NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 10:41:21 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX ------------------------------------------------------------------------------------------------------------------------------------ 14 WEEK SSAC FINAL #1; REVISION #1 REASONS FOR REMOVAL: 25017 Scheduled Sacrifice REMOVAL DATE RANGE: 011300 011400 TREATMENT GROUPS: INCLUDE 001 0 NG TEQ/KG INCLUDE 002 7 NG TEQ/KG INCLUDE 003 22 NG TEQ/KG INCLUDE 004 72 NG TEQ/KG INCLUDE 005 216 NG TEQ/KG INCLUDE 006 360 NG TEQ/KG NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 10:41:21 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF TEF EVALUATION (PCB MIXTURE;PCB 126/P =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Liver Fatty Change Diffuse Necrosis Pigmentation Toxic Hepatopathy Liver: Hepatocyte Hypertrophy Multinucleated Lung Hemorrhage Infiltration Cellular Histiocyte Inflammation Lung: Alveolar Epithelium Hyperplasia Thymus Atrophy Thyroid Gland: Follicular Cell Hypertrophy =============================================================== Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) | |POLY-3 RATE (b) | 0/0.01 0/0.01 0/0.01 0/0.01 2/2.01 0/0.01 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 99.7% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 92 (I) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.235 (e) (e) (e) P=0.234 (e) | |POLY 3 | P=0.121 (e) (e) (e) P=0.067 (e) | |POLY 1.5 | P=0.124 (e) (e) (e) P=0.070 (e) | |POLY 6 | P=0.119 (e) (e) (e) P=0.067 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.233 (e) (e) (e) P=0.237 (e) | |ORDER RESTRICTED | P=0.595 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Fatty Change Diffuse | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) 10/10 (100%) | |POLY-3 RATE (b) | 0/0.01 0/0.01 0/0.01 0/0.01 5/5.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 99.9% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) 10/10 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.022 * P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.016 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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% | |INT SACRIFICE 1 (c)| 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) | |-------------------| | |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 | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) 2/10 (20%) 0/10 (0%) | |POLY-3 RATE (b) | 0/0.01 1/1.01 1/1.01 1/1.01 2/2.01 0/0.01 | |POLY-3 PERCENT (g) | 0.0% 99.3% 99.3% 99.3% 99.7% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) 2/10 (20%) 0/10 (0%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 92 (I) 92 (I) 92 (I) 92 (I) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.557N P=0.500 P=0.500 P=0.500 P=0.234 (e) | |POLY 3 | P=0.474N P=0.159 P=0.159 P=0.159 P=0.067 (e) | |POLY 1.5 | P=0.476N P=0.167 P=0.167 P=0.167 P=0.070 (e) | |POLY 6 | P=0.475N P=0.159 P=0.159 P=0.159 P=0.067 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.557N P=0.500 P=0.500 P=0.500 P=0.237 (e) | |ORDER RESTRICTED | P=0.465 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) 3/10 (30%) 1/10 (10%) | |POLY-3 RATE (b) | 0/0.01 1/1.01 1/1.01 1/1.01 3/3.01 1/1.01 | |POLY-3 PERCENT (g) | 0.0% 99.3% 99.3% 99.3% 99.8% 99.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) 3/10 (30%) 1/10 (10%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.229 P=0.500 P=0.500 P=0.500 P=0.111 P=0.500 | |POLY 3 | P=0.177 P=0.159 P=0.159 P=0.159 P=0.025 * P=0.159 | |POLY 1.5 | P=0.179 P=0.167 P=0.167 P=0.167 P=0.026 * P=0.167 | |POLY 6 | P=0.177 P=0.159 P=0.159 P=0.159 P=0.025 * P=0.159 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.227 P=0.500 P=0.500 P=0.500 P=0.105 P=0.500 | |ORDER RESTRICTED | P=0.222 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) 8/10 (80%) 9/10 (90%) | |POLY-3 RATE (b) | 0/0.01 0/0.01 9/9.00 10/10.00 8/8.00 9/9.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) 8/10 (80%) 9/10 (90%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 92 (I) 92 (I) 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) P<0.001 ** (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Toxic Hepatopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 4/10 (40%) 8/10 (80%) | |POLY-3 RATE (b) | 0/0.01 0/0.01 0/0.01 1/1.01 4/4.01 8/8.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 99.3% 99.9% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 4/10 (40%) 8/10 (80%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 92 (I) 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.500 P=0.051 P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.159 P=0.007 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.167 P=0.008 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.159 P=0.007 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P=0.043 * P<0.001 ** | |ORDER RESTRICTED | P=0.014 * (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 3/10 (30%) 3/10 (30%) 8/10 (80%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 0/0.01 3/3.01 3/3.01 8/8.00 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 99.8% 99.8% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 3/10 (30%) 3/10 (30%) 8/10 (80%) 10/10 (100%) 10/10 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.111 P=0.111 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.025 * P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.026 * P=0.026 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.025 * P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.105 P=0.105 P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Multinucleated | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) | |POLY-3 RATE (b) | 0/0.01 0/0.01 0/0.01 0/0.01 9/9.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 2/10 (20%) | |POLY-3 RATE (b) | 2/2.01 0/0.01 0/0.01 0/0.01 3/3.01 2/2.01 | |POLY-3 PERCENT (g) | 99.7% 0.0% 0.0% 0.0% 99.8% 99.7% | |INT SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 2/10 (20%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 92 (I) --- --- --- 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.064 P=0.234N P=0.234N P=0.234N P=0.500 P=0.707 | |POLY 3 | P=0.042 * P=0.067N P=0.067N P=0.067N P=0.354 P=0.544 | |POLY 1.5 | P=0.041 * P=0.070N P=0.070N P=0.070N P=0.357 P=0.548 | |POLY 6 | P=0.042 * P=0.067N P=0.067N P=0.067N P=0.355 P=0.545 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.062 P=0.237N P=0.237N P=0.237N P=0.500 P=0.709N | |ORDER RESTRICTED | P=0.006 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/10 (10%) 6/10 (60%) 7/10 (70%) 4/10 (40%) 3/10 (30%) 4/10 (40%) | |POLY-3 RATE (b) | 1/1.01 6/6.00 7/7.00 4/4.01 3/3.01 4/4.01 | |POLY-3 PERCENT (g) | 99.3% 100.0% 100.0% 99.9% 99.8% 99.9% | |INT SACRIFICE 1 (c)| 1/10 (10%) 6/10 (60%) 7/10 (70%) 4/10 (40%) 3/10 (30%) 4/10 (40%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.364N P=0.034 * P=0.013 * P=0.157 P=0.293 P=0.157 | |POLY 3 | P=0.327N P=0.005 ** P<0.001 ** P=0.066 P=0.152 P=0.066 | |POLY 1.5 | P=0.330N P=0.006 ** P<0.001 ** P=0.068 P=0.156 P=0.068 | |POLY 6 | P=0.323N P=0.005 ** P<0.001 ** P=0.067 P=0.153 P=0.067 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.363N P=0.029 * P=0.010 * P=0.152 P=0.291 P=0.152 | |ORDER RESTRICTED | P=0.023 * (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/10 (10%) 6/10 (60%) 7/10 (70%) 4/10 (40%) 3/10 (30%) 6/10 (60%) | |POLY-3 RATE (b) | 1/1.01 6/6.00 7/7.00 4/4.01 3/3.01 6/6.00 | |POLY-3 PERCENT (g) | 99.3% 100.0% 100.0% 99.9% 99.8% 100.0% | |INT SACRIFICE 1 (c)| 1/10 (10%) 6/10 (60%) 7/10 (70%) 4/10 (40%) 3/10 (30%) 6/10 (60%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.369 P=0.034 * P=0.013 * P=0.157 P=0.293 P=0.034 * | |POLY 3 | P=0.357 P=0.005 ** P<0.001 ** P=0.066 P=0.152 P=0.005 ** | |POLY 1.5 | P=0.354 P=0.006 ** P<0.001 ** P=0.068 P=0.156 P=0.006 ** | |POLY 6 | P=0.362 P=0.005 ** P<0.001 ** P=0.067 P=0.153 P=0.005 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.368 P=0.029 * P=0.010 * P=0.152 P=0.291 P=0.029 * | |ORDER RESTRICTED | P=0.010 * (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) 2/10 (20%) | |POLY-3 RATE (b) | 0/0.01 0/0.01 1/1.01 0/0.01 1/1.01 2/2.01 | |POLY-3 PERCENT (g) | 0.0% 0.0% 99.3% 0.0% 99.3% 99.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) 2/10 (20%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 92 (I) --- 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.046 * (e) P=0.500 (e) P=0.500 P=0.234 | |POLY 3 | P=0.028 * (e) P=0.159 (e) P=0.159 P=0.067 | |POLY 1.5 | P=0.028 * (e) P=0.167 (e) P=0.167 P=0.070 | |POLY 6 | P=0.028 * (e) P=0.159 (e) P=0.159 P=0.067 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.045 * (e) P=0.500 (e) P=0.500 P=0.237 | |ORDER RESTRICTED | P=0.359 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |POLY-3 RATE (b) | 10/10.00 0/0.00 0/0.00 0/0.00 0/0.00 10/10.00 | |POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% 100.0% | |INT SACRIFICE 1 (c)| 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 92 (I) --- --- --- --- 92 (I) | |-------------------| | |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: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 3/10 (30%) 1/10 (10%) 3/10 (30%) 7/10 (70%) 9/10 (90%) | |POLY-3 RATE (b) | 0/0.01 3/3.01 1/1.01 3/3.01 7/7.00 9/9.00 | |POLY-3 PERCENT (g) | 0.0% 99.8% 99.3% 99.8% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 3/10 (30%) 1/10 (10%) 3/10 (30%) 7/10 (70%) 9/10 (90%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.111 P=0.500 P=0.111 P=0.003 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.025 * P=0.159 P=0.025 * P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.026 * P=0.167 P=0.026 * P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.025 * P=0.159 P=0.025 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.105 P=0.500 P=0.105 P=0.002 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/10 (10%) 1/10 (10%) 5/10 (50%) 6/10 (60%) 8/10 (80%) 7/10 (70%) | |POLY-3 RATE (b) | 1/1.01 1/1.01 5/5.00 6/6.00 8/8.00 7/7.00 | |POLY-3 PERCENT (g) | 99.3% 99.3% 99.9% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 5/10 (50%) 6/10 (60%) 8/10 (80%) 7/10 (70%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.766 P=0.077 P=0.034 * P=0.004 ** P=0.013 * | |POLY 3 | P<0.001 ** P=0.529 P=0.023 * P=0.005 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.536 P=0.024 * P=0.006 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.530N P=0.023 * P=0.005 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.763N P=0.070 P=0.029 * P=0.003 ** P=0.010 * | |ORDER RESTRICTED | P=0.003 ** (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).