TDMS Study 05185-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: IITRI ISOBUTYL NITRITE (IBN) DATE: 05/20/95
EXPERIMENT: 05185 TEST: 03 TIME: 11:03:10
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01 ES 65143 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61052B
PATHOLOGIST: RICHARD LONG CAS: 542-56-3
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: IITRI ISOBUTYL NITRITE (IBN) DATE: 05/20/95
EXPERIMENT: 05185 TEST: 03 TIME: 11:03:10
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01 ES 65143 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61052B
PATHOLOGIST: RICHARD LONG CAS: 542-56-3
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: IITRI ISOBUTYL NITRITE (IBN) DATE: 05/20/95
EXPERIMENT: 05185 TEST: 03 TIME: 11:03:10
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01 ES 65143 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61052B
PATHOLOGIST: RICHARD LONG CAS: 542-56-3
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF ISOBUTYL NITRITE (IBN)
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Testes Adenoma
Zymbal's Gland Carcinoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Thyroid Gland: Follicular Cell
Carcinoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/54 (15%) 8/55 (15%) 8/56 (14%) 15/56 (27%) | 0/55 (0%) 3/55 (5%) 1/55 (2%) 2/56 (4%) |
|ADJUSTED (b) | 37.0% 30.0% 20.9% 45.0% | 0.0% 8.0% 2.8% 6.1% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/17 (29%) 6/23 (26%) 7/36 (19%) 10/28 (36%) | 0/29 (0%) 2/35 (6%) 0/31 (0%) 2/33 (6%) |
|FIRST INCIDENCE (DAYS) | 639 576 456 (I) 564 | --- 645 686 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.211 P=0.376N P=0.128N P=0.419 | P=0.354 P=0.152 P=0.523 P=0.267 |
|INCIDENTAL TUMOR | P=0.089 P=0.470N P=0.275N P=0.163 | P=0.277 P=0.129 P=0.477 P=0.267 |
|LOGISTIC REGRESSION | P=0.092 P=0.467N P=0.373N P=0.236 | P=0.336 P=0.129 P=0.501 P=0.267 |
|COCHRAN-ARMITAGE | P=0.047 * | P=0.346 |
|FISHER EXACT | P=0.591N P=0.575N P=0.095 | P=0.122 P=0.500 P=0.252 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Complex |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/54 (0%) 0/55 (0%) 0/56 (0%) 0/56 (0%) | 2/55 (4%) 0/55 (0%) 0/55 (0%) 0/56 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.7% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 0/23 (0%) 0/36 (0%) 0/28 (0%) | 1/29 (3%) 0/35 (0%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 602 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.114N P=0.219N P=0.232N P=0.231N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.112N P=0.350N P=0.263N P=0.226N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.115N P=0.236N P=0.238N P=0.236N |
|COCHRAN-ARMITAGE | (e) | P=0.115N |
|FISHER EXACT | (e) (e) (e) | P=0.248N P=0.248N P=0.243N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/54 (2%) 4/55 (7%) 0/56 (0%) 1/56 (2%) | 0/55 (0%) 1/55 (2%) 0/55 (0%) 0/56 (0%) |
|ADJUSTED (b) | 5.9% 16.0% 0.0% 3.6% | 0.0% 2.7% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/17 (6%) 2/23 (9%) 0/36 (0%) 1/28 (4%) | 0/29 (0%) 0/35 (0%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 718 --- 729 (T) | --- 720 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.188N P=0.284 P=0.350N P=0.647N | P=0.564N P=0.535 (e) (e) |
|INCIDENTAL TUMOR | P=0.297N P=0.272 P=0.350N P=0.647N | P=0.675N P=0.450 (e) (e) |
|LOGISTIC REGRESSION | P=0.198N P=0.280 P=0.350N P=0.647N | P=0.565N P=0.519 (e) (e) |
|COCHRAN-ARMITAGE | P=0.322N | P=0.562N |
|FISHER EXACT | P=0.187 P=0.491N P=0.743N | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/54 (15%) 11/55 (20%) 8/56 (14%) 16/56 (29%) | 2/55 (4%) 4/55 (7%) 1/55 (2%) 2/56 (4%) |
|ADJUSTED (b) | 37.0% 39.4% 20.9% 48.1% | 5.7% 10.4% 2.8% 6.1% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/17 (29%) 7/23 (30%) 7/36 (19%) 11/28 (39%) | 1/29 (3%) 2/35 (6%) 0/31 (0%) 2/33 (6%) |
|FIRST INCIDENCE (DAYS) | 639 576 456 (I) 564 | 602 645 686 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.260 P=0.560 P=0.128N P=0.351 | P=0.415N P=0.405 P=0.479N P=0.663N |
|INCIDENTAL TUMOR | P=0.092 P=0.463 P=0.275N P=0.123 | P=0.494N P=0.249 P=0.539N P=0.659N |
|LOGISTIC REGRESSION | P=0.112 P=0.465 P=0.373N P=0.179 | P=0.432N P=0.354 P=0.500N P=0.691N |
|COCHRAN-ARMITAGE | P=0.055 | P=0.421N |
|FISHER EXACT | P=0.323 P=0.575N P=0.064 | P=0.339 P=0.500N P=0.684N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/54 (6%) 5/56 (9%) 3/56 (5%) 2/56 (4%) | 1/54 (2%) 1/54 (2%) 2/54 (4%) 1/56 (2%) |
|ADJUSTED (b) | 11.7% 15.4% 8.3% 5.3% | 3.4% 2.9% 6.5% 2.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/16 (6%) 1/23 (4%) 3/36 (8%) 1/28 (4%) | 1/29 (3%) 1/35 (3%) 2/31 (6%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 583 551 729 (T) 456 (I) | 733 (T) 733 (T) 733 (T) 696 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.164N P=0.490 P=0.373N P=0.380N | P=0.612 P=0.720N P=0.523 P=0.736N |
|INCIDENTAL TUMOR | P=0.278N P=0.309 P=0.613N P=0.437N | P=0.573 P=0.720N P=0.523 P=0.703 |
|LOGISTIC REGRESSION | P=0.258N P=0.259 P=0.546N P=0.489N | P=0.598 P=0.720N P=0.523 P=0.754N |
|COCHRAN-ARMITAGE | P=0.282N | P=0.602 |
|FISHER EXACT | P=0.379 P=0.643N P=0.483N | P=0.752N P=0.500 P=0.743N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/54 (6%) 5/56 (9%) 4/56 (7%) 2/56 (4%) | 2/54 (4%) 1/54 (2%) 2/54 (4%) 1/56 (2%) |
|ADJUSTED (b) | 11.7% 15.4% 10.6% 5.3% | 5.7% 2.9% 6.5% 2.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/16 (6%) 1/23 (4%) 3/36 (8%) 1/28 (4%) | 1/29 (3%) 1/35 (3%) 2/31 (6%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 583 551 684 456 (I) | 602 733 (T) 733 (T) 696 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.176N P=0.490 P=0.492N P=0.380N | P=0.428N P=0.457N P=0.676N P=0.480N |
|INCIDENTAL TUMOR | P=0.324N P=0.309 P=0.504 P=0.437N | P=0.444N P=0.601N P=0.687 P=0.563N |
|LOGISTIC REGRESSION | P=0.276N P=0.259 P=0.634 P=0.489N | P=0.441N P=0.488N P=0.692N P=0.490N |
|COCHRAN-ARMITAGE | P=0.304N | P=0.432N |
|FISHER EXACT | P=0.379 P=0.520 P=0.483N | P=0.500N P=0.691N P=0.486N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/8 (38%) 6/9 (67%) 2/5 (40%) 4/5 (80%) | 5/6 (83%) 1/1 (100%) 0/0 (0%) 1/1 (100%) |
|ADJUSTED (b) | 41.6% 59.4% 26.8% 75.8% | 100.0% 100.0% 0.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 |
|TERMINAL (d) | 2/5 (40%) 4/7 (57%) 1/4 (25%) 3/4 (75%) | 3/3 (100%) 1/1 (100%) 0/0 1/1 (100%) |
|FIRST INCIDENCE (DAYS) | 583 551 667 722 | 516 733 (T) --- 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.492 P=0.370 P=0.494N P=0.452 | P=0.122N P=0.237N P=0.242N P=0.253N |
|INCIDENTAL TUMOR | P=0.270 P=0.312 P=0.588N P=0.362 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.120 P=0.205 P=0.643 P=0.213 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.179 | P=0.620 |
|FISHER EXACT | P=0.238 P=0.685 P=0.179 | P=0.857 P=1.000N P=0.857 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/8 (50%) 6/9 (67%) 3/5 (60%) 4/5 (80%) | 5/6 (83%) 1/1 (100%) 0/0 (0%) 1/1 (100%) |
|ADJUSTED (b) | 43.2% 59.4% 51.2% 75.8% | 100.0% 100.0% 0.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 |
|TERMINAL (d) | 2/5 (40%) 4/7 (57%) 2/4 (50%) 3/4 (75%) | 3/3 (100%) 1/1 (100%) 0/0 1/1 (100%) |
|FIRST INCIDENCE (DAYS) | 583 551 667 722 | 516 733 (T) --- 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.567N P=0.530 P=0.503N P=0.626 | P=0.122N P=0.237N P=0.242N P=0.253N |
|INCIDENTAL TUMOR | P=0.248 P=0.400 P=0.638 P=0.362 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.132 P=0.322 P=0.461 P=0.225 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.243 | P=0.620 |
|FISHER EXACT | P=0.419 P=0.587 P=0.315 | P=0.857 P=1.000N P=0.857 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/56 (0%) 4/56 (7%) 13/56 (23%) 14/56 (25%) | 0/56 (0%) 2/55 (4%) 2/56 (4%) 10/56 (18%) |
|ADJUSTED (b) | 0.0% 14.7% 33.4% 45.8% | 0.0% 5.2% 5.8% 29.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 3/23 (13%) 11/36 (31%) 12/28 (43%) | 0/29 (0%) 1/35 (3%) 1/31 (3%) 9/33 (27%) |
|FIRST INCIDENCE (DAYS) | --- 456 (I) 456 (I) 456 (I) | --- 648 653 622 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.095 P=0.005 ** P=0.001 ** | P<0.001 ** P=0.272 P=0.253 P=0.002 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.095 P=0.002 ** P<0.001 ** | P<0.001 ** P=0.232 P=0.247 P=0.002 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.070 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.241 P=0.240 P=0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.059 P<0.001 ** P<0.001 ** | P=0.243 P=0.248 P<0.001 ** |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/56 (2%) 2/56 (4%) 1/56 (2%) 6/56 (11%) | 0/56 (0%) 1/55 (2%) 0/56 (0%) 1/56 (2%) |
|ADJUSTED (b) | 1.8% 7.2% 2.8% 18.1% | 0.0% 2.4% 0.0% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 1/23 (4%) 1/36 (3%) 3/28 (11%) | 0/29 (0%) 0/35 (0%) 0/31 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 415 663 729 (T) 523 | --- 645 --- 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.041 * P=0.559 P=0.683N P=0.138 | P=0.407 P=0.520 (e) P=0.526 |
|INCIDENTAL TUMOR | P=0.003 ** P=0.439 P=0.703 P=0.011 * | P=0.344 P=0.450 (e) P=0.526 |
|LOGISTIC REGRESSION | P=0.021 * P=0.489 P=0.741 P=0.062 | P=0.404 P=0.495 (e) P=0.526 |
|COCHRAN-ARMITAGE | P=0.019 * | P=0.408 |
|FISHER EXACT | P=0.500 P=0.752N P=0.057 | P=0.495 (e) P=0.500 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/56 (2%) 6/56 (11%) 14/56 (25%) 16/56 (29%) | 0/56 (0%) 3/55 (5%) 2/56 (4%) 11/56 (20%) |
|ADJUSTED (b) | 1.8% 21.3% 36.1% 48.5% | 0.0% 7.5% 5.8% 32.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 4/23 (17%) 12/36 (33%) 12/28 (43%) | 0/29 (0%) 1/35 (3%) 1/31 (3%) 10/33 (30%) |
|FIRST INCIDENCE (DAYS) | 415 456 (I) 456 (I) 456 (I) | --- 645 653 622 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.100 P=0.012 * P=0.002 ** | P<0.001 ** P=0.148 P=0.253 P=0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.065 P=0.003 ** P<0.001 ** | P<0.001 ** P=0.100 P=0.247 P=0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.060 P=0.001 ** P<0.001 ** | P<0.001 ** P=0.120 P=0.240 P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.057 P<0.001 ** P<0.001 ** | P=0.118 P=0.248 P<0.001 ** |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/56 (0%) 0/56 (0%) 0/56 (0%) 0/56 (0%) | 3/56 (5%) 1/55 (2%) 1/56 (2%) 1/56 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 9.3% 2.9% 3.2% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 0/23 (0%) 0/36 (0%) 0/28 (0%) | 2/29 (7%) 1/35 (3%) 1/31 (3%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 641 733 (T) 733 (T) 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.228N P=0.252N P=0.286N P=0.277N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.229N P=0.370N P=0.332N P=0.291N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.242N P=0.284N P=0.294N P=0.301N |
|COCHRAN-ARMITAGE | (e) | P=0.242N |
|FISHER EXACT | (e) (e) (e) | P=0.316N P=0.309N P=0.309N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/56 (0%) 0/56 (0%) 0/56 (0%) 0/56 (0%) | 3/56 (5%) 2/55 (4%) 1/56 (2%) 2/56 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 9.3% 5.7% 3.2% 5.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 0/23 (0%) 0/36 (0%) 0/28 (0%) | 2/29 (7%) 2/35 (6%) 1/31 (3%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 641 733 (T) 733 (T) 622 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.389N P=0.425N P=0.286N P=0.474N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.381N P=0.556N P=0.332N P=0.505N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.408N P=0.468N P=0.294N P=0.502N |
|COCHRAN-ARMITAGE | (e) | P=0.402N |
|FISHER EXACT | (e) (e) (e) | P=0.509N P=0.309N P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/56 (0%) 2/56 (4%) 1/56 (2%) 0/56 (0%) | 12/56 (21%) 14/55 (25%) 20/56 (36%) 13/56 (23%) |
|ADJUSTED (b) | 0.0% 8.7% 2.8% 0.0% | 34.6% 35.7% 52.0% 34.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 2/23 (9%) 1/36 (3%) 0/28 (0%) | 8/29 (28%) 10/35 (29%) 13/31 (42%) 9/33 (27%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | 457 (I) 645 610 622 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.340N P=0.306 P=0.650 (e) | P=0.495 P=0.571N P=0.117 P=0.572N |
|INCIDENTAL TUMOR | P=0.340N P=0.306 P=0.650 (e) | P=0.299 P=0.482 P=0.070 P=0.403 |
|LOGISTIC REGRESSION | P=0.340N P=0.306 P=0.650 (e) | P=0.337 P=0.463 P=0.071 P=0.496 |
|COCHRAN-ARMITAGE | P=0.458N | P=0.437 |
|FISHER EXACT | P=0.248 P=0.500 (e) | P=0.391 P=0.071 P=0.500 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/56 (0%) 2/56 (4%) 1/56 (2%) 0/56 (0%) | 12/56 (21%) 15/55 (27%) 20/56 (36%) 13/56 (23%) |
|ADJUSTED (b) | 0.0% 8.7% 2.8% 0.0% | 34.6% 38.3% 52.0% 34.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 2/23 (9%) 1/36 (3%) 0/28 (0%) | 8/29 (28%) 11/35 (31%) 13/31 (42%) 9/33 (27%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | 457 (I) 645 610 622 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.340N P=0.306 P=0.650 (e) | P=0.527 P=0.523 P=0.117 P=0.572N |
|INCIDENTAL TUMOR | P=0.340N P=0.306 P=0.650 (e) | P=0.330 P=0.400 P=0.070 P=0.403 |
|LOGISTIC REGRESSION | P=0.340N P=0.306 P=0.650 (e) | P=0.369 P=0.379 P=0.071 P=0.496 |
|COCHRAN-ARMITAGE | P=0.458N | P=0.468 |
|FISHER EXACT | P=0.248 P=0.500 (e) | P=0.310 P=0.071 P=0.500 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/56 (0%) 2/56 (4%) 1/56 (2%) 0/56 (0%) | 14/56 (25%) 15/55 (27%) 21/56 (38%) 14/56 (25%) |
|ADJUSTED (b) | 0.0% 8.7% 2.8% 0.0% | 39.3% 38.3% 54.7% 37.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 2/23 (9%) 1/36 (3%) 0/28 (0%) | 9/29 (31%) 11/35 (31%) 14/31 (45%) 10/33 (30%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | 457 (I) 645 610 622 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.340N P=0.306 P=0.650 (e) | P=0.510N P=0.467N P=0.172 P=0.476N |
|INCIDENTAL TUMOR | P=0.340N P=0.306 P=0.650 (e) | P=0.378 P=0.530 P=0.102 P=0.497 |
|LOGISTIC REGRESSION | P=0.340N P=0.306 P=0.650 (e) | P=0.405 P=0.558 P=0.112 P=0.584 |
|COCHRAN-ARMITAGE | P=0.458N | P=0.508 |
|FISHER EXACT | P=0.248 P=0.500 (e) | P=0.477 P=0.111 P=0.586N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/56 (0%) 1/56 (2%) 0/56 (0%) 0/56 (0%) | 1/56 (2%) 1/55 (2%) 2/56 (4%) 1/56 (2%) |
|ADJUSTED (b) | 0.0% 4.3% 0.0% 0.0% | 2.2% 2.9% 6.5% 2.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 1/23 (4%) 0/36 (0%) 0/28 (0%) | 0/29 (0%) 1/35 (3%) 2/31 (6%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 516 733 (T) 733 (T) 617 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.500N P=0.560 (e) (e) | P=0.597 P=0.745N P=0.510 P=0.750 |
|INCIDENTAL TUMOR | P=0.500N P=0.560 (e) (e) | P=0.599N P=0.739 P=0.469 P=0.755N |
|LOGISTIC REGRESSION | P=0.500N P=0.560 (e) (e) | P=0.589 P=0.754 P=0.500 P=0.743N |
|COCHRAN-ARMITAGE | P=0.565N | P=0.592 |
|FISHER EXACT | P=0.500 (e) (e) | P=0.748 P=0.500 P=0.752N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/55 (55%) 25/56 (45%) 30/56 (54%) 30/55 (55%) | 26/56 (46%) 16/53 (30%) 20/55 (36%) 18/56 (32%) |
|ADJUSTED (b) | 75.3% 71.7% 62.9% 73.5% | 65.4% 42.0% 53.1% 45.7% |
|INTERIM SACRIFICE 1 (c)| 5/10 (50%) 1/10 (10%) 5/10 (50%) 3/10 (30%) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 8/16 (50%) 14/23 (61%) 19/36 (53%) 17/27 (63%) | 16/29 (55%) 12/33 (36%) 13/30 (43%) 12/33 (36%) |
|FIRST INCIDENCE (DAYS) | 427 456 (I) 456 (I) 456 (I) | 457 (I) 457 (I) 604 483 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.126N P=0.043N* P=0.016N* P=0.095N | P=0.115N P=0.019N* P=0.149N P=0.058N |
|INCIDENTAL TUMOR | P=0.391 P=0.161N P=0.474 P=0.557N | P=0.161N P=0.076N P=0.217N P=0.101N |
|LOGISTIC REGRESSION | P=0.478 P=0.141N P=0.497N P=0.490N | P=0.183N P=0.044N* P=0.171N P=0.088N |
|COCHRAN-ARMITAGE | P=0.390 | P=0.136N |
|FISHER EXACT | P=0.197N P=0.535N P=0.576N | P=0.061N P=0.189N P=0.088N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/55 (55%) 25/56 (45%) 30/56 (54%) 30/55 (55%) | 27/56 (48%) 16/53 (30%) 21/55 (38%) 18/56 (32%) |
|ADJUSTED (b) | 75.3% 71.7% 62.9% 73.5% | 66.2% 42.0% 54.3% 45.7% |
|INTERIM SACRIFICE 1 (c)| 5/10 (50%) 1/10 (10%) 5/10 (50%) 3/10 (30%) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 8/16 (50%) 14/23 (61%) 19/36 (53%) 17/27 (63%) | 16/29 (55%) 12/33 (36%) 13/30 (43%) 12/33 (36%) |
|FIRST INCIDENCE (DAYS) | 427 456 (I) 456 (I) 456 (I) | 457 (I) 457 (I) 604 483 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.126N P=0.043N* P=0.016N* P=0.095N | P=0.095N P=0.013N* P=0.155N P=0.043N* |
|INCIDENTAL TUMOR | P=0.391 P=0.161N P=0.474 P=0.557N | P=0.133N P=0.065N P=0.231N P=0.073N |
|LOGISTIC REGRESSION | P=0.478 P=0.141N P=0.497N P=0.490N | P=0.156N P=0.030N* P=0.237N P=0.061N |
|COCHRAN-ARMITAGE | P=0.390 | P=0.109N |
|FISHER EXACT | P=0.197N P=0.535N P=0.576N | P=0.042N* P=0.191N P=0.061N |
|=================================================================================================================================|
| |
|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) | 3/56 (5%) 4/56 (7%) 4/56 (7%) 1/56 (2%) | 1/56 (2%) 1/55 (2%) 0/56 (0%) 1/56 (2%) |
|ADJUSTED (b) | 13.5% 13.6% 10.8% 3.3% | 3.4% 2.7% 0.0% 2.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/17 (6%) 2/23 (9%) 3/36 (8%) 0/28 (0%) | 1/29 (3%) 0/35 (0%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 639 645 719 722 | 733 (T) 720 --- 617 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.092N P=0.649N P=0.462N P=0.177N | P=0.613N P=0.719N P=0.487N P=0.749N |
|INCIDENTAL TUMOR | P=0.225N P=0.584 P=0.519 P=0.358N | P=0.648 P=0.755 P=0.487N P=0.751 |
|LOGISTIC REGRESSION | P=0.138N P=0.571 P=0.619N P=0.232N | P=0.619N P=0.736N P=0.487N P=0.761 |
|COCHRAN-ARMITAGE | P=0.211N | P=0.614N |
|FISHER EXACT | P=0.500 P=0.500 P=0.309N | P=0.748 P=0.500N P=0.752N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/56 (0%) 0/56 (0%) 1/56 (2%) 2/56 (4%) | 0/56 (0%) 2/55 (4%) 0/56 (0%) 1/56 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 2.8% 7.1% | 0.0% 4.6% 0.0% 1.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 0/23 (0%) 1/36 (3%) 2/28 (7%) | 0/29 (0%) 1/35 (3%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | --- 378 --- 394 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.103 (e) P=0.650 P=0.353 | P=0.545 P=0.258 (e) P=0.496 |
|INCIDENTAL TUMOR | P=0.103 (e) P=0.650 P=0.353 | P=0.619 P=0.214 (e) P=0.557 |
|LOGISTIC REGRESSION | P=0.103 (e) P=0.650 P=0.352 | P=0.626 P=0.229 (e) P=0.687 |
|COCHRAN-ARMITAGE | P=0.070 | P=0.543 |
|FISHER EXACT | (e) P=0.500 P=0.248 | P=0.243 (e) P=0.500 |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/56 (2%) 0/56 (0%) 2/56 (4%) 2/56 (4%) | 1/56 (2%) 2/55 (4%) 0/56 (0%) 1/56 (2%) |
|ADJUSTED (b) | 2.7% 0.0% 5.6% 7.1% | 3.4% 4.6% 0.0% 1.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 0/23 (0%) 2/36 (6%) 2/28 (7%) | 1/29 (3%) 1/35 (3%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 611 --- 729 (T) 729 (T) | 733 (T) 378 --- 394 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.341 P=0.490N P=0.682 P=0.620 | P=0.490N P=0.541 P=0.487N P=0.748N |
|INCIDENTAL TUMOR | P=0.336 P=0.657N P=0.538 P=0.591 | P=0.423N P=0.497 P=0.487N P=0.714N |
|LOGISTIC REGRESSION | P=0.294 P=0.505N P=0.577 P=0.561 | P=0.454N P=0.486 P=0.487N P=0.742N |
|COCHRAN-ARMITAGE | P=0.244 | P=0.496N |
|FISHER EXACT | P=0.500N P=0.500 P=0.500 | P=0.493 P=0.500N P=0.752N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/56 (4%) 2/56 (4%) 2/56 (4%) 1/56 (2%) | 0/56 (0%) 0/55 (0%) 0/56 (0%) 0/56 (0%) |
|ADJUSTED (b) | 10.8% 7.1% 5.6% 3.3% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/17 (6%) 1/23 (4%) 2/36 (6%) 0/28 (0%) | 0/29 (0%) 0/35 (0%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 695 651 729 (T) 722 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.225N P=0.574N P=0.410N P=0.324N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.376N P=0.580N P=0.565N P=0.548N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.280N P=0.631N P=0.498N P=0.382N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.373N | (e) |
|FISHER EXACT | P=0.691N P=0.691N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/56 (5%) 3/56 (5%) 3/56 (5%) 1/56 (2%) | 1/56 (2%) 1/55 (2%) 0/56 (0%) 1/56 (2%) |
|ADJUSTED (b) | 13.5% 11.3% 8.1% 3.3% | 3.4% 2.7% 0.0% 2.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/17 (6%) 2/23 (9%) 2/36 (6%) 0/28 (0%) | 1/29 (3%) 0/35 (0%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 639 651 719 722 | 733 (T) 720 --- 617 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.103N P=0.524N P=0.352N P=0.177N | P=0.613N P=0.719N P=0.487N P=0.749N |
|INCIDENTAL TUMOR | P=0.233N P=0.604N P=0.635 P=0.358N | P=0.648 P=0.755 P=0.487N P=0.751 |
|LOGISTIC REGRESSION | P=0.147N P=0.591N P=0.500N P=0.232N | P=0.619N P=0.736N P=0.487N P=0.761 |
|COCHRAN-ARMITAGE | P=0.222N | P=0.614N |
|FISHER EXACT | P=0.661N P=0.661N P=0.309N | P=0.748 P=0.500N P=0.752N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/56 (4%) 2/56 (4%) 2/56 (4%) 1/56 (2%) | 1/56 (2%) 1/55 (2%) 0/56 (0%) 1/56 (2%) |
|ADJUSTED (b) | 10.8% 7.1% 5.6% 3.3% | 3.4% 2.7% 0.0% 2.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/17 (6%) 1/23 (4%) 2/36 (6%) 0/28 (0%) | 1/29 (3%) 0/35 (0%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 695 651 729 (T) 722 | 733 (T) 720 --- 617 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.225N P=0.574N P=0.410N P=0.324N | P=0.613N P=0.719N P=0.487N P=0.749N |
|INCIDENTAL TUMOR | P=0.376N P=0.580N P=0.565N P=0.548N | P=0.648 P=0.755 P=0.487N P=0.751 |
|LOGISTIC REGRESSION | P=0.280N P=0.631N P=0.498N P=0.382N | P=0.619N P=0.736N P=0.487N P=0.761 |
|COCHRAN-ARMITAGE | P=0.373N | P=0.614N |
|FISHER EXACT | P=0.691N P=0.691N P=0.500N | P=0.748 P=0.500N P=0.752N |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/56 (2%) 1/55 (2%) 0/56 (0%) 2/55 (4%) | 0/56 (0%) 0/55 (0%) 0/54 (0%) 1/56 (2%) |
|ADJUSTED (b) | 5.9% 4.3% 0.0% 6.9% | 0.0% 0.0% 0.0% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/17 (6%) 1/23 (4%) 0/36 (0%) 1/28 (4%) | 0/29 (0%) 0/35 (0%) 0/31 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- 728 | --- --- --- 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.497 P=0.694N P=0.350N P=0.674 | P=0.205 (e) (e) P=0.526 |
|INCIDENTAL TUMOR | P=0.399 P=0.694N P=0.350N P=0.547 | P=0.205 (e) (e) P=0.526 |
|LOGISTIC REGRESSION | P=0.504 P=0.694N P=0.350N P=0.683 | P=0.205 (e) (e) P=0.526 |
|COCHRAN-ARMITAGE | P=0.363 | P=0.200 |
|FISHER EXACT | P=0.748 P=0.500N P=0.493 | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/56 (61%) 34/56 (61%) 38/56 (68%) 39/56 (70%) | |
|ADJUSTED (b) | 90.7% 81.7% 86.0% 84.0% | |
|INTERIM SACRIFICE 1 (c)| 3/10 (30%) 6/10 (60%) 4/10 (40%) 8/10 (80%) | |
|TERMINAL (d) | 14/17 (82%) 16/23 (70%) 30/36 (83%) 21/28 (75%) | |
|FIRST INCIDENCE (DAYS) | 427 456 (I) 456 (I) 456 (I) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.165N P=0.150N P=0.006N** P=0.182N | |
|INCIDENTAL TUMOR | P=0.261 P=0.471N P=0.534N P=0.275 | |
|LOGISTIC REGRESSION | P=0.220 P=0.486N P=0.518 P=0.291 | |
|COCHRAN-ARMITAGE | P=0.143 | |
|FISHER EXACT | P=0.577N P=0.277 P=0.214 | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/55 (2%) 1/56 (2%) 5/56 (9%) 4/56 (7%) | 1/56 (2%) 4/55 (7%) 2/56 (4%) 3/56 (5%) |
|ADJUSTED (b) | 3.2% 1.9% 13.9% 13.7% | 3.4% 11.4% 5.8% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 0/23 (0%) 5/36 (14%) 3/28 (11%) | 1/29 (3%) 4/35 (11%) 1/31 (3%) 3/33 (9%) |
|FIRST INCIDENCE (DAYS) | 640 456 (I) 729 (T) 722 | 733 (T) 733 (T) 674 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.161 P=0.738N P=0.316 P=0.331 | P=0.406 P=0.239 P=0.532 P=0.352 |
|INCIDENTAL TUMOR | P=0.128 P=0.677 P=0.206 P=0.230 | P=0.371 P=0.239 P=0.515 P=0.352 |
|LOGISTIC REGRESSION | P=0.105 P=0.756 P=0.214 P=0.269 | P=0.376 P=0.239 P=0.512 P=0.352 |
|COCHRAN-ARMITAGE | P=0.081 | P=0.376 |
|FISHER EXACT | P=0.748N P=0.107 P=0.187 | P=0.176 P=0.500 P=0.309 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/55 (2%) 0/56 (0%) 0/56 (0%) 1/56 (2%) | 0/56 (0%) 2/55 (4%) 0/56 (0%) 0/56 (0%) |
|ADJUSTED (b) | 4.3% 0.0% 0.0% 3.6% | 0.0% 5.7% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 0/23 (0%) 0/36 (0%) 1/28 (4%) | 0/29 (0%) 2/35 (6%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 667 --- --- 729 (T) | --- 733 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.675 P=0.428N P=0.385N P=0.658N | P=0.387N P=0.280 (e) (e) |
|INCIDENTAL TUMOR | P=0.576 P=0.438N P=0.657N P=0.761N | P=0.387N P=0.280 (e) (e) |
|LOGISTIC REGRESSION | P=0.630 P=0.484N P=0.478N P=0.717N | P=0.387N P=0.280 (e) (e) |
|COCHRAN-ARMITAGE | P=0.597 | P=0.400N |
|FISHER EXACT | P=0.495N P=0.495N P=0.748N | P=0.243 (e) (e) |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/55 (4%) 1/56 (2%) 5/56 (9%) 5/56 (9%) | 1/56 (2%) 5/55 (9%) 2/56 (4%) 3/56 (5%) |
|ADJUSTED (b) | 7.4% 1.9% 13.9% 17.1% | 3.4% 14.3% 5.8% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 0/23 (0%) 5/36 (14%) 4/28 (14%) | 1/29 (3%) 5/35 (14%) 1/31 (3%) 3/33 (9%) |
|FIRST INCIDENCE (DAYS) | 640 456 (I) 729 (T) 722 | 733 (T) 733 (T) 674 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.175 P=0.435N P=0.535 P=0.421 | P=0.477 P=0.149 P=0.532 P=0.352 |
|INCIDENTAL TUMOR | P=0.120 P=0.552N P=0.312 P=0.266 | P=0.443 P=0.149 P=0.515 P=0.352 |
|LOGISTIC REGRESSION | P=0.111 P=0.507N P=0.369 P=0.328 | P=0.446 P=0.149 P=0.512 P=0.352 |
|COCHRAN-ARMITAGE | P=0.083 | P=0.443 |
|FISHER EXACT | P=0.493N P=0.226 P=0.226 | P=0.099 P=0.500 P=0.309 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/55 (2%) 1/56 (2%) 2/56 (4%) 1/56 (2%) | 0/56 (0%) 0/55 (0%) 0/56 (0%) 2/56 (4%) |
|ADJUSTED (b) | 5.9% 2.9% 5.1% 3.4% | 0.0% 0.0% 0.0% 6.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/17 (6%) 0/23 (0%) 1/36 (3%) 0/28 (0%) | 0/29 (0%) 0/35 (0%) 0/31 (0%) 2/33 (6%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 651 631 728 | --- --- --- 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.550N P=0.701N P=0.692 P=0.641N | P=0.049 * (e) (e) P=0.267 |
|INCIDENTAL TUMOR | P=0.554 P=0.691N P=0.538 P=0.761N | P=0.049 * (e) (e) P=0.267 |
|LOGISTIC REGRESSION | P=0.604N P=0.733N P=0.593 P=0.641N | P=0.049 * (e) (e) P=0.267 |
|COCHRAN-ARMITAGE | P=0.595 | P=0.047 * |
|FISHER EXACT | P=0.748N P=0.507 P=0.748N | (e) (e) P=0.248 |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/56 (0%) 1/56 (2%) 0/56 (0%) 0/56 (0%) | 1/56 (2%) 1/55 (2%) 2/56 (4%) 1/56 (2%) |
|ADJUSTED (b) | 0.0% 4.3% 0.0% 0.0% | 2.2% 2.9% 6.5% 2.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 1/23 (4%) 0/36 (0%) 0/28 (0%) | 0/29 (0%) 1/35 (3%) 2/31 (6%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 516 733 (T) 733 (T) 617 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.500N P=0.560 (e) (e) | P=0.597 P=0.745N P=0.510 P=0.750 |
|INCIDENTAL TUMOR | P=0.500N P=0.560 (e) (e) | P=0.599N P=0.739 P=0.469 P=0.755N |
|LOGISTIC REGRESSION | P=0.500N P=0.560 (e) (e) | P=0.589 P=0.754 P=0.500 P=0.743N |
|COCHRAN-ARMITAGE | P=0.565N | P=0.592 |
|FISHER EXACT | P=0.500 (e) (e) | P=0.748 P=0.500 P=0.752N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 2/56 (4%) 5/55 (9%) 6/56 (11%) 2/56 (4%) |
|ADJUSTED (b) | | 6.1% 12.5% 17.6% 4.8% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | | 1/29 (3%) 3/35 (9%) 4/31 (13%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | | 658 457 (I) 650 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.456N P=0.281 P=0.160 P=0.667N |
|INCIDENTAL TUMOR | | P=0.554N P=0.233 P=0.147 P=0.649 |
|LOGISTIC REGRESSION | | P=0.487N P=0.215 P=0.142 P=0.694N |
|COCHRAN-ARMITAGE | | P=0.477N |
|FISHER EXACT | | P=0.212 P=0.135 P=0.691N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 3/56 (5%) 5/55 (9%) 6/56 (11%) 2/56 (4%) |
|ADJUSTED (b) | | 8.2% 12.5% 17.6% 4.8% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | | 1/29 (3%) 3/35 (9%) 4/31 (13%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | | 516 457 (I) 650 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.343N P=0.425 P=0.274 P=0.481N |
|INCIDENTAL TUMOR | | P=0.410N P=0.348 P=0.240 P=0.521N |
|LOGISTIC REGRESSION | | P=0.365N P=0.345 P=0.247 P=0.489N |
|COCHRAN-ARMITAGE | | P=0.359N |
|FISHER EXACT | | P=0.348 P=0.245 P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/56 (0%) 3/56 (5%) 1/56 (2%) 1/56 (2%) | 0/56 (0%) 0/55 (0%) 0/56 (0%) 0/56 (0%) |
|ADJUSTED (b) | 0.0% 8.3% 2.6% 1.8% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 1/23 (4%) 0/36 (0%) 0/28 (0%) | 0/29 (0%) 0/35 (0%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 436 712 330 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.578N P=0.148 P=0.649 P=0.500 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.519 P=0.040 * P=0.343 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.561 P=0.111 P=0.582 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.593 | (e) |
|FISHER EXACT | P=0.122 P=0.500 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/56 (2%) 1/56 (2%) 0/56 (0%) 2/56 (4%) | 0/56 (0%) 0/55 (0%) 0/56 (0%) 1/56 (2%) |
|ADJUSTED (b) | 5.9% 4.3% 0.0% 6.9% | 0.0% 0.0% 0.0% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/17 (6%) 1/23 (4%) 0/36 (0%) 1/28 (4%) | 0/29 (0%) 0/35 (0%) 0/31 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- 728 | --- --- --- 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.497 P=0.694N P=0.350N P=0.674 | P=0.205 (e) (e) P=0.526 |
|INCIDENTAL TUMOR | P=0.409 P=0.694N P=0.350N P=0.563 | P=0.205 (e) (e) P=0.526 |
|LOGISTIC REGRESSION | P=0.504 P=0.694N P=0.350N P=0.683 | P=0.205 (e) (e) P=0.526 |
|COCHRAN-ARMITAGE | P=0.367 | P=0.199 |
|FISHER EXACT | P=0.752N P=0.500N P=0.500 | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 27/56 (48%) 2/56 (4%) 1/56 (2%) 1/56 (2%) | 15/56 (27%) 1/55 (2%) 0/56 (0%) 1/56 (2%) |
|ADJUSTED (b) | 79.2% 8.0% 2.3% 2.6% | 38.3% 2.5% 0.0% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 11/17 (65%) 1/23 (4%) 0/36 (0%) 0/28 (0%) | 6/29 (21%) 0/35 (0%) 0/31 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 495 702 552 611 | 457 (I) 659 --- 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P<0.001N** P<0.001N** P<0.001N** | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** P<0.001N** P<0.001N** P<0.001N** | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** P<0.001N** P<0.001N** P<0.001N** | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** |
|FISHER EXACT | P<0.001N** P<0.001N** P<0.001N** | P<0.001N** P<0.001N** P<0.001N** |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/56 (2%) 1/56 (2%) 4/56 (7%) 2/56 (4%) | 0/56 (0%) 0/55 (0%) 0/56 (0%) 0/56 (0%) |
|ADJUSTED (b) | 1.9% 4.3% 10.0% 6.2% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/17 (0%) 1/23 (4%) 3/36 (8%) 1/28 (4%) | 0/29 (0%) 0/35 (0%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 729 (T) 200 636 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.424 P=0.727N P=0.332 P=0.570 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.470 P=0.727N P=0.516 P=0.534 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.412 P=0.754 P=0.147 P=0.483 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.312 | (e) |
|FISHER EXACT | P=0.752N P=0.182 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 50/56 (89%) 52/56 (93%) 49/56 (88%) 54/56 (96%) | 35/56 (63%) 36/55 (65%) 35/56 (63%) 34/56 (61%) |
|ADJUSTED (b) | 96.1% 100.0% 96.0% 100.0% | 78.7% 78.0% 81.4% 77.0% |
|INTERIM SACRIFICE 1 (c)| 8/10 (80%) 8/10 (80%) 7/10 (70%) 10/10 (100%)| 3/10 (30%) 2/10 (20%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 15/17 (88%) 23/23 (100%) 34/36 (94%) 28/28 (100%)| 20/29 (69%) 25/35 (71%) 23/31 (74%) 23/33 (70%) |
|FIRST INCIDENCE (DAYS) | 427 456 (I) 456 (I) 456 (I) | 457 (I) 378 604 394 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.030N* P=0.139N P<0.001N** P=0.064N | P=0.335N P=0.306N P=0.436N P=0.326N |
|INCIDENTAL TUMOR | P=0.124 P=0.382 P=0.596N P=0.075 | P=0.533 P=0.426 P=0.529 P=0.574N |
|LOGISTIC REGRESSION | P=0.113 P=0.411 P=0.386N P=0.172 | P=0.536N P=0.502 P=0.485 P=0.542N |
|COCHRAN-ARMITAGE | P=0.156 | P=0.408N |
|FISHER EXACT | P=0.371 P=0.500N P=0.135 | P=0.450 P=0.577N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 32/56 (57%) 15/56 (27%) 14/56 (25%) 15/56 (27%) | 22/56 (39%) 7/55 (13%) 6/56 (11%) 8/56 (14%) |
|ADJUSTED (b) | 84.5% 46.2% 32.7% 40.1% | 51.2% 18.0% 16.2% 22.1% |
|INTERIM SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 12/17 (71%) 7/23 (30%) 8/36 (22%) 7/28 (25%) | 9/29 (31%) 4/35 (11%) 2/31 (6%) 6/33 (18%) |
|FIRST INCIDENCE (DAYS) | 415 436 200 330 | 457 (I) 645 504 533 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P<0.001N** P<0.001N** P<0.001N** | P=0.005N** P<0.001N** P=0.001N** P=0.003N** |
|INCIDENTAL TUMOR | P=0.006N** P=0.001N** P=0.002N** P=0.001N** | P=0.006N** P=0.003N** P<0.001N** P=0.006N** |
|LOGISTIC REGRESSION | P=0.002N** P<0.001N** P<0.001N** P<0.001N** | P=0.007N** P=0.005N** P<0.001N** P=0.006N** |
|COCHRAN-ARMITAGE | P=0.003N** | P=0.004N** |
|FISHER EXACT | P=0.001N** P<0.001N** P=0.001N** | P=0.001N** P<0.001N** P=0.003N** |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05185 TEST: 03 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ISOBUTYL NITRITE (IBN)
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 37.5 PPM 75 PPM 150 PPM | CONTROL 37.5 PPM 75 PPM 150 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 54/56 (96%) 53/56 (95%) 52/56 (93%) 56/56 (100%)| 44/56 (79%) 36/55 (65%) 37/56 (66%) 36/56 (64%) |
|ADJUSTED (b) | 100.0% 100.0% 98.1% 100.0% | 89.6% 78.0% 84.1% 79.8% |
|INTERIM SACRIFICE 1 (c)| 8/10 (80%) 8/10 (80%) 7/10 (70%) 10/10 (100%)| 4/10 (40%) 2/10 (20%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 17/17 (100%) 23/23 (100%) 35/36 (97%) 28/28 (100%)| 24/29 (83%) 25/35 (71%) 24/31 (77%) 24/33 (73%) |
|FIRST INCIDENCE (DAYS) | 415 436 200 330 | 457 (I) 378 504 394 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.018N* P=0.062N P<0.001N** P=0.032N* | P=0.104N P=0.023N* P=0.100N P=0.057N |
|INCIDENTAL TUMOR | P=0.130 P=0.707 P=0.385N P=0.234 | P=0.142N P=0.096N P=0.096N P=0.096N |
|LOGISTIC REGRESSION | P=0.214 P=0.574N P=0.283N P=0.224 | P=0.151N P=0.061N P=0.135N P=0.078N |
|COCHRAN-ARMITAGE | P=0.194 | P=0.099N |
|FISHER EXACT | P=0.500N P=0.339N P=0.248 | P=0.092N P=0.102N P=0.071N |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(c) Observed incidence at interim kill.
Male interim sacrifices(days): 456
Female interim sacrifices(days): 457
(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).