TDMS Study 96020-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04 EXPERIMENT: 96020 TEST: 01 TIME: 14:09:40 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020 PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX ------------------------------------------------------------------------------------------------------------------------------------ 53 WEEK SSAC FINAL #1 REASONS FOR REMOVAL: 25017 Scheduled Sacrifice REMOVAL DATE RANGE: 091699 091799 TREATMENT GROUPS: INCLUDE 001 0 NG / 0 UG INCLUDE 004 300 NG /100 UG INCLUDE 005 300 NG /300 UG INCLUDE 006 300 NG /3000 UG NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04 EXPERIMENT: 96020 TEST: 01 TIME: 14:09:40 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020 PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF TEF EVALUATION (BINARY MIXTURE; PCB 126 =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Liver Fatty Change Diffuse Pigmentation Toxic Hepatopathy Liver: Bile Duct Hyperplasia Liver: Hepatocyte Hypertrophy Multinucleated Lung Infiltration Cellular Histiocyte Lung: Alveolar Epithelium Metaplasia Bronchiolar Mammary Gland Hyperplasia Pancreas: Acinus Vacuolization Cytoplasmic Thymus Atrophy Thyroid Gland: C-Cell Hyperplasia Thyroid Gland: Follicular Cell Hypertrophy Uterus Inflammation Uterus: Endometrium Hyperplasia Cystic =============================================================== Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/8 (25%) 1/10 (10%) 1/8 (13%) 1/9 (11%) | |POLY-3 RATE (b) | 2/2.30 1/1.44 1/1.34 1/1.39 | |POLY-3 PERCENT (g) | 87.1% 69.3% 74.4% 71.8% | |INT SACRIFICE 1 (c)| 2/8 (25%) 1/10 (10%) 1/8 (12.5%) 1/9 (11.1%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.561N P=0.418N P=0.500N P=0.457N | |POLY 3 | P=0.394N P=0.240N P=0.314N P=0.274N | |POLY 1.5 | P=0.424N P=0.273N P=0.348N P=0.308N | |POLY 6 | P=0.386N P=0.231N P=0.304N P=0.264N | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.562N P=0.412N P=0.500N P=0.453N | |ORDER RESTRICTED | P=0.413N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/8 (13%) 3/10 (30%) 1/8 (13%) 1/9 (11%) | |POLY-3 RATE (b) | 1/1.34 3/3.34 1/1.34 1/1.39 | |POLY-3 PERCENT (g) | 74.4% 89.7% 74.4% 71.8% | |INT SACRIFICE 1 (c)| 1/8 (12.5%) 3/10 (30%) 1/8 (12.5%) 1/9 (11.1%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.463N P=0.379 P=0.768 P=0.741N | |POLY 3 | P=0.315N P=0.228 P=0.548 P=0.513N | |POLY 1.5 | P=0.341N P=0.255 P=0.590 P=0.556N | |POLY 6 | P=0.308N P=0.220 P=0.536 P=0.501N | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.463N P=0.382 P=0.767N P=0.735N | |ORDER RESTRICTED | P=0.491N (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/8 (50%) 5/10 (50%) 5/8 (63%) 3/9 (33%) | |POLY-3 RATE (b) | 4/4.20 5/5.25 5/5.15 3/3.30 | |POLY-3 PERCENT (g) | 95.3% 95.3% 97.1% 91.1% | |INT SACRIFICE 1 (c)| 4/8 (50%) 5/10 (50%) 5/8 (62.5%) 3/9 (33.3%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.261N P=0.678 P=0.500 P=0.422N | |POLY 3 | P=0.201N P=0.593 P=0.420 P=0.321N | |POLY 1.5 | P=0.213N P=0.608N P=0.435 P=0.340N | |POLY 6 | P=0.198N P=0.590N P=0.417 P=0.317N | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.258N P=0.681N P=0.500 P=0.419N | |ORDER RESTRICTED | P=0.306N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 2/10 (20%) 1/8 (13%) 1/9 (11%) | |POLY-3 RATE (b) | 0/0.39 2/2.39 1/1.34 1/1.39 | |POLY-3 PERCENT (g) | 0.0% 83.6% 74.4% 71.8% | |INT SACRIFICE 1 (c)| 0/8 (0%) 2/10 (20%) 1/8 (12.5%) 1/9 (11.1%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.709 P=0.284 P=0.500 P=0.523 | |POLY 3 | P=0.531 P=0.098 P=0.173 P=0.189 | |POLY 1.5 | P=0.564 P=0.127 P=0.228 P=0.245 | |POLY 6 | P=0.522 P=0.092 P=0.159 P=0.174 | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.712 P=0.294 P=0.500 P=0.529 | |ORDER RESTRICTED | P=0.260 (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Fatty Change Diffuse | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 1/10 (10%) 3/8 (38%) 9/9 (100%) | |POLY-3 RATE (b) | 0/0.39 1/1.44 3/3.25 9/9.00 | |POLY-3 PERCENT (g) | 0.0% 69.3% 92.4% 100.0% | |INT SACRIFICE 1 (c)| 0/8 (0%) 1/10 (10%) 3/8 (37.5%) 9/9 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.545 P=0.107 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.203 P=0.022 * P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.260 P=0.031 * P<0.001 ** | |POLY 6 | P<0.001 ** P=0.188 P=0.020 * P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.556 P=0.100 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/8 (100%) 10/10 (100%) 8/8 (100%) 9/9 (100%) | |POLY-3 RATE (b) | 8/8.00 10/10.00 8/8.00 9/9.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 8/8 (100%) 10/10 (100%) 8/8 (100%) 9/9 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/8 (63%) 9/10 (90%) 2/8 (25%) 6/9 (67%) | |POLY-3 RATE (b) | 5/5.15 9/9.05 2/2.30 6/6.15 | |POLY-3 PERCENT (g) | 97.1% 99.5% 87.1% 97.6% | |INT SACRIFICE 1 (c)| 5/8 (62.5%) 9/10 (90%) 2/8 (25%) 6/9 (66.7%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.604 P=0.212 P=0.165N P=0.625 | |POLY 3 | P=0.552 P=0.164 P=0.089N P=0.560 | |POLY 1.5 | P=0.563 P=0.172 P=0.101N P=0.571 | |POLY 6 | P=0.551 P=0.162 P=0.085N P=0.557 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.629 | |COCH-ARM / FISHERS | P=0.605 P=0.206 P=0.157N P=0.627 | |ORDER RESTRICTED | P=0.103N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 10/10 (100%) 8/8 (100%) 9/9 (100%) | |POLY-3 RATE (b) | 0/0.39 10/10.00 8/8.00 9/9.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/8 (0%) 10/10 (100%) 8/8 (100%) 9/9 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.039 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P=0.037N* P<0.001 ** P<0.001 ** P<0.001N** | |POLY 1.5 | P=0.037N* P<0.001 ** P<0.001 ** P<0.001N** | |POLY 6 | P=0.037N* P<0.001 ** P<0.001 ** P<0.001N** | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.037 * P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Toxic Hepatopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 3/10 (30%) 0/8 (0%) 6/9 (67%) | |POLY-3 RATE (b) | 0/0.39 3/3.34 0/0.39 6/6.15 | |POLY-3 PERCENT (g) | 0.0% 89.7% 0.0% 97.6% | |INT SACRIFICE 1 (c)| 0/8 (0%) 3/10 (30%) 0/8 (0%) 6/9 (66.7%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 366 (I) --- 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** P=0.151 (e) P=0.011 * | |POLY 3 | P<0.001 ** P=0.044 * (e) P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.058 (e) P<0.001 ** | |POLY 6 | P<0.001 ** P=0.041 * (e) P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.002 ** P=0.147 (e) P=0.007 ** | |ORDER RESTRICTED | P=0.027 * (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 2/10 (20%) 0/8 (0%) 5/9 (56%) | |POLY-3 RATE (b) | 0/0.39 2/2.39 0/0.39 5/5.20 | |POLY-3 PERCENT (g) | 0.0% 83.6% 0.0% 96.2% | |INT SACRIFICE 1 (c)| 0/8 (0%) 2/10 (20%) 0/8 (0%) 5/9 (55.6%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 366 (I) --- 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.005 ** P=0.284 (e) P=0.028 * | |POLY 3 | P<0.001 ** P=0.098 (e) P=0.002 ** | |POLY 1.5 | P<0.001 ** P=0.127 (e) P=0.003 ** | |POLY 6 | P<0.001 ** P=0.092 (e) P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.005 ** P=0.294 (e) P=0.020 * | |ORDER RESTRICTED | P=0.061 (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 10/10 (100%) 8/8 (100%) 9/9 (100%) | |POLY-3 RATE (b) | 0/0.39 10/10.00 8/8.00 9/9.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/8 (0%) 10/10 (100%) 8/8 (100%) 9/9 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.039 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P=0.037N* P<0.001N** P<0.001N** P<0.001N** | |POLY 1.5 | P=0.037N* P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P=0.037N* P<0.001N** P<0.001N** P<0.001N** | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.037 * P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Multinucleated | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 3/10 (30%) 2/8 (25%) 7/9 (78%) | |POLY-3 RATE (b) | 0/0.39 3/3.34 2/2.30 7/7.10 | |POLY-3 PERCENT (g) | 0.0% 89.7% 87.1% 98.6% | |INT SACRIFICE 1 (c)| 0/8 (0%) 3/10 (30%) 2/8 (25%) 7/9 (77.8%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** P=0.151 P=0.232 P=0.004 ** | |POLY 3 | P<0.001 ** P=0.044 * P=0.069 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.058 P=0.093 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.041 * P=0.064 P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.002 ** P=0.147 P=0.233 P=0.002 ** | |ORDER RESTRICTED | P=0.011 * (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver: Oval Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 1/10 (10%) 0/8 (0%) 2/9 (22%) | |POLY-3 RATE (b) | 0/0.39 1/1.44 0/0.39 2/2.34 | |POLY-3 PERCENT (g) | 0.0% 69.3% 0.0% 85.3% | |INT SACRIFICE 1 (c)| 0/8 (0%) 1/10 (10%) 0/8 (0%) 2/9 (22.2%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 366 (I) --- 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.155 P=0.545 (e) P=0.259 | |POLY 3 | P=0.056 P=0.203 (e) P=0.084 | |POLY 1.5 | P=0.072 P=0.260 (e) P=0.111 | |POLY 6 | P=0.054 P=0.188 (e) P=0.078 | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.152 P=0.556 (e) P=0.265 | |ORDER RESTRICTED | P=0.230 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/8 (50%) 0/10 (0%) 2/8 (25%) 4/9 (44%) | |POLY-3 RATE (b) | 4/4.20 0/0.49 2/2.30 4/4.25 | |POLY-3 PERCENT (g) | 95.3% 0.0% 87.1% 94.2% | |INT SACRIFICE 1 (c)| 4/8 (50%) 0/10 (0%) 2/8 (25%) 4/9 (44.4%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) --- 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.226 P=0.028N* P=0.309N P=0.599N | |POLY 3 | P=0.147 P=0.002N** P=0.204N P=0.506N | |POLY 1.5 | P=0.158 P=0.003N** P=0.224N P=0.522N | |POLY 6 | P=0.145 P<0.001N** P=0.199N P=0.502N | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.223 P=0.023N* P=0.304N P=0.601N | |ORDER RESTRICTED | P=0.095N (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Metaplasia Bronchiolar | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 3/10 (30%) 1/8 (13%) 0/9 (0%) | |POLY-3 RATE (b) | 0/0.39 3/3.34 1/1.34 0/0.44 | |POLY-3 PERCENT (g) | 0.0% 89.7% 74.4% 0.0% | |INT SACRIFICE 1 (c)| 0/8 (0%) 3/10 (30%) 1/8 (12.5%) 0/9 (0%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 366 (I) 366 (I) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.263N P=0.151 P=0.500 (e) | |POLY 3 | P=0.111N P=0.044 * P=0.173 (e) | |POLY 1.5 | P=0.133N P=0.058 P=0.228 (e) | |POLY 6 | P=0.107N P=0.041 * P=0.159 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.260N P=0.147 P=0.500 (e) | |ORDER RESTRICTED | P=0.322N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Mammary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/8 (13%) 0/2 (0%) 2/5 (40%) 0/9 (0%) | |POLY-3 RATE (b) | 1/1.34 0/0.10 2/2.15 0/0.44 | |POLY-3 PERCENT (g) | 74.4% 0.0% 93.1% 0.0% | |INT SACRIFICE 1 (c)| 1/8 (12.5%) 0/2 (0%) 2/5 (40%) 0/9 (0%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) --- 366 (I) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.240N P=0.773N P=0.326 P=0.477N | |POLY 3 | P=0.093N P=0.339N P=0.167 P=0.158N | |POLY 1.5 | P=0.117N P=0.421N P=0.198 P=0.210N | |POLY 6 | P=0.089N P=0.317N P=0.158 P=0.144N | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.235N P=0.800N P=0.315 P=0.471N | |ORDER RESTRICTED | P=0.101N (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/8 (50%) 0/2 (0%) 1/5 (20%) 0/9 (0%) | |POLY-3 RATE (b) | 4/4.20 0/0.10 1/1.20 0/0.44 | |POLY-3 PERCENT (g) | 95.3% 0.0% 83.6% 0.0% | |INT SACRIFICE 1 (c)| 4/8 (50%) 0/2 (0%) 1/5 (20%) 0/9 (0%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) --- 366 (I) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.064N P=0.323N P=0.317N P=0.036N* | |POLY 3 | P=0.014N* P=0.110N P=0.187N P=0.003N** | |POLY 1.5 | P=0.018N* P=0.140N P=0.211N P=0.004N** | |POLY 6 | P=0.014N* P=0.103N P=0.181N P=0.002N** | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.060N P=0.333N P=0.315N P=0.029N* | |ORDER RESTRICTED | P=0.013N* (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Ovary | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/8 (88%) 8/10 (80%) 7/8 (88%) 8/9 (89%) | |POLY-3 RATE (b) | 7/7.05 8/8.10 7/7.05 8/8.05 | |POLY-3 PERCENT (g) | 99.3% 98.8% 99.3% 99.4% | |INT SACRIFICE 1 (c)| 7/8 (87.5%) 8/10 (80%) 7/8 (87.5%) 8/9 (88.9%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.576 P=0.582N P=0.768 P=0.741 | |POLY 3 | P=0.554 P=0.545N P=0.735 P=0.709 | |POLY 1.5 | P=0.557 P=0.551N P=0.739 P=0.713 | |POLY 6 | P=0.554 P=0.545N P=0.735 P=0.709 | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.577 P=0.588N P=0.767N P=0.735 | |ORDER RESTRICTED | P=0.589 (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pancreas: Acinus | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 0/10 (0%) 0/8 (0%) 6/9 (67%) | |POLY-3 RATE (b) | 0/0.39 0/0.49 0/0.39 6/6.15 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 97.6% | |INT SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/8 (0%) 6/9 (66.7%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.011 * | |POLY 3 | P<0.001 ** (e) (e) P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.007 ** | |ORDER RESTRICTED | P=0.026 * (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/8 (100%) 0/0 (0%) 0/0 (0%) 9/9 (100%) | |POLY-3 RATE (b) | 8/8.00 0/0.00 0/0.00 9/9.00 | |POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 100.0% | |INT SACRIFICE 1 (c)| 8/8 (100%) 0/0 (0%) 0/0 (0%) 9/9 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) --- --- 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/8 (63%) 10/10 (100%) 8/8 (100%) 9/9 (100%) | |POLY-3 RATE (b) | 5/5.15 10/10.00 8/8.00 9/9.00 | |POLY-3 PERCENT (g) | 97.1% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 5/8 (62.5%) 10/10 (100%) 8/8 (100%) 9/9 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.276 P=0.074 P=0.107 P=0.089 | |POLY 3 | P=0.249 P=0.036 * P=0.062 P=0.047 * | |POLY 1.5 | P=0.248 P=0.039 * P=0.067 P=0.051 | |POLY 6 | P=0.252 P=0.036 * P=0.062 P=0.047 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.273 P=0.069 P=0.100 P=0.082 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/8 (25%) 0/10 (0%) 0/8 (0%) 1/9 (11%) | |POLY-3 RATE (b) | 2/2.30 0/0.49 0/0.39 1/1.39 | |POLY-3 PERCENT (g) | 87.1% 0.0% 0.0% 71.8% | |INT SACRIFICE 1 (c)| 2/8 (25%) 0/10 (0%) 0/8 (0%) 1/9 (11.1%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) --- --- 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.674 P=0.185N P=0.232N P=0.457N | |POLY 3 | P=0.461 P=0.047N* P=0.069N P=0.274N | |POLY 1.5 | P=0.500 P=0.066N P=0.093N P=0.308N | |POLY 6 | P=0.452 P=0.043N* P=0.064N P=0.264N | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.677 P=0.183N P=0.233N P=0.453N | |ORDER RESTRICTED | P=0.072N (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 7/10 (70%) 6/8 (75%) 6/9 (67%) | |POLY-3 RATE (b) | 0/0.39 7/7.15 6/6.10 6/6.15 | |POLY-3 PERCENT (g) | 0.0% 97.9% 98.4% 97.6% | |INT SACRIFICE 1 (c)| 0/8 (0%) 7/10 (70%) 6/8 (75%) 6/9 (66.7%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.241 P=0.007 ** P=0.006 ** P=0.011 * | |POLY 3 | P=0.170 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P=0.175 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P=0.171 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.238 P=0.004 ** P=0.003 ** P=0.007 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Uterus | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 0/10 (0%) 0/8 (0%) 6/9 (67%) | |POLY-3 RATE (b) | 0/0.39 0/0.49 0/0.39 6/6.15 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 97.6% | |INT SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/8 (0%) 6/9 (66.7%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.011 * | |POLY 3 | P<0.001 ** (e) (e) P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.007 ** | |ORDER RESTRICTED | P=0.026 * (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Uterus | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/8 (88%) 9/10 (90%) 7/8 (88%) 7/9 (78%) | |POLY-3 RATE (b) | 7/7.05 9/9.05 7/7.05 7/7.10 | |POLY-3 PERCENT (g) | 99.3% 99.5% 99.3% 98.6% | |INT SACRIFICE 1 (c)| 7/8 (87.5%) 9/10 (90%) 7/8 (87.5%) 7/9 (77.8%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.395N P=0.716 P=0.768 P=0.543N | |POLY 3 | P=0.363N P=0.685 P=0.735 P=0.504N | |POLY 1.5 | P=0.369N P=0.689 P=0.739 P=0.511N | |POLY 6 | P=0.362N P=0.685 P=0.735 P=0.503N | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.393N P=0.706 P=0.767N P=0.547N | |ORDER RESTRICTED | P=0.419N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 300 NG / 300 NG / 300 NG / | | | 0 UG 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/8 (63%) 0/10 (0%) 0/8 (0%) 2/9 (22%) | |POLY-3 RATE (b) | 5/5.15 0/0.49 0/0.39 2/2.34 | |POLY-3 PERCENT (g) | 97.1% 0.0% 0.0% 85.3% | |INT SACRIFICE 1 (c)| 5/8 (62.5%) 0/10 (0%) 0/8 (0%) 2/9 (22.2%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 366 (I) --- --- 366 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.663N P=0.010N* P=0.018N* P=0.124N | |POLY 3 | P=0.539N P<0.001N** P<0.001N** P=0.058N | |POLY 1.5 | P=0.566N P<0.001N** P<0.001N** P=0.068N | |POLY 6 | P=0.531N P<0.001N** P<0.001N** P=0.056N | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.665N P=0.007N** P=0.013N* P=0.117N | |ORDER RESTRICTED | P<0.001N** (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).