TDMS Study 05201-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 09/09/97 EXPERIMENT: 05201 TEST: 06 TIME: 16:22:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: MILLER, RODNEY CAS: 0098-00-0000 Mice(B6C3F1) ----------------------------- 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: 09/09/97 EXPERIMENT: 05201 TEST: 06 TIME: 16:22:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: MILLER, RODNEY CAS: 0098-00-0000 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF FURFURYL ALCOHOL =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Kidney, Renal Tubule (Step Section) Carcinoma and Adenoma Kidney, Renal Tubule (Step and Original Sections) Adenoma Carcinoma Carcinoma and Adenoma Kidney: Renal Tubule Adenoma Carcinoma Carcinoma or Adenoma =============================================================== Date: 09/09/97 EXPERIMENT: 05201 TEST: 06 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | | Carcinoma and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 2/38 (5%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- --- --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.054 (e) (e) P=0.263 |(e) (e) (e) (e) | |POLY 3 | P=0.046 * (e) (e) P=0.251 |(e) (e) (e) (e) | |POLY 1.5 | P=0.045 * (e) (e) P=0.245 |(e) (e) (e) (e) | |POLY 6 | P=0.048 * (e) (e) P=0.257 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.263 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |(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 | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step Section) | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/49 (10%) 3/49 (6%) 2/50 (4%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 6.9% 11.7% 7.7% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/34 (6%) 5/36 (14%) 3/30 (10%) 2/38 (5%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 697 733 (T) 733 (T) 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.227N P=0.384 P=0.599 P=0.446N |(e) (e) (e) (e) | |POLY 3 | P=0.237N P=0.350 P=0.614 P=0.474N |(e) (e) (e) (e) | |POLY 1.5 | P=0.251N P=0.348 P=0.628 P=0.485N |(e) (e) (e) (e) | |POLY 6 | P=0.222N P=0.353 P=0.598 P=0.462N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.218N P=0.360 P=0.595 P=0.456N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.271N P=0.346 P=0.651 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/09/97 EXPERIMENT: 05201 TEST: 06 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/49 (10%) 3/49 (6%) 3/50 (6%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 6.9% 11.7% 7.7% 6.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/34 (6%) 5/36 (14%) 3/30 (10%) 3/38 (8%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 697 733 (T) 733 (T) 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.389N P=0.384 P=0.599 P=0.607N |(e) (e) (e) (e) | |POLY 3 | P=0.407N P=0.350 P=0.614 P=0.636N |(e) (e) (e) (e) | |POLY 1.5 | P=0.425N P=0.348 P=0.628 P=0.647N |(e) (e) (e) (e) | |POLY 6 | P=0.388N P=0.353 P=0.598 P=0.624N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.376N P=0.360 P=0.595 P=0.617N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.450N P=0.346 P=0.651 P=0.661N |(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 | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step Section) | | Hyperplasia, Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/49 (10%) 3/49 (6%) 4/50 (8%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 6.9% 11.7% 7.7% 8.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/34 (6%) 5/36 (14%) 3/30 (10%) 4/38 (11%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 697 733 (T) 733 (T) 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.561N P=0.384 P=0.599 P=0.563 |(e) (e) (e) (e) | |POLY 3 | P=0.585N P=0.350 P=0.614 P=0.531 |(e) (e) (e) (e) | |POLY 1.5 | P=0.596 P=0.348 P=0.628 P=0.518 |(e) (e) (e) (e) | |POLY 6 | P=0.565N P=0.353 P=0.598 P=0.545 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.547N P=0.360 P=0.595 P=0.557 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.569 P=0.346 P=0.651 P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/09/97 EXPERIMENT: 05201 TEST: 06 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 3/50 (6%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 6.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 3/38 (8%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- --- --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.013 * (e) (e) P=0.141 |(e) (e) (e) (e) | |POLY 3 | P=0.009 ** (e) (e) P=0.130 |(e) (e) (e) (e) | |POLY 1.5 | P=0.009 ** (e) (e) P=0.125 |(e) (e) (e) (e) | |POLY 6 | P=0.010 * (e) (e) P=0.135 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.141 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.009 ** (e) (e) P=0.121 |(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 | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step and Original Sections) | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 2/38 (5%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- --- --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.054 (e) (e) P=0.263 |(e) (e) (e) (e) | |POLY 3 | P=0.046 * (e) (e) P=0.251 |(e) (e) (e) (e) | |POLY 1.5 | P=0.045 * (e) (e) P=0.245 |(e) (e) (e) (e) | |POLY 6 | P=0.048 * (e) (e) P=0.257 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.263 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/09/97 EXPERIMENT: 05201 TEST: 06 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 5/50 (10%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 10.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 5/38 (13%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- --- --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) (e) P=0.043 * |(e) (e) (e) (e) | |POLY 3 | P<0.001 ** (e) (e) P=0.036 * |(e) (e) (e) (e) | |POLY 1.5 | P<0.001 ** (e) (e) P=0.034 * |(e) (e) (e) (e) | |POLY 6 | P<0.001 ** (e) (e) P=0.038 * |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.043 * |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.028 * |(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 | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step and Original Sections) | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 8/49 (16%) 3/49 (6%) 5/50 (10%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 9.3% 18.7% 7.7% 10.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/34 (9%) 8/36 (22%) 3/30 (10%) 4/38 (11%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 697 733 (T) 733 (T) 646 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.430N P=0.202 P=0.572N P=0.568 |(e) (e) (e) (e) | |POLY 3 | P=0.447N P=0.170 P=0.557N P=0.540 |(e) (e) (e) (e) | |POLY 1.5 | P=0.471N P=0.169 P=0.540N P=0.523 |(e) (e) (e) (e) | |POLY 6 | P=0.418N P=0.171 P=0.574N P=0.559 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.421N P=0.179 P=0.582N P=0.545 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.507N P=0.168 P=0.511N P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/09/97 EXPERIMENT: 05201 TEST: 06 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 4/50 (8%) 8/49 (16%) 3/49 (6%) 6/50 (12%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 9.3% 18.7% 7.7% 13.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/34 (9%) 8/36 (22%) 3/30 (10%) 5/38 (13%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 697 733 (T) 733 (T) 646 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.577N P=0.202 P=0.572N P=0.442 |(e) (e) (e) (e) | |POLY 3 | P=0.573 P=0.170 P=0.557N P=0.410 |(e) (e) (e) (e) | |POLY 1.5 | P=0.548 P=0.169 P=0.540N P=0.393 |(e) (e) (e) (e) | |POLY 6 | P=0.571N P=0.171 P=0.574N P=0.430 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.568N P=0.179 P=0.582N P=0.417 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.512 P=0.168 P=0.511N P=0.370 |(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 | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step and Original Sections) | | Hyperplasia, Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 8/49 (16%) 3/49 (6%) 8/50 (16%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 9.3% 18.7% 7.7% 17.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/34 (9%) 8/36 (22%) 3/30 (10%) 7/38 (18%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 697 733 (T) 733 (T) 646 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.312 P=0.202 P=0.572N P=0.238 |(e) (e) (e) (e) | |POLY 3 | P=0.287 P=0.170 P=0.557N P=0.209 |(e) (e) (e) (e) | |POLY 1.5 | P=0.266 P=0.169 P=0.540N P=0.195 |(e) (e) (e) (e) | |POLY 6 | P=0.314 P=0.171 P=0.574N P=0.225 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.322 P=0.179 P=0.582N P=0.218 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.238 P=0.168 P=0.511N P=0.178 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/09/97 EXPERIMENT: 05201 TEST: 06 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 2/38 (5%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- --- --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.054 (e) (e) P=0.263 |(e) (e) (e) (e) | |POLY 3 | P=0.046 * (e) (e) P=0.251 |(e) (e) (e) (e) | |POLY 1.5 | P=0.045 * (e) (e) P=0.245 |(e) (e) (e) (e) | |POLY 6 | P=0.048 * (e) (e) P=0.257 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.263 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |(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 | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 2/38 (5%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- --- --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.054 (e) (e) P=0.263 |(e) (e) (e) (e) | |POLY 3 | P=0.046 * (e) (e) P=0.251 |(e) (e) (e) (e) | |POLY 1.5 | P=0.045 * (e) (e) P=0.245 |(e) (e) (e) (e) | |POLY 6 | P=0.048 * (e) (e) P=0.257 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.263 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/09/97 EXPERIMENT: 05201 TEST: 06 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 4/50 (8%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 8.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 4/38 (11%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- --- --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.003 ** (e) (e) P=0.078 |(e) (e) (e) (e) | |POLY 3 | P=0.002 ** (e) (e) P=0.068 |(e) (e) (e) (e) | |POLY 1.5 | P=0.002 ** (e) (e) P=0.065 |(e) (e) (e) (e) | |POLY 6 | P=0.002 ** (e) (e) P=0.072 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.078 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.002 ** (e) (e) P=0.059 |(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 | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/49 (6%) 0/49 (0%) 3/50 (6%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.3% 7.0% 0.0% 6.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/34 (3%) 3/36 (8%) 0/30 (0%) 2/38 (5%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- 646 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.358 P=0.325 P=0.525N P=0.343 |(e) (e) (e) (e) | |POLY 3 | P=0.346 P=0.303 P=0.520N P=0.330 |(e) (e) (e) (e) | |POLY 1.5 | P=0.332 P=0.300 P=0.514N P=0.319 |(e) (e) (e) (e) | |POLY 6 | P=0.363 P=0.305 P=0.526N P=0.342 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.355 P=0.325 (e) P=0.320 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.314 P=0.301 P=0.505N P=0.309 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/09/97 EXPERIMENT: 05201 TEST: 06 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/49 (6%) 0/49 (0%) 3/50 (6%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.3% 7.0% 0.0% 6.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/34 (3%) 3/36 (8%) 0/30 (0%) 2/38 (5%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- 646 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.358 P=0.325 P=0.525N P=0.343 |(e) (e) (e) (e) | |POLY 3 | P=0.346 P=0.303 P=0.520N P=0.330 |(e) (e) (e) (e) | |POLY 1.5 | P=0.332 P=0.300 P=0.514N P=0.319 |(e) (e) (e) (e) | |POLY 6 | P=0.363 P=0.305 P=0.526N P=0.342 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.355 P=0.325 (e) P=0.320 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.314 P=0.301 P=0.505N P=0.309 |(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 | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia, Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/49 (6%) 0/49 (0%) 5/50 (10%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.3% 7.0% 0.0% 10.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/34 (3%) 3/36 (8%) 0/30 (0%) 4/38 (11%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- 646 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.080 P=0.325 P=0.525N P=0.130 |(e) (e) (e) (e) | |POLY 3 | P=0.068 P=0.303 P=0.520N P=0.117 |(e) (e) (e) (e) | |POLY 1.5 | P=0.063 P=0.300 P=0.514N P=0.111 |(e) (e) (e) (e) | |POLY 6 | P=0.075 P=0.305 P=0.526N P=0.126 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.080 P=0.325 (e) P=0.118 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.058 P=0.301 P=0.505N P=0.102 |(e) (e) (e) (e) | |=================================================================================================================================| (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).