TDMS Study 60968-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest ISOBUTYRALDEHYDE DATE: 08/06/96
EXPERIMENT: 60968 TEST: 01 TIME: 16:54:50
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-95241 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60968B
PATHOLOGIST: R. RENNE RENNE, R. CAS: 0078-84-2
------------------------------------------------------------------------------------------------------------------------------------
CORE STUDY
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest ISOBUTYRALDEHYDE DATE: 08/06/96
EXPERIMENT: 60968 TEST: 01 TIME: 16:54:50
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-95241 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60968B
PATHOLOGIST: R. RENNE RENNE, R. CAS: 0078-84-2
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 Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Larynx
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 ISOBUTYRALDEHYDE DATE: 08/06/96
EXPERIMENT: 60968 TEST: 01 TIME: 16:54:50
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-95241 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60968B
PATHOLOGIST: R. RENNE RENNE, R. CAS: 0078-84-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF ISOBUTYRALDEHYDE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Skin: Sebaceous Gland Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
====================================================================================================
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | 1/49 (2%) 0/49 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.7% 0.0% 4.2% 6.3% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 1/27 (4%) 0/24 (0%) 1/24 (4%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 734 (T) --- 734 (T) 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.309 P=0.523N P=0.736 P=0.560 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.309 P=0.523N P=0.736 P=0.560 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.309 P=0.523N P=0.736 P=0.560 |
|COCHRAN-ARMITAGE | (e) | P=0.253 |
|FISHER EXACT | (e) (e) (e) | P=0.500N P=0.747N P=0.508 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/49 (22%) 12/49 (24%) 12/50 (24%) 15/50 (30%) | 1/49 (2%) 0/49 (0%) 2/47 (4%) 0/49 (0%) |
|ADJUSTED (b) | 59.1% 57.3% 60.7% 67.3% | 3.7% 0.0% 8.7% 0.0% |
|TERMINAL (d) | 5/12 (42%) 7/15 (47%) 5/11 (45%) 4/10 (40%) | 1/27 (4%) 0/24 (0%) 2/23 (9%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 663 579 523 581 | 734 (T) --- 734 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.051 P=0.513N P=0.392 P=0.094 | P=0.411N P=0.523N P=0.444 P=0.466N |
|INCIDENTAL TUMOR | P=0.070 P=0.559 P=0.333 P=0.088 | P=0.411N P=0.523N P=0.444 P=0.466N |
|LOGISTIC REGRESSION | P=0.059 P=0.585 P=0.340 P=0.084 | P=0.411N P=0.523N P=0.444 P=0.466N |
|COCHRAN-ARMITAGE | P=0.224 | P=0.462N |
|FISHER EXACT | P=0.500 P=0.522 P=0.266 | P=0.500N P=0.484 P=0.500N |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | 0/49 (0%) 0/49 (0%) 0/47 (0%) 1/49 (2%) |
|ADJUSTED (b) | 12.8% 0.0% 3.6% 2.9% | 0.0% 0.0% 0.0% 2.0% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 0/27 (0%) 0/24 (0%) 0/23 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 642 --- 616 582 | --- --- --- 471 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.380N P=0.116N P=0.380N P=0.411N | P=0.205 (e) (e) P=0.517 |
|INCIDENTAL TUMOR | P=0.305N P=0.139N P=0.379N P=0.327N | P=0.159 (e) (e) P=0.398 |
|LOGISTIC REGRESSION | P=0.296N P=0.115N P=0.321N P=0.313N | P=0.089 (e) (e) P=0.333 |
|COCHRAN-ARMITAGE | P=0.290N | P=0.199 |
|FISHER EXACT | P=0.121N P=0.301N P=0.301N | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/49 (29%) 12/49 (24%) 12/50 (24%) 16/50 (32%) | 1/49 (2%) 0/49 (0%) 2/47 (4%) 1/49 (2%) |
|ADJUSTED (b) | 64.5% 57.3% 60.7% 68.3% | 3.7% 0.0% 8.7% 2.0% |
|TERMINAL (d) | 5/12 (42%) 7/15 (47%) 5/11 (45%) 4/10 (40%) | 1/27 (4%) 0/24 (0%) 2/23 (9%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 642 579 523 581 | 734 (T) --- 734 (T) 471 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.093 P=0.260N P=0.542N P=0.176 | P=0.551 P=0.523N P=0.444 P=0.732N |
|INCIDENTAL TUMOR | P=0.134 P=0.364N P=0.586 P=0.196 | P=0.513 P=0.523N P=0.444 P=0.726 |
|LOGISTIC REGRESSION | P=0.121 P=0.320N P=0.577N P=0.205 | P=0.486 P=0.523N P=0.444 P=0.716 |
|COCHRAN-ARMITAGE | P=0.340 | P=0.499 |
|FISHER EXACT | P=0.410N P=0.387N P=0.440 | P=0.500N P=0.484 P=0.753N |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 1/50 (2%) 0/50 (0%) | 1/48 (2%) 2/50 (4%) 0/50 (0%) 1/48 (2%) |
|ADJUSTED (b) | 0.0% 11.3% 3.1% 0.0% | 3.7% 7.7% 0.0% 3.3% |
|TERMINAL (d) | 0/12 (0%) 1/15 (7%) 0/11 (0%) 0/10 (0%) | 1/27 (4%) 1/24 (4%) 0/24 (0%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | --- 692 586 --- | 734 (T) 705 --- 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.539N P=0.264 P=0.471 (e) | P=0.457N P=0.464 P=0.523N P=0.739N |
|INCIDENTAL TUMOR | P=0.496N P=0.243 P=0.500 (e) | P=0.464N P=0.534 P=0.523N P=0.739N |
|LOGISTIC REGRESSION | P=0.489N P=0.254 P=0.510 (e) | P=0.479N P=0.495 P=0.523N P=0.739N |
|COCHRAN-ARMITAGE | P=0.459N | P=0.503N |
|FISHER EXACT | P=0.242 P=0.500 (e) | P=0.515 P=0.490N P=0.753N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/49 (4%) 4/50 (8%) 3/50 (6%) | 4/48 (8%) 5/50 (10%) 4/50 (8%) 3/48 (6%) |
|ADJUSTED (b) | 14.9% 8.6% 16.6% 20.9% | 13.9% 17.1% 16.7% 10.0% |
|TERMINAL (d) | 1/12 (8%) 1/15 (7%) 1/11 (9%) 1/10 (10%) | 3/27 (11%) 3/24 (13%) 4/24 (17%) 3/30 (10%) |
|FIRST INCIDENCE (DAYS) | 720 384 419 652 | 690 544 734 (T) 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.262 P=0.641N P=0.297 P=0.379 | P=0.297N P=0.454 P=0.592 P=0.448N |
|INCIDENTAL TUMOR | P=0.386 P=0.674 P=0.432 P=0.378 | P=0.301N P=0.489 P=0.644N P=0.440N |
|LOGISTIC REGRESSION | P=0.362 P=0.687 P=0.339 P=0.390 | P=0.324N P=0.535 P=0.638N P=0.470N |
|COCHRAN-ARMITAGE | P=0.360 | P=0.366N |
|FISHER EXACT | P=0.684 P=0.339 P=0.500 | P=0.526 P=0.619N P=0.500N |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/49 (8%) 5/50 (10%) 3/50 (6%) | 5/48 (10%) 7/50 (14%) 4/50 (8%) 4/48 (8%) |
|ADJUSTED (b) | 14.9% 19.3% 19.2% 20.9% | 17.5% 24.0% 16.7% 13.3% |
|TERMINAL (d) | 1/12 (8%) 2/15 (13%) 1/11 (9%) 1/10 (10%) | 4/27 (15%) 4/24 (17%) 4/24 (17%) 4/30 (13%) |
|FIRST INCIDENCE (DAYS) | 720 384 419 652 | 690 544 734 (T) 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.335 P=0.401 P=0.184 P=0.379 | P=0.245N P=0.326 P=0.562N P=0.439N |
|INCIDENTAL TUMOR | P=0.475 P=0.321 P=0.289 P=0.378 | P=0.249N P=0.386 P=0.504N P=0.431N |
|LOGISTIC REGRESSION | P=0.458 P=0.338 P=0.222 P=0.390 | P=0.274N P=0.413 P=0.495N P=0.467N |
|COCHRAN-ARMITAGE | P=0.467 | P=0.320N |
|FISHER EXACT | P=0.329 P=0.218 P=0.500 | P=0.409 P=0.474N P=0.500N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/49 (6%) 1/50 (2%) 3/50 (6%) | 2/50 (4%) 1/48 (2%) 0/49 (0%) 1/50 (2%) |
|ADJUSTED (b) | 6.3% 10.4% 7.7% 18.5% | 6.1% 4.2% 0.0% 3.1% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 1/10 (10%) | 0/27 (0%) 1/24 (4%) 0/24 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 706 616 720 636 | 687 734 (T) --- 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.202 P=0.335 P=0.745 P=0.221 | P=0.336N P=0.521N P=0.224N P=0.477N |
|INCIDENTAL TUMOR | P=0.243 P=0.262 P=0.670 P=0.252 | P=0.334N P=0.419N P=0.091N P=0.480N |
|LOGISTIC REGRESSION | P=0.252 P=0.307 P=0.730 P=0.243 | P=0.341N P=0.502N P=0.232N P=0.476N |
|COCHRAN-ARMITAGE | P=0.316 | P=0.364N |
|FISHER EXACT | P=0.301 P=0.753N P=0.309 | P=0.515N P=0.253N P=0.500N |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/48 (0%) 0/49 (0%) 1/50 (2%) |
|ADJUSTED (b) | 13.2% 2.1% 9.1% 10.0% | 0.0% 0.0% 0.0% 2.7% |
|TERMINAL (d) | 1/12 (8%) 0/15 (0%) 1/11 (9%) 1/10 (10%) | 0/27 (0%) 0/24 (0%) 0/24 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 695 540 733 (T) 733 (T) | --- --- --- 664 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.499N P=0.467N P=0.533N P=0.596N | P=0.204 (e) (e) P=0.511 |
|INCIDENTAL TUMOR | P=0.423N P=0.554N P=0.567N P=0.580N | P=0.160 (e) (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.469N P=0.503N P=0.552N P=0.602N | P=0.194 (e) (e) P=0.495 |
|COCHRAN-ARMITAGE | P=0.407N | P=0.201 |
|FISHER EXACT | P=0.508N P=0.500N P=0.500N | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/49 (8%) 2/50 (4%) 4/50 (8%) | 2/50 (4%) 1/48 (2%) 0/49 (0%) 2/50 (4%) |
|ADJUSTED (b) | 18.6% 12.3% 16.1% 27.6% | 6.1% 4.2% 0.0% 5.7% |
|TERMINAL (d) | 1/12 (8%) 0/15 (0%) 1/11 (9%) 2/10 (20%) | 0/27 (0%) 1/24 (4%) 0/24 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 695 540 720 636 | 687 734 (T) --- 664 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.322 P=0.544 P=0.538N P=0.358 | P=0.610N P=0.521N P=0.224N P=0.669N |
|INCIDENTAL TUMOR | P=0.404 P=0.427 P=0.626N P=0.397 | P=0.620 P=0.419N P=0.091N P=0.685N |
|LOGISTIC REGRESSION | P=0.388 P=0.500 P=0.571N P=0.373 | P=0.614 P=0.502N P=0.232N P=0.678N |
|COCHRAN-ARMITAGE | P=0.484 | P=0.594 |
|FISHER EXACT | P=0.489 P=0.500N P=0.500 | P=0.515N P=0.253N P=0.691N |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | 0/49 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 4.2% 8.3% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 0/27 (0%) 1/24 (4%) 2/24 (8%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 734 (T) 734 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.559N P=0.477 P=0.212 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.559N P=0.477 P=0.212 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.559N P=0.477 P=0.212 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.612N |
|FISHER EXACT | (e) (e) (e) | P=0.505 P=0.253 (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 8.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 0/27 (0%) 0/24 (0%) 0/24 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 678 --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.501N P=0.240 (e) (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.474N P=0.197 (e) (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.434N P=0.242 (e) (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.404N | (e) |
|FISHER EXACT | P=0.242 (e) (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | 0/49 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 8.0% 0.0% 0.0% | 0.0% 4.2% 8.3% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 0/27 (0%) 1/24 (4%) 2/24 (8%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 678 --- --- | --- 734 (T) 734 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.501N P=0.240 (e) (e) | P=0.559N P=0.477 P=0.212 (e) |
|INCIDENTAL TUMOR | P=0.474N P=0.197 (e) (e) | P=0.559N P=0.477 P=0.212 (e) |
|LOGISTIC REGRESSION | P=0.434N P=0.242 (e) (e) | P=0.559N P=0.477 P=0.212 (e) |
|COCHRAN-ARMITAGE | P=0.404N | P=0.612N |
|FISHER EXACT | P=0.242 (e) (e) | P=0.505 P=0.253 (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | 0/49 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 8.0% 0.0% 0.0% | 0.0% 4.2% 8.3% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 0/27 (0%) 1/24 (4%) 2/24 (8%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 678 --- --- | --- 734 (T) 734 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.501N P=0.240 (e) (e) | P=0.559N P=0.477 P=0.212 (e) |
|INCIDENTAL TUMOR | P=0.474N P=0.197 (e) (e) | P=0.559N P=0.477 P=0.212 (e) |
|LOGISTIC REGRESSION | P=0.434N P=0.242 (e) (e) | P=0.559N P=0.477 P=0.212 (e) |
|COCHRAN-ARMITAGE | P=0.404N | P=0.612N |
|FISHER EXACT | P=0.242 (e) (e) | P=0.505 P=0.253 (e) |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 2/50 (4%) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |
|ADJUSTED (b) | 5.0% 0.0% 0.0% 13.5% | 3.7% 0.0% 0.0% 8.3% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 1/10 (10%) | 1/27 (4%) 0/24 (0%) 0/24 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 692 --- --- 637 | 734 (T) --- --- 646 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.177 P=0.500N P=0.521N P=0.401 | P=0.112 P=0.523N P=0.523N P=0.353 |
|INCIDENTAL TUMOR | P=0.219 P=0.536N P=0.581N P=0.464 | P=0.092 P=0.523N P=0.523N P=0.360 |
|LOGISTIC REGRESSION | P=0.203 P=0.491N P=0.527N P=0.441 | P=0.094 P=0.523N P=0.523N P=0.333 |
|COCHRAN-ARMITAGE | P=0.247 | P=0.088 |
|FISHER EXACT | P=0.505N P=0.500N P=0.500 | P=0.495N P=0.495N P=0.316 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 2/50 (4%) | 2/49 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |
|ADJUSTED (b) | 5.0% 0.0% 0.0% 13.5% | 7.4% 0.0% 0.0% 8.3% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 1/10 (10%) | 2/27 (7%) 0/24 (0%) 0/24 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 692 --- --- 637 | 734 (T) --- --- 646 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.177 P=0.500N P=0.521N P=0.401 | P=0.298 P=0.264N P=0.264N P=0.560 |
|INCIDENTAL TUMOR | P=0.219 P=0.536N P=0.581N P=0.464 | P=0.282 P=0.264N P=0.264N P=0.571 |
|LOGISTIC REGRESSION | P=0.203 P=0.491N P=0.527N P=0.441 | P=0.270 P=0.264N P=0.264N P=0.542 |
|COCHRAN-ARMITAGE | P=0.247 | P=0.249 |
|FISHER EXACT | P=0.505N P=0.500N P=0.500 | P=0.242N P=0.242N P=0.510 |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 6/50 (12%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.7% 3.8% 19.7% 3.1% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 1/27 (4%) 0/24 (0%) 2/24 (8%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 734 (T) 706 664 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.558 P=0.735 P=0.059 P=0.724N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.517 P=0.730N P=0.138 P=0.724N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.521 P=0.762 P=0.071 P=0.724N |
|COCHRAN-ARMITAGE | (e) | P=0.477 |
|FISHER EXACT | (e) (e) (e) | P=0.753N P=0.056 P=0.753N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 27/50 (54%) 21/50 (42%) 24/50 (48%) 24/50 (48%) |
|ADJUSTED (b) | 8.3% 10.0% 9.1% 4.3% | 72.7% 68.0% 62.7% 66.5% |
|TERMINAL (d) | 1/12 (8%) 1/15 (7%) 1/11 (9%) 0/10 (0%) | 17/27 (63%) 15/24 (63%) 11/24 (46%) 20/32 (63%) |
|FIRST INCIDENCE (DAYS) | 733 (T) 667 733 (T) 645 | 547 511 489 646 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.609 P=0.561 P=0.746 P=0.710 | P=0.168N P=0.275N P=0.428N P=0.143N |
|INCIDENTAL TUMOR | P=0.618 P=0.531 P=0.746 P=0.703 | P=0.238N P=0.178N P=0.170N P=0.156N |
|LOGISTIC REGRESSION | P=0.621N P=0.530 P=0.746 P=0.726 | P=0.275N P=0.109N P=0.210N P=0.170N |
|COCHRAN-ARMITAGE | P=0.531N | P=0.424N |
|FISHER EXACT | P=0.500 P=0.753N P=0.753N | P=0.158N P=0.345N P=0.345N |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 27/50 (54%) 22/50 (44%) 29/50 (58%) 24/50 (48%) |
|ADJUSTED (b) | 8.3% 10.0% 9.1% 4.3% | 72.7% 69.2% 71.3% 66.5% |
|TERMINAL (d) | 1/12 (8%) 1/15 (7%) 1/11 (9%) 0/10 (0%) | 17/27 (63%) 15/24 (63%) 13/24 (54%) 20/32 (63%) |
|FIRST INCIDENCE (DAYS) | 733 (T) 667 733 (T) 645 | 547 511 489 646 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.609 P=0.561 P=0.746 P=0.710 | P=0.174N P=0.348N P=0.379 P=0.143N |
|INCIDENTAL TUMOR | P=0.618 P=0.531 P=0.746 P=0.703 | P=0.246N P=0.225N P=0.448N P=0.156N |
|LOGISTIC REGRESSION | P=0.621N P=0.530 P=0.746 P=0.726 | P=0.282N P=0.151N P=0.570N P=0.170N |
|COCHRAN-ARMITAGE | P=0.531N | P=0.443N |
|FISHER EXACT | P=0.500 P=0.753N P=0.753N | P=0.212N P=0.420 P=0.345N |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 6.7% 9.1% 6.3% | 3.7% 0.0% 3.3% 6.0% |
|TERMINAL (d) | 0/12 (0%) 1/15 (7%) 1/11 (9%) 0/10 (0%) | 1/27 (4%) 0/24 (0%) 0/24 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | --- 733 (T) 733 (T) 678 | 734 (T) --- 706 681 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.294 P=0.545 P=0.483 P=0.403 | P=0.295 P=0.523N P=0.751 P=0.543 |
|INCIDENTAL TUMOR | P=0.310 P=0.545 P=0.483 P=0.435 | P=0.263 P=0.523N P=0.690N P=0.539 |
|LOGISTIC REGRESSION | P=0.301 P=0.545 P=0.483 P=0.474 | P=0.270 P=0.523N P=0.748N P=0.531 |
|COCHRAN-ARMITAGE | P=0.384 | P=0.247 |
|FISHER EXACT | P=0.500 P=0.500 P=0.500 | P=0.500N P=0.753N P=0.500 |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 27/49 (55%) 37/49 (76%) 34/50 (68%) | 34/48 (71%) 28/50 (56%) 33/49 (67%) 29/50 (58%) |
|ADJUSTED (b) | 97.5% 78.9% 94.1% 93.1% | 80.5% 73.9% 83.8% 72.2% |
|TERMINAL (d) | 11/12 (92%) 9/15 (60%) 9/11 (82%) 8/10 (80%) | 19/27 (70%) 15/24 (63%) 18/24 (75%) 21/32 (66%) |
|FIRST INCIDENCE (DAYS) | 465 384 479 468 | 400 551 487 511 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.232 P=0.010N* P=0.492 P=0.529 | P=0.088N P=0.295N P=0.554N P=0.080N |
|INCIDENTAL TUMOR | P=0.289N P=0.003N** P=0.424N P=0.086N | P=0.148N P=0.105N P=0.320N P=0.087N |
|LOGISTIC REGRESSION | P=0.351N P=0.002N** P=0.345N P=0.109N | P=0.145N P=0.089N P=0.355N P=0.087N |
|COCHRAN-ARMITAGE | P=0.279N | P=0.211N |
|FISHER EXACT | P=0.004N** P=0.294N P=0.083N | P=0.094N P=0.440N P=0.132N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 27/49 (55%) 37/49 (76%) 34/50 (68%) | 34/48 (71%) 29/50 (58%) 33/49 (67%) 29/50 (58%) |
|ADJUSTED (b) | 97.5% 78.9% 94.1% 93.1% | 80.5% 74.7% 83.8% 72.2% |
|TERMINAL (d) | 11/12 (92%) 9/15 (60%) 9/11 (82%) 8/10 (80%) | 19/27 (70%) 15/24 (63%) 18/24 (75%) 21/32 (66%) |
|FIRST INCIDENCE (DAYS) | 465 384 479 468 | 400 551 487 511 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.232 P=0.010N* P=0.492 P=0.529 | P=0.080N P=0.354N P=0.554N P=0.080N |
|INCIDENTAL TUMOR | P=0.289N P=0.003N** P=0.424N P=0.086N | P=0.130N P=0.135N P=0.320N P=0.087N |
|LOGISTIC REGRESSION | P=0.351N P=0.002N** P=0.345N P=0.109N | P=0.127N P=0.125N P=0.355N P=0.087N |
|COCHRAN-ARMITAGE | P=0.279N | P=0.189N |
|FISHER EXACT | P=0.004N** P=0.294N P=0.083N | P=0.132N P=0.440N P=0.132N |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 13.3% 5.3% 0.0% | 0.0% 0.0% 0.0% 3.1% |
|TERMINAL (d) | 0/12 (0%) 2/15 (13%) 0/11 (0%) 0/10 (0%) | 0/27 (0%) 0/24 (0%) 0/24 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | --- 733 (T) 686 --- | --- --- --- 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.555N P=0.286 P=0.480 (e) | P=0.233 (e) (e) P=0.534 |
|INCIDENTAL TUMOR | P=0.536N P=0.286 P=0.419 (e) | P=0.233 (e) (e) P=0.534 |
|LOGISTIC REGRESSION | P=0.546N P=0.286 P=0.475 (e) | P=0.233 (e) (e) P=0.534 |
|COCHRAN-ARMITAGE | P=0.461N | P=0.198 |
|FISHER EXACT | P=0.247 P=0.500 (e) | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|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%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 13.3% 5.3% 0.0% | 0.0% 0.0% 0.0% 3.1% |
|TERMINAL (d) | 0/12 (0%) 2/15 (13%) 0/11 (0%) 0/10 (0%) | 0/27 (0%) 0/24 (0%) 0/24 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | --- 733 (T) 686 --- | --- --- --- 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.555N P=0.286 P=0.480 (e) | P=0.233 (e) (e) P=0.534 |
|INCIDENTAL TUMOR | P=0.536N P=0.286 P=0.419 (e) | P=0.233 (e) (e) P=0.534 |
|LOGISTIC REGRESSION | P=0.546N P=0.286 P=0.475 (e) | P=0.233 (e) (e) P=0.534 |
|COCHRAN-ARMITAGE | P=0.461N | P=0.198 |
|FISHER EXACT | P=0.247 P=0.500 (e) | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal |
| Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 7/50 (14%) 4/50 (8%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 15.4% 36.0% 24.8% 14.3% | 3.7% 0.0% 0.0% 6.3% |
|TERMINAL (d) | 1/12 (8%) 4/15 (27%) 2/11 (18%) 1/10 (10%) | 1/27 (4%) 0/24 (0%) 0/24 (0%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 729 674 578 652 | 734 (T) --- --- 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.525N P=0.127 P=0.289 P=0.606 | P=0.301 P=0.523N P=0.523N P=0.560 |
|INCIDENTAL TUMOR | P=0.494N P=0.086 P=0.258 P=0.601 | P=0.301 P=0.523N P=0.523N P=0.560 |
|LOGISTIC REGRESSION | P=0.499N P=0.094 P=0.267 P=0.598 | P=0.301 P=0.523N P=0.523N P=0.560 |
|COCHRAN-ARMITAGE | P=0.341N | P=0.246 |
|FISHER EXACT | P=0.080 P=0.339 P=0.691N | P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 19.9% 5.9% 4.0% 26.5% | 0.0% 0.0% 4.2% 6.3% |
|TERMINAL (d) | 2/12 (17%) 0/15 (0%) 0/11 (0%) 1/10 (10%) | 0/27 (0%) 0/24 (0%) 1/24 (4%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 678 716 636 650 | --- --- 734 (T) 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.192 P=0.255N P=0.369N P=0.355 | P=0.102 (e) P=0.477 P=0.276 |
|INCIDENTAL TUMOR | P=0.206 P=0.297N P=0.358N P=0.356 | P=0.102 (e) P=0.477 P=0.276 |
|LOGISTIC REGRESSION | P=0.205 P=0.270N P=0.355N P=0.369 | P=0.102 (e) P=0.477 P=0.276 |
|COCHRAN-ARMITAGE | P=0.302 | P=0.070 |
|FISHER EXACT | P=0.309N P=0.309N P=0.500 | (e) P=0.500 P=0.247 |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) 4/50 (8%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 19.9% 9.1% 6.5% 26.5% | 0.0% 2.0% 4.2% 6.3% |
|TERMINAL (d) | 2/12 (17%) 0/15 (0%) 0/11 (0%) 1/10 (10%) | 0/27 (0%) 0/24 (0%) 1/24 (4%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 678 664 541 650 | --- 511 734 (T) 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.227 P=0.440N P=0.574N P=0.355 | P=0.196 P=0.521 P=0.477 P=0.276 |
|INCIDENTAL TUMOR | P=0.282 P=0.509N P=0.471N P=0.356 | P=0.189 P=0.398 P=0.477 P=0.276 |
|LOGISTIC REGRESSION | P=0.280 P=0.466N P=0.533N P=0.369 | P=0.151 P=0.478 P=0.477 P=0.276 |
|COCHRAN-ARMITAGE | P=0.357 | P=0.153 |
|FISHER EXACT | P=0.500N P=0.500N P=0.500 | P=0.500 P=0.500 P=0.247 |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 15.4% 21.3% 20.6% 14.3% | 3.7% 0.0% 0.0% 3.1% |
|TERMINAL (d) | 1/12 (8%) 2/15 (13%) 2/11 (18%) 1/10 (10%) | 1/27 (4%) 0/24 (0%) 0/24 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 729 679 578 652 | 734 (T) --- --- 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.546 P=0.419 P=0.448 P=0.606 | P=0.632 P=0.523N P=0.523N P=0.724N |
|INCIDENTAL TUMOR | P=0.563 P=0.345 P=0.439 P=0.601 | P=0.632 P=0.523N P=0.523N P=0.724N |
|LOGISTIC REGRESSION | P=0.556 P=0.380 P=0.430 P=0.598 | P=0.632 P=0.523N P=0.523N P=0.724N |
|COCHRAN-ARMITAGE | P=0.479N | P=0.595 |
|FISHER EXACT | P=0.339 P=0.500 P=0.691N | P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%) |
|ADJUSTED (b) | 0.0% 10.3% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/15 (7%) 0/11 (0%) 0/10 (0%) | 0/27 (0%) 0/24 (0%) 0/24 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 674 --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.484N P=0.264 (e) (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.466N P=0.243 (e) (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.459N P=0.253 (e) (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.405N | (e) |
|FISHER EXACT | P=0.247 (e) (e) | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 3/50 (6%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 15.4% 30.2% 20.6% 14.3% | 3.7% 0.0% 0.0% 3.1% |
|TERMINAL (d) | 1/12 (8%) 3/15 (20%) 2/11 (18%) 1/10 (10%) | 1/27 (4%) 0/24 (0%) 0/24 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 729 674 578 652 | 734 (T) --- --- 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.532N P=0.192 P=0.448 P=0.606 | P=0.632 P=0.523N P=0.523N P=0.724N |
|INCIDENTAL TUMOR | P=0.507N P=0.136 P=0.439 P=0.601 | P=0.632 P=0.523N P=0.523N P=0.724N |
|LOGISTIC REGRESSION | P=0.513N P=0.155 P=0.430 P=0.598 | P=0.632 P=0.523N P=0.523N P=0.724N |
|COCHRAN-ARMITAGE | P=0.367N | P=0.595 |
|FISHER EXACT | P=0.134 P=0.500 P=0.691N | P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 3/50 (6%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 15.4% 30.2% 20.6% 14.3% | 3.7% 0.0% 0.0% 3.1% |
|TERMINAL (d) | 1/12 (8%) 3/15 (20%) 2/11 (18%) 1/10 (10%) | 1/27 (4%) 0/24 (0%) 0/24 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 729 674 578 652 | 734 (T) --- --- 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.532N P=0.192 P=0.448 P=0.606 | P=0.632 P=0.523N P=0.523N P=0.724N |
|INCIDENTAL TUMOR | P=0.507N P=0.136 P=0.439 P=0.601 | P=0.632 P=0.523N P=0.523N P=0.724N |
|LOGISTIC REGRESSION | P=0.513N P=0.155 P=0.430 P=0.598 | P=0.632 P=0.523N P=0.523N P=0.724N |
|COCHRAN-ARMITAGE | P=0.367N | P=0.595 |
|FISHER EXACT | P=0.134 P=0.500 P=0.691N | P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 8.3% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 6.3% |
|TERMINAL (d) | 1/12 (8%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 0/27 (0%) 0/24 (0%) 0/24 (0%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 733 (T) --- --- --- | --- --- --- 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.334N P=0.455N P=0.517N P=0.536N | P=0.068 (e) (e) P=0.276 |
|INCIDENTAL TUMOR | P=0.334N P=0.455N P=0.517N P=0.536N | P=0.068 (e) (e) P=0.276 |
|LOGISTIC REGRESSION | P=0.334N P=0.455N P=0.517N P=0.536N | P=0.068 (e) (e) P=0.276 |
|COCHRAN-ARMITAGE | P=0.306N | P=0.046 * |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | (e) (e) P=0.247 |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 8.3% 0.0% 0.0% 0.0% | 2.4% 0.0% 0.0% 6.3% |
|TERMINAL (d) | 1/12 (8%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 0/27 (0%) 0/24 (0%) 0/24 (0%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 733 (T) --- --- --- | 580 --- --- 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.334N P=0.455N P=0.517N P=0.536N | P=0.290 P=0.491N P=0.473N P=0.550 |
|INCIDENTAL TUMOR | P=0.334N P=0.455N P=0.517N P=0.536N | P=0.246 P=0.479N P=0.617N P=0.493 |
|LOGISTIC REGRESSION | P=0.334N P=0.455N P=0.517N P=0.536N | P=0.247 P=0.514N P=0.572N P=0.508 |
|COCHRAN-ARMITAGE | P=0.306N | P=0.246 |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 43/50 (86%) 30/50 (60%) 36/50 (72%) | |
|ADJUSTED (b) | 88.9% 100.0% 100.0% 94.0% | |
|TERMINAL (d) | 9/12 (75%) 15/15 (100%) 11/11 (100%) 8/10 (80%) | |
|FIRST INCIDENCE (DAYS) | 421 540 440 441 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.064 P=0.145 P=0.353 P=0.060 | |
|INCIDENTAL TUMOR | P=0.213 P=0.005 ** P=0.490 P=0.125 | |
|LOGISTIC REGRESSION | P=0.219 P=0.004 ** P=0.444 P=0.108 | |
|COCHRAN-ARMITAGE | P=0.388 | |
|FISHER EXACT | P=0.003 ** P=0.581N P=0.146 | |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Thymoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/49 (0%) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 12.1% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 1/11 (9%) 0/10 (0%) | 0/26 (0%) 0/24 (0%) 0/24 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 601 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.551 (e) P=0.208 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.580 (e) P=0.230 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.572 (e) P=0.219 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.592 | (e) |
|FISHER EXACT | (e) P=0.247 (e) | (e) (e) (e) |
|=================================================================================================================================|
| |
|Thymus |
| Thymoma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 3/50 (6%) 0/49 (0%) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 20.9% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 2/11 (18%) 0/10 (0%) | 0/26 (0%) 0/24 (0%) 0/24 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 601 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.478 (e) P=0.099 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.504 (e) P=0.110 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.485 (e) P=0.097 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.536 | (e) |
|FISHER EXACT | (e) P=0.121 (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 4/50 (8%) 2/50 (4%) | 1/49 (2%) 4/49 (8%) 2/50 (4%) 3/50 (6%) |
|ADJUSTED (b) | 5.6% 11.3% 22.2% 20.0% | 3.7% 14.6% 8.3% 9.4% |
|TERMINAL (d) | 0/12 (0%) 1/15 (7%) 1/11 (9%) 2/10 (20%) | 1/27 (4%) 3/24 (13%) 2/24 (8%) 3/32 (9%) |
|FIRST INCIDENCE (DAYS) | 698 692 617 733 (T) | 734 (T) 624 734 (T) 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.247 P=0.532 P=0.150 P=0.411 | P=0.472 P=0.159 P=0.459 P=0.367 |
|INCIDENTAL TUMOR | P=0.282 P=0.483 P=0.111 P=0.420 | P=0.441 P=0.152 P=0.459 P=0.367 |
|LOGISTIC REGRESSION | P=0.273 P=0.526 P=0.143 P=0.397 | P=0.430 P=0.186 P=0.459 P=0.367 |
|COCHRAN-ARMITAGE | P=0.390 | P=0.382 |
|FISHER EXACT | P=0.492 P=0.181 P=0.500 | P=0.181 P=0.508 P=0.316 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/49 (2%) 1/50 (2%) 1/50 (2%) | 1/49 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 19.0% 3.6% 2.4% 7.1% | 3.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/12 (17%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 1/27 (4%) 0/24 (0%) 0/24 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 608 667 520 680 | 734 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.331N P=0.255N P=0.351N P=0.396N | P=0.288N P=0.523N P=0.523N P=0.466N |
|INCIDENTAL TUMOR | P=0.247N P=0.277N P=0.240N P=0.351N | P=0.288N P=0.523N P=0.523N P=0.466N |
|LOGISTIC REGRESSION | P=0.257N P=0.291N P=0.317N P=0.366N | P=0.288N P=0.523N P=0.523N P=0.466N |
|COCHRAN-ARMITAGE | P=0.240N | P=0.303N |
|FISHER EXACT | P=0.316N P=0.309N P=0.309N | P=0.500N P=0.495N P=0.495N |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/49 (6%) 5/50 (10%) 3/50 (6%) | 2/49 (4%) 4/49 (8%) 2/50 (4%) 3/50 (6%) |
|ADJUSTED (b) | 23.5% 14.5% 24.0% 25.7% | 7.4% 14.6% 8.3% 9.4% |
|TERMINAL (d) | 2/12 (17%) 1/15 (7%) 1/11 (9%) 2/10 (20%) | 2/27 (7%) 3/24 (13%) 2/24 (8%) 3/32 (9%) |
|FIRST INCIDENCE (DAYS) | 608 667 520 680 | 734 (T) 624 734 (T) 734 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.476 P=0.433N P=0.425 P=0.635N | P=0.537N P=0.301 P=0.654 P=0.578 |
|INCIDENTAL TUMOR | P=0.571 P=0.485N P=0.460 P=0.593N | P=0.567N P=0.292 P=0.654 P=0.578 |
|LOGISTIC REGRESSION | P=0.564 P=0.472N P=0.448 P=0.629N | P=0.581N P=0.344 P=0.654 P=0.578 |
|COCHRAN-ARMITAGE | P=0.478N | P=0.532 |
|FISHER EXACT | P=0.511N P=0.500 P=0.500N | P=0.339 P=0.684N P=0.510 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) | 1/49 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 5.9% 0.0% | 3.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 1/27 (4%) 0/24 (0%) 0/24 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 576 --- | 734 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.574 (e) P=0.212 (e) | P=0.288N P=0.523N P=0.523N P=0.466N |
|INCIDENTAL TUMOR | P=0.629 (e) P=0.236 (e) | P=0.288N P=0.523N P=0.523N P=0.466N |
|LOGISTIC REGRESSION | P=0.605 (e) P=0.248 (e) | P=0.288N P=0.523N P=0.523N P=0.466N |
|COCHRAN-ARMITAGE | P=0.596 | P=0.303N |
|FISHER EXACT | (e) P=0.247 (e) | P=0.500N P=0.495N P=0.495N |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) | 1/49 (2%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 5.9% 0.0% | 3.7% 0.0% 2.6% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 1/27 (4%) 0/24 (0%) 0/24 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 576 --- | 734 (T) --- 681 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.574 (e) P=0.212 (e) | P=0.381N P=0.523N P=0.758N P=0.466N |
|INCIDENTAL TUMOR | P=0.629 (e) P=0.236 (e) | P=0.373N P=0.523N P=0.678N P=0.466N |
|LOGISTIC REGRESSION | P=0.605 (e) P=0.248 (e) | P=0.385N P=0.523N P=0.741N P=0.466N |
|COCHRAN-ARMITAGE | P=0.596 | P=0.400N |
|FISHER EXACT | (e) P=0.247 (e) | P=0.500N P=0.747N P=0.495N |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 5/50 (10%) 1/50 (2%) 6/50 (12%) |
|ADJUSTED (b) | | 6.5% 18.6% 4.2% 16.3% |
|TERMINAL (d) | | 1/27 (4%) 4/24 (17%) 1/24 (4%) 4/32 (13%) |
|FIRST INCIDENCE (DAYS) | | 679 575 734 (T) 549 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.229 P=0.188 P=0.514N P=0.189 |
|INCIDENTAL TUMOR | | P=0.170 P=0.212 P=0.437N P=0.137 |
|LOGISTIC REGRESSION | | P=0.170 P=0.225 P=0.472N P=0.146 |
|COCHRAN-ARMITAGE | | P=0.151 |
|FISHER EXACT | | P=0.218 P=0.500N P=0.134 |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | | 0.0% 7.1% 0.0% 2.0% |
|TERMINAL (d) | | 0/27 (0%) 1/24 (4%) 0/24 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | | --- 681 --- 441 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.565 P=0.227 (e) P=0.512 |
|INCIDENTAL TUMOR | | P=0.543 P=0.270 (e) P=0.455 |
|LOGISTIC REGRESSION | | P=0.486 P=0.242 (e) P=0.325 |
|COCHRAN-ARMITAGE | | P=0.539 |
|FISHER EXACT | | P=0.247 (e) P=0.500 |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 6/50 (12%) 1/50 (2%) 7/50 (14%) |
|ADJUSTED (b) | | 6.5% 21.0% 4.2% 18.0% |
|TERMINAL (d) | | 1/27 (4%) 4/24 (17%) 1/24 (4%) 4/32 (13%) |
|FIRST INCIDENCE (DAYS) | | 679 575 734 (T) 441 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.174 P=0.117 P=0.514N P=0.123 |
|INCIDENTAL TUMOR | | P=0.121 P=0.148 P=0.437N P=0.079 |
|LOGISTIC REGRESSION | | P=0.110 P=0.141 P=0.472N P=0.071 |
|COCHRAN-ARMITAGE | | P=0.109 |
|FISHER EXACT | | P=0.134 P=0.500N P=0.080 |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 32/50 (64%) 23/50 (46%) 34/50 (68%) | 12/50 (24%) 19/50 (38%) 18/50 (36%) 25/50 (50%) |
|ADJUSTED (b) | 84.9% 85.1% 77.5% 91.0% | 28.7% 54.0% 46.5% 57.4% |
|TERMINAL (d) | 7/12 (58%) 10/15 (67%) 6/11 (55%) 7/10 (70%) | 2/27 (7%) 9/24 (38%) 6/24 (25%) 14/32 (44%) |
|FIRST INCIDENCE (DAYS) | 259 554 468 441 | 428 608 580 541 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.133 P=0.309N P=0.233N P=0.164 | P=0.065 P=0.116 P=0.201 P=0.047 * |
|INCIDENTAL TUMOR | P=0.300 P=0.407N P=0.114N P=0.285 | P=0.004 ** P=0.121 P=0.156 P=0.003 ** |
|LOGISTIC REGRESSION | P=0.406 P=0.459N P=0.046N* P=0.428 | P=0.008 ** P=0.094 P=0.087 P=0.005 ** |
|COCHRAN-ARMITAGE | P=0.520 | P=0.008 ** |
|FISHER EXACT | P=0.500N P=0.035N* P=0.500 | P=0.097 P=0.138 P=0.006 ** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated |
| Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 2.3% 3.3% 0.0% 0.0% | 0.0% 0.0% 6.3% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | 0/27 (0%) 0/24 (0%) 1/24 (4%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 549 663 --- --- | --- --- 608 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.286N P=0.749N P=0.530N P=0.514N | P=0.625 (e) P=0.244 (e) |
|INCIDENTAL TUMOR | P=0.253N P=0.756 P=0.500N P=0.461N | P=0.563 (e) P=0.166 (e) |
|LOGISTIC REGRESSION | P=0.229N P=0.759 P=0.496N P=0.504N | P=0.591 (e) P=0.230 (e) |
|COCHRAN-ARMITAGE | P=0.236N | P=0.595 |
|FISHER EXACT | P=0.753N P=0.500N P=0.500N | (e) P=0.247 (e) |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 8.1% 0.0% 5.3% 11.9% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/11 (0%) 1/10 (10%) | 0/27 (0%) 0/24 (0%) 0/24 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 604 --- 686 463 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.378 P=0.225N P=0.546N P=0.631 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.476 P=0.244N P=0.594N P=0.662N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.468 P=0.236N P=0.524N P=0.691N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.469 | (e) |
|FISHER EXACT | P=0.247N P=0.500N P=0.691N | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 49/50 (98%) 46/50 (92%) 49/50 (98%) | 44/50 (88%) 37/50 (74%) 44/50 (88%) 41/50 (82%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 97.8% 89.4% 97.7% 97.6% |
|TERMINAL (d) | 12/12 (100%) 15/15 (100%) 11/11 (100%) 10/10 (100%)| 26/27 (96%) 20/24 (83%) 23/24 (96%) 31/32 (97%) |
|FIRST INCIDENCE (DAYS) | 421 384 440 441 | 400 511 487 511 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.060 P=0.392N P=0.318 P=0.110 | P=0.103N P=0.269N P=0.479 P=0.070N |
|INCIDENTAL TUMOR | P=0.336 P=0.318 P=0.606N P=0.378 | P=0.221N P=0.077N P=0.330N P=0.064N |
|LOGISTIC REGRESSION | P=0.408 P=0.245 P=0.543N P=0.364 | P=0.249N P=0.034N* P=0.279N P=0.053N |
|COCHRAN-ARMITAGE | P=0.343 | P=0.475N |
|FISHER EXACT | P=0.309 P=0.500N P=0.309 | P=0.062N P=0.620N P=0.288N |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 40/50 (80%) 38/50 (76%) 33/50 (66%) 36/50 (72%) | 21/50 (42%) 30/50 (60%) 25/50 (50%) 30/50 (60%) |
|ADJUSTED (b) | 92.5% 89.8% 86.6% 91.3% | 50.4% 74.3% 61.8% 65.9% |
|TERMINAL (d) | 9/12 (75%) 11/15 (73%) 7/11 (64%) 7/10 (70%) | 8/27 (30%) 14/24 (58%) 10/24 (42%) 17/32 (53%) |
|FIRST INCIDENCE (DAYS) | 259 384 419 441 | 428 511 580 441 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.284 P=0.257N P=0.432N P=0.358 | P=0.368 P=0.081 P=0.330 P=0.231 |
|INCIDENTAL TUMOR | P=0.238N P=0.403N P=0.134N P=0.365N | P=0.087 P=0.070 P=0.344 P=0.037 * |
|LOGISTIC REGRESSION | P=0.215N P=0.384N P=0.091N P=0.267N | P=0.101 P=0.058 P=0.367 P=0.041 * |
|COCHRAN-ARMITAGE | P=0.186N | P=0.098 |
|FISHER EXACT | P=0.405N P=0.088N P=0.241N | P=0.055 P=0.274 P=0.055 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 49/50 (98%) 49/50 (98%) 50/50 (100%)| 48/50 (96%) 49/50 (98%) 50/50 (100%) 49/50 (98%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 98.0% 100.0% 100.0% 98.0% |
|TERMINAL (d) | 12/12 (100%) 15/15 (100%) 11/11 (100%) 10/10 (100%)| 26/27 (96%) 24/24 (100%) 24/24 (100%) 31/32 (97%) |
|FIRST INCIDENCE (DAYS) | 259 384 419 441 | 400 511 487 441 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.080 P=0.267N P=0.319 P=0.162 | P=0.158N P=0.367 P=0.395 P=0.239N |
|INCIDENTAL TUMOR | P=0.686N P=0.500N P=0.690N (e) | P=0.632N P=0.523 P=0.523 P=0.724 |
|LOGISTIC REGRESSION | P=0.590N P=0.500N P=0.450N (e) | P=0.624N P=0.613 P=0.494 P=0.697 |
|COCHRAN-ARMITAGE | P=0.595 | P=0.366 |
|FISHER EXACT | P=0.500N P=0.500N P=1.000N | P=0.500 P=0.247 P=0.500 |
|=================================================================================================================================|
DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(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. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's 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).