TDMS Study 96022-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 04/27/04 EXPERIMENT: 96022 TEST: 02 TIME: 13:18:05 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 REASONS FOR REMOVAL: 25017 Scheduled Sacrifice REMOVAL DATE RANGE: 051600 051700 TREATMENT GROUPS: INCLUDE 001 0 NG / 0 UG INCLUDE 002 80 NG /10 UG INCLUDE 003 240 NG /30 UG INCLUDE 004 800 NG /100 UG INCLUDE 005 2400 NG/300 UG INCLUDE 006 4000 NG/500 UG NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 04/27/04 EXPERIMENT: 96022 TEST: 02 TIME: 13:18:05 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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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: 04/27/04 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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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 / 80 NG / 240 NG / 800 NG / 2400 NG/ 4000 NG/ | | | 0 UG 10 UG 30 UG 100 UG 300 UG 500 UG | |=================================================================================================================================| | | |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).