TDMS Study 05102-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus BENZETHONIUM CHLORIDE DATE: 05/19/95
EXPERIMENT: 05102 TEST: 05 TIME: 18:22:45
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75177 ROUTE: DERMAL,SOLUTION NTP C#: 61494B
PATHOLOGIST: R. PERSING S. EUSTIS CAS: 121-54-0
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus BENZETHONIUM CHLORIDE DATE: 05/19/95
EXPERIMENT: 05102 TEST: 05 TIME: 18:22:45
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75177 ROUTE: DERMAL,SOLUTION NTP C#: 61494B
PATHOLOGIST: R. PERSING S. EUSTIS CAS: 121-54-0
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 BENZETHONIUM CHLORIDE DATE: 05/19/95
EXPERIMENT: 05102 TEST: 05 TIME: 18:22:45
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75177 ROUTE: DERMAL,SOLUTION NTP C#: 61494B
PATHOLOGIST: R. PERSING S. EUSTIS CAS: 121-54-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF BENZETHONIUM CHLORIDE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Basal Cell Adenoma or Basosquamous Tumor Benign
Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma
Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,
malignant or NOS), or Trichoepithelioma
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal
Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
Keratoacanthoma
Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
Squamous Cell Papilloma, Papilloma, or Keratoacanthoma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/27 (19%) 0/0 (0%) 0/0 (0%) 7/29 (24%) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 1/2 (50%) |
|ADJUSTED (b) | 31.0% 0.0% 0.0% 32.5% | 50.0% 0.0% 0.0% 2.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 |
|TERMINAL (d) | 2/8 (25%) 0/0 0/0 3/13 (23%) | 3/6 (50%) 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 556 --- --- 619 | 729 (T) --- --- 634 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.416 P=0.636N P=0.489N P=0.522 | P=0.630 (e) (e) P=0.719 |
|INCIDENTAL TUMOR | P=0.350 (e) (e) P=0.391 | P=0.555 (e) (e) P=0.649 |
|LOGISTIC REGRESSION | P=0.350 (e) (e) P=0.391 | P=0.555 (e) (e) P=0.649 |
|COCHRAN-ARMITAGE | P=0.384 | P=0.500 |
|FISHER EXACT | P=1.000N P=1.000N P=0.427 | P=1.000N P=1.000N P=0.576 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/27 (19%) 0/0 (0%) 0/0 (0%) 8/29 (28%) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 1/2 (50%) |
|ADJUSTED (b) | 31.0% 0.0% 0.0% 34.0% | 50.0% 0.0% 0.0% 2.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 |
|TERMINAL (d) | 2/8 (25%) 0/0 0/0 3/13 (23%) | 3/6 (50%) 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 556 --- --- 556 | 729 (T) --- --- 634 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.299 P=0.636N P=0.489N P=0.405 | P=0.630 (e) (e) P=0.719 |
|INCIDENTAL TUMOR | P=0.234 (e) (e) P=0.267 | P=0.555 (e) (e) P=0.649 |
|LOGISTIC REGRESSION | P=0.234 (e) (e) P=0.267 | P=0.555 (e) (e) P=0.649 |
|COCHRAN-ARMITAGE | P=0.277 | P=0.500 |
|FISHER EXACT | P=1.000N P=1.000N P=0.315 | P=1.000N P=1.000N P=0.576 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/0 (0%) 0/0 (0%) 1/60 (2%) | 4/59 (7%) 0/0 (0%) 0/0 (0%) 4/59 (7%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 2.1% | 11.9% 0.0% 0.0% 16.7% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 1/9 (11%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/0 0/0 0/16 (0%) | 2/24 (8%) 0/0 0/0 4/24 (17%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 549 | 456 (I) --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.334 (e) (e) P=0.496 | P=0.577 P=0.999N P=0.965N P=0.627 |
|INCIDENTAL TUMOR | P=0.393 (e) (e) P=0.525 | P=0.589N (e) (e) P=0.636N |
|LOGISTIC REGRESSION | P=0.393 (e) (e) P=0.525 | P=0.589N (e) (e) P=0.636N |
|COCHRAN-ARMITAGE | P=0.369 | P=0.596 |
|FISHER EXACT | (e) (e) P=0.500 | P=1.000N P=1.000N P=0.642N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/0 (0%) 0/0 (0%) 0/60 (0%) | 0/59 (0%) 0/0 (0%) 0/0 (0%) 2/59 (3%) |
|ADJUSTED (b) | 4.4% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 8.3% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/0 0/0 0/16 (0%) | 0/24 (0%) 0/0 0/0 2/24 (8%) |
|FIRST INCIDENCE (DAYS) | 437 --- --- --- | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.196N P=0.770N P=0.641N P=0.253N | P=0.170 (e) (e) P=0.237 |
|INCIDENTAL TUMOR | P=0.127N (e) (e) P=0.183N | P=0.170 (e) (e) P=0.237 |
|LOGISTIC REGRESSION | P=0.127N (e) (e) P=0.183N | P=0.170 (e) (e) P=0.237 |
|COCHRAN-ARMITAGE | P=0.171N | P=0.171 |
|FISHER EXACT | P=1.000N P=1.000N P=0.248N | (e) (e) P=0.248 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/0 (0%) 0/0 (0%) 1/60 (2%) | 4/59 (7%) 0/0 (0%) 0/0 (0%) 6/59 (10%) |
|ADJUSTED (b) | 4.4% 0.0% 0.0% 2.1% | 11.9% 0.0% 0.0% 25.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 1/9 (11%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/0 0/0 0/16 (0%) | 2/24 (8%) 0/0 0/0 6/24 (25%) |
|FIRST INCIDENCE (DAYS) | 437 --- --- 549 | 456 (I) --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.481N P=0.770N P=0.641N P=0.516N | P=0.309 P=0.999N P=0.965N P=0.352 |
|INCIDENTAL TUMOR | P=0.349N (e) (e) P=0.424N | P=0.333 (e) (e) P=0.375 |
|LOGISTIC REGRESSION | P=0.349N (e) (e) P=0.424N | P=0.333 (e) (e) P=0.375 |
|COCHRAN-ARMITAGE | P=0.423N | P=0.330 |
|FISHER EXACT | P=1.000N P=1.000N P=0.500N | P=1.000N P=1.000N P=0.371 |
|=================================================================================================================================|
| |
|Ear |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/6 (0%) 0/9 (0%) 0/60 (0%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 17.9% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 2/15 (13%) 0/4 (0%) 0/3 (0%) 0/16 (0%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 714 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.103N P=0.444N P=0.520N P=0.117N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.106N P=0.556N P=0.491N P=0.128N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.098N P=0.499N P=0.526N P=0.115N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.094N | (e) |
|FISHER EXACT | P=0.748N P=0.653N P=0.122N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/0 (0%) 0/0 (0%) 3/60 (5%) | 0/60 (0%) 0/0 (0%) 0/0 (0%) 0/60 (0%) |
|ADJUSTED (b) | 2.9% 0.0% 0.0% 18.8% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/0 0/0 3/16 (19%) | 0/24 (0%) 0/0 0/0 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 634 --- --- 729 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.248 P=0.905N P=0.790N P=0.322 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.273 (e) (e) P=0.333 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.273 (e) (e) P=0.333 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.249 | (e) |
|FISHER EXACT | P=1.000N P=1.000N P=0.309 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/0 (0%) 0/0 (0%) 3/60 (5%) | 0/60 (0%) 0/0 (0%) 0/0 (0%) 1/60 (2%) |
|ADJUSTED (b) | 2.9% 0.0% 0.0% 18.8% | 0.0% 0.0% 0.0% 3.7% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/0 0/0 3/16 (19%) | 0/24 (0%) 0/0 0/0 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 634 --- --- 729 (T) | --- --- --- 699 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.248 P=0.905N P=0.790N P=0.322 | P=0.330 (e) (e) P=0.472 |
|INCIDENTAL TUMOR | P=0.273 (e) (e) P=0.333 | P=0.315 (e) (e) P=0.443 |
|LOGISTIC REGRESSION | P=0.273 (e) (e) P=0.333 | P=0.315 (e) (e) P=0.443 |
|COCHRAN-ARMITAGE | P=0.249 | P=0.369 |
|FISHER EXACT | P=1.000N P=1.000N P=0.309 | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/6 (0%) 0/9 (0%) 0/60 (0%) | 3/60 (5%) 0/1 (0%) 0/3 (0%) 2/60 (3%) |
|ADJUSTED (b) | 6.7% 0.0% 0.0% 0.0% | 10.5% 0.0% 0.0% 7.2% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 1/15 (7%) 0/4 (0%) 0/3 (0%) 0/16 (0%) | 1/24 (4%) 0/1 (0%) 0/3 (0%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 648 --- --- 658 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.396N P=0.761N P=0.814N P=0.487N | P=0.484N P=0.893N P=0.656N P=0.518N |
|INCIDENTAL TUMOR | P=0.396N P=0.761N P=0.814N P=0.487N | P=0.531N P=0.991N P=0.892N P=0.579N |
|LOGISTIC REGRESSION | P=0.396N P=0.761N P=0.814N P=0.487N | P=0.483N P=0.950N P=0.753N P=0.527N |
|COCHRAN-ARMITAGE | P=0.387N | P=0.452N |
|FISHER EXACT | P=0.909N P=0.870N P=0.500N | P=0.951N P=0.862N P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/6 (0%) 0/9 (0%) 0/60 (0%) | 3/60 (5%) 0/1 (0%) 0/3 (0%) 3/60 (5%) |
|ADJUSTED (b) | 6.7% 0.0% 0.0% 0.0% | 10.5% 0.0% 0.0% 11.2% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 1/15 (7%) 0/4 (0%) 0/3 (0%) 0/16 (0%) | 1/24 (4%) 0/1 (0%) 0/3 (0%) 2/24 (8%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 648 --- --- 658 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.396N P=0.761N P=0.814N P=0.487N | P=0.565 P=0.893N P=0.656N P=0.645 |
|INCIDENTAL TUMOR | P=0.396N P=0.761N P=0.814N P=0.487N | P=0.523 P=0.991N P=0.892N P=0.596 |
|LOGISTIC REGRESSION | P=0.396N P=0.761N P=0.814N P=0.487N | P=0.559 P=0.950N P=0.753N P=0.633 |
|COCHRAN-ARMITAGE | P=0.387N | P=0.597 |
|FISHER EXACT | P=0.909N P=0.870N P=0.500N | P=0.951N P=0.862N P=0.660N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/6 (0%) 0/9 (0%) 3/60 (5%) | 17/60 (28%) 0/1 (0%) 0/3 (0%) 17/60 (28%) |
|ADJUSTED (b) | 2.5% 0.0% 0.0% 17.4% | 53.6% 0.0% 0.0% 56.2% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/4 (0%) 0/3 (0%) 2/16 (13%) | 10/24 (42%) 0/1 (0%) 0/3 (0%) 12/24 (50%) |
|FIRST INCIDENCE (DAYS) | 606 --- --- 722 | 572 --- --- 525 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.194 P=0.923N P=0.814N P=0.329 | P=0.433 P=0.431N P=0.132N P=0.545 |
|INCIDENTAL TUMOR | P=0.192 P=0.965N P=0.882N P=0.307 | P=0.415 P=0.581N P=0.223N P=0.510 |
|LOGISTIC REGRESSION | P=0.185 P=0.933N P=0.897N P=0.299 | P=0.409 P=0.536N P=0.168N P=0.498 |
|COCHRAN-ARMITAGE | P=0.204 | P=0.514 |
|FISHER EXACT | P=0.909N P=0.870N P=0.309 | P=0.721N P=0.382N P=0.580N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/6 (0%) 0/9 (0%) 1/60 (2%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 1/60 (2%) |
|ADJUSTED (b) | 16.1% 0.0% 0.0% 4.3% | 0.0% 0.0% 0.0% 4.2% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 2/15 (13%) 0/4 (0%) 0/3 (0%) 0/16 (0%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 648 --- --- 683 | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.302N P=0.478N P=0.489N P=0.302N | P=0.352 (e) (e) P=0.500 |
|INCIDENTAL TUMOR | P=0.320N P=0.556N P=0.491N P=0.339N | P=0.352 (e) (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.293N P=0.587N P=0.507N P=0.308N | P=0.352 (e) (e) P=0.500 |
|COCHRAN-ARMITAGE | P=0.280N | P=0.362 |
|FISHER EXACT | P=0.748N P=0.653N P=0.309N | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 0/6 (0%) 0/9 (0%) 4/60 (7%) | 19/60 (32%) 0/1 (0%) 0/3 (0%) 19/60 (32%) |
|ADJUSTED (b) | 24.5% 0.0% 0.0% 21.0% | 56.6% 0.0% 0.0% 61.1% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 3/15 (20%) 0/4 (0%) 0/3 (0%) 2/16 (13%) | 10/24 (42%) 0/1 (0%) 0/3 (0%) 13/24 (54%) |
|FIRST INCIDENCE (DAYS) | 606 --- --- 683 | 572 --- --- 525 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.558N P=0.335N P=0.333N P=0.475N | P=0.420 P=0.400N P=0.115N P=0.535 |
|INCIDENTAL TUMOR | P=0.575N P=0.392N P=0.352N P=0.521N | P=0.377 P=0.581N P=0.223N P=0.473 |
|LOGISTIC REGRESSION | P=0.560N P=0.455N P=0.350N P=0.507N | P=0.400 P=0.503N P=0.137N P=0.492 |
|COCHRAN-ARMITAGE | P=0.527N | P=0.509 |
|FISHER EXACT | P=0.611N P=0.486N P=0.500N | P=0.689N P=0.334N P=0.578N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 0/6 (0%) 0/9 (0%) 4/60 (7%) | 19/60 (32%) 0/1 (0%) 0/3 (0%) 20/60 (33%) |
|ADJUSTED (b) | 24.5% 0.0% 0.0% 21.0% | 56.6% 0.0% 0.0% 64.7% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 3/15 (20%) 0/4 (0%) 0/3 (0%) 2/16 (13%) | 10/24 (42%) 0/1 (0%) 0/3 (0%) 14/24 (58%) |
|FIRST INCIDENCE (DAYS) | 606 --- --- 683 | 572 --- --- 525 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.558N P=0.335N P=0.333N P=0.475N | P=0.344 P=0.400N P=0.115N P=0.458 |
|INCIDENTAL TUMOR | P=0.575N P=0.392N P=0.352N P=0.521N | P=0.296 P=0.581N P=0.223N P=0.388 |
|LOGISTIC REGRESSION | P=0.560N P=0.455N P=0.350N P=0.507N | P=0.314 P=0.503N P=0.137N P=0.404 |
|COCHRAN-ARMITAGE | P=0.527N | P=0.430 |
|FISHER EXACT | P=0.611N P=0.486N P=0.500N | P=0.689N P=0.334N P=0.500 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/6 (0%) 0/9 (0%) 0/60 (0%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 7.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/4 (0%) 0/3 (0%) 0/16 (0%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 653 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.183N P=0.703N P=0.570N P=0.232N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.214N (e) P=0.601N P=0.293N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.187N P=0.770N P=0.673N P=0.242N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.183N | (e) |
|FISHER EXACT | P=0.825N P=0.754N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/60 (57%) 0/0 (0%) 0/0 (0%) 25/60 (42%) | 29/60 (48%) 0/0 (0%) 0/0 (0%) 28/60 (47%) |
|ADJUSTED (b) | 85.1% 0.0% 0.0% 66.2% | 74.4% 0.0% 0.0% 66.1% |
|INTERIM SACRIFICE 1 (c)| 3/8 (38%) 0/0 0/0 2/4 (50%) | 1/9 (11%) 0/0 0/0 1/7 (14%) |
|TERMINAL (d) | 10/15 (67%) 0/0 0/0 6/16 (38%) | 15/24 (63%) 0/0 0/0 11/24 (46%) |
|FIRST INCIDENCE (DAYS) | 406 --- --- 408 | 456 (I) --- --- 456 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.272N P=0.078N P=0.041N* P=0.171N | P=0.498 P=0.603N P=0.304N P=0.557 |
|INCIDENTAL TUMOR | P=0.108N (e) (e) P=0.120N | P=0.526N (e) (e) P=0.551N |
|LOGISTIC REGRESSION | P=0.108N (e) (e) P=0.120N | P=0.526N (e) (e) P=0.551N |
|COCHRAN-ARMITAGE | P=0.064N | P=0.476N |
|FISHER EXACT | P=1.000N P=1.000N P=0.072N | P=1.000N P=1.000N P=0.500N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/0 (0%) 0/0 (0%) 0/60 (0%) | 2/60 (3%) 0/0 (0%) 0/0 (0%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 7.9% 0.0% 0.0% 6.1% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/0 0/0 0/16 (0%) | 1/24 (4%) 0/0 0/0 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 724 --- --- 562 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.608 P=0.993N P=0.904N P=0.683 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.603 (e) (e) P=0.667 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.603 (e) (e) P=0.667 |
|COCHRAN-ARMITAGE | (e) | P=0.633 |
|FISHER EXACT | (e) (e) (e) | P=1.000N P=1.000N P=0.691N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/60 (57%) 0/0 (0%) 0/0 (0%) 25/60 (42%) | 31/60 (52%) 0/0 (0%) 0/0 (0%) 30/60 (50%) |
|ADJUSTED (b) | 85.1% 0.0% 0.0% 66.2% | 78.1% 0.0% 0.0% 68.2% |
|INTERIM SACRIFICE 1 (c)| 3/8 (38%) 0/0 0/0 2/4 (50%) | 1/9 (11%) 0/0 0/0 1/7 (14%) |
|TERMINAL (d) | 10/15 (67%) 0/0 0/0 6/16 (38%) | 16/24 (67%) 0/0 0/0 11/24 (46%) |
|FIRST INCIDENCE (DAYS) | 406 --- --- 408 | 456 (I) --- --- 456 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.272N P=0.078N P=0.041N* P=0.171N | P=0.490 P=0.574N P=0.276N P=0.552 |
|INCIDENTAL TUMOR | P=0.108N (e) (e) P=0.120N | P=0.538N (e) (e) P=0.564N |
|LOGISTIC REGRESSION | P=0.108N (e) (e) P=0.120N | P=0.538N (e) (e) P=0.564N |
|COCHRAN-ARMITAGE | P=0.064N | P=0.476N |
|FISHER EXACT | P=1.000N P=1.000N P=0.072N | P=1.000N P=1.000N P=0.500N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma or Basosquamous Tumor Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/6 (0%) 2/9 (22%) 0/60 (0%) | 1/60 (2%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 34.4% 0.0% | 3.7% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/4 (0%) 0/3 (0%) 0/16 (0%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 635 --- | 722 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.552N (e) P=0.016 * (e) | P=0.392N P=0.994N P=0.909N P=0.515N |
|INCIDENTAL TUMOR | P=0.539N (e) P=0.008 ** (e) | P=0.424N (e) (e) P=0.557N |
|LOGISTIC REGRESSION | P=0.545N (e) P=0.007 ** (e) | P=0.396N P=0.997N P=0.935N P=0.523N |
|COCHRAN-ARMITAGE | P=0.534N | P=0.373N |
|FISHER EXACT | (e) P=0.015 * (e) | P=0.984N P=0.952N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/6 (0%) 2/9 (22%) 0/60 (0%) | 1/60 (2%) 0/1 (0%) 1/3 (33%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 34.4% 0.0% | 3.7% 0.0% 33.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/4 (0%) 0/3 (0%) 0/16 (0%) | 0/24 (0%) 0/1 (0%) 1/3 (33%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 635 --- | 722 --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.552N (e) P=0.016 * (e) | P=0.340N P=0.994N P=0.253 P=0.515N |
|INCIDENTAL TUMOR | P=0.539N (e) P=0.008 ** (e) | P=0.362N (e) P=0.108 P=0.557N |
|LOGISTIC REGRESSION | P=0.545N (e) P=0.007 ** (e) | P=0.357N P=0.997N P=0.207 P=0.523N |
|COCHRAN-ARMITAGE | P=0.534N | P=0.323N |
|FISHER EXACT | (e) P=0.015 * (e) | P=0.984N P=0.094 P=0.500N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, |
| malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/6 (0%) 2/9 (22%) 0/60 (0%) | 1/60 (2%) 0/1 (0%) 1/3 (33%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 34.4% 0.0% | 3.7% 0.0% 33.3% 4.2% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/4 (0%) 0/3 (0%) 0/16 (0%) | 0/24 (0%) 0/1 (0%) 1/3 (33%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | --- --- 635 --- | 722 --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.552N (e) P=0.016 * (e) | P=0.611N P=0.994N P=0.253 P=0.752 |
|INCIDENTAL TUMOR | P=0.539N (e) P=0.008 ** (e) | P=0.627N (e) P=0.108 P=0.729 |
|LOGISTIC REGRESSION | P=0.545N (e) P=0.007 ** (e) | P=0.642N P=0.997N P=0.207 P=0.737 |
|COCHRAN-ARMITAGE | P=0.534N | P=0.588N |
|FISHER EXACT | (e) P=0.015 * (e) | P=0.984N P=0.094 P=0.752N |
|=================================================================================================================================|
| |
|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) | 2/60 (3%) 0/6 (0%) 6/9 (67%) 2/60 (3%) | 1/60 (2%) 0/1 (0%) 1/3 (33%) 1/60 (2%) |
|ADJUSTED (b) | 11.9% 0.0% 84.4% 9.7% | 3.7% 0.0% 33.3% 4.2% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 1/15 (7%) 0/4 (0%) 2/3 (67%) 1/16 (6%) | 0/24 (0%) 0/1 (0%) 1/3 (33%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 716 --- 635 660 | 722 --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.436N P=0.576N P<0.001 ** P=0.675N | P=0.611N P=0.994N P=0.253 P=0.752 |
|INCIDENTAL TUMOR | P=0.462N P=0.761N P<0.001 ** P=0.661 | P=0.627N (e) P=0.108 P=0.729 |
|LOGISTIC REGRESSION | P=0.427N P=0.638N P<0.001 ** P=0.694 | P=0.642N P=0.997N P=0.207 P=0.737 |
|COCHRAN-ARMITAGE | P=0.398N | P=0.588N |
|FISHER EXACT | P=0.825N P<0.001 ** P=0.691N | P=0.984N P=0.094 P=0.752N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/6 (33%) 1/9 (11%) 1/60 (2%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 37.5% 11.1% 2.9% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 1/4 (25%) 0/3 (0%) 0/16 (0%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- 457 556 639 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.504N P=0.010 * P=0.182 P=0.506 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.433N P=0.028 * P=0.118 P=0.525 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.471N P<0.001 ** P=0.052 P=0.497 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.492N | (e) |
|FISHER EXACT | P=0.007 ** P=0.130 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/6 (33%) 0/9 (0%) 0/60 (0%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 37.5% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 1/4 (25%) 0/3 (0%) 0/16 (0%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- 457 --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.280N P=0.010 * (e) (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.240N P=0.028 * (e) (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.258N P<0.001 ** (e) (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.272N | (e) |
|FISHER EXACT | P=0.007 ** (e) (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/6 (0%) 4/9 (44%) 1/60 (2%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 6.7% 0.0% 76.2% 3.7% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 1/15 (7%) 0/4 (0%) 2/3 (67%) 0/16 (0%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 663 660 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.471N P=0.761N P<0.001 ** P=0.745N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.505N P=0.761N P<0.001 ** P=0.740 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.469N P=0.761N P<0.001 ** P=0.760 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.445N | (e) |
|FISHER EXACT | P=0.909N P<0.001 ** P=0.752N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/6 (0%) 4/9 (44%) 2/60 (3%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 11.9% 0.0% 76.2% 9.7% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 1/15 (7%) 0/4 (0%) 2/3 (67%) 1/16 (6%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 716 --- 663 660 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.503N P=0.576N P=0.003 ** P=0.675N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.541N P=0.761N P=0.003 ** P=0.661 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.500N P=0.638N P=0.001 ** P=0.694 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.469N | (e) |
|FISHER EXACT | P=0.825N P=0.002 ** P=0.691N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/6 (0%) 4/9 (44%) 2/60 (3%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 11.9% 0.0% 76.2% 9.7% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 1/15 (7%) 0/4 (0%) 2/3 (67%) 1/16 (6%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 716 --- 663 660 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.503N P=0.576N P=0.003 ** P=0.675N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.541N P=0.761N P=0.003 ** P=0.661 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.500N P=0.638N P=0.001 ** P=0.694 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.469N | (e) |
|FISHER EXACT | P=0.825N P=0.002 ** P=0.691N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 45/60 (75%) 0/0 (0%) 0/0 (0%) 40/60 (67%) | |
|ADJUSTED (b) | 100.0% 0.0% 0.0% 97.3% | |
|INTERIM SACRIFICE 1 (c)| 3/8 (38%) 0/0 0/0 0/4 (0%) | |
|TERMINAL (d) | 15/15 (100%) 0/0 0/0 15/16 (94%) | |
|FIRST INCIDENCE (DAYS) | 456 (I) --- --- 465 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.480N P=0.047N* P=0.020N* P=0.292N | |
|INCIDENTAL TUMOR | P=0.227N (e) (e) P=0.252N | |
|LOGISTIC REGRESSION | P=0.227N (e) (e) P=0.252N | |
|COCHRAN-ARMITAGE | P=0.192N | |
|FISHER EXACT | P=1.000N P=1.000N P=0.211N | |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/59 (12%) 0/0 (0%) 0/0 (0%) 9/60 (15%) | 11/60 (18%) 0/0 (0%) 0/0 (0%) 5/60 (8%) |
|ADJUSTED (b) | 33.5% 0.0% 0.0% 33.8% | 35.1% 0.0% 0.0% 18.8% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 2/4 (50%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 4/15 (27%) 0/0 0/0 4/16 (25%) | 6/24 (25%) 0/0 0/0 4/24 (17%) |
|FIRST INCIDENCE (DAYS) | 585 --- --- 456 (I) | 515 --- --- 613 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.274 P=0.617N P=0.495N P=0.352 | P=0.088N P=0.837N P=0.570N P=0.099N |
|INCIDENTAL TUMOR | P=0.319 (e) (e) P=0.352 | P=0.081N (e) (e) P=0.095N |
|LOGISTIC REGRESSION | P=0.319 (e) (e) P=0.352 | P=0.081N (e) (e) P=0.095N |
|COCHRAN-ARMITAGE | P=0.374 | P=0.076N |
|FISHER EXACT | P=1.000N P=1.000N P=0.409 | P=1.000N P=1.000N P=0.089N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/59 (12%) 0/0 (0%) 0/0 (0%) 9/60 (15%) | 11/60 (18%) 0/0 (0%) 0/0 (0%) 5/60 (8%) |
|ADJUSTED (b) | 33.5% 0.0% 0.0% 33.8% | 35.1% 0.0% 0.0% 18.8% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 2/4 (50%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 4/15 (27%) 0/0 0/0 4/16 (25%) | 6/24 (25%) 0/0 0/0 4/24 (17%) |
|FIRST INCIDENCE (DAYS) | 585 --- --- 456 (I) | 515 --- --- 613 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.274 P=0.617N P=0.495N P=0.352 | P=0.088N P=0.837N P=0.570N P=0.099N |
|INCIDENTAL TUMOR | P=0.319 (e) (e) P=0.352 | P=0.081N (e) (e) P=0.095N |
|LOGISTIC REGRESSION | P=0.319 (e) (e) P=0.352 | P=0.081N (e) (e) P=0.095N |
|COCHRAN-ARMITAGE | P=0.374 | P=0.076N |
|FISHER EXACT | P=1.000N P=1.000N P=0.409 | P=1.000N P=1.000N P=0.089N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/59 (2%) 0/0 (0%) 0/0 (0%) 2/60 (3%) | 0/60 (0%) 0/0 (0%) 0/0 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.0% 0.0% 0.0% 7.3% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/0 0/0 0/16 (0%) | 0/24 (0%) 0/0 0/0 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 679 --- --- 643 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.352 P=0.853N P=0.814N P=0.487 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.387 (e) (e) P=0.464 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.387 (e) (e) P=0.464 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.429 | (e) |
|FISHER EXACT | P=1.000N P=1.000N P=0.506 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 3/60 (5%) 0/1 (0%) 0/3 (0%) 7/60 (12%) |
|ADJUSTED (b) | | 10.2% 0.0% 0.0% 22.0% |
|INTERIM SACRIFICE 1 (c)| | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | | 2/24 (8%) 0/1 (0%) 0/3 (0%) 4/24 (17%) |
|FIRST INCIDENCE (DAYS) | | 485 --- --- 533 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.116 P=0.906N P=0.673N P=0.166 |
|INCIDENTAL TUMOR | | P=0.117 P=0.939N P=0.738N P=0.162 |
|LOGISTIC REGRESSION | | P=0.118 P=0.980N P=0.836N P=0.156 |
|COCHRAN-ARMITAGE | | P=0.123 |
|FISHER EXACT | | P=0.951N P=0.862N P=0.161 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/6 (0%) 0/9 (0%) 0/60 (0%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 9.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 1/15 (7%) 0/4 (0%) 0/3 (0%) 0/16 (0%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 606 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.188N P=0.655N P=0.624N P=0.233N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.175N P=0.684N P=0.669N P=0.219N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.188N P=0.757N P=0.658N P=0.242N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.183N | (e) |
|FISHER EXACT | P=0.825N P=0.754N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/6 (0%) 0/9 (0%) 0/60 (0%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 6.3% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/4 (0%) 0/3 (0%) 0/16 (0%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 612 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.177N P=0.729N P=0.583N P=0.226N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.187N P=0.965N P=0.655N P=0.253N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.184N P=0.785N P=0.698N P=0.240N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.183N | (e) |
|FISHER EXACT | P=0.825N P=0.754N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 1/6 (17%) 1/9 (11%) 3/60 (5%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 6.2% 20.0% 33.3% 10.9% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/4 (0%) 1/3 (33%) 1/16 (6%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 513 579 729 (T) 557 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.522N P=0.412 P=0.571 P=0.657 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.427N P=0.420 P=0.433 P=0.587N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.482N P=0.359 P=0.444 P=0.646N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.499N | (e) |
|FISHER EXACT | P=0.323 P=0.436 P=0.660N | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 23/60 (38%) 0/6 (0%) 0/9 (0%) 30/60 (50%) | 18/60 (30%) 0/1 (0%) 0/3 (0%) 18/60 (30%) |
|ADJUSTED (b) | 61.7% 0.0% 0.0% 82.0% | 47.8% 0.0% 0.0% 53.7% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 5/15 (33%) 0/4 (0%) 0/3 (0%) 11/16 (69%) | 6/24 (25%) 0/1 (0%) 0/3 (0%) 10/24 (42%) |
|FIRST INCIDENCE (DAYS) | 549 --- --- 396 | 485 --- --- 303 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.055 P=0.051N P=0.027N* P=0.211 | P=0.417 P=0.452N P=0.164N P=0.515 |
|INCIDENTAL TUMOR | P=0.046 * P=0.091N P=0.013N* P=0.169 | P=0.496 P=0.729N P=0.405N P=0.570 |
|LOGISTIC REGRESSION | P=0.025 * P=0.064N P=0.021N* P=0.089 | P=0.454 P=0.587N P=0.221N P=0.533 |
|COCHRAN-ARMITAGE | P=0.042 * | P=0.512 |
|FISHER EXACT | P=0.067N P=0.019N* P=0.135 | P=0.705N P=0.357N P=0.579N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 1/6 (17%) 1/9 (11%) 3/60 (5%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 6.2% 20.0% 33.3% 10.9% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/4 (0%) 1/3 (33%) 1/16 (6%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 513 579 729 (T) 557 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.522N P=0.412 P=0.571 P=0.657 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.427N P=0.420 P=0.433 P=0.587N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.482N P=0.359 P=0.444 P=0.646N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.499N | (e) |
|FISHER EXACT | P=0.323 P=0.436 P=0.660N | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/6 (0%) 0/9 (0%) 2/60 (3%) | 0/60 (0%) 0/1 (0%) 0/3 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.8% 0.0% 0.0% 4.6% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 0/9 (0%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 0/15 (0%) 0/4 (0%) 0/3 (0%) 0/16 (0%) | 0/24 (0%) 0/1 (0%) 0/3 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 709 --- --- 364 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.364 P=0.823N P=0.872N P=0.494 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.654 (e) P=0.795N P=0.747 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.415 P=0.863N P=0.822N P=0.528 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.379 | (e) |
|FISHER EXACT | P=0.909N P=0.870N P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 55/60 (92%) 0/6 (0%) 7/9 (78%) 54/60 (90%) | 41/60 (68%) 0/1 (0%) 1/3 (33%) 42/60 (70%) |
|ADJUSTED (b) | 100.0% 0.0% 86.1% 100.0% | 88.7% 0.0% 33.3% 93.0% |
|INTERIM SACRIFICE 1 (c)| 5/8 (63%) 0/0 0/0 3/4 (75%) | 3/9 (33%) 0/0 0/0 1/7 (14%) |
|TERMINAL (d) | 15/15 (100%) 0/4 (0%) 2/3 (67%) 16/16 (100%)| 19/24 (79%) 0/1 (0%) 1/3 (33%) 21/24 (88%) |
|FIRST INCIDENCE (DAYS) | 406 --- 556 364 | 456 (I) --- 729 (T) 456 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.196 P<0.001N** P=0.201N P=0.508 | P=0.286 P=0.171N P=0.053N P=0.406 |
|INCIDENTAL TUMOR | P=0.118 P<0.001N** P=0.094N P=0.610 | P=0.242 P=0.271N P=0.161N P=0.348 |
|LOGISTIC REGRESSION | P=0.136 P<0.001N** P=0.085N P=0.520 | P=0.317 P=0.232N P=0.113N P=0.428 |
|COCHRAN-ARMITAGE | P=0.243 | P=0.406 |
|FISHER EXACT | P<0.001N** P=0.224N P=0.500N | P=0.328N P=0.256N P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 30/60 (50%) 3/6 (50%) 2/9 (22%) 33/60 (55%) | 23/60 (38%) 0/1 (0%) 1/3 (33%) 21/60 (35%) |
|ADJUSTED (b) | 70.7% 50.0% 66.7% 83.3% | 57.2% 0.0% 33.3% 59.4% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/0 0/0 0/4 (0%) | 1/9 (11%) 0/0 0/0 0/7 (0%) |
|TERMINAL (d) | 6/15 (40%) 1/4 (25%) 2/3 (67%) 11/16 (69%) | 8/24 (33%) 0/1 (0%) 1/3 (33%) 11/24 (46%) |
|FIRST INCIDENCE (DAYS) | 437 457 729 (T) 396 | 456 (I) --- 729 (T) 303 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.268 P=0.330N P=0.081N P=0.419 | P=0.542N P=0.386N P=0.307N P=0.503N |
|INCIDENTAL TUMOR | P=0.363 P=0.681N P=0.070N P=0.480 | P=0.447N P=0.650N P=0.738 P=0.445N |
|LOGISTIC REGRESSION | P=0.198 P=0.426 P=0.063N P=0.249 | P=0.481N P=0.520N P=0.534N P=0.470N |
|COCHRAN-ARMITAGE | P=0.283 | P=0.424N |
|FISHER EXACT | P=0.664N P=0.114N P=0.357 | P=0.623N P=0.678N P=0.425N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05102 TEST: 05 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 57/60 (95%) 3/6 (50%) 8/9 (89%) 57/60 (95%) | 46/60 (77%) 0/1 (0%) 2/3 (67%) 50/60 (83%) |
|ADJUSTED (b) | 100.0% 50.0% 100.0% 100.0% | 91.8% 0.0% 66.7% 98.0% |
|INTERIM SACRIFICE 1 (c)| 5/8 (63%) 0/0 0/0 3/4 (75%) | 3/9 (33%) 0/0 0/0 1/7 (14%) |
|TERMINAL (d) | 15/15 (100%) 1/4 (25%) 3/3 (100%) 16/16 (100%)| 20/24 (83%) 0/1 (0%) 2/3 (67%) 23/24 (96%) |
|FIRST INCIDENCE (DAYS) | 406 457 556 364 | 456 (I) --- 729 (T) 303 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.240 P=0.017N* P=0.270N P=0.461 | P=0.167 P=0.145N P=0.114N P=0.257 |
|INCIDENTAL TUMOR | P=0.170 P=0.003N** P=0.205N P=0.582 | P=0.095 P=0.227N P=0.534N P=0.153 |
|LOGISTIC REGRESSION | P=0.061 P<0.001N** P=0.227N P=0.247 | P=0.105 P=0.137N P=0.416N P=0.163 |
|COCHRAN-ARMITAGE | P=0.305 | P=0.181 |
|FISHER EXACT | P=0.008N** P=0.436N P=0.660N | P=0.246N P=0.564N P=0.247 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(c) Observed incidence at interim kill.
Male interim sacrifices(days): 456
Female interim sacrifices(days): 456
(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).