TDMS Study 05163-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: HLA, VA C. I. ACID RED 114 DATE: 09/17/94
EXPERIMENT: 05163 TEST: 01 TIME: 22:05:25
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 61096
PATHOLOGIST: G. PARKER S. EUSTIS CAS: 6459-94-5
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: HLA, VA C. I. ACID RED 114 DATE: 09/17/94
EXPERIMENT: 05163 TEST: 01 TIME: 22:05:25
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 61096
PATHOLOGIST: G. PARKER S. EUSTIS CAS: 6459-94-5
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 Gland
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: HLA, VA C. I. ACID RED 114 DATE: 09/17/94
EXPERIMENT: 05163 TEST: 01 TIME: 22:05:25
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 61096
PATHOLOGIST: G. PARKER S. EUSTIS CAS: 6459-94-5
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF C. I. ACID RED 114
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)
Papilloma Squamous or Papilloma
Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Basal Cell Adenoma
Basal Cell Carcinoma
Keratoacanthoma
Squamous Cell Carcinoma
Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
Squamous Cell Papilloma
Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma
Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
Skin: Sebaceous Gland Carcinoma, Basal Cell Carcinoma or Adenoma
Testes Adenoma
Thyroid Gland: Follicular Cell
Adenoma
Tongue Squamous Cell Carcinoma or Papilloma Squamous
Squamous Cell Papilloma
Zymbal's Gland Carcinoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: HLA, VA C. I. ACID RED 114 DATE: 09/17/94
EXPERIMENT: 05163 TEST: 01 TIME: 22:05:25
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 61096
PATHOLOGIST: G. PARKER S. EUSTIS CAS: 6459-94-5
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF C. I. ACID RED 114
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Mammary Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)
Papilloma Squamous or Papilloma
Squamous Cell Carcinoma
Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
Pharynx Squamous Cell Carcinoma
Squamous Cell Papilloma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Basal Cell Adenoma
Basal Cell Carcinoma
Squamous Cell Carcinoma
Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma
Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
Skin: Subcutaneous Tissue Fibroma
Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
Neurofibroma, or Fibroma
Thyroid Gland: C-Cell Adenoma
Carcinoma
Carcinoma or Adenoma
Thyroid Gland: Follicular Cell
Adenoma
Carcinoma or Adenoma
Tongue Squamous Cell Carcinoma or Papilloma Squamous
Squamous Cell Papilloma
Tooth Odontoma
Uterus Polyp Stromal
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: HLA, VA C. I. ACID RED 114 DATE: 09/17/94
EXPERIMENT: 05163 TEST: 01 TIME: 22:05:25
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 61096
PATHOLOGIST: G. PARKER S. EUSTIS CAS: 6459-94-5
Sarcoma Stromal or Polyp Stromal
Zymbal's Gland Adenoma
Carcinoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Malignant Lymphoma And Histiocytic Sarcoma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 11/35 (31%) 24/63 (38%) 20/49 (41%) | 1/50 (2%) 3/35 (9%) 4/64 (6%) 1/50 (2%) |
|ADJUSTED (b) | 50.8% 59.1% 60.5% 100.0% | 2.4% 17.8% 31.1% 5.6% |
|TERMINAL (d) | 10/24 (42%) 8/15 (53%) 12/26 (46%) 1/1 (100%) | 0/36 (0%) 2/13 (15%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | 607 524 565 524 | 641 411 521 456 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.503 P=0.216 P<0.001 ** | P=0.011 * P=0.096 P=0.021 * P=0.301 |
|INCIDENTAL TUMOR | P=0.007 ** P=0.496 P=0.338 P=0.025 * | P=0.566 P=0.199 P=0.400 P=0.517N |
|LOGISTIC REGRESSION | P=0.003 ** P=0.573 P=0.312 P=0.007 ** | P=0.460 P=0.259 P=0.156 P=0.871N |
|COCHRAN-ARMITAGE | P=0.171 | P=0.461N |
|FISHER EXACT | P=0.574N P=0.318 P=0.241 | P=0.187 P=0.268 P=0.753N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/35 (0%) 3/63 (5%) 2/49 (4%) | 0/50 (0%) 0/35 (0%) 1/64 (2%) 0/50 (0%) |
|ADJUSTED (b) | 5.3% 0.0% 10.2% 6.0% | 0.0% 0.0% 10.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 2/26 (8%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 607 --- 691 412 | --- --- 715 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.168 P=0.339N P=0.568 P=0.511 | P=0.277 (e) P=0.236 (e) |
|INCIDENTAL TUMOR | P=0.497 P=0.390N P=0.638 P=0.481N | P=0.676 (e) P=0.718 (e) |
|LOGISTIC REGRESSION | P=0.478 P=0.319N P=0.607 P=0.639N | P=0.363 (e) P=0.318 (e) |
|COCHRAN-ARMITAGE | P=0.459 | P=0.713 |
|FISHER EXACT | P=0.343N P=0.609 P=0.684 | (e) P=0.561 (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 11/35 (31%) 27/63 (43%) 22/49 (45%) | 1/50 (2%) 3/35 (9%) 5/64 (8%) 1/50 (2%) |
|ADJUSTED (b) | 52.2% 59.1% 67.1% 100.0% | 2.4% 17.8% 38.7% 5.6% |
|TERMINAL (d) | 10/24 (42%) 8/15 (53%) 14/26 (54%) 1/1 (100%) | 0/36 (0%) 2/13 (15%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | 607 524 565 412 | 641 411 521 456 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.572 P=0.142 P<0.001 ** | P=0.003 ** P=0.096 P=0.004 ** P=0.301 |
|INCIDENTAL TUMOR | P=0.003 ** P=0.585 P=0.237 P=0.027 * | P=0.479 P=0.199 P=0.311 P=0.517N |
|LOGISTIC REGRESSION | P=0.002 ** P=0.542N P=0.212 P=0.009 ** | P=0.306 P=0.259 P=0.060 P=0.871N |
|COCHRAN-ARMITAGE | P=0.105 | P=0.479N |
|FISHER EXACT | P=0.496N P=0.223 P=0.183 | P=0.187 P=0.171 P=0.753N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/44 (5%) 1/34 (3%) 2/60 (3%) 1/48 (2%) | 7/48 (15%) 10/32 (31%) 10/62 (16%) 10/50 (20%) |
|ADJUSTED (b) | 11.1% 7.1% 4.6% 0.0% | 18.9% 52.7% 62.7% 45.3% |
|TERMINAL (d) | 2/18 (11%) 1/14 (7%) 0/22 (0%) 0/0 | 5/34 (15%) 4/11 (36%) 3/6 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 732 (T) 732 (T) 565 456 | 663 538 403 351 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.496 P=0.589N P=0.620N P=0.496 | P<0.001 ** P=0.004 ** P=0.002 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.493N P=0.589N P=0.561N P=0.805 | P=0.211 P=0.072 P=0.197 P=0.322 |
|LOGISTIC REGRESSION | P=0.391N P=0.589N P=0.573N P=0.516N | P=0.091 P=0.028 * P=0.271 P=0.231 |
|COCHRAN-ARMITAGE | P=0.372N | P=0.480 |
|FISHER EXACT | P=0.597N P=0.566N P=0.467N | P=0.067 P=0.520 P=0.330 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/44 (11%) 3/34 (9%) 3/60 (5%) 4/48 (8%) | 4/48 (8%) 9/32 (28%) 19/62 (31%) 15/50 (30%) |
|ADJUSTED (b) | 21.6% 13.1% 5.6% 0.0% | 10.5% 47.6% 76.8% 100.0% |
|TERMINAL (d) | 3/18 (17%) 1/14 (7%) 0/22 (0%) 0/0 | 2/34 (6%) 4/11 (36%) 3/6 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 680 530 530 530 | 641 411 400 339 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.318 P=0.545N P=0.252N P=0.093 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.176N P=0.392N P=0.202N P=0.606N | P=0.009 ** P=0.034 * P=0.012 * P=0.148 |
|LOGISTIC REGRESSION | P=0.323N P=0.502N P=0.199N P=0.586N | P=0.003 ** P=0.030 * P=0.001 ** P=0.022 * |
|COCHRAN-ARMITAGE | P=0.363N | P=0.016 * |
|FISHER EXACT | P=0.509N P=0.202N P=0.444N | P=0.021 * P=0.003 ** P=0.006 ** |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/44 (16%) 4/34 (12%) 5/60 (8%) 5/48 (10%) | 11/48 (23%) 17/32 (53%) 28/62 (45%) 23/50 (46%) |
|ADJUSTED (b) | 32.0% 19.8% 10.0% 0.0% | 28.2% 81.7% 100.0% 100.0% |
|TERMINAL (d) | 5/18 (28%) 2/14 (14%) 0/22 (0%) 0/0 | 7/34 (21%) 8/11 (73%) 6/6 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 680 530 530 456 | 641 411 400 339 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.274 P=0.458N P=0.252N P=0.053 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.158N P=0.327N P=0.181N P=0.662N | P=0.003 ** P=0.006 ** P=0.003 ** P=0.067 |
|LOGISTIC REGRESSION | P=0.237N P=0.423N P=0.182N P=0.449N | P<0.001 ** P=0.003 ** P=0.001 ** P=0.014 * |
|COCHRAN-ARMITAGE | P=0.260N | P=0.041 * |
|FISHER EXACT | P=0.428N P=0.188N P=0.318N | P=0.006 ** P=0.013 * P=0.014 * |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 2/65 (3%) 0/50 (0%) | 0/50 (0%) 0/35 (0%) 0/64 (0%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 6.3% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 1/26 (4%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 681 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.355 (e) P=0.267 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.515 (e) P=0.307 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.487 (e) P=0.290 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.619 | (e) |
|FISHER EXACT | (e) P=0.317 (e) | (e) (e) (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/35 (3%) 0/65 (0%) 0/50 (0%) | 1/50 (2%) 0/35 (0%) 1/63 (2%) 0/49 (0%) |
|ADJUSTED (b) | 6.2% 4.3% 0.0% 0.0% | 2.8% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/15 (0%) 0/26 (0%) 0/1 (0%) | 1/36 (3%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 454 658 --- --- | 733 (T) --- 575 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.132N P=0.643N P=0.202N P=0.478N | P=0.670 P=0.702N P=0.577 (e) |
|INCIDENTAL TUMOR | P=0.051N P=0.527N P=0.231N P=0.195N | P=0.677N P=0.702N P=0.804 (e) |
|LOGISTIC REGRESSION | P=0.070N P=0.631N P=0.205N P=0.201N | P=0.632N P=0.702N P=0.778N (e) |
|COCHRAN-ARMITAGE | P=0.083N | P=0.381N |
|FISHER EXACT | P=0.633N P=0.187N P=0.247N | P=0.588N P=0.691N P=0.505N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/35 (3%) 10/65 (15%) 15/50 (30%) | 0/50 (0%) 0/35 (0%) 15/63 (24%) 6/50 (12%) |
|ADJUSTED (b) | 6.5% 6.7% 31.9% 100.0% | 0.0% 0.0% 64.0% 100.0% |
|TERMINAL (d) | 1/24 (4%) 1/15 (7%) 7/26 (27%) 1/1 (100%) | 0/36 (0%) 0/13 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | 607 732 (T) 641 531 | --- --- 403 411 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.651N P=0.030 * P<0.001 ** | P<0.001 ** (e) P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.731 P=0.040 * P=0.001 ** | P=0.002 ** (e) P=0.006 ** P=0.195 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.631N P=0.042 * P<0.001 ** | P<0.001 ** (e) P<0.001 ** P=0.009 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.011 * |
|FISHER EXACT | P=0.633N P=0.043 * P<0.001 ** | (e) P<0.001 ** P=0.013 * |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/35 (3%) 6/65 (9%) 7/50 (14%) | 0/50 (0%) 0/35 (0%) 6/63 (10%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 4.8% 21.4% 31.5% | 0.0% 0.0% 31.2% 100.0% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 5/26 (19%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 694 687 530 | --- --- 400 501 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.422 P=0.023 * P<0.001 ** | P<0.001 ** (e) P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.001 ** P=0.467 P=0.027 * P=0.053 | P=0.040 * (e) P=0.203 P=0.274 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.423 P=0.023 * P=0.008 ** | P=0.003 ** (e) P=0.026 * P=0.009 ** |
|COCHRAN-ARMITAGE | P=0.003 ** | P=0.063 |
|FISHER EXACT | P=0.412 P=0.029 * P=0.006 ** | (e) P=0.027 * P=0.121 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/35 (6%) 15/65 (23%) 20/50 (40%) | 0/50 (0%) 0/35 (0%) 19/63 (30%) 8/50 (16%) |
|ADJUSTED (b) | 6.5% 11.1% 47.7% 100.0% | 0.0% 0.0% 72.4% 100.0% |
|TERMINAL (d) | 1/24 (4%) 1/15 (7%) 11/26 (42%) 1/1 (100%) | 0/36 (0%) 0/13 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | 607 694 641 530 | --- --- 400 411 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.532 P=0.002 ** P<0.001 ** | P<0.001 ** (e) P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.479 P=0.003 ** P<0.001 ** | P<0.001 ** (e) P=0.002 ** P=0.101 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.553 P=0.003 ** P<0.001 ** | P<0.001 ** (e) P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.003 ** |
|FISHER EXACT | P=0.547 P=0.003 ** P<0.001 ** | (e) P<0.001 ** P=0.003 ** |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/35 (6%) 15/65 (23%) 20/50 (40%) | 0/50 (0%) 0/35 (0%) 19/63 (30%) 8/50 (16%) |
|ADJUSTED (b) | 6.5% 11.1% 47.7% 100.0% | 0.0% 0.0% 72.4% 100.0% |
|TERMINAL (d) | 1/24 (4%) 1/15 (7%) 11/26 (42%) 1/1 (100%) | 0/36 (0%) 0/13 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | 607 694 641 530 | --- --- 400 411 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.532 P=0.002 ** P<0.001 ** | P<0.001 ** (e) P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.479 P=0.003 ** P<0.001 ** | P<0.001 ** (e) P=0.002 ** P=0.101 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.553 P=0.003 ** P<0.001 ** | P<0.001 ** (e) P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.003 ** |
|FISHER EXACT | P=0.547 P=0.003 ** P<0.001 ** | (e) P<0.001 ** P=0.003 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/35 (6%) 1/65 (2%) 3/50 (6%) | 1/50 (2%) 2/35 (6%) 8/65 (12%) 4/50 (8%) |
|ADJUSTED (b) | 0.0% 11.9% 2.1% 100.0% | 2.8% 8.3% 46.0% 30.5% |
|TERMINAL (d) | 0/24 (0%) 1/15 (7%) 0/26 (0%) 1/1 (100%) | 1/36 (3%) 0/13 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 701 654 694 | 733 (T) 411 582 454 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003 ** P=0.140 P=0.563 P<0.001 ** | P<0.001 ** P=0.263 P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.067 P=0.173 P=0.605 P=0.037 * | P=0.035 * P=0.504 P=0.051 P=0.369 |
|LOGISTIC REGRESSION | P=0.022 * P=0.148 P=0.550 P=0.002 ** | P=0.013 * P=0.508 P=0.003 ** P=0.120 |
|COCHRAN-ARMITAGE | P=0.131 | P=0.151 |
|FISHER EXACT | P=0.167 P=0.565 P=0.121 | P=0.367 P=0.040 * P=0.181 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/35 (0%) 1/65 (2%) 0/50 (0%) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 0/50 (0%) |
|ADJUSTED (b) | 8.3% 0.0% 3.8% 0.0% | 0.0% 0.0% 7.1% 0.0% |
|TERMINAL (d) | 2/24 (8%) 0/15 (0%) 1/26 (4%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 732 (T) --- 732 (T) --- | --- --- 693 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.455N P=0.346N P=0.472N P=0.939N | P=0.325 (e) P=0.296 (e) |
|INCIDENTAL TUMOR | P=0.455N P=0.346N P=0.472N P=0.939N | P=0.676 (e) P=0.718 (e) |
|LOGISTIC REGRESSION | P=0.455N P=0.346N P=0.472N P=0.939N | P=0.473 (e) P=0.407 (e) |
|COCHRAN-ARMITAGE | P=0.167N | P=0.714 |
|FISHER EXACT | P=0.343N P=0.402N P=0.247N | (e) P=0.565 (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/35 (6%) 2/65 (3%) 3/50 (6%) | 1/50 (2%) 2/35 (6%) 9/65 (14%) 4/50 (8%) |
|ADJUSTED (b) | 8.3% 11.9% 5.8% 100.0% | 2.8% 8.3% 50.1% 30.5% |
|TERMINAL (d) | 2/24 (8%) 1/15 (7%) 1/26 (4%) 1/1 (100%) | 1/36 (3%) 0/13 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | 732 (T) 701 654 694 | 733 (T) 411 582 454 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.020 * P=0.512 P=0.644N P<0.001 ** | P<0.001 ** P=0.263 P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.157 P=0.547 P=0.625N P=0.058 | P=0.025 * P=0.504 P=0.036 * P=0.369 |
|LOGISTIC REGRESSION | P=0.102 P=0.521 P=0.618N P=0.017 * | P=0.007 ** P=0.508 P=0.001 ** P=0.120 |
|COCHRAN-ARMITAGE | P=0.450 | P=0.151 |
|FISHER EXACT | P=0.547 P=0.586N P=0.500 | P=0.367 P=0.024 * P=0.181 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/35 (3%) 0/65 (0%) 0/50 (0%) | 1/50 (2%) 1/35 (3%) 4/65 (6%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 6.7% 0.0% 0.0% | 2.6% 5.3% 27.5% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/15 (7%) 0/26 (0%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 732 (T) --- --- | 711 663 538 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.822N P=0.406 (e) (e) | P=0.048 * P=0.558 P=0.022 * (e) |
|INCIDENTAL TUMOR | P=0.822N P=0.406 (e) (e) | P=0.628N P=0.629N P=0.400 (e) |
|LOGISTIC REGRESSION | P=0.822N P=0.406 (e) (e) | P=0.433 P=0.672 P=0.166 P=0.999N |
|COCHRAN-ARMITAGE | P=0.533N | P=0.394N |
|FISHER EXACT | P=0.412 (e) (e) | P=0.657 P=0.274 P=0.500N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 0/50 (0%) | 0/50 (0%) 3/35 (9%) 6/65 (9%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 12.6% 29.2% 7.7% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 0/26 (0%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 582 285 351 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P<0.001 ** P=0.042 * P=0.003 ** P=0.081 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.527 P=0.220 P=0.089 P=0.897 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.456 P=0.089 P=0.061 P=0.755 |
|COCHRAN-ARMITAGE | (e) | P=0.202 |
|FISHER EXACT | (e) (e) (e) | P=0.066 P=0.029 * P=0.121 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/35 (3%) 0/65 (0%) 0/50 (0%) | 1/50 (2%) 4/35 (11%) 10/65 (15%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 6.7% 0.0% 0.0% | 2.6% 17.2% 50.7% 7.7% |
|TERMINAL (d) | 0/24 (0%) 1/15 (7%) 0/26 (0%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 2/6 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 732 (T) --- --- | 711 582 285 351 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.822N P=0.406 (e) (e) | P<0.001 ** P=0.040 * P<0.001 ** P=0.081 |
|INCIDENTAL TUMOR | P=0.822N P=0.406 (e) (e) | P=0.548 P=0.362 P=0.058 P=0.897 |
|LOGISTIC REGRESSION | P=0.822N P=0.406 (e) (e) | P=0.388 P=0.107 P=0.018 * P=0.803N |
|COCHRAN-ARMITAGE | P=0.533N | P=0.358 |
|FISHER EXACT | P=0.412 (e) (e) | P=0.090 P=0.014 * P=0.309 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/35 (0%) 3/65 (5%) 1/50 (2%) | 19/50 (38%) 13/35 (37%) 12/65 (18%) 1/50 (2%) |
|ADJUSTED (b) | 8.3% 0.0% 11.5% 20.0% | 47.5% 74.4% 78.3% 50.0% |
|TERMINAL (d) | 2/24 (8%) 0/15 (0%) 3/26 (12%) 0/1 (0%) | 15/36 (42%) 9/13 (69%) 4/6 (67%) 0/0 |
|FIRST INCIDENCE (DAYS) | 732 (T) --- 732 (T) 711 | 683 638 538 603 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.142 P=0.346N P=0.537 P=0.275 | P<0.001 ** P=0.038 * P=0.004 ** P=0.015 * |
|INCIDENTAL TUMOR | P=0.251 P=0.346N P=0.537 P=0.622 | P=0.551 P=0.283 P=0.609 P=0.567 |
|LOGISTIC REGRESSION | P=0.216 P=0.346N P=0.537 P=0.495 | P=0.394 P=0.194 P=0.466 P=0.641 |
|COCHRAN-ARMITAGE | P=0.513N | P<0.001N** |
|FISHER EXACT | P=0.343N P=0.623 P=0.500N | P=0.560N P=0.017N* P<0.001N** |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/35 (3%) 3/65 (5%) 1/50 (2%) | 19/50 (38%) 13/35 (37%) 14/65 (22%) 1/50 (2%) |
|ADJUSTED (b) | 8.3% 6.7% 11.5% 20.0% | 47.5% 74.4% 90.0% 50.0% |
|TERMINAL (d) | 2/24 (8%) 1/15 (7%) 3/26 (12%) 0/1 (0%) | 15/36 (42%) 9/13 (69%) 5/6 (83%) 0/0 |
|FIRST INCIDENCE (DAYS) | 732 (T) 732 (T) 732 (T) 711 | 683 638 538 603 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.170 P=0.664N P=0.537 P=0.275 | P<0.001 ** P=0.038 * P<0.001 ** P=0.015 * |
|INCIDENTAL TUMOR | P=0.278 P=0.664N P=0.537 P=0.622 | P=0.355 P=0.283 P=0.352 P=0.567 |
|LOGISTIC REGRESSION | P=0.249 P=0.664N P=0.537 P=0.495 | P=0.202 P=0.194 P=0.214 P=0.641 |
|COCHRAN-ARMITAGE | P=0.421N | P<0.001N** |
|FISHER EXACT | P=0.633N P=0.623 P=0.500N | P=0.560N P=0.042N* P<0.001N** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/35 (3%) 3/65 (5%) 1/50 (2%) | 19/50 (38%) 16/35 (46%) 18/65 (28%) 4/50 (8%) |
|ADJUSTED (b) | 8.3% 6.7% 11.5% 20.0% | 47.5% 77.7% 91.0% 53.9% |
|TERMINAL (d) | 2/24 (8%) 1/15 (7%) 3/26 (12%) 0/1 (0%) | 15/36 (42%) 9/13 (69%) 5/6 (83%) 0/0 |
|FIRST INCIDENCE (DAYS) | 732 (T) 732 (T) 732 (T) 711 | 683 582 285 351 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.170 P=0.664N P=0.537 P=0.275 | P<0.001 ** P=0.006 ** P<0.001 ** P=0.007 ** |
|INCIDENTAL TUMOR | P=0.278 P=0.664N P=0.537 P=0.622 | P=0.484 P=0.128 P=0.251 P=0.483 |
|LOGISTIC REGRESSION | P=0.249 P=0.664N P=0.537 P=0.495 | P=0.479 P=0.068 P=0.288 P=0.673N |
|COCHRAN-ARMITAGE | P=0.421N | P<0.001N** |
|FISHER EXACT | P=0.633N P=0.623 P=0.500N | P=0.313 P=0.166N P<0.001N** |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 2/50 (4%) | 0/50 (0%) 3/35 (9%) 6/65 (9%) 4/50 (8%) |
|ADJUSTED (b) | 0.0% 0.0% 3.8% 100.0% | 0.0% 18.3% 15.7% 20.3% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 1/26 (4%) 1/1 (100%) | 0/36 (0%) 2/13 (15%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 732 (T) 663 | --- 567 487 349 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** (e) P=0.516 P=0.011 * | P<0.001 ** P=0.023 * P=0.011 * P=0.005 ** |
|INCIDENTAL TUMOR | P=0.007 ** (e) P=0.516 P=0.051 | P=0.410 P=0.040 * P=0.254 P=0.632 |
|LOGISTIC REGRESSION | P=0.013 * (e) P=0.516 P=0.077 | P=0.193 P=0.059 P=0.066 P=0.302 |
|COCHRAN-ARMITAGE | P=0.080 | P=0.110 |
|FISHER EXACT | (e) P=0.565 P=0.247 | P=0.066 P=0.029 * P=0.059 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 0/50 (0%) | 0/50 (0%) 0/35 (0%) 3/65 (5%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 6.2% 5.6% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 0/26 (0%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 454 372 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.016 * (e) P=0.129 P=0.167 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.539 (e) P=0.476 P=0.744 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.408 (e) P=0.295 P=0.795 |
|COCHRAN-ARMITAGE | (e) | P=0.115 |
|FISHER EXACT | (e) (e) (e) | (e) P=0.177 P=0.247 |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 2/50 (4%) | 0/50 (0%) 3/35 (9%) 9/65 (14%) 6/50 (12%) |
|ADJUSTED (b) | 0.0% 0.0% 3.8% 100.0% | 0.0% 18.3% 20.9% 24.8% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 1/26 (4%) 1/1 (100%) | 0/36 (0%) 2/13 (15%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 732 (T) 663 | --- 567 454 349 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** (e) P=0.516 P=0.011 * | P<0.001 ** P=0.023 * P=0.002 ** P=0.001 ** |
|INCIDENTAL TUMOR | P=0.007 ** (e) P=0.516 P=0.051 | P=0.366 P=0.040 * P=0.142 P=0.475 |
|LOGISTIC REGRESSION | P=0.013 * (e) P=0.516 P=0.077 | P=0.156 P=0.059 P=0.025 * P=0.225 |
|COCHRAN-ARMITAGE | P=0.080 | P=0.030 * |
|FISHER EXACT | (e) P=0.565 P=0.247 | P=0.066 P=0.005 ** P=0.013 * |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Pharynx |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 0/50 (0%) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 2.5% 5.6% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 0/26 (0%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 575 372 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.020 * (e) P=0.481 P=0.167 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.263 (e) P=0.783 P=0.744 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.256 (e) P=0.634 P=0.795 |
|COCHRAN-ARMITAGE | (e) | P=0.081 |
|FISHER EXACT | (e) (e) (e) | (e) P=0.565 P=0.247 |
|=================================================================================================================================|
| |
|Pharynx |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 0/50 (0%) | 0/50 (0%) 1/35 (3%) 4/65 (6%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 3.8% 0.0% | 0.0% 7.7% 10.5% 9.1% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 1/26 (4%) 0/1 (0%) | 0/36 (0%) 1/13 (8%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 732 (T) --- | --- 733 (T) 487 501 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.526 (e) P=0.516 (e) | P=0.008 ** P=0.298 P=0.048 * P=0.207 |
|INCIDENTAL TUMOR | P=0.526 (e) P=0.516 (e) | P=0.612 P=0.298 P=0.379 P=0.897 |
|LOGISTIC REGRESSION | P=0.526 (e) P=0.516 (e) | P=0.390 P=0.298 P=0.162 P=0.718 |
|COCHRAN-ARMITAGE | P=0.710 | P=0.383 |
|FISHER EXACT | (e) P=0.565 (e) | P=0.412 P=0.098 P=0.500 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 7/35 (20%) 14/65 (22%) 4/47 (9%) | 25/50 (50%) 17/35 (49%) 17/64 (27%) 5/49 (10%) |
|ADJUSTED (b) | 35.7% 32.4% 38.4% 10.3% | 59.0% 74.5% 69.2% 56.7% |
|TERMINAL (d) | 4/24 (17%) 3/15 (20%) 7/26 (27%) 0/1 (0%) | 19/36 (53%) 8/13 (62%) 2/6 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | 590 530 567 383 | 524 411 538 355 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.426 P=0.522N P=0.561 P=0.569 | P<0.001 ** P=0.046 * P=0.008 ** P=0.016 * |
|INCIDENTAL TUMOR | P=0.054N P=0.371N P=0.381N P=0.019N* | P=0.092N P=0.467 P=0.170N P=0.090N |
|LOGISTIC REGRESSION | P=0.073N P=0.449N P=0.463N P=0.050N* | P=0.117N P=0.505 P=0.290N P=0.116N |
|COCHRAN-ARMITAGE | P=0.036N* | P<0.001N** |
|FISHER EXACT | P=0.436N P=0.463N P=0.036N* | P=0.536N P=0.009N** P<0.001N** |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/35 (11%) 26/65 (40%) 30/50 (60%) | 0/50 (0%) 3/35 (9%) 5/65 (8%) 3/50 (6%) |
|ADJUSTED (b) | 4.2% 23.2% 77.4% 100.0% | 0.0% 19.8% 28.1% 20.5% |
|TERMINAL (d) | 1/24 (4%) 3/15 (20%) 19/26 (73%) 1/1 (100%) | 0/36 (0%) 2/13 (15%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | 732 (T) 651 641 473 | --- 663 521 454 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.071 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.016 * P=0.005 ** P=0.006 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.078 P<0.001 ** P<0.001 ** | P=0.085 P=0.045 * P=0.089 P=0.632 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.073 P<0.001 ** P<0.001 ** | P=0.040 * P=0.036 * P=0.049 * P=0.211 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.203 |
|FISHER EXACT | P=0.090 P<0.001 ** P<0.001 ** | P=0.066 P=0.054 P=0.121 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/35 (3%) 5/65 (8%) 6/50 (12%) | 0/50 (0%) 1/35 (3%) 2/65 (3%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 6.3% 17.4% 30.6% | 0.0% 3.8% 11.5% 26.7% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 4/26 (15%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 724 673 473 | --- 614 581 344 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.411 P=0.043 * P=0.002 ** | P=0.002 ** P=0.404 P=0.104 P=0.049 * |
|INCIDENTAL TUMOR | P=0.004 ** P=0.467 P=0.049 * P=0.088 | P=0.264 P=0.567 P=0.539 P=0.567 |
|LOGISTIC REGRESSION | P=0.003 ** P=0.408 P=0.046 * P=0.020 * | P=0.170 P=0.494 P=0.241 P=0.496 |
|COCHRAN-ARMITAGE | P=0.007 ** | P=0.187 |
|FISHER EXACT | P=0.412 P=0.054 P=0.013 * | P=0.412 P=0.317 P=0.247 |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/35 (3%) 4/65 (6%) 7/50 (14%) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 1/50 (2%) |
|ADJUSTED (b) | 4.2% 6.7% 15.4% 100.0% | 0.0% 0.0% 0.0% 6.3% |
|TERMINAL (d) | 1/24 (4%) 1/15 (7%) 4/26 (15%) 1/1 (100%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 732 (T) 732 (T) 732 (T) 582 | --- --- --- 473 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.654 P=0.200 P<0.001 ** | P=0.090 (e) (e) P=0.278 |
|INCIDENTAL TUMOR | P<0.001 ** P=0.654 P=0.200 P=0.007 ** | P=0.452 (e) (e) P=0.897 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.654 P=0.200 P=0.005 ** | P=0.327 (e) (e) P=0.795 |
|COCHRAN-ARMITAGE | P=0.008 ** | P=0.211 |
|FISHER EXACT | P=0.657 P=0.274 P=0.030 * | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/35 (6%) 8/65 (12%) 7/50 (14%) | 0/50 (0%) 0/35 (0%) 3/65 (5%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 13.3% 25.1% 26.3% | 0.0% 0.0% 33.3% 0.0% |
|TERMINAL (d) | 0/24 (0%) 2/15 (13%) 5/26 (19%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 732 (T) 565 512 | --- --- 715 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.141 P=0.009 ** P=0.002 ** | P=0.003 ** (e) P=0.002 ** (e) |
|INCIDENTAL TUMOR | P=0.005 ** P=0.141 P=0.013 * P=0.126 | P=0.069 (e) P=0.107 (e) |
|LOGISTIC REGRESSION | P=0.006 ** P=0.141 P=0.013 * P=0.017 * | P=0.009 ** (e) P=0.007 ** (e) |
|COCHRAN-ARMITAGE | P=0.008 ** | P=0.575 |
|FISHER EXACT | P=0.167 P=0.009 ** P=0.006 ** | (e) P=0.177 (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/35 (6%) 11/65 (17%) 9/50 (18%) | 0/50 (0%) 0/35 (0%) 4/65 (6%) 1/50 (2%) |
|ADJUSTED (b) | 4.2% 13.3% 31.8% 59.0% | 0.0% 0.0% 35.7% 3.0% |
|TERMINAL (d) | 1/24 (4%) 2/15 (13%) 6/26 (23%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | 732 (T) 732 (T) 565 512 | --- --- 614 403 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.336 P=0.007 ** P<0.001 ** | P<0.001 ** (e) P=0.001 ** P=0.417 |
|INCIDENTAL TUMOR | P=0.002 ** P=0.336 P=0.011 * P=0.057 | P=0.077 (e) P=0.094 P=0.897 |
|LOGISTIC REGRESSION | P=0.001 ** P=0.336 P=0.010 * P=0.011 * | P=0.034 * (e) P=0.011 * P=0.931 |
|COCHRAN-ARMITAGE | P=0.005 ** | P=0.281 |
|FISHER EXACT | P=0.367 P=0.008 ** P=0.008 ** | (e) P=0.098 P=0.500 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/35 (0%) 3/65 (5%) 2/50 (4%) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 1/50 (2%) |
|ADJUSTED (b) | 4.2% 0.0% 8.1% 44.4% | 0.0% 0.0% 3.6% 3.0% |
|TERMINAL (d) | 1/24 (4%) 0/15 (0%) 1/26 (4%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 732 (T) --- 654 704 | --- --- 614 403 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.020 * P=0.594N P=0.368 P=0.012 * | P=0.064 (e) P=0.419 P=0.417 |
|INCIDENTAL TUMOR | P=0.183 P=0.594N P=0.417 P=0.351 | P=0.447 (e) P=0.783 P=0.897 |
|LOGISTIC REGRESSION | P=0.093 P=0.594N P=0.401 P=0.078 | P=0.396 (e) P=0.582 P=0.931 |
|COCHRAN-ARMITAGE | P=0.275 | P=0.256 |
|FISHER EXACT | P=0.588N P=0.414 P=0.500 | (e) P=0.565 P=0.500 |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/35 (14%) 28/65 (43%) 32/50 (64%) | 0/50 (0%) 4/35 (11%) 7/65 (11%) 5/50 (10%) |
|ADJUSTED (b) | 4.2% 28.0% 81.1% 100.0% | 0.0% 22.9% 36.4% 41.7% |
|TERMINAL (d) | 1/24 (4%) 3/15 (20%) 20/26 (77%) 1/1 (100%) | 0/36 (0%) 2/13 (15%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | 732 (T) 651 641 473 | --- 614 521 344 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.032 * P<0.001 ** P<0.001 ** | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.039 * P<0.001 ** P<0.001 ** | P=0.039 * P=0.030 * P=0.058 P=0.369 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.030 * P<0.001 ** P<0.001 ** | P=0.012 * P=0.020 * P=0.013 * P=0.071 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.083 |
|FISHER EXACT | P=0.041 * P<0.001 ** P<0.001 ** | P=0.026 * P=0.016 * P=0.028 * |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/35 (17%) 33/65 (51%) 39/50 (78%) | 0/50 (0%) 4/35 (11%) 11/65 (17%) 7/50 (14%) |
|ADJUSTED (b) | 12.5% 34.0% 85.7% 100.0% | 0.0% 22.9% 60.7% 47.0% |
|TERMINAL (d) | 3/24 (13%) 4/15 (27%) 21/26 (81%) 1/1 (100%) | 0/36 (0%) 2/13 (15%) 2/6 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | 732 (T) 651 565 473 | --- 614 521 344 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.071 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.083 P<0.001 ** P<0.001 ** | P=0.004 ** P=0.030 * P=0.006 ** P=0.288 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.069 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.020 * P<0.001 ** P=0.035 * |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.024 * |
|FISHER EXACT | P=0.100 P<0.001 ** P<0.001 ** | P=0.026 * P=0.001 ** P=0.006 ** |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Carcinoma, Basal Cell Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/35 (3%) 5/65 (8%) 6/50 (12%) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.4% 6.7% 16.8% 54.8% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/15 (7%) 4/26 (15%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 706 732 (T) 593 512 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.638 P=0.132 P=0.001 ** | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.009 ** P=0.689 P=0.164 P=0.226 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.007 ** P=0.663 P=0.166 P=0.036 * | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.022 * | (e) |
|FISHER EXACT | P=0.657 P=0.176 P=0.056 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/35 (9%) 5/65 (8%) 1/50 (2%) | 3/50 (6%) 0/35 (0%) 3/65 (5%) 1/50 (2%) |
|ADJUSTED (b) | 14.8% 11.2% 15.3% 6.3% | 8.3% 0.0% 13.3% 50.0% |
|TERMINAL (d) | 3/24 (13%) 0/15 (0%) 2/26 (8%) 0/1 (0%) | 3/36 (8%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 641 631 641 663 | 733 (T) --- 567 603 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.583N P=0.593 P=0.580 P=0.647 | P=0.026 * P=0.346N P=0.168 P=0.015 * |
|INCIDENTAL TUMOR | P=0.188N P=0.423 P=0.605N P=0.602N | P=0.415 P=0.346N P=0.626 P=0.567 |
|LOGISTIC REGRESSION | P=0.239N P=0.616 P=0.629N P=0.449N | P=0.317 P=0.346N P=0.540 P=0.381 |
|COCHRAN-ARMITAGE | P=0.130N | P=0.320N |
|FISHER EXACT | P=0.612 P=0.608N P=0.181N | P=0.198N P=0.529N P=0.309N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/35 (9%) 5/65 (8%) 1/50 (2%) | 4/50 (8%) 0/35 (0%) 3/65 (5%) 2/50 (4%) |
|ADJUSTED (b) | 17.6% 11.2% 15.3% 6.3% | 10.2% 0.0% 13.3% 52.8% |
|TERMINAL (d) | 3/24 (13%) 0/15 (0%) 2/26 (8%) 0/1 (0%) | 3/36 (8%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 641 631 641 663 | 431 --- 567 456 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.469N P=0.594N P=0.553N P=0.705 | P=0.029 * P=0.219N P=0.351 P=0.095 |
|INCIDENTAL TUMOR | P=0.102N P=0.576 P=0.434N P=0.331N | P=0.608N P=0.158N P=0.452N P=0.580N |
|LOGISTIC REGRESSION | P=0.156N P=0.569N P=0.473N P=0.328N | P=0.621 P=0.089N P=0.429N P=0.736N |
|COCHRAN-ARMITAGE | P=0.076N | P=0.370N |
|FISHER EXACT | P=0.568N P=0.455N P=0.102N | P=0.114N P=0.356N P=0.339N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 44/50 (88%) 35/35 (100%) 59/64 (92%) 43/50 (86%) | |
|ADJUSTED (b) | 97.7% 100.0% 98.3% 100.0% | |
|TERMINAL (d) | 23/24 (96%) 15/15 (100%) 25/26 (96%) 1/1 (100%) | |
|FIRST INCIDENCE (DAYS) | 454 352 499 456 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.129 P=0.201 P<0.001 ** | |
|INCIDENTAL TUMOR | P=0.540N P=0.036 * P=0.493 P=0.407 | |
|LOGISTIC REGRESSION | P=0.489 P=0.045 * P=0.468 P=0.288 | |
|COCHRAN-ARMITAGE | P=0.232N | |
|FISHER EXACT | P=0.036 * P=0.331 P=0.500N | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/35 (6%) 6/65 (9%) 3/49 (6%) | 6/50 (12%) 2/35 (6%) 2/64 (3%) 3/50 (6%) |
|ADJUSTED (b) | 15.8% 13.3% 18.0% 20.5% | 16.1% 15.4% 21.3% 40.9% |
|TERMINAL (d) | 2/24 (8%) 2/15 (13%) 3/26 (12%) 0/1 (0%) | 5/36 (14%) 2/13 (15%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | 636 732 (T) 530 638 | 711 733 (T) 658 411 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.163 P=0.436N P=0.594 P=0.283 | P=0.002 ** P=0.621N P=0.447 P=0.003 ** |
|INCIDENTAL TUMOR | P=0.552N P=0.443N P=0.564N P=0.473N | P=0.156 P=0.500N P=0.557N P=0.420 |
|LOGISTIC REGRESSION | P=0.553 P=0.398N P=0.568N P=0.651N | P=0.230 P=0.556N P=0.606N P=0.327 |
|COCHRAN-ARMITAGE | P=0.363N | P=0.178N |
|FISHER EXACT | P=0.388N P=0.567N P=0.369N | P=0.280N P=0.071N P=0.243N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/35 (3%) 0/65 (0%) 1/49 (2%) | 6/50 (12%) 0/35 (0%) 2/64 (3%) 0/50 (0%) |
|ADJUSTED (b) | 4.0% 4.5% 0.0% 6.3% | 15.2% 0.0% 19.6% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 0/26 (0%) 0/1 (0%) | 4/36 (11%) 0/13 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 666 --- 663 | 589 --- 614 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.495 P=0.648 P=0.492N P=0.384 | P=0.510N P=0.117N P=0.642 P=0.961N |
|INCIDENTAL TUMOR | P=0.502N P=0.727 P=0.395N P=0.689N | P=0.108N P=0.055N P=0.260N P=0.158N |
|LOGISTIC REGRESSION | P=0.657 P=0.674 P=0.486N P=0.606 | P=0.107N P=0.051N P=0.234N P=0.297N |
|COCHRAN-ARMITAGE | P=0.583N | P=0.009N** |
|FISHER EXACT | P=0.657 P=0.435N P=0.747 | P=0.036N* P=0.071N P=0.013N* |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/35 (9%) 6/65 (9%) 4/49 (8%) | 12/50 (24%) 2/35 (6%) 4/64 (6%) 3/50 (6%) |
|ADJUSTED (b) | 19.2% 17.3% 18.0% 25.8% | 30.3% 15.4% 39.3% 40.9% |
|TERMINAL (d) | 2/24 (8%) 2/15 (13%) 3/26 (12%) 0/1 (0%) | 9/36 (25%) 2/13 (15%) 2/6 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | 636 666 530 638 | 589 733 (T) 614 411 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.135 P=0.510N P=0.524N P=0.147 | P=0.020 * P=0.175N P=0.439 P=0.006 ** |
|INCIDENTAL TUMOR | P=0.475N P=0.473N P=0.409N P=0.428N | P=0.602 P=0.074N P=0.229N P=0.485N |
|LOGISTIC REGRESSION | P=0.544 P=0.463N P=0.428N P=0.568 | P=0.537N P=0.064N P=0.204N P=0.725 |
|COCHRAN-ARMITAGE | P=0.344N | P=0.008N** |
|FISHER EXACT | P=0.449N P=0.427N P=0.383N | P=0.023N* P=0.007N** P=0.011N* |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 2/49 (4%) | 0/50 (0%) 1/35 (3%) 3/64 (5%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 3.8% 100.0% | 0.0% 7.7% 23.1% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 1/26 (4%) 1/1 (100%) | 0/36 (0%) 1/13 (8%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 732 (T) 524 | --- 733 (T) 515 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.004 ** (e) P=0.516 P=0.033 * | P=0.028 * P=0.298 P=0.022 * (e) |
|INCIDENTAL TUMOR | P=0.022 * (e) P=0.516 P=0.069 | P=0.308 P=0.298 P=0.123 (e) |
|LOGISTIC REGRESSION | P=0.055 (e) P=0.516 P=0.218 | P=0.246 P=0.298 P=0.124 (e) |
|COCHRAN-ARMITAGE | P=0.077 | P=0.596N |
|FISHER EXACT | (e) P=0.565 P=0.242 | P=0.412 P=0.173 (e) |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/35 (6%) 2/65 (3%) 0/49 (0%) | 0/50 (0%) 2/35 (6%) 0/64 (0%) 1/50 (2%) |
|ADJUSTED (b) | 7.7% 10.4% 3.4% 0.0% | 0.0% 15.4% 0.0% 3.2% |
|TERMINAL (d) | 1/24 (4%) 1/15 (7%) 0/26 (0%) 0/1 (0%) | 0/36 (0%) 2/13 (15%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 715 651 565 --- | --- 733 (T) --- 411 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.345N P=0.521 P=0.625N P=0.842N | P=0.067 P=0.058 (e) P=0.405 |
|INCIDENTAL TUMOR | P=0.141N P=0.576 P=0.537N P=0.410N | P=0.223 P=0.058 (e) P=0.897 |
|LOGISTIC REGRESSION | P=0.144N P=0.542 P=0.605N P=0.632N | P=0.391 P=0.058 (e) P=0.919 |
|COCHRAN-ARMITAGE | P=0.132N | P=0.574 |
|FISHER EXACT | P=0.547 P=0.586N P=0.253N | P=0.167 (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/35 (6%) 3/65 (5%) 2/49 (4%) | 0/50 (0%) 3/35 (9%) 3/64 (5%) 1/50 (2%) |
|ADJUSTED (b) | 7.7% 10.4% 7.1% 100.0% | 0.0% 23.1% 23.1% 3.2% |
|TERMINAL (d) | 1/24 (4%) 1/15 (7%) 1/26 (4%) 1/1 (100%) | 0/36 (0%) 3/13 (23%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | 715 651 565 524 | --- 733 (T) 515 411 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.195 P=0.521 P=0.573 P=0.093 | P=0.002 ** P=0.011 * P=0.022 * P=0.405 |
|INCIDENTAL TUMOR | P=0.530 P=0.576 P=0.656 P=0.492 | P=0.095 P=0.011 * P=0.123 P=0.897 |
|LOGISTIC REGRESSION | P=0.572 P=0.542 P=0.618 P=0.536 | P=0.135 P=0.011 * P=0.124 P=0.919 |
|COCHRAN-ARMITAGE | P=0.560N | P=0.580 |
|FISHER EXACT | P=0.547 P=0.623 P=0.684 | P=0.066 P=0.173 P=0.500 |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 0/50 (0%) | 0/50 (0%) 0/35 (0%) 2/65 (3%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 3.8% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 0/26 (0%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 454 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.406 (e) P=0.261 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.359N (e) P=0.614 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.565N (e) P=0.478 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.624 |
|FISHER EXACT | (e) (e) (e) | (e) P=0.317 (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 2/50 (4%) | 0/50 (0%) 2/35 (6%) 4/65 (6%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 100.0% | 0.0% 10.9% 9.3% 12.4% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 0/26 (0%) 1/1 (100%) | 0/36 (0%) 1/13 (8%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- 663 | --- 567 454 349 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003 ** (e) (e) P=0.011 * | P=0.001 ** P=0.102 P=0.058 P=0.034 * |
|INCIDENTAL TUMOR | P=0.012 * (e) (e) P=0.051 | P=0.604 P=0.163 P=0.386 P=0.744 |
|LOGISTIC REGRESSION | P=0.015 * (e) (e) P=0.077 | P=0.386 P=0.184 P=0.187 P=0.546 |
|COCHRAN-ARMITAGE | P=0.052 | P=0.143 |
|FISHER EXACT | (e) (e) P=0.247 | P=0.167 P=0.098 P=0.121 |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 2/50 (4%) | 0/50 (0%) 2/35 (6%) 2/65 (3%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 100.0% | 0.0% 10.9% 5.8% 12.4% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 0/26 (0%) 1/1 (100%) | 0/36 (0%) 1/13 (8%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- 663 | --- 567 531 349 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003 ** (e) (e) P=0.011 * | P=0.001 ** P=0.102 P=0.192 P=0.034 * |
|INCIDENTAL TUMOR | P=0.012 * (e) (e) P=0.051 | P=0.402 P=0.163 P=0.597 P=0.744 |
|LOGISTIC REGRESSION | P=0.015 * (e) (e) P=0.077 | P=0.280 P=0.184 P=0.365 P=0.546 |
|COCHRAN-ARMITAGE | P=0.052 | P=0.133 |
|FISHER EXACT | (e) (e) P=0.247 | P=0.167 P=0.317 P=0.121 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Odontoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 0/50 (0%) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 10.7% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 0/26 (0%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- --- 413 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.010 * (e) (e) P=0.069 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.240 (e) (e) P=0.744 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.143 (e) (e) P=0.579 |
|COCHRAN-ARMITAGE | (e) | P=0.052 |
|FISHER EXACT | (e) (e) (e) | (e) (e) P=0.247 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 4/50 (8%) 8/35 (23%) 8/65 (12%) 2/50 (4%) |
|ADJUSTED (b) | | 10.4% 38.9% 37.2% 19.0% |
|TERMINAL (d) | | 3/36 (8%) 2/13 (15%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | | 562 567 400 456 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P<0.001 ** P=0.008 ** P=0.007 ** P=0.058 |
|INCIDENTAL TUMOR | | P=0.358N P=0.098 P=0.507 P=0.726N |
|LOGISTIC REGRESSION | | P=0.490 P=0.041 * P=0.276 P=0.761 |
|COCHRAN-ARMITAGE | | P=0.135N |
|FISHER EXACT | | P=0.054 P=0.334 P=0.339N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 1/50 (2%) 2/35 (6%) 2/65 (3%) 0/50 (0%) |
|ADJUSTED (b) | | 2.8% 12.8% 19.0% 0.0% |
|TERMINAL (d) | | 1/36 (3%) 1/13 (8%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | | 733 (T) 665 588 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.131 P=0.197 P=0.136 (e) |
|INCIDENTAL TUMOR | | P=0.420 P=0.338 P=0.259 (e) |
|LOGISTIC REGRESSION | | P=0.465 P=0.293 P=0.386 (e) |
|COCHRAN-ARMITAGE | | P=0.256N |
|FISHER EXACT | | P=0.367 P=0.598 P=0.500N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 5/50 (10%) 9/35 (26%) 10/65 (15%) 2/50 (4%) |
|ADJUSTED (b) | | 13.1% 42.3% 49.2% 19.0% |
|TERMINAL (d) | | 4/36 (11%) 2/13 (15%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | | 562 567 400 456 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P<0.001 ** P=0.006 ** P=0.001 ** P=0.058 |
|INCIDENTAL TUMOR | | P=0.434N P=0.101 P=0.266 P=0.726N |
|LOGISTIC REGRESSION | | P=0.429 P=0.038 * P=0.173 P=0.761 |
|COCHRAN-ARMITAGE | | P=0.087N |
|FISHER EXACT | | P=0.053 P=0.287 P=0.218N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 27
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 1/50 (2%) | 0/50 (0%) 0/35 (0%) 2/65 (3%) 6/50 (12%) |
|ADJUSTED (b) | 0.0% 0.0% 1.9% 4.2% | 0.0% 0.0% 19.4% 100.0% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 0/26 (0%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 641 625 | --- --- 599 412 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.156 (e) P=0.566 P=0.403 | P<0.001 ** (e) P=0.060 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.360 (e) P=0.607 P=0.571 | P=0.002 ** (e) P=0.149 P=0.195 |
|LOGISTIC REGRESSION | P=0.266 (e) P=0.545 P=0.502 | P<0.001 ** (e) P=0.191 P=0.007 ** |
|COCHRAN-ARMITAGE | P=0.254 | P=0.001 ** |
|FISHER EXACT | (e) P=0.565 P=0.500 | (e) P=0.317 P=0.013 * |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 7/65 (11%) 6/50 (12%) | 0/50 (0%) 3/35 (9%) 17/65 (26%) 13/50 (26%) |
|ADJUSTED (b) | 0.0% 0.0% 16.6% 30.1% | 0.0% 13.0% 53.5% 70.0% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 2/26 (8%) 0/1 (0%) | 0/36 (0%) 1/13 (8%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 325 524 | --- 411 403 355 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.022 * P=0.002 ** | P<0.001 ** P=0.042 * P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.014 * (e) P=0.016 * P=0.088 | P=0.095 P=0.095 P=0.008 ** P=0.135 |
|LOGISTIC REGRESSION | P=0.011 * (e) P=0.013 * P=0.018 * | P=0.073 P=0.163 P<0.001 ** P=0.021 * |
|COCHRAN-ARMITAGE | P=0.004 ** | P<0.001 ** |
|FISHER EXACT | (e) P=0.016 * P=0.013 * | P=0.066 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 28
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/35 (0%) 8/65 (12%) 7/50 (14%) | 0/50 (0%) 3/35 (9%) 18/65 (28%) 19/50 (38%) |
|ADJUSTED (b) | 0.0% 0.0% 18.2% 33.0% | 0.0% 13.0% 55.0% 100.0% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 2/26 (8%) 0/1 (0%) | 0/36 (0%) 1/13 (8%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 325 524 | --- 411 403 355 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.014 * P<0.001 ** | P<0.001 ** P=0.042 * P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.009 ** (e) P=0.011 * P=0.055 | P=0.004 ** P=0.095 P=0.006 ** P=0.026 * |
|LOGISTIC REGRESSION | P=0.005 ** (e) P=0.008 ** P=0.009 ** | P=0.002 ** P=0.163 P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.002 ** | P<0.001 ** |
|FISHER EXACT | (e) P=0.009 ** P=0.006 ** | P=0.066 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 20/35 (57%) 37/65 (57%) 12/50 (24%) | 12/50 (24%) 13/35 (37%) 18/65 (28%) 5/50 (10%) |
|ADJUSTED (b) | 54.8% 73.4% 69.0% 100.0% | 28.4% 58.4% 79.6% 57.7% |
|TERMINAL (d) | 9/24 (38%) 8/15 (53%) 11/26 (42%) 1/1 (100%) | 7/36 (19%) 4/13 (31%) 3/6 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 564 352 455 456 | 533 607 344 229 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.021 * P=0.081 P=0.053 P=0.027 * | P<0.001 ** P=0.012 * P<0.001 ** P=0.007 ** |
|INCIDENTAL TUMOR | P=0.049N* P=0.059 P=0.114 P=0.229N | P=0.573 P=0.328 P=0.425 P=0.160N |
|LOGISTIC REGRESSION | P=0.112N P=0.084 P=0.118 P=0.261N | P=0.371 P=0.319 P=0.107 P=0.093N |
|COCHRAN-ARMITAGE | P=0.028N* | P=0.023N* |
|FISHER EXACT | P=0.090 P=0.053 P=0.066N | P=0.143 P=0.410 P=0.054N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 29
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/35 (0%) 0/65 (0%) 1/50 (2%) | 0/50 (0%) 0/35 (0%) 2/65 (3%) 1/50 (2%) |
|ADJUSTED (b) | 2.6% 0.0% 0.0% 20.0% | 0.0% 0.0% 9.0% 3.7% |
|TERMINAL (d) | 0/24 (0%) 0/15 (0%) 0/26 (0%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 641 --- --- 711 | --- --- 599 412 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.436 P=0.568N P=0.434N P=0.498 | P=0.020 * (e) P=0.122 P=0.377 |
|INCIDENTAL TUMOR | P=0.661N P=0.748N P=0.393N P=0.676N | P=0.322 (e) P=0.539 P=0.897 |
|LOGISTIC REGRESSION | P=0.578 P=0.572N P=0.455N P=0.689 | P=0.279 (e) P=0.257 P=0.917 |
|COCHRAN-ARMITAGE | P=0.619 | P=0.272 |
|FISHER EXACT | P=0.588N P=0.435N P=0.753N | (e) P=0.317 P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/35 (17%) 4/65 (6%) 3/50 (6%) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 0/50 (0%) |
|ADJUSTED (b) | 11.3% 25.7% 13.0% 7.9% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 2/15 (13%) 2/26 (8%) 0/1 (0%) | 0/36 (0%) 0/13 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 458 447 693 501 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.476 P=0.161 P=0.571N P=0.510 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.074N P=0.343 P=0.516N P=0.087N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.169N P=0.165 P=0.499N P=0.382N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.233N | (e) |
|FISHER EXACT | P=0.172 P=0.488N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 30
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 35/35 (100%) 61/65 (94%) 45/50 (90%) | 41/50 (82%) 31/35 (89%) 50/65 (77%) 32/50 (64%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 89.1% 96.8% 100.0% 100.0% |
|TERMINAL (d) | 24/24 (100%) 15/15 (100%) 26/26 (100%) 1/1 (100%) | 31/36 (86%) 12/13 (92%) 6/6 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 454 352 499 383 | 524 411 400 349 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.265 P=0.309 P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.222N P=0.362 P=0.142N P=0.391N | P=0.081 P=0.196 P=0.137 P=0.240 |
|LOGISTIC REGRESSION | P=0.211N P=0.477 P=0.165N P=0.421N | P=0.009 ** P=0.108 P=0.047 * P=0.044 * |
|COCHRAN-ARMITAGE | P=0.069N | P=0.008N** |
|FISHER EXACT | P=0.343 P=0.471N P=0.218N | P=0.305 P=0.335N P=0.035N* |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 27/35 (77%) 54/65 (83%) 43/50 (86%) | 22/50 (44%) 25/35 (71%) 53/65 (82%) 42/50 (84%) |
|ADJUSTED (b) | 75.7% 83.9% 88.0% 100.0% | 49.4% 85.4% 97.8% 100.0% |
|TERMINAL (d) | 14/24 (58%) 10/15 (67%) 19/26 (73%) 1/1 (100%) | 14/36 (39%) 9/13 (69%) 5/6 (83%) 0/0 |
|FIRST INCIDENCE (DAYS) | 131 352 325 377 | 431 411 285 229 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.185 P=0.055 P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.120 P=0.284 P=0.045 * P=0.202 | P=0.003 ** P=0.041 * P=0.004 ** P=0.105 |
|LOGISTIC REGRESSION | P=0.022 * P=0.199 P=0.027 * P=0.019 * | P=0.002 ** P=0.019 * P<0.001 ** P=0.130 |
|COCHRAN-ARMITAGE | P=0.011 * | P<0.001 ** |
|FISHER EXACT | P=0.193 P=0.029 * P=0.017 * | P=0.011 * P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05163 TEST: 01 PAGE 31
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.007 0.015 0.03 | CONTROL 0.015 0.03 0.06 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 35/35 (100%) 64/65 (98%) 49/50 (98%) | 47/50 (94%) 35/35 (100%) 61/65 (94%) 47/50 (94%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 95.9% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 24/24 (100%) 15/15 (100%) 26/26 (100%) 1/1 (100%) | 34/36 (94%) 13/13 (100%) 6/6 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 131 352 325 377 | 431 411 285 229 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.311 P=0.253 P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.462N P=0.638 P=0.753N P=0.638N | P=0.149 P=0.212 P=0.370 P=0.580 |
|LOGISTIC REGRESSION | P=0.605N P=0.724 P=0.765N P=0.776N | P=0.066 P=0.157 P=0.142 P=0.431 |
|COCHRAN-ARMITAGE | P=0.569N | P=0.434N |
|FISHER EXACT | P=0.588 P=0.683 P=0.753N | P=0.198 P=0.644N P=0.661N |
|=================================================================================================================================|
(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).