https://ntp.niehs.nih.gov/go/14987

TDMS Study 88139-06 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: BIORELIANCE                                    BENZYLTRIMETHYL AMMONIUM CHLORIDE                          DATE: 10/25/04       
EXPERIMENT: 88139 TEST: 06                                                                                     TIME: 10:35:12       
TEST TYPE:  SUBCHRON 90-DAY                                                                                    PAGE:       1        
CONT: NO1-ES-15319                              ROUTE: GAVAGE                                                  NTP C#: 88139C       
PATHOLOGIST: MISSING                                                                                           CAS: 56-93-9         
------------------------------------------------------------------------------------------------------------------------------------
               REASONS FOR REMOVAL:    ALL                                                                                          
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
       Date:  10/25/04                           EXPERIMENT: 88139 TEST: 06                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Mice(B6C3F1)  -             BENZYLTRIMETHYL AMMONIUM CHLORI                
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Bilateral, Capsule                                                                                               | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)                        | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           0/9.25                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/9 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Bilateral, Capsule                                                                                               | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/10 (50%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)                       | 
|POLY-3 RATE (b)    |        5/10.00          0/0.00           0/0.00           0/0.00           5/9.10                           | 
|POLY-3 PERCENT (g) |        50.0%            0.0%             0.0%             0.0%             55.0%                            | 
|TERMINAL (d)       |        5/10 (50%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         5/9 (56%)                        | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              92 (T)                           | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.495          P=1.000N         P=1.000N         P=1.000N         P=0.584                          | 
|POLY 3             |        (e)              (e)              (e)              (e)              P=0.591                          | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              P=0.610                          | 
|POLY 6             |        (e)              (e)              (e)              (e)              P=0.583                          | 
|LOGISTIC REGRESSION|        P=0.495          (e)              (e)              (e)              P=0.584                          | 
|COCH-ARM / FISHERS |        P=0.588          P=1.000          P=1.000          P=1.000          P=0.672N                         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
       Date:  10/25/04                           EXPERIMENT: 88139 TEST: 06                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -             BENZYLTRIMETHYL AMMONIUM CHLORI                 
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Capsule                                                                                                          | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)                       | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           1/9.25                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             10.8%                            | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         1/9 (11%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              92 (T)                           | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.290          (e)              (e)              (e)              P=0.479                          | 
|POLY 3             |        (e)              (e)              (e)              (e)              P=0.484                          | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              P=0.490                          | 
|POLY 6             |        (e)              (e)              (e)              (e)              P=0.480                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P=0.479                          | 
|COCH-ARM / FISHERS |        P=0.304          (e)              (e)              (e)              P=0.500                          | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Capsule                                                                                                          | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/10 (60%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)                       | 
|POLY-3 RATE (b)    |        6/10.00          0/0.00           0/0.00           0/0.00           5/9.10                           | 
|POLY-3 PERCENT (g) |        60.0%            0.0%             0.0%             0.0%             55.0%                            | 
|TERMINAL (d)       |        6/10 (60%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         5/9 (56%)                        | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              92 (T)                           | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.514N         P=1.000N         P=1.000N         P=1.000N         P=0.603N                         | 
|POLY 3             |        (e)              (e)              (e)              (e)              P=0.591N                         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              P=0.569N                         | 
|POLY 6             |        (e)              (e)              (e)              (e)              P=0.600N                         | 
|LOGISTIC REGRESSION|        P=0.514N         (e)              (e)              (e)              P=0.603N                         | 
|COCH-ARM / FISHERS |        P=0.411N         P=1.000          P=1.000          P=1.000          P=0.500N                         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
       Date:  10/25/04                           EXPERIMENT: 88139 TEST: 06                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -             BENZYLTRIMETHYL AMMONIUM CHLORI                 
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)                        | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           0/9.25                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/9 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)                       | 
|POLY-3 RATE (b)    |        2/10.00          0/0.00           0/0.00           0/0.00           1/10.00                          | 
|POLY-3 PERCENT (g) |        20.0%            0.0%             0.0%             0.0%             10.0%                            | 
|TERMINAL (d)       |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/9 (0%)                         | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              42                               | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.463N         P=1.000N         P=1.000N         P=1.000N         P=0.525N                         | 
|POLY 3             |        (e)              (e)              (e)              (e)              P=0.500N                         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              P=0.500N                         | 
|POLY 6             |        (e)              (e)              (e)              (e)              P=0.500N                         | 
|LOGISTIC REGRESSION|        P=0.463N         (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.377N         P=1.000          P=1.000          P=1.000          P=0.500N                         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
       Date:  10/25/04                           EXPERIMENT: 88139 TEST: 06                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -             BENZYLTRIMETHYL AMMONIUM CHLORI                 
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte, Centrilobular                                                                                                 | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         3/10 (30%)                       | 
|POLY-3 RATE (b)    |        3/10.00          0/0.00           0/0.00           0/0.00           3/9.25                           | 
|POLY-3 PERCENT (g) |        30.0%            0.0%             0.0%             0.0%             32.4%                            | 
|TERMINAL (d)       |        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         3/9 (33%)                        | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              92 (T)                           | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.535          P=1.000N         P=1.000N         P=1.000N         P=0.629                          | 
|POLY 3             |        (e)              (e)              (e)              (e)              P=0.640                          | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              P=0.654                          | 
|POLY 6             |        (e)              (e)              (e)              (e)              P=0.629                          | 
|LOGISTIC REGRESSION|        P=0.535          (e)              (e)              (e)              P=0.629                          | 
|COCH-ARM / FISHERS |        P=0.596          P=1.000          P=1.000          P=1.000          P=0.686N                         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte, Centrilobular                                                                                                 | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         3/10 (30%)                       | 
|POLY-3 RATE (b)    |        3/10.00          0/0.00           0/0.00           0/0.00           3/9.10                           | 
|POLY-3 PERCENT (g) |        30.0%            0.0%             0.0%             0.0%             33.0%                            | 
|TERMINAL (d)       |        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         3/9 (33%)                        | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              92 (T)                           | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.535          P=1.000N         P=1.000N         P=1.000N         P=0.629                          | 
|POLY 3             |        (e)              (e)              (e)              (e)              P=0.631                          | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              P=0.643                          | 
|POLY 6             |        (e)              (e)              (e)              (e)              P=0.626                          | 
|LOGISTIC REGRESSION|        P=0.535          (e)              (e)              (e)              P=0.629                          | 
|COCH-ARM / FISHERS |        P=0.596          P=1.000          P=1.000          P=1.000          P=0.686N                         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
       Date:  10/25/04                           EXPERIMENT: 88139 TEST: 06                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -             BENZYLTRIMETHYL AMMONIUM CHLORI                 
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Interstitium                                                                                                               | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)                        | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           0/9.25                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/9 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Interstitium                                                                                                               | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         2/10 (20%)                       | 
|POLY-3 RATE (b)    |        1/10.00          0/0.00           0/0.00           0/0.00           2/9.10                           | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             0.0%             22.0%                            | 
|TERMINAL (d)       |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         2/9 (22%)                        | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              92 (T)                           | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.343          P=1.000N         P=1.000N         P=1.000N         P=0.461                          | 
|POLY 3             |        (e)              (e)              (e)              (e)              P=0.466                          | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              P=0.474                          | 
|POLY 6             |        (e)              (e)              (e)              (e)              P=0.462                          | 
|LOGISTIC REGRESSION|        P=0.343          (e)              (e)              (e)              P=0.461                          | 
|COCH-ARM / FISHERS |        P=0.377          P=1.000          P=1.000          P=1.000          P=0.500                          | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
       Date:  10/25/04                           EXPERIMENT: 88139 TEST: 06                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -             BENZYLTRIMETHYL AMMONIUM CHLORI                 
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)                       | 
|POLY-3 RATE (b)    |        1/10.00          0/0.00           0/0.00           0/0.00           1/9.25                           | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             0.0%             10.8%                            | 
|TERMINAL (d)       |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         1/9 (11%)                        | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              92 (T)                           | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.613          P=1.000N         P=1.000N         P=1.000N         P=0.743                          | 
|POLY 3             |        (e)              (e)              (e)              (e)              P=0.743                          | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              P=0.749                          | 
|POLY 6             |        (e)              (e)              (e)              (e)              P=0.739                          | 
|LOGISTIC REGRESSION|        P=0.613          (e)              (e)              (e)              P=0.743                          | 
|COCH-ARM / FISHERS |        P=0.645          P=1.000          P=1.000          P=1.000          P=0.763N                         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         3/10 (30%)                       | 
|POLY-3 RATE (b)    |        1/10.00          0/0.00           0/0.00           0/0.00           3/9.10                           | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             0.0%             33.0%                            | 
|TERMINAL (d)       |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         3/9 (33%)                        | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              92 (T)                           | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.174          P=1.000N         P=1.000N         P=1.000N         P=0.253                          | 
|POLY 3             |        (e)              (e)              (e)              (e)              P=0.255                          | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              P=0.263                          | 
|POLY 6             |        (e)              (e)              (e)              (e)              P=0.251                          | 
|LOGISTIC REGRESSION|        P=0.174          (e)              (e)              (e)              P=0.253                          | 
|COCH-ARM / FISHERS |        P=0.201          P=1.000          P=1.000          P=1.000          P=0.291                          | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
       Date:  10/25/04                           EXPERIMENT: 88139 TEST: 06                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -             BENZYLTRIMETHYL AMMONIUM CHLORI                 
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         2/10 (20%)                       | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           2/9.25                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             21.6%                            | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         2/9 (22%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              92 (T)                           | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.121          (e)              (e)              (e)              P=0.210                          | 
|POLY 3             |        (e)              (e)              (e)              (e)              P=0.208                          | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              P=0.214                          | 
|POLY 6             |        (e)              (e)              (e)              (e)              P=0.203                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P=0.210                          | 
|COCH-ARM / FISHERS |        P=0.132          (e)              (e)              (e)              P=0.237                          | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Lymphoid Follicle                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)                        | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.00           0/0.00           0/9.10                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/9 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
       Date:  10/25/04                           EXPERIMENT: 88139 TEST: 06                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -             BENZYLTRIMETHYL AMMONIUM CHLORI                 
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          12.5             25.0             50.0             100.0                            | 
|                   |                         MG/KG            MG/KG            MG/KG            MG/KG                            | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)                        | 
|POLY-3 RATE (b)    |        3/10.00          0/0.00           0/0.00           0/0.00           0/9.10                           | 
|POLY-3 PERCENT (g) |        30.0%            0.0%             0.0%             0.0%             0.0%                             | 
|TERMINAL (d)       |        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/9 (0%)                         | 
|FIRST INCIDENCE    |        92 (T)           ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.075N         P=1.000N         P=1.000N         P=1.000N         P=0.129N                         | 
|POLY 3             |        (e)              (e)              (e)              (e)              P=0.113N                         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              P=0.108N                         | 
|POLY 6             |        (e)              (e)              (e)              (e)              P=0.115N                         | 
|LOGISTIC REGRESSION|        P=0.075N         (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.059N         P=1.000          P=1.000          P=1.000          P=0.105N                         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(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.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(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).