TDMS Study 05166-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: HLA, VA 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE DATE: 09/18/94
EXPERIMENT: 05166 TEST: 01 TIME: 01:07:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 99990
PATHOLOGIST: G. PARKER S. EUSTIS CAS: 612-82-8
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: HLA, VA 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE DATE: 09/18/94
EXPERIMENT: 05166 TEST: 01 TIME: 01:07:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 99990
PATHOLOGIST: G. PARKER S. EUSTIS CAS: 612-82-8
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 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE DATE: 09/18/94
EXPERIMENT: 05166 TEST: 01 TIME: 01:07:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 99990
PATHOLOGIST: G. PARKER S. EUSTIS CAS: 612-82-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Brain Oligodendroglioma, Glioma, or Astrocytoma
Clitoral/Preputial Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Intestine Large Carcinoma
Carcinoma or Adenoma
Polyp Adenomatous
Intestine Small Carcinoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
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 Papilloma
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
Skin: Subcutaneous Tissue Fibroma
Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
Neurofibroma, or Fibroma
Testes Adenoma
Thyroid Gland: C-Cell Adenoma
Tongue Squamous Cell Carcinoma
Squamous Cell Carcinoma or Papilloma Squamous
Zymbal's Gland Adenoma
Carcinoma
Carcinoma or Adenoma
All Organs Mesothelioma Benign, Malignant, NOS
Benign Tumors
Malignant Tumors
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: HLA, VA 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE DATE: 09/18/94
EXPERIMENT: 05166 TEST: 01 TIME: 01:07:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 99990
PATHOLOGIST: G. PARKER S. EUSTIS CAS: 612-82-8
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Intestine Large Polyp Adenomatous
Intestine Small Carcinoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Mammary Gland Carcinoma
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
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
Tongue Squamous Cell Carcinoma or Papilloma Squamous
Squamous Cell Papilloma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
Zymbal's Gland Adenoma
Carcinoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/45 (4%) 1/75 (1%) 3/59 (5%) | 0/60 (0%) 0/45 (0%) 0/74 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 4.9% 2.0% 56.7% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/60 (0%) 2/41 (5%) 1/50 (2%) 0/0 | 0/59 (0%) 0/39 (0%) 0/32 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- 419 (T) 419 (T) 349 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.160 P=0.464 P<0.001 ** | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.129 P=0.160 P=0.464 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.029 * P=0.160 P=0.464 P=0.024 * | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.129 | (e) |
|FISHER EXACT | P=0.181 P=0.556 P=0.119 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 1/75 (1%) 1/60 (2%) | 0/60 (0%) 1/45 (2%) 2/75 (3%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 2.0% 6.7% | 0.0% 2.6% 6.1% 3.8% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 1/50 (2%) 0/0 | 0/59 (0%) 1/39 (3%) 1/32 (3%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 419 (T) 350 | --- 421 (T) 419 383 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.022 * (e) P=0.464 P=0.227 | P=0.075 P=0.417 P=0.122 P=0.333 |
|INCIDENTAL TUMOR | P=0.368 (e) P=0.464 (e) | P=0.429 P=0.417 P=0.357 P=0.983 |
|LOGISTIC REGRESSION | P=0.185 (e) P=0.464 P=0.656 | P=0.190 P=0.417 P=0.136 P=0.518 |
|COCHRAN-ARMITAGE | P=0.262 | P=0.428 |
|FISHER EXACT | (e) P=0.556 P=0.500 | P=0.429 P=0.307 P=0.500 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 4/45 (9%) 4/75 (5%) 8/60 (13%) | 0/60 (0%) 9/45 (20%) 32/75 (43%) 17/59 (29%) |
|ADJUSTED (b) | 3.3% 9.8% 8.0% 38.3% | 0.0% 20.9% 61.1% 66.9% |
|TERMINAL (d) | 2/60 (3%) 4/41 (10%) 4/50 (8%) 0/0 | 0/59 (0%) 5/39 (13%) 14/32 (44%) 5/10 (50%) |
|FIRST INCIDENCE (DAYS) | 419 (T) 419 (T) 419 (T) 280 | --- 391 229 296 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.182 P=0.258 P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.044 * P=0.182 P=0.258 (e) | P=0.019 * P=0.003 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P=0.016 * P=0.182 P=0.258 P=0.036 * | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.043 * | P<0.001 ** |
|FISHER EXACT | P=0.214 P=0.451 P=0.047 * | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 2/75 (3%) 1/60 (2%) | 0/60 (0%) 5/45 (11%) 11/75 (15%) 18/59 (31%) |
|ADJUSTED (b) | 0.0% 0.0% 4.0% 2.6% | 0.0% 12.8% 22.4% 65.1% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 2/50 (4%) 0/0 | 0/59 (0%) 5/39 (13%) 3/32 (9%) 3/10 (30%) |
|FIRST INCIDENCE (DAYS) | --- --- 419 (T) 308 | --- 421 (T) 315 254 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.025 * (e) P=0.200 P=0.409 | P<0.001 ** P=0.010 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.160 (e) P=0.200 (e) | P<0.001 ** P=0.010 ** P=0.033 * P<0.001 ** |
|LOGISTIC REGRESSION | P=0.231 (e) P=0.200 P=0.902 | P<0.001 ** P=0.010 ** P=0.004 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.283 | P<0.001 ** |
|FISHER EXACT | (e) P=0.307 P=0.500 | P=0.013 * P=0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 4/45 (9%) 6/75 (8%) 9/60 (15%) | 0/60 (0%) 14/45 (31%) 42/75 (56%) 32/59 (54%) |
|ADJUSTED (b) | 3.3% 9.8% 12.0% 39.9% | 0.0% 32.6% 70.4% 89.2% |
|TERMINAL (d) | 2/60 (3%) 4/41 (10%) 6/50 (12%) 0/0 | 0/59 (0%) 10/39 (26%) 16/32 (50%) 7/10 (70%) |
|FIRST INCIDENCE (DAYS) | 419 (T) 419 (T) 419 (T) 280 | --- 391 229 254 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.182 P=0.086 P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.012 * P=0.182 P=0.086 (e) | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P=0.006 ** P=0.182 P=0.086 P=0.030 * | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.023 * | P<0.001 ** |
|FISHER EXACT | P=0.214 P=0.222 P=0.027 * | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Intestine Large |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 7/60 (12%) | 0/60 (0%) 0/45 (0%) 1/75 (1%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 33.9% | 0.0% 0.0% 2.1% 6.3% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 0/50 (0%) 0/0 | 0/59 (0%) 0/39 (0%) 0/32 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 309 | --- --- 390 405 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** | P=0.083 (e) P=0.451 P=0.242 |
|INCIDENTAL TUMOR | P=0.189 (e) (e) (e) | P=0.587 (e) P=0.989 P=0.983 |
|LOGISTIC REGRESSION | P<0.001 ** (e) (e) P=0.003 ** | P=0.189 (e) P=0.584 P=0.372 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.262 |
|FISHER EXACT | (e) (e) P=0.006 ** | (e) P=0.556 P=0.500 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Intestine Large: Colon |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 6/60 (10%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 31.3% | 0.0% 0.0% 0.0% 6.3% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 0/50 (0%) 0/0 | 0/59 (0%) 0/39 (0%) 0/32 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 309 | --- --- --- 405 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** | P=0.069 (e) (e) P=0.242 |
|INCIDENTAL TUMOR | P=0.230 (e) (e) (e) | P=0.391 (e) (e) P=0.983 |
|LOGISTIC REGRESSION | P=0.001 ** (e) (e) P=0.007 ** | P=0.118 (e) (e) P=0.372 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.209 |
|FISHER EXACT | (e) (e) P=0.014 * | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Intestine Large: Colon |
| Polyp Adenomatous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 5/75 (7%) 5/60 (8%) | 0/60 (0%) 1/45 (2%) 4/75 (5%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 9.5% 24.9% | 0.0% 2.6% 10.7% 12.7% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 4/50 (8%) 0/0 | 0/59 (0%) 1/39 (3%) 3/32 (9%) 1/10 (10%) |
|FIRST INCIDENCE (DAYS) | --- --- 384 308 | --- 421 (T) 310 355 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.024 * P<0.001 ** | P=0.009 ** P=0.417 P=0.023 * P=0.046 * |
|INCIDENTAL TUMOR | P=0.041 * (e) P=0.043 * (e) | P=0.067 P=0.417 P=0.039 * P=0.157 |
|LOGISTIC REGRESSION | P=0.005 ** (e) P=0.039 * P=0.046 * | P=0.134 P=0.417 P=0.091 P=0.171 |
|COCHRAN-ARMITAGE | P=0.009 ** | P=0.214 |
|FISHER EXACT | (e) P=0.050 * P=0.029 * | P=0.429 P=0.092 P=0.248 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Intestine Large: Rectum |
| Polyp Adenomatous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 3/60 (5%) | 0/60 (0%) 0/45 (0%) 2/75 (3%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 35.8% | 0.0% 0.0% 4.6% 12.5% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 0/50 (0%) 0/0 | 0/59 (0%) 0/39 (0%) 1/32 (3%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 338 | --- --- 338 405 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** | P=0.008 ** (e) P=0.180 P=0.031 * |
|INCIDENTAL TUMOR | P=0.060 (e) (e) (e) | P=0.266 (e) P=0.378 P=0.916 |
|LOGISTIC REGRESSION | P=0.014 * (e) (e) P=0.026 * | P=0.063 (e) P=0.344 P=0.084 |
|COCHRAN-ARMITAGE | P=0.012 * | P=0.102 |
|FISHER EXACT | (e) (e) P=0.122 | (e) P=0.307 P=0.248 |
|=================================================================================================================================|
| |
|Intestine Small |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 3/75 (4%) 8/60 (13%) | 0/60 (0%) 0/45 (0%) 2/75 (3%) 5/60 (8%) |
|ADJUSTED (b) | 0.0% 0.0% 6.0% 61.2% | 0.0% 0.0% 3.1% 24.4% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 3/50 (6%) 0/0 | 0/59 (0%) 0/39 (0%) 0/32 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 419 (T) 211 | --- --- 309 251 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.092 P<0.001 ** | P<0.001 ** (e) P=0.252 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.010 ** (e) P=0.092 (e) | P=0.160 (e) (e) P=0.785 |
|LOGISTIC REGRESSION | P=0.003 ** (e) P=0.092 P=0.096 | P=0.009 ** (e) P=0.487 P=0.026 * |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.003 ** |
|FISHER EXACT | (e) P=0.168 P=0.003 ** | (e) P=0.307 P=0.029 * |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Duodenum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 2/75 (3%) 0/60 (0%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 4.0% 0.0% | 0.0% 0.0% 0.0% 1.8% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 2/50 (4%) 0/0 | 0/59 (0%) 0/39 (0%) 0/32 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 419 (T) --- | --- --- --- 251 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.187 (e) P=0.200 (e) | P=0.203 (e) (e) P=0.490 |
|INCIDENTAL TUMOR | P=0.187 (e) P=0.200 (e) | P=0.561 (e) (e) P=1.000 |
|LOGISTIC REGRESSION | P=0.187 (e) P=0.200 (e) | P=0.445 (e) (e) P=0.973 |
|COCHRAN-ARMITAGE | P=0.649 | P=0.209 |
|FISHER EXACT | (e) P=0.307 (e) | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 1/75 (1%) 7/60 (12%) | 0/60 (0%) 0/45 (0%) 2/75 (3%) 3/60 (5%) |
|ADJUSTED (b) | 0.0% 0.0% 2.0% 22.3% | 0.0% 0.0% 3.1% 16.7% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 1/50 (2%) 0/0 | 0/59 (0%) 0/39 (0%) 0/32 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 419 (T) 211 | --- --- 309 391 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.464 P<0.001 ** | P=0.002 ** (e) P=0.252 P=0.006 ** |
|INCIDENTAL TUMOR | P=0.105 (e) P=0.464 (e) | P=0.394 (e) (e) P=0.846 |
|LOGISTIC REGRESSION | P=0.006 ** (e) P=0.464 P=0.247 | P=0.042 * (e) P=0.487 P=0.029 * |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.034 * |
|FISHER EXACT | (e) P=0.556 P=0.006 ** | (e) P=0.307 P=0.122 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 29/75 (39%) 26/60 (43%) | 0/60 (0%) 0/45 (0%) 7/74 (9%) 3/60 (5%) |
|ADJUSTED (b) | 0.0% 0.0% 51.7% 100.0% | 0.0% 0.0% 20.3% 13.0% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 23/50 (46%) 0/0 | 0/59 (0%) 0/39 (0%) 6/32 (19%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 393 280 | --- --- 378 343 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P<0.001 ** (e) P<0.001 ** P=0.021 * |
|INCIDENTAL TUMOR | P<0.001 ** (e) P<0.001 ** (e) | P=0.024 * (e) P=0.001 ** P=0.983 |
|LOGISTIC REGRESSION | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P=0.015 * (e) P=0.003 ** P=0.133 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.074 |
|FISHER EXACT | (e) P<0.001 ** P<0.001 ** | (e) P=0.014 * P=0.122 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 12/75 (16%) 12/60 (20%) | 0/60 (0%) 0/45 (0%) 1/74 (1%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 23.3% 75.5% | 0.0% 0.0% 3.1% 6.3% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 11/50 (22%) 0/0 | 0/59 (0%) 0/39 (0%) 1/32 (3%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 379 238 | --- --- 421 (T) 405 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P=0.048 * (e) P=0.378 P=0.242 |
|INCIDENTAL TUMOR | P<0.001 ** (e) P<0.001 ** (e) | P=0.225 (e) P=0.378 P=0.983 |
|LOGISTIC REGRESSION | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P=0.094 (e) P=0.378 P=0.372 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.262 |
|FISHER EXACT | (e) P<0.001 ** P<0.001 ** | (e) P=0.552 P=0.500 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 12/75 (16%) 12/60 (20%) | 0/60 (0%) 0/45 (0%) 1/74 (1%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 23.3% 75.5% | 0.0% 0.0% 3.1% 6.3% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 11/50 (22%) 0/0 | 0/59 (0%) 0/39 (0%) 1/32 (3%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 379 238 | --- --- 421 (T) 405 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P=0.048 * (e) P=0.378 P=0.242 |
|INCIDENTAL TUMOR | P<0.001 ** (e) P<0.001 ** (e) | P=0.225 (e) P=0.378 P=0.983 |
|LOGISTIC REGRESSION | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P=0.094 (e) P=0.378 P=0.372 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.262 |
|FISHER EXACT | (e) P<0.001 ** P<0.001 ** | (e) P=0.552 P=0.500 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 35/75 (47%) 33/60 (55%) | 0/60 (0%) 0/45 (0%) 7/74 (9%) 4/60 (7%) |
|ADJUSTED (b) | 0.0% 0.0% 61.3% 100.0% | 0.0% 0.0% 20.3% 18.4% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 28/50 (56%) 0/0 | 0/59 (0%) 0/39 (0%) 6/32 (19%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 379 238 | --- --- 378 343 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P<0.001 ** (e) P<0.001 ** P=0.004 ** |
|INCIDENTAL TUMOR | P<0.001 ** (e) P<0.001 ** (e) | P=0.012 * (e) P=0.001 ** P=0.916 |
|LOGISTIC REGRESSION | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P=0.003 ** (e) P=0.003 ** P=0.042 * |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.032 * |
|FISHER EXACT | (e) P<0.001 ** P<0.001 ** | (e) P=0.014 * P=0.059 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 35/75 (47%) 33/60 (55%) | 0/60 (0%) 0/45 (0%) 7/74 (9%) 4/60 (7%) |
|ADJUSTED (b) | 0.0% 0.0% 61.3% 100.0% | 0.0% 0.0% 20.3% 18.4% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 28/50 (56%) 0/0 | 0/59 (0%) 0/39 (0%) 6/32 (19%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 379 238 | --- --- 378 343 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P<0.001 ** (e) P<0.001 ** P=0.004 ** |
|INCIDENTAL TUMOR | P<0.001 ** (e) P<0.001 ** (e) | P=0.012 * (e) P=0.001 ** P=0.916 |
|LOGISTIC REGRESSION | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P=0.003 ** (e) P=0.003 ** P=0.042 * |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.032 * |
|FISHER EXACT | (e) P<0.001 ** P<0.001 ** | (e) P=0.014 * P=0.059 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/45 (0%) 7/75 (9%) 6/60 (10%) | 1/60 (2%) 1/45 (2%) 3/74 (4%) 3/60 (5%) |
|ADJUSTED (b) | 1.7% 0.0% 13.7% 100.0% | 1.7% 2.6% 7.7% 16.3% |
|TERMINAL (d) | 1/60 (2%) 0/41 (0%) 6/50 (12%) 0/0 | 1/59 (2%) 1/39 (3%) 2/32 (6%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | 419 (T) --- 406 226 | 421 (T) 421 (T) 338 370 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.576N P=0.019 * P<0.001 ** | P=0.006 ** P=0.666 P=0.165 P=0.023 * |
|INCIDENTAL TUMOR | P=0.003 ** P=0.576N P=0.035 * (e) | P=0.202 P=0.666 P=0.293 P=0.842N |
|LOGISTIC REGRESSION | P=0.025 * P=0.576N P=0.026 * P=0.472 | P=0.086 P=0.666 P=0.369 P=0.130 |
|COCHRAN-ARMITAGE | P=0.015 * | P=0.201 |
|FISHER EXACT | P=0.571N P=0.061 P=0.057 | P=0.676 P=0.393 P=0.309 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/45 (0%) 8/75 (11%) 6/60 (10%) | 1/60 (2%) 1/45 (2%) 3/74 (4%) 4/60 (7%) |
|ADJUSTED (b) | 1.7% 0.0% 15.6% 100.0% | 1.7% 2.6% 7.7% 19.6% |
|TERMINAL (d) | 1/60 (2%) 0/41 (0%) 7/50 (14%) 0/0 | 1/59 (2%) 1/39 (3%) 2/32 (6%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | 419 (T) --- 406 226 | 421 (T) 421 (T) 338 370 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.576N P=0.010 ** P<0.001 ** | P=0.001 ** P=0.666 P=0.165 P=0.006 ** |
|INCIDENTAL TUMOR | P=0.001 ** P=0.576N P=0.018 * (e) | P=0.115 P=0.666 P=0.293 P=0.806 |
|LOGISTIC REGRESSION | P=0.006 ** P=0.576N P=0.013 * P=0.472 | P=0.032 * P=0.666 P=0.369 P=0.060 |
|COCHRAN-ARMITAGE | P=0.017 * | P=0.095 |
|FISHER EXACT | P=0.571N P=0.036 * P=0.057 | P=0.676 P=0.393 P=0.182 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) | 0/60 (0%) 1/45 (2%) 3/75 (4%) 6/60 (10%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 2.6% 6.5% 36.6% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 0/50 (0%) 0/0 | 0/59 (0%) 1/39 (3%) 1/32 (3%) 3/10 (30%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 421 (T) 363 285 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P<0.001 ** P=0.417 P=0.084 P<0.001 ** |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.001 ** P=0.417 P=0.357 P<0.001 ** |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.002 ** P=0.417 P=0.189 P=0.004 ** |
|COCHRAN-ARMITAGE | (e) | P=0.005 ** |
|FISHER EXACT | (e) (e) (e) | P=0.429 P=0.168 P=0.014 * |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) | 2/60 (3%) 1/45 (2%) 4/75 (5%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.4% 2.6% 11.7% 0.0% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 0/50 (0%) 0/0 | 2/59 (3%) 1/39 (3%) 3/32 (9%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 421 (T) 421 (T) 406 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.426 P=0.642N P=0.122 P=0.665N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.633 P=0.642N P=0.230 P=0.665N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.549 P=0.642N P=0.182 P=0.665N |
|COCHRAN-ARMITAGE | (e) | P=0.235N |
|FISHER EXACT | (e) (e) (e) | P=0.607N P=0.451 P=0.248N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) | 2/60 (3%) 2/45 (4%) 7/75 (9%) 6/60 (10%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.4% 5.1% 17.7% 36.6% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 0/50 (0%) 0/0 | 2/59 (3%) 2/39 (5%) 4/32 (13%) 3/10 (30%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 421 (T) 421 (T) 363 285 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P<0.001 ** P=0.538 P=0.017 * P<0.001 ** |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.009 ** P=0.538 P=0.104 P=0.011 * |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.013 * P=0.538 P=0.081 P=0.040 * |
|COCHRAN-ARMITAGE | (e) | P=0.084 |
|FISHER EXACT | (e) (e) (e) | P=0.576 P=0.149 P=0.136 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 3/75 (4%) 2/60 (3%) | 0/60 (0%) 3/45 (7%) 7/75 (9%) 9/60 (15%) |
|ADJUSTED (b) | 0.0% 0.0% 6.0% 35.4% | 0.0% 7.7% 16.5% 43.7% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 3/50 (6%) 0/0 | 0/59 (0%) 3/39 (8%) 3/32 (9%) 3/10 (30%) |
|FIRST INCIDENCE (DAYS) | --- --- 419 (T) 324 | --- 421 (T) 363 229 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.092 P=0.017 * | P<0.001 ** P=0.060 P=0.002 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.018 * (e) P=0.092 (e) | P=0.001 ** P=0.060 P=0.038 * P<0.001 ** |
|LOGISTIC REGRESSION | P=0.019 * (e) P=0.092 P=0.212 | P<0.001 ** P=0.060 P=0.013 * P=0.002 ** |
|COCHRAN-ARMITAGE | P=0.120 | P=0.002 ** |
|FISHER EXACT | (e) P=0.168 P=0.248 | P=0.076 P=0.014 * P=0.001 ** |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 1/75 (1%) 3/60 (5%) | 0/60 (0%) 1/45 (2%) 2/75 (3%) 4/60 (7%) |
|ADJUSTED (b) | 0.0% 0.0% 1.5% 13.9% | 0.0% 2.6% 6.3% 17.5% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 0/50 (0%) 0/0 | 0/59 (0%) 1/39 (3%) 2/32 (6%) 1/10 (10%) |
|FIRST INCIDENCE (DAYS) | --- --- 341 324 | --- 421 (T) 421 (T) 338 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.001 ** (e) P=0.522 P=0.015 * | P<0.001 ** P=0.417 P=0.118 P=0.007 ** |
|INCIDENTAL TUMOR | P=0.654N (e) P=1.000 (e) | P=0.009 ** P=0.417 P=0.118 P=0.164 |
|LOGISTIC REGRESSION | P=0.075 (e) P=0.650 P=0.159 | P=0.013 * P=0.417 P=0.118 P=0.065 |
|COCHRAN-ARMITAGE | P=0.023 * | P=0.029 * |
|FISHER EXACT | (e) P=0.556 P=0.122 | P=0.429 P=0.307 P=0.059 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 4/75 (5%) 5/60 (8%) | 0/60 (0%) 3/45 (7%) 9/75 (12%) 13/60 (22%) |
|ADJUSTED (b) | 0.0% 0.0% 7.4% 44.4% | 0.0% 7.7% 22.2% 55.8% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 3/50 (6%) 0/0 | 0/59 (0%) 3/39 (8%) 5/32 (16%) 4/10 (40%) |
|FIRST INCIDENCE (DAYS) | --- --- 341 324 | --- 421 (T) 363 229 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.052 P<0.001 ** | P<0.001 ** P=0.060 P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.077 (e) P=0.092 (e) | P<0.001 ** P=0.060 P=0.004 ** P<0.001 ** |
|LOGISTIC REGRESSION | P=0.007 ** (e) P=0.094 P=0.017 * | P<0.001 ** P=0.060 P=0.003 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.007 ** | P<0.001 ** |
|FISHER EXACT | (e) P=0.092 P=0.029 * | P=0.076 P=0.004 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Pharynx |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 1/75 (1%) 1/60 (2%) | 0/60 (0%) 0/45 (0%) 2/75 (3%) 3/60 (5%) |
|ADJUSTED (b) | 0.0% 0.0% 1.5% 3.7% | 0.0% 0.0% 6.3% 15.4% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 0/50 (0%) 0/0 | 0/59 (0%) 0/39 (0%) 2/32 (6%) 1/10 (10%) |
|FIRST INCIDENCE (DAYS) | --- --- 341 338 | --- --- 421 (T) 343 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.108 (e) P=0.522 P=0.341 | P<0.001 ** (e) P=0.118 P=0.015 * |
|INCIDENTAL TUMOR | P=0.446N (e) P=1.000 (e) | P=0.007 ** (e) P=0.118 P=0.164 |
|LOGISTIC REGRESSION | P=0.425 (e) P=0.650 P=0.745 | P=0.011 * (e) P=0.118 P=0.094 |
|COCHRAN-ARMITAGE | P=0.262 | P=0.034 * |
|FISHER EXACT | (e) P=0.556 P=0.500 | (e) P=0.307 P=0.122 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Pharynx |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 2/75 (3%) 2/60 (3%) | 0/60 (0%) 1/45 (2%) 5/75 (7%) 4/60 (7%) |
|ADJUSTED (b) | 0.0% 0.0% 4.0% 35.4% | 0.0% 2.6% 11.6% 26.3% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 2/50 (4%) 0/0 | 0/59 (0%) 1/39 (3%) 2/32 (6%) 2/10 (20%) |
|FIRST INCIDENCE (DAYS) | --- --- 419 (T) 324 | --- 421 (T) 363 229 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.200 P=0.017 * | P<0.001 ** P=0.417 P=0.014 * P=0.001 ** |
|INCIDENTAL TUMOR | P=0.042 * (e) P=0.200 (e) | P=0.036 * P=0.417 P=0.113 P=0.010 ** |
|LOGISTIC REGRESSION | P=0.036 * (e) P=0.200 P=0.212 | P=0.033 * P=0.417 P=0.048 * P=0.062 |
|COCHRAN-ARMITAGE | P=0.102 | P=0.046 * |
|FISHER EXACT | (e) P=0.307 P=0.248 | P=0.429 P=0.050 * P=0.059 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 2/45 (4%) 4/75 (5%) 1/60 (2%) | 3/58 (5%) 1/45 (2%) 4/75 (5%) 0/60 (0%) |
|ADJUSTED (b) | 1.7% 4.9% 7.4% 2.4% | 5.3% 2.6% 9.5% 0.0% |
|TERMINAL (d) | 1/60 (2%) 2/41 (5%) 3/50 (6%) 0/0 | 3/57 (5%) 1/39 (3%) 2/32 (6%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | 419 (T) 419 (T) 343 303 | 421 (T) 421 (T) 363 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.057 P=0.369 P=0.147 P=0.424 | P=0.604N P=0.449N P=0.284 P=0.534N |
|INCIDENTAL TUMOR | P=0.521 P=0.369 P=0.244 (e) | P=0.203N P=0.449N P=0.612 P=0.534N |
|LOGISTIC REGRESSION | P=0.515 P=0.369 P=0.246 P=0.875N | P=0.245N P=0.449N P=0.588 P=0.534N |
|COCHRAN-ARMITAGE | P=0.526N | P=0.130N |
|FISHER EXACT | P=0.393 P=0.260 P=0.752N | P=0.410N P=0.641 P=0.116N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 10/45 (22%) 52/75 (69%) 29/60 (48%) | 0/60 (0%) 3/45 (7%) 5/75 (7%) 5/60 (8%) |
|ADJUSTED (b) | 0.0% 24.4% 82.4% 100.0% | 0.0% 7.7% 12.2% 30.8% |
|TERMINAL (d) | 0/60 (0%) 10/41 (24%) 39/50 (78%) 0/0 | 0/59 (0%) 3/39 (8%) 3/32 (9%) 2/10 (20%) |
|FIRST INCIDENCE (DAYS) | --- 419 (T) 307 281 | --- 421 (T) 338 370 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.060 P=0.013 * P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** (e) | P=0.011 * P=0.060 P=0.039 * P=0.013 * |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.009 ** P=0.060 P=0.062 P=0.002 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.059 |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.076 P=0.050 * P=0.029 * |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/45 (2%) 4/75 (5%) 2/60 (3%) | 0/60 (0%) 0/45 (0%) 5/75 (7%) 4/60 (7%) |
|ADJUSTED (b) | 0.0% 2.4% 8.0% 5.9% | 0.0% 0.0% 11.3% 14.9% |
|TERMINAL (d) | 0/60 (0%) 1/41 (2%) 4/50 (8%) 0/0 | 0/59 (0%) 0/39 (0%) 1/32 (3%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- 419 (T) 419 (T) 296 | --- --- 315 336 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.424 P=0.043 * P=0.127 | P<0.001 ** (e) P=0.015 * P=0.010 ** |
|INCIDENTAL TUMOR | P=0.036 * P=0.424 P=0.043 * (e) | P=0.433 (e) P=0.319 P=0.983 |
|LOGISTIC REGRESSION | P=0.075 P=0.424 P=0.043 * P=0.577 | P=0.040 * (e) P=0.063 P=0.098 |
|COCHRAN-ARMITAGE | P=0.214 | P=0.024 * |
|FISHER EXACT | P=0.429 P=0.092 P=0.248 | (e) P=0.050 * P=0.059 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/45 (2%) 8/75 (11%) 5/60 (8%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 1/60 (2%) |
|ADJUSTED (b) | 1.7% 2.4% 15.4% 44.0% | 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 1/60 (2%) 1/41 (2%) 7/50 (14%) 0/0 | 0/59 (0%) 0/39 (0%) 0/32 (0%) 1/10 (10%) |
|FIRST INCIDENCE (DAYS) | 419 (T) 419 (T) 379 338 | --- --- --- 421 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.674 P=0.010 * P<0.001 ** | P=0.037 * (e) (e) P=0.157 |
|INCIDENTAL TUMOR | P=0.002 ** P=0.674 P=0.018 * (e) | P=0.037 * (e) (e) P=0.157 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.674 P=0.020 * P=0.008 ** | P=0.037 * (e) (e) P=0.157 |
|COCHRAN-ARMITAGE | P=0.060 | P=0.209 |
|FISHER EXACT | P=0.676 P=0.036 * P=0.103 | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/45 (4%) 10/75 (13%) 13/60 (22%) | 0/60 (0%) 2/45 (4%) 4/75 (5%) 7/60 (12%) |
|ADJUSTED (b) | 0.0% 4.7% 19.5% 64.1% | 0.0% 5.1% 11.7% 40.5% |
|TERMINAL (d) | 0/60 (0%) 1/41 (2%) 9/50 (18%) 0/0 | 0/59 (0%) 2/39 (5%) 3/32 (9%) 3/10 (30%) |
|FIRST INCIDENCE (DAYS) | --- 391 406 211 | --- 421 (T) 406 338 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.165 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.153 P=0.016 * P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.424 P=0.001 ** (e) | P<0.001 ** P=0.153 P=0.039 * P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.202 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.153 P=0.027 * P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.005 ** |
|FISHER EXACT | P=0.181 P=0.002 ** P<0.001 ** | P=0.181 P=0.092 P=0.006 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/45 (4%) 17/75 (23%) 27/60 (45%) | 0/60 (0%) 3/45 (7%) 9/75 (12%) 12/60 (20%) |
|ADJUSTED (b) | 0.0% 4.7% 32.0% 100.0% | 0.0% 7.7% 24.4% 52.0% |
|TERMINAL (d) | 0/60 (0%) 1/41 (2%) 14/50 (28%) 0/0 | 0/59 (0%) 3/39 (8%) 6/32 (19%) 3/10 (30%) |
|FIRST INCIDENCE (DAYS) | --- 391 405 211 | --- 421 (T) 391 264 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.165 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.060 P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.424 P<0.001 ** (e) | P<0.001 ** P=0.060 P=0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.202 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.060 P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.181 P<0.001 ** P<0.001 ** | P=0.076 P=0.004 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 8/75 (11%) 15/60 (25%) | 0/60 (0%) 1/45 (2%) 6/75 (8%) 5/60 (8%) |
|ADJUSTED (b) | 0.0% 0.0% 15.2% 100.0% | 0.0% 2.6% 16.4% 19.0% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 6/50 (12%) 0/0 | 0/59 (0%) 1/39 (3%) 4/32 (13%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 405 238 | --- 421 (T) 391 264 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.003 ** P<0.001 ** | P<0.001 ** P=0.417 P=0.003 ** P=0.002 ** |
|INCIDENTAL TUMOR | P<0.001 ** (e) P=0.010 ** (e) | P=0.035 * P=0.417 P=0.013 * P=0.846 |
|LOGISTIC REGRESSION | P<0.001 ** (e) P=0.005 ** P<0.001 ** | P=0.011 * P=0.417 P=0.010 * P=0.056 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.022 * |
|FISHER EXACT | (e) P=0.008 ** P<0.001 ** | P=0.429 P=0.027 * P=0.029 * |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 11/45 (24%) 54/75 (72%) 30/60 (50%) | 0/60 (0%) 3/45 (7%) 10/75 (13%) 9/60 (15%) |
|ADJUSTED (b) | 0.0% 26.8% 85.6% 100.0% | 0.0% 7.7% 22.4% 41.1% |
|TERMINAL (d) | 0/60 (0%) 11/41 (27%) 41/50 (82%) 0/0 | 0/59 (0%) 3/39 (8%) 4/32 (13%) 2/10 (20%) |
|FIRST INCIDENCE (DAYS) | --- 419 (T) 307 281 | --- 421 (T) 315 336 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.060 P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** (e) | P=0.017 * P=0.060 P=0.013 * P=0.013 * |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.001 ** P=0.060 P=0.005 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.004 ** |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.076 P=0.002 ** P=0.001 ** |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 13/45 (29%) 60/75 (80%) 40/60 (67%) | 0/60 (0%) 6/45 (13%) 18/75 (24%) 20/60 (33%) |
|ADJUSTED (b) | 1.7% 30.9% 93.7% 100.0% | 0.0% 15.4% 41.7% 73.7% |
|TERMINAL (d) | 1/60 (2%) 12/41 (29%) 46/50 (92%) 0/0 | 0/59 (0%) 6/39 (15%) 10/32 (31%) 5/10 (50%) |
|FIRST INCIDENCE (DAYS) | 419 (T) 391 307 211 | --- 421 (T) 315 264 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** (e) | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.005 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Carcinoma, Basal Cell Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 7/75 (9%) 5/60 (8%) | 0/60 (0%) 0/45 (0%) 1/75 (1%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 13.3% 21.9% | 0.0% 0.0% 3.1% 7.7% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 5/50 (10%) 0/0 | 0/59 (0%) 0/39 (0%) 1/32 (3%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 405 280 | --- --- 421 (T) 406 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.006 ** P=0.001 ** | P=0.040 * (e) P=0.378 P=0.203 |
|INCIDENTAL TUMOR | P=0.039 * (e) P=0.021 * (e) | P=0.222 (e) P=0.378 P=0.983 |
|LOGISTIC REGRESSION | P=0.003 ** (e) P=0.010 ** P=0.058 | P=0.090 (e) P=0.378 P=0.363 |
|COCHRAN-ARMITAGE | P=0.013 * | P=0.262 |
|FISHER EXACT | (e) P=0.014 * P=0.029 * | (e) P=0.556 P=0.500 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 2/60 (3%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 100.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 0/50 (0%) 0/0 | 0/59 (0%) 0/39 (0%) 0/32 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 350 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.001 ** | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.232 (e) (e) (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.042 * (e) (e) P=0.080 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.049 * | (e) |
|FISHER EXACT | (e) (e) P=0.248 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/45 (0%) 0/75 (0%) 2/60 (3%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 1.7% 0.0% 0.0% 100.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/60 (2%) 0/41 (0%) 0/50 (0%) 0/0 | 0/59 (0%) 0/39 (0%) 0/32 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | 419 (T) --- --- 350 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.007 ** P=0.576N P=0.536N P=0.001 ** | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.452 P=0.576N P=0.536N (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.170 P=0.576N P=0.536N P=0.152 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.249 | (e) |
|FISHER EXACT | P=0.571N P=0.444N P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/60 (40%) 26/45 (58%) 26/75 (35%) 2/60 (3%) | |
|ADJUSTED (b) | 40.0% 61.9% 45.9% 13.1% | |
|TERMINAL (d) | 24/60 (40%) 25/41 (61%) 20/50 (40%) 0/0 | |
|FIRST INCIDENCE (DAYS) | 419 (T) 405 341 348 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.043 * P=0.020 * P=0.186 P=0.026 * | |
|INCIDENTAL TUMOR | P=0.237N P=0.031 * P=0.577 (e) | |
|LOGISTIC REGRESSION | P=0.453N P=0.025 * P=0.497 P=0.802N | |
|COCHRAN-ARMITAGE | P<0.001N** | |
|FISHER EXACT | P=0.054 P=0.323N P<0.001N** | |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 1/44 (2%) 3/75 (4%) 1/60 (2%) | 1/60 (2%) 1/45 (2%) 2/74 (3%) 1/60 (2%) |
|ADJUSTED (b) | 3.3% 2.4% 5.5% 100.0% | 1.7% 2.6% 5.4% 2.1% |
|TERMINAL (d) | 2/60 (3%) 1/41 (2%) 2/50 (4%) 0/0 | 1/59 (2%) 1/39 (3%) 1/32 (3%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | 419 (T) 419 (T) 379 384 | 421 (T) 421 (T) 405 296 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.063 P=0.631N P=0.437 P<0.001 ** | P=0.236 P=0.666 P=0.324 P=0.558 |
|INCIDENTAL TUMOR | P=0.421 P=0.631N P=0.627 (e) | P=0.662 P=0.666 P=0.591 P=0.843N |
|LOGISTIC REGRESSION | P=0.340 P=0.631N P=0.559 P=0.429 | P=0.646 P=0.666 P=0.424 P=0.673N |
|COCHRAN-ARMITAGE | P=0.429N | P=0.612N |
|FISHER EXACT | P=0.616N P=0.605 P=0.500N | P=0.676 P=0.579 P=0.752N |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 2/60 (3%) | 0/60 (0%) 1/45 (2%) 0/75 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 10.6% | 0.0% 2.6% 0.0% 2.4% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 0/50 (0%) 0/0 | 0/59 (0%) 1/39 (3%) 0/32 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 324 | --- 421 (T) --- 338 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.006 ** (e) (e) P=0.055 | P=0.239 P=0.417 (e) P=0.424 |
|INCIDENTAL TUMOR | P=0.554 (e) (e) (e) | P=0.577 P=0.417 (e) P=1.000 |
|LOGISTIC REGRESSION | P=0.100 (e) (e) P=0.353 | P=0.508 P=0.417 (e) P=0.724 |
|COCHRAN-ARMITAGE | P=0.049 * | P=0.449 |
|FISHER EXACT | (e) (e) P=0.248 | P=0.429 (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 1/75 (1%) 2/60 (3%) | 0/60 (0%) 2/45 (4%) 2/75 (3%) 8/60 (13%) |
|ADJUSTED (b) | 0.0% 0.0% 2.0% 10.6% | 0.0% 5.1% 5.3% 36.1% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 1/50 (2%) 0/0 | 0/59 (0%) 2/39 (5%) 1/32 (3%) 2/10 (20%) |
|FIRST INCIDENCE (DAYS) | --- --- 419 (T) 324 | --- 421 (T) 391 285 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** (e) P=0.464 P=0.055 | P<0.001 ** P=0.153 P=0.149 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.287 (e) P=0.464 (e) | P<0.001 ** P=0.153 P=0.357 P=0.013 * |
|LOGISTIC REGRESSION | P=0.094 (e) P=0.464 P=0.353 | P<0.001 ** P=0.153 P=0.239 P=0.002 ** |
|COCHRAN-ARMITAGE | P=0.079 | P=0.001 ** |
|FISHER EXACT | (e) P=0.556 P=0.248 | P=0.181 P=0.307 P=0.003 ** |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 1/75 (1%) 0/60 (0%) | 0/60 (0%) 2/45 (4%) 2/75 (3%) 7/60 (12%) |
|ADJUSTED (b) | 0.0% 0.0% 2.0% 0.0% | 0.0% 5.1% 5.3% 34.5% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 1/50 (2%) 0/0 | 0/59 (0%) 2/39 (5%) 1/32 (3%) 2/10 (20%) |
|FIRST INCIDENCE (DAYS) | --- --- 419 (T) --- | --- 421 (T) 391 285 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.518 (e) P=0.464 (e) | P<0.001 ** P=0.153 P=0.149 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.518 (e) P=0.464 (e) | P=0.001 ** P=0.153 P=0.357 P=0.013 * |
|LOGISTIC REGRESSION | P=0.518 (e) P=0.464 (e) | P<0.001 ** P=0.153 P=0.239 P=0.002 ** |
|COCHRAN-ARMITAGE | P=0.736 | P=0.003 ** |
|FISHER EXACT | (e) P=0.556 (e) | P=0.181 P=0.307 P=0.006 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 11/60 (18%) 9/45 (20%) 3/75 (4%) 1/60 (2%) |
|ADJUSTED (b) | | 18.6% 22.4% 7.1% 6.3% |
|TERMINAL (d) | | 11/59 (19%) 8/39 (21%) 1/32 (3%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | | 421 (T) 391 338 405 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.140N P=0.397 P=0.168N P=0.395N |
|INCIDENTAL TUMOR | | P=0.012N* P=0.479 P=0.043N* P=0.170N |
|LOGISTIC REGRESSION | | P=0.016N* P=0.471 P=0.032N* P=0.246N |
|COCHRAN-ARMITAGE | | P<0.001N** |
|FISHER EXACT | | P=0.511 P=0.007N** P=0.002N** |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 11/60 (18%) 10/45 (22%) 4/75 (5%) 1/60 (2%) |
|ADJUSTED (b) | | 18.6% 24.9% 10.1% 6.3% |
|TERMINAL (d) | | 11/59 (19%) 9/39 (23%) 2/32 (6%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | | 421 (T) 391 338 405 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.183N P=0.290 P=0.287N P=0.395N |
|INCIDENTAL TUMOR | | P=0.021N* P=0.362 P=0.104N P=0.170N |
|LOGISTIC REGRESSION | | P=0.024N* P=0.354 P=0.075N P=0.246N |
|COCHRAN-ARMITAGE | | P<0.001N** |
|FISHER EXACT | | P=0.400 P=0.017N* P=0.002N** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/45 (2%) 13/75 (17%) 16/60 (27%) | 0/60 (0%) 4/45 (9%) 11/75 (15%) 12/60 (20%) |
|ADJUSTED (b) | 1.7% 2.4% 23.9% 100.0% | 0.0% 10.3% 24.4% 49.6% |
|TERMINAL (d) | 1/60 (2%) 1/41 (2%) 10/50 (20%) 0/0 | 0/59 (0%) 4/39 (10%) 5/32 (16%) 3/10 (30%) |
|FIRST INCIDENCE (DAYS) | 419 (T) 419 (T) 378 254 | --- 421 (T) 338 251 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.674 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.024 * P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.674 P=0.002 ** (e) | P=0.002 ** P=0.024 * P=0.004 ** P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.674 P=0.001 ** P<0.001 ** | P<0.001 ** P=0.024 * P=0.003 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.676 P=0.002 ** P<0.001 ** | P=0.031 * P=0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/45 (4%) 21/75 (28%) 23/60 (38%) | 0/60 (0%) 2/45 (4%) 22/75 (29%) 35/60 (58%) |
|ADJUSTED (b) | 0.0% 4.6% 30.8% 67.9% | 0.0% 4.5% 35.0% 77.1% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 6/50 (12%) 0/0 | 0/59 (0%) 0/39 (0%) 1/32 (3%) 3/10 (30%) |
|FIRST INCIDENCE (DAYS) | --- 359 229 209 | --- 357 184 229 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.170 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.176 P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.493N (e) P=0.010 ** (e) | P=0.002 ** P=0.814 P=0.190 P<0.001 ** |
|LOGISTIC REGRESSION | P=0.009 ** P=0.265 P=0.003 ** P=0.056 | P<0.001 ** P=0.821 P=0.012 * P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.181 P<0.001 ** P<0.001 ** | P=0.181 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 3/45 (7%) 32/75 (43%) 36/60 (60%) | 0/60 (0%) 6/45 (13%) 32/75 (43%) 42/60 (70%) |
|ADJUSTED (b) | 1.7% 6.9% 46.8% 100.0% | 0.0% 14.3% 50.4% 86.4% |
|TERMINAL (d) | 1/60 (2%) 1/41 (2%) 15/50 (30%) 0/0 | 0/59 (0%) 4/39 (10%) 6/32 (19%) 5/10 (50%) |
|FIRST INCIDENCE (DAYS) | 419 (T) 359 229 209 | --- 357 184 229 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.192 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.006 ** P=0.674 P<0.001 ** (e) | P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.280 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.023 * P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.209 P<0.001 ** P<0.001 ** | P=0.005 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/45 (2%) 1/75 (1%) 1/60 (2%) | 1/60 (2%) 3/45 (7%) 6/75 (8%) 4/60 (7%) |
|ADJUSTED (b) | 0.0% 2.2% 2.0% 2.6% | 1.7% 7.7% 16.2% 23.8% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 1/50 (2%) 0/0 | 0/59 (0%) 3/39 (8%) 4/32 (13%) 1/10 (10%) |
|FIRST INCIDENCE (DAYS) | --- 250 419 (T) 308 | 390 421 (T) 363 364 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.231 P=0.443 P=0.464 P=0.409 | P<0.001 ** P=0.181 P=0.015 * P=0.007 ** |
|INCIDENTAL TUMOR | P=0.445N (e) P=0.464 (e) | P=0.141 P=0.303 P=0.115 P=0.842N |
|LOGISTIC REGRESSION | P=0.631N (e) P=0.464 P=0.902 | P=0.028 * P=0.276 P=0.058 P=0.060 |
|COCHRAN-ARMITAGE | P=0.438 | P=0.214 |
|FISHER EXACT | P=0.429 P=0.556 P=0.500 | P=0.209 P=0.102 P=0.182 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 2/75 (3%) 0/60 (0%) | 0/60 (0%) 1/45 (2%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 3.5% 0.0% | 0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 1/50 (2%) 0/0 | 0/59 (0%) 0/39 (0%) 0/32 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 355 --- | --- 357 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.262 (e) P=0.228 (e) | P=0.640N P=0.443 (e) (e) |
|INCIDENTAL TUMOR | P=0.632N (e) P=0.464 (e) | P=0.128N (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.672 (e) P=0.316 (e) | P=0.421N (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.649 | P=0.536N |
|FISHER EXACT | (e) P=0.307 (e) | P=0.429 (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 2/75 (3%) 0/60 (0%) | 0/60 (0%) 1/45 (2%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 3.5% 0.0% | 0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 1/50 (2%) 0/0 | 0/59 (0%) 0/39 (0%) 0/32 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 355 --- | --- 357 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.262 (e) P=0.228 (e) | P=0.640N P=0.443 (e) (e) |
|INCIDENTAL TUMOR | P=0.632N (e) P=0.464 (e) | P=0.128N (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.672 (e) P=0.316 (e) | P=0.421N (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.649 | P=0.536N |
|FISHER EXACT | (e) P=0.307 (e) | P=0.429 (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 27
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 3/75 (4%) 4/60 (7%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 6.0% 70.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/60 (0%) 0/41 (0%) 3/50 (6%) 0/0 | 0/59 (0%) 0/39 (0%) 0/32 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 419 (T) 308 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.092 P<0.001 ** | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.004 ** (e) P=0.092 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.002 ** (e) P=0.092 P=0.011 * | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.015 * | (e) |
|FISHER EXACT | (e) P=0.168 P=0.059 | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 28/60 (47%) 34/45 (76%) 66/75 (88%) 47/60 (78%) | 17/60 (28%) 24/45 (53%) 54/75 (72%) 41/60 (68%) |
|ADJUSTED (b) | 46.7% 81.0% 97.1% 100.0% | 28.8% 55.8% 92.5% 100.0% |
|TERMINAL (d) | 28/60 (47%) 33/41 (80%) 48/50 (96%) 0/0 | 17/59 (29%) 20/39 (51%) 28/32 (88%) 10/10 (100%)|
|FIRST INCIDENCE (DAYS) | 419 (T) 405 307 226 | 421 (T) 391 229 229 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** (e) | P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.002 ** P<0.001 ** P<0.001 ** | P=0.008 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 28
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.003 0.007 0.015 | CONTROL 0.003 0.007 0.015 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 6/45 (13%) 48/75 (64%) 50/60 (83%) | 1/60 (2%) 14/45 (31%) 49/75 (65%) 56/60 (93%) |
|ADJUSTED (b) | 1.7% 13.3% 69.1% 97.1% | 1.7% 33.0% 72.2% 98.2% |
|TERMINAL (d) | 1/60 (2%) 2/41 (5%) 29/50 (58%) 0/0 | 0/59 (0%) 11/39 (28%) 14/32 (44%) 9/10 (90%) |
|FIRST INCIDENCE (DAYS) | 419 (T) 250 229 209 | 390 357 184 229 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.369 P<0.001 ** (e) | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.369 P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.023 * P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 28/60 (47%) 38/45 (84%) 73/75 (97%) 58/60 (97%) | 18/60 (30%) 33/45 (73%) 71/75 (95%) 58/60 (97%) |
|ADJUSTED (b) | 46.7% 84.4% 100.0% 100.0% | 30.0% 73.3% 97.3% 100.0% |
|TERMINAL (d) | 28/60 (47%) 34/41 (83%) 50/50 (100%) 0/0 | 17/59 (29%) 27/39 (69%) 30/32 (94%) 10/10 (100%)|
|FIRST INCIDENCE (DAYS) | 419 (T) 250 229 209 | 390 357 184 229 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** (e) | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P=0.057 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05166 TEST: 01 PAGE 29
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 60 WEEKS
FEMALE TERMINAL SACRIFICE AT 61 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's exact tests compare directly the overall incidence rates.
For all tests, a negative trend is indicated by "N".
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).
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