TDMS Study 88004-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest DIVINYLBENZENE DATE: 12/17/03 EXPERIMENT: 88004 TEST: 05 TIME: 11:44:02 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88004B PATHOLOGIST: RENNE, ROGER CAS: 1321-74-0 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 RATS REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest DIVINYLBENZENE DATE: 12/17/03 EXPERIMENT: 88004 TEST: 05 TIME: 11:44:02 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88004B PATHOLOGIST: RENNE, ROGER CAS: 1321-74-0 Rats(FISCHER 344) ----------------------------- 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 Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Pituitary Gland Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest DIVINYLBENZENE DATE: 12/17/03 EXPERIMENT: 88004 TEST: 05 TIME: 11:44:02 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88004B PATHOLOGIST: RENNE, ROGER CAS: 1321-74-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF DIVINYLBENZENE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Kidney: Renal Tubule Carcinoma Skin Basal Cell Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Malignant Tumors =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Mammary Gland Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Thyroid Gland: C-Cell Adenoma All Organs Histiocytic Sarcoma Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 4/50 (8%) 9/50 (18%) 7/50 (14%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 2/50 (4%) | |POLY-3 RATE (b) | 12/44.11 4/45.38 9/44.10 7/45.14 |2/42.30 2/43.64 3/43.84 2/38.10 | |POLY-3 PERCENT (g) | 27.2% 8.8% 20.4% 15.5% |4.7% 4.6% 6.8% 5.3% | |TERMINAL (d) | 8/31 (26%) 4/35 (11%) 8/32 (25%) 6/32 (19%) |2/33 (6%) 1/30 (3%) 3/33 (9%) 0/22 (0%) | |FIRST INCIDENCE | 623 729 (T) 722 674 |731 (T) 696 731 (T) 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.256N P=0.017N* P=0.286N P=0.136N |P=0.410 P=0.668 P=0.500 P=0.552 | |POLY 3 | P=0.248N P=0.021N* P=0.308N P=0.136N |P=0.506 P=0.683N P=0.516 P=0.656 | |POLY 1.5 | P=0.247N P=0.024N* P=0.314N P=0.141N |P=0.534 P=0.686N P=0.511 P=0.674 | |POLY 6 | P=0.255N P=0.018N* P=0.305N P=0.133N |P=0.461 P=0.685N P=0.520 P=0.623 | |LOGISTIC REGRESSION| P=0.233N P=0.019N* P=0.273N P=0.125N |P=0.472 P=0.693N P=0.500 P=0.634 | |COCH-ARM / FISHERS | P=0.257N P=0.027N* P=0.312N P=0.154N |P=0.569 P=0.691N P=0.500 P=0.691N | |ORDER RESTRICTED | P=0.094N (e) (e) (e) |P=0.607 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 1/43.15 2/45.38 2/44.10 1/45.12 |0/42.30 0/43.50 1/44.53 1/38.21 | |POLY-3 PERCENT (g) | 2.3% 4.4% 4.5% 2.2% |0.0% 0.0% 2.3% 2.6% | |TERMINAL (d) | 1/31 (3%) 2/35 (6%) 1/32 (3%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 722 680 |--- --- 497 589 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.552N P=0.543 P=0.514 P=0.742N |P=0.232 (e) P=0.509 P=0.485 | |POLY 3 | P=0.541N P=0.518 P=0.508 P=0.751N |P=0.204 (e) P=0.510 P=0.480 | |POLY 1.5 | P=0.545N P=0.508 P=0.502 P=0.754N |P=0.218 (e) P=0.507 P=0.489 | |POLY 6 | P=0.537N P=0.531 P=0.514 P=0.747N |P=0.182 (e) P=0.513 P=0.462 | |LOGISTIC REGRESSION| P=0.546N P=0.543 P=0.521 P=0.756N |P=0.327 (e) P=0.456 P=0.535 | |COCH-ARM / FISHERS | P=0.556N P=0.500 P=0.500 P=0.753N |P=0.236 (e) P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.540N (e) (e) (e) |P=0.232 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 6/50 (12%) 11/50 (22%) 8/50 (16%) |2/50 (4%) 2/50 (4%) 4/50 (8%) 3/50 (6%) | |POLY-3 RATE (b) | 13/44.11 6/45.38 11/44.13 8/45.33 |2/42.30 2/43.64 4/44.53 3/38.58 | |POLY-3 PERCENT (g) | 29.5% 13.2% 24.9% 17.7% |4.7% 4.6% 9.0% 7.8% | |TERMINAL (d) | 9/31 (29%) 6/35 (17%) 9/32 (28%) 6/32 (19%) |2/33 (6%) 1/30 (3%) 3/33 (9%) 0/22 (0%) | |FIRST INCIDENCE | 623 729 (T) 722 674 |731 (T) 696 497 589 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.250N P=0.036N* P=0.375N P=0.143N |P=0.226 P=0.668 P=0.341 P=0.361 | |POLY 3 | P=0.236N P=0.050N P=0.405N P=0.140N |P=0.300 P=0.683N P=0.361 P=0.458 | |POLY 1.5 | P=0.237N P=0.056N P=0.411N P=0.148N |P=0.325 P=0.686N P=0.352 P=0.478 | |POLY 6 | P=0.239N P=0.043N* P=0.401N P=0.136N |P=0.263 P=0.685N P=0.367 P=0.423 | |LOGISTIC REGRESSION| P=0.225N P=0.041N* P=0.358N P=0.132N |P=0.342 P=0.693N P=0.341 P=0.474 | |COCH-ARM / FISHERS | P=0.251N P=0.062N P=0.408N P=0.163N |P=0.357 P=0.691N P=0.339 P=0.500 | |ORDER RESTRICTED | P=0.130N (e) (e) (e) |P=0.400 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Brain | | Astrocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.15 0/45.38 2/44.07 0/44.93 |0/42.30 0/43.50 1/44.71 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% |0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 0/30 (0%) 0/35 (0%) 2/32 (6%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- 729 (T) --- |--- --- 374 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.600 (e) P=0.252 (e) |P=0.692 (e) P=0.500 (e) | |POLY 3 | P=0.614 (e) P=0.247 (e) |P=0.633 (e) P=0.511 (e) | |POLY 1.5 | P=0.611 (e) P=0.244 (e) |P=0.662 (e) P=0.507 (e) | |POLY 6 | P=0.615 (e) P=0.252 (e) |P=0.581 (e) P=0.513 (e) | |LOGISTIC REGRESSION| (e) (e) P=0.252 (e) |P=0.619N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.598 (e) P=0.253 (e) |P=0.694 (e) P=0.500 (e) | |ORDER RESTRICTED | P=0.256 (e) (e) (e) |P=0.393 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.15 1/45.87 3/44.07 0/44.93 |0/42.30 0/43.50 1/44.71 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 2.2% 6.8% 0.0% |0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 0/30 (0%) 0/35 (0%) 3/32 (9%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 582 729 (T) --- |--- --- 374 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.630N P=0.509 P=0.132 (e) |P=0.692 (e) P=0.500 (e) | |POLY 3 | P=0.614N P=0.517 P=0.126 (e) |P=0.633 (e) P=0.511 (e) | |POLY 1.5 | P=0.619N P=0.510 P=0.124 (e) |P=0.662 (e) P=0.507 (e) | |POLY 6 | P=0.612N P=0.526 P=0.130 (e) |P=0.581 (e) P=0.513 (e) | |LOGISTIC REGRESSION| P=0.629N P=0.531 P=0.132 (e) |P=0.619N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.629N P=0.505 P=0.125 (e) |P=0.694 (e) P=0.500 (e) | |ORDER RESTRICTED | P=0.231 (e) (e) (e) |P=0.393 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 2/50 (4%) 0/50 (0%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/41.16 2/46.40 0/44.07 2/44.42 |0/42.30 0/43.50 1/43.88 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 4.3% 0.0% 4.5% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/30 (0%) 0/35 (0%) 0/32 (0%) 0/31 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 393 --- 638 |--- --- 722 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.256 P=0.257 (e) P=0.257 |P=0.655 (e) P=0.506 (e) | |POLY 3 | P=0.264 P=0.265 (e) P=0.254 |P=0.635 (e) P=0.507 (e) | |POLY 1.5 | P=0.258 P=0.256 (e) P=0.250 |P=0.663 (e) P=0.505 (e) | |POLY 6 | P=0.271 P=0.276 (e) P=0.260 |P=0.584 (e) P=0.509 (e) | |LOGISTIC REGRESSION| P=0.206 P=0.281 (e) P=0.214 |P=0.669 (e) P=0.508 (e) | |COCH-ARM / FISHERS | P=0.249 P=0.258 (e) P=0.253 |P=0.694 (e) P=0.500 (e) | |ORDER RESTRICTED | P=0.130 (e) (e) (e) |P=0.389 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 8/48 (17%) 2/50 (4%) 9/50 (18%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 5/43.75 8/44.47 2/44.24 9/45.84 |1/42.30 0/43.50 1/43.84 1/38.36 | |POLY-3 PERCENT (g) | 11.4% 18.0% 4.5% 19.6% |2.4% 0.0% 2.3% 2.6% | |TERMINAL (d) | 3/31 (10%) 7/34 (21%) 1/32 (3%) 6/32 (19%) |1/33 (3%) 0/30 (0%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 543 704 687 614 |731 (T) --- 731 (T) 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.240 P=0.343 P=0.207N P=0.225 |P=0.486 P=0.519N P=0.762 P=0.729 | |POLY 3 | P=0.255 P=0.285 P=0.211N P=0.218 |P=0.503 P=0.494N P=0.753N P=0.739 | |POLY 1.5 | P=0.248 P=0.270 P=0.216N P=0.209 |P=0.519 P=0.496N P=0.755N P=0.749 | |POLY 6 | P=0.262 P=0.306 P=0.204N P=0.230 |P=0.478 P=0.496N P=0.751N P=0.718 | |LOGISTIC REGRESSION| P=0.249 P=0.297 P=0.215N P=0.200 |P=0.553 (e) P=0.762 P=0.745N | |COCH-ARM / FISHERS | P=0.240 P=0.250 P=0.218N P=0.194 |P=0.539 P=0.500N P=0.753N P=0.753N | |ORDER RESTRICTED | P=0.190 (e) (e) (e) |P=0.500 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 8/48 (17%) 3/50 (6%) 10/50 (20%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 6/43.75 8/44.47 3/44.24 10/45.84 |1/42.30 0/43.50 1/43.84 2/38.97 | |POLY-3 PERCENT (g) | 13.7% 18.0% 6.8% 21.8% |2.4% 0.0% 2.3% 5.1% | |TERMINAL (d) | 4/31 (13%) 7/34 (21%) 2/32 (6%) 7/32 (22%) |1/33 (3%) 0/30 (0%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 543 704 687 614 |731 (T) --- 731 (T) 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.218 P=0.462 P=0.230N P=0.239 |P=0.209 P=0.519N P=0.762 P=0.474 | |POLY 3 | P=0.233 P=0.399 P=0.236N P=0.234 |P=0.226 P=0.494N P=0.753N P=0.471 | |POLY 1.5 | P=0.228 P=0.380 P=0.242N P=0.224 |P=0.235 P=0.496N P=0.755N P=0.485 | |POLY 6 | P=0.239 P=0.423 P=0.228N P=0.247 |P=0.212 P=0.496N P=0.751N P=0.445 | |LOGISTIC REGRESSION| P=0.230 P=0.418 P=0.235N P=0.221 |P=0.289 (e) P=0.762 P=0.554 | |COCH-ARM / FISHERS | P=0.220 P=0.355 P=0.243N P=0.207 |P=0.247 P=0.500N P=0.753N P=0.500 | |ORDER RESTRICTED | P=0.180 (e) (e) (e) |P=0.196 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 0/44.07 2/44.14 |0/42.30 0/43.50 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 1/32 (3%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- --- 682 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.046 * (e) (e) P=0.252 |(e) (e) (e) (e) | |POLY 3 | P=0.044 * (e) (e) P=0.242 |(e) (e) (e) (e) | |POLY 1.5 | P=0.045 * (e) (e) P=0.239 |(e) (e) (e) (e) | |POLY 6 | P=0.044 * (e) (e) P=0.246 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.046 * (e) (e) P=0.240 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.242 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.031 * (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 0/44.07 0/44.93 |0/42.30 2/43.90 2/43.84 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.6% 4.6% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 1/30 (3%) 2/33 (6%) 0/22 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 617 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.597N P=0.237 P=0.238 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.551N P=0.245 P=0.245 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.527N P=0.243 P=0.242 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.592N P=0.245 P=0.246 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.534N P=0.233 P=0.238 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.500N P=0.247 P=0.247 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.288 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 3/50 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 0/44.07 0/44.93 |0/42.30 2/43.90 3/43.92 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.6% 6.8% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 1/30 (3%) 2/33 (6%) 0/22 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 617 711 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.612 P=0.237 P=0.128 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.596N P=0.245 P=0.125 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.566N P=0.243 P=0.123 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.558 P=0.245 P=0.127 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.574N P=0.233 P=0.127 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.531N P=0.247 P=0.121 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.242 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 3/50 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 0/44.07 0/44.93 |0/42.30 2/43.90 3/43.92 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.6% 6.8% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 1/30 (3%) 2/33 (6%) 0/22 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 617 711 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.612 P=0.237 P=0.128 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.596N P=0.245 P=0.125 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.566N P=0.243 P=0.123 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.558 P=0.245 P=0.127 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.574N P=0.233 P=0.127 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.531N P=0.247 P=0.121 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.242 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/43.15 1/45.38 0/44.07 1/44.93 |0/42.30 0/43.50 0/43.84 2/37.73 | |POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 2.2% |0.0% 0.0% 0.0% 5.3% | |TERMINAL (d) | 0/31 (0%) 1/35 (3%) 0/32 (0%) 1/32 (3%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 2/22 (9%) | |FIRST INCIDENCE | --- 729 (T) --- 729 (T) |--- --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.403 P=0.524 (e) P=0.506 |P=0.023 * (e) (e) P=0.154 | |POLY 3 | P=0.417 P=0.510 (e) P=0.508 |P=0.041 * (e) (e) P=0.212 | |POLY 1.5 | P=0.413 P=0.504 (e) P=0.505 |P=0.043 * (e) (e) P=0.224 | |POLY 6 | P=0.421 P=0.518 (e) P=0.511 |P=0.039 * (e) (e) P=0.193 | |LOGISTIC REGRESSION| (e) P=0.524 (e) P=0.506 |(e) (e) (e) P=0.154 | |COCH-ARM / FISHERS | P=0.405 P=0.500 (e) P=0.500 |P=0.046 * (e) (e) P=0.247 | |ORDER RESTRICTED | P=0.259 (e) (e) (e) |P=0.022 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 1/43.15 1/45.38 1/44.07 1/44.93 |0/42.30 0/43.50 0/43.84 2/37.73 | |POLY-3 PERCENT (g) | 2.3% 2.2% 2.3% 2.2% |0.0% 0.0% 0.0% 5.3% | |TERMINAL (d) | 1/31 (3%) 1/35 (3%) 1/32 (3%) 1/32 (3%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 2/22 (9%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.633 P=0.735N P=0.755N P=0.755N |P=0.023 * (e) (e) P=0.154 | |POLY 3 | P=0.627N P=0.749N P=0.756N P=0.752N |P=0.041 * (e) (e) P=0.212 | |POLY 1.5 | P=0.628N P=0.756N P=0.759N P=0.755N |P=0.043 * (e) (e) P=0.224 | |POLY 6 | P=0.628N P=0.741N P=0.752N P=0.749N |P=0.039 * (e) (e) P=0.193 | |LOGISTIC REGRESSION| P=0.633 P=0.735N P=0.755N P=0.755N |(e) (e) (e) P=0.154 | |COCH-ARM / FISHERS | P=0.634 P=0.753N P=0.753N P=0.753N |P=0.046 * (e) (e) P=0.247 | |ORDER RESTRICTED | P=0.735N (e) (e) (e) |P=0.022 * (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |3/50 (6%) 5/50 (10%) 4/50 (8%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.15 0/45.38 1/44.07 0/44.93 |3/42.30 5/44.54 4/43.84 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 0.0% 2.3% 0.0% |7.1% 11.2% 9.1% 0.0% | |TERMINAL (d) | 1/31 (3%) 0/35 (0%) 1/32 (3%) 0/32 (0%) |3/33 (9%) 2/30 (7%) 4/33 (12%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- |731 (T) 374 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.406N P=0.476N P=0.755N P=0.494N |P=0.150N P=0.320 P=0.500 P=0.200N | |POLY 3 | P=0.406N P=0.490N P=0.756N P=0.492N |P=0.110N P=0.385 P=0.520 P=0.140N | |POLY 1.5 | P=0.404N P=0.496N P=0.759N P=0.495N |P=0.095N P=0.377 P=0.513 P=0.130N | |POLY 6 | P=0.410N P=0.482N P=0.752N P=0.489N |P=0.140N P=0.385 P=0.523 P=0.160N | |LOGISTIC REGRESSION| P=0.406N (e) P=0.755N (e) |P=0.091N P=0.353 P=0.500 (e) | |COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.753N P=0.500N |P=0.079N P=0.357 P=0.500 P=0.121N | |ORDER RESTRICTED | P=0.243N (e) (e) (e) |P=0.090N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |3/50 (6%) 6/50 (12%) 4/50 (8%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.15 1/45.38 1/44.07 0/44.93 |3/42.30 6/44.77 4/43.84 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 2.2% 2.3% 0.0% |7.1% 13.4% 9.1% 0.0% | |TERMINAL (d) | 1/31 (3%) 1/35 (3%) 1/32 (3%) 0/32 (0%) |3/33 (9%) 2/30 (7%) 4/33 (12%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |731 (T) 374 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.311N P=0.735N P=0.755N P=0.494N |P=0.134N P=0.219 P=0.500 P=0.200N | |POLY 3 | P=0.307N P=0.749N P=0.756N P=0.492N |P=0.093N P=0.270 P=0.520 P=0.140N | |POLY 1.5 | P=0.308N P=0.756N P=0.759N P=0.495N |P=0.079N P=0.262 P=0.513 P=0.130N | |POLY 6 | P=0.306N P=0.741N P=0.752N P=0.489N |P=0.122N P=0.272 P=0.523 P=0.160N | |LOGISTIC REGRESSION| P=0.311N P=0.735N P=0.755N (e) |P=0.075N P=0.238 P=0.500 (e) | |COCH-ARM / FISHERS | P=0.311N P=0.753N P=0.753N P=0.500N |P=0.066N P=0.243 P=0.500 P=0.121N | |ORDER RESTRICTED | P=0.320N (e) (e) (e) |P=0.067N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 5/50 (10%) 2/50 (4%) |20/50 (40%) 22/50 (44%) 19/50 (38%) 14/50 (28%) | |POLY-3 RATE (b) | 1/43.15 0/45.38 5/44.58 2/44.93 |20/43.01 22/45.41 19/44.55 14/39.80 | |POLY-3 PERCENT (g) | 2.3% 0.0% 11.2% 4.5% |46.5% 48.4% 42.7% 35.2% | |TERMINAL (d) | 1/31 (3%) 0/35 (0%) 4/32 (13%) 2/32 (6%) |15/33 (46%) 12/30 (40%) 13/33 (39%) 8/22 (36%) | |FIRST INCIDENCE | 729 (T) --- 578 729 (T) |631 617 666 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.228 P=0.476N P=0.111 P=0.511 |P=0.476N P=0.335 P=0.484N P=0.572 | |POLY 3 | P=0.240 P=0.490N P=0.108 P=0.514 |P=0.133N P=0.512 P=0.441N P=0.200N | |POLY 1.5 | P=0.239 P=0.496N P=0.104 P=0.509 |P=0.104N P=0.478 P=0.462N P=0.169N | |POLY 6 | P=0.237 P=0.482N P=0.114 P=0.519 |P=0.202N P=0.538 P=0.428N P=0.280N | |LOGISTIC REGRESSION| P=0.240 (e) P=0.106 P=0.511 |P=0.201N P=0.470 P=0.426N P=0.309N | |COCH-ARM / FISHERS | P=0.232 P=0.500N P=0.102 P=0.500 |P=0.080N P=0.420 P=0.500N P=0.146N | |ORDER RESTRICTED | P=0.097 (e) (e) (e) |P=0.204N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 5/50 (10%) 2/50 (4%) |20/50 (40%) 23/50 (46%) 19/50 (38%) 14/50 (28%) | |POLY-3 RATE (b) | 1/43.15 1/45.38 5/44.58 2/44.93 |20/43.01 23/45.64 19/44.55 14/39.80 | |POLY-3 PERCENT (g) | 2.3% 2.2% 11.2% 4.5% |46.5% 50.4% 42.7% 35.2% | |TERMINAL (d) | 1/31 (3%) 1/35 (3%) 4/32 (13%) 2/32 (6%) |15/33 (46%) 12/30 (40%) 13/33 (39%) 8/22 (36%) | |FIRST INCIDENCE | 729 (T) 729 (T) 578 729 (T) |631 617 666 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.298 P=0.735N P=0.111 P=0.511 |P=0.455N P=0.276 P=0.484N P=0.572 | |POLY 3 | P=0.316 P=0.749N P=0.108 P=0.514 |P=0.119N P=0.438 P=0.441N P=0.200N | |POLY 1.5 | P=0.313 P=0.756N P=0.104 P=0.509 |P=0.092N P=0.401 P=0.462N P=0.169N | |POLY 6 | P=0.315 P=0.741N P=0.114 P=0.519 |P=0.186N P=0.471 P=0.428N P=0.280N | |LOGISTIC REGRESSION| P=0.312 P=0.735N P=0.106 P=0.511 |P=0.178N P=0.389 P=0.426N P=0.309N | |COCH-ARM / FISHERS | P=0.302 P=0.753N P=0.102 P=0.500 |P=0.070N P=0.343 P=0.500N P=0.146N | |ORDER RESTRICTED | P=0.182 (e) (e) (e) |P=0.172N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 5/50 (10%) 2/50 (4%) |22/50 (44%) 25/50 (50%) 21/50 (42%) 14/50 (28%) | |POLY-3 RATE (b) | 1/43.15 1/45.38 5/44.58 2/44.93 |22/43.01 25/46.62 21/44.55 14/39.80 | |POLY-3 PERCENT (g) | 2.3% 2.2% 11.2% 4.5% |51.2% 53.6% 47.1% 35.2% | |TERMINAL (d) | 1/31 (3%) 1/35 (3%) 4/32 (13%) 2/32 (6%) |17/33 (52%) 12/30 (40%) 15/33 (46%) 8/22 (36%) | |FIRST INCIDENCE | 729 (T) 729 (T) 578 729 (T) |631 374 666 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.298 P=0.735N P=0.111 P=0.511 |P=0.330N P=0.276 P=0.484N P=0.461N | |POLY 3 | P=0.316 P=0.749N P=0.108 P=0.514 |P=0.057N P=0.491 P=0.435N P=0.099N | |POLY 1.5 | P=0.313 P=0.756N P=0.104 P=0.509 |P=0.041N* P=0.435 P=0.458N P=0.082N | |POLY 6 | P=0.315 P=0.741N P=0.114 P=0.519 |P=0.103N P=0.539 P=0.420N P=0.153N | |LOGISTIC REGRESSION| P=0.312 P=0.735N P=0.106 P=0.511 |P=0.077N P=0.391 P=0.418N P=0.189N | |COCH-ARM / FISHERS | P=0.302 P=0.753N P=0.102 P=0.500 |P=0.029N* P=0.344 P=0.500N P=0.072N | |ORDER RESTRICTED | P=0.182 (e) (e) (e) |P=0.088N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/50 (72%) 30/50 (60%) 31/50 (62%) 29/49 (59%) |37/50 (74%) 34/50 (68%) 39/50 (78%) 28/50 (56%) | |POLY-3 RATE (b) | 36/47.03 30/47.41 31/46.48 29/45.96 |37/46.77 34/46.44 39/47.30 28/42.25 | |POLY-3 PERCENT (g) | 76.6% 63.3% 66.7% 63.1% |79.1% 73.2% 82.5% 66.3% | |TERMINAL (d) | 24/31 (77%) 22/35 (63%) 20/32 (63%) 19/32 (59%) |26/33 (79%) 22/30 (73%) 27/33 (82%) 16/22 (73%) | |FIRST INCIDENCE | 506 569 586 614 |455 374 493 529 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.167N P=0.066N P=0.191N P=0.106N |P=0.358 P=0.511N P=0.468 P=0.484 | |POLY 3 | P=0.150N P=0.113N P=0.197N P=0.109N |P=0.138N P=0.330N P=0.438 P=0.114N | |POLY 1.5 | P=0.145N P=0.135N P=0.208N P=0.113N |P=0.084N P=0.318N P=0.425 P=0.073N | |POLY 6 | P=0.162N P=0.088N P=0.181N P=0.108N |P=0.275N P=0.368N P=0.450 P=0.234N | |LOGISTIC REGRESSION| P=0.121N P=0.117N P=0.175N P=0.086N |P=0.100N P=0.266N P=0.476 P=0.086N | |COCH-ARM / FISHERS | P=0.157N P=0.146N P=0.198N P=0.129N |P=0.044N* P=0.330N P=0.408 P=0.046N* | |ORDER RESTRICTED | P=0.121N (e) (e) (e) |P=0.107N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 2/45.38 0/44.07 0/43.95 |0/42.30 0/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 2/35 (6%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 729 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.406N P=0.265 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.394N P=0.248 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.401N P=0.242 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.386N P=0.257 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.265 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.409N P=0.247 (e) (e) |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.254N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.38 1/44.58 3/44.93 |0/42.30 0/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 6.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 3/32 (9%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- 578 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.020 * (e) P=0.504 P=0.126 |(e) (e) (e) (e) | |POLY 3 | P=0.020 * (e) P=0.507 P=0.126 |(e) (e) (e) (e) | |POLY 1.5 | P=0.020 * (e) P=0.503 P=0.123 |(e) (e) (e) (e) | |POLY 6 | P=0.020 * (e) P=0.512 P=0.128 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.020 * (e) P=0.535 P=0.126 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.020 * (e) P=0.500 P=0.121 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.023 * (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma, Basosquamous Tumor Benign, or | | Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.15 0/45.38 1/44.58 3/44.93 |0/42.30 0/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 0.0% 2.2% 6.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 0/35 (0%) 0/32 (0%) 3/32 (9%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) --- 578 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.095 P=0.476N P=0.754N P=0.316 |(e) (e) (e) (e) | |POLY 3 | P=0.097 P=0.490N P=0.753N P=0.320 |(e) (e) (e) (e) | |POLY 1.5 | P=0.098 P=0.496N P=0.758N P=0.315 |(e) (e) (e) (e) | |POLY 6 | P=0.096 P=0.482N P=0.748N P=0.324 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.098 (e) P=0.759N P=0.316 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.097 P=0.500N P=0.753N P=0.309 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.089 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous | | Tumor (benign, malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.15 0/45.38 1/44.58 3/44.93 |0/42.30 1/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 0.0% 2.2% 6.7% |0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 0/35 (0%) 0/32 (0%) 3/32 (9%) |0/33 (0%) 1/30 (3%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) --- 578 729 (T) |--- 731 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.095 P=0.476N P=0.754N P=0.316 |P=0.625N P=0.481 (e) (e) | |POLY 3 | P=0.097 P=0.490N P=0.753N P=0.320 |P=0.563N P=0.506 (e) (e) | |POLY 1.5 | P=0.098 P=0.496N P=0.758N P=0.315 |P=0.565N P=0.504 (e) (e) | |POLY 6 | P=0.096 P=0.482N P=0.748N P=0.324 |P=0.561N P=0.504 (e) (e) | |LOGISTIC REGRESSION| P=0.098 (e) P=0.759N P=0.316 |(e) P=0.481 (e) (e) | |COCH-ARM / FISHERS | P=0.097 P=0.500N P=0.753N P=0.309 |P=0.567N P=0.500 (e) (e) | |ORDER RESTRICTED | P=0.089 (e) (e) (e) |P=0.405N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor | | (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/43.52 0/45.38 1/44.58 3/44.93 |0/42.30 1/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 4.6% 0.0% 2.2% 6.7% |0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 0/35 (0%) 0/32 (0%) 3/32 (9%) |0/33 (0%) 1/30 (3%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 623 --- 578 729 (T) |--- 731 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.243 P=0.217N P=0.491N P=0.518 |P=0.625N P=0.481 (e) (e) | |POLY 3 | P=0.241 P=0.228N P=0.492N P=0.515 |P=0.563N P=0.506 (e) (e) | |POLY 1.5 | P=0.244 P=0.233N P=0.497N P=0.510 |P=0.565N P=0.504 (e) (e) | |POLY 6 | P=0.237 P=0.221N P=0.485N P=0.518 |P=0.561N P=0.504 (e) (e) | |LOGISTIC REGRESSION| P=0.239 P=0.239N P=0.488N P=0.518 |(e) P=0.481 (e) (e) | |COCH-ARM / FISHERS | P=0.242 P=0.247N P=0.500N P=0.500 |P=0.567N P=0.500 (e) (e) | |ORDER RESTRICTED | P=0.195 (e) (e) (e) |P=0.405N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 7/50 (14%) 4/50 (8%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 5/44.12 7/45.64 4/44.07 3/45.64 |0/42.30 0/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 11.3% 15.3% 9.1% 6.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/31 (10%) 6/35 (17%) 4/32 (13%) 1/32 (3%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 536 659 729 (T) 569 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.194N P=0.457 P=0.483N P=0.334N |(e) (e) (e) (e) | |POLY 3 | P=0.183N P=0.403 P=0.501N P=0.338N |(e) (e) (e) (e) | |POLY 1.5 | P=0.187N P=0.388 P=0.504N P=0.344N |(e) (e) (e) (e) | |POLY 6 | P=0.180N P=0.424 P=0.498N P=0.332N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.191N P=0.387 P=0.497N P=0.406N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.196N P=0.380 P=0.500N P=0.357N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.235N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 8/50 (16%) 4/50 (8%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 6/44.15 8/45.71 4/44.07 5/45.67 |0/42.30 0/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 13.6% 17.5% 9.1% 11.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/31 (10%) 6/35 (17%) 4/32 (13%) 2/32 (6%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 536 659 729 (T) 569 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.312N P=0.476 P=0.353N P=0.469N |(e) (e) (e) (e) | |POLY 3 | P=0.297N P=0.413 P=0.370N P=0.476N |(e) (e) (e) (e) | |POLY 1.5 | P=0.302N P=0.396 P=0.373N P=0.484N |(e) (e) (e) (e) | |POLY 6 | P=0.295N P=0.437 P=0.367N P=0.469N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.303N P=0.399 P=0.365N P=0.525N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.313N P=0.387 P=0.370N P=0.500N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.343N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 38/50 (76%) 45/50 (90%) 43/50 (86%) 42/50 (84%) | | |POLY-3 RATE (b) | 38/46.19 45/48.30 43/48.17 42/48.66 | | |POLY-3 PERCENT (g) | 82.3% 93.2% 89.3% 86.3% | | |TERMINAL (d) | 30/31 (97%) 33/35 (94%) 30/32 (94%) 28/32 (88%) | | |FIRST INCIDENCE | 543 393 460 562 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.367 P=0.400 P=0.298 P=0.397 | | |POLY 3 | P=0.509 P=0.075 P=0.232 P=0.390 | | |POLY 1.5 | P=0.427 P=0.052 P=0.174 P=0.317 | | |POLY 6 | P=0.527N P=0.124 P=0.329 P=0.499 | | |LOGISTIC REGRESSION| P=0.393 P=0.067 P=0.154 P=0.335 | | |COCH-ARM / FISHERS | P=0.301 P=0.054 P=0.154 P=0.227 | | |ORDER RESTRICTED | P=0.191 (e) (e) (e) | | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 2/50 (4%) 2/49 (4%) |0/50 (0%) 5/50 (10%) 1/50 (2%) 4/50 (8%) | |POLY-3 RATE (b) | 2/43.15 5/45.65 2/44.07 2/43.95 |0/42.30 5/44.49 1/43.84 4/38.55 | |POLY-3 PERCENT (g) | 4.6% 11.0% 4.5% 4.6% |0.0% 11.2% 2.3% 10.4% | |TERMINAL (d) | 2/31 (7%) 4/35 (11%) 2/32 (6%) 2/32 (6%) |0/33 (0%) 3/30 (10%) 1/33 (3%) 2/22 (9%) | |FIRST INCIDENCE | 729 (T) 654 729 (T) 729 (T) |--- 506 731 (T) 563 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.397N P=0.270 P=0.684N P=0.684N |P=0.088 P=0.033 * P=0.500 P=0.035 * | |POLY 3 | P=0.388N P=0.239 P=0.686N P=0.687N |P=0.134 P=0.035 * P=0.507 P=0.049 * | |POLY 1.5 | P=0.395N P=0.227 P=0.691N P=0.692N |P=0.145 P=0.033 * P=0.505 P=0.054 | |POLY 6 | P=0.383N P=0.258 P=0.680N P=0.683N |P=0.115 P=0.035 * P=0.509 P=0.040 * | |LOGISTIC REGRESSION| P=0.395N P=0.252 P=0.684N P=0.684N |P=0.163 P=0.031 * P=0.500 P=0.059 | |COCH-ARM / FISHERS | P=0.406N P=0.218 P=0.691N P=0.684 |P=0.162 P=0.028 * P=0.500 P=0.059 | |ORDER RESTRICTED | P=0.414N (e) (e) (e) |P=0.035 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 2/50 (4%) 3/49 (6%) |1/50 (2%) 6/50 (12%) 2/50 (4%) 4/50 (8%) | |POLY-3 RATE (b) | 3/43.15 5/45.65 2/44.07 3/43.95 |1/42.37 6/44.66 2/43.91 4/38.55 | |POLY-3 PERCENT (g) | 7.0% 11.0% 4.5% 6.8% |2.4% 13.4% 4.6% 10.4% | |TERMINAL (d) | 3/31 (10%) 4/35 (11%) 2/32 (6%) 3/32 (9%) |0/33 (0%) 3/30 (10%) 1/33 (3%) 2/22 (9%) | |FIRST INCIDENCE | 729 (T) 654 729 (T) 729 (T) |716 506 715 563 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.443N P=0.426 P=0.485N P=0.650N |P=0.194 P=0.058 P=0.503 P=0.101 | |POLY 3 | P=0.438N P=0.388 P=0.490N P=0.654N |P=0.282 P=0.064 P=0.512 P=0.150 | |POLY 1.5 | P=0.443N P=0.370 P=0.497N P=0.660N |P=0.304 P=0.062 P=0.508 P=0.163 | |POLY 6 | P=0.435N P=0.412 P=0.482N P=0.649N |P=0.246 P=0.065 P=0.515 P=0.129 | |LOGISTIC REGRESSION| P=0.442N P=0.410 P=0.485N P=0.650N |P=0.320 P=0.056 P=0.514 P=0.164 | |COCH-ARM / FISHERS | P=0.453N P=0.357 P=0.500N P=0.651 |P=0.331 P=0.056 P=0.500 P=0.181 | |ORDER RESTRICTED | P=0.441N (e) (e) (e) |P=0.143 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |9/50 (18%) 6/50 (12%) 8/50 (16%) 7/50 (14%) | |POLY-3 RATE (b) | |9/42.59 6/44.04 8/45.13 7/38.66 | |POLY-3 PERCENT (g) | |21.1% 13.6% 17.7% 18.1% | |TERMINAL (d) | |7/33 (21%) 3/30 (10%) 5/33 (15%) 4/22 (18%) | |FIRST INCIDENCE | |687 670 481 589 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.405 P=0.341N P=0.484N P=0.498 | |POLY 3 | |P=0.501N P=0.261N P=0.447N P=0.475N | |POLY 1.5 | |P=0.466N P=0.269N P=0.466N P=0.435N | |POLY 6 | |P=0.541 P=0.261N P=0.433N P=0.547N | |LOGISTIC REGRESSION| |P=0.510N P=0.269N P=0.478N P=0.563N | |COCH-ARM / FISHERS | |P=0.420N P=0.288N P=0.500N P=0.393N | |ORDER RESTRICTED | |P=0.464N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | |0/42.30 2/44.05 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | |0.0% 4.5% 0.0% 0.0% | |TERMINAL (d) | |0/33 (0%) 1/30 (3%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | |--- 561 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.441N P=0.239 (e) (e) | |POLY 3 | |P=0.412N P=0.246 (e) (e) | |POLY 1.5 | |P=0.408N P=0.243 (e) (e) | |POLY 6 | |P=0.422N P=0.246 (e) (e) | |LOGISTIC REGRESSION| |P=0.385N P=0.221 (e) (e) | |COCH-ARM / FISHERS | |P=0.405N P=0.247 (e) (e) | |ORDER RESTRICTED | |P=0.279N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |9/50 (18%) 8/50 (16%) 8/50 (16%) 7/50 (14%) | |POLY-3 RATE (b) | |9/42.59 8/44.58 8/45.13 7/38.66 | |POLY-3 PERCENT (g) | |21.1% 17.9% 17.7% 18.1% | |TERMINAL (d) | |7/33 (21%) 4/30 (13%) 5/33 (15%) 4/22 (18%) | |FIRST INCIDENCE | |687 561 481 589 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.477 P=0.550N P=0.484N P=0.498 | |POLY 3 | |P=0.430N P=0.458N P=0.447N P=0.475N | |POLY 1.5 | |P=0.394N P=0.472N P=0.466N P=0.435N | |POLY 6 | |P=0.488N P=0.454N P=0.433N P=0.547N | |LOGISTIC REGRESSION| |P=0.418N P=0.477N P=0.478N P=0.563N | |COCH-ARM / FISHERS | |P=0.348N P=0.500N P=0.500N P=0.393N | |ORDER RESTRICTED | |P=0.561N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/43.15 0/45.38 2/44.21 0/44.93 |1/42.47 0/43.50 0/43.84 2/38.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% |2.4% 0.0% 0.0% 5.3% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 1/22 (5%) | |FIRST INCIDENCE | --- --- 694 --- |687 --- --- 617 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.596 (e) P=0.252 (e) |P=0.173 P=0.505N P=0.500N P=0.382 | |POLY 3 | P=0.609 (e) P=0.242 (e) |P=0.233 P=0.495N P=0.494N P=0.462 | |POLY 1.5 | P=0.607 (e) P=0.239 (e) |P=0.237 P=0.496N P=0.496N P=0.480 | |POLY 6 | P=0.609 (e) P=0.247 (e) |P=0.228 P=0.497N P=0.493N P=0.431 | |LOGISTIC REGRESSION| P=0.600 (e) P=0.243 (e) |P=0.243 P=0.499N P=0.499N P=0.486 | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.246 P=0.500N P=0.500N P=0.500 | |ORDER RESTRICTED | P=0.252 (e) (e) (e) |P=0.105 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.15 0/45.38 0/44.07 0/44.93 |2/43.70 0/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |4.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- |436 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.305N P=0.476N P=0.494N P=0.494N |P=0.115N P=0.232N P=0.237N P=0.237N | |POLY 3 | P=0.314N P=0.490N P=0.496N P=0.492N |P=0.107N P=0.238N P=0.236N P=0.271N | |POLY 1.5 | P=0.310N P=0.496N P=0.499N P=0.495N |P=0.110N P=0.237N P=0.236N P=0.255N | |POLY 6 | P=0.319N P=0.482N P=0.492N P=0.489N |P=0.099N P=0.242N P=0.237N P=0.298N | |LOGISTIC REGRESSION| P=0.305N (e) (e) (e) |P=0.051N P=0.306N P=0.280N P=0.137N | |COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.115N P=0.247N P=0.247N P=0.247N | |ORDER RESTRICTED | P=0.113N (e) (e) (e) |P=0.043N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 22/50 (44%) 13/50 (26%) 14/50 (28%) 10/50 (20%) |10/50 (20%) 18/50 (36%) 22/50 (44%) 22/50 (44%) | |POLY-3 RATE (b) | 22/47.44 13/46.73 14/45.29 10/46.51 |10/43.58 18/46.27 22/46.74 22/44.29 | |POLY-3 PERCENT (g) | 46.4% 27.8% 30.9% 21.5% |23.0% 38.9% 47.1% 49.7% | |TERMINAL (d) | 9/31 (29%) 6/35 (17%) 9/32 (28%) 4/32 (13%) |6/33 (18%) 8/30 (27%) 12/33 (36%) 5/22 (23%) | |FIRST INCIDENCE | 355 569 544 569 |477 542 481 516 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.022N* P=0.039N* P=0.086N P=0.016N* |P<0.001 ** P=0.067 P=0.021 * P=0.003 ** | |POLY 3 | P=0.013N* P=0.047N* P=0.092N P=0.008N** |P=0.008 ** P=0.078 P=0.013 * P=0.007 ** | |POLY 1.5 | P=0.012N* P=0.049N* P=0.086N P=0.008N** |P=0.009 ** P=0.069 P=0.010 * P=0.007 ** | |POLY 6 | P=0.014N* P=0.044N* P=0.103N P=0.009N** |P=0.007 ** P=0.085 P=0.015 * P=0.006 ** | |LOGISTIC REGRESSION| P=0.014N* P=0.050N P=0.072N P=0.014N* |P=0.012 * P=0.061 P=0.010 * P=0.011 * | |COCH-ARM / FISHERS | P=0.013N* P=0.046N* P=0.072N P=0.009N** |P=0.011 * P=0.059 P=0.009 ** P=0.009 ** | |ORDER RESTRICTED | P=0.005N** (e) (e) (e) |P=0.006 ** (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/43.35 2/45.38 1/44.28 2/45.47 |0/42.30 0/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 4.6% 4.4% 2.3% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 2/35 (6%) 0/32 (0%) 1/32 (3%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 675 729 (T) 676 562 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.566N P=0.649N P=0.475N P=0.670N |(e) (e) (e) (e) | |POLY 3 | P=0.567N P=0.678N P=0.493N P=0.677N |(e) (e) (e) (e) | |POLY 1.5 | P=0.570N P=0.687N P=0.498N P=0.683N |(e) (e) (e) (e) | |POLY 6 | P=0.566N P=0.665N P=0.486N P=0.671N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.579N P=0.669N P=0.499N P=0.674 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.577N P=0.691N P=0.500N P=0.691N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.593N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/43.35 2/45.38 1/44.28 2/45.47 |0/42.30 0/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 4.6% 4.4% 2.3% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 2/35 (6%) 0/32 (0%) 1/32 (3%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 675 729 (T) 676 562 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.566N P=0.649N P=0.475N P=0.670N |(e) (e) (e) (e) | |POLY 3 | P=0.567N P=0.678N P=0.493N P=0.677N |(e) (e) (e) (e) | |POLY 1.5 | P=0.570N P=0.687N P=0.498N P=0.683N |(e) (e) (e) (e) | |POLY 6 | P=0.566N P=0.665N P=0.486N P=0.671N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.579N P=0.669N P=0.499N P=0.674 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.577N P=0.691N P=0.500N P=0.691N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.593N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/43.75 2/45.81 0/44.07 0/44.93 |0/42.30 1/44.21 0/43.84 1/37.73 | |POLY-3 PERCENT (g) | 2.3% 4.4% 0.0% 0.0% |0.0% 2.3% 0.0% 2.7% | |TERMINAL (d) | 0/31 (0%) 1/35 (3%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 1/22 (5%) | |FIRST INCIDENCE | 536 605 --- --- |--- 487 --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.187N P=0.522 P=0.500N P=0.496N |P=0.373 P=0.517 (e) P=0.419 | |POLY 3 | P=0.184N P=0.516 P=0.499N P=0.495N |P=0.378 P=0.509 (e) P=0.477 | |POLY 1.5 | P=0.186N P=0.507 P=0.500N P=0.496N |P=0.391 P=0.506 (e) P=0.488 | |POLY 6 | P=0.182N P=0.529 P=0.496N P=0.493N |P=0.357 P=0.509 (e) P=0.458 | |LOGISTIC REGRESSION| P=0.197N P=0.516 P=0.442N P=0.674N |P=0.454 P=0.435 (e) P=0.419 | |COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.405 P=0.500 (e) P=0.500 | |ORDER RESTRICTED | P=0.171N (e) (e) (e) |P=0.229 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/43.75 2/45.81 0/44.07 0/44.93 |0/42.30 1/44.21 0/43.84 1/37.73 | |POLY-3 PERCENT (g) | 2.3% 4.4% 0.0% 0.0% |0.0% 2.3% 0.0% 2.7% | |TERMINAL (d) | 0/31 (0%) 1/35 (3%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 1/22 (5%) | |FIRST INCIDENCE | 536 605 --- --- |--- 487 --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.187N P=0.522 P=0.500N P=0.496N |P=0.373 P=0.517 (e) P=0.419 | |POLY 3 | P=0.184N P=0.516 P=0.499N P=0.495N |P=0.378 P=0.509 (e) P=0.477 | |POLY 1.5 | P=0.186N P=0.507 P=0.500N P=0.496N |P=0.391 P=0.506 (e) P=0.488 | |POLY 6 | P=0.182N P=0.529 P=0.496N P=0.493N |P=0.357 P=0.509 (e) P=0.458 | |LOGISTIC REGRESSION| P=0.197N P=0.516 P=0.442N P=0.674N |P=0.454 P=0.435 (e) P=0.419 | |COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.405 P=0.500 (e) P=0.500 | |ORDER RESTRICTED | P=0.171N (e) (e) (e) |P=0.229 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 49/50 (98%) 49/50 (98%) 48/50 (96%) 48/50 (96%) |43/50 (86%) 42/50 (84%) 45/50 (90%) 36/50 (72%) | |POLY-3 RATE (b) | 49/49.12 49/49.00 48/48.98 48/49.17 |43/46.94 42/47.57 45/48.01 36/43.88 | |POLY-3 PERCENT (g) | 99.8% 100.0% 98.0% 97.6% |91.6% 88.3% 93.7% 82.0% | |TERMINAL (d) | 31/31 (100%) 35/35 (100%) 32/32 (100%) 32/32 (100%)|31/33 (94%) 26/30 (87%) 32/33 (97%) 20/22 (91%) | |FIRST INCIDENCE | 506 393 460 562 |455 374 481 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.432N P=0.210N P=0.385N P=0.361N |P=0.151 P=0.459 P=0.468 P=0.207 | |POLY 3 | P=0.198N P=1.000 P=0.554N P=0.477N |P=0.103N P=0.418N P=0.498 P=0.114N | |POLY 1.5 | P=0.187N P=0.980 P=0.608N P=0.446N |P=0.066N P=0.437N P=0.446 P=0.084N | |POLY 6 | P=0.281N P=1.000 P=0.526N P=0.626N |P=0.248N P=0.428N P=0.537 P=0.244N | |LOGISTIC REGRESSION| P=0.110N (e) P=0.629N P=0.198N |P=0.095N P=0.363N P=0.505 P=0.111N | |COCH-ARM / FISHERS | P=0.337N P=0.753N P=0.500N P=0.500N |P=0.043N* P=0.500N P=0.380 P=0.070N | |ORDER RESTRICTED | P=0.184N (e) (e) (e) |P=0.078N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 29/50 (58%) 20/50 (40%) 24/50 (48%) 18/50 (36%) |17/50 (34%) 27/50 (54%) 28/50 (56%) 27/50 (54%) | |POLY-3 RATE (b) | 29/48.05 20/48.14 24/45.66 18/47.96 |17/45.21 27/48.77 28/48.74 27/45.16 | |POLY-3 PERCENT (g) | 60.4% 41.6% 52.6% 37.5% |37.6% 55.4% 57.5% 59.8% | |TERMINAL (d) | 15/31 (48%) 10/35 (29%) 16/32 (50%) 6/32 (19%) |9/33 (27%) 11/30 (37%) 14/33 (42%) 8/22 (36%) | |FIRST INCIDENCE | 355 393 544 562 |436 374 374 516 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.069N P=0.046N* P=0.211N P=0.040N* |P=0.008 ** P=0.055 P=0.059 P=0.008 ** | |POLY 3 | P=0.037N* P=0.048N* P=0.288N P=0.018N* |P=0.038 * P=0.062 P=0.040 * P=0.025 * | |POLY 1.5 | P=0.037N* P=0.053N P=0.265N P=0.019N* |P=0.042 * P=0.050 P=0.032 * P=0.027 * | |POLY 6 | P=0.038N* P=0.042N* P=0.322N P=0.018N* |P=0.031 * P=0.074 P=0.048 * P=0.021 * | |LOGISTIC REGRESSION| P=0.042N* P=0.061N P=0.210N P=0.032N* |P=0.082 P=0.027 * P=0.018 * P=0.040 * | |COCH-ARM / FISHERS | P=0.040N* P=0.055N P=0.212N P=0.022N* |P=0.055 P=0.035 * P=0.022 * P=0.035 * | |ORDER RESTRICTED | P=0.014N* (e) (e) (e) |P=0.024 * (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 22 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 49/50 (98%) 49/50 (98%) 49/50 (98%) |46/50 (92%) 46/50 (92%) 49/50 (98%) 47/50 (94%) | |POLY-3 RATE (b) | 50/50.00 49/49.00 49/49.00 49/49.35 |46/48.43 46/50.00 49/50.00 47/48.56 | |POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 99.3% |95.0% 92.0% 98.0% 96.8% | |TERMINAL (d) | 31/31 (100%) 35/35 (100%) 32/32 (100%) 32/32 (100%)|31/33 (94%) 26/30 (87%) 32/33 (97%) 21/22 (96%) | |FIRST INCIDENCE | 355 393 460 562 |436 374 374 516 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.457N P=0.167N P=0.388N P=0.362N |P=0.010 * P=0.412 P=0.411 P=0.020 * | |POLY 3 | P=0.660N P=1.000N P=1.000N P=0.968N |P=0.276 P=0.423N P=0.391 P=0.528 | |POLY 1.5 | P=0.366N P=1.000N P=1.000N P=0.754N |P=0.265 P=0.500N P=0.298 P=0.483 | |POLY 6 | P=1.000N P=1.000N P=1.000N P=1.000N |P=0.272 P=0.371N P=0.465 P=0.547 | |LOGISTIC REGRESSION| P=0.062N (e) (e) P=0.288N |P=0.266 P=0.620N P=0.208 P=0.387 | |COCH-ARM / FISHERS | P=0.384N P=0.500N P=0.500N P=0.500N |P=0.344 P=0.643N P=0.181 P=0.500 | |ORDER RESTRICTED | P=0.119N (e) (e) (e) |P=0.273 (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).