TDMS Study 88004-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest DIVINYLBENZENE DATE: 07/14/05 EXPERIMENT: 88004 TEST: 05 TIME: 13:30:09 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88004B PATHOLOGIST: RENNE, ROGER CAS: 1321-74-0 Rats(F 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. --------------- Kidney Kidney, Renal Tubule (Step Section) Kidney, Renal Tubule (Step and Original Sections) NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest DIVINYLBENZENE DATE: 07/14/05 EXPERIMENT: 88004 TEST: 05 TIME: 13:30:09 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88004B PATHOLOGIST: RENNE, ROGER CAS: 1321-74-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF DIVINYLBENZENE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Kidney, Renal Tubule (Step Section) Hyperplasia Hyperplasia and Adenoma Hyperplasia, Carcinoma or Adenoma Kidney, Renal Tubule (Step and Original Sections) Carcinoma Carcinoma and Adenoma Hyperplasia Hyperplasia and Adenoma Hyperplasia, Carcinoma or Adenoma Kidney: Renal Tubule Carcinoma =============================================================== Date: 07/14/05 EXPERIMENT: 88004 TEST: 05 Page 1 Statistical Analysis of Primary Tumors in Rats(F 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step Section) | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 1/49 (2%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 2/44.46 1/44.04 |0/42.30 0/43.50 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- 619 708 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.250 (e) P=0.249 P=0.517 |(e) (e) (e) (e) | |POLY 3 | P=0.249 (e) P=0.244 P=0.504 |(e) (e) (e) (e) | |POLY 1.5 | P=0.247 (e) P=0.240 P=0.501 |(e) (e) (e) (e) | |POLY 6 | P=0.248 (e) P=0.249 P=0.507 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.240 (e) P=0.238 P=0.503 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.242 (e) P=0.247 P=0.495 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.172 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step Section) | | Carcinoma and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 1/49 (2%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 2/44.46 1/44.04 |0/42.30 0/43.50 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- 619 708 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.250 (e) P=0.249 P=0.517 |(e) (e) (e) (e) | |POLY 3 | P=0.249 (e) P=0.244 P=0.504 |(e) (e) (e) (e) | |POLY 1.5 | P=0.247 (e) P=0.240 P=0.501 |(e) (e) (e) (e) | |POLY 6 | P=0.248 (e) P=0.249 P=0.507 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.240 (e) P=0.238 P=0.503 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.242 (e) P=0.247 P=0.495 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.172 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 07/14/05 EXPERIMENT: 88004 TEST: 05 Page 2 Statistical Analysis of Primary Tumors in Rats(F 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step Section) | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/49 (6%) 5/50 (10%) 14/49 (29%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/43.15 3/45.37 5/45.22 14/44.97 |0/42.30 0/43.50 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 4.6% 6.6% 11.1% 31.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/31 (7%) 3/35 (9%) 2/32 (6%) 10/32 (31%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 578 569 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.556 P=0.237 P=0.002 ** |(e) (e) (e) (e) | |POLY 3 | P<0.001 ** P=0.523 P=0.235 P<0.001 ** |(e) (e) (e) (e) | |POLY 1.5 | P<0.001 ** P=0.509 P=0.225 P<0.001 ** |(e) (e) (e) (e) | |POLY 6 | P<0.001 ** P=0.540 P=0.250 P<0.001 ** |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** P=0.556 P=0.217 P<0.001 ** |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.490 P=0.218 P<0.001 ** |(e) (e) (e) (e) | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step Section) | | Hyperplasia and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/49 (6%) 7/50 (14%) 14/49 (29%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/43.15 3/45.37 7/45.61 14/44.97 |0/42.30 0/43.50 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 4.6% 6.6% 15.4% 31.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/31 (7%) 3/35 (9%) 3/32 (9%) 10/32 (31%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 578 569 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.556 P=0.097 P=0.002 ** |(e) (e) (e) (e) | |POLY 3 | P<0.001 ** P=0.523 P=0.092 P<0.001 ** |(e) (e) (e) (e) | |POLY 1.5 | P<0.001 ** P=0.509 P=0.085 P<0.001 ** |(e) (e) (e) (e) | |POLY 6 | P<0.001 ** P=0.540 P=0.103 P<0.001 ** |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** P=0.556 P=0.081 P<0.001 ** |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.490 P=0.080 P<0.001 ** |(e) (e) (e) (e) | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 07/14/05 EXPERIMENT: 88004 TEST: 05 Page 3 Statistical Analysis of Primary Tumors in Rats(F 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step Section) | | Hyperplasia, Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/49 (6%) 7/50 (14%) 14/49 (29%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/43.15 3/45.37 7/45.61 14/44.97 |0/42.30 0/43.50 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 4.6% 6.6% 15.4% 31.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/31 (7%) 3/35 (9%) 3/32 (9%) 10/32 (31%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 578 569 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.556 P=0.097 P=0.002 ** |(e) (e) (e) (e) | |POLY 3 | P<0.001 ** P=0.523 P=0.092 P<0.001 ** |(e) (e) (e) (e) | |POLY 1.5 | P<0.001 ** P=0.509 P=0.085 P<0.001 ** |(e) (e) (e) (e) | |POLY 6 | P<0.001 ** P=0.540 P=0.103 P<0.001 ** |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** P=0.556 P=0.081 P<0.001 ** |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.490 P=0.080 P<0.001 ** |(e) (e) (e) (e) | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step and Original Sections) | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 1/49 (2%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 2/44.46 1/44.04 |0/42.30 0/43.50 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- 619 708 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.250 (e) P=0.249 P=0.517 |(e) (e) (e) (e) | |POLY 3 | P=0.249 (e) P=0.244 P=0.504 |(e) (e) (e) (e) | |POLY 1.5 | P=0.247 (e) P=0.240 P=0.501 |(e) (e) (e) (e) | |POLY 6 | P=0.248 (e) P=0.249 P=0.507 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.240 (e) P=0.238 P=0.503 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.242 (e) P=0.247 P=0.495 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.172 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 07/14/05 EXPERIMENT: 88004 TEST: 05 Page 4 Statistical Analysis of Primary Tumors in Rats(F 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step and Original Sections) | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 0/44.07 2/44.14 |0/42.30 0/43.50 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 1/32 (3%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- --- 682 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.046 * (e) (e) P=0.252 |(e) (e) (e) (e) | |POLY 3 | P=0.044 * (e) (e) P=0.242 |(e) (e) (e) (e) | |POLY 1.5 | P=0.045 * (e) (e) P=0.239 |(e) (e) (e) (e) | |POLY 6 | P=0.044 * (e) (e) P=0.246 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.046 * (e) (e) P=0.240 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.242 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.031 * (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step and Original Sections) | | Carcinoma and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 3/49 (6%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 2/44.46 3/44.22 |0/42.30 0/43.50 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 6.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 1/32 (3%) 1/32 (3%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- 619 682 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.029 * (e) P=0.249 P=0.136 |(e) (e) (e) (e) | |POLY 3 | P=0.027 * (e) P=0.244 P=0.123 |(e) (e) (e) (e) | |POLY 1.5 | P=0.027 * (e) P=0.240 P=0.120 |(e) (e) (e) (e) | |POLY 6 | P=0.027 * (e) P=0.249 P=0.126 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.027 * (e) P=0.238 P=0.122 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.027 * (e) P=0.247 P=0.117 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.038 * (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 07/14/05 EXPERIMENT: 88004 TEST: 05 Page 5 Statistical Analysis of Primary Tumors in Rats(F 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step and Original Sections) | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/49 (10%) 5/50 (10%) 15/49 (31%) |1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/43.15 5/45.37 5/45.22 15/45.18 |1/42.30 1/43.64 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 7.0% 11.0% 11.1% 33.2% |2.4% 2.3% 0.0% 0.0% | |TERMINAL (d) | 3/31 (10%) 5/35 (14%) 2/32 (6%) 10/32 (31%) |1/33 (3%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 578 569 |731 (T) 696 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.423 P=0.379 P=0.004 ** |P=0.283N P=0.750 P=0.500N P=0.581N | |POLY 3 | P<0.001 ** P=0.384 P=0.382 P=0.002 ** |P=0.237N P=0.754N P=0.495N P=0.523N | |POLY 1.5 | P<0.001 ** P=0.368 P=0.368 P<0.001 ** |P=0.238N P=0.756N P=0.498N P=0.512N | |POLY 6 | P<0.001 ** P=0.406 P=0.402 P=0.002 ** |P=0.234N P=0.755N P=0.493N P=0.542N | |LOGISTIC REGRESSION| P<0.001 ** P=0.423 P=0.356 P=0.002 ** |P=0.256N P=0.758N (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.346 P=0.357 P<0.001 ** |P=0.236N P=0.753N P=0.505N P=0.500N | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.274N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step and Original Sections) | | Hyperplasia and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/49 (10%) 7/50 (14%) 15/49 (31%) |1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/43.15 5/45.37 7/45.61 15/45.18 |1/42.30 1/43.64 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 7.0% 11.0% 15.4% 33.2% |2.4% 2.3% 0.0% 0.0% | |TERMINAL (d) | 3/31 (10%) 5/35 (14%) 3/32 (9%) 10/32 (31%) |1/33 (3%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 578 569 |731 (T) 696 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.423 P=0.181 P=0.004 ** |P=0.283N P=0.750 P=0.500N P=0.581N | |POLY 3 | P<0.001 ** P=0.384 P=0.180 P=0.002 ** |P=0.237N P=0.754N P=0.495N P=0.523N | |POLY 1.5 | P<0.001 ** P=0.368 P=0.168 P<0.001 ** |P=0.238N P=0.756N P=0.498N P=0.512N | |POLY 6 | P<0.001 ** P=0.406 P=0.198 P=0.002 ** |P=0.234N P=0.755N P=0.493N P=0.542N | |LOGISTIC REGRESSION| P<0.001 ** P=0.423 P=0.159 P=0.002 ** |P=0.256N P=0.758N (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.346 P=0.159 P<0.001 ** |P=0.236N P=0.753N P=0.505N P=0.500N | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.274N (e) (e) (e) | |=================================================================================================================================| Date: 07/14/05 EXPERIMENT: 88004 TEST: 05 Page 6 Statistical Analysis of Primary Tumors in Rats(F 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney, Renal Tubule (Step and Original Sections) | | Hyperplasia, Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/49 (10%) 7/50 (14%) 17/49 (35%) |1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/43.15 5/45.37 7/45.61 17/45.36 |1/42.30 1/43.64 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 7.0% 11.0% 15.4% 37.5% |2.4% 2.3% 0.0% 0.0% | |TERMINAL (d) | 3/31 (10%) 5/35 (14%) 3/32 (9%) 11/32 (34%) |1/33 (3%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 578 569 |731 (T) 696 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.423 P=0.181 P<0.001 ** |P=0.283N P=0.750 P=0.500N P=0.581N | |POLY 3 | P<0.001 ** P=0.384 P=0.180 P<0.001 ** |P=0.237N P=0.754N P=0.495N P=0.523N | |POLY 1.5 | P<0.001 ** P=0.368 P=0.168 P<0.001 ** |P=0.238N P=0.756N P=0.498N P=0.512N | |POLY 6 | P<0.001 ** P=0.406 P=0.198 P<0.001 ** |P=0.234N P=0.755N P=0.493N P=0.542N | |LOGISTIC REGRESSION| P<0.001 ** P=0.423 P=0.159 P<0.001 ** |P=0.256N P=0.758N (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.346 P=0.159 P<0.001 ** |P=0.236N P=0.753N P=0.505N P=0.500N | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.274N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 0/44.07 2/44.14 |0/42.30 0/43.50 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 1/32 (3%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- --- 682 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.046 * (e) (e) P=0.252 |(e) (e) (e) (e) | |POLY 3 | P=0.044 * (e) (e) P=0.242 |(e) (e) (e) (e) | |POLY 1.5 | P=0.045 * (e) (e) P=0.239 |(e) (e) (e) (e) | |POLY 6 | P=0.044 * (e) (e) P=0.246 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.046 * (e) (e) P=0.240 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.242 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.031 * (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 07/14/05 EXPERIMENT: 88004 TEST: 05 Page 7 Statistical Analysis of Primary Tumors in Rats(F 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 2/49 (4%) |1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.15 2/45.37 0/44.07 2/44.25 |1/42.30 1/43.64 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 4.4% 0.0% 4.5% |2.4% 2.3% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 2/35 (6%) 0/32 (0%) 0/32 (0%) |1/33 (3%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 674 |731 (T) 696 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.476 P=0.543 P=0.494N P=0.528 |P=0.283N P=0.750 P=0.500N P=0.581N | |POLY 3 | P=0.476 P=0.518 P=0.496N P=0.509 |P=0.237N P=0.754N P=0.495N P=0.523N | |POLY 1.5 | P=0.472 P=0.507 P=0.499N P=0.503 |P=0.238N P=0.756N P=0.498N P=0.512N | |POLY 6 | P=0.480 P=0.531 P=0.492N P=0.515 |P=0.234N P=0.755N P=0.493N P=0.542N | |LOGISTIC REGRESSION| P=0.470 P=0.543 (e) P=0.503 |P=0.256N P=0.758N (e) (e) | |COCH-ARM / FISHERS | P=0.465 P=0.492 P=0.500N P=0.492 |P=0.236N P=0.753N P=0.505N P=0.500N | |ORDER RESTRICTED | P=0.418 (e) (e) (e) |P=0.274N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia and Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 2/49 (4%) |1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.15 2/45.37 0/44.07 2/44.25 |1/42.30 1/43.64 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 4.4% 0.0% 4.5% |2.4% 2.3% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 2/35 (6%) 0/32 (0%) 0/32 (0%) |1/33 (3%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 674 |731 (T) 696 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.476 P=0.543 P=0.494N P=0.528 |P=0.283N P=0.750 P=0.500N P=0.581N | |POLY 3 | P=0.476 P=0.518 P=0.496N P=0.509 |P=0.237N P=0.754N P=0.495N P=0.523N | |POLY 1.5 | P=0.472 P=0.507 P=0.499N P=0.503 |P=0.238N P=0.756N P=0.498N P=0.512N | |POLY 6 | P=0.480 P=0.531 P=0.492N P=0.515 |P=0.234N P=0.755N P=0.493N P=0.542N | |LOGISTIC REGRESSION| P=0.470 P=0.543 (e) P=0.503 |P=0.256N P=0.758N (e) (e) | |COCH-ARM / FISHERS | P=0.465 P=0.492 P=0.500N P=0.492 |P=0.236N P=0.753N P=0.505N P=0.500N | |ORDER RESTRICTED | P=0.418 (e) (e) (e) |P=0.274N (e) (e) (e) | |=================================================================================================================================| Date: 07/14/05 EXPERIMENT: 88004 TEST: 05 Page 8 Statistical Analysis of Primary Tumors in Rats(F 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia, Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 4/49 (8%) |1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.15 2/45.37 0/44.07 4/44.43 |1/42.30 1/43.64 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 4.4% 0.0% 9.0% |2.4% 2.3% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 2/35 (6%) 0/32 (0%) 1/32 (3%) |1/33 (3%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 674 |731 (T) 696 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.112 P=0.543 P=0.494N P=0.207 |P=0.283N P=0.750 P=0.500N P=0.581N | |POLY 3 | P=0.108 P=0.518 P=0.496N P=0.187 |P=0.237N P=0.754N P=0.495N P=0.523N | |POLY 1.5 | P=0.107 P=0.507 P=0.499N P=0.182 |P=0.238N P=0.756N P=0.498N P=0.512N | |POLY 6 | P=0.110 P=0.531 P=0.492N P=0.194 |P=0.234N P=0.755N P=0.493N P=0.542N | |LOGISTIC REGRESSION| P=0.107 P=0.543 (e) P=0.182 |P=0.256N P=0.758N (e) (e) | |COCH-ARM / FISHERS | P=0.105 P=0.492 P=0.500N P=0.175 |P=0.236N P=0.753N P=0.505N P=0.500N | |ORDER RESTRICTED | P=0.079 (e) (e) (e) |P=0.274N (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).