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TDMS Study 61938-01 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Northwest                                      1-NITROPYRENE                                     DATE: 10/18/04       
EXPERIMENT: 61938 TEST: 01                                                                                     TIME: 08:36:31       
TEST TYPE:  SUBCHRON 90-DAY                                                                                    PAGE:       1        
CONT: N01-ES-85232                              ROUTE: RESPIRATORY EXPOSURE NASAL                              NTP C#: C61938       
PATHOLOGIST: R. MILLER                       R. RENNE                        P.                                CAS: 5522-43-0       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Northwest                                      1-NITROPYRENE                                     DATE: 10/18/04       
EXPERIMENT: 61938 TEST: 01                                                                                     TIME: 08:36:31       
TEST TYPE:  SUBCHRON 90-DAY                                                                                                         
CONT: N01-ES-85232                              ROUTE: RESPIRATORY EXPOSURE NASAL                              NTP C#: C61938       
PATHOLOGIST: R. MILLER                       R. RENNE                        P.                                CAS: 5522-43-0       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                     1-NITROPYRENE                                                                                
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Larynx: Epiglottis                     Metaplasia                                                                                   
Liver                                  Hepatodiaphragmatic Nodule                                                                   
Lung: Bronchus                         Metaplasia                                                                                   
Nose: Respiratory Epithelium           Cytoplasmic Alteration                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Larynx: Epiglottis                     Metaplasia                                                                                   
Liver                                  Hepatodiaphragmatic Nodule                                                                   
Lung                                   Hemorrhage                                                                                   
                                       Inflammation Chronic                                                                         
Lung: Bronchus                         Metaplasia                                                                                   
Nose: Respiratory Epithelium           Cytoplasmic Alteration                                                                       
===============================================================                                                                     
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 61938 TEST: 01                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -                      1-NITROPYRENE                    
                                         Terminal Sacrifice at 13 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Hypospermia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/9 (100%)       10/10 (100%)     10/10 (100%)     9/9 (100%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        9/9.00           10/10.00         10/10.00         9/9.00           10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           100.0%           100.0%           100.0%          | 
|TERMINAL (d)       |        9/9 (100%)       10/10 (100%)     10/10 (100%)     9/9 (100%)       10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        91 (T)           91 (T)           91 (T)           91 (T)           91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|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)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Hypospermia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|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   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 61938 TEST: 01                                            Page 2       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      1-NITROPYRENE
                                         Terminal Sacrifice at 13 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/10 (60%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         4/10 (40%)      | 
|POLY-3 RATE (b)    |        6/10.00          0/0.00           0/0.00           0/0.00           0/0.00           4/10.00         | 
|POLY-3 PERCENT (g) |        60.0%            0.0%             0.0%             0.0%             0.0%             40.0%           | 
|TERMINAL (d)       |        6/10 (60%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         4/10 (40%)      | 
|FIRST INCIDENCE    |        91 (T)           ---              ---              ---              ---              91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.271N         P=1.000          P=1.000          P=1.000          P=1.000N         P=0.331N        | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.333N        | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.333N        | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.333N        | 
|LOGISTIC REGRESSION|        P=0.271N         (e)              (e)              (e)              (e)              P=0.331N        | 
|COCH-ARM / FISHERS |        P=0.266N         P=1.000          P=1.000          P=1.000          P=1.000          P=0.328N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|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    |        91 (T)           ---              ---              ---              ---              91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.605          P=1.000          P=1.000          P=1.000          P=1.000          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=0.605          (e)              (e)              (e)              (e)              P=0.672         | 
|COCH-ARM / FISHERS |        P=0.608          P=1.000          P=1.000          P=1.000          P=1.000          P=0.675N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 61938 TEST: 01                                            Page 3       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      1-NITROPYRENE
                                         Terminal Sacrifice at 13 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/10 (50%)       0/0 (0%)         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           0/0.00           5/10.00         | 
|POLY-3 PERCENT (g) |        50.0%            0.0%             0.0%             0.0%             0.0%             50.0%           | 
|TERMINAL (d)       |        5/10 (50%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)      | 
|FIRST INCIDENCE    |        91 (T)           ---              ---              ---              ---              91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.603          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.669         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.664         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.664         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.664         | 
|LOGISTIC REGRESSION|        P=0.603          (e)              (e)              (e)              (e)              P=0.669         | 
|COCH-ARM / FISHERS |        P=0.606          P=1.000          P=1.000          P=1.000          P=1.000          P=0.672N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/0 (0%)         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           0/0.00           1/10.00         | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             0.0%             0.0%             10.0%           | 
|TERMINAL (d)       |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)      | 
|FIRST INCIDENCE    |        91 (T)           ---              ---              ---              ---              91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.669          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.766         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.760         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.760         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.760         | 
|LOGISTIC REGRESSION|        P=0.669          (e)              (e)              (e)              (e)              P=0.766         | 
|COCH-ARM / FISHERS |        P=0.673          P=1.000          P=1.000          P=1.000          P=1.000          P=0.763N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 61938 TEST: 01                                            Page 4       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      1-NITROPYRENE
                                         Terminal Sacrifice at 13 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Larynx: Epiglottis                                                                                                               | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        5/10 (50%)       10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          5/10.00          10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             50.0%            100.0%           100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        5/10 (50%)       10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              91 (T)           91 (T)           91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              P=0.022 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              P=0.008 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              P=0.008 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              P=0.008 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              P=0.022 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.016 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Larynx: Epiglottis                                                                                                               | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        4/10 (40%)       4/10 (40%)       10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          4/10.00          4/10.00          10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             40.0%            40.0%            100.0%           100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        4/10 (40%)       4/10 (40%)       10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              91 (T)           91 (T)           91 (T)           91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.051          P=0.051          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.033 *        P=0.033 *        P<0.001 **       P<0.001 **       P<0.001N**      | 
|POLY 1.5           |        P<0.001 **       P=0.033 *        P=0.033 *        P<0.001 **       P<0.001 **       P<0.001N**      | 
|POLY 6             |        P<0.001 **       P=0.033 *        P=0.033 *        P<0.001 **       P<0.001 **       P<0.001N**      | 
|LOGISTIC REGRESSION|        (e)              P=0.051          P=0.051          P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.043 *        P=0.043 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 61938 TEST: 01                                            Page 5       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      1-NITROPYRENE
                                         Terminal Sacrifice at 13 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       2/2 (100%)       4/4 (100%)       1/1 (100%)       1/1 (100%)       1/10 (10%)      | 
|POLY-3 RATE (b)    |        2/10.00          2/2.00           4/4.00           1/1.00           1/1.00           1/10.00         | 
|POLY-3 PERCENT (g) |        20.0%            100.0%           100.0%           100.0%           100.0%           10.0%           | 
|TERMINAL (d)       |        2/10 (20%)       2/2 (100%)       4/4 (100%)       1/1 (100%)       1/1 (100%)       1/10 (10%)      | 
|FIRST INCIDENCE    |        91 (T)           91 (T)           91 (T)           91 (T)           91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.038N*        P=0.095          P=0.020 *        P=0.305          P=0.305          P=0.500N        | 
|POLY 3             |        P=0.004N**       P=0.053          P=0.002 **       P=0.286          P=0.286          P=0.500N        | 
|POLY 1.5           |        P=0.004N**       P=0.053          P=0.002 **       P=0.286          P=0.286          P=0.500N        | 
|POLY 6             |        P=0.004N**       P=0.053          P=0.002 **       P=0.286          P=0.286          P=0.500N        | 
|LOGISTIC REGRESSION|        P=0.038N*        P=0.095          P=0.020 *        P=0.305          P=0.305          P=0.500N        | 
|COCH-ARM / FISHERS |        P=0.035N*        P=0.091          P=0.015 *        P=0.273          P=0.273          P=0.500N        | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        2/3 (67%)        1/1 (100%)       4/4 (100%)       1/1 (100%)       1/10 (10%)      | 
|POLY-3 RATE (b)    |        0/10.00          2/3.00           1/1.00           4/4.00           1/1.00           1/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             66.7%            100.0%           100.0%           100.0%           10.0%           | 
|TERMINAL (d)       |        0/10 (0%)        2/3 (67%)        1/1 (100%)       4/4 (100%)       1/1 (100%)       1/10 (10%)      | 
|FIRST INCIDENCE    |        ---              91 (T)           91 (T)           91 (T)           91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.182N         P=0.034 *        P=0.077          P<0.001 **       P=0.077          P=0.500         | 
|POLY 3             |        P=0.051N         P=0.003 **       P=0.091          P<0.001 **       P=0.091          P=0.500         | 
|POLY 1.5           |        P=0.051N         P=0.003 **       P=0.091          P<0.001 **       P=0.091          P=0.500         | 
|POLY 6             |        P=0.051N         P=0.003 **       P=0.091          P<0.001 **       P=0.091          P=0.500         | 
|LOGISTIC REGRESSION|        (e)              P=0.034 *        P=0.077          P<0.001 **       P=0.077          P=0.500         | 
|COCH-ARM / FISHERS |        P=0.178N         P=0.038 *        P=0.091          P<0.001 **       P=0.091          P=0.500         | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 61938 TEST: 01                                            Page 6       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      1-NITROPYRENE
                                         Terminal Sacrifice at 13 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     8/8 (100%)       10/10 (100%)     9/10 (90%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        10/10.00         8/8.00           10/10.00         9/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           90.0%            100.0%           100.0%          | 
|TERMINAL (d)       |        10/10 (100%)     8/8 (100%)       10/10 (100%)     9/10 (90%)       10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        91 (T)           91 (T)           91 (T)           91 (T)           91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.695          (e)              (e)              P=0.500N         (e)              (e)             | 
|POLY 3             |        P=0.695          (e)              (e)              P=0.500N         (e)              (e)             | 
|POLY 1.5           |        P=0.695          (e)              (e)              P=0.500N         (e)              (e)             | 
|POLY 6             |        P=0.695          (e)              (e)              P=0.500N         (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.695          (e)              (e)              P=0.500N         (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.697          (e)              (e)              P=0.500N         (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.513N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     8/10 (80%)       6/10 (60%)       9/10 (90%)       7/10 (70%)       9/10 (90%)      | 
|POLY-3 RATE (b)    |        10/10.00         8/10.00          6/10.00          9/10.00          7/10.00          9/10.00         | 
|POLY-3 PERCENT (g) |        100.0%           80.0%            60.0%            90.0%            70.0%            90.0%           | 
|TERMINAL (d)       |        10/10 (100%)     8/10 (80%)       6/10 (60%)       9/10 (90%)       7/10 (70%)       9/10 (90%)      | 
|FIRST INCIDENCE    |        91 (T)           91 (T)           91 (T)           91 (T)           91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.459          P=0.234N         P=0.051N         P=0.500N         P=0.111N         P=0.500N        | 
|POLY 3             |        P=0.458          P=0.227N         P=0.033N*        P=0.500N         P=0.095N         P=0.500N        | 
|POLY 1.5           |        P=0.458          P=0.227N         P=0.033N*        P=0.500N         P=0.095N         P=0.500N        | 
|POLY 6             |        P=0.458          P=0.227N         P=0.033N*        P=0.500N         P=0.095N         P=0.500N        | 
|LOGISTIC REGRESSION|        P=0.459          P=0.234N         P=0.051N         P=0.500N         P=0.111N         P=0.500N        | 
|COCH-ARM / FISHERS |        P=0.458          P=0.237N         P=0.043N*        P=0.500N         P=0.105N         P=0.500N        | 
|ORDER RESTRICTED   |        P=0.159N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 61938 TEST: 01                                            Page 7       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      1-NITROPYRENE
                                         Terminal Sacrifice at 13 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        3/8 (38%)        1/10 (10%)       2/10 (20%)       1/10 (10%)       0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          3/8.00           1/10.00          2/10.00          1/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             37.5%            10.0%            20.0%            10.0%            0.0%            | 
|TERMINAL (d)       |        0/10 (0%)        3/8 (38%)        1/10 (10%)       2/10 (20%)       1/10 (10%)       0/10 (0%)       | 
|FIRST INCIDENCE    |        ---              91 (T)           91 (T)           91 (T)           91 (T)           ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.171N         P=0.074          P=0.500          P=0.234          P=0.500          (e)             | 
|POLY 3             |        P=0.163N         P=0.053          P=0.500          P=0.227          P=0.500          (e)             | 
|POLY 1.5           |        P=0.163N         P=0.053          P=0.500          P=0.227          P=0.500          (e)             | 
|POLY 6             |        P=0.163N         P=0.053          P=0.500          P=0.227          P=0.500          (e)             | 
|LOGISTIC REGRESSION|        (e)              P=0.074          P=0.500          P=0.234          P=0.500          (e)             | 
|COCH-ARM / FISHERS |        P=0.169N         P=0.069          P=0.500          P=0.237          P=0.500          (e)             | 
|ORDER RESTRICTED   |        P=0.205N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        5/10 (50%)       2/10 (20%)       0/10 (0%)        2/10 (20%)       2/10 (20%)      | 
|POLY-3 RATE (b)    |        0/10.00          5/10.00          2/10.00          0/10.00          2/10.00          2/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             50.0%            20.0%            0.0%             20.0%            20.0%           | 
|TERMINAL (d)       |        0/10 (0%)        5/10 (50%)       2/10 (20%)       0/10 (0%)        2/10 (20%)       2/10 (20%)      | 
|FIRST INCIDENCE    |        ---              91 (T)           91 (T)           ---              91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.602N         P=0.022 *        P=0.234          (e)              P=0.234          P=0.234         | 
|POLY 3             |        P=0.609N         P=0.008 **       P=0.227          (e)              P=0.227          P=0.227         | 
|POLY 1.5           |        P=0.609N         P=0.008 **       P=0.227          (e)              P=0.227          P=0.227         | 
|POLY 6             |        P=0.609N         P=0.008 **       P=0.227          (e)              P=0.227          P=0.227         | 
|LOGISTIC REGRESSION|        (e)              P=0.022 *        P=0.234          (e)              P=0.234          P=0.234         | 
|COCH-ARM / FISHERS |        P=0.603N         P=0.016 *        P=0.237          (e)              P=0.237          P=0.237         | 
|ORDER RESTRICTED   |        P=0.152          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 61938 TEST: 01                                            Page 8       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      1-NITROPYRENE
                                         Terminal Sacrifice at 13 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Bronchus                                                                                                                   | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/8 (0%)         0/10 (0%)        1/10 (10%)       2/10 (20%)       5/10 (50%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/8.00           0/10.00          1/10.00          2/10.00          5/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             10.0%            20.0%            50.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/8 (0%)         0/10 (0%)        1/10 (10%)       2/10 (20%)       5/10 (50%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              91 (T)           91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.500          P=0.234          P=0.022 *       | 
|POLY 3             |        P<0.001 **       (e)              (e)              P=0.500          P=0.227          P=0.008 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.500          P=0.227          P=0.008 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P=0.500          P=0.227          P=0.008 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.500          P=0.234          P=0.022 *       | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.500          P=0.237          P=0.016 *       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Bronchus                                                                                                                   | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        2/10 (20%)       3/10 (30%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          2/10.00          3/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             20.0%            30.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        2/10 (20%)       3/10 (30%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.002 **       (e)              (e)              (e)              P=0.234          P=0.111         | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P=0.227          P=0.095         | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P=0.227          P=0.095         | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P=0.227          P=0.095         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P=0.234          P=0.111         | 
|COCH-ARM / FISHERS |        P=0.002 **       (e)              (e)              (e)              P=0.237          P=0.105         | 
|ORDER RESTRICTED   |        P=0.007 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 61938 TEST: 01                                            Page 9       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      1-NITROPYRENE
                                         Terminal Sacrifice at 13 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Olfactory Epithelium                                                                                                       | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        10/10.00         10/10.00         10/10.00         10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           100.0%           100.0%           100.0%          | 
|TERMINAL (d)       |        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        91 (T)           91 (T)           91 (T)           91 (T)           91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|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)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Olfactory Epithelium                                                                                                       | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        10/10.00         10/10.00         10/10.00         10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           100.0%           100.0%           100.0%          | 
|TERMINAL (d)       |        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        91 (T)           91 (T)           91 (T)           91 (T)           91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|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:  10/18/04                           EXPERIMENT: 61938 TEST: 01                                            Page 10      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      1-NITROPYRENE
                                         Terminal Sacrifice at 13 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Respiratory Epithelium                                                                                                     | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        8/10 (80%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          8/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             80.0%            100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        8/10 (80%)       10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              91 (T)           91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|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 **       P<0.001 **      | 
|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)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Respiratory Epithelium                                                                                                     | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|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          0/10.00          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%)        0/10 (0%)        0/10 (0%)        6/10 (60%)       10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              91 (T)           91 (T)           91 (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<0.001N**      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001N**      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001N**      | 
|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)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 61938 TEST: 01                                            Page 11      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      1-NITROPYRENE
                                         Terminal Sacrifice at 13 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        10/10.00         10/10.00         10/10.00         10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           100.0%           100.0%           100.0%          | 
|TERMINAL (d)       |        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        91 (T)           91 (T)           91 (T)           91 (T)           91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|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)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|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   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/18/04                           EXPERIMENT: 61938 TEST: 01                                            Page 12      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      1-NITROPYRENE
                                         Terminal Sacrifice at 13 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        2/10 (20%)       1/10 (10%)      | 
|POLY-3 RATE (b)    |        1/10.00          0/10.00          0/10.00          0/10.00          2/10.00          1/10.00         | 
|POLY-3 PERCENT (g) |        10.0%            0.0%             0.0%             0.0%             20.0%            10.0%           | 
|TERMINAL (d)       |        1/10 (10%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        2/10 (20%)       1/10 (10%)      | 
|FIRST INCIDENCE    |        91 (T)           ---              ---              ---              91 (T)           91 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.269          P=0.500N         P=0.500N         P=0.500N         P=0.500          P=0.766         | 
|POLY 3             |        P=0.268          P=0.500N         P=0.500N         P=0.500N         P=0.500          P=0.760         | 
|POLY 1.5           |        P=0.268          P=0.500N         P=0.500N         P=0.500N         P=0.500          P=0.760         | 
|POLY 6             |        P=0.268          P=0.500N         P=0.500N         P=0.500N         P=0.500          P=0.760         | 
|LOGISTIC REGRESSION|        P=0.269          (e)              (e)              (e)              P=0.500          P=0.766         | 
|COCH-ARM / FISHERS |        P=0.267          P=0.500N         P=0.500N         P=0.500N         P=0.500          P=0.763N        | 
|ORDER RESTRICTED   |        P=0.232          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        CONTROL          0.5              2.0              8.0              20.0             50.0            | 
|                   |                         MG/M3            MG/M3            MG/M3            MG/M3            MG/M3           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|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   |                                                                                                             | 
|=================================================================================================================================| 
(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).