TDMS Study 05130-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Microbiological Assoc. C. I. DIRECT BLUE 218 DATE: 09/17/94
EXPERIMENT: 05130 TEST: 02 TIME: 00:05:08
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-5096 ROUTE: DOSED FEED NTP C#: 60877B
PATHOLOGIST: L. BRENNECKE CAS: 10401-500
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Microbiological Assoc. C. I. DIRECT BLUE 218 DATE: 09/17/94
EXPERIMENT: 05130 TEST: 02 TIME: 00:05:08
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-5096 ROUTE: DOSED FEED NTP C#: 60877B
PATHOLOGIST: L. BRENNECKE CAS: 10401-500
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
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: Microbiological Assoc. C. I. DIRECT BLUE 218 DATE: 09/17/94
EXPERIMENT: 05130 TEST: 02 TIME: 00:05:08
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-5096 ROUTE: DOSED FEED NTP C#: 60877B
PATHOLOGIST: L. BRENNECKE CAS: 10401-500
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF C. I. DIRECT BLUE 218
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Harderian Gland Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Hemangiosarcoma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | 0/49 (0%) 0/49 (0%) 0/48 (0%) 1/48 (2%) |
|ADJUSTED (b) | 0.0% 6.5% 2.4% 0.0% | 0.0% 0.0% 0.0% 2.7% |
|TERMINAL (d) | 0/44 (0%) 3/46 (7%) 1/42 (2%) 0/45 (0%) | 0/37 (0%) 0/40 (0%) 0/46 (0%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | --- 737 (T) 737 (T) --- | --- --- --- 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.280N P=0.129 P=0.491 (e) | P=0.208 (e) (e) P=0.500 |
|INCIDENTAL TUMOR | P=0.280N P=0.129 P=0.491 (e) | P=0.208 (e) (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.280N P=0.129 P=0.491 (e) | P=0.208 (e) (e) P=0.500 |
|COCHRAN-ARMITAGE | P=0.280N | P=0.218 |
|FISHER EXACT | P=0.121 P=0.500 (e) | (e) (e) P=0.495 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/49 (0%) 1/49 (2%) 2/48 (4%) 0/47 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 2.5% 4.3% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/46 (0%) 0/42 (0%) 0/45 (0%) | 0/37 (0%) 1/40 (3%) 2/46 (4%) 0/36 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 739 (T) 739 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.522N P=0.516 P=0.288 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.522N P=0.516 P=0.288 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.522N P=0.516 P=0.288 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.512N |
|FISHER EXACT | (e) (e) (e) | P=0.500 P=0.242 (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 4/50 (8%) 0/50 (0%) | 3/49 (6%) 0/50 (0%) 2/49 (4%) 0/49 (0%) |
|ADJUSTED (b) | 6.6% 8.7% 9.2% 0.0% | 8.1% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 2/44 (5%) 4/46 (9%) 3/42 (7%) 0/45 (0%) | 3/37 (8%) 0/40 (0%) 2/46 (4%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 613 737 (T) 686 --- | 739 (T) --- 739 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.067N P=0.524 P=0.487 P=0.119N | P=0.175N P=0.108N P=0.401N P=0.116N |
|INCIDENTAL TUMOR | P=0.047N* P=0.358 P=0.560 P=0.082N | P=0.175N P=0.108N P=0.401N P=0.116N |
|LOGISTIC REGRESSION | P=0.065N P=0.504 P=0.497 P=0.127N | P=0.175N P=0.108N P=0.401N P=0.115N |
|COCHRAN-ARMITAGE | P=0.066N | P=0.178N |
|FISHER EXACT | P=0.500 P=0.500 P=0.121N | P=0.117N P=0.500N P=0.121N |
|=================================================================================================================================|
| |
|Intestine Small |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | 0/49 (0%) 0/50 (0%) 1/49 (2%) 1/49 (2%) |
|ADJUSTED (b) | 2.3% 2.2% 0.0% 6.7% | 0.0% 0.0% 2.2% 2.6% |
|TERMINAL (d) | 1/44 (2%) 1/46 (2%) 0/42 (0%) 3/45 (7%) | 0/37 (0%) 0/40 (0%) 1/46 (2%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 737 (T) 737 (T) --- 737 (T) | --- --- 739 (T) 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.127 P=0.752N P=0.509N P=0.314 | P=0.316 (e) P=0.543 P=0.505 |
|INCIDENTAL TUMOR | P=0.127 P=0.752N P=0.509N P=0.314 | P=0.316 (e) P=0.543 P=0.505 |
|LOGISTIC REGRESSION | P=0.127 P=0.752N P=0.509N P=0.314 | P=0.316 (e) P=0.543 P=0.505 |
|COCHRAN-ARMITAGE | P=0.123 | P=0.323 |
|FISHER EXACT | P=0.753N P=0.500N P=0.309 | (e) P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | 0/49 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) |
|ADJUSTED (b) | 2.3% 0.0% 0.0% 6.7% | 0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/44 (2%) 0/46 (0%) 0/42 (0%) 3/45 (7%) | 0/37 (0%) 0/40 (0%) 1/46 (2%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 737 (T) --- --- 737 (T) | --- --- 739 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.055 P=0.491N P=0.509N P=0.314 | P=0.788N (e) P=0.543 (e) |
|INCIDENTAL TUMOR | P=0.055 P=0.491N P=0.509N P=0.314 | P=0.788N (e) P=0.543 (e) |
|LOGISTIC REGRESSION | P=0.055 P=0.491N P=0.509N P=0.314 | P=0.788N (e) P=0.543 (e) |
|COCHRAN-ARMITAGE | P=0.053 | P=0.781N |
|FISHER EXACT | P=0.500N P=0.500N P=0.309 | (e) P=0.500 (e) |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 4.3% 2.4% 2.2% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 2/46 (4%) 1/42 (2%) 1/45 (2%) | 0/37 (0%) 0/40 (0%) 0/46 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | --- 737 (T) 737 (T) 737 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.628 P=0.248 P=0.491 P=0.504 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.628 P=0.248 P=0.491 P=0.504 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.628 P=0.248 P=0.491 P=0.504 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.627 | (e) |
|FISHER EXACT | P=0.247 P=0.500 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 6.5% 2.4% 2.2% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 3/46 (7%) 1/42 (2%) 1/45 (2%) | 0/37 (0%) 0/40 (0%) 0/46 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | --- 737 (T) 737 (T) 737 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.588N P=0.129 P=0.491 P=0.504 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.588N P=0.129 P=0.491 P=0.504 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.588N P=0.129 P=0.491 P=0.504 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.592N | (e) |
|FISHER EXACT | P=0.121 P=0.500 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | 1/49 (2%) 3/50 (6%) 0/49 (0%) 1/49 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 2.1% 2.1% | 2.2% 7.5% 0.0% 2.6% |
|TERMINAL (d) | 0/44 (0%) 0/46 (0%) 0/42 (0%) 0/45 (0%) | 0/37 (0%) 3/40 (8%) 0/46 (0%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- 646 660 | 580 739 (T) --- 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.332 (e) P=0.508 P=0.508 | P=0.465N P=0.334 P=0.487N P=0.758 |
|INCIDENTAL TUMOR | P=0.321 (e) P=0.718 P=0.581 | P=0.561N P=0.307 (e) P=0.609 |
|LOGISTIC REGRESSION | P=0.271 (e) P=0.461 P=0.464 | P=0.457N P=0.307 P=0.616N P=0.763N |
|COCHRAN-ARMITAGE | P=0.325 | P=0.457N |
|FISHER EXACT | (e) P=0.500 P=0.500 | P=0.316 P=0.500N P=0.753N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 19/50 (38%) 17/50 (34%) 40/50 (80%) | 7/49 (14%) 12/50 (24%) 17/49 (35%) 41/49 (84%) |
|ADJUSTED (b) | 34.7% 40.4% 38.6% 81.6% | 18.4% 30.0% 36.1% 91.1% |
|TERMINAL (d) | 14/44 (32%) 18/46 (39%) 15/42 (36%) 36/45 (80%) | 6/37 (16%) 12/40 (30%) 16/46 (35%) 34/38 (89%) |
|FIRST INCIDENCE (DAYS) | 519 689 686 576 | 701 739 (T) 676 541 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.401 P=0.447 P<0.001 ** | P<0.001 ** P=0.198 P=0.066 P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.306 P=0.499 P<0.001 ** | P<0.001 ** P=0.215 P=0.047 * P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.371 P=0.526 P<0.001 ** | P<0.001 ** P=0.185 P=0.041 * P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.338 P=0.500 P<0.001 ** | P=0.166 P=0.017 * P<0.001 ** |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) 8/50 (16%) 17/50 (34%) | 5/49 (10%) 5/50 (10%) 6/49 (12%) 12/49 (24%) |
|ADJUSTED (b) | 15.9% 6.5% 17.1% 36.0% | 13.5% 12.0% 13.0% 30.6% |
|TERMINAL (d) | 7/44 (16%) 3/46 (7%) 4/42 (10%) 15/45 (33%) | 5/37 (14%) 4/40 (10%) 6/46 (13%) 11/38 (29%) |
|FIRST INCIDENCE (DAYS) | 737 (T) 737 (T) 622 568 | 739 (T) 648 739 (T) 689 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.141N P=0.479 P=0.022 * | P=0.012 * P=0.578N P=0.603N P=0.061 |
|INCIDENTAL TUMOR | P=0.001 ** P=0.141N P=0.585N P=0.027 * | P=0.014 * P=0.553N P=0.603N P=0.067 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.141N P=0.506 P=0.019 * | P=0.012 * P=0.586N P=0.603N P=0.061 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.014 * |
|FISHER EXACT | P=0.159N P=0.500 P=0.017 * | P=0.617N P=0.500 P=0.054 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) 8/50 (16%) 17/50 (34%) | 5/49 (10%) 5/50 (10%) 6/49 (12%) 13/49 (27%) |
|ADJUSTED (b) | 15.9% 6.5% 17.1% 36.0% | 13.5% 12.0% 13.0% 33.2% |
|TERMINAL (d) | 7/44 (16%) 3/46 (7%) 4/42 (10%) 15/45 (33%) | 5/37 (14%) 4/40 (10%) 6/46 (13%) 12/38 (32%) |
|FIRST INCIDENCE (DAYS) | 737 (T) 737 (T) 622 568 | 739 (T) 648 739 (T) 689 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.141N P=0.479 P=0.022 * | P=0.005 ** P=0.578N P=0.603N P=0.038 * |
|INCIDENTAL TUMOR | P=0.001 ** P=0.141N P=0.585N P=0.027 * | P=0.006 ** P=0.553N P=0.603N P=0.042 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.141N P=0.506 P=0.019 * | P=0.005 ** P=0.586N P=0.603N P=0.038 * |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.006 ** |
|FISHER EXACT | P=0.159N P=0.500 P=0.017 * | P=0.617N P=0.500 P=0.033 * |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 20/50 (40%) 23/50 (46%) 45/50 (90%) | 10/49 (20%) 15/50 (30%) 21/49 (43%) 45/49 (92%) |
|ADJUSTED (b) | 45.5% 42.6% 48.8% 90.0% | 26.3% 36.4% 44.7% 100.0% |
|TERMINAL (d) | 19/44 (43%) 19/46 (41%) 18/42 (43%) 40/45 (89%) | 9/37 (24%) 14/40 (35%) 20/46 (43%) 38/38 (100%)|
|FIRST INCIDENCE (DAYS) | 519 689 622 568 | 701 648 676 541 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.428N P=0.369 P<0.001 ** | P<0.001 ** P=0.239 P=0.072 P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.523N P=0.484 P<0.001 ** | P<0.001 ** P=0.269 P=0.054 P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.451N P=0.446 P<0.001 ** | P<0.001 ** P=0.226 P=0.045 * P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.500N P=0.420 P<0.001 ** | P=0.193 P=0.014 * P<0.001 ** |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 20/50 (40%) 23/50 (46%) 45/50 (90%) | 10/49 (20%) 15/50 (30%) 21/49 (43%) 45/49 (92%) |
|ADJUSTED (b) | 45.5% 42.6% 48.8% 90.0% | 26.3% 36.4% 44.7% 100.0% |
|TERMINAL (d) | 19/44 (43%) 19/46 (41%) 18/42 (43%) 40/45 (89%) | 9/37 (24%) 14/40 (35%) 20/46 (43%) 38/38 (100%)|
|FIRST INCIDENCE (DAYS) | 519 689 622 568 | 701 648 676 541 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.428N P=0.369 P<0.001 ** | P<0.001 ** P=0.239 P=0.072 P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.523N P=0.484 P<0.001 ** | P<0.001 ** P=0.269 P=0.054 P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.451N P=0.446 P<0.001 ** | P<0.001 ** P=0.226 P=0.045 * P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.500N P=0.420 P<0.001 ** | P=0.193 P=0.014 * P<0.001 ** |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 9/50 (18%) 7/50 (14%) 4/50 (8%) | 5/49 (10%) 7/50 (14%) 4/49 (8%) 1/49 (2%) |
|ADJUSTED (b) | 28.2% 19.6% 16.7% 8.9% | 13.5% 17.5% 8.7% 2.6% |
|TERMINAL (d) | 11/44 (25%) 9/46 (20%) 7/42 (17%) 4/45 (9%) | 5/37 (14%) 7/40 (18%) 4/46 (9%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 613 737 (T) 737 (T) 737 (T) | 739 (T) 739 (T) 739 (T) 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.020N* P=0.204N P=0.128N P=0.016N* | P=0.038N* P=0.434 P=0.365N P=0.096N |
|INCIDENTAL TUMOR | P=0.015N* P=0.259N P=0.103N P=0.011N* | P=0.038N* P=0.434 P=0.365N P=0.096N |
|LOGISTIC REGRESSION | P=0.018N* P=0.208N P=0.096N P=0.014N* | P=0.038N* P=0.434 P=0.365N P=0.096N |
|COCHRAN-ARMITAGE | P=0.020N* | P=0.041N* |
|FISHER EXACT | P=0.235N P=0.105N P=0.016N* | P=0.394 P=0.500N P=0.102N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|ADJUSTED (b) | 2.3% 6.5% 4.7% 2.2% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/44 (2%) 3/46 (7%) 1/42 (2%) 1/45 (2%) | 0/37 (0%) 0/40 (0%) 0/46 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 737 (T) 737 (T) 704 737 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.418N P=0.321 P=0.487 P=0.757N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.413N P=0.321 P=0.608 P=0.757N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.414N P=0.321 P=0.506 P=0.757N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.422N | (e) |
|FISHER EXACT | P=0.309 P=0.500 P=0.753N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 12/50 (24%) 9/50 (18%) 5/50 (10%) | 5/49 (10%) 7/50 (14%) 4/49 (8%) 1/49 (2%) |
|ADJUSTED (b) | 30.4% 26.1% 20.9% 11.1% | 13.5% 17.5% 8.7% 2.6% |
|TERMINAL (d) | 12/44 (27%) 12/46 (26%) 8/42 (19%) 5/45 (11%) | 5/37 (14%) 7/40 (18%) 4/46 (9%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 613 737 (T) 704 737 (T) | 739 (T) 739 (T) 739 (T) 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.016N* P=0.362N P=0.205N P=0.020N* | P=0.038N* P=0.434 P=0.365N P=0.096N |
|INCIDENTAL TUMOR | P=0.012N* P=0.433N P=0.141N P=0.014N* | P=0.038N* P=0.434 P=0.365N P=0.096N |
|LOGISTIC REGRESSION | P=0.014N* P=0.369N P=0.157N P=0.017N* | P=0.038N* P=0.434 P=0.365N P=0.096N |
|COCHRAN-ARMITAGE | P=0.016N* | P=0.041N* |
|FISHER EXACT | P=0.410N P=0.171N P=0.020N* | P=0.394 P=0.500N P=0.102N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 2/47 (4%) 1/50 (2%) 0/48 (0%) 1/49 (2%) |
|ADJUSTED (b) | | 5.4% 2.5% 0.0% 2.6% |
|TERMINAL (d) | | 2/37 (5%) 1/40 (3%) 0/46 (0%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | | 739 (T) 739 (T) --- 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.534N P=0.473N P=0.192N P=0.491N |
|INCIDENTAL TUMOR | | P=0.534N P=0.473N P=0.192N P=0.491N |
|LOGISTIC REGRESSION | | P=0.534N P=0.473N P=0.192N P=0.491N |
|COCHRAN-ARMITAGE | | P=0.520N |
|FISHER EXACT | | P=0.477N P=0.242N P=0.484N |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/47 (0%) 1/50 (2%) 2/48 (4%) 0/49 (0%) |
|ADJUSTED (b) | | 0.0% 2.5% 4.3% 0.0% |
|TERMINAL (d) | | 0/37 (0%) 1/40 (3%) 2/46 (4%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | | --- 739 (T) 739 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.506N P=0.516 P=0.288 (e) |
|INCIDENTAL TUMOR | | P=0.506N P=0.516 P=0.288 (e) |
|LOGISTIC REGRESSION | | P=0.506N P=0.516 P=0.288 (e) |
|COCHRAN-ARMITAGE | | P=0.495N |
|FISHER EXACT | | P=0.515 P=0.253 (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | 2/48 (4%) 6/50 (12%) 2/49 (4%) 0/45 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.6% 15.0% 4.3% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/44 (0%) 0/41 (0%) 0/43 (0%) | 2/36 (6%) 6/40 (15%) 2/46 (4%) 0/35 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 739 (T) 739 (T) 739 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.056N P=0.169 P=0.604N P=0.244N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.056N P=0.169 P=0.604N P=0.244N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.056N P=0.169 P=0.604N P=0.244N |
|COCHRAN-ARMITAGE | (e) | P=0.061N |
|FISHER EXACT | (e) (e) (e) | P=0.148 P=0.684N P=0.264N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 0/49 (0%) 2/50 (4%) 0/49 (0%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 2.4% 0.0% | 0.0% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/46 (0%) 1/42 (2%) 0/45 (0%) | 0/37 (0%) 1/40 (3%) 0/46 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 737 (T) --- | --- 693 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.776N (e) P=0.491 (e) | P=0.389N P=0.254 (e) (e) |
|INCIDENTAL TUMOR | P=0.776N (e) P=0.491 (e) | P=0.361N P=0.305 (e) (e) |
|LOGISTIC REGRESSION | P=0.776N (e) P=0.491 (e) | P=0.396N P=0.249 (e) (e) |
|COCHRAN-ARMITAGE | P=0.779N | P=0.394N |
|FISHER EXACT | (e) P=0.500 (e) | P=0.253 (e) (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | 0/49 (0%) 1/50 (2%) 0/49 (0%) 1/49 (2%) |
|ADJUSTED (b) | 4.5% 4.3% 0.0% 4.4% | 0.0% 2.5% 0.0% 2.6% |
|TERMINAL (d) | 2/44 (5%) 2/46 (4%) 0/42 (0%) 2/45 (4%) | 0/37 (0%) 1/40 (3%) 0/46 (0%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 737 (T) 737 (T) --- 737 (T) | --- 739 (T) --- 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.607 P=0.679N P=0.249N P=0.686N | P=0.458 P=0.516 (e) P=0.505 |
|INCIDENTAL TUMOR | P=0.607 P=0.679N P=0.249N P=0.686N | P=0.458 P=0.516 (e) P=0.505 |
|LOGISTIC REGRESSION | P=0.607 P=0.679N P=0.249N P=0.686N | P=0.458 P=0.516 (e) P=0.505 |
|COCHRAN-ARMITAGE | P=0.605 | P=0.462 |
|FISHER EXACT | P=0.691N P=0.247N P=0.691N | P=0.505 (e) P=0.500 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | 0/49 (0%) 2/50 (4%) 0/49 (0%) 1/49 (2%) |
|ADJUSTED (b) | 4.5% 4.3% 0.0% 4.4% | 0.0% 4.5% 0.0% 2.6% |
|TERMINAL (d) | 2/44 (5%) 2/46 (4%) 0/42 (0%) 2/45 (4%) | 0/37 (0%) 1/40 (3%) 0/46 (0%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 737 (T) 737 (T) --- 737 (T) | --- 554 --- 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.607 P=0.679N P=0.249N P=0.686N | P=0.610 P=0.258 (e) P=0.505 |
|INCIDENTAL TUMOR | P=0.607 P=0.679N P=0.249N P=0.686N | P=0.489 P=0.223 (e) P=0.505 |
|LOGISTIC REGRESSION | P=0.607 P=0.679N P=0.249N P=0.686N | P=0.626 P=0.191 (e) P=0.505 |
|COCHRAN-ARMITAGE | P=0.605 | P=0.615 |
|FISHER EXACT | P=0.691N P=0.247N P=0.691N | P=0.253 (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 1/49 (2%) 1/50 (2%) 2/49 (4%) 1/49 (2%) |
|ADJUSTED (b) | | 2.5% 2.5% 4.3% 2.6% |
|TERMINAL (d) | | 0/37 (0%) 1/40 (3%) 2/46 (4%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | | 688 739 (T) 739 (T) 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.641N P=0.749N P=0.569 P=0.749N |
|INCIDENTAL TUMOR | | P=0.617N P=0.695N P=0.504 P=0.702N |
|LOGISTIC REGRESSION | | P=0.645N P=0.753N P=0.521 P=0.761N |
|COCHRAN-ARMITAGE | | P=0.639N |
|FISHER EXACT | | P=0.747N P=0.500 P=0.753N |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | 1/49 (2%) 0/50 (0%) 1/49 (2%) 2/49 (4%) |
|ADJUSTED (b) | 0.0% 2.2% 0.0% 4.4% | 2.4% 0.0% 2.2% 5.3% |
|TERMINAL (d) | 0/44 (0%) 1/46 (2%) 0/42 (0%) 2/45 (4%) | 0/37 (0%) 0/40 (0%) 1/46 (2%) 2/38 (5%) |
|FIRST INCIDENCE (DAYS) | --- 737 (T) --- 737 (T) | 627 --- 739 (T) 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.152 P=0.509 (e) P=0.243 | P=0.228 P=0.478N P=0.721N P=0.509 |
|INCIDENTAL TUMOR | P=0.152 P=0.509 (e) P=0.243 | P=0.141 P=0.545N P=0.543 P=0.344 |
|LOGISTIC REGRESSION | P=0.152 P=0.509 (e) P=0.243 | P=0.234 P=0.548N P=0.747 P=0.501 |
|COCHRAN-ARMITAGE | P=0.149 | P=0.236 |
|FISHER EXACT | P=0.500 (e) P=0.247 | P=0.495N P=0.753N P=0.500 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | 1/49 (2%) 6/50 (12%) 0/49 (0%) 2/49 (4%) |
|ADJUSTED (b) | 2.3% 2.1% 4.4% 4.2% | 2.2% 14.0% 0.0% 5.3% |
|TERMINAL (d) | 1/44 (2%) 0/46 (0%) 1/42 (2%) 0/45 (0%) | 0/37 (0%) 4/40 (10%) 0/46 (0%) 2/38 (5%) |
|FIRST INCIDENCE (DAYS) | 737 (T) 659 646 660 | 580 522 --- 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.406 P=0.751N P=0.494 P=0.512 | P=0.442N P=0.077 P=0.487N P=0.501 |
|INCIDENTAL TUMOR | P=0.409 P=0.711N P=0.608 P=0.604 | P=0.444N P=0.059 (e) P=0.344 |
|LOGISTIC REGRESSION | P=0.351 P=0.755 P=0.494 P=0.472 | P=0.425N P=0.046 * P=0.616N P=0.500 |
|COCHRAN-ARMITAGE | P=0.395 | P=0.434N |
|FISHER EXACT | P=0.753N P=0.500 P=0.500 | P=0.059 P=0.500N P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 4/50 (8%) | 2/49 (4%) 6/50 (12%) 1/49 (2%) 4/49 (8%) |
|ADJUSTED (b) | 2.3% 4.2% 4.4% 8.4% | 4.6% 14.0% 2.2% 10.5% |
|TERMINAL (d) | 1/44 (2%) 1/46 (2%) 1/42 (2%) 2/45 (4%) | 0/37 (0%) 4/40 (10%) 1/46 (2%) 4/38 (11%) |
|FIRST INCIDENCE (DAYS) | 737 (T) 659 646 660 | 580 522 739 (T) 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.138 P=0.515 P=0.494 P=0.193 | P=0.485 P=0.169 P=0.452N P=0.346 |
|INCIDENTAL TUMOR | P=0.123 P=0.557 P=0.608 P=0.227 | P=0.423 P=0.123 P=0.543 P=0.147 |
|LOGISTIC REGRESSION | P=0.111 P=0.494 P=0.494 P=0.170 | P=0.502 P=0.106 P=0.594N P=0.337 |
|COCHRAN-ARMITAGE | P=0.128 | P=0.495 |
|FISHER EXACT | P=0.500 P=0.500 P=0.181 | P=0.141 P=0.500N P=0.339 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 2/50 (4%) 3/50 (6%) | 7/49 (14%) 12/50 (24%) 8/49 (16%) 5/49 (10%) |
|ADJUSTED (b) | 6.7% 8.4% 4.8% 6.7% | 17.5% 26.0% 16.6% 12.7% |
|TERMINAL (d) | 2/44 (5%) 3/46 (7%) 2/42 (5%) 3/45 (7%) | 5/37 (14%) 7/40 (18%) 6/46 (13%) 4/38 (11%) |
|FIRST INCIDENCE (DAYS) | 676 455 737 (T) 737 (T) | 518 554 532 694 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.539N P=0.523 P=0.517N P=0.651N | P=0.148N P=0.221 P=0.559N P=0.362N |
|INCIDENTAL TUMOR | P=0.602 P=0.497 P=0.425N P=0.622N | P=0.177N P=0.164 P=0.421 P=0.390N |
|LOGISTIC REGRESSION | P=0.567N P=0.455 P=0.492N P=0.651N | P=0.133N P=0.142 P=0.467 P=0.376N |
|COCHRAN-ARMITAGE | P=0.546N | P=0.137N |
|FISHER EXACT | P=0.500 P=0.500N P=0.661N | P=0.166 P=0.500 P=0.380N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 2/50 (4%) | 7/49 (14%) 11/50 (22%) 8/49 (16%) 5/49 (10%) |
|ADJUSTED (b) | 4.4% 8.4% 4.8% 4.4% | 17.5% 24.5% 16.6% 12.7% |
|TERMINAL (d) | 1/44 (2%) 3/46 (7%) 2/42 (5%) 2/45 (4%) | 5/37 (14%) 7/40 (18%) 6/46 (13%) 4/38 (11%) |
|FIRST INCIDENCE (DAYS) | 676 455 737 (T) 737 (T) | 518 590 532 694 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.446N P=0.360 P=0.681 P=0.685N | P=0.172N P=0.289 P=0.559N P=0.362N |
|INCIDENTAL TUMOR | P=0.526N P=0.331 P=0.617N P=0.651N | P=0.181N P=0.243 P=0.421 P=0.390N |
|LOGISTIC REGRESSION | P=0.478N P=0.285 P=0.690N P=0.691N | P=0.162N P=0.221 P=0.467 P=0.376N |
|COCHRAN-ARMITAGE | P=0.450N | P=0.163N |
|FISHER EXACT | P=0.339 P=0.691N P=0.691N | P=0.232 P=0.500 P=0.380N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 31/50 (62%) 21/50 (42%) 42/50 (84%) | 20/49 (41%) 21/50 (42%) 26/49 (53%) 42/49 (86%) |
|ADJUSTED (b) | 53.1% 66.0% 47.7% 85.7% | 49.7% 52.5% 55.3% 91.3% |
|TERMINAL (d) | 22/44 (50%) 30/46 (65%) 19/42 (45%) 38/45 (84%) | 17/37 (46%) 21/40 (53%) 25/46 (54%) 34/38 (89%) |
|FIRST INCIDENCE (DAYS) | 519 689 686 576 | 184 739 (T) 676 108 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.231 P=0.344N P=0.002 ** | P<0.001 ** P=0.536N P=0.485 P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.167 P=0.261N P<0.001 ** | P<0.001 ** P=0.553 P=0.273 P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.202 P=0.240N P<0.001 ** | P<0.001 ** P=0.548 P=0.221 P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.157 P=0.274N P<0.001 ** | P=0.534 P=0.156 P<0.001 ** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 15/50 (30%) 12/50 (24%) 24/50 (48%) | 14/49 (29%) 24/50 (48%) 17/49 (35%) 24/49 (49%) |
|ADJUSTED (b) | 31.1% 30.0% 25.4% 48.9% | 33.6% 48.9% 34.7% 55.6% |
|TERMINAL (d) | 13/44 (30%) 11/46 (24%) 7/42 (17%) 20/45 (44%) | 10/37 (27%) 15/40 (38%) 14/46 (30%) 19/38 (50%) |
|FIRST INCIDENCE (DAYS) | 676 455 622 568 | 518 522 532 108 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.018 * P=0.555 P=0.450N P=0.047 * | P=0.102 P=0.086 P=0.576N P=0.052 |
|INCIDENTAL TUMOR | P=0.016 * P=0.589 P=0.238N P=0.064 | P=0.088 P=0.049 * P=0.273 P=0.038 * |
|LOGISTIC REGRESSION | P=0.013 * P=0.504 P=0.392N P=0.036 * | P=0.067 P=0.033 * P=0.339 P=0.031 * |
|COCHRAN-ARMITAGE | P=0.010 * | P=0.090 |
|FISHER EXACT | P=0.500 P=0.410N P=0.032 * | P=0.037 * P=0.332 P=0.031 * |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 02 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1000 PPM 3000 PPM 10000PPM | CONTROL 1000 PPM 3000 PPM 10000PPM |
| | MALE LOW MALE MID MALE HIGHMALE | FEMALE LOW FEM MID FEM HIGH FEM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 37/50 (74%) 28/50 (56%) 46/50 (92%) | 29/49 (59%) 35/50 (70%) 34/49 (69%) 46/49 (94%) |
|ADJUSTED (b) | 65.9% 74.0% 59.5% 92.0% | 65.6% 71.4% 69.4% 100.0% |
|TERMINAL (d) | 28/44 (64%) 33/46 (72%) 23/42 (55%) 41/45 (91%) | 22/37 (59%) 26/40 (65%) 31/46 (67%) 38/38 (100%)|
|FIRST INCIDENCE (DAYS) | 519 455 622 568 | 184 522 532 108 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003 ** P=0.251 P=0.434N P=0.004 ** | P<0.001 ** P=0.335 P=0.472N P=0.002 ** |
|INCIDENTAL TUMOR | P=0.001 ** P=0.167 P=0.269N P=0.001 ** | P<0.001 ** P=0.216 P=0.209 P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.173 P=0.295N P<0.001 ** | P<0.001 ** P=0.185 P=0.232 P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.142 P=0.342N P<0.001 ** | P=0.180 P=0.200 P<0.001 ** |
|=================================================================================================================================|
(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).