TDMS Study 05040-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: American Biogenics HYDROQUINONE DATE: 09/05/94
EXPERIMENT: 05040 TEST: 01 TIME: 10:31:31
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: ROUTE: GAVAGE NTP C#: 55834B
PATHOLOGIST: K. SMITH S. EUSTIS CAS: 000123319
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: American Biogenics HYDROQUINONE DATE: 09/05/94
EXPERIMENT: 05040 TEST: 01 TIME: 10:31:31
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: ROUTE: GAVAGE NTP C#: 55834B
PATHOLOGIST: K. SMITH S. EUSTIS CAS: 000123319
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
Larynx
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: American Biogenics HYDROQUINONE DATE: 09/05/94
EXPERIMENT: 05040 TEST: 01 TIME: 10:31:31
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: ROUTE: GAVAGE NTP C#: 55834B
PATHOLOGIST: K. SMITH S. EUSTIS CAS: 000123319
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF HYDROQUINONE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Kidney: Renal Tubule Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Testes Adenoma
All Organs Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Thyroid Gland: C-Cell Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/55 (24%) 17/48 (35%) 19/55 (35%) | 2/54 (4%) 1/55 (2%) 4/54 (7%) |
|ADJUSTED (b) | 39.4% 65.2% 64.7% | 4.9% 2.1% 11.3% |
|TERMINAL (d) | 8/27 (30%) 6/12 (50%) 9/18 (50%) | 1/40 (3%) 0/27 (0%) 3/32 (9%) |
|FIRST INCIDENCE (DAYS) | 616 576 598 | 722 625 652 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.022 * P=0.021 * P=0.024 * | P=0.191 P=0.593N P=0.256 |
|INCIDENTAL TUMOR | P=0.127 P=0.074 P=0.131 | P=0.257 P=0.338N P=0.335 |
|LOGISTIC REGRESSION | P=0.086 P=0.050 P=0.088 | P=0.230 P=0.496N P=0.310 |
|COCHRAN-ARMITAGE | P=0.128 | P=0.238 |
|FISHER EXACT | P=0.137 P=0.147 | P=0.493N P=0.339 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/55 (2%) 2/48 (4%) 3/55 (5%) | 1/54 (2%) 1/55 (2%) 1/54 (2%) |
|ADJUSTED (b) | 3.7% 12.3% 14.0% | 2.5% 3.7% 2.9% |
|TERMINAL (d) | 1/27 (4%) 1/12 (8%) 2/18 (11%) | 1/40 (3%) 1/27 (4%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 718 676 | 729 (T) 729 (T) 714 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.131 P=0.290 P=0.191 | P=0.574 P=0.672 P=0.714 |
|INCIDENTAL TUMOR | P=0.180 P=0.354 P=0.235 | P=0.629 P=0.672 P=0.739N |
|LOGISTIC REGRESSION | P=0.163 P=0.306 P=0.241 | P=0.599 P=0.672 P=0.741 |
|COCHRAN-ARMITAGE | P=0.227 | P=0.640 |
|FISHER EXACT | P=0.449 P=0.309 | P=0.748N P=0.752N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/55 (25%) 19/48 (40%) 21/55 (38%) | 3/54 (6%) 3/55 (5%) 5/54 (9%) |
|ADJUSTED (b) | 42.5% 72.3% 69.7% | 7.3% 9.4% 14.0% |
|TERMINAL (d) | 9/27 (33%) 7/12 (58%) 10/18 (56%) | 2/40 (5%) 2/27 (7%) 3/32 (9%) |
|FIRST INCIDENCE (DAYS) | 616 576 598 | 722 625 652 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.012 * P=0.009 ** P=0.014 * | P=0.207 P=0.502 P=0.259 |
|INCIDENTAL TUMOR | P=0.084 P=0.037 * P=0.087 | P=0.285 P=0.655N P=0.369 |
|LOGISTIC REGRESSION | P=0.055 P=0.024 * P=0.057 | P=0.260 P=0.629 P=0.320 |
|COCHRAN-ARMITAGE | P=0.096 | P=0.283 |
|FISHER EXACT | P=0.093 P=0.110 | P=0.652N P=0.358 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/53 (21%) 8/34 (24%) 7/54 (13%) | 4/51 (8%) 3/24 (13%) 9/52 (17%) |
|ADJUSTED (b) | 38.5% 72.5% 26.5% | 10.1% 100.0% 26.8% |
|TERMINAL (d) | 10/27 (37%) 2/3 (67%) 3/18 (17%) | 3/38 (8%) 1/1 (100%) 8/32 (25%) |
|FIRST INCIDENCE (DAYS) | 616 536 606 | 710 672 669 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.483N P=0.024 * P=0.485N | P=0.054 P=0.111 P=0.066 |
|INCIDENTAL TUMOR | P=0.332N P=0.052 P=0.341N | P=0.068 P=0.254 P=0.082 |
|LOGISTIC REGRESSION | P=0.226N P=0.281 P=0.289N | P=0.072 P=0.061 P=0.089 |
|COCHRAN-ARMITAGE | P=0.179N | P=0.097 |
|FISHER EXACT | P=0.480 P=0.207N | P=0.397 P=0.125 |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/53 (2%) 1/34 (3%) 3/54 (6%) | 0/51 (0%) 0/24 (0%) 0/52 (0%) |
|ADJUSTED (b) | 3.7% 3.2% 9.2% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/3 (0%) 1/18 (6%) | 0/38 (0%) 0/1 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 662 501 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.170 P=0.534 P=0.246 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.186 P=0.613 P=0.233 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.219 P=0.608 P=0.306 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.222 | (e) |
|FISHER EXACT | P=0.632 P=0.316 | (e) (e) |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/53 (21%) 9/34 (26%) 10/54 (19%) | 4/51 (8%) 3/24 (13%) 9/52 (17%) |
|ADJUSTED (b) | 38.5% 73.4% 34.1% | 10.1% 100.0% 26.8% |
|TERMINAL (d) | 10/27 (37%) 2/3 (67%) 4/18 (22%) | 3/38 (8%) 1/1 (100%) 8/32 (25%) |
|FIRST INCIDENCE (DAYS) | 616 536 501 | 710 672 669 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.325 P=0.013 * P=0.402 | P=0.054 P=0.111 P=0.066 |
|INCIDENTAL TUMOR | P=0.472 P=0.032 * P=0.530 | P=0.068 P=0.254 P=0.082 |
|LOGISTIC REGRESSION | P=0.467N P=0.185 P=0.524N | P=0.072 P=0.061 P=0.089 |
|COCHRAN-ARMITAGE | P=0.433N | P=0.097 |
|FISHER EXACT | P=0.357 P=0.481N | P=0.397 P=0.125 |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/55 (4%) 0/38 (0%) 1/55 (2%) | 0/55 (0%) 0/28 (0%) 0/55 (0%) |
|ADJUSTED (b) | 6.1% 0.0% 5.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/1 (0%) 1/18 (6%) | 0/40 (0%) 0/0 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 637 --- 731 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.475N P=0.492N P=0.596N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.431N P=0.451N P=0.538N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.398N P=0.383N P=0.520N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.368N | (e) |
|FISHER EXACT | P=0.347N P=0.500N | (e) (e) |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/55 (0%) 4/55 (7%) 8/55 (15%) | 0/55 (0%) 0/55 (0%) 0/55 (0%) |
|ADJUSTED (b) | 0.0% 15.0% 35.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 2/18 (11%) 5/18 (28%) | 0/40 (0%) 0/27 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 392 598 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.042 * P=0.001 ** | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.002 ** P=0.048 * P=0.003 ** | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.003 ** P=0.069 P=0.003 ** | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.003 ** | (e) |
|FISHER EXACT | P=0.059 P=0.003 ** | (e) (e) |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/55 (5%) 2/55 (4%) 2/55 (4%) | 0/55 (0%) 0/55 (0%) 0/55 (0%) |
|ADJUSTED (b) | 10.2% 11.1% 10.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/27 (7%) 2/18 (11%) 1/18 (6%) | 0/40 (0%) 0/27 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 710 731 (T) 718 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.585N P=0.673N P=0.670N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.489N P=0.618N P=0.533N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.548N P=0.626N P=0.624N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.407N | (e) |
|FISHER EXACT | P=0.500N P=0.500N | (e) (e) |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/55 (2%) 0/55 (0%) 0/55 (0%) | 0/55 (0%) 2/55 (4%) 0/55 (0%) |
|ADJUSTED (b) | 3.7% 0.0% 0.0% | 0.0% 7.4% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/18 (0%) 0/18 (0%) | 0/40 (0%) 2/27 (7%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) --- --- | --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.334N P=0.581N P=0.581N | P=0.612 P=0.157 (e) |
|INCIDENTAL TUMOR | P=0.334N P=0.581N P=0.581N | P=0.612 P=0.157 (e) |
|LOGISTIC REGRESSION | P=0.334N P=0.581N P=0.581N | P=0.612 P=0.157 (e) |
|COCHRAN-ARMITAGE | P=0.270N | P=0.668 |
|FISHER EXACT | P=0.500N P=0.500N | P=0.248 (e) |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/55 (2%) 0/55 (0%) 0/55 (0%) | 3/55 (5%) 0/55 (0%) 1/55 (2%) |
|ADJUSTED (b) | 3.7% 0.0% 0.0% | 6.8% 0.0% 3.1% |
|TERMINAL (d) | 1/27 (4%) 0/18 (0%) 0/18 (0%) | 1/40 (3%) 0/27 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 731 (T) --- --- | 646 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.334N P=0.581N P=0.581N | P=0.228N P=0.175N P=0.371N |
|INCIDENTAL TUMOR | P=0.334N P=0.581N P=0.581N | P=0.158N P=0.070N P=0.266N |
|LOGISTIC REGRESSION | P=0.334N P=0.581N P=0.581N | P=0.183N P=0.123N P=0.312N |
|COCHRAN-ARMITAGE | P=0.270N | P=0.176N |
|FISHER EXACT | P=0.500N P=0.500N | P=0.122N P=0.309N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/55 (4%) 0/55 (0%) 0/55 (0%) | 3/55 (5%) 2/55 (4%) 1/55 (2%) |
|ADJUSTED (b) | 7.4% 0.0% 0.0% | 6.8% 7.4% 3.1% |
|TERMINAL (d) | 2/27 (7%) 0/18 (0%) 0/18 (0%) | 1/40 (3%) 2/27 (7%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 731 (T) --- --- | 646 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.149N P=0.331N P=0.331N | P=0.297N P=0.641N P=0.371N |
|INCIDENTAL TUMOR | P=0.149N P=0.331N P=0.331N | P=0.235N P=0.494N P=0.266N |
|LOGISTIC REGRESSION | P=0.149N P=0.331N P=0.331N | P=0.240N P=0.534N P=0.312N |
|COCHRAN-ARMITAGE | P=0.096N | P=0.222N |
|FISHER EXACT | P=0.248N P=0.248N | P=0.500N P=0.309N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/55 (5%) 0/55 (0%) 0/55 (0%) | 29/55 (53%) 22/55 (40%) 22/55 (40%) |
|ADJUSTED (b) | 11.1% 0.0% 0.0% | 61.2% 54.9% 55.0% |
|TERMINAL (d) | 3/27 (11%) 0/18 (0%) 0/18 (0%) | 22/40 (55%) 10/27 (37%) 15/32 (47%) |
|FIRST INCIDENCE (DAYS) | 731 (T) --- --- | 500 595 588 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.072N P=0.199N P=0.199N | P=0.377N P=0.519 P=0.397N |
|INCIDENTAL TUMOR | P=0.072N P=0.199N P=0.199N | P=0.116N P=0.128N P=0.167N |
|LOGISTIC REGRESSION | P=0.072N P=0.199N P=0.199N | P=0.121N P=0.161N P=0.138N |
|COCHRAN-ARMITAGE | P=0.037N* | P=0.106N |
|FISHER EXACT | P=0.122N P=0.122N | P=0.126N P=0.126N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/55 (7%) 0/55 (0%) 0/55 (0%) | 29/55 (53%) 23/55 (42%) 22/55 (40%) |
|ADJUSTED (b) | 14.8% 0.0% 0.0% | 61.2% 57.5% 55.0% |
|TERMINAL (d) | 4/27 (15%) 0/18 (0%) 0/18 (0%) | 22/40 (55%) 11/27 (41%) 15/32 (47%) |
|FIRST INCIDENCE (DAYS) | 731 (T) --- --- | 500 595 588 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.036N* P=0.122N P=0.122N | P=0.382N P=0.439 P=0.397N |
|INCIDENTAL TUMOR | P=0.036N* P=0.122N P=0.122N | P=0.119N P=0.184N P=0.167N |
|LOGISTIC REGRESSION | P=0.036N* P=0.122N P=0.122N | P=0.122N P=0.217N P=0.138N |
|COCHRAN-ARMITAGE | P=0.015N* | P=0.106N |
|FISHER EXACT | P=0.059N P=0.059N | P=0.170N P=0.126N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 5/55 (9%) 0/55 (0%) 0/55 (0%) | 30/55 (55%) 23/55 (42%) 22/55 (40%) |
|ADJUSTED (b) | 18.5% 0.0% 0.0% | 62.1% 57.5% 55.0% |
|TERMINAL (d) | 5/27 (19%) 0/18 (0%) 0/18 (0%) | 22/40 (55%) 11/27 (41%) 15/32 (47%) |
|FIRST INCIDENCE (DAYS) | 731 (T) --- --- | 500 595 588 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.018N* P=0.075N P=0.075N | P=0.326N P=0.496 P=0.339N |
|INCIDENTAL TUMOR | P=0.018N* P=0.075N P=0.075N | P=0.081N P=0.123N P=0.115N |
|LOGISTIC REGRESSION | P=0.018N* P=0.075N P=0.075N | P=0.087N P=0.165N P=0.100N |
|COCHRAN-ARMITAGE | P=0.006N** | P=0.075N |
|FISHER EXACT | P=0.028N* P=0.028N* | P=0.126N P=0.091N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/54 (24%) 9/54 (17%) 5/54 (9%) | 23/54 (43%) 21/54 (39%) 16/54 (30%) |
|ADJUSTED (b) | 35.5% 35.2% 18.7% | 50.4% 54.7% 44.5% |
|TERMINAL (d) | 6/27 (22%) 3/17 (18%) 1/18 (6%) | 17/39 (44%) 11/27 (41%) 13/32 (41%) |
|FIRST INCIDENCE (DAYS) | 459 466 598 | 476 492 492 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.125N P=0.538N P=0.127N | P=0.295N P=0.272 P=0.300N |
|INCIDENTAL TUMOR | P=0.022N* P=0.258N P=0.028N* | P=0.182N P=0.492N P=0.259N |
|LOGISTIC REGRESSION | P=0.031N* P=0.303N P=0.038N* | P=0.108N P=0.456N P=0.126N |
|COCHRAN-ARMITAGE | P=0.026N* | P=0.098N |
|FISHER EXACT | P=0.237N P=0.034N* | P=0.422N P=0.115N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/54 (24%) 10/54 (19%) 5/54 (9%) | 24/54 (44%) 22/54 (41%) 16/54 (30%) |
|ADJUSTED (b) | 35.5% 37.0% 18.7% | 52.6% 56.2% 44.5% |
|TERMINAL (d) | 6/27 (22%) 3/17 (18%) 1/18 (6%) | 18/39 (46%) 11/27 (41%) 13/32 (41%) |
|FIRST INCIDENCE (DAYS) | 459 466 598 | 476 492 492 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.130N P=0.548 P=0.127N | P=0.247N P=0.256 P=0.242N |
|INCIDENTAL TUMOR | P=0.022N* P=0.340N P=0.028N* | P=0.133N P=0.482N P=0.203N |
|LOGISTIC REGRESSION | P=0.033N* P=0.392N P=0.038N* | P=0.077N P=0.463N P=0.090N |
|COCHRAN-ARMITAGE | P=0.028N* | P=0.069N |
|FISHER EXACT | P=0.319N P=0.034N* | P=0.423N P=0.081N |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/55 (0%) 0/55 (0%) 2/55 (4%) | 0/55 (0%) 1/55 (2%) 0/55 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 10.1% | 0.0% 1.8% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/18 (0%) 1/18 (6%) | 0/40 (0%) 0/27 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 718 | --- 373 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.066 (e) P=0.161 | P=0.730 P=0.504 (e) |
|INCIDENTAL TUMOR | P=0.095 (e) P=0.238 | P=0.656 P=0.500 (e) |
|LOGISTIC REGRESSION | P=0.070 (e) P=0.175 | P=0.679N P=0.493 (e) |
|COCHRAN-ARMITAGE | P=0.096 | P=0.730 |
|FISHER EXACT | (e) P=0.248 | P=0.500 (e) |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/55 (4%) 0/55 (0%) 2/55 (4%) | 0/55 (0%) 1/55 (2%) 2/55 (4%) |
|ADJUSTED (b) | 5.8% 0.0% 7.7% | 0.0% 3.7% 6.3% |
|TERMINAL (d) | 1/27 (4%) 0/18 (0%) 1/18 (6%) | 0/40 (0%) 1/27 (4%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 567 --- 606 | --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.559 P=0.289N P=0.628 | P=0.116 P=0.422 P=0.191 |
|INCIDENTAL TUMOR | P=0.609N P=0.270N P=0.685N | P=0.116 P=0.422 P=0.191 |
|LOGISTIC REGRESSION | P=0.621 P=0.236N P=0.695 | P=0.116 P=0.422 P=0.189 |
|COCHRAN-ARMITAGE | P=0.622N | P=0.142 |
|FISHER EXACT | P=0.248N P=0.691N | P=0.500 P=0.248 |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/55 (4%) 0/55 (0%) 4/55 (7%) | 0/55 (0%) 2/55 (4%) 2/55 (4%) |
|ADJUSTED (b) | 5.8% 0.0% 17.2% | 0.0% 5.5% 6.3% |
|TERMINAL (d) | 1/27 (4%) 0/18 (0%) 2/18 (11%) | 0/40 (0%) 1/27 (4%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 567 --- 606 | --- 373 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.158 P=0.289N P=0.234 | P=0.148 P=0.199 P=0.191 |
|INCIDENTAL TUMOR | P=0.231 P=0.270N P=0.349 | P=0.118 P=0.197 P=0.191 |
|LOGISTIC REGRESSION | P=0.219 P=0.236N P=0.332 | P=0.180 P=0.262 P=0.189 |
|COCHRAN-ARMITAGE | P=0.222 | P=0.176 |
|FISHER EXACT | P=0.248N P=0.339 | P=0.248 P=0.248 |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/55 (4%) 2/55 (4%) 0/55 (0%) | 0/55 (0%) 0/55 (0%) 1/55 (2%) |
|ADJUSTED (b) | 4.4% 8.0% 0.0% | 0.0% 0.0% 2.9% |
|TERMINAL (d) | 0/27 (0%) 1/18 (6%) 0/18 (0%) | 0/40 (0%) 0/27 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 596 625 --- | --- --- 711 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.202N P=0.643 P=0.233N | P=0.255 (e) P=0.468 |
|INCIDENTAL TUMOR | P=0.123N P=0.697 P=0.135N | P=0.308 (e) P=0.588 |
|LOGISTIC REGRESSION | P=0.175N P=0.689N P=0.250N | P=0.265 (e) P=0.492 |
|COCHRAN-ARMITAGE | P=0.176N | P=0.270 |
|FISHER EXACT | P=0.691N P=0.248N | (e) P=0.500 |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 46/54 (85%) 49/54 (91%) 49/55 (89%) | |
|ADJUSTED (b) | 97.8% 100.0% 100.0% | |
|TERMINAL (d) | 26/27 (96%) 17/17 (100%) 18/18 (100%) | |
|FIRST INCIDENCE (DAYS) | 483 392 522 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.025 * P=0.015 * P=0.028 * | |
|INCIDENTAL TUMOR | P=0.301 P=0.048 * P=0.418 | |
|LOGISTIC REGRESSION | P=0.422 P=0.061 P=0.489 | |
|COCHRAN-ARMITAGE | P=0.315 | |
|FISHER EXACT | P=0.278 P=0.374 | |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/55 (9%) 2/38 (5%) 3/55 (5%) | 9/55 (16%) 3/54 (6%) 5/55 (9%) |
|ADJUSTED (b) | 16.9% 100.0% 10.6% | 21.2% 10.0% 13.9% |
|TERMINAL (d) | 4/27 (15%) 1/1 (100%) 1/18 (6%) | 7/40 (18%) 2/27 (7%) 3/32 (9%) |
|FIRST INCIDENCE (DAYS) | 637 540 581 | 674 700 676 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.458N P=0.326 P=0.510N | P=0.245N P=0.187N P=0.322N |
|INCIDENTAL TUMOR | P=0.412N P=0.376 P=0.398N | P=0.161N P=0.099N P=0.212N |
|LOGISTIC REGRESSION | P=0.303N P=0.559N P=0.377N | P=0.172N P=0.110N P=0.230N |
|COCHRAN-ARMITAGE | P=0.284N | P=0.137N |
|FISHER EXACT | P=0.396N P=0.358N | P=0.066N P=0.196N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/55 (4%) 2/38 (5%) 3/55 (5%) | 4/55 (7%) 1/54 (2%) 3/55 (5%) |
|ADJUSTED (b) | 6.3% 5.5% 14.4% | 9.4% 3.1% 9.4% |
|TERMINAL (d) | 1/27 (4%) 0/1 (0%) 2/18 (11%) | 3/40 (8%) 0/27 (0%) 3/32 (9%) |
|FIRST INCIDENCE (DAYS) | 676 610 700 | 647 709 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.296 P=0.462 P=0.356 | P=0.511N P=0.285N P=0.606N |
|INCIDENTAL TUMOR | P=0.412 P=0.603 P=0.467 | P=0.453N P=0.177N P=0.570N |
|LOGISTIC REGRESSION | P=0.388 P=0.486 P=0.434 | P=0.448N P=0.207N P=0.536N |
|COCHRAN-ARMITAGE | P=0.411 | P=0.412N |
|FISHER EXACT | P=0.542 P=0.500 | P=0.187N P=0.500N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/55 (13%) 4/38 (11%) 6/55 (11%) | 13/55 (24%) 4/54 (7%) 8/55 (15%) |
|ADJUSTED (b) | 22.7% 100.0% 24.0% | 29.9% 12.8% 22.8% |
|TERMINAL (d) | 5/27 (19%) 1/1 (100%) 3/18 (17%) | 10/40 (25%) 2/27 (7%) 6/32 (19%) |
|FIRST INCIDENCE (DAYS) | 637 540 581 | 647 700 676 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.448 P=0.213 P=0.515 | P=0.244N P=0.089N P=0.320N |
|INCIDENTAL TUMOR | P=0.546N P=0.325 P=0.559N | P=0.147N P=0.027N* P=0.207N |
|LOGISTIC REGRESSION | P=0.470N P=0.590 P=0.550N | P=0.153N P=0.034N* P=0.205N |
|COCHRAN-ARMITAGE | P=0.441N | P=0.116N |
|FISHER EXACT | P=0.508N P=0.500N | P=0.018N* P=0.166N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/55 (4%) 0/38 (0%) 0/55 (0%) | 1/55 (2%) 1/54 (2%) 0/55 (0%) |
|ADJUSTED (b) | 6.8% 0.0% 0.0% | 2.2% 2.6% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/1 (0%) 0/18 (0%) | 0/40 (0%) 0/27 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 715 --- --- | 685 668 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.178N P=0.529N P=0.331N | P=0.359N P=0.717 P=0.523N |
|INCIDENTAL TUMOR | P=0.125N P=0.413N P=0.232N | P=0.237N P=0.630N P=0.412N |
|LOGISTIC REGRESSION | P=0.163N P=0.561N P=0.291N | P=0.329N P=0.762N P=0.498N |
|COCHRAN-ARMITAGE | P=0.108N | P=0.332N |
|FISHER EXACT | P=0.347N P=0.248N | P=0.748 P=0.500N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/55 (5%) 0/38 (0%) 1/55 (2%) | 1/55 (2%) 2/54 (4%) 0/55 (0%) |
|ADJUSTED (b) | 10.4% 0.0% 3.2% | 2.2% 6.2% 0.0% |
|TERMINAL (d) | 2/27 (7%) 0/1 (0%) 0/18 (0%) | 0/40 (0%) 1/27 (4%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 715 --- 676 | 685 668 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.305N P=0.502N P=0.435N | P=0.406N P=0.411 P=0.523N |
|INCIDENTAL TUMOR | P=0.215N P=0.392N P=0.298N | P=0.309N P=0.588 P=0.412N |
|LOGISTIC REGRESSION | P=0.247N P=0.458N P=0.353N | P=0.363N P=0.487 P=0.498N |
|COCHRAN-ARMITAGE | P=0.189N | P=0.361N |
|FISHER EXACT | P=0.202N P=0.309N | P=0.493 P=0.500N |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 12/55 (22%) 6/55 (11%) 9/55 (16%) |
|ADJUSTED (b) | | 27.4% 15.9% 23.3% |
|TERMINAL (d) | | 9/40 (23%) 2/27 (7%) 5/32 (16%) |
|FIRST INCIDENCE (DAYS) | | 647 625 597 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.407N P=0.270N P=0.479N |
|INCIDENTAL TUMOR | | P=0.204N P=0.070N P=0.266N |
|LOGISTIC REGRESSION | | P=0.271N P=0.114N P=0.331N |
|COCHRAN-ARMITAGE | | P=0.260N |
|FISHER EXACT | | P=0.098N P=0.314N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 13/55 (24%) 7/55 (13%) 9/55 (16%) |
|ADJUSTED (b) | | 28.8% 17.4% 23.3% |
|TERMINAL (d) | | 9/40 (23%) 2/27 (7%) 5/32 (16%) |
|FIRST INCIDENCE (DAYS) | | 501 487 597 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.324N P=0.283N P=0.390N |
|INCIDENTAL TUMOR | | P=0.171N P=0.082N P=0.221N |
|LOGISTIC REGRESSION | | P=0.187N P=0.099N P=0.240N |
|COCHRAN-ARMITAGE | | P=0.190N |
|FISHER EXACT | | P=0.108N P=0.238N |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/55 (2%) 3/55 (5%) 1/55 (2%) | 0/55 (0%) 0/55 (0%) 1/55 (2%) |
|ADJUSTED (b) | 2.6% 12.2% 1.9% | 0.0% 0.0% 2.0% |
|TERMINAL (d) | 0/27 (0%) 1/18 (6%) 0/18 (0%) | 0/40 (0%) 0/27 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 654 653 473 | --- --- 590 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.543 P=0.232 P=0.758 | P=0.276 (e) P=0.508 |
|INCIDENTAL TUMOR | P=0.595N P=0.355 P=0.741 | P=0.366 (e) P=0.718 |
|LOGISTIC REGRESSION | P=0.610 P=0.276 P=0.736 | P=0.274 (e) P=0.514 |
|COCHRAN-ARMITAGE | P=0.610 | P=0.270 |
|FISHER EXACT | P=0.309 P=0.752N | (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/55 (2%) 4/55 (7%) 1/55 (2%) | 0/55 (0%) 0/55 (0%) 1/55 (2%) |
|ADJUSTED (b) | 2.6% 16.4% 1.9% | 0.0% 0.0% 2.0% |
|TERMINAL (d) | 0/27 (0%) 1/18 (6%) 0/18 (0%) | 0/40 (0%) 0/27 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 654 653 473 | --- --- 590 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.505 P=0.117 P=0.758 | P=0.276 (e) P=0.508 |
|INCIDENTAL TUMOR | P=0.559N P=0.231 P=0.741 | P=0.366 (e) P=0.718 |
|LOGISTIC REGRESSION | P=0.600 P=0.149 P=0.736 | P=0.274 (e) P=0.514 |
|COCHRAN-ARMITAGE | P=0.601 | P=0.270 |
|FISHER EXACT | P=0.182 P=0.752N | (e) P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/55 (4%) 1/55 (2%) 1/55 (2%) | 0/55 (0%) 0/55 (0%) 0/55 (0%) |
|ADJUSTED (b) | 4.2% 2.4% 2.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/18 (0%) 0/18 (0%) | 0/40 (0%) 0/27 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 459 610 554 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.370N P=0.512N P=0.486N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.300N P=0.454N P=0.465N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.388N P=0.430N P=0.571N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.378N | (e) |
|FISHER EXACT | P=0.500N P=0.500N | (e) (e) |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 28/55 (51%) 26/55 (47%) 31/55 (56%) | 9/55 (16%) 15/55 (27%) 22/55 (40%) |
|ADJUSTED (b) | 71.6% 67.3% 79.9% | 19.4% 37.9% 49.6% |
|TERMINAL (d) | 17/27 (63%) 7/18 (39%) 12/18 (67%) | 4/40 (10%) 6/27 (22%) 11/32 (34%) |
|FIRST INCIDENCE (DAYS) | 367 263 522 | 553 576 492 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.083 P=0.263 P=0.086 | P=0.003 ** P=0.048 * P=0.003 ** |
|INCIDENTAL TUMOR | P=0.317 P=0.497N P=0.221 | P=0.010 * P=0.362 P=0.016 * |
|LOGISTIC REGRESSION | P=0.314 P=0.488N P=0.350 | P=0.009 ** P=0.293 P=0.006 ** |
|COCHRAN-ARMITAGE | P=0.317 | P=0.004 ** |
|FISHER EXACT | P=0.424N P=0.351 | P=0.124 P=0.005 ** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/55 (4%) 1/55 (2%) 1/55 (2%) | 0/55 (0%) 0/55 (0%) 0/55 (0%) |
|ADJUSTED (b) | 4.2% 2.4% 2.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/18 (0%) 0/18 (0%) | 0/40 (0%) 0/27 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 459 610 554 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.370N P=0.512N P=0.486N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.300N P=0.454N P=0.465N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.388N P=0.430N P=0.571N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.378N | (e) |
|FISHER EXACT | P=0.500N P=0.500N | (e) (e) |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/55 (2%) 3/55 (5%) 1/55 (2%) | 0/55 (0%) 0/55 (0%) 0/55 (0%) |
|ADJUSTED (b) | 3.7% 10.2% 5.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 1/18 (6%) 1/18 (6%) | 0/40 (0%) 0/27 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 392 731 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.514 P=0.227 P=0.669 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.505 P=0.277 P=0.669 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.610 P=0.319 P=0.669 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.610 | (e) |
|FISHER EXACT | P=0.309 P=0.752N | (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 50/55 (91%) 50/55 (91%) 52/55 (95%) | 44/55 (80%) 41/55 (75%) 42/55 (76%) |
|ADJUSTED (b) | 100.0% 98.0% 100.0% | 83.0% 86.8% 89.1% |
|TERMINAL (d) | 27/27 (100%) 17/18 (94%) 18/18 (100%) | 31/40 (78%) 21/27 (78%) 27/32 (84%) |
|FIRST INCIDENCE (DAYS) | 459 392 522 | 476 373 492 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.037 * P=0.054 P=0.039 * | P=0.214 P=0.098 P=0.239 |
|INCIDENTAL TUMOR | P=0.362 P=0.279 P=0.482 | P=0.459N P=0.338N P=0.514N |
|LOGISTIC REGRESSION | P=0.443 P=0.338 P=0.598 | P=0.394N P=0.377N P=0.438N |
|COCHRAN-ARMITAGE | P=0.298 | P=0.367N |
|FISHER EXACT | P=0.629N P=0.358 | P=0.325N P=0.409N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 25 MG/KG 50 MG/KG | VEHICLE 25 MG/KG 50 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 35/55 (64%) 37/55 (67%) 38/55 (69%) | 18/55 (33%) 24/55 (44%) 32/55 (58%) |
|ADJUSTED (b) | 78.0% 82.7% 88.3% | 36.9% 55.9% 67.1% |
|TERMINAL (d) | 18/27 (67%) 11/18 (61%) 14/18 (78%) | 10/40 (25%) 10/27 (37%) 17/32 (53%) |
|FIRST INCIDENCE (DAYS) | 367 207 473 | 501 444 458 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.077 P=0.090 P=0.087 | P=0.004 ** P=0.041 * P=0.004 ** |
|INCIDENTAL TUMOR | P=0.272 P=0.407 P=0.181 | P=0.008 ** P=0.356 P=0.015 * |
|LOGISTIC REGRESSION | P=0.307 P=0.412 P=0.346 | P=0.008 ** P=0.183 P=0.012 * |
|COCHRAN-ARMITAGE | P=0.307 | P=0.005 ** |
|FISHER EXACT | P=0.421 P=0.343 | P=0.163 P=0.006 ** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 53/55 (96%) 53/55 (96%) 54/55 (98%) | 47/55 (85%) 49/55 (89%) 50/55 (91%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 87.0% 90.7% 96.1% |
|TERMINAL (d) | 27/27 (100%) 18/18 (100%) 18/18 (100%) | 33/40 (83%) 22/27 (81%) 30/32 (94%) |
|FIRST INCIDENCE (DAYS) | 367 207 473 | 476 373 458 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.051 P=0.053 P=0.056 | P=0.061 P=0.021 * P=0.058 |
|INCIDENTAL TUMOR | P=0.367 P=0.445 P=0.414 | P=0.208 P=0.591 P=0.259 |
|LOGISTIC REGRESSION | P=0.485 P=0.431 P=0.713 | P=0.255 P=0.394 P=0.315 |
|COCHRAN-ARMITAGE | P=0.390 | P=0.228 |
|FISHER EXACT | P=0.691N P=0.500 | P=0.388 P=0.278 |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05040 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HYDROQUINONE
TERMINAL SACRIFICE AT 105 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's exact tests compare directly the overall incidence rates.
For all tests, a negative trend is indicated by "N".
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).
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