TDMS Study 05188-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SODIUM XYLENESULFONATE DATE: 04/04/96
EXPERIMENT: 05188 TEST: 06 TIME: 05:12:45
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55403D
PATHOLOGIST: SINGER, A. 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: 06 TIME: 05:12:45
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55403D
PATHOLOGIST: SINGER, A. CAS: 1300-72-7
MICE(B6C3F1)
----------------------------
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
Epididymis
Gallbladder
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: 06 TIME: 05:12:45
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55403D
PATHOLOGIST: SINGER, A. CAS: 1300-72-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF SODIUM XYLENESULFONATE
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated
Cell Type
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Uterus Polyp Stromal
All Organs Hemangiosarcoma
Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/12 (0%) 0/11 (0%) 2/50 (4%) | 0/50 (0%) 0/17 (0%) 0/18 (0%) 1/48 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 5.2% | 0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/32 (0%) 0/0 0/0 0/35 (0%) | 0/31 (0%) 0/0 0/0 0/35 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 707 | --- --- --- 686 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.052 (e) (e) P=0.278 | P=0.227 (e) (e) P=0.535 |
|INCIDENTAL TUMOR | P=0.034 * (e) (e) P=0.122 | P=0.187 (e) (e) P=0.455 |
|LOGISTIC REGRESSION | P=0.123 (e) (e) P=0.239 | P=0.258 (e) (e) P=0.488 |
|COCHRAN-ARMITAGE | P=0.106 | P=0.253 |
|FISHER EXACT | (e) (e) P=0.247 | (e) (e) P=0.490 |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | 3/50 (6%) 0/49 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 2.4% 0.0% 2.5% 2.9% | 8.9% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/32 (0%) 0/37 (0%) 0/39 (0%) 1/35 (3%) | 2/31 (6%) 0/32 (0%) 0/32 (0%) 0/36 (0%) |
|FIRST INCIDENCE (DAYS) | 686 --- 722 733 (T) | 670 --- --- 707 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.551 P=0.505N P=0.730N P=0.750N | P=0.220N P=0.122N P=0.121N P=0.258N |
|INCIDENTAL TUMOR | P=0.445 P=0.638N P=0.461 P=0.711 | P=0.248N P=0.139N P=0.125N P=0.318N |
|LOGISTIC REGRESSION | P=0.541 P=0.496N P=0.762 P=0.762N | P=0.235N P=0.125N P=0.116N P=0.292N |
|COCHRAN-ARMITAGE | P=0.539 | P=0.246N |
|FISHER EXACT | P=0.500N P=0.753N P=0.753N | P=0.125N P=0.121N P=0.309N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 2/49 (4%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 2.9% | 2.0% 4.9% 2.7% 5.6% |
|TERMINAL (d) | 0/32 (0%) 0/37 (0%) 0/39 (0%) 1/35 (3%) | 0/31 (0%) 0/32 (0%) 0/32 (0%) 2/36 (6%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 733 (T) | 453 636 674 740 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.200 (e) (e) P=0.518 | P=0.484 P=0.484 P=0.760 P=0.532 |
|INCIDENTAL TUMOR | P=0.200 (e) (e) P=0.518 | P=0.380 P=0.459 P=0.479 P=0.457 |
|LOGISTIC REGRESSION | P=0.200 (e) (e) P=0.518 | P=0.431 P=0.549 P=0.636 P=0.497 |
|COCHRAN-ARMITAGE | P=0.198 | P=0.447 |
|FISHER EXACT | (e) (e) P=0.500 | P=0.492 P=0.753N P=0.500 |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 4/50 (8%) 2/49 (4%) 1/50 (2%) 3/50 (6%) |
|ADJUSTED (b) | 2.4% 0.0% 2.5% 5.7% | 10.7% 4.9% 2.7% 7.9% |
|TERMINAL (d) | 0/32 (0%) 0/37 (0%) 0/39 (0%) 2/35 (6%) | 2/31 (6%) 0/32 (0%) 0/32 (0%) 2/36 (6%) |
|FIRST INCIDENCE (DAYS) | 686 --- 722 733 (T) | 453 636 674 707 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.257 P=0.505N P=0.730N P=0.521 | P=0.402N P=0.350N P=0.183N P=0.435N |
|INCIDENTAL TUMOR | P=0.195 P=0.638N P=0.461 P=0.457 | P=0.506N P=0.389N P=0.318N P=0.540N |
|LOGISTIC REGRESSION | P=0.249 P=0.496N P=0.762 P=0.505 | P=0.465N P=0.326N P=0.216N P=0.506N |
|COCHRAN-ARMITAGE | P=0.247 | P=0.453N |
|FISHER EXACT | P=0.500N P=0.753N P=0.500 | P=0.349N P=0.181N P=0.500N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/12 (0%) 0/11 (0%) 0/50 (0%) | 2/50 (4%) 0/17 (0%) 1/18 (6%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.3% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/0 0/0 0/35 (0%) | 0/31 (0%) 0/0 0/0 0/36 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 495 --- 654 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.180N P=0.252N P=0.490N P=0.233N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.258N P=0.240N P=0.688N P=0.351N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.200N P=0.310N P=0.680 P=0.204N |
|COCHRAN-ARMITAGE | (e) | P=0.191N |
|FISHER EXACT | (e) (e) (e) | P=0.554N P=0.609 P=0.247N |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/13 (0%) 0/11 (0%) 2/50 (4%) | 0/50 (0%) 0/17 (0%) 0/18 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 5.7% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/0 0/0 2/35 (6%) | 0/31 (0%) 0/0 0/0 0/36 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 733 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.157 (e) (e) P=0.258 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.157 (e) (e) P=0.258 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.157 (e) (e) P=0.258 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.105 | (e) |
|FISHER EXACT | (e) (e) P=0.247 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.1% 0.0% 0.0% 2.2% | 5.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/37 (0%) 0/39 (0%) 0/35 (0%) | 1/31 (3%) 0/32 (0%) 0/32 (0%) 0/36 (0%) |
|FIRST INCIDENCE (DAYS) | 706 --- --- 631 | 670 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.443N P=0.209N P=0.195N P=0.470N | P=0.107N P=0.242N P=0.239N P=0.211N |
|INCIDENTAL TUMOR | P=0.468N P=0.295N P=0.338N P=0.495N | P=0.118N P=0.275N P=0.248N P=0.247N |
|LOGISTIC REGRESSION | P=0.463N P=0.232N P=0.229N P=0.499N | P=0.112N P=0.244N P=0.234N P=0.234N |
|COCHRAN-ARMITAGE | P=0.461N | P=0.115N |
|FISHER EXACT | P=0.247N P=0.247N P=0.500N | P=0.253N P=0.247N P=0.247N |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 4/50 (8%) 2/50 (4%) | 0/50 (0%) 1/49 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 13.6% 7.4% 10.3% 5.7% | 0.0% 3.1% 3.1% 0.0% |
|TERMINAL (d) | 3/32 (9%) 1/37 (3%) 4/39 (10%) 2/35 (6%) | 0/31 (0%) 1/32 (3%) 1/32 (3%) 0/36 (0%) |
|FIRST INCIDENCE (DAYS) | 647 658 733 (T) 733 (T) | --- 740 (T) 740 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.178N P=0.313N P=0.405N P=0.196N | P=0.563N P=0.506 P=0.506 (e) |
|INCIDENTAL TUMOR | P=0.255N P=0.507N P=0.561N P=0.254N | P=0.563N P=0.506 P=0.506 (e) |
|LOGISTIC REGRESSION | P=0.196N P=0.356N P=0.481N P=0.213N | P=0.563N P=0.506 P=0.506 (e) |
|COCHRAN-ARMITAGE | P=0.200N | P=0.593N |
|FISHER EXACT | P=0.357N P=0.500N P=0.218N | P=0.495 P=0.500 (e) |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 10.8% 0.0% 5.7% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 4/37 (11%) 0/39 (0%) 2/35 (6%) | 0/31 (0%) 0/32 (0%) 0/32 (0%) 0/36 (0%) |
|FIRST INCIDENCE (DAYS) | --- 733 (T) --- 733 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.466 P=0.082 (e) P=0.258 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.466 P=0.082 (e) P=0.258 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.466 P=0.082 (e) P=0.258 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.444 | (e) |
|FISHER EXACT | P=0.059 (e) P=0.247 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 37/50 (74%) 32/50 (64%) 21/50 (42%) 29/50 (58%) | 18/50 (36%) 17/49 (35%) 18/50 (36%) 28/50 (56%) |
|ADJUSTED (b) | 85.6% 72.5% 51.0% 74.0% | 54.1% 47.8% 49.0% 69.8% |
|TERMINAL (d) | 26/32 (81%) 25/37 (68%) 19/39 (49%) 25/35 (71%) | 16/31 (52%) 14/32 (44%) 14/32 (44%) 24/36 (67%) |
|FIRST INCIDENCE (DAYS) | 564 322 612 585 | 621 446 601 686 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.029N* P=0.080N P<0.001N** P=0.036N* | P=0.060 P=0.459N P=0.540N P=0.118 |
|INCIDENTAL TUMOR | P=0.045N* P=0.126N P<0.001N** P=0.039N* | P=0.033 * P=0.489N P=0.459N P=0.072 |
|LOGISTIC REGRESSION | P=0.043N* P=0.194N P<0.001N** P=0.063N | P=0.034 * P=0.533N P=0.553N P=0.080 |
|COCHRAN-ARMITAGE | P=0.046N* | P=0.016 * |
|FISHER EXACT | P=0.194N P=0.001N** P=0.069N | P=0.530N P=0.582N P=0.035 * |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 31/50 (62%) 22/50 (44%) 26/50 (52%) | 10/50 (20%) 13/49 (27%) 7/50 (14%) 10/50 (20%) |
|ADJUSTED (b) | 77.3% 68.8% 47.3% 56.2% | 25.5% 36.3% 17.0% 24.7% |
|TERMINAL (d) | 22/32 (69%) 23/37 (62%) 15/39 (38%) 15/35 (43%) | 4/31 (13%) 10/32 (31%) 2/32 (6%) 6/36 (17%) |
|FIRST INCIDENCE (DAYS) | 494 610 506 457 | 495 411 575 675 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.037N* P=0.144N P=0.005N** P=0.056N | P=0.292N P=0.342 P=0.297N P=0.469N |
|INCIDENTAL TUMOR | P=0.033N* P=0.338N P=0.011N* P=0.070N | P=0.445N P=0.264 P=0.394N P=0.520 |
|LOGISTIC REGRESSION | P=0.030N* P=0.264N P=0.009N** P=0.051N | P=0.397N P=0.293 P=0.360N P=0.595N |
|COCHRAN-ARMITAGE | P=0.030N* | P=0.399N |
|FISHER EXACT | P=0.263N P=0.007N** P=0.050N | P=0.298 P=0.298N P=0.598N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 31/50 (62%) 22/50 (44%) 26/50 (52%) | 10/50 (20%) 13/49 (27%) 7/50 (14%) 10/50 (20%) |
|ADJUSTED (b) | 77.3% 68.8% 47.3% 56.2% | 25.5% 36.3% 17.0% 24.7% |
|TERMINAL (d) | 22/32 (69%) 23/37 (62%) 15/39 (38%) 15/35 (43%) | 4/31 (13%) 10/32 (31%) 2/32 (6%) 6/36 (17%) |
|FIRST INCIDENCE (DAYS) | 494 610 506 457 | 495 411 575 675 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.037N* P=0.144N P=0.005N** P=0.056N | P=0.292N P=0.342 P=0.297N P=0.469N |
|INCIDENTAL TUMOR | P=0.033N* P=0.338N P=0.011N* P=0.070N | P=0.445N P=0.264 P=0.394N P=0.520 |
|LOGISTIC REGRESSION | P=0.030N* P=0.264N P=0.009N** P=0.051N | P=0.397N P=0.293 P=0.360N P=0.595N |
|COCHRAN-ARMITAGE | P=0.030N* | P=0.399N |
|FISHER EXACT | P=0.263N P=0.007N** P=0.050N | P=0.298 P=0.298N P=0.598N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 41/50 (82%) 31/50 (62%) 45/50 (90%) | 27/50 (54%) 23/49 (47%) 23/50 (46%) 33/50 (66%) |
|ADJUSTED (b) | 93.8% 85.4% 64.3% 93.7% | 68.6% 61.4% 56.4% 76.7% |
|TERMINAL (d) | 29/32 (91%) 30/37 (81%) 22/39 (56%) 32/35 (91%) | 19/31 (61%) 18/32 (56%) 15/32 (47%) 26/36 (72%) |
|FIRST INCIDENCE (DAYS) | 494 322 506 457 | 495 411 575 675 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.326N P=0.079N P=0.001N** P=0.290N | P=0.295 P=0.254N P=0.259N P=0.448 |
|INCIDENTAL TUMOR | P=0.460N P=0.129N P<0.001N** P=0.496N | P=0.121 P=0.315N P=0.270N P=0.207 |
|LOGISTIC REGRESSION | P=0.448N P=0.119N P<0.001N** P=0.501N | P=0.131 P=0.326N P=0.237N P=0.237 |
|COCHRAN-ARMITAGE | P=0.439N | P=0.088 |
|FISHER EXACT | P=0.117N P<0.001N** P=0.500N | P=0.308N P=0.274N P=0.154 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 41/50 (82%) 31/50 (62%) 45/50 (90%) | 27/50 (54%) 23/49 (47%) 23/50 (46%) 33/50 (66%) |
|ADJUSTED (b) | 93.8% 85.4% 64.3% 93.7% | 68.6% 61.4% 56.4% 76.7% |
|TERMINAL (d) | 29/32 (91%) 30/37 (81%) 22/39 (56%) 32/35 (91%) | 19/31 (61%) 18/32 (56%) 15/32 (47%) 26/36 (72%) |
|FIRST INCIDENCE (DAYS) | 494 322 506 457 | 495 411 575 675 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.326N P=0.079N P=0.001N** P=0.290N | P=0.295 P=0.254N P=0.259N P=0.448 |
|INCIDENTAL TUMOR | P=0.460N P=0.129N P<0.001N** P=0.496N | P=0.121 P=0.315N P=0.270N P=0.207 |
|LOGISTIC REGRESSION | P=0.448N P=0.119N P<0.001N** P=0.501N | P=0.131 P=0.326N P=0.237N P=0.237 |
|COCHRAN-ARMITAGE | P=0.439N | P=0.088 |
|FISHER EXACT | P=0.117N P<0.001N** P=0.500N | P=0.308N P=0.274N P=0.154 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocholangiocarcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 0/49 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 2.6% 0.0% 0.0% 0.0% | 2.3% 0.0% 2.2% 4.2% |
|TERMINAL (d) | 0/32 (0%) 0/37 (0%) 0/39 (0%) 0/35 (0%) | 0/31 (0%) 0/32 (0%) 0/32 (0%) 0/36 (0%) |
|FIRST INCIDENCE (DAYS) | 691 --- --- --- | 620 --- 602 534 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.296N P=0.495N P=0.485N P=0.485N | P=0.272 P=0.509N P=0.758N P=0.526 |
|INCIDENTAL TUMOR | P=0.395N P=0.638N P=0.748N P=0.612N | P=0.139 P=0.500N P=0.573N P=0.348 |
|LOGISTIC REGRESSION | P=0.307N P=0.498N P=0.504N P=0.500N | P=0.235 P=0.486N P=0.696 P=0.511 |
|COCHRAN-ARMITAGE | P=0.306N | P=0.249 |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.505N P=0.753N P=0.500 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 4/16 (25%) 2/15 (13%) 9/50 (18%) | 4/50 (8%) 1/18 (6%) 2/18 (11%) 6/50 (12%) |
|ADJUSTED (b) | 40.6% 8.6% 4.7% 22.9% | 11.5% 2.6% 5.4% 16.7% |
|TERMINAL (d) | 13/32 (41%) 0/3 (0%) 0/4 (0%) 6/35 (17%) | 2/31 (6%) 0/1 (0%) 0/0 6/36 (17%) |
|FIRST INCIDENCE (DAYS) | 733 (T) 540 686 543 | 659 666 654 740 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.124N P=0.382 P=0.494N P=0.160N | P=0.384 P=0.477N P=0.688N P=0.461 |
|INCIDENTAL TUMOR | P=0.151N P=0.303 P=0.640 P=0.185N | P=0.339 P=0.596N P=0.667 P=0.417 |
|LOGISTIC REGRESSION | P=0.162N P=0.460 P=0.624N P=0.212N | P=0.370 P=0.725 P=0.353 P=0.433 |
|COCHRAN-ARMITAGE | P=0.182N | P=0.267 |
|FISHER EXACT | P=0.608N P=0.258N P=0.235N | P=0.601N P=0.506 P=0.370 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/16 (6%) 1/15 (7%) 1/50 (2%) | 2/50 (4%) 0/18 (0%) 1/18 (6%) 0/50 (0%) |
|ADJUSTED (b) | 4.4% 2.6% 2.2% 2.2% | 6.5% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/3 (0%) 0/4 (0%) 0/35 (0%) | 2/31 (6%) 0/1 (0%) 0/0 0/36 (0%) |
|FIRST INCIDENCE (DAYS) | 575 702 636 631 | 740 (T) --- 622 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.410N P=0.490N P=0.505N P=0.508N | P=0.165N P=0.965N P=0.514 P=0.206N |
|INCIDENTAL TUMOR | P=0.395N P=0.626N P=0.470N P=0.443N | P=0.165N P=0.965N P=0.662 P=0.206N |
|LOGISTIC REGRESSION | P=0.380N P=0.742 P=0.714N P=0.470N | P=0.181N P=0.965N P=0.600 P=0.206N |
|COCHRAN-ARMITAGE | P=0.361N | P=0.192N |
|FISHER EXACT | P=0.572 P=0.551 P=0.500N | P=0.538N P=0.609 P=0.247N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 5/16 (31%) 3/15 (20%) 10/50 (20%) | 5/50 (10%) 1/18 (6%) 3/18 (17%) 6/50 (12%) |
|ADJUSTED (b) | 43.2% 11.0% 6.8% 24.6% | 14.6% 2.6% 7.5% 16.7% |
|TERMINAL (d) | 13/32 (41%) 0/3 (0%) 0/4 (0%) 6/35 (17%) | 3/31 (10%) 0/1 (0%) 0/0 6/36 (17%) |
|FIRST INCIDENCE (DAYS) | 575 540 636 543 | 659 666 622 740 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.102N P=0.535 P=0.363N P=0.128N | P=0.505 P=0.464N P=0.509 P=0.598 |
|INCIDENTAL TUMOR | P=0.117N P=0.388 P=0.517N P=0.131N | P=0.456 P=0.580N P=0.534 P=0.557 |
|LOGISTIC REGRESSION | P=0.124N P=0.472 P=0.551N P=0.175N | P=0.477 P=0.676N P=0.228 P=0.574 |
|COCHRAN-ARMITAGE | P=0.130N | P=0.378 |
|FISHER EXACT | P=0.578 P=0.343N P=0.178N | P=0.494N P=0.355 P=0.500 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/12 (0%) 0/10 (0%) 0/50 (0%) | 7/50 (14%) 3/17 (18%) 1/18 (6%) 5/49 (10%) |
|ADJUSTED (b) | 2.9% 0.0% 0.0% 0.0% | 20.4% 7.9% 2.3% 12.9% |
|TERMINAL (d) | 0/31 (0%) 0/0 0/0 0/35 (0%) | 5/31 (16%) 0/0 0/0 3/35 (9%) |
|FIRST INCIDENCE (DAYS) | 702 --- --- --- | 621 666 636 686 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.290N P=0.478N P=0.468N P=0.473N | P=0.208N P=0.501 P=0.495N P=0.299N |
|INCIDENTAL TUMOR | P=0.399N P=0.669N P=0.802N P=0.612N | P=0.249N P=0.364 P=0.327N P=0.379N |
|LOGISTIC REGRESSION | P=0.306N P=0.858N P=0.891N P=0.496N | P=0.225N P=0.243 P=0.451N P=0.357N |
|COCHRAN-ARMITAGE | P=0.308N | P=0.285N |
|FISHER EXACT | P=0.803N P=0.831N P=0.495N | P=0.492 P=0.316N P=0.394N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/12 (0%) 0/10 (0%) 0/50 (0%) | 1/50 (2%) 0/17 (0%) 0/18 (0%) 2/49 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.2% 0.0% 0.0% 5.7% |
|TERMINAL (d) | 0/31 (0%) 0/0 0/0 0/35 (0%) | 1/31 (3%) 0/0 0/0 2/35 (6%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 740 (T) --- --- 740 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.426 (e) (e) P=0.543 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.426 (e) (e) P=0.543 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.426 (e) (e) P=0.543 |
|COCHRAN-ARMITAGE | (e) | P=0.317 |
|FISHER EXACT | (e) (e) (e) | P=0.746N P=0.735N P=0.492 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/12 (0%) 0/10 (0%) 0/50 (0%) | 1/50 (2%) 0/17 (0%) 0/18 (0%) 3/49 (6%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.2% 0.0% 0.0% 7.8% |
|TERMINAL (d) | 0/31 (0%) 0/0 0/0 0/35 (0%) | 1/31 (3%) 0/0 0/0 2/35 (6%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 740 (T) --- --- 629 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.223 (e) (e) P=0.348 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.209 (e) (e) P=0.313 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.188 (e) (e) P=0.307 |
|COCHRAN-ARMITAGE | (e) | P=0.150 |
|FISHER EXACT | (e) (e) (e) | P=0.746N P=0.735N P=0.301 |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/13 (8%) 1/12 (8%) 3/49 (6%) | 0/50 (0%) 1/17 (6%) 0/18 (0%) 2/50 (4%) |
|ADJUSTED (b) | 5.5% 2.0% 2.2% 8.0% | 0.0% 2.5% 0.0% 5.6% |
|TERMINAL (d) | 1/32 (3%) 0/0 0/1 (0%) 2/35 (6%) | 0/31 (0%) 0/0 0/0 2/36 (6%) |
|FIRST INCIDENCE (DAYS) | 686 540 612 691 | --- 642 --- 740 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.439 P=0.758 P=0.735N P=0.531 | P=0.274 P=0.495 (e) P=0.272 |
|INCIDENTAL TUMOR | P=0.430 P=0.686 P=0.740 P=0.425 | P=0.256 P=0.500 (e) P=0.272 |
|LOGISTIC REGRESSION | P=0.410 P=0.709 P=0.618 P=0.498 | P=0.245 P=0.288 (e) P=0.272 |
|COCHRAN-ARMITAGE | P=0.428 | P=0.214 |
|FISHER EXACT | P=0.506 P=0.482 P=0.490 | P=0.254 (e) P=0.247 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.0% 0.0% 0.0% 2.9% | 0.0% 5.5% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/37 (0%) 0/39 (0%) 1/35 (3%) | 0/31 (0%) 0/32 (0%) 0/32 (0%) 0/36 (0%) |
|FIRST INCIDENCE (DAYS) | 564 --- --- 733 (T) | --- 666 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.600 P=0.504N P=0.508N P=0.753N | P=0.381N P=0.243 (e) (e) |
|INCIDENTAL TUMOR | P=0.651 P=0.443N P=0.362N P=0.694N | P=0.432N P=0.158 (e) (e) |
|LOGISTIC REGRESSION | P=0.589 P=0.400N P=0.502N P=0.754N | P=0.402N P=0.231 (e) (e) |
|COCHRAN-ARMITAGE | P=0.595 | P=0.404N |
|FISHER EXACT | P=0.500N P=0.500N P=0.753N | P=0.242 (e) (e) |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/13 (0%) 1/11 (9%) 1/50 (2%) | 2/50 (4%) 5/48 (10%) 1/50 (2%) 6/50 (12%) |
|ADJUSTED (b) | 5.9% 0.0% 2.4% 2.9% | 5.5% 16.1% 3.1% 16.0% |
|TERMINAL (d) | 1/32 (3%) 0/0 0/0 1/35 (3%) | 1/31 (3%) 5/31 (16%) 1/32 (3%) 5/36 (14%) |
|FIRST INCIDENCE (DAYS) | 702 --- 718 733 (T) | 621 740 (T) 740 (T) 707 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.410N P=0.478N P=0.715N P=0.464N | P=0.214 P=0.215 P=0.490N P=0.187 |
|INCIDENTAL TUMOR | P=0.497N P=0.638N P=0.461 P=0.543N | P=0.197 P=0.217 P=0.402N P=0.152 |
|LOGISTIC REGRESSION | P=0.398N P=0.794N P=0.313 P=0.490N | P=0.197 P=0.197 P=0.498N P=0.151 |
|COCHRAN-ARMITAGE | P=0.436N | P=0.157 |
|FISHER EXACT | P=0.627N P=0.455 P=0.500N | P=0.201 P=0.500N P=0.134 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/13 (0%) 1/11 (9%) 1/50 (2%) | 2/50 (4%) 5/48 (10%) 1/50 (2%) 7/50 (14%) |
|ADJUSTED (b) | 5.9% 0.0% 2.4% 2.9% | 5.5% 16.1% 3.1% 18.8% |
|TERMINAL (d) | 1/32 (3%) 0/0 0/0 1/35 (3%) | 1/31 (3%) 5/31 (16%) 1/32 (3%) 6/36 (17%) |
|FIRST INCIDENCE (DAYS) | 702 --- 718 733 (T) | 621 740 (T) 740 (T) 707 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.410N P=0.478N P=0.715N P=0.464N | P=0.124 P=0.215 P=0.490N P=0.122 |
|INCIDENTAL TUMOR | P=0.497N P=0.638N P=0.461 P=0.543N | P=0.112 P=0.217 P=0.402N P=0.098 |
|LOGISTIC REGRESSION | P=0.398N P=0.794N P=0.313 P=0.490N | P=0.112 P=0.197 P=0.498N P=0.096 |
|COCHRAN-ARMITAGE | P=0.436N | P=0.084 |
|FISHER EXACT | P=0.627N P=0.455 P=0.500N | P=0.201 P=0.500N P=0.080 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 3/50 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | | 9.4% 3.0% 0.0% 0.0% |
|TERMINAL (d) | | 2/31 (6%) 0/32 (0%) 0/32 (0%) 0/36 (0%) |
|FIRST INCIDENCE (DAYS) | | 734 735 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.038N* P=0.294N P=0.119N P=0.098N |
|INCIDENTAL TUMOR | | P=0.045N* P=0.364N P=0.125N P=0.118N |
|LOGISTIC REGRESSION | | P=0.037N* P=0.297N P=0.118N P=0.096N |
|COCHRAN-ARMITAGE | | P=0.044N* |
|FISHER EXACT | | P=0.316N P=0.121N P=0.121N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 2/50 (4%) 0/49 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 8.0% 0.0% 2.6% 4.4% | 5.7% 0.0% 2.4% 2.6% |
|TERMINAL (d) | 1/32 (3%) 0/37 (0%) 1/39 (3%) 0/35 (0%) | 1/31 (3%) 0/32 (0%) 0/32 (0%) 0/36 (0%) |
|FIRST INCIDENCE (DAYS) | 575 --- 733 (T) 631 | 670 --- 654 717 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.543N P=0.108N P=0.259N P=0.483N | P=0.462N P=0.242N P=0.499N P=0.453N |
|INCIDENTAL TUMOR | P=0.501N P=0.133N P=0.302N P=0.396N | P=0.519N P=0.275N P=0.521N P=0.535N |
|LOGISTIC REGRESSION | P=0.562N P=0.109N P=0.312N P=0.484N | P=0.498N P=0.244N P=0.509N P=0.493N |
|COCHRAN-ARMITAGE | P=0.556N | P=0.498N |
|FISHER EXACT | P=0.121N P=0.309N P=0.500N | P=0.253N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 6/50 (12%) 5/50 (10%) | 0/50 (0%) 2/49 (4%) 1/50 (2%) 4/50 (8%) |
|ADJUSTED (b) | 15.7% 9.3% 14.2% 13.6% | 0.0% 5.5% 3.1% 11.1% |
|TERMINAL (d) | 3/32 (9%) 1/37 (3%) 4/39 (10%) 4/35 (11%) | 0/31 (0%) 1/32 (3%) 1/32 (3%) 4/36 (11%) |
|FIRST INCIDENCE (DAYS) | 647 540 612 691 | --- 642 740 (T) 740 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.482N P=0.333N P=0.531N P=0.458N | P=0.056 P=0.240 P=0.506 P=0.083 |
|INCIDENTAL TUMOR | P=0.535 P=0.552N P=0.474 P=0.599N | P=0.049 * P=0.243 P=0.506 P=0.083 |
|LOGISTIC REGRESSION | P=0.517N P=0.359N P=0.618 P=0.496N | P=0.050 * P=0.232 P=0.506 P=0.083 |
|COCHRAN-ARMITAGE | P=0.516N | P=0.040 * |
|FISHER EXACT | P=0.370N P=0.620N P=0.500N | P=0.242 P=0.500 P=0.059 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 4/50 (8%) 7/50 (14%) 7/50 (14%) | 2/50 (4%) 2/49 (4%) 2/50 (4%) 5/50 (10%) |
|ADJUSTED (b) | 22.7% 9.3% 16.7% 17.4% | 5.7% 5.5% 5.5% 13.4% |
|TERMINAL (d) | 4/32 (13%) 1/37 (3%) 5/39 (13%) 4/35 (11%) | 1/31 (3%) 1/32 (3%) 1/32 (3%) 4/36 (11%) |
|FIRST INCIDENCE (DAYS) | 575 540 612 631 | 670 642 654 717 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.452N P=0.103N P=0.300N P=0.356N | P=0.158 P=0.691 P=0.689N P=0.281 |
|INCIDENTAL TUMOR | P=0.524N P=0.221N P=0.526N P=0.418N | P=0.127 P=0.667 P=0.682 P=0.235 |
|LOGISTIC REGRESSION | P=0.554N P=0.108N P=0.402N P=0.393N | P=0.129 P=0.685 P=0.693N P=0.249 |
|COCHRAN-ARMITAGE | P=0.486N | P=0.116 |
|FISHER EXACT | P=0.117N P=0.393N P=0.393N | P=0.684 P=0.691N P=0.218 |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 2/49 (4%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 4.8% 0.0% 0.0% | 7.0% 5.0% 6.0% 5.4% |
|TERMINAL (d) | 0/32 (0%) 1/37 (3%) 0/39 (0%) 0/35 (0%) | 0/31 (0%) 0/32 (0%) 1/32 (3%) 1/36 (3%) |
|FIRST INCIDENCE (DAYS) | --- 610 --- --- | 499 467 728 738 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.399N P=0.258 (e) (e) | P=0.382N P=0.512N P=0.487N P=0.450N |
|INCIDENTAL TUMOR | P=0.349N P=0.288 (e) (e) | P=0.550N P=0.566N P=0.642N P=0.613N |
|LOGISTIC REGRESSION | P=0.408N P=0.246 (e) (e) | P=0.446N P=0.451N P=0.570N P=0.507N |
|COCHRAN-ARMITAGE | P=0.405N | P=0.428N |
|FISHER EXACT | P=0.247 (e) (e) | P=0.510N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated |
| Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 4/50 (8%) 6/50 (12%) | 8/50 (16%) 3/49 (6%) 3/50 (6%) 5/50 (10%) |
|ADJUSTED (b) | 12.3% 0.0% 9.1% 15.6% | 24.7% 8.1% 7.4% 11.7% |
|TERMINAL (d) | 0/32 (0%) 0/37 (0%) 2/39 (5%) 4/35 (11%) | 7/31 (23%) 0/32 (0%) 0/32 (0%) 2/36 (6%) |
|FIRST INCIDENCE (DAYS) | 651 --- 548 631 | 692 625 588 403 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.219 P=0.034N* P=0.451N P=0.550 | P=0.236N P=0.096N P=0.101N P=0.204N |
|INCIDENTAL TUMOR | P=0.148 P=0.108N P=0.514 P=0.344 | P=0.319N P=0.127N P=0.083N P=0.281N |
|LOGISTIC REGRESSION | P=0.147 P=0.031N* P=0.582 P=0.500 | P=0.299N P=0.104N P=0.094N P=0.275N |
|COCHRAN-ARMITAGE | P=0.194 | P=0.294N |
|FISHER EXACT | P=0.028N* P=0.500N P=0.500 | P=0.106N P=0.100N P=0.277N |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 43/50 (86%) 33/50 (66%) 24/50 (48%) 37/50 (74%) | 29/50 (58%) 22/49 (45%) 20/50 (40%) 35/50 (70%) |
|ADJUSTED (b) | 95.4% 73.1% 55.7% 83.9% | 74.1% 56.0% 51.7% 83.3% |
|TERMINAL (d) | 30/32 (94%) 25/37 (68%) 20/39 (51%) 28/35 (80%) | 21/31 (68%) 15/32 (47%) 14/32 (44%) 29/36 (81%) |
|FIRST INCIDENCE (DAYS) | 564 322 612 543 | 589 446 601 686 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.116N P=0.010N* P<0.001N** P=0.071N | P=0.267 P=0.118N P=0.057N P=0.471 |
|INCIDENTAL TUMOR | P=0.207N P=0.013N* P<0.001N** P=0.084N | P=0.127 P=0.166N P=0.020N* P=0.252 |
|LOGISTIC REGRESSION | P=0.151N P=0.018N* P<0.001N** P=0.100N | P=0.140 P=0.132N P=0.034N* P=0.303 |
|COCHRAN-ARMITAGE | P=0.158N | P=0.074 |
|FISHER EXACT | P=0.017N* P<0.001N** P=0.105N | P=0.135N P=0.055N P=0.149 |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM XYLENESULFONATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 182 364 727 | 0 MG/KG 182 364 727 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 33/50 (66%) 29/50 (58%) 33/50 (66%) | 25/50 (50%) 22/49 (45%) 18/50 (36%) 26/50 (52%) |
|ADJUSTED (b) | 81.1% 70.1% 59.0% 68.7% | 57.3% 50.2% 39.4% 54.0% |
|TERMINAL (d) | 23/32 (72%) 23/37 (62%) 19/39 (49%) 20/35 (57%) | 13/31 (42%) 11/32 (34%) 5/32 (16%) 14/36 (39%) |
|FIRST INCIDENCE (DAYS) | 494 540 506 457 | 453 337 575 403 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.147N P=0.092N P=0.019N* P=0.129N | P=0.422N P=0.362N P=0.150N P=0.421N |
|INCIDENTAL TUMOR | P=0.158N P=0.266N P=0.058N P=0.212N | P=0.288 P=0.437N P=0.103N P=0.341 |
|LOGISTIC REGRESSION | P=0.164N P=0.133N P=0.041N* P=0.136N | P=0.274 P=0.365N P=0.054N P=0.331 |
|COCHRAN-ARMITAGE | P=0.143N | P=0.446 |
|FISHER EXACT | P=0.133N P=0.026N* P=0.133N | P=0.380N P=0.113N P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 41/50 (82%) 37/50 (74%) 47/50 (94%) | 45/50 (90%) 34/49 (69%) 31/50 (62%) 44/50 (88%) |
|ADJUSTED (b) | 98.0% 85.4% 74.0% 95.9% | 93.7% 73.8% 65.8% 89.8% |
|TERMINAL (d) | 31/32 (97%) 30/37 (81%) 26/39 (67%) 33/35 (94%) | 28/31 (90%) 20/32 (63%) 16/32 (50%) 31/36 (86%) |
|FIRST INCIDENCE (DAYS) | 494 322 506 457 | 453 337 575 403 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.336N P=0.026N* P=0.003N** P=0.218N | P=0.287N P=0.054N P=0.020N* P=0.164N |
|INCIDENTAL TUMOR | P=0.526N P=0.014N* P=0.002N** P=0.377N | P=0.424 P=0.019N* P<0.001N** P=0.537N |
|LOGISTIC REGRESSION | P=0.480N P=0.010N** P=0.002N** P=0.305N | P=0.396 P=0.012N* P<0.001N** P=0.465N |
|COCHRAN-ARMITAGE | P=0.472N | P=0.458 |
|FISHER EXACT | P=0.008N** P<0.001N** P=0.309N | P=0.010N** P<0.001N** P=0.500N |
|=================================================================================================================================|
DATE: 04/04/96 EXPERIMENT: 05188 TEST: 06 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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).