TDMS Study 05135-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest ISOPRENE DATE: 10/01/97
EXPERIMENT: 05135 TEST: 07 TIME: 13:24:18
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61825B
PATHOLOGIST: GRUMBEIN, S. CAS: 78-79-5
Rats(FISCHER344)
-----------------------------
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 ISOPRENE DATE: 10/01/97
EXPERIMENT: 05135 TEST: 07 TIME: 13:24:18
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61825B
PATHOLOGIST: GRUMBEIN, S. CAS: 78-79-5
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF ISOPRENE
===============================================================
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 Adenoma
Carcinoma or Adenoma
Hyperplasia
Hyperplasia and Adenoma
Hyperplasia, Carcinoma or Adenoma
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOPRENE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 6/50 (12%) 10/50 (20%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.4% 5.3% 16.0% 26.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 4/15 (27%) 4/15 (27%) |0/29 (0%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 704 702 566 622 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.637 P=0.093 P=0.013 * |(e) (e) (e) (e) |
|POLY 3 | P=0.004 ** P=0.688N P=0.134 P=0.014 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.004 ** P=0.687N P=0.137 P=0.013 * |(e) (e) (e) (e) |
|POLY 6 | P=0.005 ** P=0.696 P=0.123 P=0.014 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.004 ** P=0.684 P=0.118 P=0.014 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.005 ** P=0.691N P=0.134 P=0.014 * |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Carcinoma and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 6/50 (12%) 10/50 (20%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.4% 5.3% 16.0% 26.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 4/15 (27%) 4/15 (27%) |0/29 (0%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 704 702 566 622 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.637 P=0.093 P=0.013 * |(e) (e) (e) (e) |
|POLY 3 | P=0.004 ** P=0.688N P=0.134 P=0.014 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.004 ** P=0.687N P=0.137 P=0.013 * |(e) (e) (e) (e) |
|POLY 6 | P=0.005 ** P=0.696 P=0.123 P=0.014 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.004 ** P=0.684 P=0.118 P=0.014 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.005 ** P=0.691N P=0.134 P=0.014 * |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOPRENE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 9/50 (18%) 15/50 (30%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 18.7% 13.2% 23.6% 38.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/18 (22%) 3/16 (19%) 3/15 (20%) 4/15 (27%) |0/29 (0%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 539 657 566 611 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.446N P=0.303 P=0.038 * |(e) (e) (e) (e) |
|POLY 3 | P=0.007 ** P=0.370N P=0.401 P=0.045 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.007 ** P=0.367N P=0.406 P=0.042 * |(e) (e) (e) (e) |
|POLY 6 | P=0.009 ** P=0.385N P=0.383 P=0.048 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.007 ** P=0.377N P=0.378 P=0.043 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.008 ** P=0.380N P=0.393 P=0.045 * |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Hyperplasia and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 6/50 (12%) 13/50 (26%) 18/50 (36%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 21.3% 15.9% 34.1% 45.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/18 (22%) 4/16 (25%) 7/15 (47%) 6/15 (40%) |0/29 (0%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 539 657 566 611 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** P=0.466N P=0.097 P=0.017 * |(e) (e) (e) (e) |
|POLY 3 | P=0.004 ** P=0.378N P=0.154 P=0.018 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.004 ** P=0.375N P=0.164 P=0.017 * |(e) (e) (e) (e) |
|POLY 6 | P=0.005 ** P=0.398N P=0.131 P=0.019 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.004 ** P=0.387N P=0.135 P=0.018 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.005 ** P=0.387N P=0.163 P=0.020 * |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOPRENE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Hyperplasia, Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 6/50 (12%) 13/50 (26%) 18/50 (36%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 21.3% 15.9% 34.1% 45.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/18 (22%) 4/16 (25%) 7/15 (47%) 6/15 (40%) |0/29 (0%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 539 657 566 611 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** P=0.466N P=0.097 P=0.017 * |(e) (e) (e) (e) |
|POLY 3 | P=0.004 ** P=0.378N P=0.154 P=0.018 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.004 ** P=0.375N P=0.164 P=0.017 * |(e) (e) (e) (e) |
|POLY 6 | P=0.005 ** P=0.398N P=0.131 P=0.019 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.004 ** P=0.387N P=0.135 P=0.018 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.005 ** P=0.387N P=0.163 P=0.020 * |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 8/50 (16%) 15/50 (30%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.4% 10.5% 21.0% 38.5% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 4/15 (27%) 5/15 (33%) |0/29 (0%) 0/30 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | 704 559 566 622 |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.287 P=0.034 * P<0.001 ** |P=0.754N (e) P=0.493 (e) |
|POLY 3 | P<0.001 ** P=0.352 P=0.047 * P<0.001 ** |P=0.750N (e) P=0.496 (e) |
|POLY 1.5 | P<0.001 ** P=0.350 P=0.048 * P<0.001 ** |P=0.747N (e) P=0.496 (e) |
|POLY 6 | P<0.001 ** P=0.347 P=0.043 * P<0.001 ** |P=0.752N (e) P=0.496 (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.342 P=0.045 * P<0.001 ** |(e) (e) P=0.493 (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.339 P=0.046 * P<0.001 ** |P=0.740N (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOPRENE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Carcinoma and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 8/50 (16%) 15/50 (30%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.4% 10.5% 21.0% 38.5% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 4/15 (27%) 5/15 (33%) |0/29 (0%) 0/30 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | 704 559 566 622 |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.287 P=0.034 * P<0.001 ** |P=0.754N (e) P=0.493 (e) |
|POLY 3 | P<0.001 ** P=0.352 P=0.047 * P<0.001 ** |P=0.750N (e) P=0.496 (e) |
|POLY 1.5 | P<0.001 ** P=0.350 P=0.048 * P<0.001 ** |P=0.747N (e) P=0.496 (e) |
|POLY 6 | P<0.001 ** P=0.347 P=0.043 * P<0.001 ** |P=0.752N (e) P=0.496 (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.342 P=0.045 * P<0.001 ** |(e) (e) P=0.493 (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.339 P=0.046 * P<0.001 ** |P=0.740N (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 13/50 (26%) 18/50 (36%) |4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 18.7% 15.9% 33.2% 45.0% |9.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/18 (22%) 4/16 (25%) 4/15 (27%) 5/15 (33%) |4/29 (14%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 539 657 518 548 |734 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.572N P=0.080 P=0.010 * |P=0.218N P=0.058N P=0.066N P=0.071N |
|POLY 3 | P=0.003 ** P=0.493N P=0.113 P=0.009 ** |P=0.210N P=0.056N P=0.062N P=0.066N |
|POLY 1.5 | P=0.002 ** P=0.489N P=0.113 P=0.008 ** |P=0.206N P=0.058N P=0.062N P=0.065N |
|POLY 6 | P=0.004 ** P=0.513N P=0.108 P=0.010 * |P=0.214N P=0.054N P=0.062N P=0.066N |
|LOGISTIC REGRESSION| P=0.003 ** P=0.504N P=0.101 P=0.010 * |P=0.218N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.003 ** P=0.500N P=0.105 P=0.010 * |P=0.204N P=0.059N P=0.059N P=0.059N |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOPRENE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Hyperplasia and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 9/50 (18%) 19/50 (38%) 22/50 (44%) |4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 21.3% 23.4% 47.6% 54.5% |9.4% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 4/18 (22%) 5/16 (31%) 8/15 (53%) 7/15 (47%) |4/29 (14%) 0/30 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | 539 559 518 548 |734 (T) --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.414 P=0.008 ** P=0.003 ** |P=0.187N P=0.058N P=0.187N P=0.071N |
|POLY 3 | P=0.002 ** P=0.520 P=0.010 * P<0.001 ** |P=0.184N P=0.056N P=0.184N P=0.066N |
|POLY 1.5 | P=0.002 ** P=0.520 P=0.011 * P<0.001 ** |P=0.180N P=0.058N P=0.184N P=0.065N |
|POLY 6 | P=0.003 ** P=0.505 P=0.009 ** P=0.002 ** |P=0.188N P=0.054N P=0.183N P=0.066N |
|LOGISTIC REGRESSION| P=0.002 ** P=0.506 P=0.010 * P=0.002 ** |P=0.187N (e) P=0.187N (e) |
|COCH-ARM / FISHERS | P=0.003 ** P=0.500 P=0.012 * P=0.002 ** |P=0.173N P=0.059N P=0.181N P=0.059N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Hyperplasia, Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 9/50 (18%) 19/50 (38%) 22/50 (44%) |4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 21.3% 23.4% 47.6% 54.5% |9.4% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 4/18 (22%) 5/16 (31%) 8/15 (53%) 7/15 (47%) |4/29 (14%) 0/30 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | 539 559 518 548 |734 (T) --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.414 P=0.008 ** P=0.003 ** |P=0.187N P=0.058N P=0.187N P=0.071N |
|POLY 3 | P=0.002 ** P=0.520 P=0.010 * P<0.001 ** |P=0.184N P=0.056N P=0.184N P=0.066N |
|POLY 1.5 | P=0.002 ** P=0.520 P=0.011 * P<0.001 ** |P=0.180N P=0.058N P=0.184N P=0.065N |
|POLY 6 | P=0.003 ** P=0.505 P=0.009 ** P=0.002 ** |P=0.188N P=0.054N P=0.183N P=0.066N |
|LOGISTIC REGRESSION| P=0.002 ** P=0.506 P=0.010 * P=0.002 ** |P=0.187N (e) P=0.187N (e) |
|COCH-ARM / FISHERS | P=0.003 ** P=0.500 P=0.012 * P=0.002 ** |P=0.173N P=0.059N P=0.181N P=0.059N |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOPRENE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 6/50 (12%) |0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.3% 5.3% 15.8% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/18 (0%) 0/16 (0%) 0/15 (0%) 1/15 (7%) |0/29 (0%) 0/30 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | --- 559 566 630 |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * P=0.223 P=0.235 P=0.015 * |P=0.754N (e) P=0.493 (e) |
|POLY 3 | P=0.009 ** P=0.244 P=0.242 P=0.016 * |P=0.749N (e) P=0.496 (e) |
|POLY 1.5 | P=0.009 ** P=0.243 P=0.242 P=0.015 * |P=0.746N (e) P=0.496 (e) |
|POLY 6 | P=0.009 ** P=0.242 P=0.238 P=0.016 * |P=0.751N (e) P=0.496 (e) |
|LOGISTIC REGRESSION| P=0.010 * P=0.234 P=0.231 P=0.017 * |(e) (e) P=0.493 (e) |
|COCH-ARM / FISHERS | P=0.010 * P=0.247 P=0.247 P=0.013 * |P=0.739N (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 6/50 (12%) |0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.3% 5.3% 15.8% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/18 (0%) 0/16 (0%) 0/15 (0%) 1/15 (7%) |0/29 (0%) 0/30 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | --- 559 566 630 |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * P=0.223 P=0.235 P=0.015 * |P=0.754N (e) P=0.493 (e) |
|POLY 3 | P=0.009 ** P=0.244 P=0.242 P=0.016 * |P=0.749N (e) P=0.496 (e) |
|POLY 1.5 | P=0.009 ** P=0.243 P=0.242 P=0.015 * |P=0.746N (e) P=0.496 (e) |
|POLY 6 | P=0.009 ** P=0.242 P=0.238 P=0.016 * |P=0.751N (e) P=0.496 (e) |
|LOGISTIC REGRESSION| P=0.010 * P=0.234 P=0.231 P=0.017 * |(e) (e) P=0.493 (e) |
|COCH-ARM / FISHERS | P=0.010 * P=0.247 P=0.247 P=0.013 * |P=0.739N (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOPRENE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 6/50 (12%) 8/50 (16%) |4/50 (8%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.3% 15.6% 20.8% |9.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 2/15 (13%) 2/15 (13%) |4/29 (14%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | --- 702 518 548 |734 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * P=0.222 P=0.018 * P=0.005 ** |P=0.218N P=0.058N P=0.066N P=0.071N |
|POLY 3 | P=0.010 * P=0.241 P=0.017 * P=0.004 ** |P=0.210N P=0.057N P=0.062N P=0.066N |
|POLY 1.5 | P=0.009 ** P=0.242 P=0.017 * P=0.004 ** |P=0.206N P=0.060N P=0.062N P=0.065N |
|POLY 6 | P=0.010 * P=0.237 P=0.016 * P=0.004 ** |P=0.215N P=0.055N P=0.062N P=0.066N |
|LOGISTIC REGRESSION| P=0.010 * P=0.226 P=0.018 * P=0.005 ** |P=0.218N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.010 * P=0.247 P=0.013 * P=0.003 ** |P=0.202N P=0.061N P=0.059N P=0.059N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 8/50 (16%) 12/50 (24%) |4/50 (8%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.5% 20.4% 30.8% |9.4% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 2/15 (13%) 3/15 (20%) |4/29 (14%) 0/30 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | --- 559 518 548 |734 (T) --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.057 P=0.006 ** P<0.001 ** |P=0.187N P=0.058N P=0.187N P=0.071N |
|POLY 3 | P<0.001 ** P=0.064 P=0.004 ** P<0.001 ** |P=0.184N P=0.057N P=0.184N P=0.066N |
|POLY 1.5 | P<0.001 ** P=0.064 P=0.004 ** P<0.001 ** |P=0.179N P=0.060N P=0.184N P=0.065N |
|POLY 6 | P<0.001 ** P=0.062 P=0.004 ** P<0.001 ** |P=0.188N P=0.055N P=0.183N P=0.066N |
|LOGISTIC REGRESSION| P<0.001 ** P=0.065 P=0.005 ** P<0.001 ** |P=0.187N (e) P=0.187N (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.059 P=0.003 ** P<0.001 ** |P=0.172N P=0.061N P=0.181N P=0.059N |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOPRENE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia, Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 8/50 (16%) 12/50 (24%) |4/50 (8%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.5% 20.4% 30.8% |9.4% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 2/15 (13%) 3/15 (20%) |4/29 (14%) 0/30 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | --- 559 518 548 |734 (T) --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.057 P=0.006 ** P<0.001 ** |P=0.187N P=0.058N P=0.187N P=0.071N |
|POLY 3 | P<0.001 ** P=0.064 P=0.004 ** P<0.001 ** |P=0.184N P=0.057N P=0.184N P=0.066N |
|POLY 1.5 | P<0.001 ** P=0.064 P=0.004 ** P<0.001 ** |P=0.179N P=0.060N P=0.184N P=0.065N |
|POLY 6 | P<0.001 ** P=0.062 P=0.004 ** P<0.001 ** |P=0.188N P=0.055N P=0.183N P=0.066N |
|LOGISTIC REGRESSION| P<0.001 ** P=0.065 P=0.005 ** P<0.001 ** |P=0.187N (e) P=0.187N (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.059 P=0.003 ** P<0.001 ** |P=0.172N P=0.061N P=0.181N P=0.059N |
|=================================================================================================================================|
(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).