TDMS Study 60968-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest ISOBUTYRALDEHYDE DATE: 09/23/96
EXPERIMENT: 60968 TEST: 02 TIME: 16:03:49
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-95241 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60968B
PATHOLOGIST: S. GRUMBEIN GRUMBEIN, SONDRA 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: 09/23/96
EXPERIMENT: 60968 TEST: 02 TIME: 16:03:49
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-95241 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60968B
PATHOLOGIST: S. GRUMBEIN GRUMBEIN, SONDRA CAS: 0078-84-2
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 Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Epididymis
Gallbladder
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: 09/23/96
EXPERIMENT: 60968 TEST: 02 TIME: 16:03:49
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-95241 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60968B
PATHOLOGIST: S. GRUMBEIN GRUMBEIN, SONDRA CAS: 0078-84-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF ISOBUTYRALDEHYDE
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated
Cell Type
Malignant and Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Skin Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Fibrosarcoma
Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
All Organs Benign Tumors
====================================================================================================
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.0% 2.7% 2.9% 3.3% | 0.0% 6.3% 0.0% 0.0% |
|TERMINAL (d) | 2/40 (5%) 1/37 (3%) 1/35 (3%) 1/30 (3%) | 0/28 (0%) 2/32 (6%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) 733 (T) 733 (T) | --- 735 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.501N P=0.527N P=0.547N P=0.600N | P=0.352N P=0.268 (e) (e) |
|INCIDENTAL TUMOR | P=0.501N P=0.527N P=0.547N P=0.600N | P=0.352N P=0.268 (e) (e) |
|LOGISTIC REGRESSION | P=0.501N P=0.527N P=0.547N P=0.600N | P=0.352N P=0.268 (e) (e) |
|COCHRAN-ARMITAGE | P=0.409N | P=0.404N |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.242 (e) (e) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 2.7% 0.0% 2.3% | 3.6% 5.7% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 1/37 (3%) 0/35 (0%) 0/30 (0%) | 1/28 (4%) 1/32 (3%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- 733 (T) --- 616 | 735 (T) 691 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.368 P=0.484 (e) P=0.483 | P=0.156N P=0.537 P=0.450N P=0.444N |
|INCIDENTAL TUMOR | P=0.424 P=0.484 (e) P=0.638 | P=0.177N P=0.494 P=0.450N P=0.444N |
|LOGISTIC REGRESSION | P=0.414 P=0.484 (e) P=0.563 | P=0.171N P=0.521 P=0.450N P=0.444N |
|COCHRAN-ARMITAGE | P=0.405 | P=0.187N |
|FISHER EXACT | P=0.500 (e) P=0.500 | P=0.492 P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 2.7% 0.0% 2.3% | 3.6% 5.7% 0.0% 2.1% |
|TERMINAL (d) | 0/40 (0%) 1/37 (3%) 0/35 (0%) 0/30 (0%) | 1/28 (4%) 1/32 (3%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- 733 (T) --- 616 | 735 (T) 691 --- 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.368 P=0.484 (e) P=0.483 | P=0.449N P=0.537 P=0.450N P=0.719N |
|INCIDENTAL TUMOR | P=0.424 P=0.484 (e) P=0.638 | P=0.548N P=0.494 P=0.450N P=0.637 |
|LOGISTIC REGRESSION | P=0.414 P=0.484 (e) P=0.563 | P=0.496N P=0.521 P=0.450N P=0.759 |
|COCHRAN-ARMITAGE | P=0.405 | P=0.498N |
|FISHER EXACT | P=0.500 (e) P=0.500 | P=0.492 P=0.500N P=0.753N |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 1/50 (2%) 4/50 (8%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 2.5% 0.0% 2.7% 6.7% | 3.6% 11.2% 2.8% 2.7% |
|TERMINAL (d) | 1/40 (3%) 0/37 (0%) 0/35 (0%) 2/30 (7%) | 1/28 (4%) 2/32 (6%) 1/36 (3%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 733 (T) --- 711 733 (T) | 735 (T) 686 735 (T) 735 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.184 P=0.516N P=0.737 P=0.400 | P=0.300N P=0.215 P=0.705N P=0.699N |
|INCIDENTAL TUMOR | P=0.260 P=0.516N P=0.720 P=0.400 | P=0.329N P=0.165 P=0.705N P=0.699N |
|LOGISTIC REGRESSION | P=0.207 P=0.516N P=0.737 P=0.400 | P=0.333N P=0.197 P=0.705N P=0.699N |
|COCHRAN-ARMITAGE | P=0.247 | P=0.373N |
|FISHER EXACT | P=0.500N P=0.753N P=0.500 | P=0.181 P=0.753N P=0.753N |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 5.0% 4.7% 2.9% 0.0% | 3.6% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 2/40 (5%) 1/37 (3%) 1/35 (3%) 0/30 (0%) | 1/28 (4%) 0/32 (0%) 1/36 (3%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 733 (T) 580 733 (T) --- | 735 (T) --- 735 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.167N P=0.672 P=0.547N P=0.304N | P=0.352N P=0.473N P=0.705N P=0.444N |
|INCIDENTAL TUMOR | P=0.147N P=0.656N P=0.547N P=0.304N | P=0.352N P=0.473N P=0.705N P=0.444N |
|LOGISTIC REGRESSION | P=0.129N P=0.688N P=0.547N P=0.304N | P=0.352N P=0.473N P=0.705N P=0.444N |
|COCHRAN-ARMITAGE | P=0.125N | P=0.405N |
|FISHER EXACT | P=0.691N P=0.500N P=0.247N | P=0.500N P=0.753N P=0.500N |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 7.5% 4.7% 5.5% 6.7% | 7.1% 11.2% 5.6% 2.7% |
|TERMINAL (d) | 3/40 (8%) 1/37 (3%) 1/35 (3%) 2/30 (7%) | 2/28 (7%) 2/32 (6%) 2/36 (6%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 733 (T) 580 711 733 (T) | 735 (T) 686 735 (T) 735 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.543N P=0.528N P=0.555N P=0.630N | P=0.190N P=0.389 P=0.602N P=0.403N |
|INCIDENTAL TUMOR | P=0.455N P=0.467N P=0.568N P=0.630N | P=0.212N P=0.329 P=0.602N P=0.403N |
|LOGISTIC REGRESSION | P=0.463N P=0.495N P=0.556N P=0.630N | P=0.219N P=0.367 P=0.602N P=0.402N |
|COCHRAN-ARMITAGE | P=0.431N | P=0.263N |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.339 P=0.691N P=0.500N |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 5.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/35 (0%) 0/30 (0%) | 0/28 (0%) 0/32 (0%) 1/36 (3%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 631 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.633 (e) P=0.273 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.529 (e) P=0.301 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.592 (e) P=0.234 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.596 |
|FISHER EXACT | (e) (e) (e) | (e) P=0.247 (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 1/49 (2%) 3/50 (6%) 0/50 (0%) |
|ADJUSTED (b) | 2.5% 0.0% 2.9% 3.3% | 2.5% 3.0% 7.3% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/37 (0%) 1/35 (3%) 1/30 (3%) | 0/28 (0%) 0/32 (0%) 1/36 (3%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 733 (T) --- 733 (T) 733 (T) | 639 731 631 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.467 P=0.516N P=0.732 P=0.696 | P=0.354N P=0.742N P=0.339 P=0.472N |
|INCIDENTAL TUMOR | P=0.467 P=0.516N P=0.732 P=0.696 | P=0.608N P=0.725 P=0.405 P=0.846N |
|LOGISTIC REGRESSION | P=0.467 P=0.516N P=0.732 P=0.696 | P=0.424N P=0.761 P=0.273 P=0.526N |
|COCHRAN-ARMITAGE | P=0.541 | P=0.407N |
|FISHER EXACT | P=0.505N P=0.753N P=0.753N | P=0.747 P=0.309 P=0.500N |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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) | 12/49 (24%) 14/50 (28%) 15/50 (30%) 7/50 (14%) | 9/49 (18%) 12/49 (24%) 11/50 (22%) 9/50 (18%) |
|ADJUSTED (b) | 29.7% 33.4% 38.1% 19.0% | 26.3% 33.5% 28.4% 22.4% |
|TERMINAL (d) | 11/39 (28%) 10/37 (27%) 11/35 (31%) 3/30 (10%) | 5/28 (18%) 9/32 (28%) 9/36 (25%) 7/37 (19%) |
|FIRST INCIDENCE (DAYS) | 639 605 535 639 | 583 636 581 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.282N P=0.354 P=0.219 P=0.320N | P=0.254N P=0.416 P=0.585 P=0.396N |
|INCIDENTAL TUMOR | P=0.102N P=0.466 P=0.251 P=0.145N | P=0.397N P=0.345 P=0.518 P=0.603N |
|LOGISTIC REGRESSION | P=0.124N P=0.422 P=0.250 P=0.174N | P=0.379N P=0.359 P=0.476 P=0.534N |
|COCHRAN-ARMITAGE | P=0.100N | P=0.440N |
|FISHER EXACT | P=0.433 P=0.349 P=0.142N | P=0.312 P=0.421 P=0.584N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/49 (35%) 14/50 (28%) 12/50 (24%) 13/50 (26%) | 6/49 (12%) 9/49 (18%) 4/50 (8%) 3/50 (6%) |
|ADJUSTED (b) | 37.3% 30.2% 27.9% 32.4% | 16.7% 21.6% 10.8% 7.8% |
|TERMINAL (d) | 11/39 (28%) 5/37 (14%) 6/35 (17%) 5/30 (17%) | 3/28 (11%) 2/32 (6%) 3/36 (8%) 2/37 (5%) |
|FIRST INCIDENCE (DAYS) | 639 580 410 547 | 543 527 713 682 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.448N P=0.410N P=0.326N P=0.501N | P=0.060N P=0.361 P=0.268N P=0.168N |
|INCIDENTAL TUMOR | P=0.048N* P=0.140N P=0.166N P=0.067N | P=0.087N P=0.265 P=0.324N P=0.302N |
|LOGISTIC REGRESSION | P=0.092N P=0.258N P=0.120N P=0.123N | P=0.097N P=0.265 P=0.349N P=0.236N |
|COCHRAN-ARMITAGE | P=0.212N | P=0.090N |
|FISHER EXACT | P=0.308N P=0.172N P=0.235N | P=0.288 P=0.357N P=0.233N |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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) | 27/49 (55%) 25/50 (50%) 26/50 (52%) 18/50 (36%) | 12/49 (24%) 20/49 (41%) 15/50 (30%) 12/50 (24%) |
|ADJUSTED (b) | 58.4% 52.1% 57.4% 43.8% | 32.8% 47.8% 38.1% 29.4% |
|TERMINAL (d) | 20/39 (51%) 14/37 (38%) 16/35 (46%) 8/30 (27%) | 6/28 (21%) 11/32 (34%) 12/36 (33%) 9/37 (24%) |
|FIRST INCIDENCE (DAYS) | 639 580 410 547 | 543 527 581 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.276N P=0.523N P=0.427 P=0.289N | P=0.143N P=0.149 P=0.546 P=0.364N |
|INCIDENTAL TUMOR | P=0.006N** P=0.210N P=0.548N P=0.010N** | P=0.255N P=0.070 P=0.424 P=0.583 |
|LOGISTIC REGRESSION | P=0.012N* P=0.291N P=0.567N P=0.020N* | P=0.263N P=0.072 P=0.401 P=0.530N |
|COCHRAN-ARMITAGE | P=0.035N* | P=0.300N |
|FISHER EXACT | P=0.380N P=0.457N P=0.044N* | P=0.065 P=0.349 P=0.570N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 27/49 (55%) 25/50 (50%) 26/50 (52%) 18/50 (36%) | 12/49 (24%) 20/49 (41%) 15/50 (30%) 12/50 (24%) |
|ADJUSTED (b) | 58.4% 52.1% 57.4% 43.8% | 32.8% 47.8% 38.1% 29.4% |
|TERMINAL (d) | 20/39 (51%) 14/37 (38%) 16/35 (46%) 8/30 (27%) | 6/28 (21%) 11/32 (34%) 12/36 (33%) 9/37 (24%) |
|FIRST INCIDENCE (DAYS) | 639 580 410 547 | 543 527 581 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.276N P=0.523N P=0.427 P=0.289N | P=0.143N P=0.149 P=0.546 P=0.364N |
|INCIDENTAL TUMOR | P=0.006N** P=0.210N P=0.548N P=0.010N** | P=0.255N P=0.070 P=0.424 P=0.583 |
|LOGISTIC REGRESSION | P=0.012N* P=0.291N P=0.567N P=0.020N* | P=0.263N P=0.072 P=0.401 P=0.530N |
|COCHRAN-ARMITAGE | P=0.035N* | P=0.300N |
|FISHER EXACT | P=0.380N P=0.457N P=0.044N* | P=0.065 P=0.349 P=0.570N |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocholangiocarcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 2/49 (4%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 2.0% 0.0% 0.0% | 4.8% 3.1% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/37 (0%) 0/35 (0%) 0/30 (0%) | 0/28 (0%) 1/32 (3%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- 573 --- --- | 596 735 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.577N P=0.504 (e) (e) | P=0.087N P=0.477N P=0.235N P=0.215N |
|INCIDENTAL TUMOR | P=0.500N P=0.638 (e) (e) | P=0.120N P=0.510N P=0.277N P=0.424N |
|LOGISTIC REGRESSION | P=0.542N P=0.546 (e) (e) | P=0.106N P=0.512N P=0.266N P=0.264N |
|COCHRAN-ARMITAGE | P=0.565N | P=0.098N |
|FISHER EXACT | P=0.505 (e) (e) | P=0.500N P=0.242N P=0.242N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 6/50 (12%) 5/50 (10%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|ADJUSTED (b) | 12.1% 7.8% 17.1% 15.7% | 0.0% 3.1% 2.4% 8.1% |
|TERMINAL (d) | 4/40 (10%) 2/37 (5%) 6/35 (17%) 4/30 (13%) | 0/28 (0%) 1/32 (3%) 0/36 (0%) 3/37 (8%) |
|FIRST INCIDENCE (DAYS) | 682 712 733 (T) 670 | --- 735 (T) 645 735 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.281 P=0.396N P=0.408 P=0.459 | P=0.082 P=0.527 P=0.510 P=0.174 |
|INCIDENTAL TUMOR | P=0.400 P=0.364N P=0.402 P=0.592 | P=0.075 P=0.527 P=0.343 P=0.174 |
|LOGISTIC REGRESSION | P=0.352 P=0.371N P=0.414 P=0.556 | P=0.062 P=0.527 P=0.475 P=0.172 |
|COCHRAN-ARMITAGE | P=0.451 | P=0.054 |
|FISHER EXACT | P=0.357N P=0.500 P=0.630N | P=0.500 P=0.500 P=0.121 |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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 Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 4/50 (8%) 6/50 (12%) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 15.6% 16.2% 10.7% 16.5% | 9.2% 0.0% 5.6% 2.7% |
|TERMINAL (d) | 4/40 (10%) 6/37 (16%) 3/35 (9%) 3/30 (10%) | 2/28 (7%) 0/32 (0%) 2/36 (6%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 455 733 (T) 535 499 | 543 --- 735 (T) 735 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.529 P=0.557N P=0.352N P=0.582 | P=0.266N P=0.105N P=0.404N P=0.234N |
|INCIDENTAL TUMOR | P=0.430N P=0.535N P=0.233N P=0.431N | P=0.249N P=0.107N P=0.469N P=0.204N |
|LOGISTIC REGRESSION | P=0.417N P=0.487N P=0.224N P=0.399N | P=0.324N P=0.122N P=0.485N P=0.301N |
|COCHRAN-ARMITAGE | P=0.426N | P=0.337N |
|FISHER EXACT | P=0.500N P=0.262N P=0.500N | P=0.121N P=0.500N P=0.309N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 8/50 (16%) 10/50 (20%) 10/50 (20%) | 3/50 (6%) 1/50 (2%) 3/50 (6%) 4/50 (8%) |
|ADJUSTED (b) | 26.7% 21.0% 27.4% 27.8% | 9.2% 3.1% 7.9% 10.8% |
|TERMINAL (d) | 8/40 (20%) 7/37 (19%) 9/35 (26%) 6/30 (20%) | 2/28 (7%) 1/32 (3%) 2/36 (6%) 4/37 (11%) |
|FIRST INCIDENCE (DAYS) | 455 712 535 499 | 543 735 (T) 645 735 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.398 P=0.291N P=0.547N P=0.550 | P=0.389 P=0.268N P=0.573N P=0.630 |
|INCIDENTAL TUMOR | P=0.479N P=0.253N P=0.452N P=0.366N | P=0.394 P=0.271N P=0.632 P=0.649N |
|LOGISTIC REGRESSION | P=0.488N P=0.224N P=0.454N P=0.355N | P=0.306 P=0.300N P=0.661N P=0.533 |
|COCHRAN-ARMITAGE | P=0.452N | P=0.282 |
|FISHER EXACT | P=0.227N P=0.405N P=0.405N | P=0.309N P=0.661N P=0.500 |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.6% 2.6% 5.2% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/35 (0%) 0/30 (0%) | 1/28 (4%) 0/32 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 735 (T) 686 665 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.323N P=0.739N P=0.566 P=0.444N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.396N P=0.741 P=0.349 P=0.444N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.358N P=0.752N P=0.518 P=0.444N |
|COCHRAN-ARMITAGE | (e) | P=0.366N |
|FISHER EXACT | (e) (e) (e) | P=0.753N P=0.500 P=0.500N |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenocarcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | | 0.0% 6.3% 0.0% 0.0% |
|TERMINAL (d) | | 0/28 (0%) 2/32 (6%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | | --- 735 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.352N P=0.268 (e) (e) |
|INCIDENTAL TUMOR | | P=0.352N P=0.268 (e) (e) |
|LOGISTIC REGRESSION | | P=0.352N P=0.268 (e) (e) |
|COCHRAN-ARMITAGE | | P=0.404N |
|FISHER EXACT | | P=0.242 (e) (e) |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 1/50 (2%) 5/49 (10%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | | 3.6% 14.6% 2.8% 4.9% |
|TERMINAL (d) | | 1/28 (4%) 4/32 (13%) 1/36 (3%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | | 735 (T) 623 735 (T) 653 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.417N P=0.131 P=0.705N P=0.587 |
|INCIDENTAL TUMOR | | P=0.487N P=0.131 P=0.705N P=0.541 |
|LOGISTIC REGRESSION | | P=0.489N P=0.113 P=0.705N P=0.522 |
|COCHRAN-ARMITAGE | | P=0.520N |
|FISHER EXACT | | P=0.098 P=0.753N P=0.500 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/47 (0%) 0/49 (0%) 0/49 (0%) | 10/50 (20%) 9/49 (18%) 6/50 (12%) 9/49 (18%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 30.5% 27.7% 15.8% 24.0% |
|TERMINAL (d) | 0/39 (0%) 0/34 (0%) 0/35 (0%) 0/29 (0%) | 7/28 (25%) 8/31 (26%) 4/36 (11%) 8/36 (22%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 533 681 674 653 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.240N P=0.414N P=0.111N P=0.298N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.275N P=0.470N P=0.238N P=0.324N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.354N P=0.468N P=0.169N P=0.447N |
|COCHRAN-ARMITAGE | (e) | P=0.437N |
|FISHER EXACT | (e) (e) (e) | P=0.520N P=0.207N P=0.520N |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 4.4% 0.0% 4.8% 0.0% | 0.0% 2.4% 0.0% 4.6% |
|TERMINAL (d) | 0/40 (0%) 0/37 (0%) 1/35 (3%) 0/30 (0%) | 0/28 (0%) 0/32 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 520 --- 322 --- | --- 636 --- 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.277N P=0.242N P=0.659 P=0.259N | P=0.158 P=0.500 (e) P=0.261 |
|INCIDENTAL TUMOR | P=0.135N P=0.290N P=0.440N P=0.148N | P=0.032 * P=0.531 (e) P=0.068 |
|LOGISTIC REGRESSION | P=0.177N P=0.194N P=0.514N P=0.155N | P=0.112 P=0.487 (e) P=0.208 |
|COCHRAN-ARMITAGE | P=0.247N | P=0.140 |
|FISHER EXACT | P=0.247N P=0.691N P=0.247N | P=0.500 (e) P=0.247 |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 2.0% 0.0% 0.0% 0.0% | 0.0% 2.4% 0.0% 4.6% |
|TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/35 (0%) 0/30 (0%) | 0/28 (0%) 0/32 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 520 --- --- --- | --- 636 --- 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.312N P=0.500N P=0.521N P=0.504N | P=0.158 P=0.500 (e) P=0.261 |
|INCIDENTAL TUMOR | P=0.244N P=0.638N P=0.318N P=0.500N | P=0.032 * P=0.531 (e) P=0.068 |
|LOGISTIC REGRESSION | P=0.245N P=0.434N P=0.355N P=0.379N | P=0.112 P=0.487 (e) P=0.208 |
|COCHRAN-ARMITAGE | P=0.306N | P=0.140 |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.500 (e) P=0.247 |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 4.4% 0.0% 4.8% 0.0% | 0.0% 2.4% 0.0% 4.6% |
|TERMINAL (d) | 0/40 (0%) 0/37 (0%) 1/35 (3%) 0/30 (0%) | 0/28 (0%) 0/32 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 520 --- 322 --- | --- 636 --- 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.277N P=0.242N P=0.659 P=0.259N | P=0.158 P=0.500 (e) P=0.261 |
|INCIDENTAL TUMOR | P=0.135N P=0.290N P=0.440N P=0.148N | P=0.032 * P=0.531 (e) P=0.068 |
|LOGISTIC REGRESSION | P=0.177N P=0.194N P=0.514N P=0.155N | P=0.112 P=0.487 (e) P=0.208 |
|COCHRAN-ARMITAGE | P=0.247N | P=0.140 |
|FISHER EXACT | P=0.247N P=0.691N P=0.247N | P=0.500 (e) P=0.247 |
|=================================================================================================================================|
| |
|Skin |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 3.3% | 0.0% 5.3% 2.8% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/35 (0%) 1/30 (3%) | 0/28 (0%) 0/32 (0%) 1/36 (3%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 733 (T) | --- 623 735 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.165 (e) (e) P=0.443 | P=0.415N P=0.253 P=0.550 (e) |
|INCIDENTAL TUMOR | P=0.165 (e) (e) P=0.443 | P=0.540N P=0.221 P=0.550 (e) |
|LOGISTIC REGRESSION | P=0.165 (e) (e) P=0.443 | P=0.461N P=0.232 P=0.550 (e) |
|COCHRAN-ARMITAGE | P=0.198 | P=0.461N |
|FISHER EXACT | (e) (e) P=0.500 | P=0.247 P=0.500 (e) |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 1/49 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 2.5% 5.4% 2.8% 0.0% | 0.0% 2.4% 2.8% 0.0% |
|TERMINAL (d) | 1/40 (3%) 2/37 (5%) 0/35 (0%) 0/30 (0%) | 0/28 (0%) 0/32 (0%) 1/36 (3%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) 728 --- | --- 623 735 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.313N P=0.473 P=0.734 P=0.557N | P=0.557N P=0.500 P=0.550 (e) |
|INCIDENTAL TUMOR | P=0.240N P=0.473 P=0.720 P=0.557N | P=0.685N P=0.500 P=0.550 (e) |
|LOGISTIC REGRESSION | P=0.297N P=0.473 P=0.737 P=0.557N | P=0.602N P=0.478 P=0.550 (e) |
|COCHRAN-ARMITAGE | P=0.247N | P=0.593N |
|FISHER EXACT | P=0.500 P=0.753N P=0.500N | P=0.495 P=0.500 (e) |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 2.5% 0.0% 2.6% 0.0% | 0.0% 0.0% 8.3% 2.7% |
|TERMINAL (d) | 1/40 (3%) 0/37 (0%) 0/35 (0%) 0/30 (0%) | 0/28 (0%) 0/32 (0%) 3/36 (8%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 733 (T) --- 672 --- | --- --- 735 (T) 735 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.451N P=0.516N P=0.732 P=0.557N | P=0.313 (e) P=0.168 P=0.556 |
|INCIDENTAL TUMOR | P=0.340N P=0.516N P=0.720 P=0.557N | P=0.313 (e) P=0.168 P=0.556 |
|LOGISTIC REGRESSION | P=0.410N P=0.516N P=0.754 P=0.557N | P=0.313 (e) P=0.168 P=0.556 |
|COCHRAN-ARMITAGE | P=0.405N | P=0.247 |
|FISHER EXACT | P=0.500N P=0.753N P=0.500N | (e) P=0.121 P=0.500 |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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 |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 5/50 (10%) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 7.0% 5.4% 2.9% 16.0% | 10.7% 3.1% 5.6% 2.7% |
|TERMINAL (d) | 2/40 (5%) 2/37 (5%) 1/35 (3%) 4/30 (13%) | 3/28 (11%) 1/32 (3%) 2/36 (6%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 639 733 (T) 733 (T) 723 | 735 (T) 735 (T) 735 (T) 735 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.129 P=0.538N P=0.362N P=0.229 | P=0.197N P=0.257N P=0.385N P=0.211N |
|INCIDENTAL TUMOR | P=0.182 P=0.467N P=0.343N P=0.339 | P=0.197N P=0.257N P=0.385N P=0.211N |
|LOGISTIC REGRESSION | P=0.168 P=0.504N P=0.332N P=0.298 | P=0.197N P=0.257N P=0.385N P=0.211N |
|COCHRAN-ARMITAGE | P=0.216 | P=0.279N |
|FISHER EXACT | P=0.500N P=0.309N P=0.357 | P=0.309N P=0.500N P=0.309N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 2/50 (4%) 5/50 (10%) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 9.0% 5.4% 5.3% 16.0% | 10.7% 3.1% 5.6% 2.7% |
|TERMINAL (d) | 2/40 (5%) 2/37 (5%) 1/35 (3%) 4/30 (13%) | 3/28 (11%) 1/32 (3%) 2/36 (6%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 639 733 (T) 649 723 | 735 (T) 735 (T) 735 (T) 735 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.225 P=0.380N P=0.415N P=0.355 | P=0.197N P=0.257N P=0.385N P=0.211N |
|INCIDENTAL TUMOR | P=0.349 P=0.258N P=0.384N P=0.531 | P=0.197N P=0.257N P=0.385N P=0.211N |
|LOGISTIC REGRESSION | P=0.301 P=0.331N P=0.331N P=0.470 | P=0.197N P=0.257N P=0.385N P=0.211N |
|COCHRAN-ARMITAGE | P=0.331 | P=0.279N |
|FISHER EXACT | P=0.339N P=0.339N P=0.500 | P=0.309N P=0.500N P=0.309N |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ISOBUTYRALDEHYDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 500 PPM 1000 PPM 2000 PPM | CONTROL 500 PPM 1000 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 2/50 (4%) 1/50 (2%) 5/50 (10%) |
|ADJUSTED (b) | | 5.6% 6.3% 2.8% 13.5% |
|TERMINAL (d) | | 1/28 (4%) 2/32 (6%) 1/36 (3%) 5/37 (14%) |
|FIRST INCIDENCE (DAYS) | | 344 735 (T) 735 (T) 735 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.179 P=0.656N P=0.437N P=0.325 |
|INCIDENTAL TUMOR | | P=0.094 P=0.643 P=0.705N P=0.176 |
|LOGISTIC REGRESSION | | P=0.116 P=0.674 P=0.592N P=0.207 |
|COCHRAN-ARMITAGE | | P=0.114 |
|FISHER EXACT | | P=0.691N P=0.500N P=0.218 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 4/50 (8%) 4/50 (8%) 1/50 (2%) |
|ADJUSTED (b) | 5.0% 5.4% 2.8% 3.3% | 7.1% 9.9% 11.1% 2.6% |
|TERMINAL (d) | 2/40 (5%) 2/37 (5%) 0/35 (0%) 1/30 (3%) | 2/28 (7%) 0/32 (0%) 4/36 (11%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) 728 733 (T) | 735 (T) 595 735 (T) 702 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.432N P=0.667 P=0.543N P=0.600N | P=0.233N P=0.388 P=0.457 P=0.409N |
|INCIDENTAL TUMOR | P=0.359N P=0.667 P=0.557N P=0.600N | P=0.355N P=0.332 P=0.457 P=0.459N |
|LOGISTIC REGRESSION | P=0.413N P=0.667 P=0.540N P=0.600N | P=0.300N P=0.339 P=0.457 P=0.454N |
|COCHRAN-ARMITAGE | P=0.337N | P=0.319N |
|FISHER EXACT | P=0.691N P=0.500N P=0.500N | P=0.339 P=0.339 P=0.500N |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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 |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 4/50 (8%) 5/50 (10%) 1/50 (2%) |
|ADJUSTED (b) | 5.0% 5.4% 2.8% 3.3% | 7.1% 9.9% 13.3% 2.6% |
|TERMINAL (d) | 2/40 (5%) 2/37 (5%) 0/35 (0%) 1/30 (3%) | 2/28 (7%) 0/32 (0%) 4/36 (11%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) 728 733 (T) | 735 (T) 595 653 702 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.432N P=0.667 P=0.543N P=0.600N | P=0.253N P=0.388 P=0.317 P=0.409N |
|INCIDENTAL TUMOR | P=0.359N P=0.667 P=0.557N P=0.600N | P=0.389N P=0.332 P=0.259 P=0.459N |
|LOGISTIC REGRESSION | P=0.413N P=0.667 P=0.540N P=0.600N | P=0.329N P=0.339 P=0.256 P=0.454N |
|COCHRAN-ARMITAGE | P=0.337N | P=0.344N |
|FISHER EXACT | P=0.691N P=0.500N P=0.500N | P=0.339 P=0.218 P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.6% 0.0% 7.4% 2.7% |
|TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/35 (0%) 0/30 (0%) | 1/28 (4%) 0/32 (0%) 1/36 (3%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 735 (T) --- 581 735 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.530 P=0.473N P=0.360 P=0.699N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.443 P=0.473N P=0.307 P=0.699N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.471 P=0.473N P=0.299 P=0.699N |
|COCHRAN-ARMITAGE | (e) | P=0.469 |
|FISHER EXACT | (e) (e) (e) | P=0.500N P=0.309 P=0.753N |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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 Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated |
| Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 1/50 (2%) 6/50 (12%) | 12/50 (24%) 13/50 (26%) 12/50 (24%) 19/50 (38%) |
|ADJUSTED (b) | 2.1% 13.5% 2.9% 16.8% | 35.7% 35.0% 30.0% 47.3% |
|TERMINAL (d) | 0/40 (0%) 5/37 (14%) 1/35 (3%) 2/30 (7%) | 8/28 (29%) 9/32 (28%) 9/36 (25%) 16/37 (43%) |
|FIRST INCIDENCE (DAYS) | 639 733 (T) 733 (T) 665 | 533 611 547 653 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.042 * P=0.087 P=0.722 P=0.038 * | P=0.234 P=0.554N P=0.378N P=0.318 |
|INCIDENTAL TUMOR | P=0.125 P=0.114 P=0.746 P=0.163 | P=0.114 P=0.567 P=0.491N P=0.207 |
|LOGISTIC REGRESSION | P=0.067 P=0.100 P=0.766N P=0.063 | P=0.096 P=0.547 P=0.543N P=0.151 |
|COCHRAN-ARMITAGE | P=0.080 | P=0.068 |
|FISHER EXACT | P=0.102 P=0.753N P=0.056 | P=0.500 P=0.592N P=0.097 |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 19/50 (38%) 22/50 (44%) 19/50 (38%) | 26/50 (52%) 34/50 (68%) 26/50 (52%) 25/50 (50%) |
|ADJUSTED (b) | 50.9% 44.7% 54.5% 51.7% | 70.9% 84.8% 60.4% 58.9% |
|TERMINAL (d) | 19/40 (48%) 14/37 (38%) 17/35 (49%) 13/30 (43%) | 18/28 (64%) 26/32 (81%) 19/36 (53%) 20/37 (54%) |
|FIRST INCIDENCE (DAYS) | 639 605 359 616 | 344 623 581 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.309 P=0.462N P=0.356 P=0.409 | P=0.032N* P=0.243 P=0.230N P=0.129N |
|INCIDENTAL TUMOR | P=0.438N P=0.312N P=0.475 P=0.431N | P=0.109N P=0.104 P=0.542N P=0.375N |
|LOGISTIC REGRESSION | P=0.455N P=0.364N P=0.444 P=0.474N | P=0.137N P=0.114 P=0.476N P=0.392N |
|COCHRAN-ARMITAGE | P=0.367N | P=0.243N |
|FISHER EXACT | P=0.342N P=0.580N P=0.342N | P=0.076 P=0.579N P=0.500N |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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) | 28/50 (56%) 27/50 (54%) 22/50 (44%) 25/50 (50%) | 25/50 (50%) 28/50 (56%) 26/50 (52%) 24/50 (48%) |
|ADJUSTED (b) | 56.0% 57.3% 49.1% 56.1% | 62.2% 58.8% 56.1% 55.7% |
|TERMINAL (d) | 18/40 (45%) 17/37 (46%) 13/35 (37%) 11/30 (37%) | 14/28 (50%) 13/32 (41%) 16/36 (44%) 18/37 (49%) |
|FIRST INCIDENCE (DAYS) | 455 573 322 499 | 76 93 537 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.406 P=0.512 P=0.389N P=0.404 | P=0.134N P=0.530 P=0.342N P=0.176N |
|INCIDENTAL TUMOR | P=0.076N P=0.371N P=0.093N P=0.096N | P=0.508N P=0.339 P=0.503 P=0.552N |
|LOGISTIC REGRESSION | P=0.127N P=0.464N P=0.090N P=0.155N | P=0.428N P=0.297 P=0.459 P=0.469N |
|COCHRAN-ARMITAGE | P=0.267N | P=0.378N |
|FISHER EXACT | P=0.500N P=0.159N P=0.344N | P=0.344 P=0.500 P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 40/50 (80%) 36/50 (72%) 39/50 (78%) 34/50 (68%) | 38/50 (76%) 45/50 (90%) 37/50 (74%) 40/50 (80%) |
|ADJUSTED (b) | 80.0% 73.5% 81.2% 73.7% | 90.0% 91.8% 77.0% 86.9% |
|TERMINAL (d) | 30/40 (75%) 24/37 (65%) 26/35 (74%) 18/30 (60%) | 24/28 (86%) 28/32 (88%) 25/36 (69%) 31/37 (84%) |
|FIRST INCIDENCE (DAYS) | 455 573 322 499 | 76 93 537 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.318 P=0.473N P=0.304 P=0.414 | P=0.070N P=0.391 P=0.129N P=0.143N |
|INCIDENTAL TUMOR | P=0.046N* P=0.154N P=0.473N P=0.050N* | P=0.499N P=0.079 P=0.410N P=0.442 |
|LOGISTIC REGRESSION | P=0.081N P=0.223N P=0.474N P=0.073N | P=0.442N P=0.060 P=0.486N P=0.523 |
|COCHRAN-ARMITAGE | P=0.142N | P=0.500N |
|FISHER EXACT | P=0.241N P=0.500N P=0.127N | P=0.054 P=0.500N P=0.405 |
|=================================================================================================================================|
DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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).