TDMS Study 88070-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest ISOBUTENE DATE: 06/19/97 EXPERIMENT: 88070 TEST: 03 TIME: 12:22:01 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15313 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88070 PATHOLOGIST: GRUMBEIN, S. CAS: 115-11-0007 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 ISOBUTENE DATE: 06/19/97 EXPERIMENT: 88070 TEST: 03 TIME: 12:22:01 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15313 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88070 PATHOLOGIST: GRUMBEIN, S. CAS: 115-11-0007 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF ISOBUTENE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Islets, Pancreatic Carcinoma or Adenoma Skin Basal Cell Adenoma Thyroid Gland: Follicular Cell Carcinoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Malignant Tumors =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Benign Clitoral/Preputial Gland Carcinoma or Adenoma Pituitary Gland: Pars Distalis or UnspeAdenomaSite All Organs Benign Tumors Malignant and Benign Tumors =============================================================== Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 23/50 (46%) 18/49 (37%) 16/50 (32%) 23/50 (46%) |3/50 (6%) 3/50 (6%) 10/49 (20%) 4/49 (8%) | |POLY-3 ADJUSTED (b)| 60.0% 52.1% 46.2% 56.9% |7.5% 8.2% 22.7% 10.2% | |TERMINAL (d) | 6/7 (86%) 4/5 (80%) 4/6 (67%) 6/8 (75%) |3/23 (13%) 2/19 (11%) 7/33 (21%) 2/22 (9%) | |FIRST INCIDENCE | 539 526 496 525 |733 (T) 722 626 650 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.426N P=0.524 P=0.328N P=0.432N |P=0.544 P=0.570 P=0.115 P=0.476 | |POLY 3 | P=0.497 P=0.309N P=0.146N P=0.476N |P=0.589 P=0.625 P=0.050 P=0.493 | |POLY 1.5 | P=0.410 P=0.270N P=0.124N P=0.515N |P=0.571 P=0.636 P=0.042 * P=0.489 | |POLY 6 | P=0.544N P=0.405N P=0.205N P=0.447N |P=0.588N P=0.611 P=0.063 P=0.493 | |LOGISTIC REGRESSION| P=0.506N P=0.360N P=0.205N P=0.401N |P=0.554 P=0.571 P=0.055 P=0.474 | |COCH-ARM / FISHERS | P=0.307 P=0.232N P=0.109N P=0.579N |P=0.545 P=0.661N P=0.033 * P=0.489 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/49 (2%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 3.2% 3.2% 8.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 1/8 (13%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 664 453 631 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.118 P=0.471 P=0.500 P=0.142 |(e) (e) (e) (e) | |POLY 3 | P=0.085 P=0.485 P=0.489 P=0.132 |(e) (e) (e) (e) | |POLY 1.5 | P=0.080 P=0.490 P=0.494 P=0.127 |(e) (e) (e) (e) | |POLY 6 | P=0.093 P=0.476 P=0.480 P=0.137 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.075 P=0.477 P=0.562 P=0.134 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.072 P=0.495 P=0.500 P=0.121 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 23/50 (46%) 18/49 (37%) 17/50 (34%) 24/50 (48%) |4/50 (8%) 3/50 (6%) 10/49 (20%) 4/49 (8%) | |POLY-3 ADJUSTED (b)| 60.0% 52.1% 48.0% 59.1% |10.0% 8.2% 22.7% 10.2% | |TERMINAL (d) | 6/7 (86%) 4/5 (80%) 4/6 (67%) 6/8 (75%) |4/23 (17%) 2/19 (11%) 7/33 (21%) 2/22 (9%) | |FIRST INCIDENCE | 539 526 453 525 |733 (T) 722 626 650 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.493N P=0.524 P=0.397N P=0.498N |P=0.559N P=0.608N P=0.206 P=0.620 | |POLY 3 | P=0.399 P=0.309N P=0.187N P=0.564N |P=0.516N P=0.545N P=0.101 P=0.638 | |POLY 1.5 | P=0.323 P=0.270N P=0.166N P=0.580 |P=0.531N P=0.532N P=0.086 P=0.633 | |POLY 6 | P=0.515 P=0.405N P=0.245N P=0.539N |P=0.507N P=0.563N P=0.124 P=0.639 | |LOGISTIC REGRESSION| P=0.512 P=0.360N P=0.262N P=0.481N |P=0.549N P=0.612N P=0.110 P=0.617 | |COCH-ARM / FISHERS | P=0.237 P=0.232N P=0.154N P=0.500 |P=0.554N P=0.500N P=0.068 P=0.631 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.8% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 379 --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.296N P=0.253N P=0.275N P=0.230N |(e) (e) (e) (e) | |POLY 3 | P=0.272N P=0.263N P=0.263N P=0.229N |(e) (e) (e) (e) | |POLY 1.5 | P=0.287N P=0.252N P=0.251N P=0.232N |(e) (e) (e) (e) | |POLY 6 | P=0.249N P=0.282N P=0.282N P=0.229N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.414N P=0.149N P=0.184N P=0.445N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.308N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 2/49 (4%) 1/50 (2%) |3/50 (6%) 3/49 (6%) 6/47 (13%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 11.4% 6.4% 6.4% 2.8% |7.5% 8.4% 14.2% 0.0% | |TERMINAL (d) | 1/7 (14%) 1/5 (20%) 0/6 (0%) 0/8 (0%) |3/23 (13%) 3/18 (17%) 4/31 (13%) 0/22 (0%) | |FIRST INCIDENCE | 467 583 628 700 |733 (T) 733 (T) 620 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.156N P=0.416N P=0.428N P=0.167N |P=0.072N P=0.547 P=0.388 P=0.127N | |POLY 3 | P=0.170N P=0.386N P=0.390N P=0.167N |P=0.080N P=0.611 P=0.269 P=0.129N | |POLY 1.5 | P=0.185N P=0.364N P=0.370N P=0.171N |P=0.082N P=0.624 P=0.245 P=0.129N | |POLY 6 | P=0.154N P=0.423N P=0.420N P=0.166N |P=0.082N P=0.593 P=0.299 P=0.132N | |LOGISTIC REGRESSION| P=0.191N P=0.344N P=0.346N P=0.187N |P=0.084N P=0.547 P=0.281 (e) | |COCH-ARM / FISHERS | P=0.207N P=0.339N P=0.349N P=0.181N |P=0.086N P=0.651 P=0.213 P=0.129N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/49 (4%) 3/50 (6%) |1/50 (2%) 0/49 (0%) 5/47 (11%) 1/48 (2%) | |POLY-3 ADJUSTED (b)| 2.9% 9.4% 6.3% 8.2% |2.5% 0.0% 12.0% 2.7% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |0/23 (0%) 0/18 (0%) 4/31 (13%) 1/22 (5%) | |FIRST INCIDENCE | 560 526 520 540 |664 --- 720 733 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.455 P=0.225 P=0.471 P=0.339 |P=0.633N P=0.525N P=0.177 P=0.752 | |POLY 3 | P=0.431 P=0.278 P=0.474 P=0.331 |P=0.622N P=0.523N P=0.109 P=0.746 | |POLY 1.5 | P=0.411 P=0.290 P=0.483 P=0.321 |P=0.627N P=0.517N P=0.100 P=0.747 | |POLY 6 | P=0.455 P=0.260 P=0.461 P=0.340 |P=0.625N P=0.532N P=0.119 P=0.740 | |LOGISTIC REGRESSION| P=0.352 P=0.303 P=0.538 P=0.279 |P=0.640 P=0.510N P=0.125 P=0.748 | |COCH-ARM / FISHERS | P=0.381 P=0.309 P=0.492 P=0.309 |P=0.636N P=0.505N P=0.088 P=0.742 | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 4/49 (8%) 4/50 (8%) |4/50 (8%) 3/49 (6%) 11/47 (23%) 1/48 (2%) | |POLY-3 ADJUSTED (b)| 14.1% 15.5% 12.4% 10.9% |10.0% 8.4% 26.1% 2.7% | |TERMINAL (d) | 1/7 (14%) 1/5 (20%) 0/6 (0%) 0/8 (0%) |3/23 (13%) 3/18 (17%) 8/31 (26%) 1/22 (5%) | |FIRST INCIDENCE | 467 526 520 540 |664 733 (T) 620 733 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.335N P=0.502 P=0.590N P=0.457N |P=0.113N P=0.625N P=0.130 P=0.192N | |POLY 3 | P=0.383N P=0.572 P=0.562N P=0.477N |P=0.115N P=0.564N P=0.051 P=0.199N | |POLY 1.5 | P=0.407N P=0.597 P=0.540N P=0.484N |P=0.118N P=0.547N P=0.043 * P=0.197N | |POLY 6 | P=0.359N P=0.531 P=0.593N P=0.476N |P=0.118N P=0.588N P=0.063 P=0.206N | |LOGISTIC REGRESSION| P=0.444N P=0.624 P=0.483N P=0.529N |P=0.132N P=0.607N P=0.062 P=0.210N | |COCH-ARM / FISHERS | P=0.444N P=0.630N P=0.513N P=0.500N |P=0.132N P=0.511N P=0.034 * P=0.194N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/49 (0%) 1/50 (2%) 4/50 (8%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 11.8% 0.0% 3.2% 10.8% |2.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/7 (14%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 666 --- 714 618 |726 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.306 P=0.123N P=0.246N P=0.608N |P=0.549N P=0.547N P=0.436N P=0.508N | |POLY 3 | P=0.276 P=0.071N P=0.203N P=0.599N |P=0.548N P=0.517N P=0.484N P=0.505N | |POLY 1.5 | P=0.249 P=0.067N P=0.191N P=0.617N |P=0.548N P=0.512N P=0.492N P=0.505N | |POLY 6 | P=0.324 P=0.079N P=0.225N P=0.580N |P=0.549N P=0.523N P=0.476N P=0.507N | |LOGISTIC REGRESSION| P=0.293 P=0.092N P=0.238N P=0.600N |P=0.554N P=0.533N P=0.465N P=0.515N | |COCH-ARM / FISHERS | P=0.218 P=0.061N P=0.181N P=0.643N |P=0.550N P=0.500N P=0.505N P=0.505N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/49 (4%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 11.6% 6.4% 3.2% 10.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/7 (14%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 477 664 620 534 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.490 P=0.473N P=0.257N P=0.610N |(e) (e) (e) (e) | |POLY 3 | P=0.451 P=0.383N P=0.206N P=0.609N |(e) (e) (e) (e) | |POLY 1.5 | P=0.422 P=0.367N P=0.193N P=0.622N |(e) (e) (e) (e) | |POLY 6 | P=0.491 P=0.413N P=0.227N P=0.598N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.433 P=0.378N P=0.191N P=0.632N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.385 P=0.349N P=0.181N P=0.643N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 2/49 (4%) 2/50 (4%) 8/50 (16%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 22.8% 6.4% 6.4% 21.0% |2.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/7 (29%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 477 664 620 534 |726 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.287 P=0.131N P=0.101N P=0.556N |P=0.549N P=0.547N P=0.436N P=0.508N | |POLY 3 | P=0.238 P=0.060N P=0.058N P=0.540N |P=0.548N P=0.517N P=0.484N P=0.505N | |POLY 1.5 | P=0.201 P=0.055N P=0.052N P=0.568N |P=0.548N P=0.512N P=0.492N P=0.505N | |POLY 6 | P=0.306 P=0.071N P=0.071N P=0.506N |P=0.549N P=0.523N P=0.476N P=0.507N | |LOGISTIC REGRESSION| P=0.237 P=0.070N P=0.068N P=0.557N |P=0.554N P=0.533N P=0.465N P=0.515N | |COCH-ARM / FISHERS | P=0.163 P=0.049N* P=0.046N* P=0.607N |P=0.550N P=0.500N P=0.505N P=0.505N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 6.0% 3.2% 0.0% 5.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 1/8 (13%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 719 684 --- 610 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.563 P=0.682N P=0.353N P=0.691N |(e) (e) (e) (e) | |POLY 3 | P=0.525 P=0.527N P=0.255N P=0.669N |(e) (e) (e) (e) | |POLY 1.5 | P=0.505 P=0.516N P=0.246N P=0.678N |(e) (e) (e) (e) | |POLY 6 | P=0.552 P=0.547N P=0.268N P=0.660N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.550 P=0.606N P=0.280N P=0.668N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.479 P=0.500N P=0.247N P=0.691N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 6.4% 0.0% |2.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 1/6 (17%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- 701 --- |552 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.603N (e) P=0.214 (e) |P=0.543N P=0.519N P=0.482N P=0.500N | |POLY 3 | P=0.621N (e) P=0.219 (e) |P=0.546N P=0.519N P=0.487N P=0.507N | |POLY 1.5 | P=0.633N (e) P=0.227 (e) |P=0.546N P=0.513N P=0.494N P=0.507N | |POLY 6 | P=0.608N (e) P=0.206 (e) |P=0.545N P=0.528N P=0.480N P=0.511N | |LOGISTIC REGRESSION| P=0.602N (e) P=0.186 (e) |P=0.540N P=0.448N P=0.605N P=0.468N | |COCH-ARM / FISHERS | P=0.652N (e) P=0.247 (e) |P=0.550N P=0.500N P=0.505N P=0.505N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 6.0% 3.2% 6.4% 5.5% |2.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 1/6 (17%) 1/8 (13%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 719 684 701 610 |552 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.632 P=0.682N P=0.578 P=0.691N |P=0.543N P=0.519N P=0.482N P=0.500N | |POLY 3 | P=0.602 P=0.527N P=0.668 P=0.669N |P=0.546N P=0.519N P=0.487N P=0.507N | |POLY 1.5 | P=0.577 P=0.516N P=0.680 P=0.678N |P=0.546N P=0.513N P=0.494N P=0.507N | |POLY 6 | P=0.632 P=0.547N P=0.648 P=0.660N |P=0.545N P=0.528N P=0.480N P=0.511N | |LOGISTIC REGRESSION| P=0.626 P=0.606N P=0.622 P=0.668N |P=0.540N P=0.448N P=0.605N P=0.468N | |COCH-ARM / FISHERS | P=0.542 P=0.500N P=0.691N P=0.691N |P=0.550N P=0.500N P=0.505N P=0.505N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.9% 6.3% 6.3% 0.0% |5.0% 2.7% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |2/23 (9%) 1/19 (5%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 580 579 607 --- |733 (T) 733 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.126N P=0.604 P=0.592 P=0.234N |P=0.205N P=0.567N P=0.162N P=0.247N | |POLY 3 | P=0.134N P=0.669 P=0.669 P=0.225N |P=0.215N P=0.529N P=0.215N P=0.240N | |POLY 1.5 | P=0.143N P=0.679 P=0.680 P=0.229N |P=0.213N P=0.521N P=0.224N P=0.240N | |POLY 6 | P=0.125N P=0.653 P=0.652 P=0.222N |P=0.218N P=0.541N P=0.206N P=0.243N | |LOGISTIC REGRESSION| P=0.144N P=0.679 P=0.674 P=0.230N |P=0.205N P=0.567N (e) (e) | |COCH-ARM / FISHERS | P=0.157N P=0.691N P=0.691N P=0.247N |P=0.212N P=0.500N P=0.247N P=0.247N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 6.4% 3.2% 2.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 1/5 (20%) 0/6 (0%) 1/8 (13%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 692 706 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.657N P=0.169 P=0.464 P=0.527 |(e) (e) (e) (e) | |POLY 3 | P=0.681 P=0.219 P=0.485 P=0.513 |(e) (e) (e) (e) | |POLY 1.5 | P=0.670 P=0.227 P=0.492 P=0.508 |(e) (e) (e) (e) | |POLY 6 | P=0.683N P=0.206 P=0.474 P=0.518 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.645N P=0.162 P=0.458 P=0.527 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.654 P=0.247 P=0.500 P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.9% 12.6% 9.5% 2.8% |5.0% 2.7% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 1/5 (20%) 0/6 (0%) 1/8 (13%) |2/23 (9%) 1/19 (5%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 580 579 607 733 (T) |733 (T) 733 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.175N P=0.226 P=0.387 P=0.479N |P=0.205N P=0.567N P=0.162N P=0.247N | |POLY 3 | P=0.196N P=0.301 P=0.466 P=0.482N |P=0.215N P=0.529N P=0.215N P=0.240N | |POLY 1.5 | P=0.209N P=0.316 P=0.482 P=0.488N |P=0.213N P=0.521N P=0.224N P=0.240N | |POLY 6 | P=0.184N P=0.277 P=0.444 P=0.481N |P=0.218N P=0.541N P=0.206N P=0.243N | |LOGISTIC REGRESSION| P=0.179N P=0.284 P=0.457 P=0.472N |P=0.205N P=0.567N (e) (e) | |COCH-ARM / FISHERS | P=0.230N P=0.339 P=0.500 P=0.500N |P=0.212N P=0.500N P=0.247N P=0.247N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 4/50 (8%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 3.0% 3.2% 0.0% 0.0% |4.9% 5.5% 9.1% 10.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |1/23 (4%) 2/19 (11%) 3/33 (9%) 2/22 (9%) | |FIRST INCIDENCE | 681 614 --- --- |488 733 (T) 701 597 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.322N P=0.703 P=0.576N P=0.500N |P=0.258 P=0.636 P=0.470 P=0.332 | |POLY 3 | P=0.331N P=0.746 P=0.517N P=0.488N |P=0.284 P=0.658 P=0.377 P=0.331 | |POLY 1.5 | P=0.339N P=0.752 P=0.509N P=0.492N |P=0.280 P=0.669 P=0.361 P=0.331 | |POLY 6 | P=0.321N P=0.735 P=0.531N P=0.485N |P=0.285 P=0.643 P=0.395 P=0.327 | |LOGISTIC REGRESSION| P=0.333N P=0.749 P=0.531N P=0.484N |P=0.272 P=0.681 P=0.345 P=0.340 | |COCH-ARM / FISHERS | P=0.348N P=0.753N P=0.500N P=0.500N |P=0.272 P=0.691N P=0.339 P=0.339 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 3/50 (6%) 5/50 (10%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 3.0% 3.2% 0.0% 0.0% |7.4% 8.2% 11.3% 10.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |2/23 (9%) 3/19 (16%) 4/33 (12%) 2/22 (9%) | |FIRST INCIDENCE | 681 614 --- --- |488 733 (T) 701 597 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.322N P=0.703 P=0.576N P=0.500N |P=0.449 P=0.583 P=0.527 P=0.488 | |POLY 3 | P=0.331N P=0.746 P=0.517N P=0.488N |P=0.478 P=0.616 P=0.403 P=0.494 | |POLY 1.5 | P=0.339N P=0.752 P=0.509N P=0.492N |P=0.472 P=0.630 P=0.385 P=0.494 | |POLY 6 | P=0.321N P=0.735 P=0.531N P=0.485N |P=0.480 P=0.597 P=0.426 P=0.490 | |LOGISTIC REGRESSION| P=0.333N P=0.749 P=0.531N P=0.484N |P=0.464 P=0.627 P=0.393 P=0.499 | |COCH-ARM / FISHERS | P=0.348N P=0.753N P=0.500N P=0.500N |P=0.462 P=0.661N P=0.357 P=0.500 | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |22/50 (44%) 19/50 (38%) 30/50 (60%) 27/50 (54%) | |POLY-3 ADJUSTED (b)| 3.0% 0.0% 3.2% 2.8% |52.9% 46.6% 65.6% 62.9% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 1/6 (17%) 0/8 (0%) |14/23 (61%) 8/19 (42%) 23/33 (70%) 16/22 (73%) | |FIRST INCIDENCE | 719 --- 733 (T) 664 |581 440 560 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.626 P=0.638N P=0.686 P=0.754N |P=0.118 P=0.542 P=0.563 P=0.170 | |POLY 3 | P=0.607 P=0.516N P=0.744 P=0.746N |P=0.144 P=0.357N P=0.152 P=0.230 | |POLY 1.5 | P=0.589 P=0.509N P=0.752 P=0.751N |P=0.136 P=0.367N P=0.117 P=0.214 | |POLY 6 | P=0.630 P=0.529N P=0.731 P=0.741N |P=0.138 P=0.353N P=0.199 P=0.230 | |LOGISTIC REGRESSION| P=0.616 P=0.576N P=0.723 P=0.745N |P=0.129 P=0.456N P=0.211 P=0.179 | |COCH-ARM / FISHERS | P=0.563 P=0.500N P=0.753N P=0.753N |P=0.131 P=0.342N P=0.080 P=0.212 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |22/50 (44%) 20/50 (40%) 31/50 (62%) 27/50 (54%) | |POLY-3 ADJUSTED (b)| 3.0% 0.0% 3.2% 2.8% |52.9% 49.1% 67.8% 62.9% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 1/6 (17%) 0/8 (0%) |14/23 (61%) 9/19 (47%) 24/33 (73%) 16/22 (73%) | |FIRST INCIDENCE | 719 --- 733 (T) 664 |581 440 560 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.626 P=0.638N P=0.686 P=0.754N |P=0.140 P=0.462 P=0.500 P=0.170 | |POLY 3 | P=0.607 P=0.516N P=0.744 P=0.746N |P=0.178 P=0.446N P=0.104 P=0.230 | |POLY 1.5 | P=0.589 P=0.509N P=0.752 P=0.751N |P=0.168 P=0.453N P=0.079 P=0.214 | |POLY 6 | P=0.630 P=0.529N P=0.731 P=0.741N |P=0.172 P=0.446N P=0.140 P=0.230 | |LOGISTIC REGRESSION| P=0.616 P=0.576N P=0.723 P=0.745N |P=0.158 P=0.547N P=0.156 P=0.179 | |COCH-ARM / FISHERS | P=0.563 P=0.500N P=0.753N P=0.753N |P=0.159 P=0.420N P=0.054 P=0.212 | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |23/50 (46%) 21/50 (42%) 32/50 (64%) 30/50 (60%) | |POLY-3 ADJUSTED (b)| 5.9% 3.2% 3.2% 2.8% |54.4% 51.5% 69.8% 68.5% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 1/6 (17%) 0/8 (0%) |14/23 (61%) 10/19 (53%) 24/33 (73%) 17/22 (77%) | |FIRST INCIDENCE | 681 614 733 (T) 664 |488 440 560 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.442N P=0.636N P=0.619N P=0.493N |P=0.068 P=0.453 P=0.508 P=0.102 | |POLY 3 | P=0.478N P=0.526N P=0.531N P=0.477N |P=0.081 P=0.481N P=0.092 P=0.117 | |POLY 1.5 | P=0.496N P=0.515N P=0.516N P=0.485N |P=0.072 P=0.474N P=0.072 P=0.108 | |POLY 6 | P=0.455N P=0.546N P=0.556N P=0.470N |P=0.085 P=0.497N P=0.120 P=0.121 | |LOGISTIC REGRESSION| P=0.456N P=0.548N P=0.576N P=0.470N |P=0.067 P=0.541N P=0.143 P=0.094 | |COCH-ARM / FISHERS | P=0.521N P=0.500N P=0.500N P=0.500N |P=0.070 P=0.420N P=0.054 P=0.115 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 5.9% 3.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/7 (14%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 691 684 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.182N P=0.608N P=0.273N P=0.232N |(e) (e) (e) (e) | |POLY 3 | P=0.190N P=0.528N P=0.255N P=0.222N |(e) (e) (e) (e) | |POLY 1.5 | P=0.200N P=0.516N P=0.246N P=0.228N |(e) (e) (e) (e) | |POLY 6 | P=0.177N P=0.548N P=0.269N P=0.218N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.182N P=0.596N P=0.282N P=0.222N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.212N P=0.500N P=0.247N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 43/50 (86%) 40/49 (82%) 40/50 (80%) 41/49 (84%) |39/50 (78%) 33/49 (67%) 37/50 (74%) 36/49 (73%) | |POLY-3 ADJUSTED (b)| 93.0% 89.2% 87.1% 86.9% |87.8% 77.1% 76.5% 83.7% | |TERMINAL (d) | 6/7 (86%) 3/5 (60%) 5/6 (83%) 6/8 (75%) |21/23 (91%) 13/18 (72%) 25/33 (76%) 21/22 (96%) | |FIRST INCIDENCE | 476 460 453 490 |496 455 399 469 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.155N P=0.289 P=0.355 P=0.297N |P=0.543N P=0.509 P=0.030N* P=0.484N | |POLY 3 | P=0.280N P=0.377N P=0.240N P=0.233N |P=0.492 P=0.126N P=0.111N P=0.391N | |POLY 1.5 | P=0.385N P=0.386N P=0.260N P=0.321N |P=0.525 P=0.160N P=0.200N P=0.399N | |POLY 6 | P=0.210N P=0.378N P=0.244N P=0.179N |P=0.401 P=0.104N P=0.060N P=0.462N | |LOGISTIC REGRESSION| P=0.442N P=0.467N P=0.374N P=0.404N |P=0.495N P=0.308N P=0.201N P=0.299N | |COCH-ARM / FISHERS | P=0.566 P=0.376N P=0.298N P=0.483N |P=0.555 P=0.168N P=0.408N P=0.385N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- --- 688 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.074 (e) (e) P=0.266 |(e) (e) (e) (e) | |POLY 3 | P=0.048 * (e) (e) P=0.253 |(e) (e) (e) (e) | |POLY 1.5 | P=0.045 * (e) (e) P=0.247 |(e) (e) (e) (e) | |POLY 6 | P=0.052 (e) (e) P=0.260 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.061 (e) (e) P=0.255 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 6.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 1/5 (20%) 0/6 (0%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 607 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.341N P=0.193 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.382N P=0.221 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.386N P=0.228 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.380N P=0.210 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.362N P=0.207 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.390N P=0.247 (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous | | Tumor (benign, malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 6.4% 0.0% 5.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 1/5 (20%) 0/6 (0%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 607 --- 688 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.385 P=0.193 (e) P=0.266 |(e) (e) (e) (e) | |POLY 3 | P=0.314 P=0.221 (e) P=0.253 |(e) (e) (e) (e) | |POLY 1.5 | P=0.303 P=0.228 (e) P=0.247 |(e) (e) (e) (e) | |POLY 6 | P=0.326 P=0.210 (e) P=0.260 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.347 P=0.207 (e) P=0.255 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.290 P=0.247 (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 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%) 7/50 (14%) 3/50 (6%) 7/50 (14%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.8% 21.5% 9.5% 19.2% |2.5% 0.0% 4.5% 0.0% | |TERMINAL (d) | 1/7 (14%) 2/5 (40%) 1/6 (17%) 3/8 (38%) |1/23 (4%) 0/19 (0%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 621 552 574 688 |733 (T) --- 651 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.402 P=0.092 P=0.560 P=0.187 |P=0.437N P=0.538N P=0.601 P=0.509N | |POLY 3 | P=0.275 P=0.128 P=0.631 P=0.176 |P=0.423N P=0.517N P=0.537 P=0.503N | |POLY 1.5 | P=0.257 P=0.140 P=0.646 P=0.170 |P=0.427N P=0.512N P=0.522 P=0.502N | |POLY 6 | P=0.292 P=0.111 P=0.608 P=0.177 |P=0.423N P=0.523N P=0.554 P=0.506N | |LOGISTIC REGRESSION| P=0.350 P=0.109 P=0.614 P=0.180 |P=0.436N (e) P=0.534 (e) | |COCH-ARM / FISHERS | P=0.230 P=0.159 P=0.661N P=0.159 |P=0.437N P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 3.0% 0.0% 6.4% 0.0% |2.5% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |1/23 (4%) 0/19 (0%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 648 --- 678 --- |733 (T) --- 733 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.404N P=0.535N P=0.421 P=0.464N |P=0.483N P=0.538N P=0.679N P=0.509N | |POLY 3 | P=0.396N P=0.518N P=0.472 P=0.488N |P=0.469N P=0.517N P=0.738N P=0.503N | |POLY 1.5 | P=0.412N P=0.510N P=0.485 P=0.493N |P=0.472N P=0.512N P=0.747N P=0.502N | |POLY 6 | P=0.377N P=0.532N P=0.452 P=0.487N |P=0.469N P=0.523N P=0.728N P=0.506N | |LOGISTIC REGRESSION| P=0.393N P=0.514N P=0.449 P=0.495N |P=0.483N (e) P=0.679N (e) | |COCH-ARM / FISHERS | P=0.437N P=0.500N P=0.500 P=0.500N |P=0.478N P=0.500N P=0.753N P=0.500N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |3/50 (6%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.9% 0.0% 6.4% 0.0% |7.4% 8.0% 2.3% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |2/23 (9%) 1/19 (5%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 639 --- 678 --- |488 548 733 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.257N P=0.277N P=0.601 P=0.205N |P=0.074N P=0.594 P=0.212N P=0.128N | |POLY 3 | P=0.248N P=0.258N P=0.664 P=0.225N |P=0.079N P=0.625 P=0.276N P=0.123N | |POLY 1.5 | P=0.265N P=0.249N P=0.678 P=0.229N |P=0.078N P=0.635 P=0.288N P=0.122N | |POLY 6 | P=0.228N P=0.277N P=0.640 P=0.224N |P=0.082N P=0.612 P=0.263N P=0.127N | |LOGISTIC REGRESSION| P=0.257N P=0.249N P=0.653 P=0.233N |P=0.076N P=0.658 P=0.315N P=0.119N | |COCH-ARM / FISHERS | P=0.290N P=0.247N P=0.691N P=0.247N |P=0.076N P=0.661N P=0.309N P=0.121N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 3.0% 0.0% 0.0% 0.0% |4.9% 8.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |1/23 (4%) 1/19 (5%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 639 --- --- --- |488 548 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.504N P=0.532N P=0.560N P=0.472N |P=0.110N P=0.440 P=0.196N P=0.245N | |POLY 3 | P=0.524N P=0.518N P=0.518N P=0.489N |P=0.117N P=0.462 P=0.219N P=0.244N | |POLY 1.5 | P=0.535N P=0.510N P=0.509N P=0.493N |P=0.114N P=0.473 P=0.226N P=0.242N | |POLY 6 | P=0.505N P=0.532N P=0.532N P=0.487N |P=0.122N P=0.449 P=0.211N P=0.249N | |LOGISTIC REGRESSION| P=0.538N P=0.509N P=0.509N P=0.500N |P=0.111N P=0.509 P=0.293N P=0.221N | |COCH-ARM / FISHERS | P=0.547N P=0.500N P=0.500N P=0.500N |P=0.110N P=0.500 P=0.247N P=0.247N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/50 (8%) 2/50 (4%) 4/50 (8%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.8% 12.5% 6.4% 11.1% |2.5% 0.0% 2.3% 0.0% | |TERMINAL (d) | 1/7 (14%) 1/5 (20%) 1/6 (17%) 2/8 (25%) |1/23 (4%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 621 552 574 700 |733 (T) --- 651 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.598 P=0.390 P=0.593N P=0.522 |P=0.477N P=0.538N P=0.702N P=0.509N | |POLY 3 | P=0.523 P=0.463 P=0.538N P=0.530 |P=0.470N P=0.517N P=0.737N P=0.503N | |POLY 1.5 | P=0.502 P=0.478 P=0.520N P=0.520 |P=0.472N P=0.512N P=0.746N P=0.502N | |POLY 6 | P=0.544 P=0.436 P=0.569N P=0.536 |P=0.470N P=0.523N P=0.725N P=0.506N | |LOGISTIC REGRESSION| P=0.573 P=0.438 P=0.552N P=0.544 |P=0.477N (e) P=0.756N (e) | |COCH-ARM / FISHERS | P=0.469 P=0.500 P=0.500N P=0.500 |P=0.478N P=0.500N P=0.753N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 3.0% 0.0% 0.0% 0.0% |2.5% 5.4% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |1/23 (4%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 639 --- --- --- |733 (T) 548 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.504N P=0.532N P=0.560N P=0.472N |P=0.243N P=0.453 P=0.428N P=0.509N | |POLY 3 | P=0.524N P=0.518N P=0.518N P=0.489N |P=0.252N P=0.477 P=0.480N P=0.503N | |POLY 1.5 | P=0.535N P=0.510N P=0.509N P=0.493N |P=0.248N P=0.483 P=0.488N P=0.502N | |POLY 6 | P=0.505N P=0.532N P=0.532N P=0.487N |P=0.259N P=0.470 P=0.471N P=0.506N | |LOGISTIC REGRESSION| P=0.538N P=0.509N P=0.509N P=0.500N |P=0.240N P=0.491 (e) (e) | |COCH-ARM / FISHERS | P=0.547N P=0.500N P=0.500N P=0.500N |P=0.240N P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 3.2% 6.4% 2.8% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 1/6 (17%) 1/8 (13%) |0/23 (0%) 0/19 (0%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | --- 684 654 733 (T) |--- --- 733 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.645 P=0.459 P=0.197 P=0.527 |P=0.786N (e) P=0.572 (e) | |POLY 3 | P=0.601 P=0.485 P=0.220 P=0.513 |P=0.768N (e) P=0.520 (e) | |POLY 1.5 | P=0.587 P=0.491 P=0.228 P=0.508 |P=0.769N (e) P=0.512 (e) | |POLY 6 | P=0.615 P=0.475 P=0.208 P=0.518 |P=0.769N (e) P=0.529 (e) | |LOGISTIC REGRESSION| P=0.624 P=0.463 P=0.195 P=0.527 |(e) (e) P=0.572 (e) | |COCH-ARM / FISHERS | P=0.563 P=0.500 P=0.247 P=0.500 |P=0.772N (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 3/50 (6%) 5/50 (10%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.8% 15.6% 9.5% 13.9% |2.5% 0.0% 4.5% 0.0% | |TERMINAL (d) | 1/7 (14%) 1/5 (20%) 1/6 (17%) 3/8 (38%) |1/23 (4%) 0/19 (0%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 621 552 574 700 |733 (T) --- 651 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.543 P=0.254 P=0.560 P=0.383 |P=0.437N P=0.538N P=0.601 P=0.509N | |POLY 3 | P=0.442 P=0.318 P=0.631 P=0.384 |P=0.423N P=0.517N P=0.537 P=0.503N | |POLY 1.5 | P=0.422 P=0.334 P=0.646 P=0.375 |P=0.427N P=0.512N P=0.522 P=0.502N | |POLY 6 | P=0.459 P=0.293 P=0.608 P=0.385 |P=0.423N P=0.523N P=0.554 P=0.506N | |LOGISTIC REGRESSION| P=0.509 P=0.289 P=0.614 P=0.392 |P=0.436N (e) P=0.534 (e) | |COCH-ARM / FISHERS | P=0.387 P=0.357 P=0.661N P=0.357 |P=0.437N P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 3/50 (6%) 5/50 (10%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.8% 15.6% 9.5% 13.9% |2.5% 0.0% 4.5% 0.0% | |TERMINAL (d) | 1/7 (14%) 1/5 (20%) 1/6 (17%) 3/8 (38%) |1/23 (4%) 0/19 (0%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 621 552 574 700 |733 (T) --- 651 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.543 P=0.254 P=0.560 P=0.383 |P=0.437N P=0.538N P=0.601 P=0.509N | |POLY 3 | P=0.442 P=0.318 P=0.631 P=0.384 |P=0.423N P=0.517N P=0.537 P=0.503N | |POLY 1.5 | P=0.422 P=0.334 P=0.646 P=0.375 |P=0.427N P=0.512N P=0.522 P=0.502N | |POLY 6 | P=0.459 P=0.293 P=0.608 P=0.385 |P=0.423N P=0.523N P=0.554 P=0.506N | |LOGISTIC REGRESSION| P=0.509 P=0.289 P=0.614 P=0.392 |P=0.436N (e) P=0.534 (e) | |COCH-ARM / FISHERS | P=0.387 P=0.357 P=0.661N P=0.357 |P=0.437N P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin: Sebaceous Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 6.4% 3.2% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 664 700 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.311N P=0.202 P=0.500 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.347N P=0.221 P=0.485 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.355N P=0.228 P=0.492 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.340N P=0.211 P=0.474 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.325N P=0.204 P=0.460 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.366N P=0.247 P=0.500 (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 23/50 (46%) 28/50 (56%) 29/50 (58%) 25/50 (50%) | | |POLY-3 ADJUSTED (b)| 59.1% 70.4% 74.2% 61.1% | | |TERMINAL (d) | 5/7 (71%) 3/5 (60%) 6/6 (100%) 6/8 (75%) | | |FIRST INCIDENCE | 379 460 496 583 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.183N P=0.065 P=0.066 P=0.553N | | |POLY 3 | P=0.343N P=0.180 P=0.087 P=0.522 | | |POLY 1.5 | P=0.400N P=0.181 P=0.116 P=0.476 | | |POLY 6 | P=0.288N P=0.208 P=0.057 P=0.584 | | |LOGISTIC REGRESSION| P=0.214N P=0.117 P=0.061 P=0.585N | | |COCH-ARM / FISHERS | P=0.489N P=0.212 P=0.158 P=0.421 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/48 (10%) 4/48 (8%) 5/48 (10%) 7/50 (14%) |7/50 (14%) 6/50 (12%) 3/49 (6%) 5/49 (10%) | |POLY-3 ADJUSTED (b)| 14.8% 12.8% 16.5% 18.3% |17.6% 16.4% 6.8% 12.7% | |TERMINAL (d) | 2/7 (29%) 0/5 (0%) 1/6 (17%) 0/8 (0%) |7/23 (30%) 6/19 (32%) 1/33 (3%) 3/22 (14%) | |FIRST INCIDENCE | 540 583 678 534 |733 (T) 733 (T) 552 663 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.395 P=0.630 P=0.518 P=0.441 |P=0.422N P=0.600 P=0.062N P=0.410N | |POLY 3 | P=0.360 P=0.549N P=0.563 P=0.468 |P=0.416N P=0.565N P=0.117N P=0.384N | |POLY 1.5 | P=0.319 P=0.529N P=0.594 P=0.443 |P=0.419N P=0.546N P=0.136N P=0.392N | |POLY 6 | P=0.419 P=0.578N P=0.518 P=0.502 |P=0.420N P=0.593N P=0.097N P=0.381N | |LOGISTIC REGRESSION| P=0.346 P=0.568N P=0.500 P=0.421 |P=0.413N P=0.600 P=0.131N P=0.420N | |COCH-ARM / FISHERS | P=0.266 P=0.500N P=0.630N P=0.409 |P=0.425N P=0.500N P=0.167N P=0.394N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 2/48 (4%) 1/50 (2%) |2/50 (4%) 3/50 (6%) 6/49 (12%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 6.6% 2.8% |5.0% 8.0% 13.7% 5.1% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 1/6 (17%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 4/33 (12%) 1/22 (5%) | |FIRST INCIDENCE | --- --- 520 607 |720 603 534 729 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.482 (e) P=0.218 P=0.533 |P=0.452N P=0.422 P=0.247 P=0.673 | |POLY 3 | P=0.472 (e) P=0.219 P=0.520 |P=0.444N P=0.473 P=0.164 P=0.686 | |POLY 1.5 | P=0.456 (e) P=0.227 P=0.516 |P=0.447N P=0.479 P=0.148 P=0.685 | |POLY 6 | P=0.491 (e) P=0.207 P=0.525 |P=0.452N P=0.467 P=0.183 P=0.682 | |LOGISTIC REGRESSION| P=0.422 (e) P=0.234 P=0.484 |P=0.445N P=0.480 P=0.151 P=0.670 | |COCH-ARM / FISHERS | P=0.431 (e) P=0.247 P=0.510 |P=0.453N P=0.500 P=0.128 P=0.684 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/48 (10%) 4/48 (8%) 7/48 (15%) 8/50 (16%) |9/50 (18%) 9/50 (18%) 9/49 (18%) 7/49 (14%) | |POLY-3 ADJUSTED (b)| 14.8% 12.8% 22.7% 20.7% |22.5% 23.9% 20.1% 17.7% | |TERMINAL (d) | 2/7 (29%) 0/5 (0%) 2/6 (33%) 0/8 (0%) |7/23 (30%) 6/19 (32%) 5/33 (15%) 4/22 (18%) | |FIRST INCIDENCE | 540 583 520 534 |720 603 534 663 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.325 P=0.630 P=0.277 P=0.345 |P=0.339N P=0.428 P=0.336N P=0.434N | |POLY 3 | P=0.290 P=0.549N P=0.310 P=0.365 |P=0.326N P=0.550 P=0.495N P=0.400N | |POLY 1.5 | P=0.248 P=0.529N P=0.341 P=0.338 |P=0.332N P=0.561 P=0.547N P=0.408N | |POLY 6 | P=0.356 P=0.578N P=0.266 P=0.403 |P=0.332N P=0.538 P=0.433N P=0.398N | |LOGISTIC REGRESSION| P=0.261 P=0.568N P=0.256 P=0.309 |P=0.321N P=0.480 P=0.548N P=0.444N | |COCH-ARM / FISHERS | P=0.195 P=0.500N P=0.379 P=0.304 |P=0.341N P=0.602N P=0.584 P=0.410N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/48 (0%) 0/48 (0%) 5/50 (10%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 3.0% 0.0% 0.0% 13.5% |2.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |1/23 (4%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 661 --- --- 618 |733 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.010 * P=0.528N P=0.572N P=0.134 |P=0.553N P=0.538N P=0.428N P=0.509N | |POLY 3 | P=0.004 ** P=0.519N P=0.521N P=0.125 |P=0.549N P=0.517N P=0.484N P=0.505N | |POLY 1.5 | P=0.004 ** P=0.511N P=0.511N P=0.120 |P=0.548N P=0.512N P=0.492N P=0.505N | |POLY 6 | P=0.005 ** P=0.534N P=0.536N P=0.130 |P=0.550N P=0.523N P=0.475N P=0.507N | |LOGISTIC REGRESSION| P=0.006 ** P=0.521N P=0.523N P=0.124 |P=0.553N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.004 ** P=0.500N P=0.500N P=0.112 |P=0.550N P=0.500N P=0.505N P=0.505N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |8/50 (16%) 9/50 (18%) 8/50 (16%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| |18.9% 23.0% 18.0% 12.1% | |TERMINAL (d) | |1/23 (4%) 4/19 (21%) 7/33 (21%) 2/22 (9%) | |FIRST INCIDENCE | |529 420 626 407 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.178N P=0.381 P=0.396N P=0.297N | |POLY 3 | |P=0.169N P=0.429 P=0.567N P=0.287N | |POLY 1.5 | |P=0.169N P=0.451 P=0.581N P=0.283N | |POLY 6 | |P=0.181N P=0.396 P=0.557N P=0.307N | |LOGISTIC REGRESSION| |P=0.172N P=0.521 P=0.605 P=0.248N | |COCH-ARM / FISHERS | |P=0.172N P=0.500 P=0.607N P=0.277N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 22 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 6.3% 3.2% 0.0% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 607 714 --- |--- --- 680 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.322N P=0.216 P=0.455 (e) |P=0.793N (e) P=0.545 (e) | |POLY 3 | P=0.346N P=0.223 P=0.484 (e) |P=0.768N (e) P=0.521 (e) | |POLY 1.5 | P=0.354N P=0.229 P=0.492 (e) |P=0.769N (e) P=0.512 (e) | |POLY 6 | P=0.339N P=0.215 P=0.473 (e) |P=0.769N (e) P=0.530 (e) | |LOGISTIC REGRESSION| P=0.342N P=0.234 P=0.457 (e) |P=0.773N (e) P=0.499 (e) | |COCH-ARM / FISHERS | P=0.366N P=0.247 P=0.500 (e) |P=0.772N (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 3.0% 0.0% 6.3% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 1/6 (17%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 705 --- 496 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.416N P=0.623N P=0.468 P=0.573N |(e) (e) (e) (e) | |POLY 3 | P=0.395N P=0.517N P=0.478 P=0.487N |(e) (e) (e) (e) | |POLY 1.5 | P=0.412N P=0.509N P=0.489 P=0.492N |(e) (e) (e) (e) | |POLY 6 | P=0.375N P=0.530N P=0.462 P=0.484N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.417N P=0.557N P=0.480 P=0.487N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.437N P=0.500N P=0.500 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 23 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 21/50 (42%) 21/50 (42%) 20/50 (40%) 31/50 (62%) |18/50 (36%) 16/50 (32%) 22/50 (44%) 17/50 (34%) | |POLY-3 ADJUSTED (b)| 54.9% 55.5% 52.4% 71.1% |41.6% 39.9% 46.8% 37.3% | |TERMINAL (d) | 6/7 (86%) 4/5 (80%) 2/6 (33%) 7/8 (88%) |7/23 (30%) 7/19 (37%) 13/33 (39%) 3/22 (14%) | |FIRST INCIDENCE | 467 514 497 505 |421 420 534 407 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.188 P=0.255 P=0.380 P=0.137 |P=0.504N P=0.523 P=0.494N P=0.535N | |POLY 3 | P=0.028 * P=0.575 P=0.504N P=0.075 |P=0.349N P=0.525N P=0.386 P=0.421N | |POLY 1.5 | P=0.019 * P=0.569 P=0.506N P=0.053 |P=0.402N P=0.494N P=0.338 P=0.457N | |POLY 6 | P=0.047 * P=0.586 P=0.484N P=0.115 |P=0.313N P=0.568N P=0.443 P=0.398N | |LOGISTIC REGRESSION| P=0.030 * P=0.468 P=0.571 P=0.063 |P=0.489N P=0.466N P=0.284 P=0.482N | |COCH-ARM / FISHERS | P=0.011 * P=0.580N P=0.500N P=0.036 * |P=0.489N P=0.417N P=0.270 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 3.0% 0.0% 6.3% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 1/6 (17%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 705 --- 496 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.416N P=0.623N P=0.468 P=0.573N |(e) (e) (e) (e) | |POLY 3 | P=0.395N P=0.517N P=0.478 P=0.487N |(e) (e) (e) (e) | |POLY 1.5 | P=0.412N P=0.509N P=0.489 P=0.492N |(e) (e) (e) (e) | |POLY 6 | P=0.375N P=0.530N P=0.462 P=0.484N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.417N P=0.557N P=0.480 P=0.487N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.437N P=0.500N P=0.500 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 24 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.7% 6.3% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/5 (0%) 0/6 (0%) 0/8 (0%) |0/23 (0%) 0/19 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 544 547 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.082N P=0.570N P=0.160N P=0.110N |(e) (e) (e) (e) | |POLY 3 | P=0.081N P=0.540N P=0.138N P=0.110N |(e) (e) (e) (e) | |POLY 1.5 | P=0.087N P=0.522N P=0.128N P=0.113N |(e) (e) (e) (e) | |POLY 6 | P=0.073N P=0.570N P=0.155N P=0.110N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.099N P=0.495N P=0.120N P=0.128N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.098N P=0.500N P=0.121N P=0.121N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 48/50 (96%) 46/50 (92%) 49/50 (98%) 49/50 (98%) |42/50 (84%) 45/50 (90%) 48/50 (96%) 46/50 (92%) | |POLY-3 ADJUSTED (b)| 98.3% 98.3% 99.8% 98.4% |92.7% 94.8% 96.1% 95.7% | |TERMINAL (d) | 7/7 (100%) 5/5 (100%) 6/6 (100%) 8/8 (100%) |22/23 (96%) 17/19 (90%) 32/33 (97%) 21/22 (96%) | |FIRST INCIDENCE | 379 460 453 490 |496 420 399 407 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.192N P=0.230 P=0.191 P=0.403N |P=0.342 P=0.105 P=0.192N P=0.241 | |POLY 3 | P=0.793N P=0.898 P=0.659 P=0.821 |P=0.444 P=0.507 P=0.375 P=0.417 | |POLY 1.5 | P=0.536 P=0.666N P=0.510 P=0.671 |P=0.342 P=0.316 P=0.170 P=0.248 | |POLY 6 | P=0.701N P=0.998 P=0.993 P=0.864N |P=0.508 P=0.698N P=0.642 P=0.611 | |LOGISTIC REGRESSION| P=0.612 P=0.528N P=0.418 P=0.571 |P=0.262 P=0.086 P=0.145 P=0.135 | |COCH-ARM / FISHERS | P=0.249 P=0.339N P=0.500 P=0.500 |P=0.263 P=0.277 P=0.046 * P=0.178 | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 03 Page 25 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 31/50 (62%) 33/50 (66%) 28/50 (56%) 40/50 (80%) |30/50 (60%) 24/50 (48%) 30/50 (60%) 25/50 (50%) | |POLY-3 ADJUSTED (b)| 72.1% 78.4% 68.5% 87.1% |63.6% 56.1% 63.6% 54.3% | |TERMINAL (d) | 7/7 (100%) 5/5 (100%) 5/6 (83%) 7/8 (88%) |12/23 (52%) 9/19 (47%) 20/33 (61%) 9/22 (41%) | |FIRST INCIDENCE | 379 469 453 505 |390 216 534 407 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.413 P=0.147 P=0.443 P=0.263 |P=0.368N P=0.440N P=0.151N P=0.317N | |POLY 3 | P=0.030 * P=0.314 P=0.445N P=0.040 * |P=0.257N P=0.303N P=0.585 P=0.237N | |POLY 1.5 | P=0.025 * P=0.343 P=0.398N P=0.038 * |P=0.280N P=0.252N P=0.578 P=0.236N | |POLY 6 | P=0.042 * P=0.290 P=0.521N P=0.052 |P=0.254N P=0.361N P=0.573N P=0.251N | |LOGISTIC REGRESSION| P=0.050 P=0.339 P=0.385N P=0.062 |P=0.310N P=0.149N P=0.537 P=0.197N | |COCH-ARM / FISHERS | P=0.022 * P=0.418 P=0.342N P=0.038 * |P=0.310N P=0.158N P=0.581N P=0.211N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 48/50 (96%) 49/50 (98%) 50/50 (100%)|50/50 (100%) 48/50 (96%) 49/50 (98%) 48/50 (96%) | |POLY-3 ADJUSTED (b)| 100.0% 99.6% 99.8% 100.0% |100.0% 98.0% 98.0% 98.0% | |TERMINAL (d) | 7/7 (100%) 5/5 (100%) 6/6 (100%) 8/8 (100%) |23/23 (100%) 18/19 (95%) 32/33 (97%) 21/22 (96%) | |FIRST INCIDENCE | 379 460 453 490 |390 216 399 407 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.166N P=0.231 P=0.258 (e) |P=0.510N P=0.283 P=0.027N* P=0.544N | |POLY 3 | P=1.000 P=1.000N P=1.000N (e) |P=0.521N P=0.496N P=0.500N P=0.496N | |POLY 1.5 | P=0.816 P=0.830N P=0.976N (e) |P=0.521N P=0.495N P=0.500N P=0.496N | |POLY 6 | P=1.000 P=1.000N P=1.000N (e) |P=0.521N P=0.496N P=0.500N P=0.496N | |LOGISTIC REGRESSION| (e) P=0.431N (e) (e) |P=0.387N P=0.422N (e) P=0.365N | |COCH-ARM / FISHERS | P=0.366 P=0.247N P=0.500N (e) |P=0.342N P=0.247N P=0.500N P=0.247N | |=================================================================================================================================| (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).