TDMS Study 05172-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: HLA, VA 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE DATE: 09/18/94
EXPERIMENT: 05172 TEST: 01 TIME: 06:46:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 99989
PATHOLOGIST: B. ULLAND CAS: 20325400
------------------------------------------------------------------------------------------------------------------------------------
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-DIMETHOXYBENZIDINE DIHYDROCHLORIDE DATE: 09/18/94
EXPERIMENT: 05172 TEST: 01 TIME: 06:46:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 99989
PATHOLOGIST: B. ULLAND CAS: 20325400
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-DIMETHOXYBENZIDINE DIHYDROCHLORIDE DATE: 09/18/94
EXPERIMENT: 05172 TEST: 01 TIME: 06:46:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 99989
PATHOLOGIST: B. ULLAND CAS: 20325400
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma Malignant
Pheochromocytoma: Benign, Complex, Malignant, NOS
Brain Astrocytoma Malignant
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 Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung 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
Pancreas Adenoma
Pharynx Squamous Cell Papilloma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Salivary Glands Schwannoma Malignant
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: Subcutaneous Tissue Fibroma
Neurofibroma
Neurofibroma or Fibroma
Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
Neurofibroma, or Fibroma
Testes Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma
Carcinoma or Adenoma
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: HLA, VA 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE DATE: 09/18/94
EXPERIMENT: 05172 TEST: 01 TIME: 06:46:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 99989
PATHOLOGIST: B. ULLAND CAS: 20325400
Thyroid Gland: Follicular Cell
Carcinoma or Adenoma
Tongue Squamous Cell Carcinoma or Papilloma Squamous
Squamous Cell Papilloma
Zymbal's Gland Adenoma
Carcinoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Mesothelioma Benign, Malignant, NOS
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Intestine Large Carcinoma or Adenoma
Polyp Adenomatous
Intestine Small Carcinoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
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 Papilloma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Basal Cell Adenoma
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
Thyroid Gland: Follicular Cell
Carcinoma or Adenoma
Tongue Squamous Cell Carcinoma
Squamous Cell Carcinoma or Papilloma Squamous
Squamous Cell Papilloma
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: HLA, VA 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE DATE: 09/18/94
EXPERIMENT: 05172 TEST: 01 TIME: 06:46:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 99989
PATHOLOGIST: B. ULLAND CAS: 20325400
Uterus Adenoma
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: 05172 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/60 (23%) 17/44 (39%) 23/74 (31%) 9/60 (15%) | 5/60 (8%) 1/45 (2%) 1/74 (1%) 0/59 (0%) |
|ADJUSTED (b) | 28.6% 69.0% 100.0% 73.0% | 10.5% 6.7% 5.6% 0.0% |
|TERMINAL (d) | 10/44 (23%) 3/8 (38%) 0/0 0/0 | 4/45 (9%) 1/15 (7%) 0/5 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 573 480 417 527 | 574 648 (T) 562 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.601N P=0.462N P=0.652 P=0.936N |
|INCIDENTAL TUMOR | P=0.148N P=0.328 P=0.523 P=0.466N | P=0.288N P=0.358N P=0.437N P=0.500N |
|LOGISTIC REGRESSION | P=0.540 P=0.018 * P=0.007 ** P=0.653N | P=0.247N P=0.298N P=0.470N P=0.490N |
|COCHRAN-ARMITAGE | P=0.077N | P=0.012N* |
|FISHER EXACT | P=0.071 P=0.211 P=0.177N | P=0.184N P=0.063N P=0.030N* |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 1/44 (2%) 3/74 (4%) 0/60 (0%) | 0/60 (0%) 0/45 (0%) 0/74 (0%) 0/59 (0%) |
|ADJUSTED (b) | 4.1% 2.9% 43.8% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/44 (2%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/5 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 603 556 557 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.102 P=0.672 P=0.006 ** (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.294N P=0.387N P=0.644N P=0.362N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.654N P=0.609N P=0.171 P=0.706N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.213N | (e) |
|FISHER EXACT | P=0.616N P=0.599 P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/60 (25%) 18/44 (41%) 23/74 (31%) 9/60 (15%) | 5/60 (8%) 1/45 (2%) 1/74 (1%) 0/59 (0%) |
|ADJUSTED (b) | 29.9% 69.9% 100.0% 73.0% | 10.5% 6.7% 5.6% 0.0% |
|TERMINAL (d) | 10/44 (23%) 3/8 (38%) 0/0 0/0 | 4/45 (9%) 1/15 (7%) 0/5 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 573 480 417 527 | 574 648 (T) 562 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.601N P=0.462N P=0.652 P=0.936N |
|INCIDENTAL TUMOR | P=0.076N P=0.445 P=0.528N P=0.274N | P=0.288N P=0.358N P=0.437N P=0.500N |
|LOGISTIC REGRESSION | P=0.396N P=0.215 P=0.013 * P=0.444N | P=0.247N P=0.298N P=0.470N P=0.490N |
|COCHRAN-ARMITAGE | P=0.047N* | P=0.012N* |
|FISHER EXACT | P=0.066 P=0.280 P=0.127N | P=0.184N P=0.063N P=0.030N* |
|=================================================================================================================================|
| |
|Brain |
| Astrocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/44 (5%) 3/75 (4%) 1/60 (2%) | 0/60 (0%) 1/45 (2%) 1/75 (1%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 19.6% 54.3% 3.3% | 0.0% 3.7% 16.7% 0.0% |
|TERMINAL (d) | 0/44 (0%) 1/7 (14%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 618 536 506 | --- 602 648 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** P=0.021 * P=0.004 ** P=0.372 | P=0.206 P=0.373 P=0.118 (e) |
|INCIDENTAL TUMOR | P=0.510 P=0.138 P=0.508 P=0.912 | P=0.509 P=0.609 P=0.118 (e) |
|LOGISTIC REGRESSION | P=0.143 P=0.073 P=0.057 P=0.594 | P=0.371 P=0.460 P=0.118 (e) |
|COCHRAN-ARMITAGE | P=0.480 | P=0.567N |
|FISHER EXACT | P=0.177 P=0.168 P=0.500 | P=0.429 P=0.556 (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/60 (23%) 6/43 (14%) 19/73 (26%) 12/59 (20%) | 5/58 (9%) 15/44 (34%) 13/74 (18%) 16/55 (29%) |
|ADJUSTED (b) | 28.7% 34.7% 80.5% 80.5% | 11.4% 61.7% 43.4% 100.0% |
|TERMINAL (d) | 10/44 (23%) 1/8 (13%) 0/0 0/0 | 5/44 (11%) 7/15 (47%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 531 485 333 423 | 648 (T) 436 358 262 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.202 P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.233 P=0.458N P=0.284 P=0.340 | P=0.012 * P<0.001 ** P=0.258 P=0.006 ** |
|LOGISTIC REGRESSION | P=0.076 P=0.307N P=0.107 P=0.196 | P=0.002 ** P<0.001 ** P=0.133 P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.539 | P=0.036 * |
|FISHER EXACT | P=0.176N P=0.439 P=0.431N | P=0.002 ** P=0.108 P=0.005 ** |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 6/43 (14%) 15/73 (21%) 19/59 (32%) | 2/58 (3%) 17/44 (39%) 41/74 (55%) 30/55 (55%) |
|ADJUSTED (b) | 3.9% 37.7% 43.4% 50.1% | 4.5% 59.3% 88.3% 79.6% |
|TERMINAL (d) | 0/44 (0%) 1/8 (13%) 0/0 0/0 | 2/44 (5%) 5/15 (33%) 3/6 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 603 603 284 267 | 648 (T) 373 220 270 |
|-----------------------| | |
|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=0.021 * P=0.520 P=0.458 P=0.267 | P=0.001 ** P<0.001 ** P<0.001 ** P=0.007 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.020 * P=0.011 * P=0.003 ** | P<0.001 ** P<0.001 ** P<0.001 ** P=0.004 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.054 P=0.002 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/60 (27%) 12/43 (28%) 33/73 (45%) 29/59 (49%) | 7/58 (12%) 27/44 (61%) 48/74 (65%) 41/55 (75%) |
|ADJUSTED (b) | 31.6% 60.7% 89.3% 89.3% | 15.9% 83.6% 91.7% 100.0% |
|TERMINAL (d) | 10/44 (23%) 2/8 (25%) 0/0 0/0 | 7/44 (16%) 10/15 (67%) 3/6 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 531 485 284 267 | 648 (T) 373 220 262 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.017 * P=0.565N P=0.204 P=0.179 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P=0.001 ** P=0.298 P=0.007 ** P=0.036 * | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.003 ** | P<0.001 ** |
|FISHER EXACT | P=0.532 P=0.021 * P=0.009 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Intestine Large |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 4/75 (5%) 3/60 (5%) | 0/60 (0%) 1/45 (2%) 0/75 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 19.5% 8.6% | 0.0% 6.7% 0.0% 14.3% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 485 414 | --- 648 (T) --- 563 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** (e) P=0.009 ** P=0.056 | P=0.015 * P=0.282 (e) P=0.108 |
|INCIDENTAL TUMOR | P=0.273 (e) P=0.451 P=0.661 | P=0.098 P=0.282 (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.083 (e) P=0.095 P=0.249 | P=0.086 P=0.282 (e) P=0.347 |
|COCHRAN-ARMITAGE | P=0.045 * | P=0.433 |
|FISHER EXACT | (e) P=0.092 P=0.122 | P=0.429 (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large: Colon |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 4/75 (5%) 2/60 (3%) | 0/60 (0%) 1/45 (2%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 19.5% 6.5% | 0.0% 6.7% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 485 414 | --- 648 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.006 ** (e) P=0.009 ** P=0.131 | P=0.732 P=0.282 (e) (e) |
|INCIDENTAL TUMOR | P=0.415 (e) P=0.451 P=0.769 | P=0.732 P=0.282 (e) (e) |
|LOGISTIC REGRESSION | P=0.144 (e) P=0.095 P=0.368 | P=0.732 P=0.282 (e) (e) |
|COCHRAN-ARMITAGE | P=0.113 | P=0.531N |
|FISHER EXACT | (e) P=0.092 P=0.248 | P=0.429 (e) (e) |
|=================================================================================================================================|
| |
|Intestine Large: Colon |
| Polyp Adenomatous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/45 (2%) 4/75 (5%) 4/60 (7%) | 0/60 (0%) 0/45 (0%) 1/75 (1%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 10.0% 25.3% 32.9% | 0.0% 0.0% 2.1% 6.3% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 644 546 486 | --- --- 424 424 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.193 P=0.002 ** P<0.001 ** | P=0.028 * (e) P=0.455 P=0.116 |
|INCIDENTAL TUMOR | P=0.056 P=0.741 P=0.401 P=0.237 | P=0.260 (e) P=0.897 P=0.730 |
|LOGISTIC REGRESSION | P=0.002 ** P=0.238 P=0.030 * P=0.039 * | P=0.201 (e) P=0.886 P=0.597 |
|COCHRAN-ARMITAGE | P=0.036 * | P=0.077 |
|FISHER EXACT | P=0.429 P=0.092 P=0.059 | (e) P=0.556 P=0.248 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 4/45 (9%) 7/75 (9%) 5/60 (8%) | 0/60 (0%) 1/45 (2%) 1/75 (1%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 26.7% 17.7% 19.6% | 0.0% 6.7% 1.9% 18.4% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 354 417 267 | --- 648 (T) 379 452 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.001 ** P=0.003 ** P=0.003 ** | P=0.005 ** P=0.282 P=0.479 P=0.019 * |
|INCIDENTAL TUMOR | P=0.572 P=0.299 P=0.326 P=0.371 | P=0.110 P=0.282 P=0.897 P=0.424 |
|LOGISTIC REGRESSION | P=0.169 P=0.043 * P=0.043 * P=0.100 | P=0.134 P=0.282 P=0.967 P=0.190 |
|COCHRAN-ARMITAGE | P=0.077 | P=0.173 |
|FISHER EXACT | P=0.031 * P=0.014 * P=0.029 * | P=0.429 P=0.556 P=0.248 |
|=================================================================================================================================|
| |
|Intestine Small: Duodenum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/45 (4%) 2/75 (3%) 0/60 (0%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 12.1% 5.9% 0.0% | 0.0% 0.0% 0.0% 14.3% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 354 485 --- | --- --- --- 563 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.387 P=0.073 P=0.147 (e) | P=0.022 * (e) (e) P=0.108 |
|INCIDENTAL TUMOR | P=0.209N P=0.514 P=0.662 (e) | P=0.154 (e) (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.334N P=0.210 P=0.360 (e) | P=0.072 (e) (e) P=0.347 |
|COCHRAN-ARMITAGE | P=0.463N | P=0.206 |
|FISHER EXACT | P=0.181 P=0.307 (e) | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/45 (4%) 5/75 (7%) 4/60 (7%) | 0/60 (0%) 1/45 (2%) 1/75 (1%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 16.7% 12.3% 17.5% | 0.0% 6.7% 1.9% 4.8% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 638 417 267 | --- 648 (T) 379 452 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.022 * P=0.014 * P=0.007 ** | P=0.088 P=0.282 P=0.479 P=0.295 |
|INCIDENTAL TUMOR | P=0.415 P=0.529 P=0.451 P=0.414 | P=0.392 P=0.282 P=0.897 P=0.887 |
|LOGISTIC REGRESSION | P=0.106 P=0.048 * P=0.101 P=0.153 | P=0.508 P=0.282 P=0.967 P=0.801 |
|COCHRAN-ARMITAGE | P=0.066 | P=0.409 |
|FISHER EXACT | P=0.181 P=0.050 * P=0.059 | P=0.429 P=0.556 P=0.500 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Lipoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/44 (0%) 0/74 (0%) 0/60 (0%) | 2/60 (3%) 0/45 (0%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 2/45 (4%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 648 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.566N P=0.500N P=0.721N (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.566N P=0.500N P=0.721N (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.566N P=0.500N P=0.721N (e) |
|COCHRAN-ARMITAGE | (e) | P=0.098N |
|FISHER EXACT | (e) (e) (e) | P=0.324N P=0.196N P=0.248N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 3/45 (7%) 7/74 (9%) 6/60 (10%) | 0/60 (0%) 1/44 (2%) 0/75 (0%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 17.9% 24.9% 39.8% | 0.0% 6.7% 0.0% 51.3% |
|TERMINAL (d) | 0/44 (0%) 1/8 (13%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 538 485 485 | --- 648 (T) --- 408 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.019 * P<0.001 ** P<0.001 ** | P=0.001 ** P=0.282 (e) P=0.021 * |
|INCIDENTAL TUMOR | P=0.043 * P=0.100 P=0.236 P=0.145 | P=0.044 * P=0.282 (e) P=0.424 |
|LOGISTIC REGRESSION | P=0.196 P=0.078 P=0.019 * P=0.007 ** | P=0.033 * P=0.282 (e) P=0.178 |
|COCHRAN-ARMITAGE | P=0.025 * | P=0.161 |
|FISHER EXACT | P=0.076 P=0.014 * P=0.014 * | P=0.423 (e) P=0.248 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/45 (2%) 0/74 (0%) 2/60 (3%) | 0/60 (0%) 0/44 (0%) 0/75 (0%) 1/60 (2%) |
|ADJUSTED (b) | 2.3% 12.5% 0.0% 15.4% | 0.0% 0.0% 0.0% 25.0% |
|TERMINAL (d) | 1/44 (2%) 1/8 (13%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) 647 (T) --- 551 | --- --- --- 602 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.001 ** P=0.352 (e) P=0.020 * | P=0.008 ** (e) (e) P=0.050 * |
|INCIDENTAL TUMOR | P=0.013 * P=0.352 (e) P=0.399 | P=0.158 (e) (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.052 P=0.352 (e) P=0.257 | P=0.026 * (e) (e) P=0.166 |
|COCHRAN-ARMITAGE | P=0.405 | P=0.207 |
|FISHER EXACT | P=0.676 P=0.448N P=0.500 | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 4/45 (9%) 7/74 (9%) 8/60 (13%) | 0/60 (0%) 1/44 (2%) 0/75 (0%) 3/60 (5%) |
|ADJUSTED (b) | 2.3% 29.6% 24.9% 50.0% | 0.0% 6.7% 0.0% 63.5% |
|TERMINAL (d) | 1/44 (2%) 2/8 (25%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) 538 485 485 | --- 648 (T) --- 408 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.282 (e) P<0.001 ** |
|INCIDENTAL TUMOR | P=0.004 ** P=0.033 * P=0.236 P=0.062 | P=0.008 ** P=0.282 (e) P=0.209 |
|LOGISTIC REGRESSION | P=0.059 P=0.072 P=0.044 * P=0.002 ** | P=0.002 ** P=0.282 (e) P=0.013 * |
|COCHRAN-ARMITAGE | P=0.021 * | P=0.055 |
|FISHER EXACT | P=0.105 P=0.059 P=0.016 * | P=0.423 (e) P=0.122 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 4/45 (9%) 7/74 (9%) 8/60 (13%) | 0/60 (0%) 1/44 (2%) 0/75 (0%) 3/60 (5%) |
|ADJUSTED (b) | 2.3% 29.6% 24.9% 50.0% | 0.0% 6.7% 0.0% 63.5% |
|TERMINAL (d) | 1/44 (2%) 2/8 (25%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) 538 485 485 | --- 648 (T) --- 408 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.282 (e) P<0.001 ** |
|INCIDENTAL TUMOR | P=0.004 ** P=0.033 * P=0.236 P=0.062 | P=0.008 ** P=0.282 (e) P=0.209 |
|LOGISTIC REGRESSION | P=0.059 P=0.072 P=0.044 * P=0.002 ** | P=0.002 ** P=0.282 (e) P=0.013 * |
|COCHRAN-ARMITAGE | P=0.021 * | P=0.055 |
|FISHER EXACT | P=0.105 P=0.059 P=0.016 * | P=0.423 (e) P=0.122 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/44 (0%) 2/75 (3%) 1/60 (2%) | 0/60 (0%) 1/45 (2%) 1/75 (1%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 7.2% 3.8% | 0.0% 6.7% 2.2% 5.6% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 555 525 | --- 648 (T) 436 483 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.040 * (e) P=0.107 P=0.344 | P=0.060 P=0.282 P=0.446 P=0.265 |
|INCIDENTAL TUMOR | P=0.379 (e) P=0.579 P=0.912 | P=0.392 P=0.282 P=0.897 P=0.887 |
|LOGISTIC REGRESSION | P=0.219 (e) P=0.277 P=0.568 | P=0.369 P=0.282 P=0.858 P=0.694 |
|COCHRAN-ARMITAGE | P=0.256 | P=0.409 |
|FISHER EXACT | (e) P=0.307 P=0.500 | P=0.429 P=0.556 P=0.500 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) | 0/60 (0%) 1/45 (2%) 0/75 (0%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 6.7% 0.0% 35.1% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 648 (T) --- 408 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.002 ** P=0.282 (e) P=0.026 * |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.043 * P=0.282 (e) P=0.424 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.034 * P=0.282 (e) P=0.184 |
|COCHRAN-ARMITAGE | (e) | P=0.160 |
|FISHER EXACT | (e) (e) (e) | P=0.429 (e) P=0.248 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) | 1/60 (2%) 2/45 (4%) 14/75 (19%) 20/60 (33%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.2% 6.7% 57.5% 88.5% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 1/45 (2%) 0/15 (0%) 2/6 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 648 (T) 512 333 284 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P<0.001 ** P=0.252 P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P<0.001 ** P=0.559 P=0.007 ** P=0.008 ** |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P<0.001 ** P=0.469 P=0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | (e) | P<0.001 ** |
|FISHER EXACT | (e) (e) (e) | P=0.393 P=0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) | 1/60 (2%) 3/45 (7%) 14/75 (19%) 21/60 (35%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.2% 12.9% 57.5% 88.8% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 1/45 (2%) 1/15 (7%) 2/6 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 648 (T) 512 333 284 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P<0.001 ** P=0.078 P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P<0.001 ** P=0.239 P=0.007 ** P=0.006 ** |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P<0.001 ** P=0.210 P=0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | (e) | P<0.001 ** |
|FISHER EXACT | (e) (e) (e) | P=0.209 P=0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/45 (0%) 2/75 (3%) 0/60 (0%) | 14/60 (23%) 11/45 (24%) 9/75 (12%) 4/60 (7%) |
|ADJUSTED (b) | 2.3% 0.0% 6.1% 0.0% | 29.3% 50.7% 57.1% 56.4% |
|TERMINAL (d) | 1/44 (2%) 0/8 (0%) 0/0 0/0 | 12/45 (27%) 6/15 (40%) 2/6 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) --- 486 --- | 532 424 476 344 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.373 P=0.831N P=0.140 (e) | P<0.001 ** P=0.038 * P=0.003 ** P=0.006 ** |
|INCIDENTAL TUMOR | P=0.577N P=0.831N P=0.662 (e) | P=0.450N P=0.256 P=0.454 P=0.429N |
|LOGISTIC REGRESSION | P=0.519N P=0.831N P=0.592 (e) | P=0.503 P=0.383 P=0.248 P=0.525N |
|COCHRAN-ARMITAGE | P=0.439N | P=0.003N** |
|FISHER EXACT | P=0.571N P=0.584 P=0.500N | P=0.537 P=0.066N P=0.010N** |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/45 (0%) 2/75 (3%) 0/60 (0%) | 14/60 (23%) 11/45 (24%) 9/75 (12%) 6/60 (10%) |
|ADJUSTED (b) | 2.3% 0.0% 6.1% 0.0% | 29.3% 50.7% 57.1% 71.7% |
|TERMINAL (d) | 1/44 (2%) 0/8 (0%) 0/0 0/0 | 12/45 (27%) 6/15 (40%) 2/6 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) --- 486 --- | 532 424 476 344 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.373 P=0.831N P=0.140 (e) | P<0.001 ** P=0.038 * P=0.003 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.577N P=0.831N P=0.662 (e) | P=0.426 P=0.256 P=0.454 P=0.672N |
|LOGISTIC REGRESSION | P=0.519N P=0.831N P=0.592 (e) | P=0.252 P=0.383 P=0.248 P=0.553 |
|COCHRAN-ARMITAGE | P=0.439N | P=0.013N* |
|FISHER EXACT | P=0.571N P=0.584 P=0.500N | P=0.537 P=0.066N P=0.042N* |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/45 (0%) 2/75 (3%) 0/60 (0%) | 15/60 (25%) 13/45 (29%) 21/75 (28%) 22/60 (37%) |
|ADJUSTED (b) | 2.3% 0.0% 6.1% 0.0% | 31.4% 54.0% 78.9% 89.5% |
|TERMINAL (d) | 1/44 (2%) 0/8 (0%) 0/0 0/0 | 13/45 (29%) 6/15 (40%) 3/6 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) --- 486 --- | 532 424 333 284 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.373 P=0.831N P=0.140 (e) | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.577N P=0.831N P=0.662 (e) | P=0.005 ** P=0.207 P=0.073 P=0.070 |
|LOGISTIC REGRESSION | P=0.519N P=0.831N P=0.592 (e) | P=0.001 ** P=0.294 P=0.024 * P=0.030 * |
|COCHRAN-ARMITAGE | P=0.439N | P=0.101 |
|FISHER EXACT | P=0.571N P=0.584 P=0.500N | P=0.410 P=0.424 P=0.118 |
|=================================================================================================================================|
| |
|Mesentery |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 3.1% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 420 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.542 (e) P=0.259 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.421N (e) P=0.769 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.632N (e) P=0.387 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.595 | (e) |
|FISHER EXACT | (e) P=0.307 (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 7/45 (16%) 10/75 (13%) 9/60 (15%) | 2/60 (3%) 2/45 (4%) 3/75 (4%) 3/60 (5%) |
|ADJUSTED (b) | 2.3% 41.9% 50.4% 100.0% | 4.4% 12.5% 21.6% 63.5% |
|TERMINAL (d) | 1/44 (2%) 2/8 (25%) 0/0 0/0 | 2/45 (4%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) 485 333 402 | 648 (T) 644 450 408 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.283 P=0.040 * P<0.001 ** |
|INCIDENTAL TUMOR | P=0.064 P=0.019 * P=0.170 P=0.081 | P=0.109 P=0.447 P=0.440 P=0.209 |
|LOGISTIC REGRESSION | P=0.015 * P=0.009 ** P=0.028 * P=0.007 ** | P=0.018 * P=0.306 P=0.257 P=0.062 |
|COCHRAN-ARMITAGE | P=0.034 * | P=0.422 |
|FISHER EXACT | P=0.011 * P=0.012 * P=0.008 ** | P=0.576 P=0.605 P=0.500 |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/45 (2%) 0/75 (0%) 2/60 (3%) | 0/60 (0%) 0/45 (0%) 3/75 (4%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 4.2% 0.0% 5.7% | 0.0% 0.0% 7.0% 10.3% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 602 --- 401 | --- --- 331 431 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.022 * P=0.342 (e) P=0.148 | P=0.016 * (e) P=0.078 P=0.055 |
|INCIDENTAL TUMOR | P=0.373 P=0.741 (e) P=0.769 | P=0.512 (e) P=0.744 P=0.730 |
|LOGISTIC REGRESSION | P=0.218 P=0.441 (e) P=0.380 | P=0.339 (e) P=0.527 P=0.429 |
|COCHRAN-ARMITAGE | P=0.160 | P=0.105 |
|FISHER EXACT | P=0.429 (e) P=0.248 | (e) P=0.168 P=0.248 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 8/45 (18%) 10/75 (13%) 11/60 (18%) | 2/60 (3%) 2/45 (4%) 6/75 (8%) 5/60 (8%) |
|ADJUSTED (b) | 2.3% 44.3% 50.4% 100.0% | 4.4% 12.5% 27.1% 67.3% |
|TERMINAL (d) | 1/44 (2%) 2/8 (25%) 0/0 0/0 | 2/45 (4%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) 485 333 401 | 648 (T) 644 331 408 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.283 P=0.004 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.042 * P=0.015 * P=0.170 P=0.068 | P=0.116 P=0.447 P=0.359 P=0.167 |
|LOGISTIC REGRESSION | P=0.007 ** P=0.004 ** P=0.028 * P=0.004 ** | P=0.028 * P=0.306 P=0.212 P=0.028 * |
|COCHRAN-ARMITAGE | P=0.014 * | P=0.141 |
|FISHER EXACT | P=0.005 ** P=0.012 * P=0.002 ** | P=0.576 P=0.222 P=0.219 |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/44 (5%) 0/75 (0%) 1/60 (2%) | 0/60 (0%) 0/43 (0%) 0/75 (0%) 0/59 (0%) |
|ADJUSTED (b) | 0.0% 15.9% 0.0% 100.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 1/8 (13%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 596 --- 597 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.043 * (e) P<0.001 ** | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.272 P=0.150 (e) P=0.638 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.103 P=0.122 (e) P=0.281 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.581 | (e) |
|FISHER EXACT | P=0.177 (e) P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Pharynx |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 4/45 (9%) 5/75 (7%) 3/60 (5%) | 1/60 (2%) 0/45 (0%) 3/75 (4%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 26.3% 32.8% 40.4% | 2.2% 0.0% 21.6% 2.6% |
|TERMINAL (d) | 0/44 (0%) 1/8 (13%) 0/0 0/0 | 1/45 (2%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 556 408 476 | 648 (T) --- 450 408 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.002 ** P=0.004 ** P=0.003 ** | P=0.027 * P=0.718N P=0.021 * P=0.412 |
|INCIDENTAL TUMOR | P=0.399 P=0.096 P=0.403 P=0.356 | P=0.455 P=0.718N P=0.379 P=0.887 |
|LOGISTIC REGRESSION | P=0.157 P=0.023 * P=0.098 P=0.092 | P=0.341 P=0.718N P=0.158 P=0.884N |
|COCHRAN-ARMITAGE | P=0.253 | P=0.490 |
|FISHER EXACT | P=0.031 * P=0.050 * P=0.122 | P=0.571N P=0.398 P=0.752N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/58 (3%) 1/43 (2%) 0/74 (0%) 3/59 (5%) | 15/60 (25%) 9/45 (20%) 5/75 (7%) 8/60 (13%) |
|ADJUSTED (b) | 4.1% 12.5% 0.0% 7.4% | 29.5% 37.2% 40.4% 70.4% |
|TERMINAL (d) | 1/44 (2%) 1/8 (13%) 0/0 0/0 | 10/45 (22%) 3/15 (20%) 2/6 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | 581 647 (T) --- 423 | 574 505 468 408 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.013 * P=0.594 P=0.767N P=0.091 | P<0.001 ** P=0.212 P=0.190 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.271 P=0.733N P=0.196N P=0.527N | P=0.558N P=0.336N P=0.176N P=0.407N |
|LOGISTIC REGRESSION | P=0.389 P=0.691N P=0.344N P=0.673 | P=0.242 P=0.528N P=0.375N P=0.388 |
|COCHRAN-ARMITAGE | P=0.393 | P=0.030N* |
|FISHER EXACT | P=0.612N P=0.191N P=0.508 | P=0.358N P=0.003N** P=0.082N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/58 (0%) 0/43 (0%) 0/74 (0%) 0/59 (0%) | 2/60 (3%) 0/45 (0%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 1/45 (2%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 600 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.462N P=0.443N P=0.674N P=0.952N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.223N P=0.277N P=0.341N P=0.500N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.297N P=0.333N P=0.484N P=0.730N |
|COCHRAN-ARMITAGE | (e) | P=0.098N |
|FISHER EXACT | (e) (e) (e) | P=0.324N P=0.196N P=0.248N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/58 (3%) 1/43 (2%) 0/74 (0%) 3/59 (5%) | 17/60 (28%) 9/45 (20%) 5/75 (7%) 8/60 (13%) |
|ADJUSTED (b) | 4.1% 12.5% 0.0% 7.4% | 32.8% 37.2% 40.4% 70.4% |
|TERMINAL (d) | 1/44 (2%) 1/8 (13%) 0/0 0/0 | 11/45 (24%) 3/15 (20%) 2/6 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | 581 647 (T) --- 423 | 574 505 468 408 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.013 * P=0.594 P=0.767N P=0.091 | P<0.001 ** P=0.309 P=0.252 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.271 P=0.733N P=0.196N P=0.527N | P=0.420N P=0.195N P=0.086N P=0.275N |
|LOGISTIC REGRESSION | P=0.389 P=0.691N P=0.344N P=0.673 | P=0.351 P=0.375N P=0.255N P=0.497 |
|COCHRAN-ARMITAGE | P=0.393 | P=0.011N* |
|FISHER EXACT | P=0.612N P=0.191N P=0.508 | P=0.227N P<0.001N** P=0.035N* |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/44 (5%) 0/75 (0%) 0/60 (0%) | 0/59 (0%) 0/44 (0%) 1/75 (1%) 0/59 (0%) |
|ADJUSTED (b) | 0.0% 13.5% 0.0% 0.0% | 0.0% 0.0% 4.2% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/44 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 596 --- --- | --- --- 550 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.413 P=0.049 * (e) (e) | P=0.465 (e) P=0.331 (e) |
|INCIDENTAL TUMOR | P=0.308N P=0.529 (e) (e) | P=0.674 (e) P=0.598 (e) |
|LOGISTIC REGRESSION | P=0.752 P=0.127 (e) (e) | P=0.672 (e) P=0.526 (e) |
|COCHRAN-ARMITAGE | P=0.359N | P=0.692 |
|FISHER EXACT | P=0.177 (e) (e) | (e) P=0.560 (e) |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 31/45 (69%) 47/75 (63%) 35/60 (58%) | 0/60 (0%) 3/45 (7%) 3/75 (4%) 2/60 (3%) |
|ADJUSTED (b) | 2.3% 96.5% 100.0% 100.0% | 0.0% 20.0% 24.5% 66.7% |
|TERMINAL (d) | 1/44 (2%) 7/8 (88%) 0/0 0/0 | 0/45 (0%) 3/15 (20%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) 480 424 419 | --- 648 (T) 423 610 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.009 ** P=0.006 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.035 * P=0.009 ** P=0.311 P=0.234 |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.003 ** P=0.009 ** P=0.058 P=0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.356 |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.076 P=0.168 P=0.248 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 4/45 (9%) 18/75 (24%) 17/60 (28%) | 0/60 (0%) 1/45 (2%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 2.3% 16.9% 47.8% 73.3% | 0.0% 6.7% 0.0% 0.0% |
|TERMINAL (d) | 1/44 (2%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) 552 417 344 | --- 648 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** | P=0.732 P=0.282 (e) (e) |
|INCIDENTAL TUMOR | P=0.009 ** P=0.384 P=0.066 P=0.027 * | P=0.732 P=0.282 (e) (e) |
|LOGISTIC REGRESSION | P=0.014 * P=0.092 P<0.001 ** P<0.001 ** | P=0.732 P=0.282 (e) (e) |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.531N |
|FISHER EXACT | P=0.105 P<0.001 ** P<0.001 ** | P=0.429 (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 5/45 (11%) 7/75 (9%) 1/60 (2%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 1.8% 30.6% 37.0% 5.6% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 573 556 391 546 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.006 ** P=0.003 ** P=0.002 ** P=0.370 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.105N P=0.554 P=0.594 P=0.451N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.572N P=0.041 * P=0.103 P=0.814 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.403N | (e) |
|FISHER EXACT | P=0.051 P=0.061 P=0.752N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 9/45 (20%) 24/75 (32%) 21/60 (35%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 48.8% 90.8% 100.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 2/8 (25%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 485 424 445 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P<0.001 ** P=0.006 ** P=0.006 ** P=0.001 ** | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P<0.001 ** | (e) |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 13/45 (29%) 28/75 (37%) 22/60 (37%) | 0/60 (0%) 0/45 (0%) 3/75 (4%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 62.0% 91.7% 100.0% | 0.0% 0.0% 20.4% 0.0% |
|TERMINAL (d) | 0/44 (0%) 3/8 (38%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 485 424 445 | --- --- 361 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.117 (e) P=0.014 * (e) |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P=0.004 ** P<0.001 ** | P=0.640N (e) P=0.351 (e) |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.547 (e) P=0.126 (e) |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.542 |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | (e) P=0.168 (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 5/45 (11%) 7/75 (9%) 5/60 (8%) | 0/60 (0%) 0/45 (0%) 3/75 (4%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 33.1% 43.7% 33.1% | 0.0% 0.0% 20.4% 0.0% |
|TERMINAL (d) | 0/44 (0%) 2/8 (25%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 515 525 445 | --- --- 361 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.117 (e) P=0.014 * (e) |
|INCIDENTAL TUMOR | P=0.250 P=0.010 ** P=0.294 P=0.216 | P=0.640N (e) P=0.351 (e) |
|LOGISTIC REGRESSION | P=0.016 * P=0.015 * P=0.004 ** P=0.031 * | P=0.547 (e) P=0.126 (e) |
|COCHRAN-ARMITAGE | P=0.107 | P=0.542 |
|FISHER EXACT | P=0.013 * P=0.014 * P=0.029 * | (e) P=0.168 (e) |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 32/45 (71%) 54/75 (72%) 40/60 (67%) | 0/60 (0%) 4/45 (9%) 3/75 (4%) 2/60 (3%) |
|ADJUSTED (b) | 4.5% 96.6% 100.0% 100.0% | 0.0% 26.7% 24.5% 66.7% |
|TERMINAL (d) | 2/44 (5%) 7/8 (88%) 0/0 0/0 | 0/45 (0%) 4/15 (27%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) 480 417 344 | --- 648 (T) 423 610 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.002 ** P=0.006 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.025 * P=0.002 ** P=0.311 P=0.234 |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.003 ** P=0.002 ** P=0.058 P=0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.440 |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.031 * P=0.168 P=0.248 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 35/45 (78%) 57/75 (76%) 43/60 (72%) | 0/60 (0%) 4/45 (9%) 5/75 (7%) 2/60 (3%) |
|ADJUSTED (b) | 6.3% 100.0% 100.0% 100.0% | 0.0% 26.7% 29.9% 66.7% |
|TERMINAL (d) | 2/44 (5%) 8/8 (100%) 0/0 0/0 | 0/45 (0%) 4/15 (27%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 573 480 391 344 | --- 648 (T) 361 610 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.057 P=0.002 ** P=0.195 P=0.234 |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.018 * P=0.002 ** P=0.031 * P=0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.407 |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.031 * P=0.050 * P=0.248 |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Carcinoma, Basal Cell Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/45 (4%) 3/75 (4%) 2/60 (3%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 14.5% 5.8% 5.1% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 1/8 (13%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 353 472 337 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.063 P=0.067 P=0.106 P=0.166 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.618N P=0.145 P=0.661 P=0.734 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.509 P=0.210 P=0.253 P=0.397 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.268 | (e) |
|FISHER EXACT | P=0.181 P=0.168 P=0.248 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 4/45 (9%) 4/75 (5%) 2/60 (3%) | 0/60 (0%) 1/45 (2%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 17.6% 22.5% 100.0% | 0.0% 6.7% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 546 556 483 | --- 648 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** P=0.009 ** P=0.003 ** P=0.016 * | P=0.732 P=0.282 (e) (e) |
|INCIDENTAL TUMOR | P=0.563N P=0.260 P=0.356 P=0.549 | P=0.732 P=0.282 (e) (e) |
|LOGISTIC REGRESSION | P=0.223 P=0.041 * P=0.043 * P=0.227 | P=0.732 P=0.282 (e) (e) |
|COCHRAN-ARMITAGE | P=0.422 | P=0.531N |
|FISHER EXACT | P=0.031 * P=0.092 P=0.248 | P=0.429 (e) (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/45 (4%) 2/75 (3%) 2/60 (3%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 18.2% 100.0% 9.7% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 641 358 424 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.018 * P=0.036 * P=0.083 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.465 P=0.529 P=0.600 P=0.549 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.257 P=0.033 * P=0.384 P=0.353 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.274 | (e) |
|FISHER EXACT | P=0.181 P=0.307 P=0.248 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibroma or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 6/45 (13%) 6/75 (8%) 4/60 (7%) | 0/60 (0%) 1/45 (2%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 33.5% 100.0% 100.0% | 0.0% 6.7% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 546 358 424 | --- 648 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P=0.001 ** | P=0.732 P=0.282 (e) (e) |
|INCIDENTAL TUMOR | P=0.510 P=0.158 P=0.242 P=0.320 | P=0.732 P=0.282 (e) (e) |
|LOGISTIC REGRESSION | P=0.115 P=0.006 ** P=0.032 * P=0.093 | P=0.732 P=0.282 (e) (e) |
|COCHRAN-ARMITAGE | P=0.241 | P=0.531N |
|FISHER EXACT | P=0.005 ** P=0.027 * P=0.059 | P=0.429 (e) (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 6/45 (13%) 6/75 (8%) 5/60 (8%) | 0/60 (0%) 1/45 (2%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.9% 33.5% 100.0% 100.0% | 0.0% 6.7% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 452 546 358 424 | --- 648 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.004 ** P=0.002 ** P=0.006 ** | P=0.732 P=0.282 (e) (e) |
|INCIDENTAL TUMOR | P=0.531N P=0.367 P=0.606 P=0.695 | P=0.732 P=0.282 (e) (e) |
|LOGISTIC REGRESSION | P=0.242 P=0.075 P=0.267 P=0.353 | P=0.732 P=0.282 (e) (e) |
|COCHRAN-ARMITAGE | P=0.341 | P=0.531N |
|FISHER EXACT | P=0.062 P=0.222 P=0.219 | P=0.429 (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/45 (0%) 0/75 (0%) 1/60 (2%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.9% 0.0% 0.0% 2.9% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 452 --- --- 485 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.558 P=0.456N P=0.490N P=0.661 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.393N P=0.388N P=0.088N P=0.231N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.345N P=0.265N P=0.131N P=0.390N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.421N | (e) |
|FISHER EXACT | P=0.324N P=0.196N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/45 (0%) 0/75 (0%) 0/60 (0%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.9% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 452 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.292N P=0.456N P=0.490N P=0.573N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.077N P=0.388N P=0.088N P=0.088N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.066N P=0.265N P=0.131N P=0.167N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.098N | (e) |
|FISHER EXACT | P=0.324N P=0.196N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 57/60 (95%) 39/45 (87%) 68/75 (91%) 42/59 (71%) | |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | |
|TERMINAL (d) | 44/44 (100%) 8/8 (100%) 0/0 0/0 | |
|FIRST INCIDENCE (DAYS) | 529 480 333 344 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |
|INCIDENTAL TUMOR | P=0.329N P=0.520 P=0.054 P=0.465 | |
|LOGISTIC REGRESSION | P=0.530N P=0.675 P=0.007 ** P=0.439 | |
|COCHRAN-ARMITAGE | P<0.001N** | |
|FISHER EXACT | P=0.124N P=0.270N P<0.001N** | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/60 (10%) 6/44 (14%) 5/74 (7%) 1/60 (2%) | 4/60 (7%) 1/44 (2%) 2/75 (3%) 1/59 (2%) |
|ADJUSTED (b) | 13.2% 34.9% 27.4% 33.3% | 8.0% 4.0% 33.3% 4.0% |
|TERMINAL (d) | 5/44 (11%) 1/8 (13%) 0/0 0/0 | 2/45 (4%) 0/15 (0%) 2/6 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | 645 578 538 592 | 543 616 648 (T) 436 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.011 * P<0.001 ** P=0.024 * | P=0.094 P=0.514N P=0.235 P=0.472 |
|INCIDENTAL TUMOR | P=0.362N P=0.277 P=0.321 P=0.638 | P=0.484N P=0.166N P=0.715 P=0.124N |
|LOGISTIC REGRESSION | P=0.450 P=0.161 P=0.283 P=0.474 | P=0.589 P=0.288N P=0.497 P=0.410N |
|COCHRAN-ARMITAGE | P=0.025N* | P=0.136N |
|FISHER EXACT | P=0.392 P=0.356N P=0.057N | P=0.293N P=0.241N P=0.187N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 27
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/44 (2%) 2/74 (3%) 1/60 (2%) | 1/60 (2%) 0/44 (0%) 1/75 (1%) 0/59 (0%) |
|ADJUSTED (b) | 0.0% 8.3% 50.7% 8.3% | 1.9% 0.0% 11.1% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 638 358 560 | 599 --- 616 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.010 ** P=0.223 P=0.044 * P=0.201 | P=0.531 P=0.620N P=0.356 P=0.954N |
|INCIDENTAL TUMOR | P=0.517 P=0.741 P=0.600 P=0.638 | P=0.426N P=0.391N P=0.649N P=0.500N |
|LOGISTIC REGRESSION | P=0.363 P=0.305 P=0.381 P=0.479 | P=0.755 P=0.536N P=0.619 P=0.820N |
|COCHRAN-ARMITAGE | P=0.391 | P=0.384N |
|FISHER EXACT | P=0.423 P=0.303 P=0.500 | P=0.577N P=0.693N P=0.504N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/60 (10%) 7/44 (16%) 7/74 (9%) 2/60 (3%) | 5/60 (8%) 1/44 (2%) 3/75 (4%) 1/59 (2%) |
|ADJUSTED (b) | 13.2% 40.3% 64.2% 38.9% | 9.8% 4.0% 40.7% 4.0% |
|TERMINAL (d) | 5/44 (11%) 1/8 (13%) 0/0 0/0 | 2/45 (4%) 0/15 (0%) 2/6 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | 645 578 358 560 | 543 616 616 436 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.003 ** P<0.001 ** P=0.002 ** | P=0.066 P=0.388N P=0.094 P=0.518 |
|INCIDENTAL TUMOR | P=0.454N P=0.227 P=0.221 P=0.399 | P=0.336N P=0.072N P=0.602N P=0.061N |
|LOGISTIC REGRESSION | P=0.389 P=0.075 P=0.288 P=0.254 | P=0.580 P=0.176N P=0.369 P=0.276N |
|COCHRAN-ARMITAGE | P=0.064N | P=0.091N |
|FISHER EXACT | P=0.272 P=0.571N P=0.136N | P=0.191N P=0.243N P=0.107N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 28
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/44 (2%) 0/74 (0%) 0/60 (0%) | 2/60 (3%) 1/44 (2%) 0/75 (0%) 0/59 (0%) |
|ADJUSTED (b) | 0.0% 5.0% 0.0% 0.0% | 4.4% 6.7% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 2/45 (4%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 606 --- --- | 648 (T) 648 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.748 P=0.314 (e) (e) | P=0.738N P=0.633 P=0.721N (e) |
|INCIDENTAL TUMOR | P=0.518N P=0.741 (e) (e) | P=0.738N P=0.633 P=0.721N (e) |
|LOGISTIC REGRESSION | P=0.802N P=0.432 (e) (e) | P=0.738N P=0.633 P=0.721N (e) |
|COCHRAN-ARMITAGE | P=0.530N | P=0.082N |
|FISHER EXACT | P=0.423 (e) (e) | P=0.616N P=0.196N P=0.252N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/44 (2%) 0/74 (0%) 1/60 (2%) | 2/60 (3%) 1/44 (2%) 1/75 (1%) 1/59 (2%) |
|ADJUSTED (b) | 0.0% 5.0% 0.0% 20.0% | 4.4% 6.7% 9.1% 14.3% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 2/45 (4%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 606 --- 585 | 648 (T) 648 (T) 597 563 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.012 * P=0.314 (e) P=0.070 | P=0.036 * P=0.633 P=0.437 P=0.108 |
|INCIDENTAL TUMOR | P=0.445 P=0.741 (e) P=0.638 | P=0.249 P=0.633 P=0.704 P=0.500 |
|LOGISTIC REGRESSION | P=0.165 P=0.432 (e) P=0.360 | P=0.207 P=0.633 P=0.615 P=0.501 |
|COCHRAN-ARMITAGE | P=0.435 | P=0.368N |
|FISHER EXACT | P=0.423 (e) P=0.500 | P=0.616N P=0.416N P=0.506N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 29
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/45 (2%) 0/75 (0%) 1/60 (2%) | 0/60 (0%) 0/45 (0%) 2/75 (3%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 4.2% 0.0% 1.9% | 0.0% 0.0% 5.6% 10.3% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 602 --- 401 | --- --- 423 431 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.145 P=0.342 (e) P=0.479 | P=0.010 * (e) P=0.142 P=0.055 |
|INCIDENTAL TUMOR | P=0.636 P=0.741 (e) P=0.912 | P=0.360 (e) P=0.744 P=0.730 |
|LOGISTIC REGRESSION | P=0.535 P=0.441 (e) P=0.631 | P=0.176 (e) P=0.497 P=0.429 |
|COCHRAN-ARMITAGE | P=0.433 | P=0.094 |
|FISHER EXACT | P=0.429 (e) P=0.500 | (e) P=0.307 P=0.248 |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 4/45 (9%) 5/75 (7%) 8/60 (13%) | 1/60 (2%) 2/45 (4%) 2/75 (3%) 4/60 (7%) |
|ADJUSTED (b) | 2.3% 22.8% 26.2% 100.0% | 2.2% 12.5% 5.6% 66.4% |
|TERMINAL (d) | 1/44 (2%) 1/8 (13%) 0/0 0/0 | 1/45 (2%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) 485 333 401 | 648 (T) 644 423 431 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.010 ** P=0.002 ** P<0.001 ** | P<0.001 ** P=0.161 P=0.209 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.028 * P=0.133 P=0.335 P=0.122 | P=0.077 P=0.318 P=0.771 P=0.187 |
|LOGISTIC REGRESSION | P=0.015 * P=0.103 P=0.185 P=0.027 * | P=0.011 * P=0.178 P=0.677 P=0.012 * |
|COCHRAN-ARMITAGE | P=0.020 * | P=0.141 |
|FISHER EXACT | P=0.105 P=0.165 P=0.016 * | P=0.393 P=0.584 P=0.182 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 30
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 3/45 (7%) 5/75 (7%) 7/60 (12%) | 1/60 (2%) 2/45 (4%) 0/75 (0%) 2/60 (3%) |
|ADJUSTED (b) | 2.3% 19.5% 26.2% 100.0% | 2.2% 12.5% 0.0% 62.5% |
|TERMINAL (d) | 1/44 (2%) 1/8 (13%) 0/0 0/0 | 1/45 (2%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 647 (T) 485 333 402 | 648 (T) 644 --- 602 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.033 * P=0.002 ** P<0.001 ** | P<0.001 ** P=0.161 P=0.882N P<0.001 ** |
|INCIDENTAL TUMOR | P=0.026 * P=0.168 P=0.335 P=0.133 | P=0.101 P=0.318 P=0.882N P=0.234 |
|LOGISTIC REGRESSION | P=0.014 * P=0.212 P=0.185 P=0.023 * | P=0.003 ** P=0.178 P=0.882N P=0.008 ** |
|COCHRAN-ARMITAGE | P=0.026 * | P=0.519 |
|FISHER EXACT | P=0.209 P=0.165 P=0.031 * | P=0.393 P=0.444N P=0.500 |
|=================================================================================================================================|
| |
|Uterus |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 0/60 (0%) 3/45 (7%) 1/75 (1%) 2/60 (3%) |
|ADJUSTED (b) | | 0.0% 16.5% 16.7% 57.1% |
|TERMINAL (d) | | 0/45 (0%) 1/15 (7%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | | --- 618 648 (T) 563 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P<0.001 ** P=0.014 * P=0.118 P<0.001 ** |
|INCIDENTAL TUMOR | | P=0.052 P=0.109 P=0.118 P=0.234 |
|LOGISTIC REGRESSION | | P=0.001 ** P=0.029 * P=0.118 P=0.010 ** |
|COCHRAN-ARMITAGE | | P=0.385 |
|FISHER EXACT | | P=0.076 P=0.556 P=0.248 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 31
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 6/60 (10%) 8/45 (18%) 7/75 (9%) 5/60 (8%) |
|ADJUSTED (b) | | 13.3% 30.3% 24.0% 32.5% |
|TERMINAL (d) | | 6/45 (13%) 2/15 (13%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | | 648 (T) 436 424 378 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P<0.001 ** P=0.020 * P=0.009 ** P<0.001 ** |
|INCIDENTAL TUMOR | | P=0.554N P=0.187 P=0.386 P=0.167 |
|LOGISTIC REGRESSION | | P=0.445 P=0.214 P=0.397 P=0.240 |
|COCHRAN-ARMITAGE | | P=0.271N |
|FISHER EXACT | | P=0.192 P=0.561N P=0.500N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 1/60 (2%) 1/45 (2%) 2/75 (3%) 1/60 (2%) |
|ADJUSTED (b) | | 2.2% 6.7% 3.0% 4.5% |
|TERMINAL (d) | | 1/45 (2%) 1/15 (7%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | | 648 (T) 648 (T) 309 450 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.161 P=0.500 P=0.331 P=0.304 |
|INCIDENTAL TUMOR | | P=0.618N P=0.500 P=0.882N P=0.887 |
|LOGISTIC REGRESSION | | P=0.419N P=0.500 P=0.560N P=0.819 |
|COCHRAN-ARMITAGE | | P=0.613N |
|FISHER EXACT | | P=0.676 P=0.584 P=0.752N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 32
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 7/60 (12%) 9/45 (20%) 9/75 (12%) 6/60 (10%) |
|ADJUSTED (b) | | 15.6% 35.7% 26.3% 35.6% |
|TERMINAL (d) | | 7/45 (16%) 3/15 (20%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | | 648 (T) 436 309 378 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P<0.001 ** P=0.012 * P=0.004 ** P<0.001 ** |
|INCIDENTAL TUMOR | | P=0.527N P=0.126 P=0.424 P=0.149 |
|LOGISTIC REGRESSION | | P=0.567 P=0.170 P=0.576 P=0.218 |
|COCHRAN-ARMITAGE | | P=0.285N |
|FISHER EXACT | | P=0.183 P=0.585 P=0.500N |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 4/45 (9%) 11/75 (15%) 9/60 (15%) | 0/60 (0%) 3/45 (7%) 4/75 (5%) 3/60 (5%) |
|ADJUSTED (b) | 0.0% 18.9% 100.0% 62.5% | 0.0% 11.2% 14.4% 26.7% |
|TERMINAL (d) | 0/44 (0%) 1/8 (13%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 353 391 445 | --- 424 424 424 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** | P<0.001 ** P=0.036 * P=0.010 ** P=0.005 ** |
|INCIDENTAL TUMOR | P=0.069 P=0.081 P=0.163 P=0.081 | P=0.408 P=0.267 P=0.277 P=0.366 |
|LOGISTIC REGRESSION | P=0.006 ** P=0.049 * P=0.004 ** P<0.001 ** | P=0.368 P=0.150 P=0.090 P=0.071 |
|COCHRAN-ARMITAGE | P=0.005 ** | P=0.195 |
|FISHER EXACT | P=0.031 * P=0.001 ** P=0.001 ** | P=0.076 P=0.092 P=0.122 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 33
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 7/45 (16%) 14/75 (19%) 21/60 (35%) | 1/60 (2%) 10/45 (22%) 17/75 (23%) 13/60 (22%) |
|ADJUSTED (b) | 0.0% 20.1% 67.3% 100.0% | 1.7% 28.4% 53.8% 51.2% |
|TERMINAL (d) | 0/44 (0%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 262 304 284 | 402 424 274 262 |
|-----------------------| | |
|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=0.019 * P=0.063 P=0.128 P=0.017 * | P=0.422 P=0.061 P=0.041 * P=0.488 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.006 ** P=0.004 ** P<0.001 ** | P=0.489 P=0.014 * P=0.011 * P=0.145 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.007 ** |
|FISHER EXACT | P=0.002 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 10/45 (22%) 25/75 (33%) 30/60 (50%) | 1/60 (2%) 12/45 (27%) 21/75 (28%) 16/60 (27%) |
|ADJUSTED (b) | 0.0% 33.7% 100.0% 100.0% | 1.7% 33.4% 60.5% 64.5% |
|TERMINAL (d) | 0/44 (0%) 1/8 (13%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 1/6 (17%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 262 304 284 | 402 424 274 262 |
|-----------------------| | |
|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=0.008 ** P=0.025 * P<0.001 ** | P=0.296 P=0.028 * P=0.012 * P=0.250 |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.354 P=0.005 ** P=0.001 ** P=0.019 * |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.002 ** |
|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: 05172 TEST: 01 PAGE 34
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 19/60 (32%) 17/45 (38%) 17/75 (23%) 4/60 (7%) | 21/60 (35%) 15/45 (33%) 12/75 (16%) 4/60 (7%) |
|ADJUSTED (b) | 38.6% 73.9% 83.2% 15.1% | 39.0% 57.6% 68.4% 58.6% |
|TERMINAL (d) | 14/44 (32%) 4/8 (50%) 0/0 0/0 | 13/45 (29%) 6/15 (40%) 3/6 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 505 515 483 486 | 532 562 419 430 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P=0.033 * | P<0.001 ** P=0.052 P=0.003 ** P=0.019 * |
|INCIDENTAL TUMOR | P=0.043N* P=0.096 P=0.326 P=0.194N | P=0.089N P=0.460N P=0.286N P=0.010N** |
|LOGISTIC REGRESSION | P=0.206N P=0.108 P=0.199 P=0.303N | P=0.128N P=0.488N P=0.311N P=0.045N* |
|COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** |
|FISHER EXACT | P=0.327 P=0.164N P<0.001N** | P=0.513N P=0.009N** P<0.001N** |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 1/45 (2%) 7/75 (9%) 6/60 (10%) | 0/60 (0%) 0/45 (0%) 0/75 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.0% 2.5% 15.4% 43.8% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/44 (2%) 0/8 (0%) 0/0 0/0 | 0/45 (0%) 0/15 (0%) 0/6 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 529 483 339 401 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.720 P=0.016 * P=0.001 ** | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.415 P=0.540N P=0.690 P=0.648 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.148 P=0.545N P=0.297 P=0.226 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.053 | (e) |
|FISHER EXACT | P=0.607N P=0.149 P=0.136 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 35
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 57/60 (95%) 43/45 (96%) 70/75 (93%) 53/60 (88%) | 35/60 (58%) 30/45 (67%) 32/75 (43%) 34/60 (57%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 66.9% 89.8% 90.7% 100.0% |
|TERMINAL (d) | 44/44 (100%) 8/8 (100%) 0/0 0/0 | 28/45 (62%) 12/15 (80%) 4/6 (67%) 0/0 |
|FIRST INCIDENCE (DAYS) | 529 353 333 332 | 532 424 333 262 |
|-----------------------| | |
|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=0.191 P=0.094 P=0.026 * P=0.029 * | P=0.028 * P=0.110 P=0.447 P=0.086 |
|LOGISTIC REGRESSION | P=0.105 P=0.050 * P=0.006 ** P=0.003 ** | P=0.003 ** P=0.132 P=0.210 P=0.012 * |
|COCHRAN-ARMITAGE | P=0.080N | P=0.264N |
|FISHER EXACT | P=0.635 P=0.489N P=0.161N | P=0.253 P=0.051N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 27/60 (45%) 36/45 (80%) 66/75 (88%) 59/60 (98%) | 27/60 (45%) 33/45 (73%) 68/75 (91%) 56/60 (93%) |
|ADJUSTED (b) | 48.8% 94.1% 97.6% 100.0% | 47.7% 83.9% 96.5% 100.0% |
|TERMINAL (d) | 16/44 (36%) 6/8 (75%) 0/0 0/0 | 16/45 (36%) 9/15 (60%) 4/6 (67%) 0/0 |
|FIRST INCIDENCE (DAYS) | 452 262 284 267 | 402 373 220 262 |
|-----------------------| | |
|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=0.018 * P=0.039 * P<0.001 ** | P=0.005 ** P=0.064 P=0.027 * P=0.241 |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P=0.052 P<0.001 ** | P=0.002 ** P=0.032 * P=0.054 P=0.386 |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.003 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05172 TEST: 01 PAGE 36
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORID
TERMINAL SACRIFICE AT 93 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 80 PPM 170 PPM 330 PPM | CONTROL 80 PPM 170 PPM 330 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 59/60 (98%) 45/45 (100%) 75/75 (100%) 60/60 (100%)| 48/60 (80%) 43/45 (96%) 73/75 (97%) 57/60 (95%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 81.4% 95.6% 100.0% 100.0% |
|TERMINAL (d) | 44/44 (100%) 8/8 (100%) 0/0 0/0 | 34/45 (76%) 13/15 (87%) 6/6 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 452 262 284 267 | 402 373 220 262 |
|-----------------------| | |
|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=0.120 P=0.282 P=0.186 P=0.128 | P=0.367 P=0.155 P=0.089 P=0.634 |
|LOGISTIC REGRESSION | P=0.120 P=0.282 P=0.186 P=0.128 | P=0.174 P=0.089 P=0.108 P=0.283 |
|COCHRAN-ARMITAGE | P=0.280 | P=0.006 ** |
|FISHER EXACT | P=0.571 P=0.444 P=0.500 | P=0.018 * P=0.001 ** P=0.012 * |
|=================================================================================================================================|
(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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