TR 351 Rat Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus PARA-CHLOROANILINE DATE: 09/03/94
EXPERIMENT: 05020 TEST: 01 TIME: 18:21:36
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1CP9565302 ROUTE: GAVAGE NTP C#: 02039B
PATHOLOGIST: J. TOFT S. EUSTIS CAS: 000106478
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus PARA-CHLOROANILINE DATE: 09/03/94
EXPERIMENT: 05020 TEST: 01 TIME: 18:21:36
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1CP9565302 ROUTE: GAVAGE NTP C#: 02039B
PATHOLOGIST: J. TOFT S. EUSTIS CAS: 000106478
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: Battelle Columbus PARA-CHLOROANILINE DATE: 09/03/94
EXPERIMENT: 05020 TEST: 01 TIME: 18:21:36
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1CP9565302 ROUTE: GAVAGE NTP C#: 02039B
PATHOLOGIST: J. TOFT S. EUSTIS CAS: 000106478
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF PARA-CHLOROANILINE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Spleen Fibroma
Fibrosarcoma
Hemangiosarcoma
Osteosarcoma
Testes Adenoma
Thyroid Gland: Follicular Cell
Carcinoma or Adenoma
All Organs Hemangiosarcoma
Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Osteosarcoma
Osteosarcoma or Osteoma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus PARA-CHLOROANILINE DATE: 09/03/94
EXPERIMENT: 05020 TEST: 01 TIME: 18:21:36
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1CP9565302 ROUTE: GAVAGE NTP C#: 02039B
PATHOLOGIST: J. TOFT S. EUSTIS CAS: 000106478
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF PARA-CHLOROANILINE
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/49 (27%) 14/49 (29%) 14/48 (29%) 25/49 (51%) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 6/50 (12%) |
|ADJUSTED (b) | 53.8% 40.3% 40.7% 79.5% | 6.2% 7.7% 2.8% 16.2% |
|TERMINAL (d) | 8/18 (44%) 11/31 (35%) 12/32 (38%) 15/21 (71%) | 1/27 (4%) 3/39 (8%) 1/36 (3%) 6/37 (16%) |
|FIRST INCIDENCE (DAYS) | 633 651 476 618 | 557 729 (T) 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.158N P=0.134N P=0.061 | P=0.091 P=0.650 P=0.415N P=0.248 |
|INCIDENTAL TUMOR | P=0.002 ** P=0.294N P=0.410N P=0.023 * | P=0.094 P=0.573 P=0.416N P=0.238 |
|LOGISTIC REGRESSION | P=0.003 ** P=0.353N P=0.504N P=0.028 * | P=0.077 P=0.553 P=0.488N P=0.192 |
|COCHRAN-ARMITAGE | P=0.003 ** | P=0.062 |
|FISHER EXACT | P=0.500 P=0.475 P=0.011 * | P=0.500 P=0.500N P=0.134 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/49 (27%) 14/49 (29%) 15/48 (31%) 26/49 (53%) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 6/50 (12%) |
|ADJUSTED (b) | 53.8% 40.3% 43.6% 82.9% | 6.2% 7.7% 2.8% 16.2% |
|TERMINAL (d) | 8/18 (44%) 11/31 (35%) 13/32 (41%) 16/21 (76%) | 1/27 (4%) 3/39 (8%) 1/36 (3%) 6/37 (16%) |
|FIRST INCIDENCE (DAYS) | 633 651 476 618 | 557 729 (T) 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.158N P=0.175N P=0.041 * | P=0.091 P=0.650 P=0.415N P=0.248 |
|INCIDENTAL TUMOR | P<0.001 ** P=0.294N P=0.481N P=0.013 * | P=0.094 P=0.573 P=0.416N P=0.238 |
|LOGISTIC REGRESSION | P=0.001 ** P=0.353N P=0.586N P=0.017 * | P=0.077 P=0.553 P=0.488N P=0.192 |
|COCHRAN-ARMITAGE | P=0.002 ** | P=0.062 |
|FISHER EXACT | P=0.500 P=0.386 P=0.006 ** | P=0.500 P=0.500N P=0.134 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/46 (2%) 7/12 (58%) 4/15 (27%) 2/48 (4%) | 1/45 (2%) 1/5 (20%) 1/11 (9%) 4/48 (8%) |
|ADJUSTED (b) | 6.7% 100.0% 80.0% 10.0% | 4.3% 50.0% 2.3% 10.6% |
|TERMINAL (d) | 1/15 (7%) 2/2 (100%) 4/5 (80%) 2/20 (10%) | 1/23 (4%) 1/2 (50%) 0/1 (0%) 3/35 (9%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 626 729 (T) 729 (T) | 729 (T) 729 (T) 605 616 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.085N P=0.004 ** P=0.004 ** P=0.602 | P=0.352 P=0.183 P=0.554 P=0.309 |
|INCIDENTAL TUMOR | P=0.059N P<0.001 ** P=0.004 ** P=0.602 | P=0.383 P=0.183 P=0.559 P=0.293 |
|LOGISTIC REGRESSION | P=0.057N P<0.001 ** P=0.004 ** P=0.602 | P=0.362 P=0.183 P=0.359 P=0.265 |
|COCHRAN-ARMITAGE | P=0.127N | P=0.265 |
|FISHER EXACT | P<0.001 ** P=0.011 * P=0.516 | P=0.192 P=0.357 P=0.201 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/46 (2%) 7/12 (58%) 4/15 (27%) 3/48 (6%) | 1/45 (2%) 1/5 (20%) 1/11 (9%) 4/48 (8%) |
|ADJUSTED (b) | 6.7% 100.0% 80.0% 12.0% | 4.3% 50.0% 2.3% 10.6% |
|TERMINAL (d) | 1/15 (7%) 2/2 (100%) 4/5 (80%) 2/20 (10%) | 1/23 (4%) 1/2 (50%) 0/1 (0%) 3/35 (9%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 626 729 (T) 535 | 729 (T) 729 (T) 605 616 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.178N P=0.004 ** P=0.004 ** P=0.393 | P=0.352 P=0.183 P=0.554 P=0.309 |
|INCIDENTAL TUMOR | P=0.120N P<0.001 ** P=0.004 ** P=0.406 | P=0.383 P=0.183 P=0.559 P=0.293 |
|LOGISTIC REGRESSION | P=0.130N P<0.001 ** P=0.004 ** P=0.347 | P=0.362 P=0.183 P=0.359 P=0.265 |
|COCHRAN-ARMITAGE | P=0.219N | P=0.265 |
|FISHER EXACT | P<0.001 ** P=0.011 * P=0.325 | P=0.192 P=0.357 P=0.201 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/48 (6%) 0/4 (0%) 0/10 (0%) 1/46 (2%) | 1/50 (2%) 0/5 (0%) 0/9 (0%) 1/48 (2%) |
|ADJUSTED (b) | 13.7% 0.0% 0.0% 3.6% | 3.4% 0.0% 0.0% 2.7% |
|TERMINAL (d) | 2/18 (11%) 0/0 0/0 0/21 (0%) | 0/27 (0%) 0/0 0/0 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 633 --- --- 712 | 722 --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.295N P=0.450N P=0.478N P=0.243N | P=0.676 P=0.431N P=0.457N P=0.697N |
|INCIDENTAL TUMOR | P=0.274N P=0.739N P=0.682N P=0.335N | P=0.640 (e) (e) P=0.727 |
|LOGISTIC REGRESSION | P=0.223N P=0.906N P=0.918N P=0.274N | P=0.630N (e) (e) P=0.716N |
|COCHRAN-ARMITAGE | P=0.291N | P=0.648 |
|FISHER EXACT | P=0.783N P=0.561N P=0.325N | P=0.909N P=0.847N P=0.742 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/48 (6%) 0/4 (0%) 0/10 (0%) 2/46 (4%) | 1/50 (2%) 0/5 (0%) 0/9 (0%) 1/48 (2%) |
|ADJUSTED (b) | 13.7% 0.0% 0.0% 8.2% | 3.4% 0.0% 0.0% 2.7% |
|TERMINAL (d) | 2/18 (11%) 0/0 0/0 1/21 (5%) | 0/27 (0%) 0/0 0/0 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 633 --- --- 712 | 722 --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.495N P=0.450N P=0.478N P=0.418N | P=0.676 P=0.431N P=0.457N P=0.697N |
|INCIDENTAL TUMOR | P=0.462N P=0.739N P=0.682N P=0.519N | P=0.640 (e) (e) P=0.727 |
|LOGISTIC REGRESSION | P=0.396N P=0.906N P=0.918N P=0.451N | P=0.630N (e) (e) P=0.716N |
|COCHRAN-ARMITAGE | P=0.511N | P=0.648 |
|FISHER EXACT | P=0.783N P=0.561N P=0.520N | P=0.909N P=0.847N P=0.742 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 5/50 (10%) 3/49 (6%) 0/49 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 15.6% 9.4% 0.0% | 3.7% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/18 (0%) 5/32 (16%) 3/32 (9%) 0/21 (0%) | 1/27 (4%) 0/39 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | 729 (T) 693 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.190N P=0.103 P=0.238 (e) | P=0.284N P=0.681N P=0.443N P=0.437N |
|INCIDENTAL TUMOR | P=0.190N P=0.103 P=0.238 (e) | P=0.328N P=0.720N P=0.443N P=0.437N |
|LOGISTIC REGRESSION | P=0.190N P=0.103 P=0.238 (e) | P=0.291N P=0.720N P=0.443N P=0.437N |
|COCHRAN-ARMITAGE | P=0.178N | P=0.305N |
|FISHER EXACT | P=0.030 * P=0.121 (e) | P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 2/49 (4%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.6% 3.1% 5.9% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 1/32 (3%) 1/32 (3%) 0/21 (0%) | 0/27 (0%) 0/39 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 716 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.345N P=0.628N P=0.693 P=0.469N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.332N P=0.628N P=0.539 P=0.469N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.322N P=0.628N P=0.647 P=0.469N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.334N | (e) |
|FISHER EXACT | P=0.747N P=0.500 P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 6/50 (12%) 5/49 (10%) 0/49 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.6% 18.8% 15.0% 0.0% | 3.7% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 6/32 (19%) 4/32 (13%) 0/21 (0%) | 1/27 (4%) 0/39 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 716 --- | 729 (T) 693 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.106N P=0.196 P=0.279 P=0.469N | P=0.284N P=0.681N P=0.443N P=0.437N |
|INCIDENTAL TUMOR | P=0.104N P=0.196 P=0.187 P=0.469N | P=0.328N P=0.720N P=0.443N P=0.437N |
|LOGISTIC REGRESSION | P=0.084N P=0.196 P=0.241 P=0.469N | P=0.291N P=0.720N P=0.443N P=0.437N |
|COCHRAN-ARMITAGE | P=0.102N | P=0.305N |
|FISHER EXACT | P=0.059 P=0.102 P=0.500N | P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 6/50 (12%) 5/49 (10%) 0/49 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.6% 18.8% 15.0% 0.0% | 3.7% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 6/32 (19%) 4/32 (13%) 0/21 (0%) | 1/27 (4%) 0/39 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 716 --- | 729 (T) 693 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.106N P=0.196 P=0.279 P=0.469N | P=0.284N P=0.681N P=0.443N P=0.437N |
|INCIDENTAL TUMOR | P=0.104N P=0.196 P=0.187 P=0.469N | P=0.328N P=0.720N P=0.443N P=0.437N |
|LOGISTIC REGRESSION | P=0.084N P=0.196 P=0.241 P=0.469N | P=0.291N P=0.720N P=0.443N P=0.437N |
|COCHRAN-ARMITAGE | P=0.102N | P=0.305N |
|FISHER EXACT | P=0.059 P=0.102 P=0.500N | P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.6% 2.6% 0.0% 8.1% |
|TERMINAL (d) | 0/18 (0%) 0/32 (0%) 0/32 (0%) 0/21 (0%) | 0/27 (0%) 1/39 (3%) 0/36 (0%) 3/37 (8%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 605 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.155 P=0.692N P=0.475N P=0.407 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.163 P=0.733 P=0.469N P=0.393 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.141 P=0.769N P=0.543N P=0.351 |
|COCHRAN-ARMITAGE | (e) | P=0.128 |
|FISHER EXACT | (e) (e) (e) | P=0.753N P=0.500N P=0.309 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 3/50 (6%) 3/50 (6%) | 8/50 (16%) 10/50 (20%) 13/50 (26%) 6/50 (12%) |
|ADJUSTED (b) | 2.6% 6.3% 9.4% 12.3% | 26.6% 25.6% 31.8% 15.7% |
|TERMINAL (d) | 0/18 (0%) 2/32 (6%) 3/32 (9%) 2/21 (10%) | 6/27 (22%) 10/39 (26%) 9/36 (25%) 5/37 (14%) |
|FIRST INCIDENCE (DAYS) | 626 729 (T) 729 (T) 680 | 400 729 (T) 539 688 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.231 P=0.655 P=0.469 P=0.356 | P=0.138N P=0.487N P=0.375 P=0.192N |
|INCIDENTAL TUMOR | P=0.247 P=0.505 P=0.376 P=0.310 | P=0.174N P=0.591N P=0.212 P=0.286N |
|LOGISTIC REGRESSION | P=0.297 P=0.558 P=0.364 P=0.345 | P=0.174N P=0.582 P=0.233 P=0.275N |
|COCHRAN-ARMITAGE | P=0.292 | P=0.229N |
|FISHER EXACT | P=0.508 P=0.316 P=0.316 | P=0.398 P=0.163 P=0.387N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 3/50 (6%) 3/50 (6%) | 9/50 (18%) 11/50 (22%) 13/50 (26%) 9/50 (18%) |
|ADJUSTED (b) | 2.6% 6.3% 9.4% 12.3% | 28.5% 28.2% 31.8% 23.6% |
|TERMINAL (d) | 0/18 (0%) 2/32 (6%) 3/32 (9%) 2/21 (10%) | 6/27 (22%) 11/39 (28%) 9/36 (25%) 8/37 (22%) |
|FIRST INCIDENCE (DAYS) | 626 729 (T) 729 (T) 680 | 400 729 (T) 539 688 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.231 P=0.655 P=0.469 P=0.356 | P=0.307N P=0.457N P=0.475 P=0.342N |
|INCIDENTAL TUMOR | P=0.247 P=0.505 P=0.376 P=0.310 | P=0.357N P=0.602N P=0.301 P=0.459N |
|LOGISTIC REGRESSION | P=0.297 P=0.558 P=0.364 P=0.345 | P=0.371N P=0.572 P=0.311 P=0.469N |
|COCHRAN-ARMITAGE | P=0.292 | P=0.451N |
|FISHER EXACT | P=0.508 P=0.316 P=0.316 | P=0.402 P=0.235 P=0.602N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 3/50 (6%) 3/50 (6%) | 9/50 (18%) 11/50 (22%) 13/50 (26%) 9/50 (18%) |
|ADJUSTED (b) | 2.6% 6.3% 9.4% 12.3% | 28.5% 28.2% 31.8% 23.6% |
|TERMINAL (d) | 0/18 (0%) 2/32 (6%) 3/32 (9%) 2/21 (10%) | 6/27 (22%) 11/39 (28%) 9/36 (25%) 8/37 (22%) |
|FIRST INCIDENCE (DAYS) | 626 729 (T) 729 (T) 680 | 400 729 (T) 539 688 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.231 P=0.655 P=0.469 P=0.356 | P=0.307N P=0.457N P=0.475 P=0.342N |
|INCIDENTAL TUMOR | P=0.247 P=0.505 P=0.376 P=0.310 | P=0.357N P=0.602N P=0.301 P=0.459N |
|LOGISTIC REGRESSION | P=0.297 P=0.558 P=0.364 P=0.345 | P=0.371N P=0.572 P=0.311 P=0.469N |
|COCHRAN-ARMITAGE | P=0.292 | P=0.451N |
|FISHER EXACT | P=0.508 P=0.316 P=0.316 | P=0.402 P=0.235 P=0.602N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 7.9% 3.1% 0.0% 2.6% | 5.9% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/32 (3%) 0/32 (0%) 0/21 (0%) | 0/27 (0%) 0/39 (0%) 1/36 (3%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 639 729 (T) --- 659 | 618 --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.495N P=0.347N P=0.170N P=0.420N | P=0.244N P=0.184N P=0.423N P=0.196N |
|INCIDENTAL TUMOR | P=0.467N P=0.572N P=0.428N P=0.500N | P=0.268N P=0.314N P=0.495N P=0.284N |
|LOGISTIC REGRESSION | P=0.492N P=0.439N P=0.219N P=0.479N | P=0.263N P=0.235N P=0.475N P=0.234N |
|COCHRAN-ARMITAGE | P=0.496N | P=0.266N |
|FISHER EXACT | P=0.492N P=0.242N P=0.492N | P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 7.9% 3.1% 0.0% 6.5% | 5.9% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/32 (3%) 0/32 (0%) 0/21 (0%) | 0/27 (0%) 0/39 (0%) 1/36 (3%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 639 729 (T) --- 659 | 618 --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.519 P=0.347N P=0.170N P=0.602N | P=0.244N P=0.184N P=0.423N P=0.196N |
|INCIDENTAL TUMOR | P=0.567 P=0.572N P=0.428N P=0.675N | P=0.268N P=0.314N P=0.495N P=0.284N |
|LOGISTIC REGRESSION | P=0.524 P=0.439N P=0.219N P=0.662N | P=0.263N P=0.235N P=0.475N P=0.234N |
|COCHRAN-ARMITAGE | P=0.517 | P=0.266N |
|FISHER EXACT | P=0.492N P=0.242N P=0.684N | P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa-Theca Tumor Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 2/15 (13%) 0/15 (0%) 0/49 (0%) |
|ADJUSTED (b) | | 0.0% 20.0% 0.0% 0.0% |
|TERMINAL (d) | | 0/27 (0%) 2/10 (20%) 0/5 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.248N P=0.061 (e) (e) |
|INCIDENTAL TUMOR | | P=0.248N P=0.061 (e) (e) |
|LOGISTIC REGRESSION | | P=0.248N P=0.061 (e) (e) |
|COCHRAN-ARMITAGE | | P=0.315N |
|FISHER EXACT | | P=0.050 (e) (e) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/47 (43%) 13/18 (72%) 11/19 (58%) 11/46 (24%) | 21/50 (42%) 13/33 (39%) 17/35 (49%) 23/50 (46%) |
|ADJUSTED (b) | 61.4% 82.4% 83.3% 38.7% | 56.9% 42.9% 53.7% 53.0% |
|TERMINAL (d) | 7/18 (39%) 8/10 (80%) 4/5 (80%) 5/20 (25%) | 12/27 (44%) 9/24 (38%) 10/22 (45%) 17/37 (46%) |
|FIRST INCIDENCE (DAYS) | 455 486 498 654 | 482 605 520 511 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.026N* P=0.179N P=0.187N P=0.023N* | P=0.529N P=0.071N P=0.347N P=0.294N |
|INCIDENTAL TUMOR | P=0.001N** P=0.065 P=0.163 P=0.020N* | P=0.454 P=0.393N P=0.483 P=0.576 |
|LOGISTIC REGRESSION | P=0.002N** P=0.048 * P=0.115 P=0.027N* | P=0.466 P=0.353N P=0.449 P=0.573N |
|COCHRAN-ARMITAGE | P=0.004N** | P=0.354 |
|FISHER EXACT | P=0.030 * P=0.195 P=0.045N* | P=0.498N P=0.352 P=0.420 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/47 (43%) 13/18 (72%) 12/19 (63%) 11/46 (24%) | 21/50 (42%) 13/33 (39%) 17/35 (49%) 24/50 (48%) |
|ADJUSTED (b) | 61.4% 82.4% 83.8% 38.7% | 56.9% 42.9% 53.7% 54.1% |
|TERMINAL (d) | 7/18 (39%) 8/10 (80%) 4/5 (80%) 5/20 (25%) | 12/27 (44%) 9/24 (38%) 10/22 (45%) 17/37 (46%) |
|FIRST INCIDENCE (DAYS) | 455 486 498 654 | 482 605 520 511 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.026N* P=0.179N P=0.234N P=0.023N* | P=0.477 P=0.071N P=0.347N P=0.353N |
|INCIDENTAL TUMOR | P<0.001N** P=0.065 P=0.076 P=0.020N* | P=0.365 P=0.393N P=0.483 P=0.494 |
|LOGISTIC REGRESSION | P=0.002N** P=0.048 * P=0.051 P=0.027N* | P=0.373 P=0.353N P=0.449 P=0.507 |
|COCHRAN-ARMITAGE | P=0.004N** | P=0.273 |
|FISHER EXACT | P=0.030 * P=0.107 P=0.045N* | P=0.498N P=0.352 P=0.344 |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.8% 3.1% 2.8% 4.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 1/32 (3%) 0/32 (0%) 0/21 (0%) | 0/27 (0%) 0/39 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 709 729 (T) 711 722 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.500N P=0.317N P=0.311N P=0.423N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.428N P=0.377N P=0.595N P=0.424N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.476N P=0.360N P=0.402N P=0.424N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.483N | (e) |
|FISHER EXACT | P=0.492N P=0.492N P=0.492N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.8% 8.9% 5.8% 4.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 2/32 (6%) 1/32 (3%) 0/21 (0%) | 0/27 (0%) 0/39 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 709 693 711 722 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.315N P=0.634N P=0.479N P=0.423N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.258N P=0.640 P=0.684 P=0.424N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.285N P=0.658 P=0.578N P=0.424N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.298N | (e) |
|FISHER EXACT | P=0.510 P=0.684N P=0.492N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/50 (4%) 1/50 (2%) 4/50 (8%) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 13.2% 5.2% 3.1% 14.7% | 7.4% 4.6% 0.0% 4.7% |
|TERMINAL (d) | 1/18 (6%) 1/32 (3%) 1/32 (3%) 2/21 (10%) | 2/27 (7%) 1/39 (3%) 0/36 (0%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 680 626 729 (T) 676 | 729 (T) 605 --- 529 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.277 P=0.314N P=0.150N P=0.605 | P=0.617N P=0.569N P=0.177N P=0.594N |
|INCIDENTAL TUMOR | P=0.340 P=0.510N P=0.316N P=0.614 | P=0.635 P=0.659N P=0.177N P=0.686N |
|LOGISTIC REGRESSION | P=0.318 P=0.425N P=0.222N P=0.584 | P=0.611 P=0.651N P=0.177N P=0.679N |
|COCHRAN-ARMITAGE | P=0.310 | P=0.617 |
|FISHER EXACT | P=0.490N P=0.301N P=0.511 | P=0.691N P=0.247N P=0.691N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.6% 4.9% 2.0% 0.0% | 0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/18 (6%) 0/32 (0%) 0/32 (0%) 0/21 (0%) | 0/27 (0%) 0/39 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 654 361 --- | --- 688 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.225N P=0.637 P=0.690N P=0.469N | P=0.570N P=0.570 (e) (e) |
|INCIDENTAL TUMOR | P=0.279N P=0.549 P=0.749N P=0.469N | P=0.652N P=0.500 (e) (e) |
|LOGISTIC REGRESSION | P=0.264N P=0.537 P=0.714 P=0.469N | P=0.582N P=0.518 (e) (e) |
|COCHRAN-ARMITAGE | P=0.232N | P=0.585N |
|FISHER EXACT | P=0.508 P=0.747N P=0.495N | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibroma or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/50 (4%) 1/50 (2%) 4/50 (8%) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 13.2% 5.2% 3.1% 14.7% | 7.4% 6.8% 0.0% 4.7% |
|TERMINAL (d) | 1/18 (6%) 1/32 (3%) 1/32 (3%) 2/21 (10%) | 2/27 (7%) 1/39 (3%) 0/36 (0%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 680 626 729 (T) 676 | 729 (T) 605 --- 529 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.277 P=0.314N P=0.150N P=0.605 | P=0.507N P=0.647 P=0.177N P=0.594N |
|INCIDENTAL TUMOR | P=0.340 P=0.510N P=0.316N P=0.614 | P=0.557N P=0.539 P=0.177N P=0.686N |
|LOGISTIC REGRESSION | P=0.318 P=0.425N P=0.222N P=0.584 | P=0.560N P=0.559 P=0.177N P=0.679N |
|COCHRAN-ARMITAGE | P=0.310 | P=0.555N |
|FISHER EXACT | P=0.490N P=0.301N P=0.511 | P=0.500 P=0.247N P=0.691N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 4/50 (8%) 2/50 (4%) 4/50 (8%) | 2/50 (4%) 4/50 (8%) 0/50 (0%) 3/50 (6%) |
|ADJUSTED (b) | 18.3% 9.8% 5.1% 14.7% | 7.4% 8.9% 0.0% 7.1% |
|TERMINAL (d) | 2/18 (11%) 1/32 (3%) 1/32 (3%) 2/21 (10%) | 2/27 (7%) 1/39 (3%) 0/36 (0%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 680 626 361 676 | 729 (T) 605 --- 529 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.566 P=0.407N P=0.164N P=0.533N | P=0.600 P=0.500 P=0.177N P=0.621 |
|INCIDENTAL TUMOR | P=0.572 P=0.626N P=0.336N P=0.529N | P=0.503 P=0.369 P=0.177N P=0.476 |
|LOGISTIC REGRESSION | P=0.586 P=0.568N P=0.328N P=0.553N | P=0.544 P=0.390 P=0.177N P=0.521 |
|COCHRAN-ARMITAGE | P=0.586 | P=0.549 |
|FISHER EXACT | P=0.631N P=0.329N P=0.631N | P=0.339 P=0.247N P=0.500 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 5.6% 4.9% 2.0% 0.0% | 0.0% 2.3% 0.0% 2.4% |
|TERMINAL (d) | 1/18 (6%) 0/32 (0%) 0/32 (0%) 0/21 (0%) | 0/27 (0%) 0/39 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 654 361 --- | --- 688 --- 665 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.225N P=0.637 P=0.690N P=0.469N | P=0.484 P=0.570 (e) P=0.556 |
|INCIDENTAL TUMOR | P=0.279N P=0.549 P=0.749N P=0.469N | P=0.363 P=0.500 (e) P=0.419 |
|LOGISTIC REGRESSION | P=0.264N P=0.537 P=0.714 P=0.469N | P=0.456 P=0.518 (e) P=0.500 |
|COCHRAN-ARMITAGE | P=0.232N | P=0.459 |
|FISHER EXACT | P=0.508 P=0.747N P=0.495N | P=0.500 (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 7.6% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/18 (0%) 0/32 (0%) 0/32 (0%) 1/21 (5%) | 0/27 (0%) 0/39 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 680 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.032 * (e) (e) P=0.279 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.053 (e) (e) P=0.285 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.042 * (e) (e) P=0.271 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.042 * | (e) |
|FISHER EXACT | (e) (e) P=0.253 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 2/50 (4%) 17/50 (34%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 2.7% 5.7% 47.1% | 0.0% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 0/18 (0%) 0/32 (0%) 1/32 (3%) 5/21 (24%) | 0/27 (0%) 0/39 (0%) 1/36 (3%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- 687 702 522 | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.570 P=0.364 P<0.001 ** | P=0.767N (e) P=0.557 (e) |
|INCIDENTAL TUMOR | P<0.001 ** P=0.485 P=0.217 P<0.001 ** | P=0.767N (e) P=0.557 (e) |
|LOGISTIC REGRESSION | P<0.001 ** P=0.523 P=0.293 P<0.001 ** | P=0.767N (e) P=0.557 (e) |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.785N |
|FISHER EXACT | P=0.505 P=0.253 P<0.001 ** | (e) P=0.500 (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 12.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/18 (0%) 0/32 (0%) 0/32 (0%) 0/21 (0%) | 0/27 (0%) 0/39 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 618 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** (e) (e) P=0.095 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.005 ** (e) (e) P=0.045 * | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.002 ** (e) (e) P=0.068 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.002 ** | (e) |
|FISHER EXACT | (e) (e) P=0.061 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Spleen |
| Osteosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 19/50 (38%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 3.1% 62.8% | 0.0% 0.0% 0.0% 2.7% |
|TERMINAL (d) | 0/18 (0%) 0/32 (0%) 1/32 (3%) 11/21 (52%) | 0/27 (0%) 0/39 (0%) 0/36 (0%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 494 | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.615 P<0.001 ** | P=0.233 (e) (e) P=0.563 |
|INCIDENTAL TUMOR | P<0.001 ** (e) P=0.615 P<0.001 ** | P=0.233 (e) (e) P=0.563 |
|LOGISTIC REGRESSION | P<0.001 ** (e) P=0.615 P<0.001 ** | P=0.233 (e) (e) P=0.563 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.215 |
|FISHER EXACT | (e) P=0.505 P<0.001 ** | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 36/49 (73%) 44/46 (96%) 44/50 (88%) 46/50 (92%) | |
|ADJUSTED (b) | 94.4% 100.0% 100.0% 100.0% | |
|TERMINAL (d) | 16/18 (89%) 30/30 (100%) 32/32 (100%) 21/21 (100%)| |
|FIRST INCIDENCE (DAYS) | 466 556 476 415 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.064 P=0.096N P=0.064N P=0.376 | |
|INCIDENTAL TUMOR | P=0.056 P=0.045 * P=0.088 P=0.029 * | |
|LOGISTIC REGRESSION | P=0.082 P=0.059 P=0.084 P=0.048 * | |
|COCHRAN-ARMITAGE | P=0.073 | |
|FISHER EXACT | P=0.003 ** P=0.056 P=0.014 * | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/48 (19%) 2/8 (25%) 0/10 (0%) 9/45 (20%) | 5/49 (10%) 0/6 (0%) 1/11 (9%) 5/48 (10%) |
|ADJUSTED (b) | 43.5% 66.7% 0.0% 36.1% | 16.9% 0.0% 2.1% 13.5% |
|TERMINAL (d) | 7/18 (39%) 2/3 (67%) 0/0 6/21 (29%) | 4/27 (15%) 0/0 0/1 (0%) 5/37 (14%) |
|FIRST INCIDENCE (DAYS) | 554 729 (T) --- 686 | 537 --- 553 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.527N P=0.520N P=0.180N P=0.440N | P=0.434N P=0.469N P=0.635N P=0.436N |
|INCIDENTAL TUMOR | P=0.422N P=0.507 P=0.682N P=0.536N | P=0.458N P=0.872N P=0.708 P=0.499N |
|LOGISTIC REGRESSION | P=0.383N P=0.377 P=0.872N P=0.507N | P=0.533N P=0.608N P=0.702 P=0.541N |
|COCHRAN-ARMITAGE | P=0.496 | P=0.513 |
|FISHER EXACT | P=0.497 P=0.157N P=0.543 | P=0.548N P=0.698N P=0.617 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/48 (21%) 3/8 (38%) 0/10 (0%) 9/45 (20%) | 6/49 (12%) 0/6 (0%) 2/11 (18%) 6/48 (13%) |
|ADJUSTED (b) | 45.0% 100.0% 0.0% 36.1% | 19.7% 0.0% 100.0% 16.2% |
|TERMINAL (d) | 7/18 (39%) 3/3 (100%) 0/0 6/21 (29%) | 4/27 (15%) 0/0 1/1 (100%) 6/37 (16%) |
|FIRST INCIDENCE (DAYS) | 554 729 (T) --- 686 | 537 --- 553 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.365N P=0.619N P=0.091N P=0.341N | P=0.396N P=0.187N P=0.631 P=0.410N |
|INCIDENTAL TUMOR | P=0.288N P=0.271 P=0.454N P=0.465N | P=0.432N P=0.685N P=0.228 P=0.521N |
|LOGISTIC REGRESSION | P=0.244N P=0.136 P=0.665N P=0.422N | P=0.462N P=0.567N P=0.321 P=0.515N |
|COCHRAN-ARMITAGE | P=0.482N | P=0.523 |
|FISHER EXACT | P=0.268 P=0.125N P=0.563N | P=0.482N P=0.454 P=0.606 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/8 (25%) 0/10 (0%) 0/45 (0%) | 0/49 (0%) 0/6 (0%) 0/11 (0%) 1/48 (2%) |
|ADJUSTED (b) | 0.0% 34.7% 0.0% 0.0% | 0.0% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/18 (0%) 1/3 (33%) 0/0 0/21 (0%) | 0/27 (0%) 0/0 0/1 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- 486 --- --- | --- --- --- 529 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.306N P=0.088 (e) (e) | P=0.225 (e) (e) P=0.527 |
|INCIDENTAL TUMOR | P=0.273N P=0.041 * (e) (e) | P=0.177 (e) (e) P=0.331 |
|LOGISTIC REGRESSION | P=0.328N P=0.008 ** (e) (e) | P=0.207 (e) (e) P=0.367 |
|COCHRAN-ARMITAGE | P=0.307N | P=0.329 |
|FISHER EXACT | P=0.018 * (e) (e) | (e) (e) P=0.495 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 7.9% 3.1% 0.0% 2.6% | 5.9% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/32 (3%) 0/32 (0%) 0/21 (0%) | 0/27 (0%) 0/39 (0%) 1/36 (3%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 639 729 (T) --- 659 | 618 --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.495N P=0.347N P=0.170N P=0.420N | P=0.244N P=0.184N P=0.423N P=0.196N |
|INCIDENTAL TUMOR | P=0.467N P=0.572N P=0.428N P=0.500N | P=0.268N P=0.314N P=0.495N P=0.284N |
|LOGISTIC REGRESSION | P=0.492N P=0.439N P=0.219N P=0.479N | P=0.263N P=0.235N P=0.475N P=0.234N |
|COCHRAN-ARMITAGE | P=0.496N | P=0.266N |
|FISHER EXACT | P=0.492N P=0.242N P=0.492N | P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 5/50 (10%) 6/50 (12%) 7/50 (14%) 6/50 (12%) |
|ADJUSTED (b) | | 15.0% 14.5% 16.1% 16.2% |
|TERMINAL (d) | | 2/27 (7%) 4/39 (10%) 3/36 (8%) 6/37 (16%) |
|FIRST INCIDENCE (DAYS) | | 529 693 332 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.548N P=0.528N P=0.529 P=0.560N |
|INCIDENTAL TUMOR | | P=0.484 P=0.501 P=0.335 P=0.583 |
|LOGISTIC REGRESSION | | P=0.497 P=0.586 P=0.304 P=0.597 |
|COCHRAN-ARMITAGE | | P=0.500 |
|FISHER EXACT | | P=0.500 P=0.380 P=0.500 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 0/18 (0%) 0/32 (0%) 0/32 (0%) 0/21 (0%) | 0/27 (0%) 1/39 (3%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 723 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.354N P=0.325 (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.406N P=0.280 (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.361N P=0.310 (e) (e) |
|COCHRAN-ARMITAGE | (e) | P=0.380N |
|FISHER EXACT | (e) (e) (e) | P=0.247 (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 12.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/18 (0%) 0/32 (0%) 0/32 (0%) 0/21 (0%) | 0/27 (0%) 0/39 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 618 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** (e) (e) P=0.095 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.005 ** (e) (e) P=0.045 * | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.002 ** (e) (e) P=0.068 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.002 ** | (e) |
|FISHER EXACT | (e) (e) P=0.061 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 21/49 (43%) 3/50 (6%) 2/50 (4%) 3/50 (6%) | 10/50 (20%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 59.7% 8.7% 5.2% 9.8% | 27.2% 4.6% 2.6% 2.7% |
|TERMINAL (d) | 5/18 (28%) 2/32 (6%) 1/32 (3%) 1/21 (5%) | 2/27 (7%) 0/39 (0%) 0/36 (0%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 466 674 498 615 | 529 617 711 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.001N** P<0.001N** P<0.001N** P<0.001N** | P=0.010N** P=0.005N** P=0.003N** P=0.002N** |
|INCIDENTAL TUMOR | P<0.001N** P<0.001N** P<0.001N** P<0.001N** | P=0.018N* P=0.029N* P=0.010N** P=0.009N** |
|LOGISTIC REGRESSION | P<0.001N** P<0.001N** P<0.001N** P<0.001N** | P=0.013N* P=0.015N* P=0.004N** P=0.004N** |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.012N* |
|FISHER EXACT | P<0.001N** P<0.001N** P<0.001N** | P=0.014N* P=0.004N** P=0.004N** |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.0% 8.0% 2.9% 7.1% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/18 (0%) 1/32 (3%) 0/32 (0%) 1/21 (5%) | 0/27 (0%) 0/39 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 639 651 716 624 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.570 P=0.478 P=0.679N P=0.543 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.602 P=0.240 P=0.572 P=0.399 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.587 P=0.333 P=0.749N P=0.512 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.581 | (e) |
|FISHER EXACT | P=0.316 P=0.747N P=0.508 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 1/50 (2%) 19/50 (38%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 2.8% 2.0% 3.1% 62.8% | 0.0% 0.0% 2.7% 2.7% |
|TERMINAL (d) | 0/18 (0%) 0/32 (0%) 1/32 (3%) 11/21 (52%) | 0/27 (0%) 0/39 (0%) 0/36 (0%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 628 529 729 (T) 494 | --- --- 721 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.718N P=0.688N P<0.001 ** | P=0.329 (e) P=0.549 P=0.563 |
|INCIDENTAL TUMOR | P<0.001 ** P=0.540 P=0.741 P<0.001 ** | P=0.277 (e) P=0.419 P=0.563 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.687 P=0.749N P<0.001 ** | P=0.323 (e) P=0.540 P=0.563 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.305 |
|FISHER EXACT | P=0.747N P=0.747N P<0.001 ** | (e) P=0.500 P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 1/50 (2%) 19/50 (38%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 2.8% 2.0% 3.1% 62.8% | 0.0% 0.0% 2.7% 2.7% |
|TERMINAL (d) | 0/18 (0%) 0/32 (0%) 1/32 (3%) 11/21 (52%) | 0/27 (0%) 0/39 (0%) 0/36 (0%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 628 529 729 (T) 494 | --- --- 721 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.718N P=0.688N P<0.001 ** | P=0.329 (e) P=0.549 P=0.563 |
|INCIDENTAL TUMOR | P<0.001 ** P=0.540 P=0.741 P<0.001 ** | P=0.277 (e) P=0.419 P=0.563 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.687 P=0.749N P<0.001 ** | P=0.323 (e) P=0.540 P=0.563 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.305 |
|FISHER EXACT | P=0.747N P=0.747N P<0.001 ** | (e) P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 44/49 (90%) 49/50 (98%) 47/50 (94%) 47/50 (94%) | 32/50 (64%) 27/50 (54%) 31/50 (62%) 36/50 (72%) |
|ADJUSTED (b) | 100.0% 98.0% 100.0% 100.0% | 79.3% 61.2% 64.2% 78.0% |
|TERMINAL (d) | 18/18 (100%) 31/32 (97%) 32/32 (100%) 21/21 (100%)| 19/27 (70%) 22/39 (56%) 19/36 (53%) 27/37 (73%) |
|FIRST INCIDENCE (DAYS) | 455 486 476 415 | 400 605 332 511 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.305 P=0.016N* P=0.009N** P=0.309N | P=0.374 P=0.009N** P=0.119N P=0.237N |
|INCIDENTAL TUMOR | P=0.352N P=0.572 P=0.700N P=0.541N | P=0.163 P=0.100N P=0.369N P=0.517 |
|LOGISTIC REGRESSION | P=0.445N P=0.548 P=0.576 P=0.564N | P=0.178 P=0.064N P=0.384N P=0.490 |
|COCHRAN-ARMITAGE | P=0.527 | P=0.093 |
|FISHER EXACT | P=0.098 P=0.346 P=0.346 | P=0.208N P=0.500N P=0.260 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 28/49 (57%) 14/50 (28%) 13/50 (26%) 43/50 (86%) | 10/50 (20%) 6/50 (12%) 4/50 (8%) 6/50 (12%) |
|ADJUSTED (b) | 70.7% 31.7% 30.8% 91.4% | 27.2% 13.7% 10.5% 14.8% |
|TERMINAL (d) | 7/18 (39%) 4/32 (13%) 5/32 (16%) 17/21 (81%) | 2/27 (7%) 2/39 (5%) 2/36 (6%) 3/37 (8%) |
|FIRST INCIDENCE (DAYS) | 330 486 338 494 | 529 617 711 644 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001N** P<0.001N** P=0.145 | P=0.223N P=0.082N P=0.038N* P=0.103N |
|INCIDENTAL TUMOR | P<0.001 ** P=0.007N** P=0.019N* P=0.002 ** | P=0.384N P=0.300N P=0.136N P=0.310N |
|LOGISTIC REGRESSION | P<0.001 ** P=0.006N** P=0.002N** P=0.003 ** | P=0.230N P=0.184N P=0.059N P=0.182N |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.284N |
|FISHER EXACT | P=0.003N** P=0.002N** P=0.001 ** | P=0.207N P=0.074N P=0.207N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05020 TEST: 01 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PARA-CHLOROANILINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG | VEHICLE 2 MG/KG 6 MG/KG 18 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 46/49 (94%) 49/50 (98%) 49/50 (98%) 49/50 (98%) | 37/50 (74%) 30/50 (60%) 34/50 (68%) 40/50 (80%) |
|ADJUSTED (b) | 100.0% 98.0% 100.0% 100.0% | 84.1% 63.8% 69.2% 83.3% |
|TERMINAL (d) | 18/18 (100%) 31/32 (97%) 32/32 (100%) 21/21 (100%)| 20/27 (74%) 22/39 (56%) 21/36 (58%) 29/37 (78%) |
|FIRST INCIDENCE (DAYS) | 330 486 338 415 | 400 605 332 511 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.269 P=0.008N** P=0.011N* P=0.305N | P=0.417 P=0.004N** P=0.059N P=0.155N |
|INCIDENTAL TUMOR | P=0.535 P=0.719N P=0.560 P=0.733N | P=0.123 P=0.047N* P=0.267N P=0.547 |
|LOGISTIC REGRESSION | P=0.580 P=0.708N P=0.567 P=0.734N | P=0.190 P=0.051N P=0.188N P=0.572N |
|COCHRAN-ARMITAGE | P=0.335 | P=0.086 |
|FISHER EXACT | P=0.301 P=0.301 P=0.301 | P=0.101N P=0.330N P=0.318 |
|=================================================================================================================================|
(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).