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TDMS Study 91001-02 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                      O-CHLOROANILINE                                    DATE: 10/20/04       
EXPERIMENT: 91001 TEST: 02                                                                                     TIME: 13:39:02       
TEST TYPE:  SUBCHRON 90-DAY                                                                                    PAGE:       1        
CONT: N01-ES-15320                              ROUTE: GAVAGE                                                  NTP C#: C91001       
PATHOLOGIST: M. RYAN                         ELWELL, MICHAEL                 LE                                CAS: 95-51-2         
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                      O-CHLOROANILINE                                    DATE: 10/20/04       
EXPERIMENT: 91001 TEST: 02                                                                                     TIME: 13:39:02       
TEST TYPE:  SUBCHRON 90-DAY                                                                                                         
CONT: N01-ES-15320                              ROUTE: GAVAGE                                                  NTP C#: C91001       
PATHOLOGIST: M. RYAN                         ELWELL, MICHAEL                 LE                                CAS: 95-51-2         
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                    O-CHLOROANILINE                                                                               
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Pigmentation Hemosiderin                                                                     
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
                                       Hematopoietic Cell Proliferation                                                             
                                       Pigmentation Hemosiderin                                                                     
===============================================================                                                                     
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 91001 TEST: 02                                            Page 1       
                     Statistical Analysis of Non-neoplastic Lesions in        Mice(B6C3F1)  -                     O-CHLOROANILINE   
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160MG/KG        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        6/10 (60%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/9.00           0/10.00          6/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             60.0%            100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/9 (0%)         0/10 (0%)        6/10 (60%)       10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.009 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.009 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.005 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160MG/KG        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/10 (90%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          9/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             90.0%            100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/10 (90%)       9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              93 (T)           86              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P<0.001 **       (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 91001 TEST: 02                                            Page 2       
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                     O-CHLOROANILINE    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160MG/KG        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation Hemosiderin                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        1/10 (10%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/9.00           0/10.00          0/10.00          1/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             10.0%            100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/10 (0%)        1/10 (10%)       10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P=0.500          P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P=0.500          P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160MG/KG        | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation Hemosiderin                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     9/10 (90%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          10/10.00         9/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             100.0%           90.0%            100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     9/10 (90%)       9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              93 (T)           93 (T)           86              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P<0.001 **       P<0.001 **       (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (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).