TDMS Study 05201-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 10/07/97 EXPERIMENT: 05201 TEST: 05 TIME: 14:59:08 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: GRUMBEIN, S. CAS: 0098-00-0000 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 NUMBER OF ANIMALS NECROPSIED. ---------------- Kidney NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 10/07/97 EXPERIMENT: 05201 TEST: 05 TIME: 14:59:08 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: GRUMBEIN, S. CAS: 0098-00-0000 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF FURFURYL ALCOHOL =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Kidney, Renal Tubule (Step Section) Adenoma Carcinoma and Adenoma Hyperplasia Hyperplasia and Adenoma Hyperplasia, Carcinoma or Adenoma Kidney, Renal Tubule (Step and Original Sections) Adenoma Carcinoma and Adenoma Hyperplasia Hyperplasia and Adenoma Hyperplasia, Carcinoma or Adenoma Kidney: Renal Tubule Hyperplasia Hyperplasia and Adenoma Hyperplasia, Carcinoma or Adenoma =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Kidney, Renal Tubule (Step Section) Hyperplasia Hyperplasia and Adenoma Hyperplasia, Carcinoma or Adenoma Kidney, Renal Tubule (Step and Original Sections) Hyperplasia Hyperplasia and Adenoma Hyperplasia, Carcinoma or Adenoma Kidney: Renal Tubule Adenoma Hyperplasia Hyperplasia and Adenoma Hyperplasia, Carcinoma or Adenoma =============================================================== Date: 10/07/97 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 | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step Section) | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 0/49 (0%) 2/49 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 3.1% 3.1% 3.0% 13.9% |0.0% 0.0% 5.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 2/22 (9%) 0/16 (0%) | |FIRST INCIDENCE | 715 735 (T) 708 609 |--- --- 735 (T) 707 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.685 P=0.734N P=0.006 ** |P=0.300 (e) P=0.201 P=0.440 | |POLY 3 | P=0.041 * P=0.758 P=0.756N P=0.137 |P=0.379 (e) P=0.234 P=0.485 | |POLY 1.5 | P=0.049 * P=0.761 P=0.756N P=0.161 |P=0.399 (e) P=0.236 P=0.493 | |POLY 6 | P=0.028 * P=0.747 P=0.758N P=0.092 |P=0.352 (e) P=0.228 P=0.474 | |LOGISTIC REGRESSION| P=0.008 ** P=0.714 P=0.756N P=0.074 |P=0.344 (e) P=0.201 P=0.475 | |COCH-ARM / FISHERS | P=0.057 P=0.753N P=0.753N P=0.181 |P=0.422 (e) P=0.242 P=0.500 | |=================================================================================================================================| | | | | | | 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 (Step Section) | | Carcinoma and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 1/49 (2%) 2/49 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 3.1% 3.1% 3.0% 13.9% |0.0% 2.4% 5.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 2/22 (9%) 0/16 (0%) | |FIRST INCIDENCE | 715 735 (T) 708 609 |--- 677 735 (T) 707 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.685 P=0.734N P=0.006 ** |P=0.447 P=0.523 P=0.201 P=0.440 | |POLY 3 | P=0.041 * P=0.758 P=0.756N P=0.137 |P=0.524 P=0.506 P=0.234 P=0.485 | |POLY 1.5 | P=0.049 * P=0.761 P=0.756N P=0.161 |P=0.544 P=0.503 P=0.236 P=0.493 | |POLY 6 | P=0.028 * P=0.747 P=0.758N P=0.092 |P=0.496 P=0.511 P=0.228 P=0.474 | |LOGISTIC REGRESSION| P=0.008 ** P=0.714 P=0.756N P=0.074 |P=0.511 P=0.496 P=0.201 P=0.475 | |COCH-ARM / FISHERS | P=0.057 P=0.753N P=0.753N P=0.181 |P=0.566 P=0.495 P=0.242 P=0.500 | |=================================================================================================================================| Date: 10/07/97 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 | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step Section) | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 5/50 (10%) 7/50 (14%) 23/50 (46%) |2/50 (4%) 1/49 (2%) 3/49 (6%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 20.5% 15.5% 20.7% 63.3% |4.9% 2.4% 7.5% 23.4% | |TERMINAL (d) | 1/8 (13%) 2/5 (40%) 4/9 (44%) 0/0 (0%) |1/26 (4%) 1/26 (4%) 2/22 (9%) 2/16 (13%) | |FIRST INCIDENCE | 581 637 666 526 |599 735 (T) 628 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.558N P=0.552N P<0.001 ** |P<0.001 ** P=0.500N P=0.453 P=0.012 * | |POLY 3 | P<0.001 ** P=0.415N P=0.614 P<0.001 ** |P<0.001 ** P=0.495N P=0.494 P=0.018 * | |POLY 1.5 | P<0.001 ** P=0.389N P=0.611N P<0.001 ** |P<0.001 ** P=0.498N P=0.498 P=0.021 * | |POLY 6 | P<0.001 ** P=0.481N P=0.587 P<0.001 ** |P<0.001 ** P=0.491N P=0.483 P=0.015 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.436N P=0.598N P<0.001 ** |P<0.001 ** P=0.499N P=0.496 P=0.020 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.380N P=0.613N P<0.001 ** |P<0.001 ** P=0.508N P=0.490 P=0.026 * | |=================================================================================================================================| | | | | | | 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 (Step Section) | | Hyperplasia and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 5/50 (10%) 7/50 (14%) 24/50 (48%) |2/50 (4%) 1/49 (2%) 4/49 (8%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 20.5% 15.5% 20.7% 65.2% |4.9% 2.4% 10.0% 25.9% | |TERMINAL (d) | 1/8 (13%) 2/5 (40%) 4/9 (44%) 0/0 (0%) |1/26 (4%) 1/26 (4%) 3/22 (14%) 2/16 (13%) | |FIRST INCIDENCE | 581 637 666 526 |599 735 (T) 628 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.558N P=0.552N P<0.001 ** |P<0.001 ** P=0.500N P=0.287 P=0.006 ** | |POLY 3 | P<0.001 ** P=0.415N P=0.614 P<0.001 ** |P<0.001 ** P=0.495N P=0.330 P=0.009 ** | |POLY 1.5 | P<0.001 ** P=0.389N P=0.611N P<0.001 ** |P<0.001 ** P=0.498N P=0.335 P=0.011 * | |POLY 6 | P<0.001 ** P=0.481N P=0.587 P<0.001 ** |P<0.001 ** P=0.491N P=0.318 P=0.007 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.436N P=0.598N P<0.001 ** |P<0.001 ** P=0.499N P=0.331 P=0.011 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.380N P=0.613N P<0.001 ** |P<0.001 ** P=0.508N P=0.329 P=0.014 * | |=================================================================================================================================| Date: 10/07/97 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 | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step Section) | | Hyperplasia, Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 5/50 (10%) 7/50 (14%) 24/50 (48%) |2/50 (4%) 2/49 (4%) 4/49 (8%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 20.5% 15.5% 20.7% 65.2% |4.9% 4.8% 10.0% 25.9% | |TERMINAL (d) | 1/8 (13%) 2/5 (40%) 4/9 (44%) 0/0 (0%) |1/26 (4%) 1/26 (4%) 3/22 (14%) 2/16 (13%) | |FIRST INCIDENCE | 581 637 666 526 |599 677 628 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.558N P=0.552N P<0.001 ** |P<0.001 ** P=0.682N P=0.287 P=0.006 ** | |POLY 3 | P<0.001 ** P=0.415N P=0.614 P<0.001 ** |P<0.001 ** P=0.687N P=0.330 P=0.009 ** | |POLY 1.5 | P<0.001 ** P=0.389N P=0.611N P<0.001 ** |P<0.001 ** P=0.691N P=0.335 P=0.011 * | |POLY 6 | P<0.001 ** P=0.481N P=0.587 P<0.001 ** |P<0.001 ** P=0.682N P=0.318 P=0.007 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.436N P=0.598N P<0.001 ** |P<0.001 ** P=0.695 P=0.331 P=0.011 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.380N P=0.613N P<0.001 ** |P<0.001 ** P=0.684 P=0.329 P=0.014 * | |=================================================================================================================================| | | | | | | 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 (Step and Original Sections) | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |0/50 (0%) 0/49 (0%) 2/49 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 6.1% 6.3% 8.9% 13.9% |0.0% 0.0% 5.0% 5.3% | |TERMINAL (d) | 0/8 (0%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 2/22 (9%) 0/16 (0%) | |FIRST INCIDENCE | 681 726 700 609 |--- --- 735 (T) 686 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.588 P=0.549 P=0.014 * |P=0.081 (e) P=0.201 P=0.190 | |POLY 3 | P=0.186 P=0.687 P=0.514 P=0.273 |P=0.130 (e) P=0.234 P=0.221 | |POLY 1.5 | P=0.218 P=0.694 P=0.511 P=0.311 |P=0.141 (e) P=0.236 P=0.229 | |POLY 6 | P=0.127 P=0.667 P=0.514 P=0.195 |P=0.116 (e) P=0.228 P=0.211 | |LOGISTIC REGRESSION| P=0.033 * P=0.630 P=0.515 P=0.150 |P=0.110 (e) P=0.201 P=0.217 | |COCH-ARM / FISHERS | P=0.244 P=0.691N P=0.500 P=0.339 |P=0.155 (e) P=0.242 P=0.247 | |=================================================================================================================================| Date: 10/07/97 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 | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step and Original Sections) | | Carcinoma and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |0/50 (0%) 1/49 (2%) 2/49 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 6.1% 6.3% 8.9% 13.9% |0.0% 2.4% 5.0% 5.3% | |TERMINAL (d) | 0/8 (0%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 2/22 (9%) 0/16 (0%) | |FIRST INCIDENCE | 681 726 700 609 |--- 677 735 (T) 686 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.588 P=0.549 P=0.014 * |P=0.168 P=0.523 P=0.201 P=0.190 | |POLY 3 | P=0.186 P=0.687 P=0.514 P=0.273 |P=0.238 P=0.506 P=0.234 P=0.221 | |POLY 1.5 | P=0.218 P=0.694 P=0.511 P=0.311 |P=0.253 P=0.503 P=0.236 P=0.229 | |POLY 6 | P=0.127 P=0.667 P=0.514 P=0.195 |P=0.217 P=0.511 P=0.228 P=0.211 | |LOGISTIC REGRESSION| P=0.033 * P=0.630 P=0.515 P=0.150 |P=0.221 P=0.496 P=0.201 P=0.217 | |COCH-ARM / FISHERS | P=0.244 P=0.691N P=0.500 P=0.339 |P=0.271 P=0.495 P=0.242 P=0.247 | |=================================================================================================================================| | | | | | | 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 (Step and Original Sections) | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 7/50 (14%) 7/50 (14%) 25/50 (50%) |2/50 (4%) 1/49 (2%) 3/49 (6%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 29.2% 21.4% 20.7% 67.0% |4.9% 2.4% 7.5% 28.4% | |TERMINAL (d) | 2/8 (25%) 2/5 (40%) 4/9 (44%) 0/0 (0%) |1/26 (4%) 1/26 (4%) 2/22 (9%) 3/16 (19%) | |FIRST INCIDENCE | 581 609 666 526 |599 735 (T) 628 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.504N P=0.245N P<0.001 ** |P<0.001 ** P=0.500N P=0.453 P=0.003 ** | |POLY 3 | P<0.001 ** P=0.320N P=0.293N P<0.001 ** |P<0.001 ** P=0.495N P=0.494 P=0.004 ** | |POLY 1.5 | P<0.001 ** P=0.299N P=0.286N P<0.001 ** |P<0.001 ** P=0.498N P=0.498 P=0.005 ** | |POLY 6 | P<0.001 ** P=0.380N P=0.322N P<0.001 ** |P<0.001 ** P=0.491N P=0.483 P=0.003 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.363N P=0.264N P<0.001 ** |P<0.001 ** P=0.499N P=0.496 P=0.006 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.298N P=0.298N P=0.002 ** |P<0.001 ** P=0.508N P=0.490 P=0.007 ** | |=================================================================================================================================| Date: 10/07/97 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 | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step and Original Sections) | | Hyperplasia and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 7/50 (14%) 9/50 (18%) 25/50 (50%) |2/50 (4%) 1/49 (2%) 4/49 (8%) 12/50 (24%) | |POLY-3 ADJUSTED (b)| 31.9% 21.4% 26.4% 67.0% |4.9% 2.4% 10.0% 30.9% | |TERMINAL (d) | 2/8 (25%) 2/5 (40%) 4/9 (44%) 0/0 (0%) |1/26 (4%) 1/26 (4%) 3/22 (14%) 3/16 (19%) | |FIRST INCIDENCE | 581 609 666 526 |599 735 (T) 628 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.417N P=0.333N P<0.001 ** |P<0.001 ** P=0.500N P=0.287 P=0.002 ** | |POLY 3 | P<0.001 ** P=0.235N P=0.404N P<0.001 ** |P<0.001 ** P=0.495N P=0.330 P=0.002 ** | |POLY 1.5 | P<0.001 ** P=0.217N P=0.392N P=0.002 ** |P<0.001 ** P=0.498N P=0.335 P=0.003 ** | |POLY 6 | P<0.001 ** P=0.290N P=0.446N P<0.001 ** |P<0.001 ** P=0.491N P=0.318 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.269N P=0.368N P<0.001 ** |P<0.001 ** P=0.499N P=0.331 P=0.003 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.218N P=0.402N P=0.003 ** |P<0.001 ** P=0.508N P=0.329 P=0.004 ** | |=================================================================================================================================| | | | | | | 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 (Step and Original Sections) | | Hyperplasia, Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 7/50 (14%) 9/50 (18%) 25/50 (50%) |2/50 (4%) 2/49 (4%) 4/49 (8%) 12/50 (24%) | |POLY-3 ADJUSTED (b)| 31.9% 21.4% 26.4% 67.0% |4.9% 4.8% 10.0% 30.9% | |TERMINAL (d) | 2/8 (25%) 2/5 (40%) 4/9 (44%) 0/0 (0%) |1/26 (4%) 1/26 (4%) 3/22 (14%) 3/16 (19%) | |FIRST INCIDENCE | 581 609 666 526 |599 677 628 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.417N P=0.333N P<0.001 ** |P<0.001 ** P=0.682N P=0.287 P=0.002 ** | |POLY 3 | P<0.001 ** P=0.235N P=0.404N P<0.001 ** |P<0.001 ** P=0.687N P=0.330 P=0.002 ** | |POLY 1.5 | P<0.001 ** P=0.217N P=0.392N P=0.002 ** |P<0.001 ** P=0.691N P=0.335 P=0.003 ** | |POLY 6 | P<0.001 ** P=0.290N P=0.446N P<0.001 ** |P<0.001 ** P=0.682N P=0.318 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.269N P=0.368N P<0.001 ** |P<0.001 ** P=0.695 P=0.331 P=0.003 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.218N P=0.402N P=0.003 ** |P<0.001 ** P=0.684 P=0.329 P=0.004 ** | |=================================================================================================================================| Date: 10/07/97 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 | | | | | |=================================================================================================================================| | | |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 ADJUSTED (b)| 3.1% 3.1% 6.0% 0.0% |0.0% 0.0% 0.0% 5.3% | |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 | |=================================================================================================================================| | | | | | | 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 ADJUSTED (b)| 3.1% 3.1% 6.0% 0.0% |0.0% 2.4% 0.0% 5.3% | |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 | |=================================================================================================================================| Date: 10/07/97 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 | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 2/50 (4%) 6/50 (12%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 15.1% 15.3% 6.0% 20.6% |0.0% 0.0% 0.0% 5.3% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | 617 609 688 580 |--- --- --- 658 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.486 P=0.188N P<0.001 ** |P=0.022 * (e) (e) P=0.178 | |POLY 3 | P=0.290 P=0.628 P=0.203N P=0.407 |P=0.037 * (e) (e) P=0.221 | |POLY 1.5 | P=0.334 P=0.630N P=0.206N P=0.464 |P=0.039 * (e) (e) P=0.229 | |POLY 6 | P=0.209 P=0.607 P=0.204N P=0.279 |P=0.034 * (e) (e) P=0.210 | |LOGISTIC REGRESSION| P=0.082 P=0.568 P=0.199N P=0.106 |P=0.035 * (e) (e) P=0.217 | |COCH-ARM / FISHERS | P=0.371 P=0.630N P=0.218N P=0.500 |P=0.043 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | 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 | | Hyperplasia and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 5/50 (10%) 4/50 (8%) 6/50 (12%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 18.0% 15.3% 11.8% 20.6% |0.0% 0.0% 0.0% 10.6% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | 617 609 688 580 |--- --- --- 658 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.595 P=0.317N P=0.002 ** |P<0.001 ** (e) (e) P=0.038 * | |POLY 3 | P=0.390 P=0.513N P=0.353N P=0.527 |P<0.001 ** (e) (e) P=0.052 | |POLY 1.5 | P=0.445 P=0.499N P=0.355N P=0.585 |P<0.001 ** (e) (e) P=0.056 | |POLY 6 | P=0.281 P=0.550N P=0.357N P=0.383 |P<0.001 ** (e) (e) P=0.047 * | |LOGISTIC REGRESSION| P=0.114 P=0.572N P=0.347N P=0.168 |P<0.001 ** (e) (e) P=0.051 | |COCH-ARM / FISHERS | P=0.489 P=0.500N P=0.370N P=0.620N |P=0.002 ** (e) (e) P=0.059 | |=================================================================================================================================| Date: 10/07/97 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 | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia, Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 5/50 (10%) 4/50 (8%) 6/50 (12%) |0/50 (0%) 1/49 (2%) 0/49 (0%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 18.0% 15.3% 11.8% 20.6% |0.0% 2.4% 0.0% 10.6% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | 617 609 688 580 |--- 677 --- 658 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.595 P=0.317N P=0.002 ** |P=0.004 ** P=0.523 (e) P=0.038 * | |POLY 3 | P=0.390 P=0.513N P=0.353N P=0.527 |P=0.008 ** P=0.506 (e) P=0.052 | |POLY 1.5 | P=0.445 P=0.499N P=0.355N P=0.585 |P=0.009 ** P=0.503 (e) P=0.056 | |POLY 6 | P=0.281 P=0.550N P=0.357N P=0.383 |P=0.007 ** P=0.511 (e) P=0.047 * | |LOGISTIC REGRESSION| P=0.114 P=0.572N P=0.347N P=0.168 |P=0.007 ** P=0.496 (e) P=0.051 | |COCH-ARM / FISHERS | P=0.489 P=0.500N P=0.370N P=0.620N |P=0.011 * P=0.495 (e) P=0.059 | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Poly-3 adjusted lifetime tumor incidence. (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. (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).