TDMS Study 05188-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SODIUM XYLENESULFONATE DATE: 04/04/96
EXPERIMENT: 05188 TEST: 05 TIME: 04:41:38
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55403D
PATHOLOGIST: TOFT, J. CAS: 1300-72-7
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SODIUM XYLENESULFONATE DATE: 04/04/96
EXPERIMENT: 05188 TEST: 05 TIME: 04:41:38
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55403D
PATHOLOGIST: TOFT, J. CAS: 1300-72-7
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 Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial 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 SODIUM XYLENESULFONATE DATE: 04/04/96
EXPERIMENT: 05188 TEST: 05 TIME: 04:41:38
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55403D
PATHOLOGIST: TOFT, J. CAS: 1300-72-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF SODIUM XYLENESULFONATE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Islets, Pancreatic Adenoma
Carcinoma or Adenoma
Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Testes Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Carcinoma or Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
Thyroid Gland: Follicular Cell
Adenoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/33 (15%) 3/41 (7%) 9/50 (18%) | 1/50 (2%) 0/35 (0%) 1/33 (3%) 2/50 (4%) |
|ADJUSTED (b) | 44.8% 24.4% 14.4% 49.7% | 4.5% 0.0% 4.5% 9.9% |
|TERMINAL (d) | 1/7 (14%) 0/0 0/0 3/10 (30%) | 1/22 (5%) 0/1 (0%) 0/0 1/16 (6%) |
|FIRST INCIDENCE (DAYS) | 554 623 594 642 | 736 (T) --- 706 651 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.506N P=0.317N P=0.234N P=0.482N | P=0.247 P=0.987N P=0.467 P=0.399 |
|INCIDENTAL TUMOR | P=0.463 P=0.474 P=0.194N P=0.428 | P=0.268 P=0.987N P=0.500 P=0.416 |
|LOGISTIC REGRESSION | P=0.518N P=0.355 P=0.277N P=0.557 | P=0.272 P=0.987N P=0.343 P=0.443 |
|COCHRAN-ARMITAGE | P=0.459 | P=0.280 |
|FISHER EXACT | P=0.586N P=0.174N P=0.500 | P=0.588N P=0.640 P=0.500 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/33 (15%) 3/41 (7%) 10/50 (20%) | 1/50 (2%) 0/35 (0%) 1/33 (3%) 2/50 (4%) |
|ADJUSTED (b) | 44.8% 24.4% 14.4% 51.0% | 4.5% 0.0% 4.5% 9.9% |
|TERMINAL (d) | 1/7 (14%) 0/0 0/0 3/10 (30%) | 1/22 (5%) 0/1 (0%) 0/0 1/16 (6%) |
|FIRST INCIDENCE (DAYS) | 554 623 594 561 | 736 (T) --- 706 651 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.482 P=0.317N P=0.234N P=0.580N | P=0.247 P=0.987N P=0.467 P=0.399 |
|INCIDENTAL TUMOR | P=0.343 P=0.474 P=0.194N P=0.321 | P=0.268 P=0.987N P=0.500 P=0.416 |
|LOGISTIC REGRESSION | P=0.457 P=0.355 P=0.277N P=0.429 | P=0.272 P=0.987N P=0.343 P=0.443 |
|COCHRAN-ARMITAGE | P=0.345 | P=0.280 |
|FISHER EXACT | P=0.586N P=0.174N P=0.398 | P=0.588N P=0.640 P=0.500 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/33 (0%) 1/40 (3%) 0/50 (0%) | 1/49 (2%) 3/50 (6%) 4/50 (8%) 0/50 (0%) |
|ADJUSTED (b) | 6.7% 0.0% 2.3% 0.0% | 4.5% 12.7% 18.6% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/0 0/0 0/10 (0%) | 1/22 (5%) 1/16 (6%) 2/17 (12%) 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 707 --- 527 --- | 736 (T) 622 602 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.395N P=0.487N P=0.728 P=0.464N | P=0.388N P=0.220 P=0.124 P=0.564N |
|INCIDENTAL TUMOR | P=0.379N P=0.619N P=0.742 P=0.545N | P=0.294N P=0.396 P=0.172 P=0.564N |
|LOGISTIC REGRESSION | P=0.390N P=0.727N P=0.722 P=0.478N | P=0.340N P=0.263 P=0.146 P=0.564N |
|COCHRAN-ARMITAGE | P=0.390N | P=0.307N |
|FISHER EXACT | P=0.602N P=0.694 P=0.500N | P=0.316 P=0.187 P=0.495N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/33 (0%) 1/40 (3%) 0/50 (0%) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 7.1% 0.0% | 0.0% 0.0% 2.2% 9.1% |
|TERMINAL (d) | 0/7 (0%) 0/0 0/0 0/10 (0%) | 0/22 (0%) 0/16 (0%) 0/17 (0%) 1/16 (6%) |
|FIRST INCIDENCE (DAYS) | --- --- 700 --- | --- --- 492 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.702 (e) P=0.461 (e) | P=0.066 (e) P=0.528 P=0.199 |
|INCIDENTAL TUMOR | P=0.677 (e) P=0.468 (e) | P=0.070 (e) P=0.540 P=0.282 |
|LOGISTIC REGRESSION | P=0.714 (e) P=0.341 (e) | P=0.073 (e) P=0.437 P=0.223 |
|COCHRAN-ARMITAGE | P=0.697 | P=0.071 |
|FISHER EXACT | (e) P=0.444 (e) | (e) P=0.505 P=0.253 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/33 (0%) 2/40 (5%) 0/50 (0%) | 1/49 (2%) 3/50 (6%) 5/50 (10%) 2/50 (4%) |
|ADJUSTED (b) | 6.7% 0.0% 9.3% 0.0% | 4.5% 12.7% 20.4% 9.1% |
|TERMINAL (d) | 0/7 (0%) 0/0 0/0 0/10 (0%) | 1/22 (5%) 1/16 (6%) 2/17 (12%) 1/16 (6%) |
|FIRST INCIDENCE (DAYS) | 707 --- 527 --- | 736 (T) 622 492 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.442N P=0.487N P=0.444 P=0.464N | P=0.364 P=0.220 P=0.075 P=0.420 |
|INCIDENTAL TUMOR | P=0.444N P=0.619N P=0.462 P=0.545N | P=0.459 P=0.396 P=0.108 P=0.514 |
|LOGISTIC REGRESSION | P=0.430N P=0.727N P=0.392 P=0.478N | P=0.420 P=0.263 P=0.100 P=0.460 |
|COCHRAN-ARMITAGE | P=0.437N | P=0.445 |
|FISHER EXACT | P=0.602N P=0.416 P=0.500N | P=0.316 P=0.107 P=0.508 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/33 (0%) 0/41 (0%) 3/50 (6%) | 0/50 (0%) 0/35 (0%) 1/33 (3%) 0/50 (0%) |
|ADJUSTED (b) | 20.6% 0.0% 0.0% 16.5% | 0.0% 0.0% 5.6% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/0 0/0 1/10 (10%) | 0/22 (0%) 0/1 (0%) 0/0 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 492 --- --- 556 | --- --- 717 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.334N P=0.040N* P=0.050N* P=0.305N | P=0.648 (e) P=0.434 (e) |
|INCIDENTAL TUMOR | P=0.339N P=0.068N P=0.038N* P=0.354N | P=0.695 (e) P=0.500 (e) |
|LOGISTIC REGRESSION | P=0.363N P=0.067N P=0.043N* P=0.354N | P=0.654 (e) P=0.170 (e) |
|COCHRAN-ARMITAGE | P=0.366N | P=0.691 |
|FISHER EXACT | P=0.073N P=0.046N* P=0.357N | (e) P=0.398 (e) |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/33 (3%) 0/41 (0%) 4/50 (8%) | 1/50 (2%) 0/35 (0%) 1/33 (3%) 0/50 (0%) |
|ADJUSTED (b) | 20.6% 6.7% 0.0% 18.8% | 2.8% 0.0% 5.6% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/0 0/0 1/10 (10%) | 0/22 (0%) 0/1 (0%) 0/0 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 492 726 --- 556 | 605 --- 717 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.452N P=0.097N P=0.050N* P=0.446N | P=0.445N P=0.543N P=0.710 P=0.517N |
|INCIDENTAL TUMOR | P=0.478N P=0.209N P=0.038N* P=0.507N | P=0.355N P=0.326N P=0.686N P=0.343N |
|LOGISTIC REGRESSION | P=0.485N P=0.239N P=0.043N* P=0.494N | P=0.408N P=0.571N P=0.622 P=0.491N |
|COCHRAN-ARMITAGE | P=0.491N | P=0.397N |
|FISHER EXACT | P=0.227N P=0.046N* P=0.500N | P=0.588N P=0.640 P=0.500N |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/33 (0%) 0/41 (0%) 1/50 (2%) | 0/50 (0%) 0/35 (0%) 0/33 (0%) 0/50 (0%) |
|ADJUSTED (b) | 18.0% 0.0% 0.0% 10.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/7 (14%) 0/0 0/0 1/10 (10%) | 0/22 (0%) 0/1 (0%) 0/0 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 658 --- --- 735 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.313N P=0.518N P=0.528N P=0.407N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.324N P=0.619N P=0.521N P=0.443N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.362N P=0.465N P=0.391N P=0.458N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.436N | (e) |
|FISHER EXACT | P=0.360N P=0.299N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/33 (3%) 1/41 (2%) 1/50 (2%) | 0/50 (0%) 0/35 (0%) 0/33 (0%) 0/50 (0%) |
|ADJUSTED (b) | 18.0% 4.5% 2.4% 10.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/7 (14%) 0/0 0/0 1/10 (10%) | 0/22 (0%) 0/1 (0%) 0/0 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 658 656 535 735 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.293N P=0.745 P=0.740 P=0.407N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.290N P=0.624 P=0.749 P=0.443N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.360N P=0.707 P=0.595N P=0.458N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.380N | (e) |
|FISHER EXACT | P=0.653N P=0.575N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/33 (0%) 0/41 (0%) 0/50 (0%) | 0/50 (0%) 0/35 (0%) 0/33 (0%) 0/50 (0%) |
|ADJUSTED (b) | 10.9% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/0 0/0 0/10 (0%) | 0/22 (0%) 0/1 (0%) 0/0 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 636 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.111N P=0.240N P=0.281N P=0.208N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.127N P=0.340N P=0.259N P=0.280N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.116N P=0.414N P=0.336N P=0.233N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.117N | (e) |
|FISHER EXACT | P=0.360N P=0.299N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/33 (0%) 0/41 (0%) 0/50 (0%) | 1/50 (2%) 0/35 (0%) 0/33 (0%) 0/50 (0%) |
|ADJUSTED (b) | 13.8% 0.0% 0.0% 0.0% | 4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/0 0/0 0/10 (0%) | 1/22 (5%) 0/1 (0%) 0/0 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 617 --- --- --- | 736 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.048N* P=0.128N P=0.149N P=0.109N | P=0.366N P=0.987N (e) P=0.564N |
|INCIDENTAL TUMOR | P=0.055N P=0.197N P=0.136N P=0.152N | P=0.366N P=0.987N (e) P=0.564N |
|LOGISTIC REGRESSION | P=0.050N P=0.247N P=0.179N P=0.120N | P=0.366N P=0.987N (e) P=0.564N |
|COCHRAN-ARMITAGE | P=0.050N* | P=0.309N |
|FISHER EXACT | P=0.213N P=0.161N P=0.121N | P=0.588N P=0.602N P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/46 (0%) 0/48 (0%) 0/50 (0%) | 16/50 (32%) 4/50 (8%) 8/50 (16%) 9/50 (18%) |
|ADJUSTED (b) | 3.7% 0.0% 0.0% 0.0% | 56.3% 16.3% 27.0% 41.8% |
|TERMINAL (d) | 0/7 (0%) 0/13 (0%) 0/7 (0%) 0/10 (0%) | 10/22 (45%) 1/16 (6%) 0/17 (0%) 5/16 (31%) |
|FIRST INCIDENCE (DAYS) | 645 --- --- --- | 490 446 441 515 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.310N P=0.523N P=0.515N P=0.508N | P=0.345N P=0.022N* P=0.162N P=0.285N |
|INCIDENTAL TUMOR | P=0.320N P=0.619N P=0.521N P=0.545N | P=0.230N P=0.018N* P=0.068N P=0.191N |
|LOGISTIC REGRESSION | P=0.305N P=0.519N P=0.511N P=0.500N | P=0.208N P=0.007N** P=0.062N P=0.151N |
|COCHRAN-ARMITAGE | P=0.305N | P=0.170N |
|FISHER EXACT | P=0.521N P=0.510N P=0.500N | P=0.003N** P=0.050N P=0.083N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/46 (2%) 0/48 (0%) 0/50 (0%) | 16/50 (32%) 5/50 (10%) 8/50 (16%) 10/50 (20%) |
|ADJUSTED (b) | 3.7% 7.1% 0.0% 0.0% | 56.3% 19.1% 27.0% 43.1% |
|TERMINAL (d) | 0/7 (0%) 0/13 (0%) 0/7 (0%) 0/10 (0%) | 10/22 (45%) 1/16 (6%) 0/17 (0%) 5/16 (31%) |
|FIRST INCIDENCE (DAYS) | 645 732 --- --- | 490 446 441 441 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.231N P=0.701N P=0.515N P=0.508N | P=0.414N P=0.046N* P=0.162N P=0.373N |
|INCIDENTAL TUMOR | P=0.253N P=0.624 P=0.521N P=0.545N | P=0.289N P=0.029N* P=0.068N P=0.273N |
|LOGISTIC REGRESSION | P=0.232N P=0.756 P=0.511N P=0.500N | P=0.263N P=0.016N* P=0.062N P=0.202N |
|COCHRAN-ARMITAGE | P=0.234N | P=0.225N |
|FISHER EXACT | P=0.731 P=0.510N P=0.500N | P=0.006N** P=0.050N P=0.127N |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/46 (0%) 0/48 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.3% 0.0% 0.0% 13.3% | 4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/13 (0%) 0/7 (0%) 1/10 (10%) | 1/22 (5%) 0/16 (0%) 0/17 (0%) 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 546 --- --- 642 | 736 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.254 P=0.540N P=0.519N P=0.530 | P=0.342N P=0.564N P=0.551N P=0.564N |
|INCIDENTAL TUMOR | P=0.282 P=0.500N P=0.500N P=0.566 | P=0.342N P=0.564N P=0.551N P=0.564N |
|LOGISTIC REGRESSION | P=0.253 P=0.465N P=0.464N P=0.500 | P=0.342N P=0.564N P=0.551N P=0.564N |
|COCHRAN-ARMITAGE | P=0.253 | P=0.306N |
|FISHER EXACT | P=0.521N P=0.510N P=0.500 | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/46 (0%) 0/48 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.3% 0.0% 0.0% 13.3% | 4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/13 (0%) 0/7 (0%) 1/10 (10%) | 1/22 (5%) 0/16 (0%) 0/17 (0%) 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 546 --- --- 642 | 736 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.254 P=0.540N P=0.519N P=0.530 | P=0.342N P=0.564N P=0.551N P=0.564N |
|INCIDENTAL TUMOR | P=0.282 P=0.500N P=0.500N P=0.566 | P=0.342N P=0.564N P=0.551N P=0.564N |
|LOGISTIC REGRESSION | P=0.253 P=0.465N P=0.464N P=0.500 | P=0.342N P=0.564N P=0.551N P=0.564N |
|COCHRAN-ARMITAGE | P=0.253 | P=0.306N |
|FISHER EXACT | P=0.521N P=0.510N P=0.500 | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/46 (0%) 0/48 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.3% 0.0% 0.0% 13.3% | 4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/13 (0%) 0/7 (0%) 1/10 (10%) | 1/22 (5%) 0/16 (0%) 0/17 (0%) 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 546 --- --- 642 | 736 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.254 P=0.540N P=0.519N P=0.530 | P=0.342N P=0.564N P=0.551N P=0.564N |
|INCIDENTAL TUMOR | P=0.282 P=0.500N P=0.500N P=0.566 | P=0.342N P=0.564N P=0.551N P=0.564N |
|LOGISTIC REGRESSION | P=0.253 P=0.465N P=0.464N P=0.500 | P=0.342N P=0.564N P=0.551N P=0.564N |
|COCHRAN-ARMITAGE | P=0.253 | P=0.306N |
|FISHER EXACT | P=0.521N P=0.510N P=0.500 | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 44/50 (88%) 27/33 (82%) 34/41 (83%) 36/50 (72%) | 34/50 (68%) 17/35 (49%) 19/33 (58%) 29/50 (58%) |
|ADJUSTED (b) | 97.5% 65.9% 81.4% 89.0% | 84.5% 100.0% 48.1% 81.4% |
|TERMINAL (d) | 6/7 (86%) 0/0 0/0 6/10 (60%) | 16/22 (73%) 1/1 (100%) 0/0 10/16 (63%) |
|FIRST INCIDENCE (DAYS) | 441 349 439 428 | 420 486 441 396 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.146N P=0.119N P=0.517N P=0.080N | P=0.407 P=0.431 P=0.356 P=0.429 |
|INCIDENTAL TUMOR | P=0.044N* P=0.440N P=0.458N P=0.063N | P=0.302N P=0.255N P=0.218N P=0.232N |
|LOGISTIC REGRESSION | P=0.022N* P=0.451N P=0.442N P=0.041N* | P=0.296N P=0.120N P=0.484N P=0.243N |
|COCHRAN-ARMITAGE | P=0.030N* | P=0.299N |
|FISHER EXACT | P=0.317N P=0.348N P=0.039N* | P=0.058N P=0.231N P=0.204N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 27/33 (82%) 34/41 (83%) 36/50 (72%) | 35/50 (70%) 17/35 (49%) 19/33 (58%) 29/50 (58%) |
|ADJUSTED (b) | 97.5% 65.9% 81.4% 89.0% | 84.8% 100.0% 48.1% 81.4% |
|TERMINAL (d) | 6/7 (86%) 0/0 0/0 6/10 (60%) | 16/22 (73%) 1/1 (100%) 0/0 10/16 (63%) |
|FIRST INCIDENCE (DAYS) | 441 349 439 428 | 420 486 441 396 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.126N P=0.100N P=0.472N P=0.066N | P=0.456 P=0.497 P=0.422 P=0.486 |
|INCIDENTAL TUMOR | P=0.024N* P=0.304N P=0.328N P=0.032N* | P=0.244N P=0.174N P=0.142N P=0.174N |
|LOGISTIC REGRESSION | P=0.012N* P=0.320N P=0.316N P=0.021N* | P=0.239N P=0.232N P=0.363N P=0.182N |
|COCHRAN-ARMITAGE | P=0.016N* | P=0.240N |
|FISHER EXACT | P=0.226N P=0.247N P=0.020N* | P=0.039N* P=0.177N P=0.149N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal |
| Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/46 (4%) 3/48 (6%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 11.6% 23.3% 16.0% | 4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/13 (0%) 1/7 (14%) 1/10 (10%) | 1/22 (5%) 0/16 (0%) 0/17 (0%) 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | --- 658 666 726 | 736 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.283 P=0.302 P=0.104 P=0.339 | P=0.342N P=0.564N P=0.551N P=0.564N |
|INCIDENTAL TUMOR | P=0.231 P=0.117 P=0.110 P=0.252 | P=0.342N P=0.564N P=0.551N P=0.564N |
|LOGISTIC REGRESSION | P=0.264 P=0.231 P=0.101 P=0.313 | P=0.342N P=0.564N P=0.551N P=0.564N |
|COCHRAN-ARMITAGE | P=0.247 | P=0.306N |
|FISHER EXACT | P=0.227 P=0.114 P=0.247 | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/46 (2%) 1/48 (2%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 4.5% 3.7% 5.3% 18.9% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/13 (0%) 0/7 (0%) 1/10 (10%) | 0/22 (0%) 0/16 (0%) 0/17 (0%) 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 672 631 666 527 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.189 P=0.742 P=0.721 P=0.367 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.179 P=0.660 P=0.740 P=0.329 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.173 P=0.742 P=0.746 P=0.307 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.172 | (e) |
|FISHER EXACT | P=0.731 P=0.742 P=0.309 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/46 (4%) 1/48 (2%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 4.5% 8.3% 5.3% 18.9% | 0.0% 0.0% 3.8% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/13 (0%) 0/7 (0%) 1/10 (10%) | 0/22 (0%) 0/16 (0%) 0/17 (0%) 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 672 631 666 527 | --- --- 660 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.270 P=0.470 P=0.721 P=0.367 | P=0.669 (e) P=0.465 (e) |
|INCIDENTAL TUMOR | P=0.249 P=0.331 P=0.740 P=0.329 | P=0.695 (e) P=0.500 (e) |
|LOGISTIC REGRESSION | P=0.249 P=0.467 P=0.746 P=0.307 | P=0.690 (e) P=0.498 (e) |
|COCHRAN-ARMITAGE | P=0.247 | P=0.694 |
|FISHER EXACT | P=0.468 P=0.742 P=0.309 | (e) P=0.500 (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/46 (2%) 2/48 (4%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 4.8% 18.8% 10.0% | 4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/13 (0%) 1/7 (14%) 1/10 (10%) | 1/22 (5%) 0/16 (0%) 0/17 (0%) 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | --- 658 666 735 (T) | 736 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.400 P=0.482 P=0.224 P=0.571 | P=0.342N P=0.564N P=0.551N P=0.564N |
|INCIDENTAL TUMOR | P=0.372 P=0.381 P=0.228 P=0.571 | P=0.342N P=0.564N P=0.551N P=0.564N |
|LOGISTIC REGRESSION | P=0.387 P=0.482 P=0.209 P=0.571 | P=0.342N P=0.564N P=0.551N P=0.564N |
|COCHRAN-ARMITAGE | P=0.374 | P=0.306N |
|FISHER EXACT | P=0.479 P=0.237 P=0.500 | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/46 (2%) 2/48 (4%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 4.8% 18.8% 10.0% | 4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/13 (0%) 1/7 (14%) 1/10 (10%) | 1/22 (5%) 0/16 (0%) 0/17 (0%) 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | --- 658 666 735 (T) | 736 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.400 P=0.482 P=0.224 P=0.571 | P=0.342N P=0.564N P=0.551N P=0.564N |
|INCIDENTAL TUMOR | P=0.372 P=0.381 P=0.228 P=0.571 | P=0.342N P=0.564N P=0.551N P=0.564N |
|LOGISTIC REGRESSION | P=0.387 P=0.482 P=0.209 P=0.571 | P=0.342N P=0.564N P=0.551N P=0.564N |
|COCHRAN-ARMITAGE | P=0.374 | P=0.306N |
|FISHER EXACT | P=0.479 P=0.237 P=0.500 | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 8/33 (24%) 13/41 (32%) 30/50 (60%) | |
|ADJUSTED (b) | 94.8% 32.8% 50.8% 95.7% | |
|TERMINAL (d) | 6/7 (86%) 0/0 0/0 9/10 (90%) | |
|FIRST INCIDENCE (DAYS) | 534 541 535 428 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.209 P=0.027N* P=0.339N P=0.484 | |
|INCIDENTAL TUMOR | P=0.089 P=0.210N P=0.266N P=0.173 | |
|LOGISTIC REGRESSION | P=0.055 P=0.135N P=0.185N P=0.137 | |
|COCHRAN-ARMITAGE | P=0.046 * | |
|FISHER EXACT | P=0.025N* P=0.087N P=0.158 | |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 3/33 (9%) 1/41 (2%) 6/50 (12%) | 10/50 (20%) 1/35 (3%) 2/33 (6%) 8/50 (16%) |
|ADJUSTED (b) | 54.2% 10.1% 3.4% 37.4% | 39.3% 4.2% 5.9% 40.6% |
|TERMINAL (d) | 2/7 (29%) 0/0 0/0 2/10 (20%) | 7/22 (32%) 0/1 (0%) 0/0 5/16 (31%) |
|FIRST INCIDENCE (DAYS) | 547 541 622 568 | 693 645 559 674 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.175N P=0.155N P=0.062N P=0.157N | P=0.437 P=0.323N P=0.577N P=0.529 |
|INCIDENTAL TUMOR | P=0.209N P=0.368N P=0.042N* P=0.322N | P=0.521 P=0.344N P=0.375N P=0.593 |
|LOGISTIC REGRESSION | P=0.203N P=0.350N P=0.042N* P=0.255N | P=0.516 P=0.294N P=0.377N P=0.601 |
|COCHRAN-ARMITAGE | P=0.247N | P=0.522N |
|FISHER EXACT | P=0.211N P=0.018N* P=0.288N | P=0.019N* P=0.070N P=0.398N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 3/33 (9%) 1/41 (2%) 7/50 (14%) | 10/50 (20%) 1/35 (3%) 2/33 (6%) 8/50 (16%) |
|ADJUSTED (b) | 54.2% 10.1% 3.4% 45.2% | 39.3% 4.2% 5.9% 40.6% |
|TERMINAL (d) | 2/7 (29%) 0/0 0/0 3/10 (30%) | 7/22 (32%) 0/1 (0%) 0/0 5/16 (31%) |
|FIRST INCIDENCE (DAYS) | 547 541 622 568 | 693 645 559 674 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.249N P=0.155N P=0.062N P=0.220N | P=0.437 P=0.323N P=0.577N P=0.529 |
|INCIDENTAL TUMOR | P=0.291N P=0.368N P=0.042N* P=0.412N | P=0.521 P=0.344N P=0.375N P=0.593 |
|LOGISTIC REGRESSION | P=0.304N P=0.350N P=0.042N* P=0.351N | P=0.516 P=0.294N P=0.377N P=0.601 |
|COCHRAN-ARMITAGE | P=0.369N | P=0.522N |
|FISHER EXACT | P=0.211N P=0.018N* P=0.393N | P=0.019N* P=0.070N P=0.398N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/33 (0%) 0/41 (0%) 0/50 (0%) | 1/50 (2%) 2/35 (6%) 0/33 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.5% 10.8% 0.0% 2.7% |
|TERMINAL (d) | 0/7 (0%) 0/0 0/0 0/10 (0%) | 1/22 (5%) 0/1 (0%) 0/0 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 736 (T) 708 --- 572 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.545N P=0.206 (e) P=0.722 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.475N P=0.176 (e) P=0.718N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.499N P=0.032 * (e) P=0.756 |
|COCHRAN-ARMITAGE | (e) | P=0.479N |
|FISHER EXACT | (e) (e) (e) | P=0.367 P=0.602N P=0.753N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/33 (0%) 1/41 (2%) 1/50 (2%) | 1/50 (2%) 2/35 (6%) 0/33 (0%) 2/50 (4%) |
|ADJUSTED (b) | 7.1% 0.0% 2.3% 10.0% | 4.5% 10.8% 0.0% 6.9% |
|TERMINAL (d) | 0/7 (0%) 0/0 0/0 1/10 (10%) | 1/22 (5%) 0/1 (0%) 0/0 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | 708 --- 527 735 (T) | 736 (T) 708 --- 572 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.629 P=0.473N P=0.736 P=0.691N | P=0.420 P=0.206 (e) P=0.430 |
|INCIDENTAL TUMOR | P=0.630N P=0.619N P=0.749 P=0.748N | P=0.496 P=0.176 (e) P=0.541 |
|LOGISTIC REGRESSION | P=0.576 P=0.731N P=0.727 P=0.720N | P=0.476 P=0.032 * (e) P=0.483 |
|COCHRAN-ARMITAGE | P=0.564 | P=0.495 |
|FISHER EXACT | P=0.602N P=0.701 P=0.753N | P=0.367 P=0.602N P=0.500 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|ADJUSTED (b) | | 6.5% 2.9% 2.2% 14.4% |
|TERMINAL (d) | | 1/22 (5%) 0/16 (0%) 0/17 (0%) 2/16 (13%) |
|FIRST INCIDENCE (DAYS) | | 408 550 492 391 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.286 P=0.553N P=0.509N P=0.401 |
|INCIDENTAL TUMOR | | P=0.286 P=0.429N P=0.508N P=0.394 |
|LOGISTIC REGRESSION | | P=0.340 P=0.451N P=0.541N P=0.524 |
|COCHRAN-ARMITAGE | | P=0.324 |
|FISHER EXACT | | P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |
|ADJUSTED (b) | | 6.5% 5.0% 6.6% 14.4% |
|TERMINAL (d) | | 1/22 (5%) 0/16 (0%) 0/17 (0%) 2/16 (13%) |
|FIRST INCIDENCE (DAYS) | | 408 446 492 391 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.339 P=0.650 P=0.670 P=0.401 |
|INCIDENTAL TUMOR | | P=0.346 P=0.632N P=0.688 P=0.394 |
|LOGISTIC REGRESSION | | P=0.406 P=0.623N P=0.687 P=0.524 |
|COCHRAN-ARMITAGE | | P=0.387 |
|FISHER EXACT | | P=0.691N P=0.691N P=0.500 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/46 (0%) 1/48 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 2.4% 8.8% | 0.0% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/7 (0%) 0/13 (0%) 0/7 (0%) 0/10 (0%) | 0/22 (0%) 0/16 (0%) 0/17 (0%) 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 538 525 | --- --- --- 338 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.086 (e) P=0.486 P=0.289 | P=0.198 (e) (e) P=0.496 |
|INCIDENTAL TUMOR | P=0.102 (e) P=0.500 P=0.252 | P=0.301 (e) (e) P=0.718 |
|LOGISTIC REGRESSION | P=0.073 (e) P=0.542 P=0.239 | P=0.187 (e) (e) P=0.655 |
|COCHRAN-ARMITAGE | P=0.075 | P=0.198 |
|FISHER EXACT | (e) P=0.490 P=0.247 | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/46 (0%) 2/48 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 6.7% 8.8% | 0.0% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/7 (0%) 0/13 (0%) 0/7 (0%) 0/10 (0%) | 0/22 (0%) 0/16 (0%) 0/17 (0%) 0/16 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 538 525 | --- --- --- 338 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.105 (e) P=0.223 P=0.289 | P=0.198 (e) (e) P=0.496 |
|INCIDENTAL TUMOR | P=0.114 (e) P=0.228 P=0.252 | P=0.301 (e) (e) P=0.718 |
|LOGISTIC REGRESSION | P=0.090 (e) P=0.241 P=0.239 | P=0.187 (e) (e) P=0.655 |
|COCHRAN-ARMITAGE | P=0.091 | P=0.198 |
|FISHER EXACT | (e) P=0.237 P=0.247 | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 24/46 (52%) 15/48 (31%) 25/50 (50%) | 17/50 (34%) 5/50 (10%) 9/50 (18%) 10/50 (20%) |
|ADJUSTED (b) | 50.5% 100.0% 91.2% 100.0% | 53.3% 21.0% 28.9% 42.3% |
|TERMINAL (d) | 1/7 (14%) 13/13 (100%) 6/7 (86%) 10/10 (100%)| 8/22 (36%) 1/16 (6%) 0/17 (0%) 5/16 (31%) |
|FIRST INCIDENCE (DAYS) | 547 491 477 541 | 485 497 517 520 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.068 P=0.090 P=0.238 P=0.060 | P=0.350N P=0.036N* P=0.183N P=0.301N |
|INCIDENTAL TUMOR | P=0.020 * P=0.005 ** P=0.248 P=0.004 ** | P=0.198N P=0.013N* P=0.040N* P=0.143N |
|LOGISTIC REGRESSION | P=0.022 * P=0.002 ** P=0.238 P=0.005 ** | P=0.212N P=0.009N** P=0.028N* P=0.136N |
|COCHRAN-ARMITAGE | P=0.031 * | P=0.179N |
|FISHER EXACT | P=0.004 ** P=0.282 P=0.006 ** | P=0.004N** P=0.055N P=0.088N |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 29/46 (63%) 39/48 (81%) 49/50 (98%) | 40/50 (80%) 23/50 (46%) 26/50 (52%) 33/50 (66%) |
|ADJUSTED (b) | 100.0% 69.9% 86.3% 100.0% | 95.1% 59.4% 61.7% 86.1% |
|TERMINAL (d) | 7/7 (100%) 1/13 (8%) 1/7 (14%) 10/10 (100%)| 20/22 (91%) 2/16 (13%) 2/17 (12%) 11/16 (69%) |
|FIRST INCIDENCE (DAYS) | 441 349 439 428 | 408 446 441 391 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.386 P=0.008N** P=0.284N P=0.286N | P=0.433 P=0.113N P=0.141N P=0.484 |
|INCIDENTAL TUMOR | P=0.051 P<0.001N** P=0.009N** P=0.684 | P=0.215N P<0.001N** P<0.001N** P=0.126N |
|LOGISTIC REGRESSION | P=0.074 P<0.001N** P=0.007N** P=0.633 | P=0.272N P<0.001N** P<0.001N** P=0.141N |
|COCHRAN-ARMITAGE | P=0.101 | P=0.295N |
|FISHER EXACT | P<0.001N** P=0.006N** P=0.753N | P<0.001N** P=0.003N** P=0.088N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 60 MG/KG 120 240 | 0 MG/KG 60 MG/KG 120 240 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 29/46 (63%) 25/48 (52%) 32/50 (64%) | 23/50 (46%) 8/50 (16%) 11/50 (22%) 15/50 (30%) |
|ADJUSTED (b) | 63.8% 100.0% 93.6% 100.0% | 61.2% 27.9% 33.1% 53.5% |
|TERMINAL (d) | 1/7 (14%) 13/13 (100%) 6/7 (86%) 10/10 (100%)| 9/22 (41%) 1/16 (6%) 0/17 (0%) 6/16 (38%) |
|FIRST INCIDENCE (DAYS) | 527 491 477 433 | 303 446 492 338 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.120 P=0.266 P=0.175 P=0.139 | P=0.361N P=0.025N* P=0.070N P=0.312N |
|INCIDENTAL TUMOR | P=0.036 * P=0.012 * P=0.142 P=0.010 * | P=0.166N P=0.002N** P=0.009N** P=0.082N |
|LOGISTIC REGRESSION | P=0.028 * P=0.012 * P=0.154 P=0.012 * | P=0.179N P=0.001N** P=0.010N** P=0.077N |
|COCHRAN-ARMITAGE | P=0.033 * | P=0.177N |
|FISHER EXACT | P=0.020 * P=0.159 P=0.014 * | P=0.001N** P=0.010N** P=0.074N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 45/46 (98%) 46/48 (96%) 49/50 (98%) | 45/50 (90%) 25/50 (50%) 27/50 (54%) 41/50 (82%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 95.7% 62.3% 63.1% 95.3% |
|TERMINAL (d) | 7/7 (100%) 13/13 (100%) 7/7 (100%) 10/10 (100%)| 20/22 (91%) 2/16 (13%) 2/17 (12%) 14/16 (88%) |
|FIRST INCIDENCE (DAYS) | 441 349 439 428 | 303 446 441 338 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.380N P=0.144N P=0.541N P=0.252N | P=0.233 P=0.072N P=0.068N P=0.272 |
|INCIDENTAL TUMOR | P=0.240N (e) P=0.500N P=0.571N | P=0.507N P<0.001N** P<0.001N** P=0.249N |
|LOGISTIC REGRESSION | P=0.221N (e) P=0.458N P=0.571N | P=0.490 P<0.001N** P<0.001N** P=0.273N |
|COCHRAN-ARMITAGE | P=0.374N | P=0.479 |
|FISHER EXACT | P=0.479N P=0.237N P=0.500N | P<0.001N** P<0.001N** P=0.194N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 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).