TDMS Study 05130-03 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: 03 TIME: 01:46:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-5096 ROUTE: DOSED FEED NTP C#: 60877B
PATHOLOGIST: L. BRENNECKE Hailey, Rick 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: 03 TIME: 01:46:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-5096 ROUTE: DOSED FEED NTP C#: 60877B
PATHOLOGIST: L. BRENNECKE Hailey, Rick CAS: 10401-500
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
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Microbiological Assoc. C. I. DIRECT BLUE 218 DATE: 09/17/94
EXPERIMENT: 05130 TEST: 03 TIME: 01:46:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-5096 ROUTE: DOSED FEED NTP C#: 60877B
PATHOLOGIST: L. BRENNECKE Hailey, Rick CAS: 10401-500
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF C. I. DIRECT BLUE 218
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma: Benign, Complex, Malignant, NOS
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)
Papilloma Squamous or Papilloma
Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
Pharynx Squamous Cell Papilloma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
All Organs Histiocytic Sarcoma
Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Malignant Lymphoma And Histiocytic Sarcoma
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Thyroid Gland: C-Cell Carcinoma
Uterus Polyp Stromal
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/49 (31%) 9/50 (18%) 12/50 (24%) 12/50 (24%) | 1/49 (2%) 0/50 (0%) 1/47 (2%) 3/49 (6%) |
|ADJUSTED (b) | 43.7% 27.4% 37.3% 40.6% | 2.9% 0.0% 3.6% 9.9% |
|TERMINAL (d) | 11/30 (37%) 4/25 (16%) 9/29 (31%) 8/24 (33%) | 1/34 (3%) 0/29 (0%) 1/28 (4%) 1/25 (4%) |
|FIRST INCIDENCE (DAYS) | 630 614 694 614 | 729 (T) --- 729 (T) 649 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.445 P=0.207N P=0.333N P=0.522N | P=0.049 * P=0.532N P=0.718 P=0.212 |
|INCIDENTAL TUMOR | P=0.533 P=0.053N P=0.189N P=0.344N | P=0.065 P=0.532N P=0.718 P=0.289 |
|LOGISTIC REGRESSION | P=0.526 P=0.088N P=0.214N P=0.363N | P=0.066 P=0.532N P=0.718 P=0.276 |
|COCHRAN-ARMITAGE | P=0.494N | P=0.082 |
|FISHER EXACT | P=0.109N P=0.304N P=0.304N | P=0.495N P=0.742 P=0.309 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) |
|ADJUSTED (b) | 6.3% 0.0% 6.9% 2.7% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/25 (0%) 2/29 (7%) 0/24 (0%) | 0/34 (0%) 0/29 (0%) 0/28 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 682 --- 729 (T) 646 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.631N P=0.263N P=0.693N P=0.526N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.593N P=0.160N P=0.627N P=0.350N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.611N P=0.226N P=0.661N P=0.500N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.588N | (e) |
|FISHER EXACT | P=0.242N P=0.684N P=0.492N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/49 (35%) 9/50 (18%) 13/50 (26%) 13/50 (26%) | 1/49 (2%) 0/50 (0%) 1/47 (2%) 3/49 (6%) |
|ADJUSTED (b) | 48.3% 27.4% 40.4% 42.3% | 2.9% 0.0% 3.6% 9.9% |
|TERMINAL (d) | 12/30 (40%) 4/25 (16%) 10/29 (34%) 8/24 (33%) | 1/34 (3%) 0/29 (0%) 1/28 (4%) 1/25 (4%) |
|FIRST INCIDENCE (DAYS) | 630 614 694 614 | 729 (T) --- 729 (T) 649 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.454 P=0.115N P=0.263N P=0.447N | P=0.049 * P=0.532N P=0.718 P=0.212 |
|INCIDENTAL TUMOR | P=0.554 P=0.016N* P=0.118N P=0.221N | P=0.065 P=0.532N P=0.718 P=0.289 |
|LOGISTIC REGRESSION | P=0.538 P=0.036N* P=0.149N P=0.213N | P=0.066 P=0.532N P=0.718 P=0.276 |
|COCHRAN-ARMITAGE | P=0.477N | P=0.082 |
|FISHER EXACT | P=0.048N* P=0.235N P=0.235N | P=0.495N P=0.742 P=0.309 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 2/49 (4%) | 2/47 (4%) 0/48 (0%) 2/49 (4%) 2/47 (4%) |
|ADJUSTED (b) | 6.7% 6.7% 6.1% 6.2% | 6.1% 0.0% 6.5% 6.0% |
|TERMINAL (d) | 2/30 (7%) 0/25 (0%) 1/29 (3%) 1/24 (4%) | 2/33 (6%) 0/29 (0%) 2/31 (6%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 618 686 506 | 729 (T) --- 729 (T) 572 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.586N P=0.514 P=0.690N P=0.631 | P=0.352 P=0.267N P=0.673 P=0.607 |
|INCIDENTAL TUMOR | P=0.561N P=0.437 P=0.627N P=0.697 | P=0.468 P=0.267N P=0.673 P=0.622N |
|LOGISTIC REGRESSION | P=0.528N P=0.485 P=0.663N P=0.687 | P=0.397 P=0.267N P=0.673 P=0.683 |
|COCHRAN-ARMITAGE | P=0.545N | P=0.432 |
|FISHER EXACT | P=0.500 P=0.691N P=0.684 | P=0.242N P=0.676N P=0.692N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 2/49 (4%) | 2/47 (4%) 1/48 (2%) 2/49 (4%) 2/47 (4%) |
|ADJUSTED (b) | 6.7% 6.7% 6.1% 6.2% | 6.1% 2.2% 6.5% 6.0% |
|TERMINAL (d) | 2/30 (7%) 0/25 (0%) 1/29 (3%) 1/24 (4%) | 2/33 (6%) 0/29 (0%) 2/31 (6%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 618 686 506 | 729 (T) 504 729 (T) 572 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.586N P=0.514 P=0.690N P=0.631 | P=0.457 P=0.530N P=0.673 P=0.607 |
|INCIDENTAL TUMOR | P=0.561N P=0.437 P=0.627N P=0.697 | P=0.545 P=0.483N P=0.673 P=0.622N |
|LOGISTIC REGRESSION | P=0.528N P=0.485 P=0.663N P=0.687 | P=0.544 P=0.490N P=0.673 P=0.683 |
|COCHRAN-ARMITAGE | P=0.545N | P=0.534 |
|FISHER EXACT | P=0.500 P=0.691N P=0.684 | P=0.492N P=0.676N P=0.692N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 3/50 (6%) 7/50 (14%) | 0/50 (0%) 1/48 (2%) 2/50 (4%) 0/48 (0%) |
|ADJUSTED (b) | 12.3% 16.4% 10.3% 25.3% | 0.0% 3.4% 6.5% 0.0% |
|TERMINAL (d) | 3/30 (10%) 2/25 (8%) 3/29 (10%) 5/24 (21%) | 0/35 (0%) 1/29 (3%) 2/31 (6%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 618 637 729 (T) 531 | --- 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.125 P=0.452 P=0.503N P=0.172 | P=0.575N P=0.462 P=0.212 (e) |
|INCIDENTAL TUMOR | P=0.169 P=0.542 P=0.602N P=0.215 | P=0.575N P=0.462 P=0.212 (e) |
|LOGISTIC REGRESSION | P=0.159 P=0.526 P=0.453N P=0.242 | P=0.575N P=0.462 P=0.212 (e) |
|COCHRAN-ARMITAGE | P=0.194 | P=0.507N |
|FISHER EXACT | P=0.500 P=0.500N P=0.262 | P=0.490 P=0.247 (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 4/50 (8%) 7/50 (14%) | 0/50 (0%) 1/48 (2%) 2/50 (4%) 0/48 (0%) |
|ADJUSTED (b) | 12.3% 16.4% 13.2% 25.3% | 0.0% 3.4% 6.5% 0.0% |
|TERMINAL (d) | 3/30 (10%) 2/25 (8%) 3/29 (10%) 5/24 (21%) | 0/35 (0%) 1/29 (3%) 2/31 (6%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 618 637 714 531 | --- 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.135 P=0.452 P=0.640 P=0.172 | P=0.575N P=0.462 P=0.212 (e) |
|INCIDENTAL TUMOR | P=0.189 P=0.542 P=0.617 P=0.215 | P=0.575N P=0.462 P=0.212 (e) |
|LOGISTIC REGRESSION | P=0.170 P=0.526 P=0.596N P=0.242 | P=0.575N P=0.462 P=0.212 (e) |
|COCHRAN-ARMITAGE | P=0.208 | P=0.507N |
|FISHER EXACT | P=0.500 P=0.643N P=0.262 | P=0.490 P=0.247 (e) |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 6.9% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 2/29 (7%) 0/24 (0%) | 0/35 (0%) 0/29 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.713N (e) P=0.230 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.713N (e) P=0.230 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.713N (e) P=0.230 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.675N | (e) |
|FISHER EXACT | (e) P=0.247 (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 6.9% 0.0% | 0.0% 0.0% 0.0% 2.7% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 2/29 (7%) 0/24 (0%) | 0/35 (0%) 0/29 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- | --- --- --- 637 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.713N (e) P=0.230 (e) | P=0.200 (e) (e) P=0.465 |
|INCIDENTAL TUMOR | P=0.713N (e) P=0.230 (e) | P=0.412 (e) (e) P=0.892 |
|LOGISTIC REGRESSION | P=0.713N (e) P=0.230 (e) | P=0.236 (e) (e) P=0.515 |
|COCHRAN-ARMITAGE | P=0.675N | P=0.221 |
|FISHER EXACT | (e) P=0.247 (e) | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) 2/50 (4%) 6/50 (12%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 16.7% 19.2% 6.9% 21.3% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 5/30 (17%) 3/25 (12%) 2/29 (7%) 4/24 (17%) | 0/35 (0%) 0/29 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 617 729 (T) 601 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.349 P=0.419 P=0.226N P=0.372 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.333 P=0.448 P=0.226N P=0.387 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.400 P=0.528 P=0.226N P=0.462 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.451 | (e) |
|FISHER EXACT | P=0.500 P=0.218N P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 5.5% 0.0% 3.4% 8.3% | 0.0% 3.1% 0.0% 8.0% |
|TERMINAL (d) | 1/30 (3%) 0/25 (0%) 1/29 (3%) 2/24 (8%) | 0/35 (0%) 0/29 (0%) 0/31 (0%) 2/25 (8%) |
|FIRST INCIDENCE (DAYS) | 572 --- 729 (T) 729 (T) | --- 713 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.355 P=0.247N P=0.500N P=0.629 | P=0.100 P=0.477 (e) P=0.167 |
|INCIDENTAL TUMOR | P=0.331 P=0.272N P=0.637N P=0.585 | P=0.121 P=0.581 (e) P=0.167 |
|LOGISTIC REGRESSION | P=0.392 P=0.254N P=0.508N P=0.688 | P=0.102 P=0.491 (e) P=0.167 |
|COCHRAN-ARMITAGE | P=0.408 | P=0.149 |
|FISHER EXACT | P=0.247N P=0.500N P=0.691N | P=0.500 (e) P=0.247 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 4.2% | 7.9% 3.4% 5.2% 4.0% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 0/29 (0%) 1/24 (4%) | 2/35 (6%) 1/29 (3%) 1/31 (3%) 1/25 (4%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 659 729 (T) 506 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.195 (e) (e) P=0.455 | P=0.440N P=0.367N P=0.542N P=0.431N |
|INCIDENTAL TUMOR | P=0.195 (e) (e) P=0.455 | P=0.448N P=0.320N P=0.545N P=0.377N |
|LOGISTIC REGRESSION | P=0.195 (e) (e) P=0.455 | P=0.369N P=0.320N P=0.496N P=0.370N |
|COCHRAN-ARMITAGE | P=0.221 | P=0.347N |
|FISHER EXACT | (e) (e) P=0.500 | P=0.309N P=0.500N P=0.309N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 4.2% | 7.9% 3.4% 5.2% 6.5% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 0/29 (0%) 1/24 (4%) | 2/35 (6%) 1/29 (3%) 1/31 (3%) 1/25 (4%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 659 729 (T) 506 618 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.195 (e) (e) P=0.455 | P=0.567 P=0.367N P=0.542N P=0.632N |
|INCIDENTAL TUMOR | P=0.195 (e) (e) P=0.455 | P=0.617N P=0.320N P=0.545N P=0.425N |
|LOGISTIC REGRESSION | P=0.195 (e) (e) P=0.455 | P=0.607N P=0.320N P=0.496N P=0.545N |
|COCHRAN-ARMITAGE | P=0.221 | P=0.591N |
|FISHER EXACT | (e) (e) P=0.500 | P=0.309N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | 19/50 (38%) 12/50 (24%) 19/50 (38%) 10/50 (20%) |
|ADJUSTED (b) | 6.4% 12.0% 2.6% 3.4% | 49.7% 35.4% 54.0% 34.3% |
|TERMINAL (d) | 1/30 (3%) 3/25 (12%) 0/29 (0%) 0/24 (0%) | 16/35 (46%) 8/29 (28%) 15/31 (48%) 7/25 (28%) |
|FIRST INCIDENCE (DAYS) | 693 729 (T) 680 702 | 666 572 629 639 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.349N P=0.431 P=0.481N P=0.541N | P=0.283N P=0.232N P=0.402 P=0.233N |
|INCIDENTAL TUMOR | P=0.300N P=0.512 P=0.299N P=0.350N | P=0.133N P=0.112N P=0.451 P=0.099N |
|LOGISTIC REGRESSION | P=0.335N P=0.497 P=0.482N P=0.206N | P=0.181N P=0.122N P=0.462 P=0.116N |
|COCHRAN-ARMITAGE | P=0.311N | P=0.069N |
|FISHER EXACT | P=0.500 P=0.500N P=0.500N | P=0.097N P=0.582N P=0.038N* |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | 19/50 (38%) 12/50 (24%) 19/50 (38%) 11/50 (22%) |
|ADJUSTED (b) | 6.4% 12.0% 2.6% 3.4% | 49.7% 35.4% 54.0% 36.1% |
|TERMINAL (d) | 1/30 (3%) 3/25 (12%) 0/29 (0%) 0/24 (0%) | 16/35 (46%) 8/29 (28%) 15/31 (48%) 7/25 (28%) |
|FIRST INCIDENCE (DAYS) | 693 729 (T) 680 702 | 666 572 629 618 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.349N P=0.431 P=0.481N P=0.541N | P=0.384N P=0.232N P=0.402 P=0.316N |
|INCIDENTAL TUMOR | P=0.300N P=0.512 P=0.299N P=0.350N | P=0.179N P=0.112N P=0.451 P=0.110N |
|LOGISTIC REGRESSION | P=0.335N P=0.497 P=0.482N P=0.206N | P=0.257N P=0.122N P=0.462 P=0.159N |
|COCHRAN-ARMITAGE | P=0.311N | P=0.111N |
|FISHER EXACT | P=0.500 P=0.500N P=0.500N | P=0.097N P=0.582N P=0.063N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | 22/50 (44%) 13/50 (26%) 20/50 (40%) 12/50 (24%) |
|ADJUSTED (b) | 6.4% 12.0% 2.6% 7.5% | 56.0% 38.5% 55.0% 39.6% |
|TERMINAL (d) | 1/30 (3%) 3/25 (12%) 0/29 (0%) 1/24 (4%) | 18/35 (51%) 9/29 (31%) 15/31 (48%) 8/25 (32%) |
|FIRST INCIDENCE (DAYS) | 693 729 (T) 680 702 | 659 572 506 618 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.606N P=0.431 P=0.481N P=0.640 | P=0.316N P=0.147N P=0.548 P=0.228N |
|INCIDENTAL TUMOR | P=0.559N P=0.512 P=0.299N P=0.601N | P=0.138N P=0.054N P=0.563N P=0.059N |
|LOGISTIC REGRESSION | P=0.593N P=0.497 P=0.482N P=0.677 | P=0.178N P=0.060N P=0.508N P=0.089N |
|COCHRAN-ARMITAGE | P=0.555N | P=0.072N |
|FISHER EXACT | P=0.500 P=0.500N P=0.691N | P=0.046N* P=0.420N P=0.028N* |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 5/50 (10%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 19.3% | 2.9% 3.4% 0.0% 5.5% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 0/29 (0%) 4/24 (17%) | 1/35 (3%) 1/29 (3%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 684 | 729 (T) 729 (T) --- 637 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.020 * | P=0.261 P=0.720 P=0.524N P=0.418 |
|INCIDENTAL TUMOR | P<0.001 ** (e) (e) P=0.029 * | P=0.393 P=0.720 P=0.524N P=0.681 |
|LOGISTIC REGRESSION | P<0.001 ** (e) (e) P=0.026 * | P=0.305 P=0.720 P=0.524N P=0.490 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.325 |
|FISHER EXACT | (e) (e) P=0.028 * | P=0.753N P=0.500N P=0.500 |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 6/50 (12%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 23.3% | 2.9% 3.4% 0.0% 5.5% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 0/29 (0%) 5/24 (21%) | 1/35 (3%) 1/29 (3%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 684 | 729 (T) 729 (T) --- 637 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.009 ** | P=0.261 P=0.720 P=0.524N P=0.418 |
|INCIDENTAL TUMOR | P<0.001 ** (e) (e) P=0.013 * | P=0.393 P=0.720 P=0.524N P=0.681 |
|LOGISTIC REGRESSION | P<0.001 ** (e) (e) P=0.013 * | P=0.305 P=0.720 P=0.524N P=0.490 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.325 |
|FISHER EXACT | (e) (e) P=0.013 * | P=0.753N P=0.500N P=0.500 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Pharynx |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 5/50 (10%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 19.3% | 2.9% 3.4% 0.0% 5.5% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 0/29 (0%) 4/24 (17%) | 1/35 (3%) 1/29 (3%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 684 | 729 (T) 729 (T) --- 637 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.020 * | P=0.261 P=0.720 P=0.524N P=0.418 |
|INCIDENTAL TUMOR | P<0.001 ** (e) (e) P=0.029 * | P=0.393 P=0.720 P=0.524N P=0.681 |
|LOGISTIC REGRESSION | P<0.001 ** (e) (e) P=0.026 * | P=0.305 P=0.720 P=0.524N P=0.490 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.325 |
|FISHER EXACT | (e) (e) P=0.028 * | P=0.753N P=0.500N P=0.500 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 14/50 (28%) 16/48 (33%) 12/50 (24%) | 28/50 (56%) 31/47 (66%) 32/49 (65%) 21/47 (45%) |
|ADJUSTED (b) | 42.1% 38.6% 45.6% 40.9% | 66.3% 78.1% 79.6% 67.6% |
|TERMINAL (d) | 10/30 (33%) 5/25 (20%) 10/28 (36%) 8/24 (33%) | 21/35 (60%) 18/26 (69%) 22/30 (73%) 14/23 (61%) |
|FIRST INCIDENCE (DAYS) | 572 369 537 601 | 499 419 533 484 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.451N P=0.562 P=0.487 P=0.516N | P=0.413N P=0.075 P=0.108 P=0.449 |
|INCIDENTAL TUMOR | P=0.308N P=0.343N P=0.568N P=0.422N | P=0.133N P=0.213 P=0.228 P=0.394N |
|LOGISTIC REGRESSION | P=0.334N P=0.474N P=0.533 P=0.363N | P=0.098N P=0.193 P=0.163 P=0.318N |
|COCHRAN-ARMITAGE | P=0.284N | P=0.046N* |
|FISHER EXACT | P=0.500N P=0.445 P=0.326N | P=0.213 P=0.229 P=0.181N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | 2/50 (4%) 0/47 (0%) 1/49 (2%) 2/47 (4%) |
|ADJUSTED (b) | 4.2% 0.0% 0.0% 0.0% | 4.6% 0.0% 2.1% 6.5% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 0/28 (0%) 0/24 (0%) | 0/35 (0%) 0/26 (0%) 0/30 (0%) 1/23 (4%) |
|FIRST INCIDENCE (DAYS) | 506 --- --- --- | 532 --- 532 502 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.273N P=0.233N P=0.237N P=0.252N | P=0.355 P=0.256N P=0.510N P=0.614 |
|INCIDENTAL TUMOR | P=0.104N P=0.500N P=0.309N P=0.091N | P=0.267 P=0.178N P=0.516N P=0.585 |
|LOGISTIC REGRESSION | P=0.229N P=0.340N P=0.333N P=0.221N | P=0.503 P=0.254N P=0.505N P=0.664N |
|COCHRAN-ARMITAGE | P=0.262N | P=0.394 |
|FISHER EXACT | P=0.247N P=0.258N P=0.247N | P=0.263N P=0.508N P=0.668 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 14/50 (28%) 16/48 (33%) 12/50 (24%) | 30/50 (60%) 31/47 (66%) 33/49 (67%) 23/47 (49%) |
|ADJUSTED (b) | 44.5% 38.6% 45.6% 40.9% | 67.9% 78.1% 80.0% 71.8% |
|TERMINAL (d) | 10/30 (33%) 5/25 (20%) 10/28 (36%) 8/24 (33%) | 21/35 (60%) 18/26 (69%) 22/30 (73%) 15/23 (65%) |
|FIRST INCIDENCE (DAYS) | 506 369 537 601 | 499 419 532 484 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.354N P=0.438N P=0.512N P=0.357N | P=0.502N P=0.141 P=0.153 P=0.421 |
|INCIDENTAL TUMOR | P=0.174N P=0.264N P=0.427N P=0.216N | P=0.215N P=0.374 P=0.296 P=0.445N |
|LOGISTIC REGRESSION | P=0.226N P=0.340N P=0.515N P=0.205N | P=0.127N P=0.330 P=0.243 P=0.295N |
|COCHRAN-ARMITAGE | P=0.200N | P=0.069N |
|FISHER EXACT | P=0.333N P=0.557N P=0.189N | P=0.346 P=0.291 P=0.187N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.7% 6.5% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 1/25 (4%) 0/29 (0%) 0/24 (0%) | 0/35 (0%) 0/29 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 651 --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.153N P=0.652 P=0.245N P=0.288N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.139N P=0.670N P=0.245N P=0.288N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.142N P=0.681N P=0.245N P=0.288N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.136N | (e) |
|FISHER EXACT | P=0.691N P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 3/50 (6%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.3% 11.0% 5.6% 9.3% | 0.0% 3.4% 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 2/25 (8%) 1/29 (3%) 1/24 (4%) | 0/35 (0%) 1/29 (3%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 713 632 601 | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.306 P=0.259 P=0.518 P=0.269 | P=0.647N P=0.462 (e) (e) |
|INCIDENTAL TUMOR | P=0.300 P=0.330 P=0.363 P=0.284 | P=0.647N P=0.462 (e) (e) |
|LOGISTIC REGRESSION | P=0.343 P=0.290 P=0.514 P=0.299 | P=0.647N P=0.462 (e) (e) |
|COCHRAN-ARMITAGE | P=0.363 | P=0.601N |
|FISHER EXACT | P=0.309 P=0.500 P=0.309 | P=0.500 (e) (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.7% 8.5% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 1/25 (4%) 0/29 (0%) 0/24 (0%) | 0/35 (0%) 0/29 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 621 --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.116N P=0.473 P=0.245N P=0.288N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.120N P=0.519 P=0.245N P=0.288N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.103N P=0.511 P=0.245N P=0.288N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.101N | (e) |
|FISHER EXACT | P=0.500 P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 2/50 (4%) 4/50 (8%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 13.3% 18.9% 5.6% 12.3% | 0.0% 3.4% 0.0% 0.0% |
|TERMINAL (d) | 4/30 (13%) 3/25 (12%) 1/29 (3%) 1/24 (4%) | 0/35 (0%) 1/29 (3%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 621 632 601 | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.567N P=0.309 P=0.333N P=0.562 | P=0.647N P=0.462 (e) (e) |
|INCIDENTAL TUMOR | P=0.562N P=0.389 P=0.435N P=0.636 | P=0.647N P=0.462 (e) (e) |
|LOGISTIC REGRESSION | P=0.514N P=0.395 P=0.297N P=0.624 | P=0.647N P=0.462 (e) (e) |
|COCHRAN-ARMITAGE | P=0.487N | P=0.601N |
|FISHER EXACT | P=0.370 P=0.339N P=0.643N | P=0.500 (e) (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 5/50 (10%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 12.3% 15.3% 15.2% 7.3% | 0.0% 0.0% 0.0% 2.6% |
|TERMINAL (d) | 3/30 (10%) 3/25 (12%) 3/29 (10%) 1/24 (4%) | 0/35 (0%) 0/29 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 618 721 686 692 | --- --- --- 595 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.309N P=0.571 P=0.515 P=0.415N | P=0.204 (e) (e) P=0.476 |
|INCIDENTAL TUMOR | P=0.277N P=0.621 P=0.531 P=0.387N | P=0.412 (e) (e) P=0.892 |
|LOGISTIC REGRESSION | P=0.278N P=0.627N P=0.547 P=0.354N | P=0.262 (e) (e) P=0.540 |
|COCHRAN-ARMITAGE | P=0.246N | P=0.221 |
|FISHER EXACT | P=0.643N P=0.500 P=0.339N | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 5/50 (10%) 3/50 (6%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 14.3% 15.3% 15.2% 10.0% | 0.0% 5.4% 3.2% 2.6% |
|TERMINAL (d) | 3/30 (10%) 3/25 (12%) 3/29 (10%) 1/24 (4%) | 0/35 (0%) 1/29 (3%) 1/31 (3%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 572 721 686 680 | --- 452 729 (T) 595 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.397N P=0.563N P=0.609N P=0.428N | P=0.576 P=0.221 P=0.476 P=0.476 |
|INCIDENTAL TUMOR | P=0.368N P=0.531N P=0.593 P=0.383N | P=0.657 P=0.238 P=0.476 P=0.892 |
|LOGISTIC REGRESSION | P=0.356N P=0.478N P=0.611N P=0.364N | P=0.667N P=0.218 P=0.476 P=0.540 |
|COCHRAN-ARMITAGE | P=0.325N | P=0.627 |
|FISHER EXACT | P=0.500N P=0.630N P=0.357N | P=0.247 P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 2.3% 0.0% 0.0% 2.9% | 0.0% 5.4% 3.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 0/29 (0%) 0/24 (0%) | 0/35 (0%) 1/29 (3%) 1/31 (3%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 572 --- --- 680 | --- 452 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.529 P=0.479N P=0.487N P=0.758 | P=0.432N P=0.221 P=0.476 (e) |
|INCIDENTAL TUMOR | P=0.512 P=0.521N P=0.739N P=0.744N | P=0.475N P=0.238 P=0.476 (e) |
|LOGISTIC REGRESSION | P=0.561 P=0.572N P=0.566N P=0.757N | P=0.344N P=0.218 P=0.476 (e) |
|COCHRAN-ARMITAGE | P=0.536 | P=0.383N |
|FISHER EXACT | P=0.500N P=0.500N P=0.753N | P=0.247 P=0.500 (e) |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 10.3% 4.2% | 0.0% 0.0% 0.0% 2.9% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 3/29 (10%) 1/24 (4%) | 0/35 (0%) 0/29 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | --- --- --- 658 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.370 (e) P=0.114 P=0.455 | P=0.192 (e) (e) P=0.453 |
|INCIDENTAL TUMOR | P=0.370 (e) P=0.114 P=0.455 | P=0.235 (e) (e) P=0.545 |
|LOGISTIC REGRESSION | P=0.370 (e) P=0.114 P=0.455 | P=0.224 (e) (e) P=0.503 |
|COCHRAN-ARMITAGE | P=0.423 | P=0.221 |
|FISHER EXACT | (e) P=0.121 P=0.500 | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 6.9% 4.2% | 0.0% 0.0% 0.0% 2.9% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 2/29 (7%) 1/24 (4%) | 0/35 (0%) 0/29 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | --- --- --- 658 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.337 (e) P=0.230 P=0.455 | P=0.192 (e) (e) P=0.453 |
|INCIDENTAL TUMOR | P=0.337 (e) P=0.230 P=0.455 | P=0.235 (e) (e) P=0.545 |
|LOGISTIC REGRESSION | P=0.337 (e) P=0.230 P=0.455 | P=0.224 (e) (e) P=0.503 |
|COCHRAN-ARMITAGE | P=0.383 | P=0.221 |
|FISHER EXACT | (e) P=0.247 P=0.500 | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 46/50 (92%) 48/50 (96%) 44/50 (88%) | |
|ADJUSTED (b) | 100.0% 97.8% 98.0% 100.0% | |
|TERMINAL (d) | 30/30 (100%) 24/25 (96%) 28/29 (97%) 24/24 (100%)| |
|FIRST INCIDENCE (DAYS) | 539 601 533 460 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.271 P=0.267 P=0.426 P=0.209 | |
|INCIDENTAL TUMOR | P=0.547 P=0.528N P=0.230 P=0.620 | |
|LOGISTIC REGRESSION | P=0.538 P=0.450N P=0.451 P=0.641 | |
|COCHRAN-ARMITAGE | P=0.325N | |
|FISHER EXACT | P=0.500 P=0.218 P=0.500N | |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 1/50 (2%) 4/50 (8%) 4/50 (8%) | 3/50 (6%) 4/50 (8%) 2/49 (4%) 3/49 (6%) |
|ADJUSTED (b) | 19.1% 4.0% 11.6% 15.4% | 8.6% 13.8% 5.8% 12.0% |
|TERMINAL (d) | 3/30 (10%) 1/25 (4%) 2/29 (7%) 3/24 (13%) | 3/35 (9%) 4/29 (14%) 1/30 (3%) 3/25 (12%) |
|FIRST INCIDENCE (DAYS) | 548 729 (T) 581 699 | 729 (T) 729 (T) 639 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.593 P=0.047N* P=0.256N P=0.360N | P=0.527 P=0.397 P=0.567N P=0.500 |
|INCIDENTAL TUMOR | P=0.589N P=0.022N* P=0.295N P=0.264N | P=0.602 P=0.397 P=0.422N P=0.500 |
|LOGISTIC REGRESSION | P=0.530N P=0.033N* P=0.273N P=0.273N | P=0.546 P=0.397 P=0.534N P=0.500 |
|COCHRAN-ARMITAGE | P=0.513N | P=0.557N |
|FISHER EXACT | P=0.030N* P=0.262N P=0.262N | P=0.500 P=0.510N P=0.651 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 3/49 (6%) |
|ADJUSTED (b) | 3.3% 0.0% 3.0% 4.2% | 2.9% 0.0% 0.0% 12.0% |
|TERMINAL (d) | 1/30 (3%) 0/25 (0%) 0/29 (0%) 1/24 (4%) | 1/35 (3%) 0/29 (0%) 0/30 (0%) 3/25 (12%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 700 729 (T) | 729 (T) --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.525 P=0.536N P=0.757N P=0.712 | P=0.028 * P=0.538N P=0.531N P=0.193 |
|INCIDENTAL TUMOR | P=0.554 P=0.536N P=0.669N P=0.712 | P=0.028 * P=0.538N P=0.531N P=0.193 |
|LOGISTIC REGRESSION | P=0.537 P=0.536N P=0.743N P=0.712 | P=0.028 * P=0.538N P=0.531N P=0.193 |
|COCHRAN-ARMITAGE | P=0.559 | P=0.051 |
|FISHER EXACT | P=0.500N P=0.753N P=0.753N | P=0.500N P=0.505N P=0.301 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 1/50 (2%) 5/50 (10%) 5/50 (10%) | 4/50 (8%) 4/50 (8%) 2/49 (4%) 6/49 (12%) |
|ADJUSTED (b) | 22.1% 4.0% 14.2% 19.4% | 11.4% 13.8% 5.8% 24.0% |
|TERMINAL (d) | 4/30 (13%) 1/25 (4%) 2/29 (7%) 4/24 (17%) | 4/35 (11%) 4/29 (14%) 1/30 (3%) 6/25 (24%) |
|FIRST INCIDENCE (DAYS) | 548 729 (T) 581 699 | 729 (T) 729 (T) 639 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.510 P=0.029N* P=0.271N P=0.393N | P=0.117 P=0.538 P=0.408N P=0.176 |
|INCIDENTAL TUMOR | P=0.528 P=0.013N* P=0.264N P=0.302N | P=0.155 P=0.538 P=0.279N P=0.176 |
|LOGISTIC REGRESSION | P=0.573 P=0.017N* P=0.278N P=0.293N | P=0.125 P=0.538 P=0.375N P=0.176 |
|COCHRAN-ARMITAGE | P=0.573N | P=0.231 |
|FISHER EXACT | P=0.015N* P=0.277N P=0.277N | P=0.643N P=0.349N P=0.357 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 6.7% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 0/29 (0%) 0/24 (0%) | 0/35 (0%) 0/29 (0%) 2/30 (7%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.735N (e) P=0.205 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.735N (e) P=0.205 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.735N (e) P=0.205 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.680N |
|FISHER EXACT | (e) (e) (e) | (e) P=0.242 (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 3.4% 3.3% | 0.0% 0.0% 6.7% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 1/29 (3%) 0/24 (0%) | 0/35 (0%) 0/29 (0%) 2/30 (7%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 699 | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.302 (e) P=0.493 P=0.493 | P=0.735N (e) P=0.205 (e) |
|INCIDENTAL TUMOR | P=0.330 (e) P=0.493 P=0.654 | P=0.735N (e) P=0.205 (e) |
|LOGISTIC REGRESSION | P=0.304 (e) P=0.493 P=0.494 | P=0.735N (e) P=0.205 (e) |
|COCHRAN-ARMITAGE | P=0.325 | P=0.680N |
|FISHER EXACT | (e) P=0.500 P=0.500 | (e) P=0.242 (e) |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 1/50 (2%) 12/50 (24%) 10/50 (20%) 10/50 (20%) |
|ADJUSTED (b) | | 2.9% 36.6% 28.4% 36.6% |
|TERMINAL (d) | | 1/35 (3%) 9/29 (31%) 7/31 (23%) 8/25 (32%) |
|FIRST INCIDENCE (DAYS) | | 729 (T) 670 583 660 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.034 * P<0.001 ** P=0.004 ** P<0.001 ** |
|INCIDENTAL TUMOR | | P=0.076 P<0.001 ** P=0.009 ** P=0.001 ** |
|LOGISTIC REGRESSION | | P=0.053 P<0.001 ** P=0.004 ** P=0.001 ** |
|COCHRAN-ARMITAGE | | P=0.131 |
|FISHER EXACT | | P<0.001 ** P=0.004 ** P=0.004 ** |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 7.3% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 0/29 (0%) 1/24 (4%) | 0/35 (0%) 0/29 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 692 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.034 * (e) (e) P=0.212 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.041 * (e) (e) P=0.293 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.035 * (e) (e) P=0.226 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.042 * | (e) |
|FISHER EXACT | (e) (e) P=0.247 | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 25/50 (50%) 23/50 (46%) 26/50 (52%) | 11/50 (22%) 16/50 (32%) 9/50 (18%) 16/50 (32%) |
|ADJUSTED (b) | 47.3% 59.3% 57.2% 64.7% | 25.6% 39.2% 24.1% 45.3% |
|TERMINAL (d) | 11/30 (37%) 9/25 (36%) 13/29 (45%) 11/24 (46%) | 5/35 (14%) 5/29 (17%) 4/31 (13%) 7/25 (28%) |
|FIRST INCIDENCE (DAYS) | 548 614 537 450 | 428 621 617 554 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.086 P=0.113 P=0.266 P=0.048 * | P=0.080 P=0.135 P=0.503N P=0.058 |
|INCIDENTAL TUMOR | P=0.119 P=0.278 P=0.121 P=0.093 | P=0.314 P=0.386 P=0.355N P=0.227 |
|LOGISTIC REGRESSION | P=0.116 P=0.124 P=0.235 P=0.074 | P=0.321 P=0.262 P=0.393N P=0.164 |
|COCHRAN-ARMITAGE | P=0.150 | P=0.235 |
|FISHER EXACT | P=0.113 P=0.208 P=0.079 | P=0.184 P=0.402N P=0.184 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 7.3% | 0.0% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/25 (0%) 0/29 (0%) 1/24 (4%) | 0/35 (0%) 0/29 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 692 | --- 494 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.034 * (e) (e) P=0.212 | P=0.609N P=0.500 (e) (e) |
|INCIDENTAL TUMOR | P=0.041 * (e) (e) P=0.293 | P=0.706N P=0.536 (e) (e) |
|LOGISTIC REGRESSION | P=0.035 * (e) (e) P=0.226 | P=0.455N P=0.427 (e) (e) |
|COCHRAN-ARMITAGE | P=0.042 * | P=0.601N |
|FISHER EXACT | (e) (e) P=0.247 | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 50/50 (100%) 49/50 (98%) 46/50 (92%) | 37/50 (74%) 39/50 (78%) 39/50 (78%) 38/50 (76%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 85.9% 86.5% 92.8% 92.4% |
|TERMINAL (d) | 30/30 (100%) 25/25 (100%) 29/29 (100%) 24/24 (100%)| 29/35 (83%) 23/29 (79%) 28/31 (90%) 22/25 (88%) |
|FIRST INCIDENCE (DAYS) | 539 369 533 460 | 499 419 533 484 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.308 P=0.182 P=0.498 P=0.217 | P=0.043 * P=0.126 P=0.156 P=0.024 * |
|INCIDENTAL TUMOR | P=0.436N P=0.500 P=0.309 P=0.697 | P=0.268 P=0.392 P=0.402 P=0.335 |
|LOGISTIC REGRESSION | P=0.328N P=0.160 P=0.309 P=0.723 | P=0.218 P=0.378 P=0.284 P=0.187 |
|COCHRAN-ARMITAGE | P=0.144N | P=0.551 |
|FISHER EXACT | P=0.121 P=0.309 P=0.500N | P=0.408 P=0.408 P=0.500 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 1000 PPM 3000 PPM 10000PPM | 0 PPM 1000 PPM 3000 PPM 10000PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 27/50 (54%) 28/50 (56%) 31/50 (62%) | 17/50 (34%) 22/50 (44%) 17/50 (34%) 22/50 (44%) |
|ADJUSTED (b) | 60.2% 61.0% 63.8% 72.6% | 37.6% 47.8% 38.8% 58.2% |
|TERMINAL (d) | 13/30 (43%) 9/25 (36%) 14/29 (48%) 13/24 (54%) | 8/35 (23%) 6/29 (21%) 6/31 (19%) 10/25 (40%) |
|FIRST INCIDENCE (DAYS) | 438 601 533 450 | 428 452 428 502 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.127 P=0.499 P=0.555 P=0.169 | P=0.092 P=0.157 P=0.473 P=0.054 |
|INCIDENTAL TUMOR | P=0.207 P=0.439N P=0.311 P=0.307 | P=0.229 P=0.445 P=0.529N P=0.195 |
|LOGISTIC REGRESSION | P=0.229 P=0.553N P=0.414 P=0.302 | P=0.374 P=0.375 P=0.399N P=0.186 |
|COCHRAN-ARMITAGE | P=0.211 | P=0.270 |
|FISHER EXACT | P=0.579N P=0.500 P=0.272 | P=0.206 P=0.583N P=0.206 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 49/50 (98%) 49/50 (98%) | 45/50 (90%) 46/50 (92%) 46/50 (92%) 45/50 (90%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 91.8% 92.0% 95.8% 97.8% |
|TERMINAL (d) | 30/30 (100%) 25/25 (100%) 29/29 (100%) 24/24 (100%)| 31/35 (89%) 25/29 (86%) 29/31 (94%) 24/25 (96%) |
|FIRST INCIDENCE (DAYS) | 438 369 533 450 | 428 419 428 484 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.200 P=0.280 P=0.501N P=0.187 | P=0.050 * P=0.166 P=0.224 P=0.031 * |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.184 P=0.538N P=0.567 P=0.292 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.197 P=0.498 P=0.486 P=0.279 |
|COCHRAN-ARMITAGE | P=0.559N | P=0.513N |
|FISHER EXACT | P=0.500 P=0.753N P=0.753N | P=0.500 P=0.500 P=0.630N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05130 TEST: 03 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
TERMINAL SACRIFICE AT 105 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's exact tests compare directly the overall incidence rates.
For all tests, a negative trend is indicated by "N".
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).