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: 10:29:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX ------------------------------------------------------------------------------------------------------------------------------------ 31 WEEK SSAC FINAL #1; REVISION #1 REASONS FOR REMOVAL: 25017 Scheduled Sacrifice REMOVAL DATE RANGE: 051600 051700 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: 10:29:35 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 ----- ---------- Adrenal Cortex Angiectasis Atrophy Hypertrophy Liver Eosinophilic Focus Fatty Change Diffuse Hyperplasia Mixed Cell Focus Pigmentation Toxic Hepatopathy Liver: Bile Duct Hyperplasia Liver: Centrilobular Fibrosis Liver: Hepatocyte Hypertrophy Multinucleated Liver: Oval Cell Hyperplasia Liver: Portal Fibrosis Lung Inflammation Granulomatous Lung: Alveolar Epithelium Metaplasia Bronchiolar Ovary Atrophy Pancreas Inflammation Chronic Pancreas: Acinus Atrophy Vacuolization Cytoplasmic Thymus Atrophy Thyroid Gland: Follicular Cell Hypertrophy Uterus Metaplasia Uterus: Endometrium Hyperplasia Cystic =============================================================== 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 | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 6/10 (60%) 2/10 (20%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | |POLY-3 RATE (b) | 0/0.10 6/6.04 2/2.08 0/0.10 1/1.09 1/1.09 | |POLY-3 PERCENT (g) | 0.0% 99.3% 96.1% 0.0% 91.7% 91.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 6/10 (60%) 2/10 (20%) 0/10 (0%) 1/10 (10%) 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 | --- 216 (I) 216 (I) --- 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.154N P=0.009 ** P=0.234 (e) P=0.500 P=0.500 | |POLY 3 | P=0.087N P<0.001 ** P=0.068 (e) P=0.161 P=0.161 | |POLY 1.5 | P=0.090N P<0.001 ** P=0.079 (e) P=0.190 P=0.190 | |POLY 6 | P=0.085N P<0.001 ** P=0.067 (e) P=0.159 P=0.159 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.152N P=0.005 ** P=0.237 (e) P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.083 (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 | |=================================================================================================================================| | | |Adrenal Cortex | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 8/10 (80%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 0/0.10 2/2.08 8/8.02 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 96.1% 99.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 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 | --- --- --- --- 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.234 P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.068 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.079 P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.067 P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.237 P<0.001 ** | |ORDER RESTRICTED | P=0.014 * (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 | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/10 (50%) 4/10 (40%) 3/10 (30%) 3/10 (30%) 3/10 (30%) 1/10 (10%) | |POLY-3 RATE (b) | 5/5.05 4/4.06 3/3.07 3/3.07 3/3.07 1/1.09 | |POLY-3 PERCENT (g) | 99.0% 98.5% 97.7% 97.7% 97.7% 91.7% | |INT SACRIFICE 1 (c)| 5/10 (50%) 4/10 (40%) 3/10 (30%) 3/10 (30%) 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 | 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.059N P=0.500N P=0.328N P=0.328N P=0.328N P=0.077N | |POLY 3 | P=0.049N* P=0.407N P=0.235N P=0.235N P=0.235N P=0.023N* | |POLY 1.5 | P=0.050N P=0.415N P=0.244N P=0.244N P=0.244N P=0.026N* | |POLY 6 | P=0.049N* P=0.407N P=0.234N P=0.234N P=0.234N P=0.023N* | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.057N P=0.500N P=0.325N P=0.325N P=0.325N P=0.070N | |ORDER RESTRICTED | P=0.074N (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 | | Cholangiofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 2/10 (20%) 1/10 (10%) | |POLY-3 RATE (b) | 1/1.09 0/0.10 0/0.10 2/2.08 2/2.08 1/1.09 | |POLY-3 PERCENT (g) | 91.7% 0.0% 0.0% 96.1% 96.1% 91.7% | |INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 2/10 (20%) 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 | 216 (I) --- --- 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.274 P=0.500N P=0.500N P=0.500 P=0.500 P=0.766 | |POLY 3 | P=0.218 P=0.161N P=0.161N P=0.301 P=0.301 P=0.531 | |POLY 1.5 | P=0.223 P=0.190N P=0.190N P=0.320 P=0.320 P=0.554 | |POLY 6 | P=0.218 P=0.159N P=0.159N P=0.299 P=0.299 P=0.529 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.272 P=0.500N P=0.500N P=0.500 P=0.500 P=0.763N | |ORDER RESTRICTED | P=0.098 (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 | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 7/10 (70%) 5/10 (50%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 0/0.10 7/7.03 5/5.05 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 99.6% 99.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 7/10 (70%) 5/10 (50%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.003 ** P=0.022 * | |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=0.002 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.002 ** P=0.016 * | |ORDER RESTRICTED | P=0.016 * (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%) 3/10 (30%) 8/10 (80%) 9/10 (90%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 3/3.07 8/8.02 9/9.01 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 97.7% 99.8% 99.9% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 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 | --- --- --- 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.111 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.025 * P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.030 * P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.025 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.105 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 | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 4/10 (40%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 0/0.10 1/1.09 4/4.06 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 91.7% 98.5% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 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 | --- --- --- --- 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.500 P=0.051 | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.161 P=0.007 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.190 P=0.009 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.159 P=0.007 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.500 P=0.043 * | |ORDER RESTRICTED | P=0.211 (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 | | 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 | 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) 216 (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 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 | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/10 (50%) 8/10 (80%) 2/10 (20%) 6/10 (60%) 0/10 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 5/5.05 8/8.02 2/2.08 6/6.04 0/0.10 0/0.10 | |POLY-3 PERCENT (g) | 99.0% 99.8% 96.1% 99.3% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 5/10 (50%) 8/10 (80%) 2/10 (20%) 6/10 (60%) 0/10 (0%) 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 | 216 (I) 216 (I) 216 (I) 216 (I) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.180 P=0.180N P=0.500 P=0.022N* P=0.022N* | |POLY 3 | P<0.001N** P=0.130 P=0.099N P=0.424 P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.134 P=0.106N P=0.431 P=0.002N** P=0.002N** | |POLY 6 | P<0.001N** P=0.130 P=0.099N P=0.425 P<0.001N** P<0.001N** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001N** P=0.175 P=0.175N P=0.500 P=0.016N* P=0.016N* | |ORDER RESTRICTED | P=0.003N** (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 | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/10 (10%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 2/10 (20%) 0/10 (0%) | |POLY-3 RATE (b) | 1/1.09 1/1.09 1/1.09 0/0.10 2/2.08 0/0.10 | |POLY-3 PERCENT (g) | 91.7% 91.7% 91.7% 0.0% 96.1% 0.0% | |INT SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 1/10 (10%) 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 | 216 (I) 216 (I) 216 (I) --- 216 (I) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.457N P=0.766 P=0.766 P=0.500N P=0.500 P=0.500N | |POLY 3 | P=0.375N P=0.531 P=0.531 P=0.161N P=0.301 P=0.161N | |POLY 1.5 | P=0.383N P=0.554 P=0.554 P=0.190N P=0.320 P=0.190N | |POLY 6 | P=0.374N P=0.529 P=0.529 P=0.159N P=0.299 P=0.159N | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.456N P=0.763N P=0.763N P=0.500N P=0.500 P=0.500N | |ORDER RESTRICTED | P=0.308N (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 | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/10 (20%) 4/10 (40%) 9/10 (90%) 10/10 (100%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 2/2.08 4/4.06 9/9.01 10/10.00 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 96.1% 98.5% 99.9% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 2/10 (20%) 4/10 (40%) 9/10 (90%) 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 | 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.317 P=0.004 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.204 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.214 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.203 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.314 P=0.003 ** P<0.001 ** 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 | |=================================================================================================================================| | | |Liver | | Toxic Hepatopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 3/3.07 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 97.7% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 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 | --- --- --- 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.111 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.025 * P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.030 * P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.025 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.105 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 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 | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 1/1.09 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 91.7% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 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 | --- --- --- 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.161 P<0.001 ** P<0.001N** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.190 P<0.001 ** P<0.001N** | |POLY 6 | P<0.001 ** (e) (e) P=0.159 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 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 | |=================================================================================================================================| | | |Liver: Centrilobular | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 3/3.07 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 97.7% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 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 | --- --- --- 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.111 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.025 * P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.030 * P<0.001N** P<0.001N** | |POLY 6 | P<0.001 ** (e) (e) P=0.025 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.105 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 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 | |=================================================================================================================================| | | |Liver: Hepatocyte | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 2/10 (20%) 4/10 (40%) 8/10 (80%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 0/0.10 2/2.08 4/4.06 8/8.02 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 96.1% 98.5% 99.8% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 4/10 (40%) 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 | --- 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.234 P=0.051 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.068 P=0.007 ** P<0.001 ** P<0.001 ** P<0.001N** | |POLY 1.5 | P<0.001 ** P=0.079 P=0.009 ** P<0.001 ** P<0.001 ** P<0.001N** | |POLY 6 | P<0.001 ** P=0.067 P=0.007 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.237 P=0.043 * P<0.001 ** 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 | |=================================================================================================================================| | | |Liver: Hepatocyte | | Multinucleated | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 3/3.07 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 97.7% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 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 | --- --- --- 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.111 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.025 * P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.030 * P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.025 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.105 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 9 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: Oval Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) 10/10 (100%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 0/0.10 8/8.02 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 99.8% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) 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 | --- --- --- --- 216 (I) 216 (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<0.001N** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001N** | |POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | 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: Portal | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 4/10 (40%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 0/0.10 1/1.09 4/4.06 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 91.7% 98.5% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 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 | --- --- --- --- 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.500 P=0.051 | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.161 P=0.007 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.190 P=0.009 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.159 P=0.007 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.500 P=0.043 * | |ORDER RESTRICTED | P=0.211 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 10 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 | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) | |POLY-3 RATE (b) | 2/2.08 0/0.10 0/0.10 1/1.09 1/1.09 0/0.10 | |POLY-3 PERCENT (g) | 96.1% 0.0% 0.0% 91.7% 91.7% 0.0% | |INT SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 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 | 216 (I) --- --- 216 (I) 216 (I) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.362N P=0.234N P=0.234N P=0.500N P=0.500N P=0.234N | |POLY 3 | P=0.273N P=0.068N P=0.068N P=0.301N P=0.301N P=0.068N | |POLY 1.5 | P=0.281N P=0.079N P=0.079N P=0.320N P=0.320N P=0.079N | |POLY 6 | P=0.272N P=0.067N P=0.067N P=0.299N P=0.299N P=0.067N | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.361N P=0.237N P=0.237N P=0.500N P=0.500N P=0.237N | |ORDER RESTRICTED | P=0.321N (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 | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/10 (30%) 2/10 (20%) 4/10 (40%) 2/10 (20%) 5/10 (50%) 2/10 (20%) | |POLY-3 RATE (b) | 3/3.07 2/2.08 4/4.06 2/2.08 5/5.05 2/2.08 | |POLY-3 PERCENT (g) | 97.7% 96.1% 98.5% 96.1% 99.0% 96.1% | |INT SACRIFICE 1 (c)| 3/10 (30%) 2/10 (20%) 4/10 (40%) 2/10 (20%) 5/10 (50%) 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 | 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.548 P=0.500N P=0.500 P=0.500N P=0.328 P=0.500N | |POLY 3 | P=0.512 P=0.354N P=0.385 P=0.354N P=0.235 P=0.354N | |POLY 1.5 | P=0.516 P=0.368N P=0.396 P=0.368N P=0.244 P=0.368N | |POLY 6 | P=0.512 P=0.353N P=0.385 P=0.353N P=0.234 P=0.353N | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.549 P=0.500N P=0.500 P=0.500N P=0.325 P=0.500N | |ORDER RESTRICTED | P=0.482N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 11 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 | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 2/10 (20%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 1/1.09 2/2.08 2/2.08 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 91.7% 96.1% 96.1% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 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 | --- --- --- 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.020 * (e) (e) P=0.500 P=0.234 P=0.234 | |POLY 3 | P=0.011 * (e) (e) P=0.161 P=0.068 P=0.068 | |POLY 1.5 | P=0.012 * (e) (e) P=0.190 P=0.079 P=0.079 | |POLY 6 | P=0.011 * (e) (e) P=0.159 P=0.067 P=0.067 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.019 * (e) (e) P=0.500 P=0.237 P=0.237 | |ORDER RESTRICTED | P=0.274 (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: Alveolar Epithelium | | Metaplasia Bronchiolar | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 3/10 (30%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 0/0.10 3/3.07 3/3.07 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 97.7% 97.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 3/10 (30%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.111 P=0.111 | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.025 * P=0.025 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.030 * P=0.030 * | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.025 * P=0.025 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.105 P=0.105 | |ORDER RESTRICTED | P=0.197 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 12 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 | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 2/2.08 0/0.00 0/0.00 0/0.00 0/0.00 0/0.10 | |POLY-3 PERCENT (g) | 96.1% 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 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 | 216 (I) --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.123N P=1.000N P=1.000 P=1.000N P=1.000N P=0.234N | |POLY 3 | (e) (e) (e) (e) (e) P=0.068N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.079N | |POLY 6 | (e) (e) (e) (e) (e) P=0.067N | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.117N P=1.000 P=1.000 P=1.000 P=1.000 P=0.237N | |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 | |=================================================================================================================================| | | |Ovary | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/10 (60%) 7/10 (70%) 7/10 (70%) 4/10 (40%) 1/10 (10%) 0/10 (0%) | |POLY-3 RATE (b) | 6/6.04 7/7.03 7/7.03 4/4.06 1/1.09 0/0.10 | |POLY-3 PERCENT (g) | 99.3% 99.6% 99.6% 98.5% 91.7% 0.0% | |INT SACRIFICE 1 (c)| 6/10 (60%) 7/10 (70%) 7/10 (70%) 4/10 (40%) 1/10 (10%) 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 | 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.500 P=0.500 P=0.331N P=0.034N* P=0.009N** | |POLY 3 | P<0.001N** P=0.439 P=0.439 P=0.254N P=0.005N** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.444 P=0.444 P=0.262N P=0.006N** P<0.001N** | |POLY 6 | P<0.001N** P=0.440 P=0.440 P=0.254N P=0.005N** P<0.001N** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001N** P=0.500 P=0.500 P=0.328N P=0.029N* P=0.005N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 13 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 | |=================================================================================================================================| | | |Pancreas | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 0/0.10 0/0.10 2/2.08 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 96.1% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 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 | --- --- --- --- --- 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.012 * (e) (e) (e) (e) P=0.234 | |POLY 3 | P=0.003 ** (e) (e) (e) (e) P=0.068 | |POLY 1.5 | P=0.004 ** (e) (e) (e) (e) P=0.079 | |POLY 6 | P=0.003 ** (e) (e) (e) (e) P=0.067 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.237 | |ORDER RESTRICTED | P=0.408 (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 | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 0/0.10 1/1.09 2/2.08 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 91.7% 96.1% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 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 | --- --- --- --- 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.010 * (e) (e) (e) P=0.500 P=0.234 | |POLY 3 | P=0.004 ** (e) (e) (e) P=0.161 P=0.068 | |POLY 1.5 | P=0.004 ** (e) (e) (e) P=0.190 P=0.079 | |POLY 6 | P=0.004 ** (e) (e) (e) P=0.159 P=0.067 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.009 ** (e) (e) (e) P=0.500 P=0.237 | |ORDER RESTRICTED | P=0.362 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 14 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 | |=================================================================================================================================| | | |Pancreas: Acinus | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 1/1.09 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 91.7% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 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 | --- --- --- 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.161 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.190 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.159 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 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 | |=================================================================================================================================| | | |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 | 216 (I) --- --- --- --- 216 (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 15 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) | 3/10 (30%) 2/10 (20%) 5/10 (50%) 9/9 (100%) 9/10 (90%) 6/6 (100%) | |POLY-3 RATE (b) | 3/3.07 2/2.08 5/5.05 9/9.00 9/9.01 6/6.00 | |POLY-3 PERCENT (g) | 97.7% 96.1% 99.0% 100.0% 99.9% 100.0% | |INT SACRIFICE 1 (c)| 3/10 (30%) 2/10 (20%) 5/10 (50%) 9/9 (100%) 9/10 (90%) 6/6 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.500N P=0.328 P=0.005 ** P=0.013 * P=0.016 * | |POLY 3 | P<0.001 ** P=0.354N P=0.235 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.368N P=0.244 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.353N P=0.234 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.325 P=0.002 ** P=0.010 * P=0.010 * | |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) | 3/10 (30%) 3/10 (30%) 7/10 (70%) 7/10 (70%) 9/10 (90%) 7/10 (70%) | |POLY-3 RATE (b) | 3/3.07 3/3.07 7/7.03 7/7.03 9/9.01 7/7.03 | |POLY-3 PERCENT (g) | 97.7% 97.7% 99.6% 99.6% 99.9% 99.6% | |INT SACRIFICE 1 (c)| 3/10 (30%) 3/10 (30%) 7/10 (70%) 7/10 (70%) 9/10 (90%) 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 | 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.024 * P=0.683 P=0.095 P=0.095 P=0.013 * P=0.095 | |POLY 3 | P=0.015 * P=0.557 P=0.047 * P=0.047 * P<0.001 ** P=0.047 * | |POLY 1.5 | P=0.015 * P=0.569 P=0.050 P=0.050 P<0.001 ** P=0.050 | |POLY 6 | P=0.015 * P=0.557 P=0.047 * P=0.047 * P<0.001 ** P=0.047 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.023 * P=0.686N P=0.089 P=0.089 P=0.010 * P=0.089 | |ORDER RESTRICTED | P=0.011 * (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 16 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 | |=================================================================================================================================| | | |Uterus | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/10 (50%) 6/10 (60%) 6/10 (60%) 4/10 (40%) 1/10 (10%) 0/10 (0%) | |POLY-3 RATE (b) | 5/5.05 6/6.04 6/6.04 4/4.06 1/1.09 0/0.10 | |POLY-3 PERCENT (g) | 99.0% 99.3% 99.3% 98.5% 91.7% 0.0% | |INT SACRIFICE 1 (c)| 5/10 (50%) 6/10 (60%) 6/10 (60%) 4/10 (40%) 1/10 (10%) 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 | 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.500 P=0.500 P=0.500N P=0.077N P=0.022N* | |POLY 3 | P<0.001N** P=0.424 P=0.424 P=0.407N P=0.023N* P<0.001N** | |POLY 1.5 | P<0.001N** P=0.431 P=0.431 P=0.415N P=0.026N* P=0.002N** | |POLY 6 | P<0.001N** P=0.425 P=0.425 P=0.407N P=0.023N* P<0.001N** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001N** P=0.500 P=0.500 P=0.500N P=0.070N P=0.016N* | |ORDER RESTRICTED | P=0.006N** (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 | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/10 (50%) 5/10 (50%) 6/10 (60%) 3/10 (30%) 1/10 (10%) 1/10 (10%) | |POLY-3 RATE (b) | 5/5.05 5/5.05 6/6.04 3/3.07 1/1.09 1/1.09 | |POLY-3 PERCENT (g) | 99.0% 99.0% 99.3% 97.7% 91.7% 91.7% | |INT SACRIFICE 1 (c)| 5/10 (50%) 5/10 (50%) 6/10 (60%) 3/10 (30%) 1/10 (10%) 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 | 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) 216 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003N** P=0.669 P=0.500 P=0.328N P=0.077N P=0.077N | |POLY 3 | P<0.001N** P=0.586 P=0.424 P=0.235N P=0.023N* P=0.023N* | |POLY 1.5 | P<0.001N** P=0.593 P=0.431 P=0.244N P=0.026N* P=0.026N* | |POLY 6 | P<0.001N** P=0.586 P=0.425 P=0.234N P=0.023N* P=0.023N* | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.003N** P=0.672N P=0.500 P=0.325N P=0.070N P=0.070N | |ORDER RESTRICTED | P=0.038N* (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).