TDMS Study 88070-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest ISOBUTENE DATE: 06/19/97 EXPERIMENT: 88070 TEST: 04 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: MILLER, R. CAS: 115-11-0007 Mice(B6C3F1) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- 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: 04 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: MILLER, R. CAS: 115-11-0007 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF ISOBUTENE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Lung Alveolar/Bronchiolar Adenoma All Organs Benign Tumors =============================================================== Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 3/49 (6%) 1/50 (2%) 3/49 (6%) |0/49 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.9% 7.0% 2.5% 7.8% |0.0% 4.6% 0.0% 2.2% | |TERMINAL (d) | 2/28 (7%) 3/32 (9%) 1/27 (4%) 3/28 (11%) |0/32 (0%) 2/31 (7%) 0/39 (0%) 1/33 (3%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |--- 735 (T) --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.435 P=0.561 P=0.513N P=0.500 |P=0.641 P=0.231 (e) P=0.506 | |POLY 3 | P=0.432 P=0.520 P=0.511N P=0.474 |P=0.649 P=0.242 (e) P=0.515 | |POLY 1.5 | P=0.440 P=0.513 P=0.504N P=0.481 |P=0.646 P=0.243 (e) P=0.512 | |POLY 6 | P=0.427 P=0.528 P=0.519N P=0.471 |P=0.649 P=0.237 (e) P=0.517 | |LOGISTIC REGRESSION| P=0.435 P=0.561 P=0.513N P=0.500 |(e) P=0.231 (e) P=0.506 | |COCH-ARM / FISHERS | P=0.461 P=0.500 P=0.492N P=0.500 |P=0.637 P=0.253 (e) P=0.505 | |=================================================================================================================================| | | | | | | 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) | 0/49 (0%) 1/49 (2%) 1/50 (2%) 2/49 (4%) |0/48 (0%) 1/49 (2%) 2/49 (4%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 2.5% 5.2% |0.0% 2.3% 4.4% 4.4% | |TERMINAL (d) | 0/28 (0%) 1/32 (3%) 1/27 (4%) 1/28 (4%) |0/32 (0%) 0/31 (0%) 2/39 (5%) 2/33 (6%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) 633 |--- 639 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.201 P=0.527 P=0.493 P=0.237 |P=0.275 P=0.505 P=0.283 P=0.245 | |POLY 3 | P=0.197 P=0.509 P=0.494 P=0.226 |P=0.292 P=0.509 P=0.257 P=0.255 | |POLY 1.5 | P=0.201 P=0.506 P=0.498 P=0.229 |P=0.285 P=0.508 P=0.252 P=0.251 | |POLY 6 | P=0.197 P=0.512 P=0.489 P=0.226 |P=0.299 P=0.507 P=0.263 P=0.258 | |LOGISTIC REGRESSION| P=0.194 P=0.527 P=0.493 P=0.231 |P=0.283 P=0.469 P=0.283 P=0.245 | |COCH-ARM / FISHERS | P=0.213 P=0.500 P=0.505 P=0.247 |P=0.270 P=0.505 P=0.253 P=0.253 | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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) | 0/49 (0%) 2/49 (4%) 1/50 (2%) 2/49 (4%) |0/48 (0%) 1/49 (2%) 2/49 (4%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 4.7% 2.5% 5.2% |0.0% 2.3% 4.4% 6.7% | |TERMINAL (d) | 0/28 (0%) 2/32 (6%) 1/27 (4%) 1/28 (4%) |0/32 (0%) 0/31 (0%) 2/39 (5%) 3/33 (9%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) 633 |--- 639 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.322 P=0.268 P=0.493 P=0.237 |P=0.106 P=0.505 P=0.283 P=0.126 | |POLY 3 | P=0.322 P=0.247 P=0.494 P=0.226 |P=0.116 P=0.509 P=0.257 P=0.133 | |POLY 1.5 | P=0.326 P=0.244 P=0.498 P=0.229 |P=0.112 P=0.508 P=0.252 P=0.130 | |POLY 6 | P=0.322 P=0.251 P=0.489 P=0.226 |P=0.120 P=0.507 P=0.263 P=0.136 | |LOGISTIC REGRESSION| P=0.313 P=0.268 P=0.493 P=0.231 |P=0.115 P=0.469 P=0.283 P=0.126 | |COCH-ARM / FISHERS | P=0.340 P=0.247 P=0.505 P=0.247 |P=0.105 P=0.505 P=0.253 P=0.125 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 7.2% 6.9% 10.0% 5.1% |2.4% 2.3% 2.2% 2.2% | |TERMINAL (d) | 2/28 (7%) 3/32 (9%) 1/27 (4%) 2/28 (7%) |0/32 (0%) 1/31 (3%) 1/39 (3%) 1/33 (3%) | |FIRST INCIDENCE | 610 733 (T) 631 733 (T) |723 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.423N P=0.607N P=0.473 P=0.505N |P=0.681N P=0.753 P=0.723N P=0.757N | |POLY 3 | P=0.434N P=0.643N P=0.480 P=0.527N |P=0.667N P=0.757N P=0.744N P=0.744N | |POLY 1.5 | P=0.421N P=0.650N P=0.487 P=0.520N |P=0.672N P=0.755N P=0.749N P=0.748N | |POLY 6 | P=0.442N P=0.638N P=0.475 P=0.531N |P=0.664N P=0.761 P=0.740N P=0.742N | |LOGISTIC REGRESSION| P=0.425N P=0.635N P=0.487 P=0.522N |P=0.659N P=0.759 P=0.738N P=0.743N | |COCH-ARM / FISHERS | P=0.390N P=0.661N P=0.500 P=0.500N |P=0.683 P=0.753N P=0.753N P=0.753N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 5.1% |2.4% 2.3% 0.0% 2.2% | |TERMINAL (d) | 1/28 (4%) 0/32 (0%) 0/27 (0%) 2/28 (7%) |0/32 (0%) 1/31 (3%) 0/39 (0%) 0/33 (0%) | |FIRST INCIDENCE | 733 (T) --- --- 733 (T) |723 735 (T) --- 715 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.164 P=0.473N P=0.507N P=0.500 |P=0.676 P=0.753 P=0.473N P=0.751N | |POLY 3 | P=0.161 P=0.490N P=0.509N P=0.483 |P=0.680 P=0.757N P=0.486N P=0.744N | |POLY 1.5 | P=0.165 P=0.493N P=0.505N P=0.487 |P=0.675 P=0.755N P=0.490N P=0.748N | |POLY 6 | P=0.158 P=0.485N P=0.512N P=0.482 |P=0.683 P=0.761 P=0.482N P=0.741N | |LOGISTIC REGRESSION| P=0.164 (e) (e) P=0.500 |P=0.686 P=0.759 P=0.482N P=0.746N | |COCH-ARM / FISHERS | P=0.175 P=0.500N P=0.500N P=0.500 |P=0.668 P=0.753N P=0.500N P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 4/50 (8%) 4/50 (8%) |2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 9.6% 6.9% 10.0% 10.2% |4.7% 4.6% 2.2% 4.4% | |TERMINAL (d) | 3/28 (11%) 3/32 (9%) 1/27 (4%) 4/28 (14%) |0/32 (0%) 2/31 (7%) 1/39 (3%) 1/33 (3%) | |FIRST INCIDENCE | 610 733 (T) 631 733 (T) |723 735 (T) 735 (T) 715 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.492 P=0.434N P=0.613 P=0.641 |P=0.622 P=0.682 P=0.445N P=0.682N | |POLY 3 | P=0.477 P=0.477N P=0.624 P=0.612 |P=0.635 P=0.688N P=0.475N P=0.667N | |POLY 1.5 | P=0.492 P=0.485N P=0.631 P=0.620 |P=0.628 P=0.686N P=0.482N P=0.674N | |POLY 6 | P=0.466 P=0.470N P=0.620 P=0.607 |P=0.641 P=0.694 P=0.469N P=0.663N | |LOGISTIC REGRESSION| P=0.483 P=0.463N P=0.627 P=0.618 |P=0.635N P=0.689 P=0.464N P=0.665N | |COCH-ARM / FISHERS | P=0.529 P=0.500N P=0.643N P=0.643N |P=0.613 P=0.691N P=0.500N P=0.691N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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) | 1/50 (2%) 0/49 (0%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 5.1% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/28 (4%) 0/32 (0%) 2/27 (7%) 0/28 (0%) |0/32 (0%) 0/31 (0%) 0/39 (0%) 0/33 (0%) | |FIRST INCIDENCE | 733 (T) --- 733 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.451N P=0.473N P=0.487 P=0.500N |(e) (e) (e) (e) | |POLY 3 | P=0.463N P=0.494N P=0.484 P=0.510N |(e) (e) (e) (e) | |POLY 1.5 | P=0.455N P=0.498N P=0.491 P=0.507N |(e) (e) (e) (e) | |POLY 6 | P=0.469N P=0.489N P=0.478 P=0.510N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.451N (e) P=0.487 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.434N P=0.505N P=0.500 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 2/49 (4%) |0/47 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 5.0% 5.2% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 1/27 (4%) 2/28 (7%) |0/32 (0%) 0/31 (0%) 0/39 (0%) 0/33 (0%) | |FIRST INCIDENCE | 664 --- 559 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.271 P=0.484N P=0.472 P=0.497 |(e) (e) (e) (e) | |POLY 3 | P=0.252 P=0.491N P=0.487 P=0.474 |(e) (e) (e) (e) | |POLY 1.5 | P=0.261 P=0.494N P=0.492 P=0.478 |(e) (e) (e) (e) | |POLY 6 | P=0.247 P=0.488N P=0.482 P=0.472 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.273 P=0.510N P=0.508 P=0.476 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.284 P=0.500N P=0.500 P=0.492 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |0/47 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 0.0% |0.0% 4.6% 0.0% 0.0% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 1/27 (4%) 0/28 (0%) |0/32 (0%) 1/31 (3%) 0/39 (0%) 0/33 (0%) | |FIRST INCIDENCE | --- --- 733 (T) --- |--- 695 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.780N (e) P=0.493 (e) |P=0.374N P=0.233 (e) (e) | |POLY 3 | P=0.787N (e) P=0.491 (e) |P=0.387N P=0.244 (e) (e) | |POLY 1.5 | P=0.784N (e) P=0.495 (e) |P=0.385N P=0.247 (e) (e) | |POLY 6 | P=0.789N (e) P=0.488 (e) |P=0.392N P=0.239 (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.493 (e) |P=0.378N P=0.242 (e) (e) | |COCH-ARM / FISHERS | P=0.776N (e) P=0.500 (e) |P=0.384N P=0.263 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 20/50 (40%) 24/50 (48%) 18/50 (36%) 17/49 (35%) |20/47 (43%) 22/50 (44%) 19/50 (38%) 20/50 (40%) | |POLY-3 ADJUSTED (b)| 46.9% 51.8% 43.6% 42.6% |46.3% 49.2% 40.8% 43.1% | |TERMINAL (d) | 14/28 (50%) 17/32 (53%) 12/27 (44%) 13/28 (46%) |16/32 (50%) 17/31 (55%) 17/39 (44%) 16/33 (49%) | |FIRST INCIDENCE | 592 522 584 330 |621 611 543 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.270N P=0.466 P=0.504N P=0.361N |P=0.430N P=0.370 P=0.234N P=0.517N | |POLY 3 | P=0.299N P=0.400 P=0.468N P=0.432N |P=0.389N P=0.474 P=0.379N P=0.462N | |POLY 1.5 | P=0.263N P=0.348 P=0.448N P=0.412N |P=0.404N P=0.497 P=0.389N P=0.467N | |POLY 6 | P=0.340N P=0.459 P=0.483N P=0.451N |P=0.377N P=0.442 P=0.364N P=0.461N | |LOGISTIC REGRESSION| P=0.289N P=0.338 P=0.506N P=0.440N |P=0.349N P=0.429 P=0.365N P=0.438N | |COCH-ARM / FISHERS | P=0.203N P=0.273 P=0.418N P=0.368N |P=0.431N P=0.525 P=0.401N P=0.480N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 13/50 (26%) 14/50 (28%) 14/49 (29%) |5/47 (11%) 8/50 (16%) 7/50 (14%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 28.6% 27.4% 31.9% 31.7% |11.7% 17.7% 15.0% 22.9% | |TERMINAL (d) | 2/28 (7%) 4/32 (13%) 5/27 (19%) 4/28 (14%) |4/32 (13%) 3/31 (10%) 5/39 (13%) 4/33 (12%) | |FIRST INCIDENCE | 399 405 389 330 |610 567 600 527 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.382 P=0.498N P=0.433 P=0.450 |P=0.125 P=0.283 P=0.499 P=0.122 | |POLY 3 | P=0.401 P=0.541N P=0.453 P=0.464 |P=0.133 P=0.315 P=0.442 P=0.132 | |POLY 1.5 | P=0.405 P=0.557N P=0.472 P=0.462 |P=0.122 P=0.316 P=0.433 P=0.121 | |POLY 6 | P=0.405 P=0.530N P=0.433 P=0.472 |P=0.148 P=0.315 P=0.457 P=0.146 | |LOGISTIC REGRESSION| P=0.491N P=0.440 P=0.570 P=0.587N |P=0.076 P=0.342 P=0.421 P=0.086 | |COCH-ARM / FISHERS | P=0.436 P=0.590N P=0.500 P=0.475 |P=0.106 P=0.318 P=0.424 P=0.108 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 13/50 (26%) 14/50 (28%) 14/49 (29%) |5/47 (11%) 10/50 (20%) 7/50 (14%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 28.6% 27.4% 31.9% 31.7% |11.7% 22.0% 15.0% 22.9% | |TERMINAL (d) | 2/28 (7%) 4/32 (13%) 5/27 (19%) 4/28 (14%) |4/32 (13%) 4/31 (13%) 5/39 (13%) 4/33 (12%) | |FIRST INCIDENCE | 399 405 389 330 |610 567 600 527 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.382 P=0.498N P=0.433 P=0.450 |P=0.193 P=0.141 P=0.499 P=0.122 | |POLY 3 | P=0.401 P=0.541N P=0.453 P=0.464 |P=0.206 P=0.158 P=0.442 P=0.132 | |POLY 1.5 | P=0.405 P=0.557N P=0.472 P=0.462 |P=0.190 P=0.159 P=0.433 P=0.121 | |POLY 6 | P=0.405 P=0.530N P=0.433 P=0.472 |P=0.226 P=0.159 P=0.457 P=0.146 | |LOGISTIC REGRESSION| P=0.491N P=0.440 P=0.570 P=0.587N |P=0.130 P=0.174 P=0.421 P=0.086 | |COCH-ARM / FISHERS | P=0.436 P=0.590N P=0.500 P=0.475 |P=0.169 P=0.160 P=0.424 P=0.108 | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/50 (60%) 32/50 (64%) 28/50 (56%) 29/49 (59%) |23/47 (49%) 28/50 (56%) 22/50 (44%) 28/50 (56%) | |POLY-3 ADJUSTED (b)| 64.2% 65.7% 62.4% 64.9% |52.7% 60.0% 46.4% 58.1% | |TERMINAL (d) | 15/28 (54%) 19/32 (59%) 15/27 (56%) 16/28 (57%) |18/32 (56%) 18/31 (58%) 18/39 (46%) 19/33 (58%) | |FIRST INCIDENCE | 399 405 389 330 |610 567 543 527 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.517 P=0.489N P=0.541N P=0.550N |P=0.356 P=0.203 P=0.224N P=0.300 | |POLY 3 | P=0.549 P=0.528 P=0.516N P=0.563 |P=0.399 P=0.309 P=0.348N P=0.377 | |POLY 1.5 | P=0.540N P=0.492 P=0.476N P=0.573 |P=0.372 P=0.309 P=0.366N P=0.350 | |POLY 6 | P=0.533 P=0.552 P=0.558N P=0.555 |P=0.426 P=0.316 P=0.323N P=0.408 | |LOGISTIC REGRESSION| P=0.462N P=0.386 P=0.433N P=0.556N |P=0.359 P=0.269 P=0.369N P=0.330 | |COCH-ARM / FISHERS | P=0.461N P=0.418 P=0.420N P=0.548N |P=0.330 P=0.311 P=0.388N P=0.311 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/50 (60%) 32/50 (64%) 28/50 (56%) 29/49 (59%) |23/47 (49%) 28/50 (56%) 22/50 (44%) 28/50 (56%) | |POLY-3 ADJUSTED (b)| 64.2% 65.7% 62.4% 64.9% |52.7% 60.0% 46.4% 58.1% | |TERMINAL (d) | 15/28 (54%) 19/32 (59%) 15/27 (56%) 16/28 (57%) |18/32 (56%) 18/31 (58%) 18/39 (46%) 19/33 (58%) | |FIRST INCIDENCE | 399 405 389 330 |610 567 543 527 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.517 P=0.489N P=0.541N P=0.550N |P=0.356 P=0.203 P=0.224N P=0.300 | |POLY 3 | P=0.549 P=0.528 P=0.516N P=0.563 |P=0.399 P=0.309 P=0.348N P=0.377 | |POLY 1.5 | P=0.540N P=0.492 P=0.476N P=0.573 |P=0.372 P=0.309 P=0.366N P=0.350 | |POLY 6 | P=0.533 P=0.552 P=0.558N P=0.555 |P=0.426 P=0.316 P=0.323N P=0.408 | |LOGISTIC REGRESSION| P=0.462N P=0.386 P=0.433N P=0.556N |P=0.359 P=0.269 P=0.369N P=0.330 | |COCH-ARM / FISHERS | P=0.461N P=0.418 P=0.420N P=0.548N |P=0.330 P=0.311 P=0.388N P=0.311 | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 7/50 (14%) 5/50 (10%) 3/50 (6%) |2/49 (4%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 28.7% 16.1% 12.5% 7.6% |4.7% 4.6% 4.4% 4.4% | |TERMINAL (d) | 9/28 (32%) 6/32 (19%) 4/27 (15%) 3/28 (11%) |1/32 (3%) 1/31 (3%) 2/39 (5%) 1/33 (3%) | |FIRST INCIDENCE | 592 698 583 733 (T) |653 639 735 (T) 701 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.031N* P=0.091N P=0.068N P=0.013N* |P=0.607N P=0.684 P=0.633N P=0.667N | |POLY 3 | P=0.031N* P=0.125N P=0.060N P=0.013N* |P=0.609N P=0.686N P=0.670N P=0.668N | |POLY 1.5 | P=0.028N* P=0.135N P=0.057N P=0.013N* |P=0.615N P=0.684N P=0.675N P=0.673N | |POLY 6 | P=0.032N* P=0.116N P=0.064N P=0.013N* |P=0.604N P=0.693N P=0.664N P=0.666N | |LOGISTIC REGRESSION| P=0.032N* P=0.106N P=0.067N P=0.014N* |P=0.617N P=0.689N P=0.672N P=0.681N | |COCH-ARM / FISHERS | P=0.024N* P=0.154N P=0.054N P=0.011N* |P=0.628N P=0.684N P=0.684N P=0.684N | |=================================================================================================================================| | | | | | | 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) | 6/50 (12%) 6/50 (12%) 4/50 (8%) 6/50 (12%) |4/49 (8%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 14.2% 13.8% 10.1% 15.3% |9.3% 4.6% 4.4% 2.2% | |TERMINAL (d) | 4/28 (14%) 6/32 (19%) 4/27 (15%) 6/28 (21%) |1/32 (3%) 1/31 (3%) 2/39 (5%) 1/33 (3%) | |FIRST INCIDENCE | 580 733 (T) 733 (T) 733 (T) |639 639 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.504 P=0.537N P=0.397N P=0.612 |P=0.192N P=0.355N P=0.279N P=0.165N | |POLY 3 | P=0.490 P=0.601N P=0.411N P=0.571 |P=0.193N P=0.331N P=0.311N P=0.161N | |POLY 1.5 | P=0.508 P=0.606N P=0.394N P=0.586 |P=0.197N P=0.326N P=0.316N P=0.164N | |POLY 6 | P=0.477 P=0.597N P=0.432N P=0.559 |P=0.189N P=0.343N P=0.307N P=0.161N | |LOGISTIC REGRESSION| P=0.489 P=0.581N P=0.400N P=0.588 |P=0.200N P=0.330N P=0.321N P=0.174N | |COCH-ARM / FISHERS | P=0.549 P=0.620N P=0.370N P=0.620N |P=0.204N P=0.329N P=0.329N P=0.175N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 9 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 13/50 (26%) 9/50 (18%) 9/50 (18%) |6/49 (12%) 4/50 (8%) 4/50 (8%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 39.7% 29.8% 22.5% 22.9% |13.8% 9.1% 8.8% 6.5% | |TERMINAL (d) | 12/28 (43%) 12/32 (38%) 8/27 (30%) 9/28 (32%) |2/32 (6%) 2/31 (7%) 4/39 (10%) 2/33 (6%) | |FIRST INCIDENCE | 580 698 583 733 (T) |639 639 735 (T) 701 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.107N P=0.141N P=0.070N P=0.056N |P=0.246N P=0.391N P=0.285N P=0.218N | |POLY 3 | P=0.119N P=0.227N P=0.070N P=0.077N |P=0.248N P=0.360N P=0.338N P=0.215N | |POLY 1.5 | P=0.107N P=0.235N P=0.062N P=0.068N |P=0.254N P=0.354N P=0.342N P=0.219N | |POLY 6 | P=0.130N P=0.225N P=0.081N P=0.086N |P=0.244N P=0.376N P=0.336N P=0.217N | |LOGISTIC REGRESSION| P=0.116N P=0.180N P=0.069N P=0.066N |P=0.257N P=0.359N P=0.340N P=0.229N | |COCH-ARM / FISHERS | P=0.084N P=0.257N P=0.055N P=0.055N |P=0.266N P=0.357N P=0.357N P=0.233N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.6% 0.0% 4.4% 0.0% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 0/27 (0%) 0/28 (0%) |0/32 (0%) 0/31 (0%) 2/39 (5%) 0/33 (0%) | |FIRST INCIDENCE | --- --- --- --- |541 --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.278N P=0.245N P=0.643N P=0.224N | |POLY 3 | (e) (e) (e) (e) |P=0.274N P=0.236N P=0.673N P=0.224N | |POLY 1.5 | (e) (e) (e) (e) |P=0.280N P=0.234N P=0.678N P=0.227N | |POLY 6 | (e) (e) (e) (e) |P=0.267N P=0.242N P=0.669N P=0.224N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.306N P=0.270N P=0.680 P=0.294N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.290N P=0.247N P=0.691N P=0.247N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 10 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |0/48 (0%) 3/50 (6%) 1/48 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |0.0% 6.8% 2.3% 4.4% | |TERMINAL (d) | |0/32 (0%) 1/31 (3%) 1/38 (3%) 2/33 (6%) | |FIRST INCIDENCE | |--- 572 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.471 P=0.127 P=0.534 P=0.245 | |POLY 3 | |P=0.486 P=0.125 P=0.509 P=0.255 | |POLY 1.5 | |P=0.482 P=0.126 P=0.506 P=0.252 | |POLY 6 | |P=0.488 P=0.122 P=0.514 P=0.257 | |LOGISTIC REGRESSION| |P=0.476 P=0.126 P=0.534 P=0.245 | |COCH-ARM / FISHERS | |P=0.472 P=0.129 P=0.500 P=0.258 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/48 (2%) 2/50 (4%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| |2.4% 4.6% 0.0% 0.0% | |TERMINAL (d) | |1/32 (3%) 2/31 (7%) 0/38 (0%) 0/33 (0%) | |FIRST INCIDENCE | |735 (T) 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.232N P=0.489 P=0.466N P=0.494N | |POLY 3 | |P=0.234N P=0.509 P=0.491N P=0.484N | |POLY 1.5 | |P=0.234N P=0.513 P=0.494N P=0.487N | |POLY 6 | |P=0.236N P=0.501 P=0.486N P=0.483N | |LOGISTIC REGRESSION| |P=0.232N P=0.489 (e) (e) | |COCH-ARM / FISHERS | |P=0.236N P=0.515 P=0.500N P=0.490N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 11 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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) | 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) |8/49 (16%) 13/49 (27%) 12/49 (24%) 12/49 (24%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |18.8% 29.8% 26.7% 26.2% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 0/27 (0%) 0/28 (0%) |6/32 (19%) 10/31 (32%) 11/39 (28%) 8/33 (24%) | |FIRST INCIDENCE | --- --- --- --- |709 615 709 672 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.435 P=0.147 P=0.385 P=0.275 | |POLY 3 | (e) (e) (e) (e) |P=0.462 P=0.171 P=0.265 P=0.279 | |POLY 1.5 | (e) (e) (e) (e) |P=0.435 P=0.171 P=0.252 P=0.261 | |POLY 6 | (e) (e) (e) (e) |P=0.492 P=0.166 P=0.281 P=0.298 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.479 P=0.153 P=0.312 P=0.286 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.387 P=0.162 P=0.226 P=0.226 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) |8/49 (16%) 13/49 (27%) 13/49 (27%) 12/49 (24%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |18.8% 29.8% 28.4% 26.2% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 0/27 (0%) 0/28 (0%) |6/32 (19%) 10/31 (32%) 11/39 (28%) 8/33 (24%) | |FIRST INCIDENCE | --- --- --- --- |709 615 477 672 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.450 P=0.147 P=0.303 P=0.275 | |POLY 3 | (e) (e) (e) (e) |P=0.476 P=0.171 P=0.206 P=0.279 | |POLY 1.5 | (e) (e) (e) (e) |P=0.449 P=0.171 P=0.191 P=0.261 | |POLY 6 | (e) (e) (e) (e) |P=0.506 P=0.166 P=0.224 P=0.298 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.475 P=0.153 P=0.199 P=0.286 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.401 P=0.162 P=0.162 P=0.226 | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 12 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 5/50 (10%) 1/50 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 2.5% |4.7% 11.3% 2.2% 6.5% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 0/27 (0%) 0/28 (0%) |0/32 (0%) 3/31 (10%) 0/39 (0%) 1/33 (3%) | |FIRST INCIDENCE | --- --- 512 508 |667 611 692 709 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.330 (e) P=0.496 P=0.491 |P=0.570N P=0.217 P=0.458N P=0.524 | |POLY 3 | P=0.330 (e) P=0.494 P=0.494 |P=0.578N P=0.228 P=0.476N P=0.532 | |POLY 1.5 | P=0.334 (e) P=0.497 P=0.494 |P=0.583N P=0.228 P=0.482N P=0.524 | |POLY 6 | P=0.328 (e) P=0.493 P=0.495 |P=0.576N P=0.223 P=0.469N P=0.536 | |LOGISTIC REGRESSION| P=0.515 (e) P=0.532 P=0.589 |P=0.597N P=0.219 P=0.501N P=0.528 | |COCH-ARM / FISHERS | P=0.348 (e) P=0.500 P=0.500 |P=0.601N P=0.218 P=0.500N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.6% 2.2% 2.2% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 0/27 (0%) 0/28 (0%) |0/32 (0%) 2/31 (7%) 0/39 (0%) 0/33 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 735 (T) 692 729 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.669 P=0.231 P=0.526 P=0.512 | |POLY 3 | (e) (e) (e) (e) |P=0.678 P=0.242 P=0.515 P=0.515 | |POLY 1.5 | (e) (e) (e) (e) |P=0.672 P=0.243 P=0.511 P=0.511 | |POLY 6 | (e) (e) (e) (e) |P=0.682 P=0.237 P=0.520 P=0.517 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.675 P=0.231 P=0.498 P=0.518 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.654 P=0.247 P=0.500 P=0.500 | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 13 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | 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) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 5/50 (10%) 1/50 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 2.5% |4.7% 11.3% 2.2% 6.5% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 0/27 (0%) 0/28 (0%) |0/32 (0%) 3/31 (10%) 0/39 (0%) 1/33 (3%) | |FIRST INCIDENCE | --- --- 512 508 |667 611 692 709 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.330 (e) P=0.496 P=0.491 |P=0.570N P=0.217 P=0.458N P=0.524 | |POLY 3 | P=0.330 (e) P=0.494 P=0.494 |P=0.578N P=0.228 P=0.476N P=0.532 | |POLY 1.5 | P=0.334 (e) P=0.497 P=0.494 |P=0.583N P=0.228 P=0.482N P=0.524 | |POLY 6 | P=0.328 (e) P=0.493 P=0.495 |P=0.576N P=0.223 P=0.469N P=0.536 | |LOGISTIC REGRESSION| P=0.515 (e) P=0.532 P=0.589 |P=0.597N P=0.219 P=0.501N P=0.528 | |COCH-ARM / FISHERS | P=0.348 (e) P=0.500 P=0.500 |P=0.601N P=0.218 P=0.500N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 2.5% |4.7% 4.5% 0.0% 4.4% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 0/27 (0%) 0/28 (0%) |0/32 (0%) 0/31 (0%) 0/39 (0%) 1/33 (3%) | |FIRST INCIDENCE | --- --- 512 508 |667 611 --- 709 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.330 (e) P=0.496 P=0.491 |P=0.612 P=0.690 P=0.214N P=0.673N | |POLY 3 | P=0.330 (e) P=0.494 P=0.494 |P=0.604 P=0.683N P=0.223N P=0.669N | |POLY 1.5 | P=0.334 (e) P=0.497 P=0.494 |P=0.600 P=0.683N P=0.227N P=0.675N | |POLY 6 | P=0.328 (e) P=0.493 P=0.495 |P=0.607 P=0.687N P=0.219N P=0.666N | |LOGISTIC REGRESSION| P=0.515 (e) P=0.532 P=0.589 |P=0.564 P=0.674 P=0.235N P=0.679N | |COCH-ARM / FISHERS | P=0.348 (e) P=0.500 P=0.500 |P=0.590 P=0.691N P=0.247N P=0.691N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 14 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 1/48 (2%) |3/49 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 0.0% 2.6% |7.1% 0.0% 0.0% 2.2% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 0/27 (0%) 1/28 (4%) |2/32 (6%) 0/31 (0%) 0/39 (0%) 1/33 (3%) | |FIRST INCIDENCE | --- 715 --- 733 (T) |709 --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.462 P=0.525 (e) P=0.500 |P=0.519N P=0.132N P=0.095N P=0.291N | |POLY 3 | P=0.463 P=0.507 (e) P=0.486 |P=0.524N P=0.115N P=0.106N P=0.280N | |POLY 1.5 | P=0.464 P=0.503 (e) P=0.487 |P=0.527N P=0.114N P=0.109N P=0.285N | |POLY 6 | P=0.463 P=0.511 (e) P=0.486 |P=0.519N P=0.118N P=0.103N P=0.276N | |LOGISTIC REGRESSION| P=0.458 P=0.510 (e) P=0.500 |P=0.504N P=0.122N P=0.102N P=0.273N | |COCH-ARM / FISHERS | P=0.470 P=0.495 (e) P=0.490 |P=0.528N P=0.117N P=0.117N P=0.301N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |1/48 (2%) 4/50 (8%) 3/49 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 0.0% |2.4% 9.2% 6.6% 4.4% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 0/27 (0%) 0/28 (0%) |1/32 (3%) 3/31 (10%) 3/39 (8%) 2/33 (6%) | |FIRST INCIDENCE | --- --- 636 --- |735 (T) 695 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.786N (e) P=0.489 (e) |P=0.515N P=0.172 P=0.378 P=0.511 | |POLY 3 | P=0.787N (e) P=0.493 (e) |P=0.499N P=0.187 P=0.330 P=0.527 | |POLY 1.5 | P=0.784N (e) P=0.496 (e) |P=0.505N P=0.190 P=0.324 P=0.523 | |POLY 6 | P=0.789N (e) P=0.491 (e) |P=0.495N P=0.180 P=0.338 P=0.530 | |LOGISTIC REGRESSION| P=0.762N (e) P=0.509 (e) |P=0.487N P=0.173 P=0.378 P=0.511 | |COCH-ARM / FISHERS | P=0.776N (e) P=0.500 (e) |P=0.518N P=0.194 P=0.316 P=0.515 | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 15 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |1/48 (2%) 4/50 (8%) 4/49 (8%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 0.0% |2.4% 9.2% 8.8% 6.6% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 0/27 (0%) 0/28 (0%) |1/32 (3%) 3/31 (10%) 4/39 (10%) 3/33 (9%) | |FIRST INCIDENCE | --- --- 636 --- |735 (T) 695 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.786N (e) P=0.489 (e) |P=0.535 P=0.172 P=0.243 P=0.315 | |POLY 3 | P=0.787N (e) P=0.493 (e) |P=0.558 P=0.187 P=0.200 P=0.334 | |POLY 1.5 | P=0.784N (e) P=0.496 (e) |P=0.549 P=0.190 P=0.194 P=0.330 | |POLY 6 | P=0.789N (e) P=0.491 (e) |P=0.565 P=0.180 P=0.207 P=0.336 | |LOGISTIC REGRESSION| P=0.762N (e) P=0.509 (e) |P=0.566 P=0.173 P=0.243 P=0.315 | |COCH-ARM / FISHERS | P=0.776N (e) P=0.500 (e) |P=0.532 P=0.194 P=0.187 P=0.324 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Tooth | | Odontoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 6.8% 5.1% 5.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/28 (0%) 1/32 (3%) 2/27 (7%) 2/28 (7%) |0/32 (0%) 0/31 (0%) 0/39 (0%) 0/33 (0%) | |FIRST INCIDENCE | 527 649 733 (T) 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.580 P=0.334 P=0.484 P=0.489 |(e) (e) (e) (e) | |POLY 3 | P=0.575 P=0.323 P=0.479 P=0.478 |(e) (e) (e) (e) | |POLY 1.5 | P=0.585 P=0.316 P=0.488 P=0.484 |(e) (e) (e) (e) | |POLY 6 | P=0.568 P=0.332 P=0.470 P=0.474 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.597 P=0.264 P=0.502 P=0.501 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.611 P=0.309 P=0.500 P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 16 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ISOBUTENE Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| |7.0% 2.3% 2.2% 0.0% | |TERMINAL (d) | |2/32 (6%) 1/31 (3%) 1/39 (3%) 0/33 (0%) | |FIRST INCIDENCE | |709 735 (T) 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.131N P=0.323N P=0.247N P=0.115N | |POLY 3 | |P=0.132N P=0.298N P=0.280N P=0.106N | |POLY 1.5 | |P=0.135N P=0.297N P=0.287N P=0.109N | |POLY 6 | |P=0.129N P=0.305N P=0.274N P=0.104N | |LOGISTIC REGRESSION| |P=0.124N P=0.311N P=0.265N P=0.105N | |COCH-ARM / FISHERS | |P=0.139N P=0.309N P=0.309N P=0.121N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |3/50 (6%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.4% 2.3% 5.0% 5.1% |7.0% 2.3% 6.5% 2.2% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 1/27 (4%) 2/28 (7%) |2/32 (6%) 1/31 (3%) 2/39 (5%) 1/33 (3%) | |FIRST INCIDENCE | 664 715 559 733 (T) |709 735 (T) 618 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.384 P=0.737N P=0.472 P=0.497 |P=0.331N P=0.323N P=0.584N P=0.291N | |POLY 3 | P=0.376 P=0.750N P=0.487 P=0.481 |P=0.323N P=0.298N P=0.625N P=0.280N | |POLY 1.5 | P=0.386 P=0.754N P=0.492 P=0.486 |P=0.331N P=0.297N P=0.636N P=0.286N | |POLY 6 | P=0.369 P=0.747N P=0.482 P=0.478 |P=0.314N P=0.305N P=0.614N P=0.276N | |LOGISTIC REGRESSION| P=0.394 P=0.761N P=0.508 P=0.483 |P=0.321N P=0.311N P=0.639N P=0.273N | |COCH-ARM / FISHERS | P=0.410 P=0.753N P=0.500 P=0.500 |P=0.346N P=0.309N P=0.661N P=0.309N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 17 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |3/50 (6%) 2/50 (4%) 4/50 (8%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.4% 2.3% 7.5% 5.1% |7.0% 4.6% 8.7% 2.2% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 2/27 (7%) 2/28 (7%) |2/32 (6%) 2/31 (7%) 3/39 (8%) 1/33 (3%) | |FIRST INCIDENCE | 664 715 559 733 (T) |709 735 (T) 618 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.418 P=0.737N P=0.283 P=0.497 |P=0.248N P=0.519N P=0.591 P=0.291N | |POLY 3 | P=0.405 P=0.750N P=0.291 P=0.481 |P=0.236N P=0.492N P=0.543 P=0.280N | |POLY 1.5 | P=0.417 P=0.754N P=0.297 P=0.486 |P=0.245N P=0.490N P=0.530 P=0.286N | |POLY 6 | P=0.396 P=0.747N P=0.286 P=0.478 |P=0.228N P=0.501N P=0.557 P=0.276N | |LOGISTIC REGRESSION| P=0.424 P=0.761N P=0.303 P=0.483 |P=0.234N P=0.510N P=0.535 P=0.273N | |COCH-ARM / FISHERS | P=0.446 P=0.753N P=0.309 P=0.500 |P=0.262N P=0.500N P=0.500 P=0.309N | |=================================================================================================================================| | | | | | | 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%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 4/50 (8%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 2.5% 2.5% |4.7% 9.1% 4.3% 0.0% | |TERMINAL (d) | 0/28 (0%) 0/32 (0%) 0/27 (0%) 1/28 (4%) |2/32 (6%) 2/31 (7%) 1/39 (3%) 0/33 (0%) | |FIRST INCIDENCE | 653 --- 708 733 (T) |735 (T) 615 628 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.538 P=0.495N P=0.737 P=0.751 |P=0.080N P=0.327 P=0.633N P=0.231N | |POLY 3 | P=0.534 P=0.491N P=0.750 P=0.749 |P=0.077N P=0.354 P=0.664N P=0.221N | |POLY 1.5 | P=0.542 P=0.494N P=0.754 P=0.752 |P=0.079N P=0.352 P=0.673N P=0.225N | |POLY 6 | P=0.528 P=0.488N P=0.746 P=0.747 |P=0.075N P=0.351 P=0.654N P=0.218N | |LOGISTIC REGRESSION| P=0.549 P=0.515N P=0.760 P=0.755 |P=0.087N P=0.344 P=0.680N (e) | |COCH-ARM / FISHERS | P=0.563 P=0.500N P=0.753N P=0.753N |P=0.087N P=0.339 P=0.691N P=0.247N | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 18 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 Lymphoma And Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) 6/50 (12%) 6/50 (12%) |18/50 (36%) 13/50 (26%) 19/50 (38%) 19/50 (38%) | |POLY-3 ADJUSTED (b)| 11.9% 4.6% 14.8% 15.1% |40.4% 29.0% 39.9% 40.7% | |TERMINAL (d) | 2/28 (7%) 2/32 (6%) 1/27 (4%) 4/28 (14%) |14/32 (44%) 9/31 (29%) 13/39 (33%) 14/33 (42%) | |FIRST INCIDENCE | 611 733 (T) 631 667 |378 506 543 583 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.236 P=0.179N P=0.456 P=0.487 |P=0.343 P=0.221N P=0.418N P=0.563 | |POLY 3 | P=0.220 P=0.202N P=0.475 P=0.460 |P=0.332 P=0.178N P=0.567N P=0.573 | |POLY 1.5 | P=0.233 P=0.207N P=0.484 P=0.470 |P=0.317 P=0.175N P=0.570 P=0.556 | |POLY 6 | P=0.213 P=0.199N P=0.470 P=0.455 |P=0.346 P=0.191N P=0.528N P=0.581 | |LOGISTIC REGRESSION| P=0.234 P=0.201N P=0.486 P=0.469 |P=0.319 P=0.181N P=0.532 P=0.574 | |COCH-ARM / FISHERS | P=0.269 P=0.218N P=0.500 P=0.500 |P=0.282 P=0.194N P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 500 PPM 2000 PPM 8000 PPM |CONTROL 500 PPM 2000 PPM 8000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 5/50 (10%) 5/50 (10%) |16/50 (32%) 9/50 (18%) 17/50 (34%) 19/50 (38%) | |POLY-3 ADJUSTED (b)| 9.6% 4.6% 12.3% 12.6% |35.9% 20.4% 36.0% 40.7% | |TERMINAL (d) | 2/28 (7%) 2/32 (6%) 1/27 (4%) 3/28 (11%) |12/32 (38%) 7/31 (23%) 12/39 (31%) 14/33 (42%) | |FIRST INCIDENCE | 611 733 (T) 631 667 |378 506 543 583 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.279 P=0.283N P=0.465 P=0.492 |P=0.127 P=0.096N P=0.441N P=0.402 | |POLY 3 | P=0.266 P=0.318N P=0.481 P=0.469 |P=0.119 P=0.079N P=0.582 P=0.398 | |POLY 1.5 | P=0.278 P=0.325N P=0.487 P=0.476 |P=0.110 P=0.075N P=0.557 P=0.386 | |POLY 6 | P=0.261 P=0.313N P=0.478 P=0.468 |P=0.131 P=0.090N P=0.564N P=0.403 | |LOGISTIC REGRESSION| P=0.277 P=0.312N P=0.487 P=0.471 |P=0.113 P=0.078N P=0.525 P=0.395 | |COCH-ARM / FISHERS | P=0.312 P=0.339N P=0.500 P=0.500 |P=0.094 P=0.083N P=0.500 P=0.338 | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 19 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 30/50 (60%) 32/50 (64%) 27/50 (54%) 23/50 (46%) |29/50 (58%) 35/50 (70%) 33/50 (66%) 32/50 (64%) | |POLY-3 ADJUSTED (b)| 68.5% 68.6% 63.6% 56.5% |65.0% 74.8% 70.8% 68.4% | |TERMINAL (d) | 21/28 (75%) 24/32 (75%) 17/27 (63%) 19/28 (68%) |21/32 (66%) 24/31 (77%) 30/39 (77%) 26/33 (79%) | |FIRST INCIDENCE | 527 522 583 330 |449 572 543 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.116N P=0.454N P=0.465N P=0.127N |P=0.472N P=0.152 P=0.455N P=0.448 | |POLY 3 | P=0.115N P=0.591 P=0.394N P=0.167N |P=0.490N P=0.205 P=0.351 P=0.450 | |POLY 1.5 | P=0.082N P=0.523 P=0.375N P=0.144N |P=0.503N P=0.194 P=0.336 P=0.429 | |POLY 6 | P=0.168N P=0.535N P=0.396N P=0.203N |P=0.504N P=0.206 P=0.349 P=0.443 | |LOGISTIC REGRESSION| P=0.093N P=0.540 P=0.453N P=0.154N |P=0.366N P=0.182 P=0.441 P=0.541 | |COCH-ARM / FISHERS | P=0.049N* P=0.418 P=0.343N P=0.115N |P=0.539 P=0.149 P=0.268 P=0.341 | |=================================================================================================================================| | | | | | | 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) | 21/50 (42%) 19/50 (38%) 23/50 (46%) 23/50 (46%) |29/50 (58%) 29/50 (58%) 30/50 (60%) 31/50 (62%) | |POLY-3 ADJUSTED (b)| 45.0% 39.7% 50.8% 50.9% |60.9% 60.7% 60.8% 63.2% | |TERMINAL (d) | 7/28 (25%) 9/32 (28%) 9/27 (33%) 12/28 (43%) |15/32 (47%) 17/31 (55%) 20/39 (51%) 18/33 (55%) | |FIRST INCIDENCE | 399 405 389 330 |322 506 477 527 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.250 P=0.317N P=0.356 P=0.391 |P=0.493 P=0.531 P=0.351N P=0.532 | |POLY 3 | P=0.237 P=0.376N P=0.363 P=0.362 |P=0.440 P=0.577N P=0.581N P=0.489 | |POLY 1.5 | P=0.258 P=0.387N P=0.385 P=0.379 |P=0.422 P=0.565N P=0.562 P=0.475 | |POLY 6 | P=0.222 P=0.377N P=0.345 P=0.345 |P=0.451 P=0.566 P=0.561N P=0.492 | |LOGISTIC REGRESSION| P=0.408 P=0.525N P=0.460 P=0.471 |P=0.311 P=0.559 P=0.436 P=0.365 | |COCH-ARM / FISHERS | P=0.315 P=0.419N P=0.420 P=0.420 |P=0.374 P=0.580N P=0.500 P=0.419 | |=================================================================================================================================| Date: 06/19/97 EXPERIMENT: 88070 TEST: 04 Page 20 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 41/50 (82%) 41/50 (82%) 36/50 (72%) 38/50 (76%) |43/50 (86%) 45/50 (90%) 44/50 (88%) 44/50 (88%) | |POLY-3 ADJUSTED (b)| 85.0% 83.6% 78.4% 83.1% |87.7% 91.3% 89.2% 89.1% | |TERMINAL (d) | 22/28 (79%) 27/32 (84%) 20/27 (74%) 24/28 (86%) |26/32 (81%) 28/31 (90%) 34/39 (87%) 29/33 (88%) | |FIRST INCIDENCE | 399 405 389 330 |322 506 477 527 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.542N P=0.302N P=0.389N P=0.433N |P=0.424N P=0.390 P=0.200N P=0.493N | |POLY 3 | P=0.530N P=0.537N P=0.281N P=0.516N |P=0.568N P=0.397 P=0.534 P=0.541 | |POLY 1.5 | P=0.447N P=0.547N P=0.226N P=0.437N |P=0.561N P=0.411 P=0.544 P=0.551 | |POLY 6 | P=0.533 P=0.558N P=0.347N P=0.612N |P=0.582 P=0.375 P=0.512 P=0.511 | |LOGISTIC REGRESSION| P=0.390N P=0.595N P=0.195N P=0.383N |P=0.556N P=0.402 P=0.543 P=0.542 | |COCH-ARM / FISHERS | P=0.296N P=0.602N P=0.171N P=0.312N |P=0.568 P=0.380 P=0.500 P=0.500 | |=================================================================================================================================| (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).