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TDMS Study 96006-05 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: BIORELIANCE                               DIMETHYLAMINOPROPYL CHLORIDE, HYDROCHLORIDE                     DATE: 03/07/05       
EXPERIMENT: 96006 TEST: 05                                                                                     TIME: 07:57:37       
TEST TYPE:  SUBCHRON 90-DAY                     CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75408                              ROUTE: GAVAGE                                                  NTP C#: 96006B       
PATHOLOGIST: MARTILIK, JOHN                                                                                    CAS: 5407-04-5       
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                                                FINAL#1, REVISION#1 (MALE RATS ONLY)                                                
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    VEHICLE CONTROL                                                               
                                       INCLUDE 002    6.25    MG/KG                                                                 
                                       INCLUDE 003    12.5    MG/KG                                                                 
                                       INCLUDE 004    25 MG/KG                                                                      
                                       INCLUDE 005    50 MG/KG                                                                      
                                       INCLUDE 006    100     MG/KG                                                                 
                                       INCLUDE 007    VEHICLE CONTROL                                                               
                                       INCLUDE 008    6.25    MG/KG                                                                 
                                       INCLUDE 009    12.5    MG/KG                                                                 
                                       INCLUDE 010    25 MG/KG                                                                      
                                       INCLUDE 011    50 MG/KG                                                                      
                                       INCLUDE 012    100     MG/KG                                                                 
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: BIORELIANCE                               DIMETHYLAMINOPROPYL CHLORIDE, HYDROCHLORIDE                     DATE: 03/07/05       
EXPERIMENT: 96006 TEST: 05                                                                                     TIME: 07:57:37       
TEST TYPE:  SUBCHRON 90-DAY                     CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75408                              ROUTE: GAVAGE                                                  NTP C#: 96006B       
PATHOLOGIST: MARTILIK, JOHN                                                                                    CAS: 5407-04-5       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF       DIMETHYLAMINOPROPYL CHLORIDE, HYDROC                                                                       
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Nose: Goblet Cell                      Hypertrophy                                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  03/07/05                           EXPERIMENT: 96006 TEST: 05                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -        DIMETHYLAMINOPROPYL CHLORIDE, HYDROC           
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        VEHICLE          6.25             12.5             25 MG/KG         50 MG/KG         100             | 
|                   |        CONTROL          MG/KG            MG/KG                                              MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Myocardium                                                                                                                | 
|     Infiltration Cellular Focal Lymphocyte                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (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           0/0.00           2/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             20.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         2/10 (20%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.138          (e)              (e)              (e)              (e)              P=0.234         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.227         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.227         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.227         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P=0.234         | 
|COCH-ARM / FISHERS |        P=0.132          (e)              (e)              (e)              (e)              P=0.237         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        VEHICLE          6.25             12.5             25 MG/KG         50 MG/KG         100             | 
|                   |        CONTROL          MG/KG            MG/KG                                              MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Myocardium                                                                                                                | 
|     Infiltration Cellular Focal Lymphocyte                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (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           0/0.00           0/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/07/05                           EXPERIMENT: 96006 TEST: 05                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -        DIMETHYLAMINOPROPYL CHLORIDE, HYDROC            
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        VEHICLE          6.25             12.5             25 MG/KG         50 MG/KG         100             | 
|                   |        CONTROL          MG/KG            MG/KG                                              MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Goblet Cell                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       2/10 (20%)       2/10 (20%)       1/10 (10%)       3/10 (30%)       7/10 (70%)      | 
|POLY-3 RATE (b)    |        1/10.00          2/10.00          2/10.00          1/10.00          3/10.00          7/10.00         | 
|POLY-3 PERCENT (g) |        10.0%            20.0%            20.0%            10.0%            30.0%            70.0%           | 
|TERMINAL (d)       |        1/10 (10%)       2/10 (20%)       2/10 (20%)       1/10 (10%)       2/9 (22%)        7/10 (70%)      | 
|FIRST INCIDENCE    |        93 (T)           93 (T)           93 (T)           93 (T)           79               93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500          P=0.500          P=0.766          P=0.272          P=0.013 *       | 
|POLY 3             |        P<0.001 **       P=0.500          P=0.500          P=0.760          P=0.292          P=0.003 **      | 
|POLY 1.5           |        P<0.001 **       P=0.500          P=0.500          P=0.760          P=0.292          P=0.003 **      | 
|POLY 6             |        P<0.001 **       P=0.500          P=0.500          P=0.760          P=0.292          P=0.003 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.500          P=0.500          P=0.766          (e)              P=0.013 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          P=0.500          P=0.763N         P=0.291          P=0.010 *       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        VEHICLE          6.25             12.5             25 MG/KG         50 MG/KG         100             | 
|                   |        CONTROL          MG/KG            MG/KG                                              MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Goblet Cell                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (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           0/0.00           0/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/07/05                           EXPERIMENT: 96006 TEST: 05                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -        DIMETHYLAMINOPROPYL CHLORIDE, HYDROC            
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        VEHICLE          6.25             12.5             25 MG/KG         50 MG/KG         100             | 
|                   |        CONTROL          MG/KG            MG/KG                                              MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Infiltration Cellular Focal Lymphocyte                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/10 (40%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         4/10 (40%)      | 
|POLY-3 RATE (b)    |        4/10.00          0/0.00           0/0.00           0/0.00           0/0.00           4/10.00         | 
|POLY-3 PERCENT (g) |        40.0%            0.0%             0.0%             0.0%             0.0%             40.0%           | 
|TERMINAL (d)       |        4/10 (40%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         4/10 (40%)      | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.588          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.672         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.667         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.667         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.667         | 
|LOGISTIC REGRESSION|        P=0.588          (e)              (e)              (e)              (e)              P=0.672         | 
|COCH-ARM / FISHERS |        P=0.590          P=1.000          P=1.000          P=1.000          P=1.000          P=0.675N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        VEHICLE          6.25             12.5             25 MG/KG         50 MG/KG         100             | 
|                   |        CONTROL          MG/KG            MG/KG                                              MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Infiltration Cellular Focal Lymphocyte                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/0 (0%)         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           0/0.00           1/10.00         | 
|POLY-3 PERCENT (g) |        20.0%            0.0%             0.0%             0.0%             0.0%             10.0%           | 
|TERMINAL (d)       |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)      | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.380N         P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.500N        | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.500N        | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.500N        | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.500N        | 
|LOGISTIC REGRESSION|        P=0.380N         (e)              (e)              (e)              (e)              P=0.500N        | 
|COCH-ARM / FISHERS |        P=0.377N         P=1.000          P=1.000          P=1.000          P=1.000          P=0.500N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/07/05                           EXPERIMENT: 96006 TEST: 05                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -        DIMETHYLAMINOPROPYL CHLORIDE, HYDROC            
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        VEHICLE          6.25             12.5             25 MG/KG         50 MG/KG         100             | 
|                   |        CONTROL          MG/KG            MG/KG                                              MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Hydrometra                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|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               |        VEHICLE          6.25             12.5             25 MG/KG         50 MG/KG         100             | 
|                   |        CONTROL          MG/KG            MG/KG                                              MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Hydrometra                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 
|POLY-3 RATE (b)    |        2/10.00          0/0.00           0/0.00           0/0.00           0/0.00           0/10.00         | 
|POLY-3 PERCENT (g) |        20.0%            0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.138N         P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.234N        | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.227N        | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.227N        | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.227N        | 
|LOGISTIC REGRESSION|        P=0.138N         (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.132N         P=1.000          P=1.000          P=1.000          P=1.000          P=0.237N        | 
|ORDER RESTRICTED   |        (e)              (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).