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.
----------------
Adrenal Gland
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
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 Adenoma
Carcinoma or Adenoma
Lung Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Testes Adenoma
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Thyroid Gland: C-Cell 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 |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 0.0% |4.7% 2.3% 4.8% 2.5% |
|TERMINAL (d) | 0/18 (0%) 0/16 (0%) 0/15 (0%) 0/15 (0%) |2/29 (7%) 1/30 (3%) 2/28 (7%) 1/27 (4%) |
|FIRST INCIDENCE | 604 --- --- --- |734 (T) 734 (T) 734 (T) 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.638N P=0.489N P=0.500N P=0.478N |P=0.526N P=0.488N P=0.684 P=0.525N |
|POLY 3 | P=0.656N P=0.498N P=0.501N P=0.500N |P=0.518N P=0.489N P=0.687 P=0.516N |
|POLY 1.5 | P=0.659N P=0.497N P=0.498N P=0.500N |P=0.511N P=0.493N P=0.688 P=0.512N |
|POLY 6 | P=0.649N P=0.504N P=0.509N P=0.503N |P=0.523N P=0.485N P=0.688 P=0.519N |
|LOGISTIC REGRESSION| P=0.645N P=0.515N P=0.514N P=0.497N |P=0.526N P=0.488N P=0.684 P=0.525N |
|COCH-ARM / FISHERS | P=0.657N P=0.500N P=0.500N P=0.500N |P=0.494N P=0.500N P=0.691N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 15/50 (30%) 20/50 (40%) 18/50 (36%) |1/50 (2%) 5/50 (10%) 4/50 (8%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 46.3% 37.0% 49.7% 44.8% |2.4% 11.4% 9.5% 7.3% |
|TERMINAL (d) | 10/18 (56%) 6/16 (38%) 9/15 (60%) 5/15 (33%) |1/29 (3%) 5/30 (17%) 2/28 (7%) 1/27 (4%) |
|FIRST INCIDENCE | 539 538 510 548 |734 (T) 734 (T) 638 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.455 P=0.431N P=0.271 P=0.465 |P=0.610 P=0.108 P=0.175 P=0.281 |
|POLY 3 | P=0.530 P=0.264N P=0.469 P=0.535N |P=0.617N P=0.108 P=0.175 P=0.291 |
|POLY 1.5 | P=0.500 P=0.284N P=0.462 P=0.565N |P=0.610N P=0.106 P=0.175 P=0.294 |
|POLY 6 | P=0.569 P=0.254N P=0.450 P=0.511N |P=0.621N P=0.109 P=0.177 P=0.290 |
|LOGISTIC REGRESSION| P=0.521 P=0.304N P=0.418 P=0.560N |P=0.617 P=0.108 P=0.173 P=0.287 |
|COCH-ARM / FISHERS | P=0.509 P=0.335N P=0.418 P=0.582N |P=0.590N P=0.102 P=0.181 P=0.309 |
|=================================================================================================================================|
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 |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.2% 2.6% 2.7% 0.0% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/18 (11%) 0/16 (0%) 1/15 (7%) 0/15 (0%) |1/29 (3%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 721 592 733 (T) --- |734 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.194N P=0.351N P=0.378N P=0.153N |P=0.671N P=0.493N P=0.507N P=0.514N |
|POLY 3 | P=0.182N P=0.293N P=0.302N P=0.115N |P=0.662N P=0.493N P=0.504N P=0.509N |
|POLY 1.5 | P=0.185N P=0.295N P=0.300N P=0.117N |P=0.659N P=0.496N P=0.504N P=0.507N |
|POLY 6 | P=0.179N P=0.295N P=0.312N P=0.116N |P=0.663N P=0.492N P=0.504N P=0.511N |
|LOGISTIC REGRESSION| P=0.180N P=0.301N P=0.363N P=0.136N |P=0.671N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.182N P=0.309N P=0.309N P=0.121N |P=0.657N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 16/50 (32%) 20/50 (40%) 18/50 (36%) |2/50 (4%) 5/50 (10%) 4/50 (8%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 51.4% 39.0% 49.7% 44.8% |4.7% 11.4% 9.5% 7.3% |
|TERMINAL (d) | 11/18 (61%) 6/16 (38%) 9/15 (60%) 5/15 (33%) |2/29 (7%) 5/30 (17%) 2/28 (7%) 1/27 (4%) |
|FIRST INCIDENCE | 539 538 510 548 |734 (T) 734 (T) 638 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.556N P=0.373N P=0.396 P=0.546N |P=0.561N P=0.226 P=0.327 P=0.466 |
|POLY 3 | P=0.496N P=0.179N P=0.530N P=0.351N |P=0.541N P=0.229 P=0.332 P=0.483 |
|POLY 1.5 | P=0.519N P=0.206N P=0.536N P=0.389N |P=0.534N P=0.224 P=0.331 P=0.486 |
|POLY 6 | P=0.465N P=0.158N P=0.554N P=0.320N |P=0.546N P=0.231 P=0.336 P=0.481 |
|LOGISTIC REGRESSION| P=0.490N P=0.232N P=0.585N P=0.384N |P=0.557N P=0.226 P=0.327 P=0.475 |
|COCH-ARM / FISHERS | P=0.503N P=0.266N P=0.581N P=0.418N |P=0.513N P=0.218 P=0.339 P=0.500 |
|=================================================================================================================================|
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 |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 3/50 (6%) |3/47 (6%) 5/48 (10%) 5/46 (11%) 6/48 (13%) |
|POLY-3 ADJUSTED (b)| 5.4% 2.7% 8.1% 8.1% |7.4% 11.8% 13.1% 15.4% |
|TERMINAL (d) | 1/18 (6%) 1/16 (6%) 3/15 (20%) 2/15 (13%) |2/27 (7%) 4/29 (14%) 4/26 (15%) 5/26 (19%) |
|FIRST INCIDENCE | 597 733 (T) 733 (T) 727 |596 670 708 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.351 P=0.521N P=0.427 P=0.445 |P=0.271 P=0.398 P=0.342 P=0.223 |
|POLY 3 | P=0.390 P=0.497N P=0.497 P=0.501 |P=0.284 P=0.379 P=0.322 P=0.220 |
|POLY 1.5 | P=0.387 P=0.495N P=0.504 P=0.500 |P=0.297 P=0.375 P=0.328 P=0.229 |
|POLY 6 | P=0.389 P=0.508N P=0.479 P=0.493 |P=0.273 P=0.382 P=0.317 P=0.213 |
|LOGISTIC REGRESSION| P=0.388 P=0.495N P=0.484 P=0.499 |P=0.276 P=0.381 P=0.326 P=0.222 |
|COCH-ARM / FISHERS | P=0.391 P=0.500N P=0.500 P=0.500 |P=0.328 P=0.369 P=0.345 P=0.254 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |2/47 (4%) 5/48 (10%) 2/46 (4%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 8.2% 5.2% 5.2% 0.0% |5.0% 11.7% 5.2% 5.1% |
|TERMINAL (d) | 3/18 (17%) 0/16 (0%) 0/15 (0%) 0/15 (0%) |1/27 (4%) 3/29 (10%) 1/26 (4%) 1/26 (4%) |
|FIRST INCIDENCE | 733 (T) 398 454 --- |714 482 617 594 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.132N P=0.541N P=0.542N P=0.151N |P=0.444N P=0.239 P=0.673 P=0.674 |
|POLY 3 | P=0.123N P=0.480N P=0.481N P=0.115N |P=0.422N P=0.242 P=0.679 P=0.686 |
|POLY 1.5 | P=0.125N P=0.484N P=0.484N P=0.117N |P=0.416N P=0.236 P=0.679 P=0.689 |
|POLY 6 | P=0.122N P=0.483N P=0.485N P=0.115N |P=0.426N P=0.246 P=0.680 P=0.685 |
|LOGISTIC REGRESSION| P=0.112N P=0.495N P=0.503N (e) |P=0.405N P=0.226 P=0.680 P=0.692 |
|COCH-ARM / FISHERS | P=0.120N P=0.500N P=0.500N P=0.121N |P=0.400N P=0.226 P=0.683 P=0.684N |
|=================================================================================================================================|
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 |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 5/50 (10%) 3/50 (6%) |5/47 (11%) 10/48 (21%) 7/46 (15%) 8/48 (17%) |
|POLY-3 ADJUSTED (b)| 13.5% 7.8% 13.1% 8.1% |12.3% 23.3% 18.2% 20.3% |
|TERMINAL (d) | 4/18 (22%) 1/16 (6%) 3/15 (20%) 2/15 (13%) |3/27 (11%) 7/29 (24%) 5/26 (19%) 6/26 (23%) |
|FIRST INCIDENCE | 597 398 454 727 |596 482 617 594 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.422N P=0.401N P=0.551 P=0.436N |P=0.426 P=0.166 P=0.357 P=0.251 |
|POLY 3 | P=0.393N P=0.336N P=0.614N P=0.353N |P=0.449 P=0.153 P=0.341 P=0.253 |
|POLY 1.5 | P=0.395N P=0.339N P=0.613N P=0.356N |P=0.464 P=0.148 P=0.345 P=0.262 |
|POLY 6 | P=0.395N P=0.345N P=0.628N P=0.361N |P=0.438 P=0.156 P=0.338 P=0.246 |
|LOGISTIC REGRESSION| P=0.382N P=0.347N P=0.626N P=0.368N |P=0.451 P=0.146 P=0.342 P=0.254 |
|COCH-ARM / FISHERS | P=0.381N P=0.357N P=0.630N P=0.357N |P=0.505 P=0.140 P=0.364 P=0.290 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 5/50 (10%) 1/49 (2%) |1/49 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.7% 5.3% 13.3% 2.7% |2.4% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 1/16 (6%) 3/15 (20%) 0/15 (0%) |1/29 (3%) 2/30 (7%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 733 (T) 592 566 621 |734 (T) 734 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.352N P=0.479 P=0.074 P=0.747 |P=0.336N P=0.512 P=0.507N P=0.514N |
|POLY 3 | P=0.323N P=0.511 P=0.103 P=0.757N |P=0.323N P=0.517 P=0.501N P=0.506N |
|POLY 1.5 | P=0.332N P=0.510 P=0.105 P=0.761N |P=0.321N P=0.513 P=0.500N P=0.503N |
|POLY 6 | P=0.318N P=0.508 P=0.097 P=0.757N |P=0.325N P=0.519 P=0.502N P=0.509N |
|LOGISTIC REGRESSION| P=0.331N P=0.505 P=0.094 P=0.763 |P=0.336N P=0.512 (e) (e) |
|COCH-ARM / FISHERS | P=0.340N P=0.500 P=0.102 P=0.747 |P=0.317N P=0.508 P=0.495N P=0.495N |
|=================================================================================================================================|
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 |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/49 (2%) |0/49 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.5% 0.0% 2.7% 2.7% |0.0% 0.0% 4.8% 2.5% |
|TERMINAL (d) | 2/18 (11%) 0/16 (0%) 0/15 (0%) 1/15 (7%) |0/29 (0%) 0/30 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | 733 (T) --- 655 733 (T) |--- --- 727 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.703 P=0.263N P=0.535N P=0.565N |P=0.526 (e) P=0.225 P=0.474 |
|POLY 3 | P=0.698N P=0.232N P=0.495N P=0.496N |P=0.532 (e) P=0.236 P=0.494 |
|POLY 1.5 | P=0.702N P=0.232N P=0.494N P=0.501N |P=0.539 (e) P=0.237 P=0.497 |
|POLY 6 | P=0.695N P=0.235N P=0.503N P=0.498N |P=0.526 (e) P=0.235 P=0.492 |
|LOGISTIC REGRESSION| P=0.695N (e) P=0.514N P=0.565N |P=0.535 (e) P=0.234 P=0.492 |
|COCH-ARM / FISHERS | P=0.702N P=0.247N P=0.500N P=0.508N |P=0.557 (e) P=0.253 P=0.505 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 6/50 (12%) 2/49 (4%) |1/49 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 8.2% 5.3% 15.9% 5.3% |2.4% 4.6% 4.8% 2.5% |
|TERMINAL (d) | 3/18 (17%) 1/16 (6%) 3/15 (20%) 1/15 (7%) |1/29 (3%) 2/30 (7%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | 733 (T) 592 566 621 |734 (T) 734 (T) 727 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.379N P=0.539N P=0.181 P=0.562N |P=0.543N P=0.512 P=0.480 P=0.738 |
|POLY 3 | P=0.343N P=0.485N P=0.252 P=0.490N |P=0.524N P=0.517 P=0.499 P=0.755 |
|POLY 1.5 | P=0.354N P=0.488N P=0.253 P=0.499N |P=0.518N P=0.513 P=0.500 P=0.757 |
|POLY 6 | P=0.336N P=0.489N P=0.244 P=0.489N |P=0.529N P=0.519 P=0.498 P=0.752 |
|LOGISTIC REGRESSION| P=0.345N P=0.503N P=0.223 P=0.507N |P=0.540N P=0.512 P=0.494 P=0.751 |
|COCH-ARM / FISHERS | P=0.360N P=0.500N P=0.243 P=0.510N |P=0.503N P=0.508 P=0.508 P=0.747N |
|=================================================================================================================================|
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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.3% 0.0% 0.0% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 0/15 (0%) 0/15 (0%) |0/29 (0%) 0/30 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | --- 592 --- --- |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.473N P=0.232 (e) (e) |P=0.754N (e) P=0.493 (e) |
|POLY 3 | P=0.456N P=0.244 (e) (e) |P=0.750N (e) P=0.496 (e) |
|POLY 1.5 | P=0.461N P=0.243 (e) (e) |P=0.747N (e) P=0.496 (e) |
|POLY 6 | P=0.454N P=0.241 (e) (e) |P=0.752N (e) P=0.496 (e) |
|LOGISTIC REGRESSION| P=0.465N P=0.240 (e) (e) |(e) (e) P=0.493 (e) |
|COCH-ARM / FISHERS | P=0.464N P=0.247 (e) (e) |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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.9% 0.0% 0.0% |0.0% 0.0% 2.4% 2.5% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 0/15 (0%) 0/15 (0%) |0/29 (0%) 0/30 (0%) 1/28 (4%) 1/27 (4%) |
|FIRST INCIDENCE | --- 592 --- --- |--- --- 734 (T) 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.343N P=0.112 (e) (e) |P=0.424 (e) P=0.493 P=0.486 |
|POLY 3 | P=0.324N P=0.124 (e) (e) |P=0.424 (e) P=0.496 P=0.491 |
|POLY 1.5 | P=0.329N P=0.123 (e) (e) |P=0.429 (e) P=0.496 P=0.493 |
|POLY 6 | P=0.321N P=0.122 (e) (e) |P=0.419 (e) P=0.496 P=0.489 |
|LOGISTIC REGRESSION| P=0.335N P=0.123 (e) (e) |(e) (e) P=0.493 P=0.486 |
|COCH-ARM / FISHERS | P=0.335N P=0.121 (e) (e) |P=0.443 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.9% 0.0% 0.0% |0.0% 0.0% 2.4% 2.5% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 0/15 (0%) 0/15 (0%) |0/29 (0%) 0/30 (0%) 1/28 (4%) 1/27 (4%) |
|FIRST INCIDENCE | --- 592 --- --- |--- --- 734 (T) 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.343N P=0.112 (e) (e) |P=0.424 (e) P=0.493 P=0.486 |
|POLY 3 | P=0.324N P=0.124 (e) (e) |P=0.424 (e) P=0.496 P=0.491 |
|POLY 1.5 | P=0.329N P=0.123 (e) (e) |P=0.429 (e) P=0.496 P=0.493 |
|POLY 6 | P=0.321N P=0.122 (e) (e) |P=0.419 (e) P=0.496 P=0.489 |
|LOGISTIC REGRESSION| P=0.335N P=0.123 (e) (e) |(e) (e) P=0.493 P=0.486 |
|COCH-ARM / FISHERS | P=0.335N P=0.121 (e) (e) |P=0.443 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.4% 0.0% 0.0% 4.9% |
|TERMINAL (d) | 0/18 (0%) 0/16 (0%) 0/15 (0%) 0/15 (0%) |1/29 (3%) 0/30 (0%) 0/28 (0%) 1/27 (4%) |
|FIRST INCIDENCE | --- --- --- --- |734 (T) --- --- 625 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.150 P=0.493N P=0.507N P=0.478 |
|POLY 3 | (e) (e) (e) (e) |P=0.154 P=0.493N P=0.504N P=0.487 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.156 P=0.496N P=0.504N P=0.489 |
|POLY 6 | (e) (e) (e) (e) |P=0.152 P=0.492N P=0.504N P=0.486 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.155 (e) (e) P=0.488 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.163 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 9
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 |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 7.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 0/16 (0%) 0/15 (0%) 0/15 (0%) |0/29 (0%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 733 (T) --- --- 630 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.040 * P=0.523N P=0.536N P=0.283 |(e) (e) (e) (e) |
|POLY 3 | P=0.043 * P=0.495N P=0.498N P=0.317 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.041 * P=0.494N P=0.495N P=0.313 |(e) (e) (e) (e) |
|POLY 6 | P=0.044 * P=0.500N P=0.504N P=0.316 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.043 * (e) (e) P=0.309 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.043 * P=0.495N P=0.495N P=0.316 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 7.9% |2.4% 0.0% 0.0% 4.9% |
|TERMINAL (d) | 1/18 (6%) 0/16 (0%) 0/15 (0%) 0/15 (0%) |1/29 (3%) 0/30 (0%) 0/28 (0%) 1/27 (4%) |
|FIRST INCIDENCE | 733 (T) --- --- 630 |734 (T) --- --- 625 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.040 * P=0.523N P=0.536N P=0.283 |P=0.150 P=0.493N P=0.507N P=0.478 |
|POLY 3 | P=0.043 * P=0.495N P=0.498N P=0.317 |P=0.154 P=0.493N P=0.504N P=0.487 |
|POLY 1.5 | P=0.041 * P=0.494N P=0.495N P=0.313 |P=0.156 P=0.496N P=0.504N P=0.489 |
|POLY 6 | P=0.044 * P=0.500N P=0.504N P=0.316 |P=0.152 P=0.492N P=0.504N P=0.486 |
|LOGISTIC REGRESSION| P=0.043 * (e) (e) P=0.309 |P=0.155 (e) (e) P=0.488 |
|COCH-ARM / FISHERS | P=0.043 * P=0.495N P=0.495N P=0.316 |P=0.163 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 10
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 |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |4/50 (8%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 2.7% 5.4% |9.4% 4.6% 2.4% 7.3% |
|TERMINAL (d) | 0/18 (0%) 0/16 (0%) 1/15 (7%) 1/15 (7%) |4/29 (14%) 1/30 (3%) 1/28 (4%) 2/27 (7%) |
|FIRST INCIDENCE | --- 717 733 (T) 721 |734 (T) 714 734 (T) 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.239 P=0.462 P=0.464 P=0.205 |P=0.496 P=0.324N P=0.187N P=0.535N |
|POLY 3 | P=0.254 P=0.504 P=0.501 P=0.240 |P=0.517 P=0.321N P=0.184N P=0.515N |
|POLY 1.5 | P=0.252 P=0.504 P=0.503 P=0.238 |P=0.522 P=0.327N P=0.184N P=0.512N |
|POLY 6 | P=0.254 P=0.501 P=0.495 P=0.237 |P=0.513 P=0.315N P=0.183N P=0.516N |
|LOGISTIC REGRESSION| P=0.243 P=0.491 P=0.464 P=0.214 |P=0.514 P=0.323N P=0.187N P=0.513N |
|COCH-ARM / FISHERS | P=0.252 P=0.500 P=0.500 P=0.247 |P=0.536 P=0.339N P=0.181N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 6/50 (12%) 21/50 (42%) |19/50 (38%) 35/50 (70%) 32/50 (64%) 32/50 (64%) |
|POLY-3 ADJUSTED (b)| 5.4% 10.5% 15.8% 54.2% |42.9% 74.3% 73.7% 73.2% |
|TERMINAL (d) | 1/18 (6%) 2/16 (13%) 1/15 (7%) 10/15 (67%) |12/29 (41%) 23/30 (77%) 22/28 (79%) 20/27 (74%) |
|FIRST INCIDENCE | 724 629 591 664 |596 482 539 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.303 P=0.117 P<0.001 ** |P=0.113 P=0.008 ** P=0.011 * P=0.008 ** |
|POLY 3 | P<0.001 ** P=0.353 P=0.140 P<0.001 ** |P=0.105 P<0.001 ** P=0.002 ** P=0.002 ** |
|POLY 1.5 | P<0.001 ** P=0.350 P=0.140 P<0.001 ** |P=0.123 P<0.001 ** P=0.003 ** P=0.003 ** |
|POLY 6 | P<0.001 ** P=0.351 P=0.137 P<0.001 ** |P=0.097 P<0.001 ** P<0.001 ** P=0.002 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.338 P=0.129 P<0.001 ** |P=0.089 P=0.002 ** P=0.003 ** P=0.003 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.339 P=0.134 P<0.001 ** |P=0.196 P<0.001 ** P=0.008 ** P=0.008 ** |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 11
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 |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 7/50 (14%) 21/50 (42%) |20/50 (40%) 35/50 (70%) 32/50 (64%) 32/50 (64%) |
|POLY-3 ADJUSTED (b)| 5.4% 13.1% 18.4% 54.2% |45.2% 74.3% 73.7% 73.2% |
|TERMINAL (d) | 1/18 (6%) 2/16 (13%) 2/15 (13%) 10/15 (67%) |13/29 (45%) 23/30 (77%) 22/28 (79%) 20/27 (74%) |
|FIRST INCIDENCE | 724 629 591 664 |596 482 539 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.185 P=0.067 P<0.001 ** |P=0.129 P=0.012 * P=0.016 * P=0.013 * |
|POLY 3 | P<0.001 ** P=0.229 P=0.083 P<0.001 ** |P=0.127 P=0.003 ** P=0.004 ** P=0.004 ** |
|POLY 1.5 | P<0.001 ** P=0.227 P=0.084 P<0.001 ** |P=0.147 P=0.002 ** P=0.005 ** P=0.006 ** |
|POLY 6 | P<0.001 ** P=0.227 P=0.080 P<0.001 ** |P=0.118 P=0.003 ** P=0.002 ** P=0.004 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.214 P=0.075 P<0.001 ** |P=0.105 P=0.003 ** P=0.006 ** P=0.005 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.218 P=0.080 P<0.001 ** |P=0.224 P=0.002 ** P=0.014 * P=0.014 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| |4.6% 0.0% 0.0% 2.5% |
|TERMINAL (d) | |1/29 (3%) 0/30 (0%) 0/28 (0%) 1/27 (4%) |
|FIRST INCIDENCE | |552 --- --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.643 P=0.231N P=0.249N P=0.524N |
|POLY 3 | |P=0.646 P=0.233N P=0.244N P=0.521N |
|POLY 1.5 | |P=0.651 P=0.234N P=0.243N P=0.515N |
|POLY 6 | |P=0.643 P=0.232N P=0.246N P=0.527N |
|LOGISTIC REGRESSION| |P=0.667 P=0.253N P=0.222N P=0.498N |
|COCH-ARM / FISHERS | |P=0.662 P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 12
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 |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.1% 2.7% 8.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 1/16 (6%) 1/15 (7%) 0/15 (0%) |0/29 (0%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 600 733 (T) 667 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.143N P=0.340N P=0.611 P=0.135N |(e) (e) (e) (e) |
|POLY 3 | P=0.132N P=0.302N P=0.663N P=0.117N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.135N P=0.300N P=0.658N P=0.118N |(e) (e) (e) (e) |
|POLY 6 | P=0.130N P=0.313N P=0.653 P=0.120N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.131N P=0.301N P=0.663 P=0.119N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.134N P=0.309N P=0.661N P=0.121N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 40/50 (80%) 39/50 (78%) 31/49 (63%) |33/50 (66%) 27/50 (54%) 36/50 (72%) 27/50 (54%) |
|POLY-3 ADJUSTED (b)| 86.0% 84.4% 82.9% 73.5% |72.2% 56.4% 78.6% 61.7% |
|TERMINAL (d) | 16/18 (89%) 12/16 (75%) 10/15 (67%) 13/15 (87%) |22/29 (76%) 14/30 (47%) 22/28 (79%) 18/27 (67%) |
|FIRST INCIDENCE | 342 420 454 560 |454 482 510 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.131N P=0.386 P=0.386 P=0.260N |P=0.357N P=0.157N P=0.302 P=0.302N |
|POLY 3 | P=0.066N P=0.529N P=0.444N P=0.095N |P=0.274N P=0.078N P=0.313 P=0.191N |
|POLY 1.5 | P=0.053N P=0.585N P=0.488N P=0.095N |P=0.228N P=0.105N P=0.298 P=0.184N |
|POLY 6 | P=0.095N P=0.475N P=0.413N P=0.106N |P=0.342N P=0.054N P=0.344 P=0.204N |
|LOGISTIC REGRESSION| P=0.025N* P=0.552 P=0.555N P=0.059N |P=0.222N P=0.134N P=0.273 P=0.207N |
|COCH-ARM / FISHERS | P=0.024N* P=0.500 P=0.595N P=0.082N |P=0.156N P=0.154N P=0.333 P=0.154N |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 13
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 |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 40/50 (80%) 39/50 (78%) 31/49 (63%) |34/50 (68%) 27/50 (54%) 37/50 (74%) 27/50 (54%) |
|POLY-3 ADJUSTED (b)| 86.0% 84.4% 82.9% 73.5% |73.5% 56.4% 80.8% 61.7% |
|TERMINAL (d) | 16/18 (89%) 12/16 (75%) 10/15 (67%) 13/15 (87%) |22/29 (76%) 14/30 (47%) 23/28 (82%) 18/27 (67%) |
|FIRST INCIDENCE | 342 420 454 560 |454 482 510 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.131N P=0.386 P=0.386 P=0.260N |P=0.312N P=0.124N P=0.301 P=0.249N |
|POLY 3 | P=0.066N P=0.529N P=0.444N P=0.095N |P=0.230N P=0.059N P=0.269 P=0.155N |
|POLY 1.5 | P=0.053N P=0.585N P=0.488N P=0.095N |P=0.184N P=0.076N P=0.272 P=0.141N |
|POLY 6 | P=0.095N P=0.475N P=0.413N P=0.106N |P=0.298N P=0.043N* P=0.278 P=0.177N |
|LOGISTIC REGRESSION| P=0.025N* P=0.552 P=0.555N P=0.059N |P=0.173N P=0.099N P=0.270 P=0.149N |
|COCH-ARM / FISHERS | P=0.024N* P=0.500 P=0.595N P=0.082N |P=0.119N P=0.109N P=0.330 P=0.109N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or |
| Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.7% 2.7% 5.4% 2.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 1/16 (6%) 0/15 (0%) 0/15 (0%) |0/29 (0%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 684 622 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.630N P=0.737 P=0.457 P=0.744 |(e) (e) (e) (e) |
|POLY 3 | P=0.609N P=0.757N P=0.504 P=0.756N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.614N P=0.756N P=0.506 P=0.759N |(e) (e) (e) (e) |
|POLY 6 | P=0.605N P=0.762N P=0.496 P=0.757N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.612N P=0.737 P=0.477 P=0.761N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.615N P=0.753N P=0.500 P=0.753N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 14
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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.7% 2.7% 5.4% 2.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 1/16 (6%) 0/15 (0%) 0/15 (0%) |0/29 (0%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 684 622 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.630N P=0.737 P=0.457 P=0.744 |(e) (e) (e) (e) |
|POLY 3 | P=0.609N P=0.757N P=0.504 P=0.756N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.614N P=0.756N P=0.506 P=0.759N |(e) (e) (e) (e) |
|POLY 6 | P=0.605N P=0.762N P=0.496 P=0.757N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.612N P=0.737 P=0.477 P=0.761N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.615N P=0.753N P=0.500 P=0.753N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 4/50 (8%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.0% 8.0% 10.8% 10.5% |4.7% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 2/18 (11%) 3/16 (19%) 2/15 (13%) 1/15 (7%) |2/29 (7%) 1/30 (3%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 454 733 (T) 684 622 |734 (T) 670 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.434 P=0.621 P=0.434 P=0.448 |P=0.245N P=0.678N P=0.246N P=0.254N |
|POLY 3 | P=0.487 P=0.664 P=0.495 P=0.507 |P=0.234N P=0.681N P=0.241N P=0.247N |
|POLY 1.5 | P=0.476 P=0.659N P=0.503 P=0.501 |P=0.231N P=0.686N P=0.241N P=0.245N |
|POLY 6 | P=0.500 P=0.652 P=0.477 P=0.508 |P=0.236N P=0.676N P=0.241N P=0.249N |
|LOGISTIC REGRESSION| P=0.483 P=0.657N P=0.500 P=0.502 |P=0.239N P=0.682N (e) (e) |
|COCH-ARM / FISHERS | P=0.478 P=0.661N P=0.500 P=0.500 |P=0.226N P=0.691N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 15
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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.4% 2.7% 5.3% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 0/15 (0%) 1/15 (7%) |0/29 (0%) 0/30 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | --- 538 591 588 |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.570 P=0.061 P=0.495 P=0.228 |P=0.754N (e) P=0.493 (e) |
|POLY 3 | P=0.587 P=0.065 P=0.504 P=0.242 |P=0.750N (e) P=0.496 (e) |
|POLY 1.5 | P=0.579 P=0.064 P=0.504 P=0.239 |P=0.747N (e) P=0.496 (e) |
|POLY 6 | P=0.591 P=0.064 P=0.500 P=0.242 |P=0.752N (e) P=0.496 (e) |
|LOGISTIC REGRESSION| P=0.575 P=0.064 P=0.479 P=0.238 |(e) (e) P=0.493 (e) |
|COCH-ARM / FISHERS | P=0.575 P=0.059 P=0.500 P=0.247 |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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.4% 5.3% 5.3% |4.6% 2.3% 2.4% 2.5% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 0/15 (0%) 1/15 (7%) |1/29 (3%) 1/30 (3%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | --- 538 580 588 |482 734 (T) 734 (T) 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.631 P=0.061 P=0.237 P=0.228 |P=0.599N P=0.490N P=0.508N P=0.516N |
|POLY 3 | P=0.642 P=0.065 P=0.244 P=0.242 |P=0.590N P=0.494N P=0.513N P=0.520N |
|POLY 1.5 | P=0.635 P=0.064 P=0.243 P=0.239 |P=0.584N P=0.496N P=0.510N P=0.515N |
|POLY 6 | P=0.645 P=0.064 P=0.241 P=0.242 |P=0.593N P=0.494N P=0.515N P=0.524N |
|LOGISTIC REGRESSION| P=0.634 P=0.064 P=0.207 P=0.238 |P=0.566N P=0.523N P=0.483N P=0.465N |
|COCH-ARM / FISHERS | P=0.632 P=0.059 P=0.247 P=0.247 |P=0.572N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 16
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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.7% 0.0% |4.6% 2.3% 0.0% 2.5% |
|TERMINAL (d) | 0/18 (0%) 0/16 (0%) 0/15 (0%) 0/15 (0%) |1/29 (3%) 1/30 (3%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | --- --- 580 --- |482 734 (T) --- 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.722N (e) P=0.500 (e) |P=0.687N P=0.490N P=0.244N P=0.516N |
|POLY 3 | P=0.739N (e) P=0.504 (e) |P=0.675N P=0.494N P=0.245N P=0.520N |
|POLY 1.5 | P=0.741N (e) P=0.504 (e) |P=0.672N P=0.496N P=0.243N P=0.515N |
|POLY 6 | P=0.740N (e) P=0.500 (e) |P=0.677N P=0.494N P=0.246N P=0.524N |
|LOGISTIC REGRESSION| P=0.720N (e) P=0.472 (e) |P=0.648N P=0.523N P=0.202N P=0.465N |
|COCH-ARM / FISHERS | P=0.740N (e) P=0.500 (e) |P=0.665N P=0.500N P=0.247N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.7% 5.3% 2.7% 5.4% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 2/16 (13%) 1/15 (7%) 1/15 (7%) |0/29 (0%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 691 |--- 670 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.455 P=0.458 P=0.722 P=0.448 |P=0.705N P=0.516 (e) (e) |
|POLY 3 | P=0.499 P=0.507 P=0.760N P=0.506 |P=0.682N P=0.508 (e) (e) |
|POLY 1.5 | P=0.493 P=0.507 P=0.758N P=0.503 |P=0.683N P=0.505 (e) (e) |
|POLY 6 | P=0.502 P=0.500 P=0.757 P=0.505 |P=0.682N P=0.510 (e) (e) |
|LOGISTIC REGRESSION| P=0.484 P=0.458 P=0.722 P=0.484 |P=0.680N P=0.493 (e) (e) |
|COCH-ARM / FISHERS | P=0.494 P=0.500 P=0.753N P=0.500 |P=0.684N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 17
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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 0.0% 0.0% |4.7% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 0/15 (0%) 0/15 (0%) |2/29 (7%) 1/30 (3%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | --- 733 (T) --- --- |734 (T) 734 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.702N P=0.477 (e) (e) |P=0.320N P=0.488N P=0.246N P=0.254N |
|POLY 3 | P=0.681N P=0.504 (e) (e) |P=0.313N P=0.489N P=0.241N P=0.247N |
|POLY 1.5 | P=0.683N P=0.504 (e) (e) |P=0.310N P=0.493N P=0.241N P=0.245N |
|POLY 6 | P=0.680N P=0.500 (e) (e) |P=0.315N P=0.485N P=0.241N P=0.249N |
|LOGISTIC REGRESSION| (e) P=0.477 (e) (e) |P=0.320N P=0.488N (e) (e) |
|COCH-ARM / FISHERS | P=0.684N P=0.500 (e) (e) |P=0.304N P=0.500N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.3% 8.0% 5.4% 8.0% |4.7% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 3/16 (19%) 2/15 (13%) 1/15 (7%) |2/29 (7%) 1/30 (3%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 454 733 (T) 733 (T) 686 |734 (T) 670 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.450 P=0.458 P=0.652 P=0.453 |P=0.245N P=0.678N P=0.246N P=0.254N |
|POLY 3 | P=0.499 P=0.500 P=0.690 P=0.501 |P=0.234N P=0.681N P=0.241N P=0.247N |
|POLY 1.5 | P=0.492 P=0.504 P=0.694N P=0.499 |P=0.231N P=0.686N P=0.241N P=0.245N |
|POLY 6 | P=0.504 P=0.487 P=0.677 P=0.498 |P=0.236N P=0.676N P=0.241N P=0.249N |
|LOGISTIC REGRESSION| P=0.499 P=0.508 P=0.692N P=0.501 |P=0.239N P=0.682N (e) (e) |
|COCH-ARM / FISHERS | P=0.495 P=0.500 P=0.691N P=0.500 |P=0.226N P=0.691N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 18
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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.7% 8.0% 2.7% 5.4% |4.7% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 3/16 (19%) 1/15 (7%) 1/15 (7%) |2/29 (7%) 1/30 (3%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 691 |734 (T) 670 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.547 P=0.258 P=0.722 P=0.448 |P=0.245N P=0.678N P=0.246N P=0.254N |
|POLY 3 | P=0.593 P=0.311 P=0.760N P=0.506 |P=0.234N P=0.681N P=0.241N P=0.247N |
|POLY 1.5 | P=0.586 P=0.312 P=0.758N P=0.503 |P=0.231N P=0.686N P=0.241N P=0.245N |
|POLY 6 | P=0.597 P=0.303 P=0.757 P=0.505 |P=0.236N P=0.676N P=0.241N P=0.249N |
|LOGISTIC REGRESSION| P=0.576 P=0.258 P=0.722 P=0.484 |P=0.239N P=0.682N (e) (e) |
|COCH-ARM / FISHERS | P=0.586 P=0.309 P=0.753N P=0.500 |P=0.226N P=0.691N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 37/50 (74%) 44/50 (88%) 48/50 (96%) | |
|POLY-3 ADJUSTED (b)| 78.4% 85.3% 94.4% 99.9% | |
|TERMINAL (d) | 16/18 (89%) 16/16 (100%) 15/15 (100%) 15/15 (100%)| |
|FIRST INCIDENCE | 454 398 454 361 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026 * P=0.183 P=0.024 * P=0.009 ** | |
|POLY 3 | P<0.001 ** P=0.259 P=0.010 * P<0.001 ** | |
|POLY 1.5 | P<0.001 ** P=0.278 P=0.008 ** P<0.001 ** | |
|POLY 6 | P=0.004 ** P=0.201 P=0.020 * P<0.001 ** | |
|LOGISTIC REGRESSION| P<0.001 ** P=0.327 P=0.008 ** P<0.001 ** | |
|COCH-ARM / FISHERS | P<0.001 ** P=0.257 P=0.008 ** P<0.001 ** | |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 19
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 |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 4/50 (8%) 3/49 (6%) 3/50 (6%) |6/48 (13%) 4/50 (8%) 2/49 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 8.1% 10.6% 8.2% 8.0% |14.4% 9.1% 4.9% 4.9% |
|TERMINAL (d) | 1/18 (6%) 2/16 (13%) 2/15 (13%) 2/15 (13%) |5/29 (17%) 3/30 (10%) 2/28 (7%) 1/27 (4%) |
|FIRST INCIDENCE | 482 702 469 581 |580 695 734 (T) 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.583N P=0.455 P=0.629 P=0.636 |P=0.247N P=0.349N P=0.145N P=0.158N |
|POLY 3 | P=0.546N P=0.506 P=0.659 P=0.657N |P=0.226N P=0.334N P=0.138N P=0.137N |
|POLY 1.5 | P=0.552N P=0.514 P=0.661N P=0.657N |P=0.220N P=0.337N P=0.135N P=0.133N |
|POLY 6 | P=0.545N P=0.488 P=0.639 P=0.664 |P=0.230N P=0.336N P=0.142N P=0.143N |
|LOGISTIC REGRESSION| P=0.548N P=0.519 P=0.645 P=0.654N |P=0.233N P=0.329N P=0.137N P=0.136N |
|COCH-ARM / FISHERS | P=0.546N P=0.511 P=0.661N P=0.651N |P=0.206N P=0.344N P=0.127N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 1/49 (2%) 3/50 (6%) |2/48 (4%) 4/50 (8%) 2/49 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.8% 2.7% 2.8% 8.0% |4.9% 9.0% 4.9% 0.0% |
|TERMINAL (d) | 1/18 (6%) 0/16 (0%) 0/15 (0%) 2/15 (13%) |2/29 (7%) 3/30 (10%) 2/28 (7%) 0/27 (0%) |
|FIRST INCIDENCE | 733 (T) 657 692 611 |734 (T) 626 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152 P=0.751 P=0.726 P=0.268 |P=0.110N P=0.354 P=0.684 P=0.254N |
|POLY 3 | P=0.171 P=0.750N P=0.760N P=0.321 |P=0.104N P=0.371 P=0.691 P=0.240N |
|POLY 1.5 | P=0.167 P=0.751N P=0.758N P=0.317 |P=0.101N P=0.366 P=0.693 P=0.237N |
|POLY 6 | P=0.172 P=0.753N P=0.758 P=0.321 |P=0.107N P=0.374 P=0.689 P=0.244N |
|LOGISTIC REGRESSION| P=0.170 P=0.756N P=0.749 P=0.312 |P=0.106N P=0.366 P=0.684 (e) |
|COCH-ARM / FISHERS | P=0.167 P=0.747N P=0.753N P=0.316 |P=0.095N P=0.359 P=0.684N P=0.237N |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 20
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 |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 5/50 (10%) 4/49 (8%) 6/50 (12%) |8/48 (17%) 8/50 (16%) 4/49 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 10.8% 13.2% 10.9% 15.7% |19.2% 18.0% 9.8% 4.9% |
|TERMINAL (d) | 2/18 (11%) 2/16 (13%) 2/15 (13%) 4/15 (27%) |7/29 (24%) 6/30 (20%) 4/28 (14%) 1/27 (4%) |
|FIRST INCIDENCE | 482 657 469 581 |580 626 734 (T) 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.305 P=0.454 P=0.592 P=0.324 |P=0.057N P=0.579N P=0.190N P=0.060N |
|POLY 3 | P=0.348 P=0.512 P=0.641 P=0.383 |P=0.048N* P=0.554N P=0.184N P=0.046N* |
|POLY 1.5 | P=0.341 P=0.518 P=0.641N P=0.381 |P=0.046N* P=0.560N P=0.180N P=0.044N* |
|POLY 6 | P=0.352 P=0.495 P=0.621 P=0.375 |P=0.050N P=0.552N P=0.190N P=0.049N* |
|LOGISTIC REGRESSION| P=0.345 P=0.524 P=0.641 P=0.384 |P=0.051N P=0.553N P=0.183N P=0.049N* |
|COCH-ARM / FISHERS | P=0.345 P=0.513 P=0.643N P=0.383 |P=0.041N* P=0.572N P=0.168N P=0.039N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 2/49 (4%) 0/50 (0%) |0/48 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.6% 5.3% 5.6% 0.0% |0.0% 0.0% 2.5% 2.5% |
|TERMINAL (d) | 1/18 (6%) 1/16 (6%) 2/15 (13%) 0/15 (0%) |0/29 (0%) 0/30 (0%) 1/28 (4%) 1/27 (4%) |
|FIRST INCIDENCE | 704 717 733 (T) --- |--- --- 734 (T) 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.178N P=0.638 P=0.628 P=0.270N |P=0.424 (e) P=0.493 P=0.486 |
|POLY 3 | P=0.158N P=0.680N P=0.695N P=0.229N |P=0.427 (e) P=0.498 P=0.497 |
|POLY 1.5 | P=0.162N P=0.679N P=0.690N P=0.231N |P=0.433 (e) P=0.500 P=0.500 |
|POLY 6 | P=0.155N P=0.689N P=0.683 P=0.231N |P=0.421 (e) P=0.497 P=0.493 |
|LOGISTIC REGRESSION| P=0.162N P=0.682 P=0.645 P=0.240N |(e) (e) P=0.493 P=0.486 |
|COCH-ARM / FISHERS | P=0.160N P=0.684N P=0.691N P=0.242N |P=0.448 (e) P=0.505 P=0.510 |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 21
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 |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |8/50 (16%) 5/50 (10%) 6/50 (12%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| |18.4% 11.3% 14.4% 19.1% |
|TERMINAL (d) | |4/29 (14%) 3/30 (10%) 5/28 (18%) 3/27 (11%) |
|FIRST INCIDENCE | |539 686 699 625 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.306 P=0.264N P=0.407N P=0.542 |
|POLY 3 | |P=0.338 P=0.262N P=0.415N P=0.580 |
|POLY 1.5 | |P=0.343 P=0.267N P=0.408N P=0.583 |
|POLY 6 | |P=0.341 P=0.259N P=0.424N P=0.583 |
|LOGISTIC REGRESSION| |P=0.327 P=0.260N P=0.401N P=0.586 |
|COCH-ARM / FISHERS | |P=0.369 P=0.277N P=0.387N P=0.607N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |8/50 (16%) 6/50 (12%) 6/50 (12%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| |18.4% 13.4% 14.4% 19.1% |
|TERMINAL (d) | |4/29 (14%) 3/30 (10%) 5/28 (18%) 3/27 (11%) |
|FIRST INCIDENCE | |539 587 699 625 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.352 P=0.364N P=0.407N P=0.542 |
|POLY 3 | |P=0.383 P=0.363N P=0.415N P=0.580 |
|POLY 1.5 | |P=0.390 P=0.372N P=0.408N P=0.583 |
|POLY 6 | |P=0.384 P=0.355N P=0.424N P=0.583 |
|LOGISTIC REGRESSION| |P=0.382 P=0.379N P=0.401N P=0.586 |
|COCH-ARM / FISHERS | |P=0.419 P=0.387N P=0.387N P=0.607N |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 22
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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 26/50 (52%) 25/50 (50%) 25/50 (50%) |14/50 (28%) 15/50 (30%) 21/50 (42%) 21/50 (42%) |
|POLY-3 ADJUSTED (b)| 57.5% 61.9% 58.8% 59.3% |30.6% 32.1% 45.6% 46.0% |
|TERMINAL (d) | 9/18 (50%) 12/16 (75%) 8/15 (53%) 8/15 (53%) |3/29 (10%) 6/30 (20%) 7/28 (25%) 9/27 (33%) |
|FIRST INCIDENCE | 468 499 510 361 |539 370 427 415 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.484 P=0.340 P=0.362 P=0.386 |P=0.121 P=0.543 P=0.128 P=0.108 |
|POLY 3 | P=0.565N P=0.424 P=0.542 P=0.525 |P=0.120 P=0.530 P=0.102 P=0.095 |
|POLY 1.5 | P=0.548 P=0.438 P=0.540 P=0.508 |P=0.121 P=0.523 P=0.099 P=0.094 |
|POLY 6 | P=0.554N P=0.380 P=0.522 P=0.521 |P=0.122 P=0.526 P=0.104 P=0.096 |
|LOGISTIC REGRESSION| P=0.552 P=0.464 P=0.526 P=0.512 |P=0.175 P=0.449 P=0.114 P=0.123 |
|COCH-ARM / FISHERS | P=0.557 P=0.421 P=0.500 P=0.500 |P=0.140 P=0.500 P=0.104 P=0.104 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 13.3% 7.9% 5.3% 10.4% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 3/18 (17%) 1/16 (6%) 1/15 (7%) 0/15 (0%) |0/29 (0%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 539 657 566 478 |--- --- --- 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.520 P=0.396N P=0.256N P=0.527N |P=0.248 (e) (e) P=0.495 |
|POLY 3 | P=0.544 P=0.353N P=0.216N P=0.489N |P=0.251 (e) (e) P=0.492 |
|POLY 1.5 | P=0.531 P=0.350N P=0.212N P=0.495N |P=0.253 (e) (e) P=0.494 |
|POLY 6 | P=0.557 P=0.368N P=0.229N P=0.492N |P=0.250 (e) (e) P=0.491 |
|LOGISTIC REGRESSION| P=0.529 P=0.347N P=0.213N P=0.499N |P=0.265 (e) (e) P=0.505 |
|COCH-ARM / FISHERS | P=0.531 P=0.357N P=0.218N P=0.500N |P=0.260 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 23
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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.3% 0.0% 2.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/16 (6%) 0/15 (0%) 0/15 (0%) |0/29 (0%) 0/30 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | --- 581 --- 727 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.626 P=0.238 (e) P=0.478 |(e) (e) (e) (e) |
|POLY 3 | P=0.635 P=0.244 (e) P=0.503 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.631 P=0.243 (e) P=0.501 |(e) (e) (e) (e) |
|POLY 6 | P=0.636 P=0.241 (e) P=0.501 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.630 P=0.239 (e) P=0.481 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.629 P=0.247 (e) P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 49/50 (98%) 48/50 (96%) |43/50 (86%) 43/50 (86%) 46/50 (92%) 41/50 (82%) |
|POLY-3 ADJUSTED (b)| 99.9% 100.0% 99.3% 99.9% |91.5% 88.6% 97.9% 90.2% |
|TERMINAL (d) | 18/18 (100%) 16/16 (100%) 15/15 (100%) 15/15 (100%)|28/29 (97%) 27/30 (90%) 28/28 (100%) 25/27 (93%) |
|FIRST INCIDENCE | 342 398 454 361 |454 482 510 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.522N P=0.375 P=0.360 P=0.452 |P=0.523 P=0.454N P=0.277 P=0.511 |
|POLY 3 | P=0.996 P=1.000 P=0.968N P=1.000 |P=0.458N P=0.442N P=0.128 P=0.564N |
|POLY 1.5 | P=0.939 P=1.000 P=0.823N P=1.000 |P=0.376N P=0.522N P=0.144 P=0.527N |
|POLY 6 | P=1.000 P=1.000 P=1.000N P=1.000 |P=0.528N P=0.349N P=0.141 P=0.573N |
|LOGISTIC REGRESSION| P=0.771 (e) P=0.452N (e) |P=0.456N P=0.512N P=0.134 P=0.596N |
|COCH-ARM / FISHERS | P=0.264N P=0.500 P=0.753N P=0.500N |P=0.223N P=0.613N P=0.262 P=0.393N |
|=================================================================================================================================|
Date: 10/01/97 EXPERIMENT: 05135 TEST: 07 Page 24
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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 33/50 (66%) 30/50 (60%) 34/50 (68%) |28/50 (56%) 27/50 (54%) 26/50 (52%) 31/50 (62%) |
|POLY-3 ADJUSTED (b)| 76.4% 73.5% 66.6% 75.0% |58.0% 55.5% 56.4% 64.9% |
|TERMINAL (d) | 15/18 (83%) 12/16 (75%) 9/15 (60%) 9/15 (60%) |12/29 (41%) 12/30 (40%) 11/28 (39%) 13/27 (48%) |
|FIRST INCIDENCE | 235 398 454 361 |398 370 427 415 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.393 P=0.510 P=0.485N P=0.430 |P=0.175 P=0.442N P=0.493N P=0.292 |
|POLY 3 | P=0.456 P=0.470N P=0.197N P=0.539N |P=0.200 P=0.484N P=0.521N P=0.312 |
|POLY 1.5 | P=0.401 P=0.477N P=0.217N P=0.591N |P=0.194 P=0.486N P=0.493N P=0.310 |
|POLY 6 | P=0.536 P=0.472N P=0.188N P=0.477N |P=0.214 P=0.492N P=0.553N P=0.318 |
|LOGISTIC REGRESSION| P=0.407 P=0.465N P=0.257N P=0.586 |P=0.258 P=0.574N P=0.404N P=0.392 |
|COCH-ARM / FISHERS | P=0.424 P=0.500N P=0.266N P=0.585N |P=0.213 P=0.500N P=0.421N P=0.342 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 220 PPM 700 PPM 7000 PPM |CONTROL 220 PPM 700 PPM 7000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 49/50 (98%) 48/50 (96%) |49/50 (98%) 48/50 (96%) 49/50 (98%) 48/50 (96%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 99.3% 99.9% |98.0% 96.0% 100.0% 98.0% |
|TERMINAL (d) | 18/18 (100%) 16/16 (100%) 15/15 (100%) 15/15 (100%)|28/29 (97%) 28/30 (93%) 28/28 (100%) 26/27 (96%) |
|FIRST INCIDENCE | 235 398 454 361 |398 370 427 415 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.499N (e) P=0.408 P=0.501 |P=0.345 P=0.390N P=0.466 P=0.431 |
|POLY 3 | P=0.997 (e) P=0.961N P=1.000N |P=0.680 P=0.500N P=0.505 P=0.755N |
|POLY 1.5 | P=0.950N (e) P=0.746N P=1.000N |P=0.694 P=0.500N P=0.527 P=0.742N |
|POLY 6 | P=1.000 (e) P=1.000N P=1.000N |P=0.680 P=0.500N P=0.504 P=0.756N |
|LOGISTIC REGRESSION| P=0.545N (e) P=0.423N (e) |P=0.651N (e) P=0.626 P=0.645N |
|COCH-ARM / FISHERS | P=0.131N (e) P=0.500N P=0.247N |P=0.494N P=0.500N P=0.753N P=0.500N |
|=================================================================================================================================|
(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).