P=0.689          P=0.236N      |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.175N         P=0.694          P=0.241N      |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.176N         P=0.691N         P=0.247N      |  (e)              (e)              (e)             |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 5
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Basophilic Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        2/50 (4%)        1/50 (2%)     |  0/50 (0%)        0/49 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        2.2%             4.5%             2.2%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        1/40 (3%)        2/37 (5%)        1/41 (2%)     |  0/37 (0%)        0/40 (0%)        0/29 (0%)       |
|FIRST INCIDENCE    |        735 (T)          735 (T)          735 (T)       |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.612N         P=0.473          P=0.756N      |  (e)              (e)              (e)             |
|POLY 3             |        P=0.617N         P=0.499          P=0.758N      |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.618N         P=0.498          P=0.758N      |  (e)              (e)              (e)             |
|POLY 6             |        P=0.615N         P=0.499          P=0.757N      |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.612N         P=0.473          P=0.756N      |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.622          P=0.500          P=0.753N      |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Clear Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        14/50 (28%)      7/50 (14%)       6/50 (12%)    |  2/50 (4%)        2/49 (4%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        31.2%            15.7%            13.2%         |  4.4%             4.4%             2.5%            |
|TERMINAL (d)       |        14/40 (35%)      7/37 (19%)       6/41 (15%)    |  1/37 (3%)        2/40 (5%)        1/29 (3%)       |
|FIRST INCIDENCE    |        735 (T)          735 (T)          735 (T)       |  602              736 (T)          736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.021N*        P=0.094N         P=0.032N*     |  P=0.463N         P=0.670N         P=0.569N        |
|POLY 3             |        P=0.021N*        P=0.066N         P=0.033N*     |  P=0.441N         P=0.689N         P=0.539N        |
|POLY 1.5           |        P=0.022N*        P=0.068N         P=0.034N*     |  P=0.424N         P=0.693N         P=0.525N        |
|POLY 6             |        P=0.020N*        P=0.065N         P=0.031N*     |  P=0.462N         P=0.684N         P=0.556N        |
|LOGISTIC REGRESSION|        P=0.021N*        P=0.094N         P=0.032N*     |  P=0.411N         P=0.678          P=0.507N        |
|COCH-ARM / FISHERS |        P=0.025N*        P=0.070N         P=0.039N*     |  P=0.391N         P=0.684          P=0.500N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 6
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Degeneration Fatty Focal                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)     |  0/50 (0%)        2/49 (4%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  0.0%             4.4%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        0/41 (0%)     |  0/37 (0%)        2/40 (5%)        0/29 (0%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  ---              736 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.624          P=0.256          (e)             |
|POLY 3             |        (e)              (e)              (e)           |  P=0.632          P=0.242          (e)             |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.645          P=0.239          (e)             |
|POLY 6             |        (e)              (e)              (e)           |  P=0.617          P=0.247          (e)             |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  (e)              P=0.256          (e)             |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.668          P=0.242          (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Eosinophilic Focus                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        15/50 (30%)      9/50 (18%)       15/50 (30%)   |  15/50 (30%)      20/49 (41%)      23/50 (46%)     |
|POLY-3 ADJUSTED (b)|        33.5%            19.6%            33.0%         |  32.3%            42.7%            53.5%           |
|TERMINAL (d)       |        15/40 (38%)      5/37 (14%)       15/41 (37%)   |  12/37 (32%)      17/40 (43%)      16/29 (55%)     |
|FIRST INCIDENCE    |        735 (T)          528              735 (T)       |  542              638              523             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.515N         P=0.166N         P=0.557N      |  P=0.010 *        P=0.290          P=0.015 *       |
|POLY 3             |        P=0.533N         P=0.104N         P=0.571N      |  P=0.027 *        P=0.205          P=0.031 *       |
|POLY 1.5           |        P=0.536N         P=0.112N         P=0.574N      |  P=0.035 *        P=0.194          P=0.042 *       |
|POLY 6             |        P=0.529N         P=0.094N         P=0.565N      |  P=0.022 *        P=0.221          P=0.024 *       |
|LOGISTIC REGRESSION|        P=0.527N         P=0.121N         P=0.557N      |  P=0.032 *        P=0.196          P=0.041 *       |
|COCH-ARM / FISHERS |        P=0.545          P=0.121N         P=0.586N      |  P=0.062          P=0.180          P=0.074         |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 7
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatodiaphragmatic Nodule                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/50 (4%)     |  0/50 (0%)        0/49 (0%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             4.4%          |  0.0%             0.0%             2.4%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        2/41 (5%)     |  0/37 (0%)        0/40 (0%)        0/29 (0%)       |
|FIRST INCIDENCE    |        ---              ---              735 (T)       |  ---              ---              457             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.102          (e)              P=0.244       |  P=0.267          (e)              P=0.496         |
|POLY 3             |        P=0.096          (e)              P=0.240       |  P=0.276          (e)              P=0.483         |
|POLY 1.5           |        P=0.095          (e)              P=0.240       |  P=0.274          (e)              P=0.489         |
|POLY 6             |        P=0.096          (e)              P=0.241       |  P=0.279          (e)              P=0.476         |
|LOGISTIC REGRESSION|        (e)              (e)              P=0.244       |  P=0.432          (e)              P=0.682         |
|COCH-ARM / FISHERS |        P=0.095          (e)              P=0.247       |  P=0.270          (e)              P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Mixed Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/50 (4%)        5/50 (10%)       2/50 (4%)     |  0/50 (0%)        0/49 (0%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        4.5%             11.2%            4.4%          |  0.0%             0.0%             4.9%            |
|TERMINAL (d)       |        2/40 (5%)        5/37 (14%)       2/41 (5%)     |  0/37 (0%)        0/40 (0%)        2/29 (7%)       |
|FIRST INCIDENCE    |        735 (T)          735 (T)          735 (T)       |  ---              ---              736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.570N         P=0.185          P=0.686N      |  P=0.068          (e)              P=0.186         |
|POLY 3             |        P=0.575N         P=0.214          P=0.689N      |  P=0.096          (e)              P=0.215         |
|POLY 1.5           |        P=0.577N         P=0.214          P=0.690N      |  P=0.095          (e)              P=0.222         |
|POLY 6             |        P=0.572N         P=0.214          P=0.687N      |  P=0.097          (e)              P=0.206         |
|LOGISTIC REGRESSION|        P=0.570N         P=0.185          P=0.686N      |  (e)              (e)              P=0.186         |
|COCH-ARM / FISHERS |        P=0.583          P=0.218          P=0.691N      |  P=0.096          (e)              P=0.247         |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 8
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Necrosis Focal                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        3/50 (6%)     |  0/50 (0%)        2/49 (4%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        2.2%             0.0%             6.4%          |  0.0%             4.3%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        1/41 (2%)     |  0/37 (0%)        1/40 (3%)        0/29 (0%)       |
|FIRST INCIDENCE    |        562              ---              519           |  ---              574              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.178          P=0.504N         P=0.305       |  P=0.640          P=0.253          (e)             |
|POLY 3             |        P=0.179          P=0.503N         P=0.315       |  P=0.632          P=0.245          (e)             |
|POLY 1.5           |        P=0.178          P=0.503N         P=0.312       |  P=0.645          P=0.240          (e)             |
|POLY 6             |        P=0.181          P=0.505N         P=0.319       |  P=0.617          P=0.251          (e)             |
|LOGISTIC REGRESSION|        P=0.141          P=0.464N         P=0.228       |  P=0.628N         P=0.181          (e)             |
|COCH-ARM / FISHERS |        P=0.176          P=0.500N         P=0.309       |  P=0.668          P=0.242          (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Bile Duct                                                                                                                 |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        0/50 (0%)     |  0/50 (0%)        0/49 (0%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        0.0%             4.5%             0.0%          |  0.0%             0.0%             2.5%            |
|TERMINAL (d)       |        0/40 (0%)        2/37 (5%)        0/41 (0%)     |  0/37 (0%)        0/40 (0%)        1/29 (3%)       |
|FIRST INCIDENCE    |        ---              735 (T)          ---           |  ---              ---              736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.661N         P=0.221          (e)           |  P=0.232          (e)              P=0.451         |
|POLY 3             |        P=0.665N         P=0.236          (e)           |  P=0.277          (e)              P=0.480         |
|POLY 1.5           |        P=0.666N         P=0.236          (e)           |  P=0.274          (e)              P=0.487         |
|POLY 6             |        P=0.663N         P=0.236          (e)           |  P=0.282          (e)              P=0.471         |
|LOGISTIC REGRESSION|        (e)              P=0.221          (e)           |  (e)              (e)              P=0.451         |
|COCH-ARM / FISHERS |        P=0.669          P=0.247          (e)           |  P=0.270          (e)              P=0.500         |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 9
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung: Alveolar Epithelium                                                                                                        |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        3/50 (6%)        2/50 (4%)     |  2/50 (4%)        1/49 (2%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        2.2%             6.7%             4.4%          |  4.5%             2.2%             2.5%            |
|TERMINAL (d)       |        1/40 (3%)        2/37 (5%)        2/41 (5%)     |  2/37 (5%)        1/40 (3%)        1/29 (3%)       |
|FIRST INCIDENCE    |        735 (T)          706              735 (T)       |  736 (T)          736 (T)          736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.412          P=0.288          P=0.509       |  P=0.449N         P=0.473N         P=0.585N        |
|POLY 3             |        P=0.407          P=0.305          P=0.505       |  P=0.412N         P=0.492N         P=0.536N        |
|POLY 1.5           |        P=0.405          P=0.304          P=0.504       |  P=0.401N         P=0.498N         P=0.524N        |
|POLY 6             |        P=0.410          P=0.305          P=0.506       |  P=0.425N         P=0.485N         P=0.550N        |
|LOGISTIC REGRESSION|        P=0.409          P=0.302          P=0.509       |  P=0.449N         P=0.473N         P=0.585N        |
|COCH-ARM / FISHERS |        P=0.399          P=0.309          P=0.500       |  P=0.379N         P=0.508N         P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mesenteric                                                                                                           |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        2/49 (4%)        2/50 (4%)     |  1/49 (2%)        0/48 (0%)        0/47 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             4.6%             4.4%          |  2.3%             0.0%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        2/36 (6%)        2/41 (5%)     |  0/36 (0%)        0/39 (0%)        0/27 (0%)       |
|FIRST INCIDENCE    |        ---              735 (T)          735 (T)       |  671              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.186          P=0.215          P=0.244       |  P=0.291N         P=0.495N         P=0.538N        |
|POLY 3             |        P=0.183          P=0.234          P=0.243       |  P=0.294N         P=0.496N         P=0.530N        |
|POLY 1.5           |        P=0.183          P=0.235          P=0.243       |  P=0.288N         P=0.499N         P=0.523N        |
|POLY 6             |        P=0.183          P=0.233          P=0.243       |  P=0.302N         P=0.493N         P=0.539N        |
|LOGISTIC REGRESSION|        (e)              P=0.215          P=0.244       |  P=0.256N         P=0.535N         P=0.498N        |
|COCH-ARM / FISHERS |        P=0.181          P=0.247          P=0.253       |  P=0.275N         P=0.505N         P=0.510N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 10
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery: Fat                                                                                                                   |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/0 (0%)         0/1 (0%)         2/2 (100%)    |  7/7 (100%)       10/10 (100%)     3/4 (75%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             100.0%        |  100.0%           100.0%           75.0%           |
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         2/2 (100%)    |  7/7 (100%)       9/9 (100%)       2/3 (67%)       |
|FIRST INCIDENCE    |        ---              ---              735 (T)       |  736 (T)          651              539             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.622N         (e)              P=0.689N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.166N         (e)              P=0.384N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.166N         (e)              P=0.384N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.166N         (e)              P=0.384N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.622N         (e)              (e)             |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.177N         (e)              P=0.364N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        2/50 (4%)        0/50 (0%)     |  0/49 (0%)        0/49 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             4.5%             0.0%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        2/37 (5%)        0/41 (0%)     |  0/36 (0%)        0/40 (0%)        0/29 (0%)       |
|FIRST INCIDENCE    |        ---              735 (T)          ---           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.661N         P=0.221          (e)           |  (e)              (e)              (e)             |
|POLY 3             |        P=0.665N         P=0.236          (e)           |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.666N         P=0.236          (e)           |  (e)              (e)              (e)             |
|POLY 6             |        P=0.663N         P=0.236          (e)           |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        (e)              P=0.221          (e)           |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.669          P=0.247          (e)           |  (e)              (e)              (e)             |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 11
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Polyp, Inflammatory                                                                                                         |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/50 (4%)     |  0/49 (0%)        0/49 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             4.4%          |  0.0%             0.0%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        2/41 (5%)     |  0/36 (0%)        0/40 (0%)        0/29 (0%)       |
|FIRST INCIDENCE    |        ---              ---              735 (T)       |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.102          (e)              P=0.244       |  (e)              (e)              (e)             |
|POLY 3             |        P=0.096          (e)              P=0.240       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.095          (e)              P=0.240       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.096          (e)              P=0.241       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        (e)              (e)              P=0.244       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.095          (e)              P=0.247       |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  6/50 (12%)       9/49 (18%)       8/50 (16%)      |
|POLY-3 ADJUSTED (b)|                                                        |  13.4%            19.3%            19.2%           |
|TERMINAL (d)       |                                                        |  6/37 (16%)       7/40 (18%)       6/29 (21%)      |
|FIRST INCIDENCE    |                                                        |  736 (T)          638              414             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.188          P=0.348          P=0.231         |
|POLY 3             |                                                        |  P=0.282          P=0.314          P=0.330         |
|POLY 1.5           |                                                        |  P=0.300          P=0.297          P=0.348         |
|POLY 6             |                                                        |  P=0.263          P=0.337          P=0.308         |
|LOGISTIC REGRESSION|                                                        |  P=0.289          P=0.309          P=0.331         |
|COCH-ARM / FISHERS |                                                        |  P=0.339          P=0.274          P=0.387         |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 12
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas: Acinus                                                                                                                 |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)     |  1/50 (2%)        2/49 (4%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  2.2%             4.4%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        0/41 (0%)     |  0/37 (0%)        2/40 (5%)        0/29 (0%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  629              736 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.417N         P=0.526          P=0.540N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.415N         P=0.505          P=0.522N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.396N         P=0.500          P=0.514N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.440N         P=0.510          P=0.531N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.364N         P=0.479          P=0.458N        |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.361N         P=0.492          P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis                                                                                                   |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/48 (0%)        1/49 (2%)        1/50 (2%)     |  11/47 (23%)      6/49 (12%)       11/50 (22%)     |
|POLY-3 ADJUSTED (b)|        0.0%             2.3%             2.2%          |  25.8%            13.1%            26.7%           |
|TERMINAL (d)       |        0/38 (0%)        1/36 (3%)        1/41 (2%)     |  8/34 (24%)       6/40 (15%)       9/29 (31%)      |
|FIRST INCIDENCE    |        ---              735 (T)          735 (T)       |  602              736 (T)          625             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.351          P=0.489          P=0.515       |  P=0.409          P=0.086N         P=0.430         |
|POLY 3             |        P=0.347          P=0.504          P=0.512       |  P=0.545          P=0.104N         P=0.564         |
|POLY 1.5           |        P=0.346          P=0.503          P=0.511       |  P=0.542N         P=0.111N         P=0.596         |
|POLY 6             |        P=0.350          P=0.504          P=0.513       |  P=0.523          P=0.098N         P=0.525         |
|LOGISTIC REGRESSION|        (e)              P=0.489          P=0.515       |  P=0.506          P=0.095N         P=0.547         |
|COCH-ARM / FISHERS |        P=0.340          P=0.505          P=0.510       |  P=0.492N         P=0.122N         P=0.530N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 13
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        23/50 (46%)      19/50 (38%)      18/50 (36%)   |                                                    |
|POLY-3 ADJUSTED (b)|        50.9%            41.8%            39.6%         |                                                    |
|TERMINAL (d)       |        22/40 (55%)      15/37 (41%)      17/41 (42%)   |                                                    |
|FIRST INCIDENCE    |        646              626              730           |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.154N         P=0.374N         P=0.171N      |                                                    |
|POLY 3             |        P=0.162N         P=0.252N         P=0.188N      |                                                    |
|POLY 1.5           |        P=0.165N         P=0.265N         P=0.192N      |                                                    |
|POLY 6             |        P=0.158N         P=0.236N         P=0.184N      |                                                    |
|LOGISTIC REGRESSION|        P=0.146N         P=0.265N         P=0.159N      |                                                    |
|COCH-ARM / FISHERS |        P=0.179N         P=0.272N         P=0.208N      |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Epidermis, Skin, Site of Application                                                                                       |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        4/50 (8%)        45/50 (90%)      50/50 (100%)  |  0/50 (0%)        42/49 (86%)      50/50 (100%)    |
|POLY-3 ADJUSTED (b)|        8.9%             90.9%            100.0%        |  0.0%             86.2%            100.0%          |
|TERMINAL (d)       |        4/40 (10%)       33/37 (89%)      41/41 (100%)  |  0/37 (0%)        34/40 (85%)      29/29 (100%)    |
|FIRST INCIDENCE    |        735 (T)          164              444           |  ---              481              84              |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|LOGISTIC REGRESSION|        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 14
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Sebaceous Gland, Skin, Site of Application                                                                                 |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        45/50 (90%)      48/50 (96%)   |  0/50 (0%)        43/49 (88%)      45/50 (90%)     |
|POLY-3 ADJUSTED (b)|        2.2%             90.9%            98.1%         |  0.0%             87.8%            90.9%           |
|TERMINAL (d)       |        1/40 (3%)        33/37 (89%)      41/41 (100%)  |  0/37 (0%)        34/40 (85%)      26/29 (90%)     |
|FIRST INCIDENCE    |        735 (T)          164              444           |  ---              481              84              |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|LOGISTIC REGRESSION|        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Skin, Site of Application                                                                                                  |
|     Hyperkeratosis                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        3/50 (6%)        45/50 (90%)      49/50 (98%)   |  4/50 (8%)        41/49 (84%)      48/50 (96%)     |
|POLY-3 ADJUSTED (b)|        6.7%             90.9%            98.0%         |  8.8%             84.2%            96.0%           |
|TERMINAL (d)       |        3/40 (8%)        33/37 (89%)      40/41 (98%)   |  0/37 (0%)        33/40 (83%)      27/29 (93%)     |
|FIRST INCIDENCE    |        735 (T)          164              444           |  646              481              84              |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|LOGISTIC REGRESSION|        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 15
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Skin, Site of Application                                                                                                  |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        13/50 (26%)      28/50 (56%)   |  0/50 (0%)        24/49 (49%)      40/50 (80%)     |
|POLY-3 ADJUSTED (b)|        2.2%             27.2%            57.1%         |  0.0%             49.6%            81.7%           |
|TERMINAL (d)       |        0/40 (0%)        7/37 (19%)       21/41 (51%)   |  0/37 (0%)        17/40 (43%)      21/29 (72%)     |
|FIRST INCIDENCE    |        344              164              444           |  ---              481              84              |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|LOGISTIC REGRESSION|        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Skin, Site of Application                                                                                                  |
|     Parakeratosis                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        1/50 (2%)        5/50 (10%)    |  0/50 (0%)        3/49 (6%)        9/50 (18%)      |
|POLY-3 ADJUSTED (b)|        0.0%             2.2%             11.0%         |  0.0%             6.5%             21.3%           |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        5/41 (12%)    |  0/37 (0%)        3/40 (8%)        5/29 (17%)      |
|FIRST INCIDENCE    |        ---              719              735 (T)       |  ---              736 (T)          476             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.013 *        P=0.490          P=0.035 *     |  P<0.001 **       P=0.135          P<0.001 **      |
|POLY 3             |        P=0.010 *        P=0.499          P=0.032 *     |  P<0.001 **       P=0.123          P<0.001 **      |
|POLY 1.5           |        P=0.010 *        P=0.499          P=0.031 *     |  P<0.001 **       P=0.120          P<0.001 **      |
|POLY 6             |        P=0.010 *        P=0.500          P=0.032 *     |  P<0.001 **       P=0.127          P<0.001 **      |
|LOGISTIC REGRESSION|        P=0.012 *        P=0.499          P=0.035 *     |  P<0.001 **       P=0.135          P=0.003 **      |
|COCH-ARM / FISHERS |        P=0.011 *        P=0.500          P=0.028 *     |  P<0.001 **       P=0.117          P<0.001 **      |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 16
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Skin, Site of Application                                                                                                  |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        2/50 (4%)     |  0/50 (0%)        0/49 (0%)        3/50 (6%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             4.4%          |  0.0%             0.0%             7.2%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        2/41 (5%)     |  0/37 (0%)        0/40 (0%)        1/29 (3%)       |
|FIRST INCIDENCE    |        ---              ---              735 (T)       |  ---              ---              476             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.102          (e)              P=0.244       |  P=0.029 *        (e)              P=0.100         |
|POLY 3             |        P=0.096          (e)              P=0.240       |  P=0.035 *        (e)              P=0.106         |
|POLY 1.5           |        P=0.095          (e)              P=0.240       |  P=0.035 *        (e)              P=0.110         |
|POLY 6             |        P=0.096          (e)              P=0.241       |  P=0.035 *        (e)              P=0.101         |
|LOGISTIC REGRESSION|        (e)              (e)              P=0.244       |  P=0.060          (e)              P=0.158         |
|COCH-ARM / FISHERS |        P=0.095          (e)              P=0.247       |  P=0.038 *        (e)              P=0.121         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hematopoietic Cell Proliferation                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        6/50 (12%)       7/50 (14%)       2/50 (4%)     |  7/50 (14%)       6/49 (12%)       9/50 (18%)      |
|POLY-3 ADJUSTED (b)|        12.8%            15.0%            4.3%          |  15.1%            12.9%            20.9%           |
|TERMINAL (d)       |        2/40 (5%)        2/37 (5%)        0/41 (0%)     |  3/37 (8%)        3/40 (8%)        2/29 (7%)       |
|FIRST INCIDENCE    |        353              415              444           |  562              638              539             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.129N         P=0.488          P=0.142N      |  P=0.224          P=0.448N         P=0.273         |
|POLY 3             |        P=0.123N         P=0.496          P=0.135N      |  P=0.292          P=0.493N         P=0.333         |
|POLY 1.5           |        P=0.121N         P=0.495          P=0.134N      |  P=0.304          P=0.502N         P=0.350         |
|POLY 6             |        P=0.124N         P=0.497          P=0.136N      |  P=0.281          P=0.484N         P=0.317         |
|LOGISTIC REGRESSION|        P=0.137N         P=0.530          P=0.157N      |  P=0.419          P=0.579N         P=0.462         |
|COCH-ARM / FISHERS |        P=0.122N         P=0.500          P=0.134N      |  P=0.336          P=0.516N         P=0.393         |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 17
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        3/50 (6%)        2/50 (4%)        0/50 (0%)     |  6/50 (12%)       3/49 (6%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        6.7%             4.5%             0.0%          |  13.3%            6.5%             2.5%            |
|TERMINAL (d)       |        3/40 (8%)        2/37 (5%)        0/41 (0%)     |  5/37 (14%)       3/40 (8%)        1/29 (3%)       |
|FIRST INCIDENCE    |        735 (T)          735 (T)          ---           |  646              736 (T)          736 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.081N         P=0.536N         P=0.117N      |  P=0.058N         P=0.206N         P=0.103N        |
|POLY 3             |        P=0.080N         P=0.502N         P=0.116N      |  P=0.048N*        P=0.234N         P=0.075N        |
|POLY 1.5           |        P=0.080N         P=0.503N         P=0.117N      |  P=0.043N*        P=0.241N         P=0.068N        |
|POLY 6             |        P=0.079N         P=0.502N         P=0.115N      |  P=0.053N         P=0.226N         P=0.085N        |
|LOGISTIC REGRESSION|        P=0.081N         P=0.536N         (e)           |  P=0.049N*        P=0.223N         P=0.083N        |
|COCH-ARM / FISHERS |        P=0.082N         P=0.500N         P=0.121N      |  P=0.036N*        P=0.254N         P=0.056N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/50 (2%)        0/50 (0%)        1/50 (2%)     |  3/50 (6%)        0/49 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        2.2%             0.0%             2.2%          |  6.5%             0.0%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        0/41 (0%)     |  1/37 (3%)        0/40 (0%)        0/29 (0%)       |
|FIRST INCIDENCE    |        616              ---              492           |  562              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.665          P=0.500N         P=0.758       |  P=0.045N*        P=0.119N         P=0.152N        |
|POLY 3             |        P=0.667N         P=0.503N         P=0.756N      |  P=0.041N*        P=0.119N         P=0.143N        |
|POLY 1.5           |        P=0.667N         P=0.502N         P=0.757N      |  P=0.039N*        P=0.120N         P=0.134N        |
|POLY 6             |        P=0.667N         P=0.504N         P=0.755N      |  P=0.044N*        P=0.117N         P=0.155N        |
|LOGISTIC REGRESSION|        P=0.646          P=0.483N         P=0.699       |  P=0.017N*        P=0.177N         P=0.073N        |
|COCH-ARM / FISHERS |        P=0.669          P=0.500N         P=0.753N      |  P=0.038N*        P=0.125N         P=0.121N        |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 18
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach: Epithelium                                                                                                 |
|     Hyperkeratosis                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)     |  2/50 (4%)        0/49 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  4.4%             0.0%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        0/41 (0%)     |  1/37 (3%)        0/40 (0%)        0/29 (0%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  643              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.109N         P=0.224N         P=0.284N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.105N         P=0.234N         P=0.262N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.101N         P=0.237N         P=0.253N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.108N         P=0.230N         P=0.274N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.090N         P=0.257N         P=0.237N        |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.096N         P=0.253N         P=0.247N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/50 (0%)        0/50 (0%)        0/50 (0%)     |  0/50 (0%)        2/49 (4%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  0.0%             4.3%             0.0%            |
|TERMINAL (d)       |        0/40 (0%)        0/37 (0%)        0/41 (0%)     |  0/37 (0%)        1/40 (3%)        0/29 (0%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  ---              666              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.628          P=0.256          (e)             |
|POLY 3             |        (e)              (e)              (e)           |  P=0.632          P=0.244          (e)             |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.645          P=0.239          (e)             |
|POLY 6             |        (e)              (e)              (e)           |  P=0.617          P=0.249          (e)             |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.666          P=0.223          (e)             |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.668          P=0.242          (e)             |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 19
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicle                                                                                                          |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        18/50 (36%)      24/50 (48%)      36/50 (72%)   |  38/50 (76%)      34/49 (69%)      36/50 (72%)     |
|POLY-3 ADJUSTED (b)|        39.9%            53.6%            77.7%         |  80.5%            73.6%            83.9%           |
|TERMINAL (d)       |        17/40 (43%)      22/37 (60%)      33/41 (81%)   |  30/37 (81%)      32/40 (80%)      27/29 (93%)     |
|FIRST INCIDENCE    |        670              717              560           |  562              666              583             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P<0.001 **       P=0.083          P<0.001 **    |  P=0.128          P=0.112N         P=0.145         |
|POLY 3             |        P<0.001 **       P=0.134          P<0.001 **    |  P=0.415          P=0.285N         P=0.433         |
|POLY 1.5           |        P<0.001 **       P=0.139          P<0.001 **    |  P=0.526          P=0.285N         P=0.563         |
|POLY 6             |        P<0.001 **       P=0.128          P<0.001 **    |  P=0.287          P=0.308N         P=0.279         |
|LOGISTIC REGRESSION|        P<0.001 **       P=0.128          P<0.001 **    |  P=0.297          P=0.137N         P=0.347         |
|COCH-ARM / FISHERS |        P<0.001 **       P=0.156          P<0.001 **    |  P=0.368N         P=0.304N         P=0.410N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Angiectasis                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  1/50 (2%)        1/49 (2%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|                                                        |  2.2%             2.2%             4.9%            |
|TERMINAL (d)       |                                                        |  1/37 (3%)        0/40 (0%)        0/29 (0%)       |
|FIRST INCIDENCE    |                                                        |  736 (T)          656              615             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.325          P=0.741N         P=0.442         |
|POLY 3             |                                                        |  P=0.363          P=0.754N         P=0.470         |
|POLY 1.5           |                                                        |  P=0.368          P=0.758N         P=0.479         |
|POLY 6             |                                                        |  P=0.359          P=0.748N         P=0.459         |
|LOGISTIC REGRESSION|                                                        |  P=0.414          P=0.748          P=0.512         |
|COCH-ARM / FISHERS |                                                        |  P=0.379          P=0.747          P=0.500         |
|=================================================================================================================================|
       Date:  08/01/97                           EXPERIMENT: 55323 TEST: 04                                            Page 20
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -   LAURIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 105 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          100              200           |  0 MG/KG          100              200             |
|                   |                         MG/KG            MG/KG         |                   MG/KG            MG/KG           |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus: Endometrium                                                                                                              |
|     Hyperplasia Cystic                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  38/50 (76%)      46/49 (94%)      39/50 (78%)     |
|POLY-3 ADJUSTED (b)|                                                        |  82.1%            96.0%            87.0%           |
|TERMINAL (d)       |                                                        |  34/37 (92%)      39/40 (98%)      28/29 (97%)     |
|FIRST INCIDENCE    |                                                        |  602              574              457             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.013 *        P=0.163          P=0.025 *       |
|POLY 3             |                                                        |  P=0.251          P=0.019 *        P=0.349         |
|POLY 1.5           |                                                        |  P=0.297          P=0.014 *        P=0.385         |
|POLY 6             |                                                        |  P=0.206          P=0.035 *        P=0.309         |
|LOGISTIC REGRESSION|                                                        |  P=0.081          P=0.029 *        P=0.137         |
|COCH-ARM / FISHERS |                                                        |  P=0.448          P=0.013 *        P=0.500         |
|=================================================================================================================================|

(a)  Number of tumor-bearing animals /  number of animals examined at site.
(b)  Poly-3 adjusted lifetime tumor incidence.
(d)  Observed incidence at terminal kill.
(f)  Beneath the control incidence are the P-values associated with the trend 
test.  Beneath the dosed group incidence are the P-values corresponding to 
pairwise comparisons between the controls and that dosed group.  The life
table analysis regards tumors in animals dying prior to  terminal kill as
 being (directly or indirectly) the cause of death.
Logistic regression is an alternative
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e)  Value of Statistic cannot be computed.
(I)  Interim sacrifice
(T)  Terminal sacrifice
#   Tumor rates based on number of animals necropsied.
*   To the right of any statistical result, indicates significance at (P<=0.05).
**  To the right of any statistical result, indicates significance at (P<=0.01).