TDMS Study 88138-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus BENZOPHENONE DATE: 10/25/04 EXPERIMENT: 88138 TEST: 02 TIME: 13:32:15 TEST TYPE: SUBCHRON 90-DAY PAGE: 1 CONT: NO1-ES-15320 ROUTE: DOSED FEED NTP C#: C88138 PATHOLOGIST: TOFT, J. CAS: 119-61-9 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus BENZOPHENONE DATE: 10/25/04 EXPERIMENT: 88138 TEST: 02 TIME: 13:32:15 TEST TYPE: SUBCHRON 90-DAY CONT: NO1-ES-15320 ROUTE: DOSED FEED NTP C#: C88138 PATHOLOGIST: TOFT, J. CAS: 119-61-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF BENZOPHENONE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Heart: Myocardium Mineralization Liver Inflammation Chronic Liver: Centrilobular Hypertrophy Liver: Hepatocyte Vacuolization Cytoplasmic Nose Inflammation Chronic Spleen: Lymphoid Follicle Depletion Cellular Thymus Atrophy =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Liver Inflammation Chronic Liver: Centrilobular Hypertrophy Liver: Hepatocyte Vacuolization Cytoplasmic Nose Inflammation Chronic Thymus Atrophy =============================================================== Date: 10/25/04 EXPERIMENT: 88138 TEST: 02 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Heart: Myocardium | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 2/10 (20%) | |POLY-3 RATE (b) | 0/10.00 0/0.02 0/0.00 0/0.00 0/10.00 2/3.32 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 60.3% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 75 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.034 * | |POLY 3 | (e) (e) (e) (e) (e) P=0.063 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.078 | |POLY 6 | (e) (e) (e) (e) (e) P=0.050 | |LOGISTIC REGRESSION| P=0.034 * (e) (e) (e) (e) P=0.055 | |COCH-ARM / FISHERS | P=0.082 (e) (e) (e) (e) P=0.237 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Heart: Myocardium | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 2/7.83 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 25.5% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/6 (33%) | |FIRST INCIDENCE | --- --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.065 (e) (e) (e) (e) P=0.128 | |POLY 3 | (e) (e) (e) (e) (e) P=0.171 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.185 | |POLY 6 | (e) (e) (e) (e) (e) P=0.152 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.128 | |COCH-ARM / FISHERS | P=0.132 (e) (e) (e) (e) P=0.237 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 02 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/10 (50%) 4/10 (40%) 8/10 (80%) 8/10 (80%) 5/10 (50%) 1/10 (10%) | |POLY-3 RATE (b) | 5/10.00 4/9.02 8/10.00 8/10.00 5/10.00 1/3.40 | |POLY-3 PERCENT (g) | 50.0% 44.3% 80.0% 80.0% 50.0% 29.4% | |TERMINAL (d) | 5/10 (50%) 4/9 (44%) 8/10 (80%) 8/10 (80%) 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 4 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.249 P=0.584N P=0.180 P=0.180 P=0.669 P=0.500 | |POLY 3 | P=0.420N P=0.580N P=0.174 P=0.174 P=0.664 P=0.491N | |POLY 1.5 | P=0.276N P=0.569N P=0.174 P=0.174 P=0.664 P=0.357N | |POLY 6 | P=0.562N P=0.582N P=0.174 P=0.174 P=0.664 P=0.657N | |LOGISTIC REGRESSION| P=0.163N P=0.586N P=0.180 P=0.180 P=0.669 P=0.151N | |COCH-ARM / FISHERS | P=0.012N* P=0.500N P=0.175 P=0.175 P=0.672N P=0.070N | |ORDER RESTRICTED | P=0.395N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/10 (80%) 9/10 (90%) 9/10 (90%) 9/10 (90%) 9/10 (90%) 3/10 (30%) | |POLY-3 RATE (b) | 8/10.00 9/10.00 9/10.00 9/10.00 9/10.00 3/8.22 | |POLY-3 PERCENT (g) | 80.0% 90.0% 90.0% 90.0% 90.0% 36.5% | |TERMINAL (d) | 8/10 (80%) 9/10 (90%) 9/10 (90%) 9/10 (90%) 9/10 (90%) 2/6 (33%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 78 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.090N P=0.500 P=0.500 P=0.500 P=0.500 P=0.253N | |POLY 3 | P=0.006N** P=0.500 P=0.500 P=0.500 P=0.500 P=0.067N | |POLY 1.5 | P=0.003N** P=0.500 P=0.500 P=0.500 P=0.500 P=0.054N | |POLY 6 | P=0.014N* P=0.500 P=0.500 P=0.500 P=0.500 P=0.091N | |LOGISTIC REGRESSION| P=0.012N* P=0.500 P=0.500 P=0.500 P=0.500 P=0.094N | |COCH-ARM / FISHERS | P<0.001N** P=0.500 P=0.500 P=0.500 P=0.500 P=0.035N* | |ORDER RESTRICTED | P=0.003N** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 02 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/10 (30%) 8/10 (80%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 3/10.00 8/9.02 10/10.00 10/10.00 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 30.0% 88.7% 100.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 3/10 (30%) 8/9 (89%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 4 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.019 * P=0.003 ** P=0.003 ** P=0.003 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.017 * P=0.003 ** P=0.003 ** P=0.003 ** (e) | |COCH-ARM / FISHERS | P=0.004 ** P=0.035 * P=0.002 ** P=0.002 ** P=0.002 ** P=0.002 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/10 (30%) 9/10 (90%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 3/10.00 9/10.00 10/10.00 10/10.00 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 30.0% 90.0% 100.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 3/10 (30%) 9/10 (90%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 6/6 (100%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 13 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.013 * P=0.003 ** P=0.003 ** P=0.003 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.013 * P=0.003 ** P=0.003 ** P=0.003 ** (e) | |COCH-ARM / FISHERS | P=0.006 ** P=0.010 * P=0.002 ** P=0.002 ** P=0.002 ** P=0.002 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 02 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) | |POLY-3 RATE (b) | 0/10.00 0/9.02 0/10.00 0/10.00 0/10.00 3/3.97 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 75.7% | |TERMINAL (d) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 65 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.011 * | |POLY 3 | P=0.003 ** (e) (e) (e) (e) P=0.008 ** | |POLY 1.5 | P=0.002 ** (e) (e) (e) (e) P=0.011 * | |POLY 6 | P=0.007 ** (e) (e) (e) (e) P=0.005 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) (e) P=0.012 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.105 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 9/10 (90%) 1/10 (10%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 2/10.00 9/10.00 1/8.22 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 20.0% 90.0% 12.2% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 9/10 (90%) 0/6 (0%) | |FIRST INCIDENCE | --- --- --- 92 (T) 92 (T) 78 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** (e) (e) P=0.234 P<0.001 ** P=0.479 | |POLY 3 | P<0.001 ** (e) (e) P=0.227 P<0.001 ** P=0.461 | |POLY 1.5 | P<0.001 ** (e) (e) P=0.227 P<0.001 ** P=0.470 | |POLY 6 | P<0.001 ** (e) (e) P=0.227 P<0.001 ** P=0.449 | |LOGISTIC REGRESSION| P=0.020 * (e) (e) P=0.234 P<0.001 ** P=0.563 | |COCH-ARM / FISHERS | P=0.039 * (e) (e) P=0.237 P<0.001 ** P=0.500 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 02 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Nose | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 1/10 (10%) | |POLY-3 RATE (b) | 0/10.00 0/0.02 0/0.00 0/0.00 0/10.00 1/2.86 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 35.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 75 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.022 * (e) (e) (e) (e) P=0.261 | |POLY 3 | (e) (e) (e) (e) (e) P=0.303 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.334 | |POLY 6 | (e) (e) (e) (e) (e) P=0.271 | |LOGISTIC REGRESSION| P=0.190 (e) (e) (e) (e) P=0.370 | |COCH-ARM / FISHERS | P=0.256 (e) (e) (e) (e) P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Nose | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) | |POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 5/8.61 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 58.1% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/6 (50%) | |FIRST INCIDENCE | --- --- --- --- --- 78 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.010 * | |POLY 3 | (e) (e) (e) (e) (e) P=0.003 ** | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.003 ** | |POLY 6 | (e) (e) (e) (e) (e) P=0.002 ** | |LOGISTIC REGRESSION| P=0.006 ** (e) (e) (e) (e) P=0.013 * | |COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.016 * | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 02 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Depletion Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 5/10 (50%) | |POLY-3 RATE (b) | 0/10.00 0/0.02 0/0.00 0/0.00 0/10.00 5/7.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 67.6% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 4 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.019 * | |POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.002 ** | |POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.003 ** (e) (e) (e) (e) P=0.016 * | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Depletion Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/8.83 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 11.3% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/6 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 13 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.107 (e) (e) (e) (e) P=0.500 | |POLY 3 | (e) (e) (e) (e) (e) P=0.475 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.486 | |POLY 6 | (e) (e) (e) (e) (e) P=0.458 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.304 (e) (e) (e) (e) P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 02 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 7/8 (88%) | |POLY-3 RATE (b) | 0/8.00 0/0.02 0/0.00 0/0.00 0/10.00 7/7.54 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 92.8% | |TERMINAL (d) | 0/8 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 4 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** | |POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** | |POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/7 (71%) | |POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 5/7.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 71.4% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/5 (60%) | |FIRST INCIDENCE | --- --- --- --- --- 13 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.006 ** | |POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** | |POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** | |POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.002 ** (e) (e) (e) (e) P=0.003 ** | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (g) Poly-3 adjusted lifetime tumor incidence. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).