TDMS Study 93023-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst 2,4-HEXADIENAL DATE: 03/14/01 EXPERIMENT: 93023 TEST: 06 TIME: 15:02:15 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-55393 ROUTE: GAVAGE NTP C#: 93023B PATHOLOGIST: HEATH, JAMES E. CAS: 142-83-6 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#1/RATS REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst 2,4-HEXADIENAL DATE: 03/14/01 EXPERIMENT: 93023 TEST: 06 TIME: 15:02:15 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55393 ROUTE: GAVAGE NTP C#: 93023B PATHOLOGIST: HEATH, JAMES E. CAS: 142-83-6 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 Heart Islets, Pancreatic Kidney Liver Lung Ovary Pancreas Pituitary Gland Prostate Salivary Glands Testes Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst 2,4-HEXADIENAL DATE: 03/14/01 EXPERIMENT: 93023 TEST: 06 TIME: 15:02:15 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55393 ROUTE: GAVAGE NTP C#: 93023B PATHOLOGIST: HEATH, JAMES E. CAS: 142-83-6 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF 2,4-HEXADIENAL =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Malignant Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Stomach, Forestomach Squamous Cell Carcinoma or Papilloma Squamous Squamous Cell Papilloma Testes Adenoma Thyroid Gland: C-Cell Carcinoma All Organs Mesothelioma: Benign, Malignant, NOS Mesothelioma: Malignant Malignant Tumors =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Mammary Gland Fibroma, Fibroadenoma, Carcinoma, or Adenoma Stomach, Forestomach Squamous Cell Carcinoma or Papilloma Squamous Squamous Cell Papilloma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated =============================================================== Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 6/49 (12%) 7/50 (14%) 7/49 (14%) |1/50 (2%) 5/49 (10%) 5/50 (10%) 1/50 (2%) | |POLY-3 RATE (b) | 7/45.23 6/42.62 7/44.04 7/40.62 |1/45.36 5/44.98 5/45.73 1/40.99 | |POLY-3 PERCENT (g) | 15.5% 14.1% 15.9% 17.2% |2.2% 11.1% 10.9% 2.4% | |TERMINAL (d) | 5/37 (14%) 6/34 (18%) 5/33 (15%) 5/29 (17%) |1/37 (3%) 4/38 (11%) 4/41 (10%) 0/31 (0%) | |FIRST INCIDENCE | 587 729 (T) 536 691 |729 (T) 719 659 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.348 P=0.560N P=0.534 P=0.444 |P=0.507N P=0.113 P=0.125 P=0.731 | |POLY 3 | P=0.437 P=0.546N P=0.593 P=0.529 |P=0.493N P=0.099 P=0.103 P=0.738 | |POLY 1.5 | P=0.460 P=0.538N P=0.604 P=0.551 |P=0.467N P=0.098 P=0.103 P=0.745 | |POLY 6 | P=0.412 P=0.554N P=0.578 P=0.504 |P=0.516N P=0.100 P=0.103 P=0.731 | |LOGISTIC REGRESSION| P=0.439 P=0.536N P=0.608 P=0.527 |P=0.458N P=0.102 P=0.103 P=0.735N | |COCH-ARM / FISHERS | P=0.503 P=0.516N P=0.613N P=0.597 |P=0.417N P=0.098 P=0.102 P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/49 (2%) 1/50 (2%) 4/49 (8%) |1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/44.63 1/42.62 1/43.01 4/41.03 |1/45.36 0/44.94 0/45.47 1/40.39 | |POLY-3 PERCENT (g) | 0.0% 2.4% 2.3% 9.8% |2.2% 0.0% 0.0% 2.5% | |TERMINAL (d) | 0/37 (0%) 1/34 (3%) 1/33 (3%) 3/29 (10%) |1/37 (3%) 0/38 (0%) 0/41 (0%) 1/31 (3%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 496 |729 (T) --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.010 * P=0.483 P=0.477 P=0.043 * |P=0.564 P=0.495N P=0.480N P=0.722 | |POLY 3 | P=0.014 * P=0.491 P=0.493 P=0.050 |P=0.578 P=0.502N P=0.500N P=0.734 | |POLY 1.5 | P=0.015 * P=0.492 P=0.496 P=0.052 |P=0.584 P=0.503N P=0.499N P=0.743 | |POLY 6 | P=0.013 * P=0.491 P=0.488 P=0.047 * |P=0.572 P=0.501N P=0.500N P=0.725 | |LOGISTIC REGRESSION| P=0.016 * P=0.483 P=0.477 P=0.061 |P=0.564 (e) (e) P=0.722 | |COCH-ARM / FISHERS | P=0.017 * P=0.495 P=0.500 P=0.056 |P=0.596 P=0.505N P=0.500N P=0.753N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 8/49 (16%) 9/50 (18%) 11/49 (22%) |2/50 (4%) 5/49 (10%) 5/50 (10%) 3/50 (6%) | |POLY-3 RATE (b) | 7/45.23 8/42.84 9/44.26 11/41.31 |2/45.36 5/44.98 5/45.73 3/41.23 | |POLY-3 PERCENT (g) | 15.5% 18.7% 20.3% 26.6% |4.4% 11.1% 10.9% 7.3% | |TERMINAL (d) | 5/37 (14%) 7/34 (21%) 6/33 (18%) 8/29 (28%) |2/37 (5%) 4/38 (11%) 4/41 (10%) 1/31 (3%) | |FIRST INCIDENCE | 587 671 536 496 |729 (T) 719 659 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.073 P=0.438 P=0.318 P=0.107 |P=0.418 P=0.232 P=0.254 P=0.431 | |POLY 3 | P=0.118 P=0.454 P=0.373 P=0.155 |P=0.446 P=0.213 P=0.219 P=0.457 | |POLY 1.5 | P=0.130 P=0.461 P=0.384 P=0.170 |P=0.470 P=0.211 P=0.220 P=0.471 | |POLY 6 | P=0.105 P=0.449 P=0.360 P=0.140 |P=0.426 P=0.215 P=0.220 P=0.445 | |LOGISTIC REGRESSION| P=0.121 P=0.462 P=0.386 P=0.162 |P=0.473 P=0.216 P=0.216 P=0.500 | |COCH-ARM / FISHERS | P=0.156 P=0.483 P=0.393 P=0.204 |P=0.522 P=0.210 P=0.218 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Brain | | Astrocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.63 0/43.62 0/43.01 1/41.62 |2/46.02 0/45.94 0/45.47 0/40.39 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.4% |4.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/35 (0%) 0/33 (0%) 0/30 (0%) |1/37 (3%) 0/39 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- 655 |511 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.184 (e) (e) P=0.480 |P=0.123N P=0.234N P=0.228N P=0.272N | |POLY 3 | P=0.191 (e) (e) P=0.486 |P=0.109N P=0.238N P=0.240N P=0.267N | |POLY 1.5 | P=0.193 (e) (e) P=0.490 |P=0.110N P=0.238N P=0.238N P=0.257N | |POLY 6 | P=0.188 (e) (e) P=0.482 |P=0.107N P=0.237N P=0.242N P=0.278N | |LOGISTIC REGRESSION| P=0.205 (e) (e) P=0.512 |P=0.092N P=0.242N P=0.264N P=0.192N | |COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.115N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.63 0/43.62 0/43.01 1/41.62 |2/46.02 1/46.83 1/45.47 0/40.39 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.4% |4.4% 2.1% 2.2% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/35 (0%) 0/33 (0%) 0/30 (0%) |1/37 (3%) 0/39 (0%) 1/41 (2%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- 655 |511 347 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.184 (e) (e) P=0.480 |P=0.169N P=0.494N P=0.476N P=0.272N | |POLY 3 | P=0.191 (e) (e) P=0.486 |P=0.172N P=0.494N P=0.504N P=0.267N | |POLY 1.5 | P=0.193 (e) (e) P=0.490 |P=0.166N P=0.496N P=0.501N P=0.257N | |POLY 6 | P=0.188 (e) (e) P=0.482 |P=0.178N P=0.493N P=0.507N P=0.278N | |LOGISTIC REGRESSION| P=0.205 (e) (e) P=0.512 |P=0.091N P=0.515N P=0.521N P=0.192N | |COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.153N P=0.500N P=0.500N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 4/50 (8%) 0/50 (0%) 1/50 (2%) |5/50 (10%) 8/50 (16%) 11/50 (22%) 7/50 (14%) | |POLY-3 RATE (b) | 1/43.75 4/43.62 0/43.01 1/41.35 |5/45.36 8/46.36 11/45.91 7/40.54 | |POLY-3 PERCENT (g) | 2.3% 9.2% 0.0% 2.4% |11.0% 17.3% 24.0% 17.3% | |TERMINAL (d) | 1/37 (3%) 4/35 (11%) 0/33 (0%) 1/30 (3%) |5/37 (14%) 7/39 (18%) 10/41 (24%) 6/31 (19%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |729 (T) 610 602 691 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.407N P=0.162 P=0.523N P=0.715 |P=0.215 P=0.310 P=0.122 P=0.259 | |POLY 3 | P=0.355N P=0.177 P=0.503N P=0.748 |P=0.242 P=0.290 P=0.087 P=0.302 | |POLY 1.5 | P=0.347N P=0.179 P=0.500N P=0.753 |P=0.279 P=0.284 P=0.087 P=0.328 | |POLY 6 | P=0.365N P=0.176 P=0.509N P=0.742 |P=0.212 P=0.297 P=0.087 P=0.280 | |LOGISTIC REGRESSION| P=0.407N P=0.162 (e) P=0.715 |P=0.234 P=0.285 P=0.084 P=0.248 | |COCH-ARM / FISHERS | P=0.332N P=0.187 P=0.495N P=0.747N |P=0.358 P=0.277 P=0.086 P=0.380 | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 3/50 (6%) 5/50 (10%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 3/50 (6%) 3/50 (6%) | |POLY-3 RATE (b) | 3/45.06 3/43.94 5/43.57 1/41.88 |2/45.49 1/45.94 3/45.47 3/40.54 | |POLY-3 PERCENT (g) | 6.7% 6.8% 11.5% 2.4% |4.4% 2.2% 6.6% 7.4% | |TERMINAL (d) | 1/37 (3%) 1/35 (3%) 3/33 (9%) 0/30 (0%) |0/37 (0%) 1/39 (3%) 3/41 (7%) 2/31 (7%) | |FIRST INCIDENCE | 259 671 620 566 |704 729 (T) 729 (T) 691 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.340N P=0.647 P=0.316 P=0.339N |P=0.222 P=0.491N P=0.530 P=0.405 | |POLY 3 | P=0.313N P=0.651 P=0.338 P=0.332N |P=0.251 P=0.497N P=0.500 P=0.448 | |POLY 1.5 | P=0.298N P=0.654 P=0.349 P=0.322N |P=0.268 P=0.498N P=0.502 P=0.466 | |POLY 6 | P=0.330N P=0.650 P=0.324 P=0.342N |P=0.236 P=0.495N P=0.497 P=0.431 | |LOGISTIC REGRESSION| P=0.232N P=0.613N P=0.378 P=0.183N |P=0.235 P=0.495N P=0.500 P=0.439 | |COCH-ARM / FISHERS | P=0.266N P=0.651N P=0.369 P=0.301N |P=0.302 P=0.500N P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 7/50 (14%) 5/50 (10%) 2/50 (4%) |7/50 (14%) 9/50 (18%) 14/50 (28%) 10/50 (20%) | |POLY-3 RATE (b) | 4/45.06 7/43.94 5/43.57 2/41.88 |7/45.49 9/46.36 14/45.91 10/40.69 | |POLY-3 PERCENT (g) | 8.9% 15.9% 11.5% 4.8% |15.4% 19.4% 30.5% 24.6% | |TERMINAL (d) | 2/37 (5%) 5/35 (14%) 3/33 (9%) 1/30 (3%) |5/37 (14%) 8/39 (21%) 13/41 (32%) 8/31 (26%) | |FIRST INCIDENCE | 259 671 620 566 |704 610 602 691 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.259N P=0.246 P=0.446 P=0.399N |P=0.110 P=0.434 P=0.110 P=0.172 | |POLY 3 | P=0.218N P=0.246 P=0.479 P=0.371N |P=0.135 P=0.408 P=0.069 P=0.212 | |POLY 1.5 | P=0.204N P=0.251 P=0.492 P=0.359N |P=0.166 P=0.402 P=0.070 P=0.240 | |POLY 6 | P=0.235N P=0.244 P=0.464 P=0.385N |P=0.112 P=0.415 P=0.068 P=0.190 | |LOGISTIC REGRESSION| P=0.165N P=0.285 P=0.527 P=0.247N |P=0.123 P=0.405 P=0.067 P=0.173 | |COCH-ARM / FISHERS | P=0.172N P=0.274 P=0.513 P=0.329N |P=0.237 P=0.393 P=0.070 P=0.298 | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 6/50 (12%) 5/50 (10%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 4/45.19 6/44.23 5/43.01 1/41.35 |1/45.37 1/45.94 1/45.47 0/40.39 | |POLY-3 PERCENT (g) | 8.9% 13.6% 11.6% 2.4% |2.2% 2.2% 2.2% 0.0% | |TERMINAL (d) | 3/37 (8%) 3/35 (9%) 5/33 (15%) 1/30 (3%) |0/37 (0%) 1/39 (3%) 1/41 (2%) 0/31 (0%) | |FIRST INCIDENCE | 554 659 729 (T) 729 (T) |727 729 (T) 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.169N P=0.355 P=0.433 P=0.238N |P=0.347N P=0.752N P=0.740N P=0.541N | |POLY 3 | P=0.141N P=0.356 P=0.469 P=0.207N |P=0.337N P=0.758N P=0.760N P=0.523N | |POLY 1.5 | P=0.129N P=0.357 P=0.484 P=0.197N |P=0.329N P=0.759N P=0.759N P=0.515N | |POLY 6 | P=0.156N P=0.359 P=0.449 P=0.217N |P=0.345N P=0.757N P=0.760 P=0.531N | |LOGISTIC REGRESSION| P=0.128N P=0.364 P=0.476 P=0.189N |P=0.354N P=0.756N P=0.759N P=0.541N | |COCH-ARM / FISHERS | P=0.109N P=0.370 P=0.500 P=0.181N |P=0.311N P=0.753N P=0.753N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.63 2/43.72 0/43.01 1/41.35 |0/45.36 1/46.19 0/45.47 0/40.39 | |POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 2.4% |0.0% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 1/35 (3%) 0/33 (0%) 1/30 (3%) |0/37 (0%) 0/39 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- 704 --- 729 (T) |--- 664 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.490 P=0.234 (e) P=0.458 |P=0.597N P=0.505 (e) (e) | |POLY 3 | P=0.511 P=0.232 (e) P=0.485 |P=0.568N P=0.504 (e) (e) | |POLY 1.5 | P=0.520 P=0.233 (e) P=0.490 |P=0.568N P=0.502 (e) (e) | |POLY 6 | P=0.501 P=0.233 (e) P=0.479 |P=0.567N P=0.506 (e) (e) | |LOGISTIC REGRESSION| P=0.508 P=0.232 (e) P=0.458 |P=0.551N P=0.497 (e) (e) | |COCH-ARM / FISHERS | P=0.539 P=0.247 (e) P=0.500 |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 7/50 (14%) 5/50 (10%) 2/50 (4%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 4/45.19 7/44.23 5/43.01 2/41.35 |1/45.37 2/46.19 1/45.47 0/40.39 | |POLY-3 PERCENT (g) | 8.9% 15.8% 11.6% 4.8% |2.2% 4.3% 2.2% 0.0% | |TERMINAL (d) | 3/37 (8%) 4/35 (11%) 5/33 (15%) 2/30 (7%) |0/37 (0%) 1/39 (3%) 1/41 (2%) 0/31 (0%) | |FIRST INCIDENCE | 554 659 729 (T) 729 (T) |727 664 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.268N P=0.250 P=0.433 P=0.424N |P=0.285N P=0.512 P=0.740N P=0.541N | |POLY 3 | P=0.226N P=0.248 P=0.469 P=0.379N |P=0.276N P=0.506 P=0.760N P=0.523N | |POLY 1.5 | P=0.209N P=0.250 P=0.484 P=0.365N |P=0.266N P=0.504 P=0.759N P=0.515N | |POLY 6 | P=0.247N P=0.250 P=0.449 P=0.395N |P=0.285N P=0.510 P=0.760 P=0.531N | |LOGISTIC REGRESSION| P=0.212N P=0.255 P=0.476 P=0.360N |P=0.269N P=0.502 P=0.759N P=0.541N | |COCH-ARM / FISHERS | P=0.179N P=0.262 P=0.500 P=0.339N |P=0.247N P=0.500 P=0.753N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 4/50 (8%) 1/50 (2%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 1/44.63 0/43.62 4/43.89 1/41.35 |3/45.46 1/45.94 1/45.47 0/40.39 | |POLY-3 PERCENT (g) | 2.2% 0.0% 9.1% 2.4% |6.6% 2.2% 2.2% 0.0% | |TERMINAL (d) | 1/37 (3%) 0/35 (0%) 3/33 (9%) 1/30 (3%) |2/37 (5%) 1/39 (3%) 1/41 (2%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) --- 364 729 (T) |704 729 (T) 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.381 P=0.511N P=0.156 P=0.715 |P=0.088N P=0.293N P=0.282N P=0.162N | |POLY 3 | P=0.400 P=0.505N P=0.173 P=0.744 |P=0.082N P=0.302N P=0.305N P=0.141N | |POLY 1.5 | P=0.414 P=0.504N P=0.177 P=0.749 |P=0.079N P=0.303N P=0.304N P=0.133N | |POLY 6 | P=0.384 P=0.505N P=0.167 P=0.738 |P=0.085N P=0.300N P=0.307N P=0.149N | |LOGISTIC REGRESSION| P=0.456 (e) P=0.184 P=0.715 |P=0.088N P=0.298N P=0.304N P=0.149N | |COCH-ARM / FISHERS | P=0.444 P=0.500N P=0.181 P=0.753N |P=0.073N P=0.309N P=0.309N P=0.121N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.63 0/43.62 3/43.01 1/41.35 |0/45.36 0/45.94 1/45.47 0/40.39 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.0% 2.4% |0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/35 (0%) 3/33 (9%) 1/30 (3%) |0/37 (0%) 0/39 (0%) 1/41 (2%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.197 (e) P=0.101 P=0.458 |P=0.679 (e) P=0.520 (e) | |POLY 3 | P=0.214 (e) P=0.112 P=0.485 |P=0.639 (e) P=0.500 (e) | |POLY 1.5 | P=0.224 (e) P=0.115 P=0.490 |P=0.659 (e) P=0.501 (e) | |POLY 6 | P=0.203 (e) P=0.107 P=0.479 |P=0.620 (e) P=0.500 (e) | |LOGISTIC REGRESSION| (e) (e) P=0.101 P=0.458 |(e) (e) P=0.520 (e) | |COCH-ARM / FISHERS | P=0.247 (e) P=0.121 P=0.500 |P=0.694 (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 6/50 (12%) 2/50 (4%) |3/50 (6%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 1/44.63 0/43.62 6/43.89 2/41.35 |3/45.46 1/45.94 2/45.47 0/40.39 | |POLY-3 PERCENT (g) | 2.2% 0.0% 13.7% 4.8% |6.6% 2.2% 4.4% 0.0% | |TERMINAL (d) | 1/37 (3%) 0/35 (0%) 5/33 (15%) 2/30 (7%) |2/37 (5%) 1/39 (3%) 2/41 (5%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) --- 364 729 (T) |704 729 (T) 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.165 P=0.511N P=0.045 * P=0.427 |P=0.128N P=0.293N P=0.465N P=0.162N | |POLY 3 | P=0.184 P=0.505N P=0.053 P=0.473 |P=0.123N P=0.302N P=0.500N P=0.141N | |POLY 1.5 | P=0.196 P=0.504N P=0.055 P=0.482 |P=0.116N P=0.303N P=0.498N P=0.133N | |POLY 6 | P=0.170 P=0.505N P=0.049 * P=0.464 |P=0.129N P=0.300N P=0.502N P=0.149N | |LOGISTIC REGRESSION| P=0.220 (e) P=0.060 P=0.427 |P=0.128N P=0.298N P=0.500N P=0.149N | |COCH-ARM / FISHERS | P=0.227 P=0.500N P=0.056 P=0.500 |P=0.104N P=0.309N P=0.500N P=0.121N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 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) | 0/44.63 0/43.62 0/43.01 0/41.35 |2/45.43 0/45.94 0/45.47 0/40.39 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/35 (0%) 0/33 (0%) 0/30 (0%) |1/37 (3%) 0/39 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |712 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.126N P=0.229N P=0.226N P=0.285N | |POLY 3 | (e) (e) (e) (e) |P=0.109N P=0.235N P=0.237N P=0.264N | |POLY 1.5 | (e) (e) (e) (e) |P=0.111N P=0.236N P=0.236N P=0.255N | |POLY 6 | (e) (e) (e) (e) |P=0.108N P=0.234N P=0.238N P=0.274N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.124N P=0.234N P=0.237N P=0.272N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 2/44.73 0/43.62 0/43.01 0/41.35 |2/45.53 3/45.98 0/45.47 1/40.39 | |POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |4.4% 6.5% 0.0% 2.5% | |TERMINAL (d) | 1/37 (3%) 0/35 (0%) 0/33 (0%) 0/30 (0%) |0/37 (0%) 2/39 (5%) 0/41 (0%) 1/31 (3%) | |FIRST INCIDENCE | 704 --- --- --- |704 719 --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.132N P=0.246N P=0.265N P=0.279N |P=0.297N P=0.520 P=0.240N P=0.577N | |POLY 3 | P=0.110N P=0.243N P=0.246N P=0.255N |P=0.260N P=0.505 P=0.237N P=0.542N | |POLY 1.5 | P=0.111N P=0.242N P=0.242N P=0.249N |P=0.254N P=0.503 P=0.237N P=0.527N | |POLY 6 | P=0.110N P=0.243N P=0.252N P=0.262N |P=0.266N P=0.506 P=0.239N P=0.556N | |LOGISTIC REGRESSION| P=0.123N P=0.242N P=0.250N P=0.259N |P=0.282N P=0.507 P=0.237N P=0.547N | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.242N P=0.500 P=0.247N P=0.500N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 3/50 (6%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 2/44.73 0/43.62 0/43.01 0/41.35 |3/45.53 3/45.98 0/45.47 1/40.39 | |POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |6.6% 6.5% 0.0% 2.5% | |TERMINAL (d) | 1/37 (3%) 0/35 (0%) 0/33 (0%) 0/30 (0%) |1/37 (3%) 2/39 (5%) 0/41 (0%) 1/31 (3%) | |FIRST INCIDENCE | 704 --- --- --- |704 719 --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.132N P=0.246N P=0.265N P=0.279N |P=0.173N P=0.638N P=0.118N P=0.385N | |POLY 3 | P=0.110N P=0.243N P=0.246N P=0.255N |P=0.147N P=0.658N P=0.119N P=0.349N | |POLY 1.5 | P=0.111N P=0.242N P=0.242N P=0.249N |P=0.142N P=0.659N P=0.118N P=0.334N | |POLY 6 | P=0.110N P=0.243N P=0.252N P=0.262N |P=0.151N P=0.656N P=0.120N P=0.365N | |LOGISTIC REGRESSION| P=0.123N P=0.242N P=0.250N P=0.259N |P=0.164N P=0.656N P=0.120N P=0.359N | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.134N P=0.661N P=0.121N P=0.309N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |22/50 (44%) 28/50 (56%) 22/50 (44%) 18/50 (36%) | |POLY-3 RATE (b) | 3/44.63 1/43.62 1/43.40 2/41.75 |22/47.24 28/47.18 22/45.73 18/42.31 | |POLY-3 PERCENT (g) | 6.7% 2.3% 2.3% 4.8% |46.6% 59.3% 48.1% 42.5% | |TERMINAL (d) | 3/37 (8%) 1/35 (3%) 0/33 (0%) 0/30 (0%) |16/37 (43%) 23/39 (59%) 21/41 (51%) 12/31 (39%) | |FIRST INCIDENCE | 729 (T) 729 (T) 620 655 |511 544 659 445 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.541N P=0.325N P=0.340N P=0.580N |P=0.349N P=0.243 P=0.431N P=0.529N | |POLY 3 | P=0.486N P=0.313N P=0.315N P=0.530N |P=0.249N P=0.148 P=0.524 P=0.432N | |POLY 1.5 | P=0.482N P=0.312N P=0.310N P=0.522N |P=0.193N P=0.151 P=0.554 P=0.373N | |POLY 6 | P=0.491N P=0.313N P=0.322N P=0.539N |P=0.306N P=0.145 P=0.485 P=0.486N | |LOGISTIC REGRESSION| P=0.491N P=0.325N P=0.312N P=0.534N |P=0.229N P=0.164 P=0.577N P=0.374N | |COCH-ARM / FISHERS | P=0.474N P=0.309N P=0.309N P=0.500N |P=0.115N P=0.159 P=0.580N P=0.270N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |23/50 (46%) 28/50 (56%) 22/50 (44%) 18/50 (36%) | |POLY-3 RATE (b) | 3/44.63 1/43.62 1/43.40 2/41.75 |23/47.24 28/47.18 22/45.73 18/42.31 | |POLY-3 PERCENT (g) | 6.7% 2.3% 2.3% 4.8% |48.7% 59.3% 48.1% 42.5% | |TERMINAL (d) | 3/37 (8%) 1/35 (3%) 0/33 (0%) 0/30 (0%) |17/37 (46%) 23/39 (59%) 21/41 (51%) 12/31 (39%) | |FIRST INCIDENCE | 729 (T) 729 (T) 620 655 |511 544 659 445 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.541N P=0.325N P=0.340N P=0.580N |P=0.293N P=0.305 P=0.353N P=0.461N | |POLY 3 | P=0.486N P=0.313N P=0.315N P=0.530N |P=0.197N P=0.201 P=0.560N P=0.355N | |POLY 1.5 | P=0.482N P=0.312N P=0.310N P=0.522N |P=0.149N P=0.204 P=0.529N P=0.299N | |POLY 6 | P=0.491N P=0.313N P=0.322N P=0.539N |P=0.247N P=0.198 P=0.566 P=0.407N | |LOGISTIC REGRESSION| P=0.491N P=0.325N P=0.312N P=0.534N |P=0.182N P=0.220 P=0.496N P=0.305N | |COCH-ARM / FISHERS | P=0.474N P=0.309N P=0.309N P=0.500N |P=0.086N P=0.212 P=0.500N P=0.208N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |24/50 (48%) 30/50 (60%) 22/50 (44%) 18/50 (36%) | |POLY-3 RATE (b) | 5/44.73 1/43.62 1/43.40 2/41.75 |24/47.34 30/47.18 22/45.73 18/42.31 | |POLY-3 PERCENT (g) | 11.2% 2.3% 2.3% 4.8% |50.7% 63.6% 48.1% 42.5% | |TERMINAL (d) | 4/37 (11%) 1/35 (3%) 0/33 (0%) 0/30 (0%) |17/37 (46%) 25/39 (64%) 21/41 (51%) 12/31 (39%) | |FIRST INCIDENCE | 704 729 (T) 620 655 |511 544 659 445 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.252N P=0.116N P=0.131N P=0.298N |P=0.208N P=0.251 P=0.289N P=0.399N | |POLY 3 | P=0.199N P=0.107N P=0.108N P=0.244N |P=0.123N P=0.143 P=0.483N P=0.287N | |POLY 1.5 | P=0.196N P=0.106N P=0.105N P=0.236N |P=0.088N P=0.147 P=0.449N P=0.235N | |POLY 6 | P=0.203N P=0.107N P=0.112N P=0.253N |P=0.164N P=0.137 P=0.528N P=0.338N | |LOGISTIC REGRESSION| P=0.209N P=0.108N P=0.110N P=0.249N |P=0.113N P=0.164 P=0.415N P=0.239N | |COCH-ARM / FISHERS | P=0.194N P=0.102N P=0.102N P=0.218N |P=0.047N* P=0.158 P=0.421N P=0.156N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 1/44.97 1/43.62 2/43.69 1/41.35 |1/45.39 0/45.94 2/46.19 1/40.39 | |POLY-3 PERCENT (g) | 2.2% 2.3% 4.6% 2.4% |2.2% 0.0% 4.3% 2.5% | |TERMINAL (d) | 0/37 (0%) 1/35 (3%) 0/33 (0%) 1/30 (3%) |0/37 (0%) 0/39 (0%) 1/41 (2%) 1/31 (3%) | |FIRST INCIDENCE | 634 729 (T) 606 729 (T) |722 --- 476 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.544 P=0.757 P=0.483 P=0.729 |P=0.448 P=0.495N P=0.522 P=0.715 | |POLY 3 | P=0.554 P=0.754 P=0.490 P=0.742 |P=0.445 P=0.498N P=0.506 P=0.734 | |POLY 1.5 | P=0.566 P=0.755 P=0.495 P=0.748 |P=0.464 P=0.499N P=0.505 P=0.743 | |POLY 6 | P=0.539 P=0.753 P=0.483 P=0.734 |P=0.427 P=0.497N P=0.507 P=0.725 | |LOGISTIC REGRESSION| P=0.598 P=0.761N P=0.504 P=0.763 |P=0.534 P=0.496N P=0.469 P=0.720 | |COCH-ARM / FISHERS | P=0.591 P=0.753N P=0.500 P=0.753N |P=0.500 P=0.500N P=0.500 P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 5/50 (10%) 9/50 (18%) 6/50 (12%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 10/44.85 5/43.62 9/43.18 6/41.35 |1/45.36 0/45.94 0/45.47 1/40.39 | |POLY-3 PERCENT (g) | 22.3% 11.5% 20.8% 14.5% |2.2% 0.0% 0.0% 2.5% | |TERMINAL (d) | 8/37 (22%) 5/35 (14%) 8/33 (24%) 6/30 (20%) |1/37 (3%) 0/39 (0%) 0/41 (0%) 1/31 (3%) | |FIRST INCIDENCE | 699 729 (T) 686 729 (T) |729 (T) --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.435N P=0.156N P=0.590 P=0.352N |P=0.562 P=0.489N P=0.480N P=0.722 | |POLY 3 | P=0.326N P=0.140N P=0.537N P=0.257N |P=0.576 P=0.497N P=0.500N P=0.734 | |POLY 1.5 | P=0.307N P=0.139N P=0.519N P=0.240N |P=0.583 P=0.499N P=0.499N P=0.743 | |POLY 6 | P=0.350N P=0.141N P=0.563N P=0.279N |P=0.571 P=0.496N P=0.500N P=0.725 | |LOGISTIC REGRESSION| P=0.390N P=0.139N P=0.585N P=0.303N |P=0.562 (e) (e) P=0.722 | |COCH-ARM / FISHERS | P=0.273N P=0.131N P=0.500N P=0.207N |P=0.595 P=0.500N P=0.500N P=0.753N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 16/50 (32%) 15/50 (30%) 19/50 (38%) |19/50 (38%) 26/50 (52%) 22/50 (44%) 20/50 (40%) | |POLY-3 RATE (b) | 12/46.24 16/45.27 15/44.33 19/43.17 |19/46.82 26/47.13 22/46.58 20/41.81 | |POLY-3 PERCENT (g) | 26.0% 35.3% 33.8% 44.0% |40.6% 55.2% 47.2% 47.8% | |TERMINAL (d) | 8/37 (22%) 10/35 (29%) 10/33 (30%) 12/30 (40%) |12/37 (32%) 21/39 (54%) 19/41 (46%) 15/31 (48%) | |FIRST INCIDENCE | 542 537 560 574 |560 610 602 560 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.039 * P=0.234 P=0.239 P=0.043 * |P=0.321 P=0.186 P=0.466 P=0.260 | |POLY 3 | P=0.055 P=0.227 P=0.277 P=0.055 |P=0.399 P=0.111 P=0.330 P=0.318 | |POLY 1.5 | P=0.067 P=0.230 P=0.299 P=0.065 |P=0.477 P=0.111 P=0.341 P=0.379 | |POLY 6 | P=0.046 * P=0.230 P=0.251 P=0.048 * |P=0.331 P=0.111 P=0.315 P=0.266 | |LOGISTIC REGRESSION| P=0.071 P=0.244 P=0.313 P=0.072 |P=0.423 P=0.119 P=0.346 P=0.334 | |COCH-ARM / FISHERS | P=0.098 P=0.252 P=0.326 P=0.097 |P=0.452N P=0.114 P=0.342 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Prostate | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 2/47 (4%) 3/50 (6%) 3/50 (6%) | | |POLY-3 RATE (b) | 2/43.63 2/40.96 3/43.01 3/41.35 | | |POLY-3 PERCENT (g) | 4.6% 4.9% 7.0% 7.3% | | |TERMINAL (d) | 2/36 (6%) 2/33 (6%) 3/33 (9%) 3/30 (10%) | | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.294 P=0.664 P=0.460 P=0.417 | | |POLY 3 | P=0.352 P=0.671 P=0.494 P=0.475 | | |POLY 1.5 | P=0.365 P=0.672 P=0.501 P=0.486 | | |POLY 6 | P=0.337 P=0.673 P=0.483 P=0.464 | | |LOGISTIC REGRESSION| P=0.294 P=0.664 P=0.460 P=0.417 | | |COCH-ARM / FISHERS | P=0.389 P=0.676 P=0.510 P=0.510 | | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |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) | 5/50 (10%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 5/44.63 2/43.62 3/43.01 2/41.35 |1/45.36 0/45.94 1/45.73 0/40.39 | |POLY-3 PERCENT (g) | 11.2% 4.6% 7.0% 4.8% |2.2% 0.0% 2.2% 0.0% | |TERMINAL (d) | 5/37 (14%) 2/35 (6%) 3/33 (9%) 2/30 (7%) |1/37 (3%) 0/39 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) --- 659 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.292N P=0.238N P=0.420N P=0.307N |P=0.441N P=0.489N P=0.752N P=0.535N | |POLY 3 | P=0.233N P=0.225N P=0.376N P=0.248N |P=0.423N P=0.497N P=0.759N P=0.523N | |POLY 1.5 | P=0.225N P=0.224N P=0.367N P=0.238N |P=0.417N P=0.499N P=0.759N P=0.515N | |POLY 6 | P=0.243N P=0.224N P=0.390N P=0.259N |P=0.429N P=0.496N P=0.759N P=0.530N | |LOGISTIC REGRESSION| P=0.292N P=0.238N P=0.420N P=0.307N |P=0.408N (e) P=0.762 (e) | |COCH-ARM / FISHERS | P=0.210N P=0.218N P=0.357N P=0.218N |P=0.405N P=0.500N P=0.753N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 6/50 (12%) 5/50 (10%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 4/45.11 3/43.93 6/43.69 5/41.95 |2/45.61 0/45.94 1/45.47 2/40.39 | |POLY-3 PERCENT (g) | 8.9% 6.8% 13.7% 11.9% |4.4% 0.0% 2.2% 5.0% | |TERMINAL (d) | 3/37 (8%) 2/35 (6%) 5/33 (15%) 3/30 (10%) |1/37 (3%) 0/39 (0%) 1/41 (2%) 2/31 (7%) | |FIRST INCIDENCE | 587 643 503 636 |664 --- 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.242 P=0.521N P=0.313 P=0.400 |P=0.408 P=0.231N P=0.479N P=0.629 | |POLY 3 | P=0.293 P=0.514N P=0.349 P=0.454 |P=0.435 P=0.236N P=0.501N P=0.649 | |POLY 1.5 | P=0.308 P=0.512N P=0.360 P=0.468 |P=0.447 P=0.236N P=0.499N P=0.665 | |POLY 6 | P=0.278 P=0.515N P=0.333 P=0.441 |P=0.425 P=0.235N P=0.504N P=0.634 | |LOGISTIC REGRESSION| P=0.317 P=0.505N P=0.367 P=0.476 |P=0.425 P=0.238N P=0.499N P=0.651 | |COCH-ARM / FISHERS | P=0.338 P=0.500N P=0.370 P=0.500 |P=0.469 P=0.247N P=0.500N P=0.691N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 4/50 (8%) 7/50 (14%) 5/50 (10%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 3/50 (6%) | |POLY-3 RATE (b) | 7/45.11 4/44.03 7/43.69 5/41.95 |2/45.61 1/45.97 2/45.73 3/40.99 | |POLY-3 PERCENT (g) | 15.5% 9.1% 16.0% 11.9% |4.4% 2.2% 4.4% 7.3% | |TERMINAL (d) | 6/37 (16%) 2/35 (6%) 6/33 (18%) 3/30 (10%) |1/37 (3%) 0/39 (0%) 1/41 (2%) 2/31 (7%) | |FIRST INCIDENCE | 587 643 503 636 |664 722 659 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.558N P=0.289N P=0.534 P=0.506N |P=0.245 P=0.488N P=0.678N P=0.429 | |POLY 3 | P=0.474N P=0.274N P=0.589 P=0.431N |P=0.274 P=0.497N P=0.693N P=0.452 | |POLY 1.5 | P=0.458N P=0.273N P=0.602 P=0.415N |P=0.287 P=0.498N P=0.692N P=0.468 | |POLY 6 | P=0.493N P=0.273N P=0.570 P=0.446N |P=0.262 P=0.496N P=0.694 P=0.436 | |LOGISTIC REGRESSION| P=0.463N P=0.271N P=0.597 P=0.422N |P=0.315 P=0.499N P=0.694 P=0.501 | |COCH-ARM / FISHERS | P=0.426N P=0.262N P=0.613N P=0.380N |P=0.313 P=0.500N P=0.691N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 3/44.63 1/43.72 1/43.01 0/41.35 |0/45.36 1/45.97 0/45.47 1/40.99 | |POLY-3 PERCENT (g) | 6.7% 2.3% 2.3% 0.0% |0.0% 2.2% 0.0% 2.4% | |TERMINAL (d) | 3/37 (8%) 0/35 (0%) 1/33 (3%) 0/30 (0%) |0/37 (0%) 0/39 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) 704 729 (T) --- |--- 722 --- 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.096N P=0.322N P=0.346N P=0.160N |P=0.370 P=0.505 (e) P=0.482 | |POLY 3 | P=0.078N P=0.313N P=0.318N P=0.133N |P=0.380 P=0.503 (e) P=0.480 | |POLY 1.5 | P=0.076N P=0.312N P=0.312N P=0.128N |P=0.388 P=0.502 (e) P=0.487 | |POLY 6 | P=0.080N P=0.311N P=0.327N P=0.138N |P=0.373 P=0.504 (e) P=0.474 | |LOGISTIC REGRESSION| P=0.087N P=0.313N P=0.346N (e) |P=0.460 P=0.504 (e) P=0.586 | |COCH-ARM / FISHERS | P=0.073N P=0.309N P=0.309N P=0.121N |P=0.405 P=0.500 (e) P=0.500 | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 3/44.63 1/43.72 1/43.01 0/41.35 |0/45.36 1/45.97 1/45.73 1/40.99 | |POLY-3 PERCENT (g) | 6.7% 2.3% 2.3% 0.0% |0.0% 2.2% 2.2% 2.4% | |TERMINAL (d) | 3/37 (8%) 0/35 (0%) 1/33 (3%) 0/30 (0%) |0/37 (0%) 0/39 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) 704 729 (T) --- |--- 722 659 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.096N P=0.322N P=0.346N P=0.160N |P=0.339 P=0.505 P=0.495 P=0.482 | |POLY 3 | P=0.078N P=0.313N P=0.318N P=0.133N |P=0.345 P=0.503 P=0.502 P=0.480 | |POLY 1.5 | P=0.076N P=0.312N P=0.312N P=0.128N |P=0.358 P=0.502 P=0.502 P=0.487 | |POLY 6 | P=0.080N P=0.311N P=0.327N P=0.138N |P=0.333 P=0.504 P=0.502 P=0.474 | |LOGISTIC REGRESSION| P=0.087N P=0.313N P=0.346N (e) |P=0.440 P=0.504 P=0.489 P=0.586 | |COCH-ARM / FISHERS | P=0.073N P=0.309N P=0.309N P=0.121N |P=0.384 P=0.500 P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/44.63 2/43.62 1/43.01 1/41.35 |1/45.36 0/45.94 0/45.47 0/40.39 | |POLY-3 PERCENT (g) | 6.7% 4.6% 2.3% 2.4% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/37 (8%) 2/35 (6%) 1/33 (3%) 1/30 (3%) |1/37 (3%) 0/39 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.256N P=0.526N P=0.346N P=0.382N |P=0.321N P=0.489N P=0.480N P=0.535N | |POLY 3 | P=0.214N P=0.510N P=0.318N P=0.333N |P=0.293N P=0.497N P=0.500N P=0.523N | |POLY 1.5 | P=0.209N P=0.509N P=0.312N P=0.324N |P=0.298N P=0.499N P=0.499N P=0.515N | |POLY 6 | P=0.221N P=0.511N P=0.327N P=0.343N |P=0.288N P=0.496N P=0.500N P=0.530N | |LOGISTIC REGRESSION| P=0.256N P=0.526N P=0.346N P=0.382N |P=0.321N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.199N P=0.500N P=0.309N P=0.309N |P=0.306N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Skin | | Neural Crest Tumor | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 1/44.63 1/44.28 0/43.01 2/41.35 |0/45.36 0/45.94 2/45.47 0/40.39 | |POLY-3 PERCENT (g) | 2.2% 2.3% 0.0% 4.8% |0.0% 0.0% 4.4% 0.0% | |TERMINAL (d) | 1/37 (3%) 0/35 (0%) 0/33 (0%) 2/30 (7%) |0/37 (0%) 0/39 (0%) 2/41 (5%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) 509 --- 729 (T) |--- --- 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.318 P=0.752 P=0.523N P=0.427 |P=0.562 (e) P=0.261 (e) | |POLY 3 | P=0.349 P=0.759 P=0.507N P=0.473 |P=0.524 (e) P=0.238 (e) | |POLY 1.5 | P=0.356 P=0.758 P=0.504N P=0.482 |P=0.549 (e) P=0.238 (e) | |POLY 6 | P=0.342 P=0.760 P=0.512N P=0.464 |P=0.500 (e) P=0.237 (e) | |LOGISTIC REGRESSION| P=0.371 P=0.743N (e) P=0.427 |(e) (e) P=0.261 (e) | |COCH-ARM / FISHERS | P=0.366 P=0.753N P=0.500N P=0.500 |P=0.595 (e) P=0.247 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Skin | | Schwannoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.63 1/43.96 0/43.01 0/41.35 |0/45.36 0/45.94 2/46.05 0/40.39 | |POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |0.0% 0.0% 4.3% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/35 (0%) 0/33 (0%) 0/30 (0%) |0/37 (0%) 0/39 (0%) 1/41 (2%) 0/31 (0%) | |FIRST INCIDENCE | --- 634 --- --- |--- --- 544 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.581N P=0.505 (e) (e) |P=0.567 (e) P=0.251 (e) | |POLY 3 | P=0.574N P=0.497 (e) (e) |P=0.522 (e) P=0.241 (e) | |POLY 1.5 | P=0.572N P=0.497 (e) (e) |P=0.548 (e) P=0.240 (e) | |POLY 6 | P=0.577N P=0.498 (e) (e) |P=0.497 (e) P=0.241 (e) | |LOGISTIC REGRESSION| P=0.551N P=0.515 (e) (e) |P=0.639 (e) P=0.210 (e) | |COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.595 (e) P=0.247 (e) | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 4/44.63 2/43.62 2/43.01 1/41.35 |1/45.36 0/45.94 0/45.47 0/40.39 | |POLY-3 PERCENT (g) | 9.0% 4.6% 4.7% 2.4% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/37 (11%) 2/35 (6%) 2/33 (6%) 1/30 (3%) |1/37 (3%) 0/39 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.189N P=0.362N P=0.390N P=0.247N |P=0.321N P=0.489N P=0.480N P=0.535N | |POLY 3 | P=0.151N P=0.348N P=0.354N P=0.202N |P=0.293N P=0.497N P=0.500N P=0.523N | |POLY 1.5 | P=0.146N P=0.346N P=0.346N P=0.195N |P=0.298N P=0.499N P=0.499N P=0.515N | |POLY 6 | P=0.158N P=0.347N P=0.366N P=0.211N |P=0.288N P=0.496N P=0.500N P=0.530N | |LOGISTIC REGRESSION| P=0.189N P=0.362N P=0.390N P=0.247N |P=0.321N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.137N P=0.339N P=0.339N P=0.181N |P=0.306N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 4/44.63 2/43.62 2/43.01 1/41.35 |1/45.36 0/45.94 0/45.47 0/40.39 | |POLY-3 PERCENT (g) | 9.0% 4.6% 4.7% 2.4% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/37 (11%) 2/35 (6%) 2/33 (6%) 1/30 (3%) |1/37 (3%) 0/39 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.189N P=0.362N P=0.390N P=0.247N |P=0.321N P=0.489N P=0.480N P=0.535N | |POLY 3 | P=0.151N P=0.348N P=0.354N P=0.202N |P=0.293N P=0.497N P=0.500N P=0.523N | |POLY 1.5 | P=0.146N P=0.346N P=0.346N P=0.195N |P=0.298N P=0.499N P=0.499N P=0.515N | |POLY 6 | P=0.158N P=0.347N P=0.366N P=0.211N |P=0.288N P=0.496N P=0.500N P=0.530N | |LOGISTIC REGRESSION| P=0.189N P=0.362N P=0.390N P=0.247N |P=0.321N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.137N P=0.339N P=0.339N P=0.181N |P=0.306N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.63 0/43.62 1/43.01 2/41.35 |0/45.36 0/45.94 0/45.47 0/40.39 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 4.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/35 (0%) 1/33 (3%) 2/30 (7%) |0/37 (0%) 0/39 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.051 (e) P=0.477 P=0.193 |(e) (e) (e) (e) | |POLY 3 | P=0.063 (e) P=0.493 P=0.220 |(e) (e) (e) (e) | |POLY 1.5 | P=0.065 (e) P=0.496 P=0.226 |(e) (e) (e) (e) | |POLY 6 | P=0.060 (e) P=0.488 P=0.215 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.477 P=0.193 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.070 (e) P=0.500 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 11/50 (22%) 29/50 (58%) |0/50 (0%) 1/50 (2%) 5/50 (10%) 17/50 (34%) | |POLY-3 RATE (b) | 0/44.63 3/43.62 11/43.16 29/43.31 |0/45.36 1/45.94 5/45.47 17/40.57 | |POLY-3 PERCENT (g) | 0.0% 6.9% 25.5% 67.0% |0.0% 2.2% 11.0% 41.9% | |TERMINAL (d) | 0/37 (0%) 3/35 (9%) 10/33 (30%) 23/30 (77%) |0/37 (0%) 1/39 (3%) 5/41 (12%) 15/31 (48%) | |FIRST INCIDENCE | --- 729 (T) 691 574 |--- 729 (T) 729 (T) 691 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.111 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.511 P=0.043 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.114 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.503 P=0.031 * P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.115 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.501 P=0.031 * P<0.001 ** | |POLY 6 | P<0.001 ** P=0.114 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.504 P=0.030 * P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.111 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.511 P=0.043 * P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.121 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.500 P=0.028 * P<0.001 ** | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 10/50 (20%) 29/50 (58%) |0/50 (0%) 1/50 (2%) 5/50 (10%) 17/50 (34%) | |POLY-3 RATE (b) | 0/44.63 3/43.62 10/43.16 29/43.31 |0/45.36 1/45.94 5/45.47 17/40.57 | |POLY-3 PERCENT (g) | 0.0% 6.9% 23.2% 67.0% |0.0% 2.2% 11.0% 41.9% | |TERMINAL (d) | 0/37 (0%) 3/35 (9%) 9/33 (27%) 23/30 (77%) |0/37 (0%) 1/39 (3%) 5/41 (12%) 15/31 (48%) | |FIRST INCIDENCE | --- 729 (T) 691 574 |--- 729 (T) 729 (T) 691 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.111 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.511 P=0.043 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.114 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.503 P=0.031 * P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.115 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.501 P=0.031 * P<0.001 ** | |POLY 6 | P<0.001 ** P=0.114 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.504 P=0.030 * P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.111 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.511 P=0.043 * P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.121 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.500 P=0.028 * P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 41/50 (82%) 45/50 (90%) 45/50 (90%) 46/50 (92%) | | |POLY-3 RATE (b) | 41/47.06 45/46.90 45/47.72 46/46.37 | | |POLY-3 PERCENT (g) | 87.1% 96.0% 94.3% 99.2% | | |TERMINAL (d) | 33/37 (89%) 35/35 (100%) 32/33 (97%) 30/30 (100%)| | |FIRST INCIDENCE | 479 509 503 496 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.007 ** P=0.144 P=0.072 P=0.013 * | | |POLY 3 | P=0.012 * P=0.098 P=0.175 P=0.015 * | | |POLY 1.5 | P=0.019 * P=0.106 P=0.179 P=0.022 * | | |POLY 6 | P=0.014 * P=0.113 P=0.187 P=0.022 * | | |LOGISTIC REGRESSION| P=0.006 ** P=0.076 P=0.103 P=0.007 ** | | |COCH-ARM / FISHERS | P=0.108 P=0.194 P=0.194 P=0.117 | | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 5/50 (10%) 6/50 (12%) 6/50 (12%) |12/50 (24%) 6/50 (12%) 7/50 (14%) 6/50 (12%) | |POLY-3 RATE (b) | 4/44.63 5/43.96 6/43.48 6/41.73 |12/45.36 6/46.19 7/45.47 6/40.54 | |POLY-3 PERCENT (g) | 9.0% 11.4% 13.8% 14.4% |26.5% 13.0% 15.4% 14.8% | |TERMINAL (d) | 4/37 (11%) 4/35 (11%) 4/33 (12%) 5/30 (17%) |12/37 (32%) 4/39 (10%) 7/41 (17%) 5/31 (16%) | |FIRST INCIDENCE | 729 (T) 634 663 620 |729 (T) 671 729 (T) 690 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.197 P=0.471 P=0.309 P=0.253 |P=0.191N P=0.078N P=0.096N P=0.180N | |POLY 3 | P=0.261 P=0.490 P=0.353 P=0.327 |P=0.155N P=0.086N P=0.149N P=0.144N | |POLY 1.5 | P=0.275 P=0.490 P=0.361 P=0.340 |P=0.139N P=0.090N P=0.149N P=0.126N | |POLY 6 | P=0.245 P=0.494 P=0.343 P=0.315 |P=0.171N P=0.081N P=0.149N P=0.162N | |LOGISTIC REGRESSION| P=0.249 P=0.486 P=0.331 P=0.302 |P=0.199N P=0.085N P=0.096N P=0.194N | |COCH-ARM / FISHERS | P=0.306 P=0.500 P=0.370 P=0.370 |P=0.111N P=0.096N P=0.154N P=0.096N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 4/50 (8%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/44.63 1/43.62 0/43.01 4/41.64 |1/45.36 1/45.94 0/45.47 1/40.39 | |POLY-3 PERCENT (g) | 2.2% 2.3% 0.0% 9.6% |2.2% 2.2% 0.0% 2.5% | |TERMINAL (d) | 1/37 (3%) 1/35 (3%) 0/33 (0%) 3/30 (10%) |1/37 (3%) 1/39 (3%) 0/41 (0%) 1/31 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 651 |729 (T) 729 (T) --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.041 * P=0.749 P=0.523N P=0.131 |P=0.655 P=0.750N P=0.480N P=0.722 | |POLY 3 | P=0.055 P=0.756 P=0.507N P=0.158 |P=0.620N P=0.758N P=0.500N P=0.734 | |POLY 1.5 | P=0.057 P=0.756 P=0.504N P=0.164 |P=0.619N P=0.759N P=0.499N P=0.743 | |POLY 6 | P=0.053 P=0.756 P=0.512N P=0.152 |P=0.621N P=0.757N P=0.500N P=0.725 | |LOGISTIC REGRESSION| P=0.049 * P=0.749 (e) P=0.152 |P=0.655 P=0.750N (e) P=0.722 | |COCH-ARM / FISHERS | P=0.062 P=0.753N P=0.500N P=0.181 |P=0.616N P=0.753N P=0.500N P=0.753N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 6/50 (12%) 6/50 (12%) 9/50 (18%) |13/50 (26%) 7/50 (14%) 7/50 (14%) 7/50 (14%) | |POLY-3 RATE (b) | 5/44.63 6/43.96 6/43.48 9/42.02 |13/45.36 7/46.19 7/45.47 7/40.54 | |POLY-3 PERCENT (g) | 11.2% 13.7% 13.8% 21.4% |28.7% 15.2% 15.4% 17.3% | |TERMINAL (d) | 5/37 (14%) 5/35 (14%) 4/33 (12%) 7/30 (23%) |13/37 (35%) 5/39 (13%) 7/41 (17%) 6/31 (19%) | |FIRST INCIDENCE | 729 (T) 634 663 620 |729 (T) 671 729 (T) 690 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.072 P=0.466 P=0.429 P=0.105 |P=0.200N P=0.084N P=0.060N P=0.200N | |POLY 3 | P=0.115 P=0.489 P=0.482 P=0.158 |P=0.159N P=0.093N P=0.100N P=0.160N | |POLY 1.5 | P=0.124 P=0.489 P=0.491 P=0.168 |P=0.142N P=0.098N P=0.100N P=0.139N | |POLY 6 | P=0.107 P=0.493 P=0.471 P=0.150 |P=0.175N P=0.088N P=0.100N P=0.180N | |LOGISTIC REGRESSION| P=0.102 P=0.484 P=0.456 P=0.141 |P=0.210N P=0.092N P=0.060N P=0.219N | |COCH-ARM / FISHERS | P=0.143 P=0.500 P=0.500 P=0.194 |P=0.113N P=0.105N P=0.105N P=0.105N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma or Papilloma Squamous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 0/44.63 1/43.62 1/43.44 0/41.35 |0/45.36 0/45.94 2/46.19 1/40.39 | |POLY-3 PERCENT (g) | 0.0% 2.3% 2.3% 0.0% |0.0% 0.0% 4.3% 2.5% | |TERMINAL (d) | 0/37 (0%) 1/35 (3%) 0/33 (0%) 0/30 (0%) |0/37 (0%) 0/39 (0%) 1/41 (2%) 1/31 (3%) | |FIRST INCIDENCE | --- 729 (T) 606 --- |--- --- 476 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.623N P=0.489 P=0.496 (e) |P=0.208 (e) P=0.256 P=0.465 | |POLY 3 | P=0.615N P=0.495 P=0.495 (e) |P=0.199 (e) P=0.241 P=0.477 | |POLY 1.5 | P=0.609N P=0.496 P=0.497 (e) |P=0.215 (e) P=0.241 P=0.485 | |POLY 6 | P=0.622N P=0.495 P=0.491 (e) |P=0.185 (e) P=0.242 P=0.470 | |LOGISTIC REGRESSION| P=0.588N P=0.489 P=0.496 (e) |P=0.289 (e) P=0.186 P=0.465 | |COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.246 (e) P=0.247 P=0.500 | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 22 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |14/50 (28%) 11/50 (22%) 9/50 (18%) 13/50 (26%) | |POLY-3 RATE (b) | |14/46.78 11/47.45 9/46.77 13/42.10 | |POLY-3 PERCENT (g) | |29.9% 23.2% 19.2% 30.9% | |TERMINAL (d) | |11/37 (30%) 8/39 (21%) 7/41 (17%) 11/31 (36%) | |FIRST INCIDENCE | |445 346 476 363 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.417 P=0.287N P=0.129N P=0.482 | |POLY 3 | |P=0.491 P=0.306N P=0.168N P=0.553 | |POLY 1.5 | |P=0.530 P=0.311N P=0.167N P=0.582N | |POLY 6 | |P=0.451 P=0.302N P=0.170N P=0.504 | |LOGISTIC REGRESSION| |P=0.453N P=0.328N P=0.175N P=0.532N | |COCH-ARM / FISHERS | |P=0.489N P=0.322N P=0.171N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |14/50 (28%) 11/50 (22%) 10/50 (20%) 13/50 (26%) | |POLY-3 RATE (b) | |14/46.78 11/47.45 10/47.21 13/42.10 | |POLY-3 PERCENT (g) | |29.9% 23.2% 21.2% 30.9% | |TERMINAL (d) | |11/37 (30%) 8/39 (21%) 7/41 (17%) 11/31 (36%) | |FIRST INCIDENCE | |445 346 476 363 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.404 P=0.287N P=0.190N P=0.482 | |POLY 3 | |P=0.475 P=0.306N P=0.231N P=0.553 | |POLY 1.5 | |P=0.516 P=0.311N P=0.233N P=0.582N | |POLY 6 | |P=0.436 P=0.302N P=0.229N P=0.504 | |LOGISTIC REGRESSION| |P=0.455N P=0.328N P=0.248N P=0.532N | |COCH-ARM / FISHERS | |P=0.500N P=0.322N P=0.241N P=0.500N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 23 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/45.19 1/43.62 0/43.01 2/41.72 |0/45.36 1/45.94 0/45.47 0/40.39 | |POLY-3 PERCENT (g) | 2.2% 2.3% 0.0% 4.8% |0.0% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 1/35 (3%) 0/33 (0%) 0/30 (0%) |0/37 (0%) 1/39 (3%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 554 729 (T) --- 643 |--- 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.332 P=0.749 P=0.509N P=0.469 |P=0.597N P=0.511 (e) (e) | |POLY 3 | P=0.350 P=0.753 P=0.510N P=0.472 |P=0.568N P=0.503 (e) (e) | |POLY 1.5 | P=0.356 P=0.755 P=0.505N P=0.481 |P=0.568N P=0.501 (e) (e) | |POLY 6 | P=0.343 P=0.751 P=0.516N P=0.463 |P=0.568N P=0.504 (e) (e) | |LOGISTIC REGRESSION| P=0.381 P=0.750N P=0.521N P=0.536 |(e) P=0.511 (e) (e) | |COCH-ARM / FISHERS | P=0.366 P=0.753N P=0.500N P=0.500 |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.61 1/43.62 0/43.01 2/41.72 |0/45.36 1/45.94 0/45.47 0/40.39 | |POLY-3 PERCENT (g) | 4.4% 2.3% 0.0% 4.8% |0.0% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 1/35 (3%) 0/33 (0%) 0/30 (0%) |0/37 (0%) 1/39 (3%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 554 729 (T) --- 643 |--- 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.553 P=0.514N P=0.250N P=0.661 |P=0.597N P=0.511 (e) (e) | |POLY 3 | P=0.574 P=0.516N P=0.250N P=0.662 |P=0.568N P=0.503 (e) (e) | |POLY 1.5 | P=0.580 P=0.511N P=0.244N P=0.672 |P=0.568N P=0.501 (e) (e) | |POLY 6 | P=0.566 P=0.520N P=0.259N P=0.650 |P=0.568N P=0.504 (e) (e) | |LOGISTIC REGRESSION| P=0.615 P=0.472N P=0.240N P=0.655N |(e) P=0.511 (e) (e) | |COCH-ARM / FISHERS | P=0.591 P=0.500N P=0.247N P=0.691N |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 24 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 11/50 (22%) 14/50 (28%) 9/50 (18%) 17/50 (34%) |10/50 (20%) 11/50 (22%) 5/50 (10%) 16/50 (32%) | |POLY-3 RATE (b) | 11/46.82 14/46.02 9/44.61 17/44.18 |10/46.45 11/46.24 5/46.29 16/41.92 | |POLY-3 PERCENT (g) | 23.5% 30.4% 20.2% 38.5% |21.5% 23.8% 10.8% 38.2% | |TERMINAL (d) | 5/37 (14%) 8/35 (23%) 4/33 (12%) 8/30 (27%) |5/37 (14%) 8/39 (21%) 3/41 (7%) 10/31 (32%) | |FIRST INCIDENCE | 554 371 483 350 |554 671 536 601 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.079 P=0.306 P=0.489N P=0.081 |P=0.048 * P=0.545 P=0.120N P=0.064 | |POLY 3 | P=0.101 P=0.303 P=0.448N P=0.091 |P=0.069 P=0.495 P=0.131N P=0.067 | |POLY 1.5 | P=0.114 P=0.307 P=0.425N P=0.103 |P=0.079 P=0.498 P=0.129N P=0.083 | |POLY 6 | P=0.089 P=0.297 P=0.480N P=0.081 |P=0.062 P=0.492 P=0.134N P=0.058 | |LOGISTIC REGRESSION| P=0.155 P=0.341 P=0.385N P=0.140 |P=0.074 P=0.507 P=0.133N P=0.081 | |COCH-ARM / FISHERS | P=0.142 P=0.322 P=0.402N P=0.133 |P=0.109 P=0.500 P=0.131N P=0.127 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 4/44.75 1/43.62 1/43.39 0/41.35 |1/45.36 0/45.94 0/45.47 0/40.39 | |POLY-3 PERCENT (g) | 8.9% 2.3% 2.3% 0.0% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/37 (8%) 1/35 (3%) 0/33 (0%) 0/30 (0%) |1/37 (3%) 0/39 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 699 729 (T) 624 --- |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.049N* P=0.198N P=0.220N P=0.094N |P=0.321N P=0.489N P=0.480N P=0.535N | |POLY 3 | P=0.036N* P=0.186N P=0.188N P=0.071N |P=0.293N P=0.497N P=0.500N P=0.523N | |POLY 1.5 | P=0.035N* P=0.185N P=0.183N P=0.067N |P=0.298N P=0.499N P=0.499N P=0.515N | |POLY 6 | P=0.037N* P=0.187N P=0.194N P=0.075N |P=0.288N P=0.496N P=0.500N P=0.530N | |LOGISTIC REGRESSION| P=0.038N* P=0.186N P=0.185N P=0.078N |P=0.321N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.034N* P=0.181N P=0.181N P=0.059N |P=0.306N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 25 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 4/44.75 1/43.62 1/43.39 0/41.35 |1/45.36 0/45.94 0/45.47 0/40.39 | |POLY-3 PERCENT (g) | 8.9% 2.3% 2.3% 0.0% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/37 (8%) 1/35 (3%) 0/33 (0%) 0/30 (0%) |1/37 (3%) 0/39 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 699 729 (T) 624 --- |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.049N* P=0.198N P=0.220N P=0.094N |P=0.321N P=0.489N P=0.480N P=0.535N | |POLY 3 | P=0.036N* P=0.186N P=0.188N P=0.071N |P=0.293N P=0.497N P=0.500N P=0.523N | |POLY 1.5 | P=0.035N* P=0.185N P=0.183N P=0.067N |P=0.298N P=0.499N P=0.499N P=0.515N | |POLY 6 | P=0.037N* P=0.187N P=0.194N P=0.075N |P=0.288N P=0.496N P=0.500N P=0.530N | |LOGISTIC REGRESSION| P=0.038N* P=0.186N P=0.185N P=0.078N |P=0.321N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.034N* P=0.181N P=0.181N P=0.059N |P=0.306N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 48/50 (96%) 47/50 (94%) 49/50 (98%) 46/50 (92%) |45/50 (90%) 45/50 (90%) 43/50 (86%) 44/50 (88%) | |POLY-3 RATE (b) | 48/49.05 47/47.26 49/49.29 46/46.37 |45/48.50 45/49.11 43/47.88 44/46.15 | |POLY-3 PERCENT (g) | 97.9% 99.5% 99.4% 99.2% |92.8% 91.6% 89.8% 95.3% | |TERMINAL (d) | 36/37 (97%) 35/35 (100%) 33/33 (100%) 30/30 (100%)|34/37 (92%) 35/39 (90%) 38/41 (93%) 30/31 (97%) | |FIRST INCIDENCE | 479 509 364 496 |445 346 476 363 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.107 P=0.492 P=0.186 P=0.166 |P=0.109 P=0.419N P=0.156N P=0.150 | |POLY 3 | P=0.467 P=0.591 P=0.592 P=0.638 |P=0.374 P=0.567N P=0.433N P=0.461 | |POLY 1.5 | P=0.677 P=0.711 P=0.609 P=0.791 |P=0.497 P=0.591N P=0.386N P=0.572 | |POLY 6 | P=0.320 P=0.519 P=0.532 P=0.529 |P=0.292 P=0.538N P=0.514N P=0.392 | |LOGISTIC REGRESSION| P=0.562 P=0.692 P=0.534 P=0.693 |P=0.366 P=0.619N P=0.326N P=0.404 | |COCH-ARM / FISHERS | P=0.292N P=0.500N P=0.500 P=0.339N |P=0.397N P=0.630N P=0.380N P=0.500N | |=================================================================================================================================| Date: 03/14/01 EXPERIMENT: 93023 TEST: 06 Page 26 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2,4-HEXADIENAL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 21/50 (42%) 23/50 (46%) 24/50 (48%) 30/50 (60%) |18/50 (36%) 19/50 (38%) 14/50 (28%) 21/50 (42%) | |POLY-3 RATE (b) | 21/49.07 23/46.83 24/46.67 30/45.67 |18/47.24 19/47.82 14/48.30 21/42.76 | |POLY-3 PERCENT (g) | 42.8% 49.1% 51.4% 65.7% |38.1% 39.7% 29.0% 49.1% | |TERMINAL (d) | 10/37 (27%) 14/35 (40%) 13/33 (39%) 18/30 (60%) |10/37 (27%) 12/39 (31%) 8/41 (20%) 13/31 (42%) | |FIRST INCIDENCE | 259 371 483 350 |511 347 476 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.017 * P=0.381 P=0.254 P=0.028 * |P=0.166 P=0.556 P=0.227N P=0.167 | |POLY 3 | P=0.014 * P=0.339 P=0.261 P=0.019 * |P=0.223 P=0.519 P=0.234N P=0.200 | |POLY 1.5 | P=0.019 * P=0.358 P=0.290 P=0.025 * |P=0.256 P=0.515 P=0.240N P=0.240 | |POLY 6 | P=0.011 * P=0.326 P=0.234 P=0.014 * |P=0.204 P=0.522 P=0.229N P=0.176 | |LOGISTIC REGRESSION| P=0.042 * P=0.452 P=0.386 P=0.064 |P=0.336 P=0.498 P=0.268N P=0.247 | |COCH-ARM / FISHERS | P=0.038 * P=0.420 P=0.344 P=0.055 |P=0.345 P=0.500 P=0.260N P=0.341 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 22.5 45 90 |0 22.5 45 90 | | | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 48/50 (96%) 50/50 (100%) 47/50 (94%) |47/50 (94%) 48/50 (96%) 48/50 (96%) 44/50 (88%) | |POLY-3 RATE (b) | 50/50.00 48/48.12 50/50.00 47/47.26 |47/49.06 48/50.00 48/49.29 44/46.15 | |POLY-3 PERCENT (g) | 100.0% 99.7% 100.0% 99.5% |95.8% 96.0% 97.4% 95.3% | |TERMINAL (d) | 37/37 (100%) 35/35 (100%) 33/33 (100%) 30/30 (100%)|35/37 (95%) 37/39 (95%) 40/41 (98%) 30/31 (97%) | |FIRST INCIDENCE | 259 371 364 350 |445 346 476 363 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.142 P=0.567 (e) P=0.215 |P=0.196 P=0.488N P=0.350N P=0.246 | |POLY 3 | P=0.940N P=1.000N (e) P=1.000N |P=0.571N P=0.676 P=0.551 P=0.663N | |POLY 1.5 | P=0.295N P=0.935N (e) P=0.642N |P=0.365N P=0.642 P=0.562 P=0.485N | |POLY 6 | P=1.000N P=1.000N (e) P=1.000N |P=0.485 P=0.685 P=0.518 P=0.639 | |LOGISTIC REGRESSION| P=0.129N P=0.336N (e) P=0.211N |P=0.339N P=0.511 P=0.586 P=0.585N | |COCH-ARM / FISHERS | P=0.097N P=0.247N (e) P=0.121N |P=0.113N P=0.500 P=0.500 P=0.243N | |=================================================================================================================================| (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).