TDMS Study 96022-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 06/10/04 EXPERIMENT: 96022 TEST: 02 TIME: 09:49:11 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX Rats(SD) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED. --------------- Adrenal Cortex Adrenal Medulla Brain Clitoral/Preputial Gland Heart Islets, Pancreatic Kidney Liver Lung Ovary Pancreas Pituitary Gland Thymus Thyroid Gland NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 06/10/04 EXPERIMENT: 96022 TEST: 02 TIME: 09:49:11 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF TEF EVALUATION (PCB MIXTURE;PCB 126/P =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Liver Cholangiocarcinoma Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Cystic Keratinizing Epithelioma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma Uterus Polyp Stromal All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 1 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Cholangiocarcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 19/50 (38%) 12/65 (18%) | |POLY-3 RATE (b) | 19/25.19 12/17.30 | |POLY-3 PERCENT (g) | 75.4% 69.4% | |TERMINAL (d) | 8/10 (80%) 0/0 (0%) | |FIRST INCIDENCE | 303 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.516N | |POLY 1.5 | P=0.091N | |POLY 6 | P=0.551 | |LOGISTIC REGRESSION| P=0.102 | |COCH-ARM / FISHERS | P=0.017N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 5/65 (8%) | |POLY-3 RATE (b) | 1/21.77 5/13.16 | |POLY-3 PERCENT (g) | 4.6% 38.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 451 245 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.025 * | |POLY 3 | P=0.038 * | |POLY 1.5 | P=0.072 | |POLY 6 | P=0.027 * | |LOGISTIC REGRESSION| P=0.156 | |COCH-ARM / FISHERS | P=0.176 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 2 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 5/65 (8%) | |POLY-3 RATE (b) | 1/21.77 5/13.16 | |POLY-3 PERCENT (g) | 4.6% 38.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 451 245 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.025 * | |POLY 3 | P=0.038 * | |POLY 1.5 | P=0.072 | |POLY 6 | P=0.027 * | |LOGISTIC REGRESSION| P=0.156 | |COCH-ARM / FISHERS | P=0.176 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 5/65 (8%) | |POLY-3 RATE (b) | 1/21.77 5/13.16 | |POLY-3 PERCENT (g) | 4.6% 38.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 451 245 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.025 * | |POLY 3 | P=0.038 * | |POLY 1.5 | P=0.072 | |POLY 6 | P=0.027 * | |LOGISTIC REGRESSION| P=0.156 | |COCH-ARM / FISHERS | P=0.176 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 3 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lung | | Cystic Keratinizing Epithelioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 12/50 (24%) 41/66 (62%) | |POLY-3 RATE (b) | 12/28.23 41/42.27 | |POLY-3 PERCENT (g) | 42.5% 97.0% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 240 260 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 12/50 (24%) 6/66 (9%) | |POLY-3 RATE (b) | 12/23.70 6/14.33 | |POLY-3 PERCENT (g) | 50.6% 41.9% | |TERMINAL (d) | 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 504 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.032 * | |POLY 3 | P=0.491N | |POLY 1.5 | P=0.124N | |POLY 6 | P=0.607 | |LOGISTIC REGRESSION| P=0.611N | |COCH-ARM / FISHERS | P=0.027N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 4 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 12/50 (24%) 6/66 (9%) | |POLY-3 RATE (b) | 12/23.70 6/14.33 | |POLY-3 PERCENT (g) | 50.6% 41.9% | |TERMINAL (d) | 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 504 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.032 * | |POLY 3 | P=0.491N | |POLY 1.5 | P=0.124N | |POLY 6 | P=0.607 | |LOGISTIC REGRESSION| P=0.611N | |COCH-ARM / FISHERS | P=0.027N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 13/50 (26%) 6/66 (9%) | |POLY-3 RATE (b) | 13/24.67 6/14.33 | |POLY-3 PERCENT (g) | 52.7% 41.9% | |TERMINAL (d) | 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 209 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.089 | |POLY 3 | P=0.445N | |POLY 1.5 | P=0.091N | |POLY 6 | P=0.652 | |LOGISTIC REGRESSION| P=0.364N | |COCH-ARM / FISHERS | P=0.015N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 5 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/49 (8%) 1/66 (2%) | |POLY-3 RATE (b) | 4/20.74 1/9.62 | |POLY-3 PERCENT (g) | 19.3% 10.4% | |TERMINAL (d) | 3/9 (33%) 0/0 (0%) | |FIRST INCIDENCE | 474 636 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.383 | |POLY 3 | P=0.640N | |POLY 1.5 | P=0.264N | |POLY 6 | P=0.978 | |LOGISTIC REGRESSION| P=0.658 | |COCH-ARM / FISHERS | P=0.104N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/49 (8%) 1/66 (2%) | |POLY-3 RATE (b) | 4/20.74 1/9.62 | |POLY-3 PERCENT (g) | 19.3% 10.4% | |TERMINAL (d) | 3/9 (33%) 0/0 (0%) | |FIRST INCIDENCE | 474 636 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.383 | |POLY 3 | P=0.640N | |POLY 1.5 | P=0.264N | |POLY 6 | P=0.978 | |LOGISTIC REGRESSION| P=0.658 | |COCH-ARM / FISHERS | P=0.104N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 6 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 8/50 (16%) 3/66 (5%) | |POLY-3 RATE (b) | 8/23.57 3/11.72 | |POLY-3 PERCENT (g) | 33.9% 25.6% | |TERMINAL (d) | 2/10 (20%) 0/0 (0%) | |FIRST INCIDENCE | 541 300 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.199 | |POLY 3 | P=0.571N | |POLY 1.5 | P=0.172N | |POLY 6 | P=0.775 | |LOGISTIC REGRESSION| P=0.459N | |COCH-ARM / FISHERS | P=0.039N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 28/50 (56%) 45/66 (68%) | |POLY-3 RATE (b) | 28/33.21 45/45.91 | |POLY-3 PERCENT (g) | 84.3% 98.0% | |TERMINAL (d) | 9/10 (90%) 0/0 (0%) | |FIRST INCIDENCE | 240 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.006 ** | |POLY 1.5 | P=0.011 * | |POLY 6 | P=0.013 * | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P=0.125 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 7 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 20/50 (40%) 14/66 (21%) | |POLY-3 RATE (b) | 20/26.17 14/18.90 | |POLY-3 PERCENT (g) | 76.4% 74.1% | |TERMINAL (d) | 8/10 (80%) 0/0 (0%) | |FIRST INCIDENCE | 209 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.635N | |POLY 1.5 | P=0.141N | |POLY 6 | P=0.442 | |LOGISTIC REGRESSION| P=0.158 | |COCH-ARM / FISHERS | P=0.023N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 36/50 (72%) 45/66 (68%) | |POLY-3 RATE (b) | 36/36.81 45/45.91 | |POLY-3 PERCENT (g) | 97.8% 98.0% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 209 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.961 | |POLY 1.5 | P=0.690N | |POLY 6 | P=1.000 | |LOGISTIC REGRESSION| P=0.353 | |COCH-ARM / FISHERS | P=0.407N | |ORDER RESTRICTED | (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).