TDMS Study 05201-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 11/15/04 EXPERIMENT: 05201 TEST: 05 TIME: 14:18:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: GRUMBEIN, S. CAS: 98-00-0 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 RATS REASONS FOR REMOVAL: 25022 Accidently Killed 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 11/15/04 EXPERIMENT: 05201 TEST: 05 TIME: 14:18:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: GRUMBEIN, S. CAS: 98-00-0 Rats(FISCHER 344) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED. --------------- Adrenal Cortex Adrenal Medulla Brain Clitoral/Preputial Gland Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Prostate Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 11/15/04 EXPERIMENT: 05201 TEST: 05 TIME: 14:18:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: GRUMBEIN, S. CAS: 98-00-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF FURFURYL ALCOHOL =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Islets, Pancreatic Carcinoma or Adenoma Nose Squamous Cell Carcinoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Skin Keratoacanthoma Skin: Sebaceous Gland Carcinoma Testes Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma Zymbal's Gland Carcinoma Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Clitoral/Preputial Gland Adenoma Carcinoma or Adenoma Kidney: Renal Tubule Adenoma Mammary Gland Carcinoma Carcinoma or Adenoma Uterus Polyp Stromal Sarcoma Stromal All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/48 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/32.38 1/32.19 1/33.46 0/27.31 |2/40.56 0/41.69 0/38.93 2/37.77 | |POLY-3 PERCENT (g) | 0.0% 3.1% 3.0% 0.0% |4.9% 0.0% 0.0% 5.3% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |1/26 (4%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | --- 606 693 --- |609 --- --- 518 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.717N P=0.513 P=0.513 (e) |P=0.264 P=0.237N P=0.258N P=0.598 | |POLY 3 | P=0.564N P=0.499 P=0.507 (e) |P=0.323 P=0.231N P=0.246N P=0.669 | |POLY 1.5 | P=0.540N P=0.501 P=0.505 (e) |P=0.333 P=0.232N P=0.243N P=0.682 | |POLY 6 | P=0.615N P=0.492 P=0.507 (e) |P=0.310 P=0.229N P=0.252N P=0.649 | |LOGISTIC REGRESSION| P=0.570N P=0.499 P=0.506 (e) |P=0.363 P=0.238N P=0.246N P=0.691N | |COCH-ARM / FISHERS | P=0.522N P=0.500 P=0.500 (e) |P=0.348 P=0.247N P=0.258N P=0.691N | |ORDER RESTRICTED | P=0.414 (e) (e) (e) |P=0.242 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 19/50 (38%) 27/50 (54%) 22/50 (44%) 26/50 (52%) |4/50 (8%) 7/50 (14%) 4/48 (8%) 7/50 (14%) | |POLY-3 RATE (b) | 19/36.35 27/39.73 22/39.32 26/37.28 |4/40.45 7/41.87 4/39.31 7/37.69 | |POLY-3 PERCENT (g) | 52.3% 68.0% 56.0% 69.7% |9.9% 16.7% 10.2% 18.6% | |TERMINAL (d) | 5/8 (63%) 4/5 (80%) 4/9 (44%) 0/0 (0%) |1/26 (4%) 5/26 (19%) 1/22 (5%) 3/16 (19%) | |FIRST INCIDENCE | 532 490 492 555 |707 693 679 670 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.044 * P=0.439 P<0.001 ** |P=0.103 P=0.275 P=0.555 P=0.110 | |POLY 3 | P=0.150 P=0.097 P=0.462 P=0.069 |P=0.260 P=0.278 P=0.629 P=0.217 | |POLY 1.5 | P=0.196 P=0.093 P=0.414 P=0.093 |P=0.286 P=0.275 P=0.631 P=0.239 | |POLY 6 | P=0.092 P=0.095 P=0.541 P=0.037 * |P=0.226 P=0.282 P=0.619 P=0.189 | |LOGISTIC REGRESSION| P=0.070 P=0.058 P=0.376 P=0.013 * |P=0.183 P=0.294 P=0.616 P=0.174 | |COCH-ARM / FISHERS | P=0.242 P=0.080 P=0.342 P=0.114 |P=0.320 P=0.262 P=0.619 P=0.262 | |ORDER RESTRICTED | P=0.066 (e) (e) (e) |P=0.211 (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/32.38 0/31.75 2/34.08 1/27.66 |1/40.12 0/41.69 0/38.93 0/37.12 | |POLY-3 PERCENT (g) | 3.1% 0.0% 5.9% 3.6% |2.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |1/26 (4%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 735 (T) --- 554 638 |735 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.307 P=0.594N P=0.497 P=0.362 |P=0.629N P=0.500N P=0.533N P=0.597N | |POLY 3 | P=0.531 P=0.504N P=0.518 P=0.726 |P=0.553N P=0.492N P=0.506N P=0.516N | |POLY 1.5 | P=0.567 P=0.500N P=0.512 P=0.747 |P=0.552N P=0.494N P=0.505N P=0.508N | |POLY 6 | P=0.444 P=0.514N P=0.525 P=0.671 |P=0.554N P=0.490N P=0.510N P=0.527N | |LOGISTIC REGRESSION| P=0.532 (e) P=0.508 P=0.544 |P=0.629N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.594 P=0.500N P=0.500 P=0.753N |P=0.546N P=0.500N P=0.510N P=0.500N | |ORDER RESTRICTED | P=0.382 (e) (e) (e) |P=0.135N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 19/50 (38%) 27/50 (54%) 24/50 (48%) 26/50 (52%) |5/50 (10%) 8/50 (16%) 4/48 (8%) 7/50 (14%) | |POLY-3 RATE (b) | 19/36.35 27/39.73 24/40.11 26/37.28 |5/40.45 8/42.40 4/39.31 7/37.69 | |POLY-3 PERCENT (g) | 52.3% 68.0% 59.8% 69.7% |12.4% 18.9% 10.2% 18.6% | |TERMINAL (d) | 5/8 (63%) 4/5 (80%) 4/9 (44%) 0/0 (0%) |2/26 (8%) 5/26 (19%) 1/22 (5%) 3/16 (19%) | |FIRST INCIDENCE | 532 490 492 555 |707 571 679 670 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.044 * P=0.314 P<0.001 ** |P=0.178 P=0.289 P=0.594N P=0.170 | |POLY 3 | P=0.162 P=0.097 P=0.319 P=0.069 |P=0.378 P=0.304 P=0.518N P=0.327 | |POLY 1.5 | P=0.211 P=0.093 P=0.271 P=0.093 |P=0.410 P=0.297 P=0.514N P=0.353 | |POLY 6 | P=0.099 P=0.095 P=0.411 P=0.037 * |P=0.336 P=0.314 P=0.531N P=0.292 | |LOGISTIC REGRESSION| P=0.080 P=0.058 P=0.232 P=0.013 * |P=0.312 P=0.305 P=0.536N P=0.264 | |COCH-ARM / FISHERS | P=0.260 P=0.080 P=0.210 P=0.114 |P=0.450 P=0.277 P=0.526N P=0.380 | |ORDER RESTRICTED | P=0.065 (e) (e) (e) |P=0.355 (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Bone | | Osteosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/49 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 0/32.38 1/32.35 0/33.30 0/27.31 |0/40.12 0/41.69 2/40.40 1/37.12 | |POLY-3 PERCENT (g) | 0.0% 3.1% 0.0% 0.0% |0.0% 0.0% 5.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | --- 543 --- --- |--- --- 628 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.609N P=0.510 (e) (e) |P=0.357 (e) P=0.240 P=0.403 | |POLY 3 | P=0.618N P=0.500 (e) (e) |P=0.378 (e) P=0.238 P=0.484 | |POLY 1.5 | P=0.613N P=0.502 (e) (e) |P=0.397 (e) P=0.238 P=0.492 | |POLY 6 | P=0.620N P=0.493 (e) (e) |P=0.350 (e) P=0.236 P=0.473 | |LOGISTIC REGRESSION| P=0.598N P=0.471 (e) (e) |P=0.421 (e) P=0.210 P=0.403 | |COCH-ARM / FISHERS | P=0.608N P=0.500 (e) (e) |P=0.420 (e) P=0.242 P=0.500 | |ORDER RESTRICTED | P=0.410N (e) (e) (e) |P=0.169 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Bone | | Osteosarcoma or Osteoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/49 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 1/32.84 1/32.35 0/33.30 0/27.31 |0/40.12 0/41.69 2/40.40 1/37.12 | |POLY-3 PERCENT (g) | 3.0% 3.1% 0.0% 0.0% |0.0% 0.0% 5.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | 595 543 --- --- |--- --- 628 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.356N P=0.751N P=0.512N P=0.512N |P=0.357 (e) P=0.240 P=0.403 | |POLY 3 | P=0.366N P=0.759 P=0.497N P=0.537N |P=0.378 (e) P=0.238 P=0.484 | |POLY 1.5 | P=0.358N P=0.761N P=0.497N P=0.515N |P=0.397 (e) P=0.238 P=0.492 | |POLY 6 | P=0.373N P=0.750 P=0.501N P=0.586N |P=0.350 (e) P=0.236 P=0.473 | |LOGISTIC REGRESSION| P=0.337N P=0.750 P=0.510N P=0.495N |P=0.421 (e) P=0.210 P=0.403 | |COCH-ARM / FISHERS | P=0.348N P=0.753N P=0.500N P=0.500N |P=0.420 (e) P=0.242 P=0.500 | |ORDER RESTRICTED | P=0.285N (e) (e) (e) |P=0.169 (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 3/50 (6%) 2/49 (4%) 2/50 (4%) |4/44 (9%) 2/45 (4%) 2/46 (4%) 7/45 (16%) | |POLY-3 RATE (b) | 2/32.60 3/32.65 2/32.48 2/27.95 |4/35.28 2/37.93 2/37.51 7/34.78 | |POLY-3 PERCENT (g) | 6.1% 9.2% 6.2% 7.2% |11.3% 5.3% 5.3% 20.1% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |3/24 (13%) 1/23 (4%) 1/21 (5%) 2/14 (14%) | |FIRST INCIDENCE | 572 616 730 609 |693 679 627 518 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.346 P=0.465 P=0.663N P=0.539 |P=0.016 * P=0.342N P=0.385N P=0.124 | |POLY 3 | P=0.608N P=0.501 P=0.695 P=0.640 |P=0.044 * P=0.302N P=0.307N P=0.246 | |POLY 1.5 | P=0.565N P=0.509 P=0.692N P=0.677 |P=0.050 P=0.309N P=0.305N P=0.261 | |POLY 6 | P=0.536 P=0.480 P=0.685 P=0.546 |P=0.038 * P=0.295N P=0.317N P=0.226 | |LOGISTIC REGRESSION| P=0.623 P=0.510 P=0.688N P=0.689 |P=0.044 * P=0.296N P=0.321N P=0.238 | |COCH-ARM / FISHERS | P=0.531N P=0.510 P=0.691N P=0.684N |P=0.059 P=0.328N P=0.317N P=0.274 | |ORDER RESTRICTED | P=0.647 (e) (e) (e) |P=0.056 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 2/50 (4%) 5/49 (10%) 3/50 (6%) |3/44 (7%) 0/45 (0%) 2/46 (4%) 2/45 (4%) | |POLY-3 RATE (b) | 3/32.45 2/32.77 5/34.01 3/29.07 |3/35.22 0/37.71 2/37.77 2/33.09 | |POLY-3 PERCENT (g) | 9.3% 6.1% 14.7% 10.3% |8.5% 0.0% 5.3% 6.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 2/9 (22%) 0/0 (0%) |2/24 (8%) 0/23 (0%) 1/21 (5%) 2/14 (14%) | |FIRST INCIDENCE | 572 399 554 522 |707 --- 522 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.248 P=0.547N P=0.386 P=0.309 |P=0.391 P=0.124N P=0.547N P=0.651 | |POLY 3 | P=0.495 P=0.495N P=0.379 P=0.614 |P=0.514 P=0.105N P=0.468N P=0.529N | |POLY 1.5 | P=0.545 P=0.487N P=0.374 P=0.651 |P=0.538 P=0.108N P=0.467N P=0.508N | |POLY 6 | P=0.377 P=0.521N P=0.381 P=0.515 |P=0.481 P=0.103N P=0.478N P=0.561N | |LOGISTIC REGRESSION| P=0.596 P=0.492N P=0.366 P=0.650N |P=0.519 P=0.104N P=0.474N P=0.641N | |COCH-ARM / FISHERS | P=0.583 P=0.490N P=0.357 P=0.651N |P=0.570 P=0.117N P=0.479N P=0.489N | |ORDER RESTRICTED | P=0.412 (e) (e) (e) |P=0.291N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 5/50 (10%) 7/49 (14%) 5/50 (10%) |7/44 (16%) 2/45 (4%) 4/46 (9%) 9/45 (20%) | |POLY-3 RATE (b) | 4/32.88 5/33.67 7/34.03 5/29.71 |7/35.39 2/37.93 4/38.15 9/34.78 | |POLY-3 PERCENT (g) | 12.2% 14.9% 20.6% 16.8% |19.8% 5.3% 10.5% 25.9% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 3/9 (33%) 0/0 (0%) |5/24 (21%) 1/23 (4%) 2/21 (10%) 4/14 (29%) | |FIRST INCIDENCE | 572 399 554 522 |693 679 522 518 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.094 P=0.441 P=0.309 P=0.132 |P=0.014 * P=0.085N P=0.325N P=0.147 | |POLY 3 | P=0.445 P=0.515 P=0.272 P=0.434 |P=0.052 P=0.059N P=0.214N P=0.372 | |POLY 1.5 | P=0.509 P=0.522 P=0.273 P=0.483 |P=0.060 P=0.063N P=0.216N P=0.394 | |POLY 6 | P=0.304 P=0.492 P=0.263 P=0.317 |P=0.042 * P=0.056N P=0.221N P=0.340 | |LOGISTIC REGRESSION| P=0.511 P=0.513 P=0.272 P=0.499 |P=0.051 P=0.058N P=0.230N P=0.322 | |COCH-ARM / FISHERS | P=0.556 P=0.513 P=0.262 P=0.513 |P=0.076 P=0.073N P=0.236N P=0.411 | |ORDER RESTRICTED | P=0.379 (e) (e) (e) |P=0.072 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 0/49 (0%) |1/49 (2%) 0/48 (0%) 3/48 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 3/32.93 0/31.75 2/33.30 0/27.04 |1/39.18 0/40.44 3/39.12 0/37.12 | |POLY-3 PERCENT (g) | 9.1% 0.0% 6.0% 0.0% |2.6% 0.0% 7.7% 0.0% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 2/9 (22%) 0/0 (0%) |1/26 (4%) 0/26 (0%) 3/22 (14%) 0/16 (0%) | |FIRST INCIDENCE | 624 --- 735 (T) --- |735 (T) --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.617N P=0.175N P=0.458N P=0.537N |P=0.555N P=0.500N P=0.245 P=0.597N | |POLY 3 | P=0.229N P=0.122N P=0.495N P=0.154N |P=0.442N P=0.494N P=0.304 P=0.511N | |POLY 1.5 | P=0.210N P=0.119N P=0.492N P=0.134N |P=0.421N P=0.497N P=0.305 P=0.503N | |POLY 6 | P=0.275N P=0.133N P=0.505N P=0.216N |P=0.473N P=0.489N P=0.297 P=0.522N | |LOGISTIC REGRESSION| P=0.448N P=0.133N P=0.485N P=0.276N |P=0.555N (e) P=0.245 (e) | |COCH-ARM / FISHERS | P=0.196N P=0.121N P=0.500N P=0.125N |P=0.397N P=0.505N P=0.301 P=0.495N | |ORDER RESTRICTED | P=0.057N (e) (e) (e) |P=0.281N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 0/49 (0%) |1/49 (2%) 1/48 (2%) 4/48 (8%) 0/50 (0%) | |POLY-3 RATE (b) | 4/32.93 1/31.75 3/33.55 0/27.04 |1/39.18 1/40.45 4/39.12 0/37.12 | |POLY-3 PERCENT (g) | 12.2% 3.2% 8.9% 0.0% |2.6% 2.5% 10.2% 0.0% | |TERMINAL (d) | 2/8 (25%) 1/5 (20%) 2/9 (22%) 0/0 (0%) |1/26 (4%) 0/26 (0%) 4/22 (18%) 0/16 (0%) | |FIRST INCIDENCE | 624 735 (T) 666 --- |735 (T) 732 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.526N P=0.293N P=0.451N P=0.537N |P=0.449N P=0.756N P=0.128 P=0.597N | |POLY 3 | P=0.128N P=0.185N P=0.489N P=0.085N |P=0.325N P=0.754N P=0.176 P=0.511N | |POLY 1.5 | P=0.111N P=0.179N P=0.489N P=0.071N |P=0.304N P=0.757N P=0.178 P=0.503N | |POLY 6 | P=0.177N P=0.203N P=0.496N P=0.135N |P=0.358N P=0.749N P=0.170 P=0.522N | |LOGISTIC REGRESSION| P=0.346N P=0.220N P=0.482N P=0.271N |P=0.430N P=0.748N P=0.128 (e) | |COCH-ARM / FISHERS | P=0.100N P=0.181N P=0.500N P=0.061N |P=0.281N P=0.747 P=0.175 P=0.495N | |ORDER RESTRICTED | P=0.042N* (e) (e) (e) |P=0.198N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 1/32.58 1/31.79 2/33.54 0/27.31 |0/40.12 0/41.22 0/39.69 2/37.42 | |POLY-3 PERCENT (g) | 3.1% 3.2% 6.0% 0.0% |0.0% 0.0% 0.0% 5.4% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 681 726 700 --- |--- --- --- 686 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.852 P=0.708 P=0.536 P=0.872N |P=0.026 * (e) (e) P=0.190 | |POLY 3 | P=0.373N P=0.757 P=0.510 P=0.535N |P=0.037 * (e) (e) P=0.221 | |POLY 1.5 | P=0.341N P=0.761 P=0.509 P=0.514N |P=0.039 * (e) (e) P=0.229 | |POLY 6 | P=0.448N P=0.746 P=0.510 P=0.584N |P=0.035 * (e) (e) P=0.211 | |LOGISTIC REGRESSION| P=0.634N P=0.732 P=0.510 P=0.697N |P=0.035 * (e) (e) P=0.217 | |COCH-ARM / FISHERS | P=0.317N P=0.753N P=0.500 P=0.500N |P=0.043 * (e) (e) P=0.247 | |ORDER RESTRICTED | P=0.305N (e) (e) (e) |P=0.024 * (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/49 (2%) 0/49 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 1/32.58 1/31.79 2/33.54 0/27.31 |0/40.12 1/41.44 0/39.69 2/37.42 | |POLY-3 PERCENT (g) | 3.1% 3.2% 6.0% 0.0% |0.0% 2.4% 0.0% 5.4% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 681 726 700 --- |--- 677 --- 686 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.852 P=0.708 P=0.536 P=0.872N |P=0.109 P=0.523 (e) P=0.190 | |POLY 3 | P=0.373N P=0.757 P=0.510 P=0.535N |P=0.142 P=0.506 (e) P=0.221 | |POLY 1.5 | P=0.341N P=0.761 P=0.509 P=0.514N |P=0.148 P=0.503 (e) P=0.229 | |POLY 6 | P=0.448N P=0.746 P=0.510 P=0.584N |P=0.134 P=0.511 (e) P=0.211 | |LOGISTIC REGRESSION| P=0.634N P=0.732 P=0.510 P=0.697N |P=0.139 P=0.496 (e) P=0.217 | |COCH-ARM / FISHERS | P=0.317N P=0.753N P=0.500 P=0.500N |P=0.155 P=0.495 (e) P=0.247 | |ORDER RESTRICTED | P=0.305N (e) (e) (e) |P=0.064 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/32.38 2/32.37 1/33.46 0/27.31 |1/40.12 0/41.69 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | 0.0% 6.2% 3.0% 0.0% |2.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |1/26 (4%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- 604 693 --- |735 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.645N P=0.234 P=0.513 (e) |P=0.629N P=0.500N P=0.533N P=0.597N | |POLY 3 | P=0.412N P=0.235 P=0.507 (e) |P=0.553N P=0.492N P=0.502N P=0.516N | |POLY 1.5 | P=0.385N P=0.238 P=0.505 (e) |P=0.552N P=0.494N P=0.501N P=0.508N | |POLY 6 | P=0.472N P=0.228 P=0.507 (e) |P=0.554N P=0.490N P=0.507N P=0.527N | |LOGISTIC REGRESSION| P=0.441N P=0.234 P=0.506 (e) |P=0.629N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.366N P=0.247 P=0.500 (e) |P=0.546N P=0.500N P=0.505N P=0.500N | |ORDER RESTRICTED | P=0.342 (e) (e) (e) |P=0.135N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/32.38 2/32.37 2/33.67 0/27.31 |1/40.12 0/41.69 1/39.69 0/37.12 | |POLY-3 PERCENT (g) | 0.0% 6.2% 5.9% 0.0% |2.5% 0.0% 2.5% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |1/26 (4%) 0/26 (0%) 1/22 (5%) 0/16 (0%) | |FIRST INCIDENCE | --- 604 679 --- |735 (T) --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.706N P=0.234 P=0.230 (e) |P=0.587N P=0.500N P=0.725 P=0.597N | |POLY 3 | P=0.408N P=0.235 P=0.244 (e) |P=0.502N P=0.492N P=0.759 P=0.516N | |POLY 1.5 | P=0.371N P=0.238 P=0.243 (e) |P=0.492N P=0.494N P=0.760 P=0.508N | |POLY 6 | P=0.497N P=0.228 P=0.246 (e) |P=0.515N P=0.490N P=0.754 P=0.527N | |LOGISTIC REGRESSION| P=0.445N P=0.234 P=0.242 (e) |P=0.587N (e) P=0.725 (e) | |COCH-ARM / FISHERS | P=0.346N P=0.247 P=0.247 (e) |P=0.477N P=0.500N P=0.747 P=0.500N | |ORDER RESTRICTED | P=0.286 (e) (e) (e) |P=0.267N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |9/50 (18%) 2/50 (4%) 2/49 (4%) 6/50 (12%) | |POLY-3 RATE (b) | 1/32.56 0/31.75 2/33.87 0/27.31 |9/40.73 2/42.59 2/39.90 6/38.11 | |POLY-3 PERCENT (g) | 3.1% 0.0% 5.9% 0.0% |22.1% 4.7% 5.0% 15.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |5/26 (19%) 0/26 (0%) 1/22 (5%) 2/16 (13%) | |FIRST INCIDENCE | 686 --- 554 --- |661 497 679 518 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.752N P=0.500N P=0.520 P=0.974N |P=0.272 P=0.029N* P=0.051N P=0.564N | |POLY 3 | P=0.490N P=0.505N P=0.514 P=0.535N |P=0.433 P=0.019N* P=0.025N* P=0.332N | |POLY 1.5 | P=0.460N P=0.500N P=0.511 P=0.514N |P=0.459 P=0.021N* P=0.025N* P=0.308N | |POLY 6 | P=0.560N P=0.517N P=0.516 P=0.583N |P=0.398 P=0.017N* P=0.028N* P=0.371N | |LOGISTIC REGRESSION| P=0.510N P=0.518N P=0.508 P=0.728N |P=0.443 P=0.024N* P=0.030N* P=0.369N | |COCH-ARM / FISHERS | P=0.437N P=0.500N P=0.500 P=0.500N |P=0.498 P=0.026N* P=0.028N* P=0.288N | |ORDER RESTRICTED | P=0.359N (e) (e) (e) |P=0.038N* (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |10/50 (20%) 2/50 (4%) 2/49 (4%) 6/50 (12%) | |POLY-3 RATE (b) | 1/32.56 0/31.75 2/33.87 0/27.31 |10/40.73 2/42.59 2/39.90 6/38.11 | |POLY-3 PERCENT (g) | 3.1% 0.0% 5.9% 0.0% |24.6% 4.7% 5.0% 15.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |6/26 (23%) 0/26 (0%) 1/22 (5%) 2/16 (13%) | |FIRST INCIDENCE | 686 --- 554 --- |661 497 679 518 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.752N P=0.500N P=0.520 P=0.974N |P=0.331 P=0.017N* P=0.032N* P=0.481N | |POLY 3 | P=0.490N P=0.505N P=0.514 P=0.535N |P=0.510 P=0.010N* P=0.013N* P=0.243N | |POLY 1.5 | P=0.460N P=0.500N P=0.511 P=0.514N |P=0.537 P=0.011N* P=0.013N* P=0.222N | |POLY 6 | P=0.560N P=0.517N P=0.516 P=0.583N |P=0.475 P=0.008N** P=0.015N* P=0.276N | |LOGISTIC REGRESSION| P=0.510N P=0.518N P=0.508 P=0.728N |P=0.514 P=0.013N* P=0.017N* P=0.282N | |COCH-ARM / FISHERS | P=0.437N P=0.500N P=0.500 P=0.500N |P=0.575 P=0.014N* P=0.015N* P=0.207N | |ORDER RESTRICTED | P=0.359N (e) (e) (e) |P=0.017N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 5/50 (10%) 0/50 (0%) |19/50 (38%) 24/50 (48%) 25/49 (51%) 20/50 (40%) | |POLY-3 RATE (b) | 2/32.69 1/32.27 5/33.77 0/27.31 |19/41.79 24/43.86 25/43.47 20/39.66 | |POLY-3 PERCENT (g) | 6.1% 3.1% 14.8% 0.0% |45.5% 54.7% 57.5% 50.4% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 4/9 (44%) 0/0 (0%) |11/26 (42%) 17/26 (65%) 13/22 (59%) 10/16 (63%) | |FIRST INCIDENCE | 648 578 592 --- |627 497 546 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.632N P=0.580N P=0.234 P=0.690N |P=0.120 P=0.253 P=0.089 P=0.097 | |POLY 3 | P=0.273N P=0.505N P=0.223 P=0.278N |P=0.556N P=0.254 P=0.176 P=0.407 | |POLY 1.5 | P=0.227N P=0.499N P=0.224 P=0.253N |P=0.478N P=0.245 P=0.168 P=0.458 | |POLY 6 | P=0.402N P=0.521N P=0.217 P=0.343N |P=0.459 P=0.258 P=0.176 P=0.331 | |LOGISTIC REGRESSION| P=0.410N P=0.507N P=0.221 P=0.498N |P=0.511 P=0.256 P=0.137 P=0.326 | |COCH-ARM / FISHERS | P=0.198N P=0.500N P=0.218 P=0.247N |P=0.390N P=0.210 P=0.135 P=0.500 | |ORDER RESTRICTED | P=0.159N (e) (e) (e) |P=0.328 (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 5/50 (10%) 0/50 (0%) |20/50 (40%) 24/50 (48%) 25/49 (51%) 20/50 (40%) | |POLY-3 RATE (b) | 2/32.69 1/32.27 5/33.77 0/27.31 |20/41.79 24/43.86 25/43.47 20/39.66 | |POLY-3 PERCENT (g) | 6.1% 3.1% 14.8% 0.0% |47.9% 54.7% 57.5% 50.4% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 4/9 (44%) 0/0 (0%) |12/26 (46%) 17/26 (65%) 13/22 (59%) 10/16 (63%) | |FIRST INCIDENCE | 648 578 592 --- |627 497 546 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.632N P=0.580N P=0.234 P=0.690N |P=0.138 P=0.317 P=0.118 P=0.125 | |POLY 3 | P=0.273N P=0.505N P=0.223 P=0.278N |P=0.506N P=0.333 P=0.242 P=0.496 | |POLY 1.5 | P=0.227N P=0.499N P=0.224 P=0.253N |P=0.430N P=0.319 P=0.229 P=0.544 | |POLY 6 | P=0.402N P=0.521N P=0.217 P=0.343N |P=0.511 P=0.340 P=0.245 P=0.418 | |LOGISTIC REGRESSION| P=0.410N P=0.507N P=0.221 P=0.498N |P=0.555 P=0.331 P=0.187 P=0.401 | |COCH-ARM / FISHERS | P=0.198N P=0.500N P=0.218 P=0.247N |P=0.346N P=0.273 P=0.184 P=0.581N | |ORDER RESTRICTED | P=0.159N (e) (e) (e) |P=0.435 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 6/50 (12%) 0/50 (0%) |25/50 (50%) 25/50 (50%) 26/49 (53%) 23/50 (46%) | |POLY-3 RATE (b) | 3/32.88 1/32.27 6/34.35 0/27.31 |25/42.23 25/44.07 26/43.68 23/40.49 | |POLY-3 PERCENT (g) | 9.1% 3.1% 17.5% 0.0% |59.2% 56.7% 59.5% 56.8% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 4/9 (44%) 0/0 (0%) |15/26 (58%) 17/26 (65%) 13/22 (59%) 11/16 (69%) | |FIRST INCIDENCE | 648 578 554 --- |627 497 546 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.513N P=0.371N P=0.269 P=0.630N |P=0.115 P=0.530N P=0.302 P=0.172 | |POLY 3 | P=0.203N P=0.309N P=0.257 P=0.152N |P=0.498N P=0.494N P=0.578 P=0.500N | |POLY 1.5 | P=0.161N P=0.304N P=0.255 P=0.131N |P=0.427N P=0.514N P=0.549 P=0.451N | |POLY 6 | P=0.330N P=0.326N P=0.253 P=0.215N |P=0.527 P=0.486N P=0.591 P=0.587N | |LOGISTIC REGRESSION| P=0.252N P=0.316N P=0.250 P=0.317N |P=0.542 P=0.494N P=0.480 P=0.564 | |COCH-ARM / FISHERS | P=0.137N P=0.309N P=0.243 P=0.121N |P=0.350N P=0.579N P=0.459 P=0.421N | |ORDER RESTRICTED | P=0.118N (e) (e) (e) |P=0.636N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/32.38 0/31.75 0/33.30 3/28.52 |0/39.18 0/41.69 0/39.24 0/36.77 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 10.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- --- 606 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.003 ** (e) (e) P=0.081 |(e) (e) (e) (e) | |POLY 3 | P=0.006 ** (e) (e) P=0.094 |(e) (e) (e) (e) | |POLY 1.5 | P=0.007 ** (e) (e) P=0.108 |(e) (e) (e) (e) | |POLY 6 | P=0.004 ** (e) (e) P=0.068 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.008 ** (e) (e) P=0.107 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.008 ** (e) (e) P=0.121 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.004 ** (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/32.38 0/31.75 0/33.30 1/27.76 |1/40.85 2/41.69 0/39.69 1/37.22 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 3.6% |2.5% 4.8% 0.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 2/26 (8%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- --- 601 |478 735 (T) --- 711 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.220 (e) (e) P=0.500 |P=0.690N P=0.505 P=0.487N P=0.740 | |POLY 3 | P=0.206 (e) (e) P=0.469 |P=0.612N P=0.507 P=0.506N P=0.740 | |POLY 1.5 | P=0.218 (e) (e) P=0.488 |P=0.604N P=0.506 P=0.503N P=0.750 | |POLY 6 | P=0.179 (e) (e) P=0.426 |P=0.623N P=0.509 P=0.512N P=0.726 | |LOGISTIC REGRESSION| P=0.234 (e) (e) P=0.502 |P=0.589N P=0.483 P=0.643N P=0.761N | |COCH-ARM / FISHERS | P=0.228 (e) (e) P=0.500 |P=0.593N P=0.500 P=0.505N P=0.753N | |ORDER RESTRICTED | P=0.097 (e) (e) (e) |P=0.409N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 0/49 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/32.38 0/31.75 0/33.30 1/27.76 |1/40.85 3/42.43 0/39.69 2/37.56 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 3.6% |2.5% 7.1% 0.0% 5.3% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 2/26 (8%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- --- 601 |478 469 --- 639 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.220 (e) (e) P=0.500 |P=0.480 P=0.313 P=0.487N P=0.472 | |POLY 3 | P=0.206 (e) (e) P=0.469 |P=0.535 P=0.318 P=0.506N P=0.471 | |POLY 1.5 | P=0.218 (e) (e) P=0.488 |P=0.549 P=0.315 P=0.503N P=0.485 | |POLY 6 | P=0.179 (e) (e) P=0.426 |P=0.518 P=0.323 P=0.512N P=0.452 | |LOGISTIC REGRESSION| P=0.234 (e) (e) P=0.502 |P=0.594 P=0.246 P=0.643N P=0.507 | |COCH-ARM / FISHERS | P=0.228 (e) (e) P=0.500 |P=0.565 P=0.309 P=0.505N P=0.500 | |ORDER RESTRICTED | P=0.097 (e) (e) (e) |P=0.402 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/50 (72%) 37/50 (74%) 39/48 (81%) 31/50 (62%) |38/50 (76%) 35/49 (71%) 34/48 (71%) 35/50 (70%) | |POLY-3 RATE (b) | 36/43.50 37/44.98 39/43.40 31/41.03 |38/46.09 35/46.25 34/44.51 35/43.99 | |POLY-3 PERCENT (g) | 82.8% 82.3% 89.9% 75.6% |82.4% 75.7% 76.4% 79.6% | |TERMINAL (d) | 7/8 (88%) 4/5 (80%) 9/9 (100%) 0/0 (0%) |21/26 (81%) 20/26 (77%) 17/22 (77%) 12/16 (75%) | |FIRST INCIDENCE | 333 399 478 472 |477 469 546 478 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.006 ** P=0.274 P=0.476 P=0.005 ** |P=0.055 P=0.328N P=0.556N P=0.158 | |POLY 3 | P=0.146N P=0.598N P=0.220 P=0.260N |P=0.545 P=0.285N P=0.315N P=0.466N | |POLY 1.5 | P=0.097N P=0.608N P=0.221 P=0.206N |P=0.498N P=0.297N P=0.300N P=0.381N | |POLY 6 | P=0.324N P=0.627N P=0.215 P=0.442N |P=0.448 P=0.293N P=0.372N P=0.576N | |LOGISTIC REGRESSION| P=0.128N P=0.519 P=0.249 P=0.263N |P=0.527N P=0.309N P=0.296N P=0.431N | |COCH-ARM / FISHERS | P=0.077N P=0.500 P=0.200 P=0.198N |P=0.370N P=0.387N P=0.363N P=0.326N | |ORDER RESTRICTED | P=0.141N (e) (e) (e) |P=0.411N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/32.38 1/31.87 3/33.79 0/27.31 |0/40.12 0/41.69 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | 0.0% 3.1% 8.9% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- 705 666 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.610 P=0.481 P=0.136 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.513N P=0.497 P=0.124 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.468N P=0.500 P=0.123 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.623N P=0.488 P=0.125 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.723N P=0.469 P=0.123 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.437N P=0.500 P=0.121 (e) |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.232 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/32.55 0/31.75 1/33.30 0/27.31 |0/40.12 0/41.69 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | 6.1% 0.0% 3.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 690 --- 735 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.874N P=0.316N P=0.465N P=0.970N |(e) (e) (e) (e) | |POLY 3 | P=0.329N P=0.241N P=0.492N P=0.276N |(e) (e) (e) (e) | |POLY 1.5 | P=0.314N P=0.237N P=0.492N P=0.252N |(e) (e) (e) (e) | |POLY 6 | P=0.358N P=0.252N P=0.495N P=0.341N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.727N P=0.275N P=0.479N P=0.762N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.300N P=0.247N P=0.500N P=0.247N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.100N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous | | Tumor (benign, malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/32.55 1/31.87 4/33.79 0/27.31 |0/40.12 0/41.69 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | 6.1% 3.1% 11.8% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 690 705 666 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.692 P=0.588N P=0.378 P=0.970N |(e) (e) (e) (e) | |POLY 3 | P=0.267N P=0.507N P=0.351 P=0.276N |(e) (e) (e) (e) | |POLY 1.5 | P=0.229N P=0.500N P=0.349 P=0.252N |(e) (e) (e) (e) | |POLY 6 | P=0.372N P=0.526N P=0.353 P=0.341N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.585N P=0.562N P=0.348 P=0.762N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.203N P=0.500N P=0.339 P=0.247N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.188N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor | | (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 4/50 (8%) 11/50 (22%) 4/50 (8%) |1/50 (2%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 7/33.30 4/32.23 11/35.77 4/28.88 |1/40.12 2/41.69 0/39.69 1/37.12 | |POLY-3 PERCENT (g) | 21.0% 12.4% 30.8% 13.9% |2.5% 4.8% 0.0% 2.7% | |TERMINAL (d) | 2/8 (25%) 1/5 (20%) 2/9 (22%) 0/0 (0%) |1/26 (4%) 2/26 (8%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | 591 644 492 555 |735 (T) 735 (T) --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.051 P=0.436N P=0.294 P=0.109 |P=0.653 P=0.500 P=0.533N P=0.650 | |POLY 3 | P=0.379N P=0.270N P=0.253 P=0.340N |P=0.610N P=0.513 P=0.502N P=0.744 | |POLY 1.5 | P=0.313N P=0.260N P=0.241 P=0.290N |P=0.603N P=0.510 P=0.501N P=0.752 | |POLY 6 | P=0.545N P=0.301N P=0.271 P=0.477N |P=0.620N P=0.518 P=0.507N P=0.731 | |LOGISTIC REGRESSION| P=0.552 P=0.332N P=0.226 P=0.648 |P=0.653 P=0.500 (e) P=0.650 | |COCH-ARM / FISHERS | P=0.271N P=0.262N P=0.218 P=0.262N |P=0.593N P=0.500 P=0.505N P=0.753N | |ORDER RESTRICTED | P=0.346N (e) (e) (e) |P=0.408N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 6/50 (12%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 3/49 (6%) 2/50 (4%) | |POLY-3 RATE (b) | 4/33.30 2/32.24 6/34.92 1/27.66 |0/40.12 0/41.69 3/39.84 2/37.27 | |POLY-3 PERCENT (g) | 12.0% 6.2% 17.2% 3.6% |0.0% 0.0% 7.5% 5.4% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 2/22 (9%) 0/16 (0%) | |FIRST INCIDENCE | 525 652 547 638 |--- --- 694 711 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.579 P=0.430N P=0.402 P=0.725 |P=0.106 (e) P=0.098 P=0.176 | |POLY 3 | P=0.261N P=0.349N P=0.396 P=0.235N |P=0.168 (e) P=0.116 P=0.220 | |POLY 1.5 | P=0.213N P=0.339N P=0.389 P=0.200N |P=0.183 (e) P=0.118 P=0.229 | |POLY 6 | P=0.390N P=0.373N P=0.406 P=0.332N |P=0.148 (e) P=0.112 P=0.209 | |LOGISTIC REGRESSION| P=0.278N P=0.354N P=0.384 P=0.298N |P=0.143 (e) P=0.108 P=0.199 | |COCH-ARM / FISHERS | P=0.181N P=0.339N P=0.370 P=0.181N |P=0.203 (e) P=0.117 P=0.247 | |ORDER RESTRICTED | P=0.228N (e) (e) (e) |P=0.079 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 1/50 (2%) 7/50 (14%) 4/50 (8%) |1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 5/33.13 1/31.75 7/35.43 4/28.88 |1/40.12 2/41.69 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | 15.1% 3.2% 19.8% 13.9% |2.5% 4.8% 0.0% 0.0% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 1/9 (11%) 0/0 (0%) |1/26 (4%) 2/26 (8%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 591 735 (T) 492 555 |735 (T) 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.040 * P=0.186N P=0.432 P=0.094 |P=0.329N P=0.500 P=0.533N P=0.597N | |POLY 3 | P=0.441 P=0.105N P=0.424 P=0.589N |P=0.250N P=0.513 P=0.502N P=0.516N | |POLY 1.5 | P=0.495 P=0.101N P=0.409 P=0.535N |P=0.245N P=0.510 P=0.501N P=0.508N | |POLY 6 | P=0.324 P=0.119N P=0.445 P=0.582 |P=0.256N P=0.518 P=0.507N P=0.527N | |LOGISTIC REGRESSION| P=0.356 P=0.128N P=0.396 P=0.523 |P=0.329N P=0.500 (e) (e) | |COCH-ARM / FISHERS | P=0.536 P=0.102N P=0.380 P=0.500N |P=0.240N P=0.500 P=0.505N P=0.500N | |ORDER RESTRICTED | P=0.288 (e) (e) (e) |P=0.190N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Schwannoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/33.31 1/32.26 0/33.30 0/27.31 |0/40.12 0/41.69 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | 6.0% 3.1% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 469 581 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.279N P=0.514N P=0.244N P=0.457N |(e) (e) (e) (e) | |POLY 3 | P=0.228N P=0.511N P=0.236N P=0.282N |(e) (e) (e) (e) | |POLY 1.5 | P=0.221N P=0.503N P=0.234N P=0.255N |(e) (e) (e) (e) | |POLY 6 | P=0.236N P=0.531N P=0.240N P=0.351N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.203N P=0.516N P=0.256N P=0.229N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.212N P=0.500N P=0.247N P=0.247N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.104N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/32.55 0/31.75 2/33.40 0/27.31 |0/40.12 0/41.69 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | 6.1% 0.0% 6.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 690 --- 708 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.918 P=0.316N P=0.645N P=0.970N |(e) (e) (e) (e) | |POLY 3 | P=0.335N P=0.241N P=0.687N P=0.276N |(e) (e) (e) (e) | |POLY 1.5 | P=0.310N P=0.237N P=0.687N P=0.252N |(e) (e) (e) (e) | |POLY 6 | P=0.395N P=0.252N P=0.692N P=0.341N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.747N P=0.275N P=0.682N P=0.762N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.290N P=0.247N P=0.691N P=0.247N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.147N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/32.38 2/32.12 0/33.30 0/27.31 |0/40.12 0/41.69 0/39.69 1/37.12 | |POLY-3 PERCENT (g) | 0.0% 6.2% 0.0% 0.0% |0.0% 0.0% 0.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | --- 644 --- --- |--- --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.701N P=0.190 (e) (e) |P=0.152 (e) (e) P=0.403 | |POLY 3 | P=0.415N P=0.233 (e) (e) |P=0.214 (e) (e) P=0.484 | |POLY 1.5 | P=0.400N P=0.238 (e) (e) |P=0.221 (e) (e) P=0.492 | |POLY 6 | P=0.438N P=0.224 (e) (e) |P=0.205 (e) (e) P=0.473 | |LOGISTIC REGRESSION| P=0.522N P=0.216 (e) (e) |(e) (e) (e) P=0.403 | |COCH-ARM / FISHERS | P=0.390N P=0.247 (e) (e) |P=0.229 (e) (e) P=0.500 | |ORDER RESTRICTED | P=0.280N (e) (e) (e) |P=0.107 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 8/50 (16%) 4/50 (8%) |1/50 (2%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 5/33.13 3/32.12 8/35.53 4/28.88 |1/40.12 2/41.69 0/39.69 1/37.12 | |POLY-3 PERCENT (g) | 15.1% 9.3% 22.5% 13.9% |2.5% 4.8% 0.0% 2.7% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 1/9 (11%) 0/0 (0%) |1/26 (4%) 2/26 (8%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | 591 644 492 555 |735 (T) 735 (T) --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.053 P=0.515N P=0.341 P=0.094 |P=0.653 P=0.500 P=0.533N P=0.650 | |POLY 3 | P=0.570 P=0.369N P=0.314 P=0.589N |P=0.610N P=0.513 P=0.502N P=0.744 | |POLY 1.5 | P=0.548N P=0.357N P=0.302 P=0.535N |P=0.603N P=0.510 P=0.501N P=0.752 | |POLY 6 | P=0.428 P=0.402N P=0.334 P=0.582 |P=0.620N P=0.518 P=0.507N P=0.731 | |LOGISTIC REGRESSION| P=0.451 P=0.421N P=0.290 P=0.523 |P=0.653 P=0.500 (e) P=0.650 | |COCH-ARM / FISHERS | P=0.500N P=0.357N P=0.277 P=0.500N |P=0.593N P=0.500 P=0.505N P=0.753N | |ORDER RESTRICTED | P=0.391 (e) (e) (e) |P=0.408N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 7/50 (14%) 4/50 (8%) |1/50 (2%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 5/33.13 3/32.12 7/35.43 4/28.88 |1/40.12 2/41.69 0/39.69 1/37.12 | |POLY-3 PERCENT (g) | 15.1% 9.3% 19.8% 13.9% |2.5% 4.8% 0.0% 2.7% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 1/9 (11%) 0/0 (0%) |1/26 (4%) 2/26 (8%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | 591 644 492 555 |735 (T) 735 (T) --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.065 P=0.515N P=0.432 P=0.094 |P=0.653 P=0.500 P=0.533N P=0.650 | |POLY 3 | P=0.561 P=0.369N P=0.424 P=0.589N |P=0.610N P=0.513 P=0.502N P=0.744 | |POLY 1.5 | P=0.565N P=0.357N P=0.409 P=0.535N |P=0.603N P=0.510 P=0.501N P=0.752 | |POLY 6 | P=0.429 P=0.402N P=0.445 P=0.582 |P=0.620N P=0.518 P=0.507N P=0.731 | |LOGISTIC REGRESSION| P=0.460 P=0.421N P=0.396 P=0.523 |P=0.653 P=0.500 (e) P=0.650 | |COCH-ARM / FISHERS | P=0.519N P=0.357N P=0.380 P=0.500N |P=0.593N P=0.500 P=0.505N P=0.753N | |ORDER RESTRICTED | P=0.468 (e) (e) (e) |P=0.408N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin: Sebaceous Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/33.22 0/31.75 0/33.30 0/27.31 |0/40.12 0/41.69 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | 6.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 522 --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.414N P=0.266N P=0.257N P=0.417N |(e) (e) (e) (e) | |POLY 3 | P=0.310N P=0.246N P=0.235N P=0.282N |(e) (e) (e) (e) | |POLY 1.5 | P=0.311N P=0.239N P=0.234N P=0.255N |(e) (e) (e) (e) | |POLY 6 | P=0.297N P=0.261N P=0.239N P=0.351N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.301N P=0.240N P=0.244N P=0.234N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.308N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.048N* (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/50 (70%) 35/50 (70%) 37/50 (74%) 32/50 (64%) | | |POLY-3 RATE (b) | 35/41.21 35/41.12 37/43.09 32/40.39 | | |POLY-3 PERCENT (g) | 84.9% 85.1% 85.9% 79.2% | | |TERMINAL (d) | 7/8 (88%) 5/5 (100%) 9/9 (100%) 0/0 (0%) | | |FIRST INCIDENCE | 469 477 428 469 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.272 P=0.537 P<0.001 ** | | |POLY 3 | P=0.202N P=0.644 P=0.594 P=0.316N | | |POLY 1.5 | P=0.207N P=0.590N P=0.536 P=0.294N | | |POLY 6 | P=0.262N P=0.575 P=0.631 P=0.460N | | |LOGISTIC REGRESSION| P=0.473N P=0.605 P=0.509 P=0.529N | | |COCH-ARM / FISHERS | P=0.244N P=0.586N P=0.412 P=0.335N | | |ORDER RESTRICTED | P=0.273N (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 6/49 (12%) 5/49 (10%) 0/47 (0%) |7/49 (14%) 5/49 (10%) 6/47 (13%) 5/48 (10%) | |POLY-3 RATE (b) | 5/32.95 6/32.14 5/33.73 0/25.76 |7/40.72 5/41.52 6/39.41 5/37.17 | |POLY-3 PERCENT (g) | 15.2% 18.7% 14.8% 0.0% |17.2% 12.0% 15.2% 13.5% | |TERMINAL (d) | 0/8 (0%) 3/5 (60%) 0/9 (0%) 0/0 (0%) |3/26 (12%) 2/26 (8%) 3/22 (14%) 2/16 (13%) | |FIRST INCIDENCE | 522 571 554 --- |477 679 547 438 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.184N P=0.345 P=0.596N P=0.291N |P=0.493 P=0.360N P=0.580N P=0.584N | |POLY 3 | P=0.034N* P=0.482 P=0.620N P=0.053N |P=0.500N P=0.364N P=0.526N P=0.443N | |POLY 1.5 | P=0.024N* P=0.498 P=0.619N P=0.040N* |P=0.471N P=0.366N P=0.520N P=0.417N | |POLY 6 | P=0.073N P=0.440 P=0.628N P=0.099N |P=0.544N P=0.360N P=0.542N P=0.483N | |LOGISTIC REGRESSION| P=0.038N* P=0.478 P=0.613N P=0.050N |P=0.457N P=0.362N P=0.529N P=0.396N | |COCH-ARM / FISHERS | P=0.019N* P=0.500 P=0.630N P=0.031N* |P=0.434N P=0.380N P=0.533N P=0.394N | |ORDER RESTRICTED | P=0.042N* (e) (e) (e) |P=0.506N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/49 (2%) 1/49 (2%) 0/47 (0%) |1/49 (2%) 1/49 (2%) 2/47 (4%) 0/48 (0%) | |POLY-3 RATE (b) | 0/31.45 1/31.43 1/33.11 0/25.76 |1/39.61 1/41.44 2/38.89 0/36.11 | |POLY-3 PERCENT (g) | 0.0% 3.2% 3.0% 0.0% |2.5% 2.4% 5.1% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 1/22 (5%) 0/16 (0%) | |FIRST INCIDENCE | --- 644 554 --- |609 677 616 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.611N P=0.457 P=0.500 (e) |P=0.374N P=0.745N P=0.484 P=0.516N | |POLY 3 | P=0.571N P=0.500 P=0.510 (e) |P=0.354N P=0.751N P=0.494 P=0.518N | |POLY 1.5 | P=0.548N P=0.502 P=0.507 (e) |P=0.340N P=0.753N P=0.494 P=0.511N | |POLY 6 | P=0.619N P=0.494 P=0.514 (e) |P=0.374N P=0.747N P=0.489 P=0.529N | |LOGISTIC REGRESSION| P=0.523N P=0.499 P=0.464 (e) |P=0.315N P=0.750 P=0.470 P=0.503N | |COCH-ARM / FISHERS | P=0.532N P=0.500 P=0.500 (e) |P=0.322N P=0.753N P=0.484 P=0.505N | |ORDER RESTRICTED | P=0.420 (e) (e) (e) |P=0.293N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 7/49 (14%) 5/49 (10%) 0/47 (0%) |8/49 (16%) 6/49 (12%) 8/47 (17%) 5/48 (10%) | |POLY-3 RATE (b) | 5/32.95 7/32.47 5/33.73 0/25.76 |8/41.15 6/41.74 8/39.83 5/37.17 | |POLY-3 PERCENT (g) | 15.2% 21.6% 14.8% 0.0% |19.4% 14.4% 20.1% 13.5% | |TERMINAL (d) | 0/8 (0%) 3/5 (60%) 0/9 (0%) 0/0 (0%) |3/26 (12%) 2/26 (8%) 4/22 (18%) 2/16 (13%) | |FIRST INCIDENCE | 522 571 554 --- |477 677 547 438 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.158N P=0.239 P=0.596N P=0.291N |P=0.534N P=0.363N P=0.523 P=0.471N | |POLY 3 | P=0.027N* P=0.362 P=0.620N P=0.053N |P=0.367N P=0.374N P=0.582 P=0.342N | |POLY 1.5 | P=0.018N* P=0.378 P=0.619N P=0.040N* |P=0.334N P=0.374N P=0.587 P=0.314N | |POLY 6 | P=0.060N P=0.324 P=0.628N P=0.099N |P=0.420N P=0.372N P=0.565 P=0.386N | |LOGISTIC REGRESSION| P=0.029N* P=0.357 P=0.613N P=0.050N |P=0.308N P=0.377N P=0.571 P=0.288N | |COCH-ARM / FISHERS | P=0.014N* P=0.380 P=0.630N P=0.031N* |P=0.295N P=0.387N P=0.572 P=0.290N | |ORDER RESTRICTED | P=0.032N* (e) (e) (e) |P=0.385N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 2/49 (4%) 0/47 (0%) |0/49 (0%) 0/49 (0%) 0/47 (0%) 1/48 (2%) | |POLY-3 RATE (b) | 0/31.45 0/31.10 2/32.70 0/25.76 |0/39.18 0/41.22 0/38.48 1/36.11 | |POLY-3 PERCENT (g) | 0.0% 0.0% 6.1% 0.0% |0.0% 0.0% 0.0% 2.8% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | --- --- 692 --- |--- --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.729 (e) P=0.267 (e) |P=0.152 (e) (e) P=0.403 | |POLY 3 | P=0.711N (e) P=0.244 (e) |P=0.213 (e) (e) P=0.484 | |POLY 1.5 | P=0.683N (e) P=0.243 (e) |P=0.219 (e) (e) P=0.490 | |POLY 6 | P=0.680 (e) P=0.245 (e) |P=0.205 (e) (e) P=0.475 | |LOGISTIC REGRESSION| P=0.748 (e) P=0.251 (e) |(e) (e) (e) P=0.403 | |COCH-ARM / FISHERS | P=0.662N (e) P=0.247 (e) |P=0.226 (e) (e) P=0.495 | |ORDER RESTRICTED | P=0.259 (e) (e) (e) |P=0.106 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 1/49 (2%) 0/47 (0%) |0/49 (0%) 2/49 (4%) 1/47 (2%) 0/48 (0%) | |POLY-3 RATE (b) | 0/31.45 0/31.10 1/32.61 0/25.76 |0/39.18 2/41.22 1/38.48 0/36.11 | |POLY-3 PERCENT (g) | 0.0% 0.0% 3.1% 0.0% |0.0% 4.9% 2.6% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 2/26 (8%) 1/22 (5%) 0/16 (0%) | |FIRST INCIDENCE | --- --- 716 --- |--- 735 (T) 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.986 (e) P=0.540 (e) |P=0.486N P=0.238 P=0.467 (e) | |POLY 3 | P=0.802N (e) P=0.507 (e) |P=0.386N P=0.248 P=0.496 (e) | |POLY 1.5 | P=0.789N (e) P=0.506 (e) |P=0.378N P=0.245 P=0.497 (e) | |POLY 6 | P=0.774 (e) P=0.509 (e) |P=0.397N P=0.253 P=0.494 (e) | |LOGISTIC REGRESSION| P=0.915 (e) P=0.516 (e) |(e) P=0.238 P=0.467 (e) | |COCH-ARM / FISHERS | P=0.780N (e) P=0.500 (e) |P=0.371N P=0.247 P=0.490 (e) | |ORDER RESTRICTED | P=0.392 (e) (e) (e) |P=0.335 (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 22 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 3/49 (6%) 0/47 (0%) |0/49 (0%) 2/49 (4%) 1/47 (2%) 1/48 (2%) | |POLY-3 RATE (b) | 0/31.45 0/31.10 3/32.78 0/25.76 |0/39.18 2/41.22 1/38.48 1/36.11 | |POLY-3 PERCENT (g) | 0.0% 0.0% 9.2% 0.0% |0.0% 4.9% 2.6% 2.8% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 2/26 (8%) 1/22 (5%) 1/16 (6%) | |FIRST INCIDENCE | --- --- 692 --- |--- 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.481 (e) P=0.152 (e) |P=0.516 P=0.238 P=0.467 P=0.403 | |POLY 3 | P=0.662N (e) P=0.123 (e) |P=0.624 P=0.248 P=0.496 P=0.484 | |POLY 1.5 | P=0.623N (e) P=0.123 (e) |P=0.636 P=0.245 P=0.497 P=0.490 | |POLY 6 | P=0.628 (e) P=0.123 (e) |P=0.607 P=0.253 P=0.494 P=0.475 | |LOGISTIC REGRESSION| P=0.619 (e) P=0.129 (e) |(e) P=0.238 P=0.467 P=0.403 | |COCH-ARM / FISHERS | P=0.594N (e) P=0.121 (e) |P=0.649 P=0.247 P=0.490 P=0.495 | |ORDER RESTRICTED | P=0.173 (e) (e) (e) |P=0.281 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma or Papilloma Squamous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 3/50 (6%) 0/49 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/32.38 0/31.75 0/33.30 0/27.31 |0/40.12 3/42.43 0/39.69 2/37.56 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 7.1% 0.0% 5.3% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 2/26 (8%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 469 --- 639 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.328 P=0.124 (e) P=0.211 | |POLY 3 | (e) (e) (e) (e) |P=0.403 P=0.128 (e) P=0.222 | |POLY 1.5 | (e) (e) (e) (e) |P=0.413 P=0.126 (e) P=0.230 | |POLY 6 | (e) (e) (e) (e) |P=0.389 P=0.132 (e) P=0.212 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.434 P=0.109 (e) P=0.230 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.424 P=0.121 (e) P=0.247 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.141 (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 23 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Tongue | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/32.38 0/31.75 0/33.30 0/27.31 |0/40.12 2/41.69 0/39.69 1/37.22 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.8% 0.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 2/26 (8%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 735 (T) --- 711 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.534 P=0.238 (e) P=0.459 | |POLY 3 | (e) (e) (e) (e) |P=0.615 P=0.245 (e) P=0.485 | |POLY 1.5 | (e) (e) (e) (e) |P=0.625 P=0.243 (e) P=0.493 | |POLY 6 | (e) (e) (e) (e) |P=0.602 P=0.248 (e) P=0.474 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.567 P=0.238 (e) P=0.471 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.634 P=0.247 (e) P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.311 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |6/50 (12%) 9/50 (18%) 6/49 (12%) 2/50 (4%) | |POLY-3 RATE (b) | |6/40.86 9/42.55 6/40.27 2/37.64 | |POLY-3 PERCENT (g) | |14.7% 21.2% 14.9% 5.3% | |TERMINAL (d) | |4/26 (15%) 5/26 (19%) 5/22 (23%) 0/16 (0%) | |FIRST INCIDENCE | |581 637 547 599 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.140N P=0.316 P=0.527 P=0.273N | |POLY 3 | |P=0.058N P=0.314 P=0.612 P=0.158N | |POLY 1.5 | |P=0.050N P=0.307 P=0.618 P=0.145N | |POLY 6 | |P=0.073N P=0.326 P=0.593 P=0.179N | |LOGISTIC REGRESSION| |P=0.059N P=0.315 P=0.610 P=0.153N | |COCH-ARM / FISHERS | |P=0.042N* P=0.288 P=0.606 P=0.134N | |ORDER RESTRICTED | |P=0.083N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 24 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) | |POLY-3 RATE (b) | |0/40.12 0/41.69 0/39.69 2/38.56 | |POLY-3 PERCENT (g) | |0.0% 0.0% 0.0% 5.2% | |TERMINAL (d) | |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | |--- --- --- 429 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.040 * (e) (e) P=0.235 | |POLY 3 | |P=0.038 * (e) (e) P=0.228 | |POLY 1.5 | |P=0.040 * (e) (e) P=0.233 | |POLY 6 | |P=0.036 * (e) (e) P=0.219 | |LOGISTIC REGRESSION| |P=0.044 * (e) (e) P=0.190 | |COCH-ARM / FISHERS | |P=0.043 * (e) (e) P=0.247 | |ORDER RESTRICTED | |P=0.026 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |6/50 (12%) 9/50 (18%) 6/49 (12%) 4/50 (8%) | |POLY-3 RATE (b) | |6/40.86 9/42.55 6/40.27 4/39.07 | |POLY-3 PERCENT (g) | |14.7% 21.2% 14.9% 10.2% | |TERMINAL (d) | |4/26 (15%) 5/26 (19%) 5/22 (23%) 0/16 (0%) | |FIRST INCIDENCE | |581 637 547 429 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.395N P=0.316 P=0.527 P=0.548N | |POLY 3 | |P=0.200N P=0.314 P=0.612 P=0.397N | |POLY 1.5 | |P=0.185N P=0.307 P=0.618 P=0.381N | |POLY 6 | |P=0.225N P=0.326 P=0.593 P=0.422N | |LOGISTIC REGRESSION| |P=0.190N P=0.315 P=0.610 P=0.361N | |COCH-ARM / FISHERS | |P=0.171N P=0.288 P=0.606 P=0.370N | |ORDER RESTRICTED | |P=0.269N (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 25 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Schwannoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |2/50 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | |2/40.57 1/42.37 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | |4.9% 2.4% 0.0% 0.0% | |TERMINAL (d) | |1/26 (4%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | |604 506 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.245N P=0.495N P=0.258N P=0.305N | |POLY 3 | |P=0.226N P=0.485N P=0.242N P=0.257N | |POLY 1.5 | |P=0.221N P=0.489N P=0.239N P=0.247N | |POLY 6 | |P=0.232N P=0.480N P=0.248N P=0.272N | |LOGISTIC REGRESSION| |P=0.201N P=0.545N P=0.242N P=0.240N | |COCH-ARM / FISHERS | |P=0.212N P=0.500N P=0.253N P=0.247N | |ORDER RESTRICTED | |P=0.087N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/32.81 0/31.75 0/33.30 3/29.06 |0/40.12 0/41.69 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | 3.1% 0.0% 0.0% 10.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 609 --- --- 347 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.033 * P=0.487N P=0.493N P=0.249 |(e) (e) (e) (e) | |POLY 3 | P=0.039 * P=0.507N P=0.497N P=0.259 |(e) (e) (e) (e) | |POLY 1.5 | P=0.043 * P=0.501N P=0.496N P=0.288 |(e) (e) (e) (e) | |POLY 6 | P=0.031 * P=0.519N P=0.500N P=0.196 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.056 P=0.501N P=0.505N P=0.304 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.048 * P=0.500N P=0.500N P=0.309 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.025 * (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 26 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/32.81 0/31.75 1/33.30 3/29.06 |0/40.12 0/41.69 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | 3.1% 0.0% 3.0% 10.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 609 --- 735 (T) 347 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.023 * P=0.487N P=0.743N P=0.249 |(e) (e) (e) (e) | |POLY 3 | P=0.064 P=0.507N P=0.759N P=0.259 |(e) (e) (e) (e) | |POLY 1.5 | P=0.073 P=0.501N P=0.757N P=0.288 |(e) (e) (e) (e) | |POLY 6 | P=0.047 * P=0.519N P=0.763 P=0.196 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.094 P=0.501N P=0.757N P=0.304 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.080 P=0.500N P=0.753N P=0.309 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.057 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/32.38 0/31.75 2/33.55 0/27.31 |0/40.12 1/42.00 0/39.69 1/37.38 | |POLY-3 PERCENT (g) | 0.0% 0.0% 6.0% 0.0% |0.0% 2.4% 0.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- 666 --- |--- 651 --- 665 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.724 (e) P=0.258 (e) |P=0.442 P=0.522 (e) P=0.481 | |POLY 3 | P=0.704N (e) P=0.244 (e) |P=0.460 P=0.509 (e) P=0.486 | |POLY 1.5 | P=0.674N (e) P=0.243 (e) |P=0.469 P=0.506 (e) P=0.493 | |POLY 6 | P=0.679 (e) P=0.244 (e) |P=0.449 P=0.513 (e) P=0.476 | |LOGISTIC REGRESSION| P=0.770 (e) P=0.243 (e) |P=0.485 P=0.491 (e) P=0.498 | |COCH-ARM / FISHERS | P=0.652N (e) P=0.247 (e) |P=0.478 P=0.500 (e) P=0.500 | |ORDER RESTRICTED | P=0.257 (e) (e) (e) |P=0.237 (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 27 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 29/50 (58%) 31/50 (62%) 28/50 (56%) 15/50 (30%) |21/50 (42%) 19/50 (38%) 18/49 (37%) 29/50 (58%) | |POLY-3 RATE (b) | 29/42.74 31/41.18 28/42.51 15/35.58 |21/44.96 19/43.15 18/43.74 29/43.77 | |POLY-3 PERCENT (g) | 67.9% 75.3% 65.9% 42.2% |46.7% 44.0% 41.2% 66.3% | |TERMINAL (d) | 6/8 (75%) 4/5 (80%) 6/9 (67%) 0/0 (0%) |8/26 (31%) 9/26 (35%) 5/22 (23%) 12/16 (75%) | |FIRST INCIDENCE | 302 490 428 421 |456 628 518 438 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.534N P=0.246 P=0.436N P=0.548 |P<0.001 ** P=0.392N P=0.487N P=0.015 * | |POLY 3 | P<0.001N** P=0.285 P=0.515N P=0.011N* |P=0.011 * P=0.484N P=0.375N P=0.043 * | |POLY 1.5 | P<0.001N** P=0.348 P=0.497N P=0.005N** |P=0.014 * P=0.448N P=0.360N P=0.057 | |POLY 6 | P=0.011N* P=0.220 P=0.554N P=0.055N |P=0.008 ** P=0.523N P=0.401N P=0.031 * | |LOGISTIC REGRESSION| P<0.001N** P=0.426 P=0.500N P=0.003N** |P=0.016 * P=0.390N P=0.385N P=0.076 | |COCH-ARM / FISHERS | P<0.001N** P=0.419 P=0.500N P=0.004N** |P=0.020 * P=0.419N P=0.371N P=0.081 | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.019 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/33.08 2/32.13 1/33.30 0/27.31 |0/40.12 0/41.69 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | 9.1% 6.2% 3.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 561 627 735 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.296N P=0.623N P=0.283N P=0.500N |(e) (e) (e) (e) | |POLY 3 | P=0.126N P=0.514N P=0.300N P=0.154N |(e) (e) (e) (e) | |POLY 1.5 | P=0.113N P=0.502N P=0.299N P=0.132N |(e) (e) (e) (e) | |POLY 6 | P=0.155N P=0.541N P=0.306N P=0.217N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.171N P=0.524N P=0.294N P=0.188N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.103N P=0.500N P=0.309N P=0.121N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.081N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 28 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/33.08 2/32.13 1/33.30 0/27.31 |0/40.12 0/41.69 0/39.69 0/37.12 | |POLY-3 PERCENT (g) | 9.1% 6.2% 3.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 561 627 735 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.296N P=0.623N P=0.283N P=0.500N |(e) (e) (e) (e) | |POLY 3 | P=0.126N P=0.514N P=0.300N P=0.154N |(e) (e) (e) (e) | |POLY 1.5 | P=0.113N P=0.502N P=0.299N P=0.132N |(e) (e) (e) (e) | |POLY 6 | P=0.155N P=0.541N P=0.306N P=0.217N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.171N P=0.524N P=0.294N P=0.188N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.103N P=0.500N P=0.309N P=0.121N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.081N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/49 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 0/32.38 1/32.35 0/33.30 0/27.31 |0/40.12 0/41.69 2/40.40 1/37.12 | |POLY-3 PERCENT (g) | 0.0% 3.1% 0.0% 0.0% |0.0% 0.0% 5.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | --- 543 --- --- |--- --- 628 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.609N P=0.510 (e) (e) |P=0.357 (e) P=0.240 P=0.403 | |POLY 3 | P=0.618N P=0.500 (e) (e) |P=0.378 (e) P=0.238 P=0.484 | |POLY 1.5 | P=0.613N P=0.502 (e) (e) |P=0.397 (e) P=0.238 P=0.492 | |POLY 6 | P=0.620N P=0.493 (e) (e) |P=0.350 (e) P=0.236 P=0.473 | |LOGISTIC REGRESSION| P=0.598N P=0.471 (e) (e) |P=0.421 (e) P=0.210 P=0.403 | |COCH-ARM / FISHERS | P=0.608N P=0.500 (e) (e) |P=0.420 (e) P=0.242 P=0.500 | |ORDER RESTRICTED | P=0.410N (e) (e) (e) |P=0.169 (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 29 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/49 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 1/32.84 1/32.35 0/33.30 0/27.31 |0/40.12 0/41.69 2/40.40 1/37.12 | |POLY-3 PERCENT (g) | 3.0% 3.1% 0.0% 0.0% |0.0% 0.0% 5.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | 595 543 --- --- |--- --- 628 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.356N P=0.751N P=0.512N P=0.512N |P=0.357 (e) P=0.240 P=0.403 | |POLY 3 | P=0.366N P=0.759 P=0.497N P=0.537N |P=0.378 (e) P=0.238 P=0.484 | |POLY 1.5 | P=0.358N P=0.761N P=0.497N P=0.515N |P=0.397 (e) P=0.238 P=0.492 | |POLY 6 | P=0.373N P=0.750 P=0.501N P=0.586N |P=0.350 (e) P=0.236 P=0.473 | |LOGISTIC REGRESSION| P=0.337N P=0.750 P=0.510N P=0.495N |P=0.421 (e) P=0.210 P=0.403 | |COCH-ARM / FISHERS | P=0.348N P=0.753N P=0.500N P=0.500N |P=0.420 (e) P=0.242 P=0.500 | |ORDER RESTRICTED | P=0.285N (e) (e) (e) |P=0.169 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 47/50 (94%) 50/50 (100%) 49/50 (98%) 47/50 (94%) |48/50 (96%) 47/50 (94%) 46/49 (94%) 43/50 (86%) | |POLY-3 RATE (b) | 47/47.32 50/50.00 49/49.28 47/47.65 |48/48.24 47/48.67 46/47.55 43/45.83 | |POLY-3 PERCENT (g) | 99.3% 100.0% 99.4% 98.6% |99.5% 96.6% 96.8% 93.8% | |TERMINAL (d) | 8/8 (100%) 5/5 (100%) 9/9 (100%) 0/0 (0%) |26/26 (100%) 25/26 (96%) 22/22 (100%) 16/16 (100%) | |FIRST INCIDENCE | 333 399 428 469 |470 469 546 438 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.191 P=0.540 P<0.001 ** |P=0.068 P=0.431N P=0.387 P=0.144 | |POLY 3 | P=0.606N P=1.000 P=0.997 P=0.925N |P=0.113N P=0.358N P=0.376N P=0.092N | |POLY 1.5 | P=0.337N P=0.508 P=0.754 P=0.734N |P=0.052N P=0.338N P=0.331N P=0.053N | |POLY 6 | P=1.000N P=1.000 P=1.000N P=1.000N |P=0.311N P=0.423N P=0.550N P=0.263N | |LOGISTIC REGRESSION| P=0.102N P=0.698 P=0.669N P=0.297N |P=0.115N P=0.295N P=0.147N P=0.088N | |COCH-ARM / FISHERS | P=0.288N P=0.121 P=0.309 P=0.661N |P=0.038N* P=0.500N P=0.490N P=0.080N | |ORDER RESTRICTED | P=0.155N (e) (e) (e) |P=0.036N* (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 05201 TEST: 05 Page 30 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 35/50 (70%) 35/50 (70%) 34/50 (68%) 26/50 (52%) |31/50 (62%) 28/50 (56%) 32/49 (65%) 36/50 (72%) | |POLY-3 RATE (b) | 35/45.06 35/42.94 34/44.29 26/40.95 |31/45.89 28/47.32 32/46.75 36/46.27 | |POLY-3 PERCENT (g) | 77.7% 81.5% 76.8% 63.5% |67.6% 59.2% 68.5% 77.8% | |TERMINAL (d) | 6/8 (75%) 5/5 (100%) 7/9 (78%) 0/0 (0%) |15/26 (58%) 10/26 (39%) 12/22 (55%) 13/16 (81%) | |FIRST INCIDENCE | 302 399 428 347 |456 428 518 429 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.063 P=0.328 P=0.435N P=0.101 |P=0.007 ** P=0.337N P=0.333 P=0.028 * | |POLY 3 | P=0.023N* P=0.419 P=0.565N P=0.086N |P=0.058 P=0.262N P=0.553 P=0.181 | |POLY 1.5 | P=0.016N* P=0.502 P=0.529N P=0.057N |P=0.069 P=0.279N P=0.528 P=0.195 | |POLY 6 | P=0.081N P=0.314 P=0.616N P=0.220N |P=0.047 * P=0.243N P=0.581 P=0.165 | |LOGISTIC REGRESSION| P=0.018N* P=0.579N P=0.499N P=0.023N* |P=0.096 P=0.345N P=0.448 P=0.183 | |COCH-ARM / FISHERS | P=0.019N* P=0.586N P=0.500N P=0.050N |P=0.089 P=0.342N P=0.447 P=0.198 | |ORDER RESTRICTED | P=0.035N* (e) (e) (e) |P=0.093 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) 50/50 (100%)|49/50 (98%) 49/50 (98%) 49/49 (100%) 49/50 (98%) | |POLY-3 RATE (b) | 50/50.00 50/50.00 50/50.00 50/50.00 |49/49.00 49/50.00 49/49.00 49/49.07 | |POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |100.0% 98.0% 100.0% 99.9% | |TERMINAL (d) | 8/8 (100%) 5/5 (100%) 9/9 (100%) 0/0 (0%) |26/26 (100%) 25/26 (96%) 22/22 (100%) 16/16 (100%) | |FIRST INCIDENCE | 302 399 428 347 |456 428 518 429 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.015 * P=0.491N P=0.289 P=0.044 * | |POLY 3 | (e) (e) (e) (e) |P=0.649 P=0.505N P=1.000 P=1.000N | |POLY 1.5 | (e) (e) (e) (e) |P=0.742 P=0.523N P=1.000 P=0.998N | |POLY 6 | (e) (e) (e) (e) |P=0.609 P=0.504N P=1.000 P=1.000N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.722N P=0.605N (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.668N P=0.753N P=0.505 P=0.753N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.407 (e) (e) (e) | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (g) Poly-3 adjusted lifetime tumor incidence. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).