TDMS Study 05109-11 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRIETHANOLAMINE DATE: 05/19/95
EXPERIMENT: 05109 TEST: 11 TIME: 23:42:26
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85226 ROUTE: DERMAL,SOLUTION NTP C#: 61621D
PATHOLOGIST: J. TOFF CAS: 102-71-6
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRIETHANOLAMINE DATE: 05/19/95
EXPERIMENT: 05109 TEST: 11 TIME: 23:42:26
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85226 ROUTE: DERMAL,SOLUTION NTP C#: 61621D
PATHOLOGIST: J. TOFF CAS: 102-71-6
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 TRIETHANOLAMINE DATE: 05/19/95
EXPERIMENT: 05109 TEST: 11 TIME: 23:42:26
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85226 ROUTE: DERMAL,SOLUTION NTP C#: 61621D
PATHOLOGIST: J. TOFF CAS: 102-71-6
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF TRIETHANOLAMINE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal
Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma
Keratoacanthoma
Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
Squamous Cell Papilloma, Papilloma, or Keratoacanthoma
Testes Adenoma
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
Uterus Polyp Stromal
====================================================================================================
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 8/60 (13%) 5/59 (8%) 3/60 (5%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 1/59 (2%) |
|ADJUSTED (b) | 11.8% 44.9% 18.3% 11.8% | 0.0% 6.3% 0.0% 2.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 1/21 (5%) 4/11 (36%) 2/18 (11%) 1/19 (5%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 702 573 456 (I) 558 | --- 708 --- 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.375N P=0.025 * P=0.337 P=0.592 | P=0.467 P=0.247 (e) P=0.500 |
|INCIDENTAL TUMOR | P=0.395N P=0.070 P=0.350 P=0.654 | P=0.489 P=0.179 (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.374N P=0.065 P=0.345 P=0.635 | P=0.535 P=0.237 (e) P=0.614 |
|COCHRAN-ARMITAGE | P=0.359N | P=0.535 |
|FISHER EXACT | P=0.102 P=0.349 P=0.660N | P=0.248 (e) P=0.496 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 8/60 (13%) 6/59 (10%) 3/60 (5%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 1/59 (2%) |
|ADJUSTED (b) | 11.8% 44.9% 20.4% 11.8% | 0.0% 6.3% 0.0% 2.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 1/21 (5%) 4/11 (36%) 2/18 (11%) 1/19 (5%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 702 573 456 (I) 558 | --- 708 --- 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.397N P=0.025 * P=0.230 P=0.592 | P=0.467 P=0.247 (e) P=0.500 |
|INCIDENTAL TUMOR | P=0.423N P=0.070 P=0.244 P=0.654 | P=0.489 P=0.179 (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.392N P=0.065 P=0.233 P=0.635 | P=0.535 P=0.237 (e) P=0.614 |
|COCHRAN-ARMITAGE | P=0.378N | P=0.535 |
|FISHER EXACT | P=0.102 P=0.237 P=0.660N | P=0.248 (e) P=0.496 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/58 (2%) 1/60 (2%) | 2/58 (3%) 6/59 (10%) 2/60 (3%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 1.7% 3.0% | 8.0% 17.3% 8.0% 7.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 2/25 (8%) 3/29 (10%) 2/25 (8%) 1/18 (6%) |
|FIRST INCIDENCE (DAYS) | --- --- 353 642 | 729 (T) 579 729 (T) 389 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.247 (e) P=0.500 P=0.500 | P=0.511N P=0.170 P=0.697 P=0.597 |
|INCIDENTAL TUMOR | P=0.103 (e) P=0.638 P=0.464 | P=0.417N P=0.138 P=0.697 P=0.701N |
|LOGISTIC REGRESSION | P=0.202 (e) P=0.382 P=0.497 | P=0.425N P=0.139 P=0.697 P=0.670 |
|COCHRAN-ARMITAGE | P=0.236 | P=0.329N |
|FISHER EXACT | (e) P=0.492 P=0.500 | P=0.141 P=0.678N P=0.678N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/60 (2%) 0/58 (0%) 0/60 (0%) | 2/58 (3%) 0/59 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.8% 5.9% 0.0% 0.0% | 5.8% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 705 719 --- --- | 593 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.246N P=0.696 P=0.500N P=0.543N | P=0.137N P=0.237N P=0.236N P=0.320N |
|INCIDENTAL TUMOR | P=0.235N P=0.693N P=0.500N P=0.483N | P=0.115N P=0.295N P=0.245N P=0.248N |
|LOGISTIC REGRESSION | P=0.243N P=0.720 P=0.508N P=0.517N | P=0.117N P=0.234N P=0.231N P=0.260N |
|COCHRAN-ARMITAGE | P=0.237N | P=0.112N |
|FISHER EXACT | P=0.752N P=0.508N P=0.500N | P=0.244N P=0.239N P=0.239N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/60 (2%) 1/58 (2%) 1/60 (2%) | 4/58 (7%) 6/59 (10%) 2/60 (3%) 2/60 (3%) |
|ADJUSTED (b) | 3.8% 5.9% 1.7% 3.0% | 13.3% 17.3% 8.0% 7.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 2/25 (8%) 3/29 (10%) 2/25 (8%) 1/18 (6%) |
|FIRST INCIDENCE (DAYS) | 705 719 353 642 | 593 579 729 (T) 389 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.628 P=0.696 P=0.760 P=0.737 | P=0.276N P=0.421 P=0.336N P=0.479N |
|INCIDENTAL TUMOR | P=0.559 P=0.693N P=0.686N P=0.750 | P=0.190N P=0.343 P=0.342N P=0.340N |
|LOGISTIC REGRESSION | P=0.632 P=0.720 P=0.744 P=0.752 | P=0.201N P=0.379 P=0.325N P=0.377N |
|COCHRAN-ARMITAGE | P=0.632 | P=0.142N |
|FISHER EXACT | P=0.752N P=0.744 P=0.752N | P=0.382 P=0.324N P=0.324N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 3/60 (5%) 3/59 (5%) 5/60 (8%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 4.8% 17.1% 14.5% 23.1% | 0.0% 6.6% 0.0% 6.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 1/21 (5%) 1/11 (9%) 2/18 (11%) 4/19 (21%) | 0/25 (0%) 1/29 (3%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 667 710 563 | --- 715 --- 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.088 P=0.167 P=0.275 P=0.080 | P=0.173 P=0.264 (e) P=0.193 |
|INCIDENTAL TUMOR | P=0.084 P=0.244 P=0.272 P=0.077 | P=0.189 P=0.226 (e) P=0.200 |
|LOGISTIC REGRESSION | P=0.070 P=0.241 P=0.300 P=0.083 | P=0.222 P=0.240 (e) P=0.259 |
|COCHRAN-ARMITAGE | P=0.081 | P=0.248 |
|FISHER EXACT | P=0.309 P=0.303 P=0.103 | P=0.248 (e) P=0.248 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 3/60 (5%) 3/59 (5%) 5/60 (8%) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 2/60 (3%) |
|ADJUSTED (b) | 4.8% 17.1% 14.5% 23.1% | 0.0% 6.6% 4.0% 6.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 1/21 (5%) 1/11 (9%) 2/18 (11%) 4/19 (21%) | 0/25 (0%) 1/29 (3%) 1/25 (4%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 667 710 563 | --- 715 729 (T) 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.088 P=0.167 P=0.275 P=0.080 | P=0.161 P=0.264 P=0.500 P=0.193 |
|INCIDENTAL TUMOR | P=0.084 P=0.244 P=0.272 P=0.077 | P=0.174 P=0.226 P=0.500 P=0.200 |
|LOGISTIC REGRESSION | P=0.070 P=0.241 P=0.300 P=0.083 | P=0.201 P=0.240 P=0.500 P=0.259 |
|COCHRAN-ARMITAGE | P=0.081 | P=0.246 |
|FISHER EXACT | P=0.309 P=0.303 P=0.103 | P=0.248 P=0.500 P=0.248 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 4/59 (7%) 2/60 (3%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 5.6% 15.2% 10.5% | 4.0% 2.9% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 1/18 (6%) 2/19 (11%) | 1/25 (4%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | --- 718 649 729 (T) | 729 (T) 678 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.179 P=0.460 P=0.060 P=0.215 | P=0.287N P=0.741N P=0.500N P=0.566N |
|INCIDENTAL TUMOR | P=0.169 P=0.562 P=0.063 P=0.215 | P=0.281N P=0.749 P=0.500N P=0.566N |
|LOGISTIC REGRESSION | P=0.154 P=0.454 P=0.060 P=0.215 | P=0.273N P=0.762 P=0.500N P=0.566N |
|COCHRAN-ARMITAGE | P=0.165 | P=0.236N |
|FISHER EXACT | P=0.500 P=0.057 P=0.248 | P=0.752N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 0/59 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 8.9% 0.0% 0.0% 5.3% | 0.0% 0.0% 0.0% 4.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 0/18 (0%) 1/19 (5%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 550 --- --- 729 (T) | --- --- --- 700 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.256N P=0.160N P=0.129N P=0.343N | P=0.142 (e) (e) P=0.416 |
|INCIDENTAL TUMOR | P=0.276N P=0.064N P=0.107N P=0.340N | P=0.163 (e) (e) P=0.427 |
|LOGISTIC REGRESSION | P=0.252N P=0.124N P=0.124N P=0.316N | P=0.158 (e) (e) P=0.439 |
|COCHRAN-ARMITAGE | P=0.249N | P=0.199 |
|FISHER EXACT | P=0.122N P=0.125N P=0.309N | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 1/59 (2%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 8.9% 0.0% 4.5% 5.3% | 0.0% 0.0% 0.0% 4.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 0/18 (0%) 1/19 (5%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 550 --- 722 729 (T) | --- --- --- 700 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.304N P=0.160N P=0.316N P=0.343N | P=0.142 (e) (e) P=0.416 |
|INCIDENTAL TUMOR | P=0.326N P=0.064N P=0.275N P=0.340N | P=0.163 (e) (e) P=0.427 |
|LOGISTIC REGRESSION | P=0.304N P=0.124N P=0.312N P=0.316N | P=0.158 (e) (e) P=0.439 |
|COCHRAN-ARMITAGE | P=0.297N | P=0.199 |
|FISHER EXACT | P=0.122N P=0.316N P=0.309N | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 1/59 (2%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 8.9% 0.0% 4.5% 5.3% | 0.0% 0.0% 0.0% 4.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 0/18 (0%) 1/19 (5%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 550 --- 722 729 (T) | --- --- --- 700 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.304N P=0.160N P=0.316N P=0.343N | P=0.142 (e) (e) P=0.416 |
|INCIDENTAL TUMOR | P=0.326N P=0.064N P=0.275N P=0.340N | P=0.163 (e) (e) P=0.427 |
|LOGISTIC REGRESSION | P=0.304N P=0.124N P=0.312N P=0.316N | P=0.158 (e) (e) P=0.439 |
|COCHRAN-ARMITAGE | P=0.297N | P=0.199 |
|FISHER EXACT | P=0.122N P=0.316N P=0.309N | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/60 (2%) 0/59 (0%) 0/60 (0%) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 4.8% 8.3% 0.0% 0.0% | 0.0% 6.9% 4.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/21 (5%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 0/25 (0%) 2/29 (7%) 1/25 (4%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 727 --- --- | --- 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.244N P=0.615 P=0.531N P=0.520N | P=0.556N P=0.271 P=0.500 (e) |
|INCIDENTAL TUMOR | P=0.237N P=0.730 P=0.531N P=0.520N | P=0.556N P=0.271 P=0.500 (e) |
|LOGISTIC REGRESSION | P=0.239N P=0.676 P=0.531N P=0.520N | P=0.556N P=0.271 P=0.500 (e) |
|COCHRAN-ARMITAGE | P=0.236N | P=0.461N |
|FISHER EXACT | P=0.752N P=0.504N P=0.500N | P=0.248 P=0.500 (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/59 (0%) 0/60 (0%) | 13/60 (22%) 13/60 (22%) 10/60 (17%) 8/60 (13%) |
|ADJUSTED (b) | 4.8% 0.0% 0.0% 0.0% | 40.8% 44.8% 28.4% 32.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/21 (5%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 7/25 (28%) 13/29 (45%) 3/25 (12%) 4/18 (22%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 636 729 (T) 619 459 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.308N P=0.629N P=0.531N P=0.520N | P=0.383N P=0.451N P=0.335N P=0.460N |
|INCIDENTAL TUMOR | P=0.308N P=0.629N P=0.531N P=0.520N | P=0.274N P=0.530N P=0.362N P=0.327N |
|LOGISTIC REGRESSION | P=0.308N P=0.629N P=0.531N P=0.520N | P=0.300N P=0.583N P=0.327N P=0.380N |
|COCHRAN-ARMITAGE | P=0.306N | P=0.107N |
|FISHER EXACT | P=0.500N P=0.504N P=0.500N | P=0.588N P=0.322N P=0.168N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/59 (0%) 0/60 (0%) | 13/60 (22%) 13/60 (22%) 11/60 (18%) 8/60 (13%) |
|ADJUSTED (b) | 4.8% 0.0% 0.0% 0.0% | 40.8% 44.8% 31.7% 32.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/21 (5%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 7/25 (28%) 13/29 (45%) 4/25 (16%) 4/18 (22%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 636 729 (T) 619 459 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.308N P=0.629N P=0.531N P=0.520N | P=0.404N P=0.451N P=0.418N P=0.460N |
|INCIDENTAL TUMOR | P=0.308N P=0.629N P=0.531N P=0.520N | P=0.293N P=0.530N P=0.459N P=0.327N |
|LOGISTIC REGRESSION | P=0.308N P=0.629N P=0.531N P=0.520N | P=0.321N P=0.583N P=0.420N P=0.380N |
|COCHRAN-ARMITAGE | P=0.306N | P=0.115N |
|FISHER EXACT | P=0.500N P=0.504N P=0.500N | P=0.588N P=0.410N P=0.168N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 1/60 (2%) 0/59 (0%) 0/60 (0%) | 13/60 (22%) 13/60 (22%) 11/60 (18%) 8/60 (13%) |
|ADJUSTED (b) | 9.5% 8.3% 0.0% 0.0% | 40.8% 44.8% 31.7% 32.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/21 (10%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 7/25 (28%) 13/29 (45%) 4/25 (16%) 4/18 (22%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 727 --- --- | 636 729 (T) 619 459 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.109N P=0.713N P=0.272N P=0.259N | P=0.404N P=0.451N P=0.418N P=0.460N |
|INCIDENTAL TUMOR | P=0.104N P=0.612N P=0.272N P=0.259N | P=0.293N P=0.530N P=0.459N P=0.327N |
|LOGISTIC REGRESSION | P=0.103N P=0.655N P=0.272N P=0.259N | P=0.321N P=0.583N P=0.420N P=0.380N |
|COCHRAN-ARMITAGE | P=0.102N | P=0.115N |
|FISHER EXACT | P=0.500N P=0.252N P=0.248N | P=0.588N P=0.410N P=0.168N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 38/60 (63%) 41/60 (68%) 37/58 (64%) 43/60 (72%) | 33/60 (55%) 27/60 (45%) 32/60 (53%) 27/60 (45%) |
|ADJUSTED (b) | 87.6% 89.0% 84.0% 95.3% | 81.2% 66.7% 75.4% 80.0% |
|INTERIM SACRIFICE 1 (c)| 3/10 (30%) 3/10 (30%) 5/10 (50%) 2/10 (20%) | 0/10 (0%) 1/10 (10%) 2/10 (20%) 4/10 (40%) |
|TERMINAL (d) | 16/21 (76%) 7/11 (64%) 11/17 (65%) 17/19 (89%) | 18/25 (72%) 16/29 (55%) 15/25 (60%) 12/18 (67%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 416 379 404 | 390 457 (I) 457 (I) 429 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.296 P=0.050 * P=0.447 P=0.149 | P=0.194 P=0.112N P=0.502N P=0.359 |
|INCIDENTAL TUMOR | P=0.192 P=0.436 P=0.530 P=0.169 | P=0.455 P=0.130N P=0.524N P=0.477N |
|LOGISTIC REGRESSION | P=0.170 P=0.323 P=0.533 P=0.131 | P=0.437 P=0.174N P=0.528N P=0.517N |
|COCHRAN-ARMITAGE | P=0.227 | P=0.236N |
|FISHER EXACT | P=0.350 P=0.556 P=0.218 | P=0.181N P=0.500N P=0.181N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, |
| malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 0/59 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.8% 13.3% 0.0% 5.3% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/21 (5%) 0/11 (0%) 0/18 (0%) 1/19 (5%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 724 --- 729 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.497N P=0.339 P=0.531N P=0.741 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.494N P=0.499 P=0.531N P=0.741 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.508N P=0.628N P=0.531N P=0.741 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.501N | (e) |
|FISHER EXACT | P=0.500 P=0.504N P=0.752N | (e) (e) (e) |
|=================================================================================================================================|
| |
|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) | 8/60 (13%) 2/60 (3%) 2/59 (3%) 3/60 (5%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 30.2% 13.3% 11.1% 15.8% | 4.0% 3.4% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/21 (24%) 0/11 (0%) 2/18 (11%) 3/19 (16%) | 1/25 (4%) 1/29 (3%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 550 724 729 (T) 729 (T) | 729 (T) 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.094N P=0.171N P=0.070N P=0.129N | P=0.282N P=0.729N P=0.500N P=0.566N |
|INCIDENTAL TUMOR | P=0.096N P=0.070N P=0.061N P=0.130N | P=0.282N P=0.729N P=0.500N P=0.566N |
|LOGISTIC REGRESSION | P=0.100N P=0.070N P=0.049N* P=0.122N | P=0.282N P=0.729N P=0.500N P=0.566N |
|COCHRAN-ARMITAGE | P=0.096N | P=0.236N |
|FISHER EXACT | P=0.047N* P=0.050N P=0.102N | P=0.752N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 2/60 (3%) 2/59 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 6.9% 4.7% 8.2% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 1/18 (6%) 0/19 (0%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 586 456 (I) 617 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.176N P=0.624 P=0.655 P=0.274N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.191N P=0.590N P=0.685N P=0.250N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.165N P=0.693N P=0.688 P=0.244N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.165N | (e) |
|FISHER EXACT | P=0.691N P=0.684 P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 2/60 (3%) 3/59 (5%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 14.0% 4.7% 9.8% 7.3% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/21 (5%) 0/11 (0%) 1/18 (6%) 1/19 (5%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 586 456 (I) 431 502 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.325N P=0.468N P=0.551N P=0.381N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.313N P=0.271N P=0.516N P=0.331N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.321N P=0.342N P=0.510N P=0.349N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.321N | (e) |
|FISHER EXACT | P=0.340N P=0.509N P=0.340N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 1/59 (2%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 7.6% 0.0% 1.8% 7.3% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/21 (5%) 0/11 (0%) 0/18 (0%) 1/19 (5%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 642 --- 431 502 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.481 P=0.339N P=0.531N P=0.673 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.537 P=0.258N P=0.534N P=0.678N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.469 P=0.262N P=0.507N P=0.686 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.469 | (e) |
|FISHER EXACT | P=0.248N P=0.506N P=0.691N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 0/60 (0%) 2/59 (3%) 2/60 (3%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 21.7% 0.0% 11.1% 10.5% | 0.0% 3.4% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/21 (19%) 0/11 (0%) 2/18 (11%) 2/19 (11%) | 0/25 (0%) 1/29 (3%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 670 --- 729 (T) 729 (T) | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.252N P=0.100N P=0.273N P=0.257N | P=0.627N P=0.530 (e) (e) |
|INCIDENTAL TUMOR | P=0.248N P=0.079N P=0.262N P=0.242N | P=0.627N P=0.530 (e) (e) |
|LOGISTIC REGRESSION | P=0.273N P=0.052N P=0.213N P=0.256N | P=0.627N P=0.530 (e) (e) |
|COCHRAN-ARMITAGE | P=0.265N | P=0.567N |
|FISHER EXACT | P=0.029N* P=0.226N P=0.219N | P=0.500 (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Neurofibrosarcoma or Schwannoma (malignant or NOS) |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/59 (0%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 7.6% 0.0% 0.0% | 3.4% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | --- 635 --- --- | 718 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.407N P=0.199 (e) (e) | P=0.346N P=0.493N P=0.493N P=0.584N |
|INCIDENTAL TUMOR | P=0.435N P=0.321 (e) (e) | P=0.340N P=0.552N P=0.516N P=0.573N |
|LOGISTIC REGRESSION | P=0.409N P=0.228 (e) (e) | P=0.342N P=0.499N P=0.501N P=0.576N |
|COCHRAN-ARMITAGE | P=0.406N | P=0.306N |
|FISHER EXACT | P=0.248 (e) (e) | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Neurofibrosarcoma, Neurofibroma, or Schwannoma (benign, malignant or NOS) |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/59 (0%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 7.6% 0.0% 0.0% | 3.4% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | --- 635 --- --- | 718 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.407N P=0.199 (e) (e) | P=0.346N P=0.493N P=0.493N P=0.584N |
|INCIDENTAL TUMOR | P=0.435N P=0.321 (e) (e) | P=0.340N P=0.552N P=0.516N P=0.573N |
|LOGISTIC REGRESSION | P=0.409N P=0.228 (e) (e) | P=0.342N P=0.499N P=0.501N P=0.576N |
|COCHRAN-ARMITAGE | P=0.406N | P=0.306N |
|FISHER EXACT | P=0.248 (e) (e) | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/59 (0%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.8% 0.0% 0.0% 7.3% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/21 (5%) 0/11 (0%) 0/18 (0%) 1/19 (5%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- 502 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.261 P=0.629N P=0.531N P=0.474 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.309 P=0.629N P=0.531N P=0.544 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.243 P=0.629N P=0.531N P=0.490 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.246 | (e) |
|FISHER EXACT | P=0.500N P=0.504N P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 1/59 (2%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 9.7% 0.0% 5.6% 0.0% | 4.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/21 (5%) 0/11 (0%) 1/18 (6%) 0/19 (0%) | 1/25 (4%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 550 --- 729 (T) --- | 729 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.091N P=0.180N P=0.343N P=0.134N | P=0.342N P=0.470N P=0.500N P=0.566N |
|INCIDENTAL TUMOR | P=0.098N P=0.104N P=0.318N P=0.149N | P=0.342N P=0.470N P=0.500N P=0.566N |
|LOGISTIC REGRESSION | P=0.089N P=0.125N P=0.313N P=0.124N | P=0.342N P=0.470N P=0.500N P=0.566N |
|COCHRAN-ARMITAGE | P=0.087N | P=0.306N |
|FISHER EXACT | P=0.122N P=0.316N P=0.122N | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 7/60 (12%) 0/60 (0%) 2/59 (3%) 2/60 (3%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 25.8% 0.0% 11.1% 10.5% | 4.0% 3.4% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/21 (19%) 0/11 (0%) 2/18 (11%) 2/19 (11%) | 1/25 (4%) 1/29 (3%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 550 --- 729 (T) 729 (T) | 729 (T) 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.094N P=0.035N* P=0.113N P=0.105N | P=0.282N P=0.729N P=0.500N P=0.566N |
|INCIDENTAL TUMOR | P=0.100N P=0.016N* P=0.099N P=0.105N | P=0.282N P=0.729N P=0.500N P=0.566N |
|LOGISTIC REGRESSION | P=0.101N P=0.013N* P=0.084N P=0.096N | P=0.282N P=0.729N P=0.500N P=0.566N |
|COCHRAN-ARMITAGE | P=0.097N | P=0.236N |
|FISHER EXACT | P=0.006N** P=0.085N P=0.081N | P=0.752N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 7/60 (12%) 0/60 (0%) 2/59 (3%) 2/60 (3%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 25.8% 0.0% 11.1% 10.5% | 4.0% 3.4% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/21 (19%) 0/11 (0%) 2/18 (11%) 2/19 (11%) | 1/25 (4%) 1/29 (3%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 550 --- 729 (T) 729 (T) | 729 (T) 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.094N P=0.035N* P=0.113N P=0.105N | P=0.282N P=0.729N P=0.500N P=0.566N |
|INCIDENTAL TUMOR | P=0.100N P=0.016N* P=0.099N P=0.105N | P=0.282N P=0.729N P=0.500N P=0.566N |
|LOGISTIC REGRESSION | P=0.101N P=0.013N* P=0.084N P=0.096N | P=0.282N P=0.729N P=0.500N P=0.566N |
|COCHRAN-ARMITAGE | P=0.097N | P=0.236N |
|FISHER EXACT | P=0.006N** P=0.085N P=0.081N | P=0.752N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/60 (57%) 40/60 (67%) 37/59 (63%) 29/60 (48%) | |
|ADJUSTED (b) | 86.1% 100.0% 87.0% 77.8% | |
|INTERIM SACRIFICE 1 (c)| 3/10 (30%) 7/10 (70%) 4/10 (40%) 4/10 (40%) | |
|TERMINAL (d) | 16/21 (76%) 11/11 (100%) 13/18 (72%) 12/19 (63%) | |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 353 456 (I) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.162N P=0.006 ** P=0.254 P=0.420N | |
|INCIDENTAL TUMOR | P=0.149N P=0.067 P=0.293 P=0.310N | |
|LOGISTIC REGRESSION | P=0.115N P=0.093 P=0.282 P=0.272N | |
|COCHRAN-ARMITAGE | P=0.110N | |
|FISHER EXACT | P=0.174 P=0.314 P=0.232N | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/60 (12%) 4/60 (7%) 8/59 (14%) 6/60 (10%) | 1/60 (2%) 2/60 (3%) 2/60 (3%) 5/59 (8%) |
|ADJUSTED (b) | 27.1% 17.3% 24.8% 20.1% | 4.0% 6.9% 8.0% 20.5% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/21 (24%) 1/11 (9%) 2/18 (11%) 2/19 (11%) | 1/25 (4%) 2/29 (7%) 2/25 (8%) 3/18 (17%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 573 456 (I) 459 | 729 (T) 729 (T) 729 (T) 429 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.547 P=0.508N P=0.436 P=0.552N | P=0.015 * P=0.552 P=0.500 P=0.053 |
|INCIDENTAL TUMOR | P=0.494 P=0.386N P=0.467 P=0.534N | P=0.026 * P=0.552 P=0.500 P=0.091 |
|LOGISTIC REGRESSION | P=0.534 P=0.294N P=0.484 P=0.520N | P=0.022 * P=0.552 P=0.500 P=0.069 |
|COCHRAN-ARMITAGE | P=0.541 | P=0.048 * |
|FISHER EXACT | P=0.264N P=0.486 P=0.500N | P=0.500 P=0.500 P=0.100 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/60 (12%) 5/60 (8%) 9/59 (15%) 6/60 (10%) | 1/60 (2%) 2/60 (3%) 2/60 (3%) 6/59 (10%) |
|ADJUSTED (b) | 27.1% 19.3% 28.2% 20.1% | 4.0% 6.9% 8.0% 25.8% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/21 (24%) 1/11 (9%) 2/18 (11%) 2/19 (11%) | 1/25 (4%) 2/29 (7%) 2/25 (8%) 4/18 (22%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 558 456 (I) 459 | 729 (T) 729 (T) 729 (T) 429 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.533N P=0.617 P=0.339 P=0.552N | P=0.004 ** P=0.552 P=0.500 P=0.024 * |
|INCIDENTAL TUMOR | P=0.512 P=0.490N P=0.368 P=0.534N | P=0.008 ** P=0.552 P=0.500 P=0.043 * |
|LOGISTIC REGRESSION | P=0.551N P=0.409N P=0.377 P=0.520N | P=0.007 ** P=0.552 P=0.500 P=0.032 * |
|COCHRAN-ARMITAGE | P=0.543N | P=0.020 * |
|FISHER EXACT | P=0.381N P=0.381 P=0.500N | P=0.500 P=0.500 P=0.054 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/59 (2%) 0/60 (0%) | 2/60 (3%) 1/60 (2%) 2/60 (3%) 2/59 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 2.8% 0.0% | 6.2% 2.2% 5.7% 4.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 1/25 (4%) 0/29 (0%) 1/25 (4%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 617 --- | 582 562 457 (I) 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.691 (e) P=0.500 (e) | P=0.446 P=0.488N P=0.690 P=0.620 |
|INCIDENTAL TUMOR | P=0.667 (e) P=0.516 (e) | P=0.568 P=0.550N P=0.681 P=0.623N |
|LOGISTIC REGRESSION | P=0.694 (e) P=0.497 (e) | P=0.596 P=0.500N P=0.693N P=0.660N |
|COCHRAN-ARMITAGE | P=0.694 | P=0.519 |
|FISHER EXACT | (e) P=0.496 (e) | P=0.500N P=0.691N P=0.684 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/59 (2%) 0/60 (0%) | 3/60 (5%) 2/60 (3%) 2/60 (3%) 2/59 (3%) |
|ADJUSTED (b) | 0.0% 4.3% 2.8% 0.0% | 10.1% 5.5% 5.7% 4.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 2/25 (8%) 0/29 (0%) 1/25 (4%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | --- 684 617 --- | 582 562 457 (I) 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.599N P=0.468 P=0.500 (e) | P=0.539N P=0.465N P=0.502N P=0.600N |
|INCIDENTAL TUMOR | P=0.634N P=0.562 P=0.516 (e) | P=0.431N P=0.549N P=0.512N P=0.457N |
|LOGISTIC REGRESSION | P=0.598N P=0.478 P=0.497 (e) | P=0.414N P=0.501N P=0.501N P=0.499N |
|COCHRAN-ARMITAGE | P=0.595N | P=0.439N |
|FISHER EXACT | P=0.500 P=0.496 (e) | P=0.500N P=0.500N P=0.508N |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 4/60 (7%) 2/60 (3%) 8/60 (13%) 7/60 (12%) |
|ADJUSTED (b) | | 9.3% 5.1% 30.2% 20.6% |
|INTERIM SACRIFICE 1 (c)| | 2/10 (20%) 1/10 (10%) 0/10 (0%) 2/10 (20%) |
|TERMINAL (d) | | 1/25 (4%) 1/29 (3%) 7/25 (28%) 2/18 (11%) |
|FIRST INCIDENCE (DAYS) | | 457 (I) 457 (I) 700 353 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.039 * P=0.316N P=0.180 P=0.186 |
|INCIDENTAL TUMOR | | P=0.104 P=0.336N P=0.172 P=0.400 |
|LOGISTIC REGRESSION | | P=0.107 P=0.337N P=0.176 P=0.403 |
|COCHRAN-ARMITAGE | | P=0.101 |
|FISHER EXACT | | P=0.340N P=0.181 P=0.264 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 1/59 (2%) 1/60 (2%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 7.2% 3.4% 2.7% | 1.7% 2.3% 0.0% 2.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | --- 558 652 572 | 457 (I) 576 --- 556 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.478 P=0.212 P=0.480 P=0.480 | P=0.655N P=0.760 P=0.500N P=0.736 |
|INCIDENTAL TUMOR | P=0.450 P=0.321 P=0.517 P=0.464 | P=0.578N P=0.729 P=0.500N P=0.747N |
|LOGISTIC REGRESSION | P=0.499 P=0.235 P=0.496 P=0.498 | P=0.510N P=0.759 P=0.455N P=0.687N |
|COCHRAN-ARMITAGE | P=0.499 | P=0.616N |
|FISHER EXACT | P=0.248 P=0.496 P=0.500 | P=0.752N P=0.500N P=0.752N |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 25/60 (42%) 16/60 (27%) 21/59 (36%) 22/60 (37%) | 13/60 (22%) 14/60 (23%) 13/60 (22%) 16/60 (27%) |
|ADJUSTED (b) | 72.7% 57.6% 64.3% 77.4% | 39.7% 39.6% 36.2% 53.9% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 13/21 (62%) 2/11 (18%) 8/18 (44%) 13/19 (68%) | 7/25 (28%) 9/29 (31%) 5/25 (20%) 6/18 (33%) |
|FIRST INCIDENCE (DAYS) | 452 558 500 424 | 636 443 484 439 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.496N P=0.424N P=0.425N P=0.514N | P=0.055 P=0.569N P=0.581 P=0.080 |
|INCIDENTAL TUMOR | P=0.515N P=0.061N P=0.363N P=0.390N | P=0.169 P=0.508 P=0.579 P=0.157 |
|LOGISTIC REGRESSION | P=0.524 P=0.087N P=0.313N P=0.439N | P=0.121 P=0.492 P=0.577 P=0.112 |
|COCHRAN-ARMITAGE | P=0.503N | P=0.303 |
|FISHER EXACT | P=0.062N P=0.312N P=0.354N | P=0.500 P=0.588N P=0.335 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 2/59 (3%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 8.3% 0.0% 5.1% 4.2% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/21 (0%) 0/11 (0%) 0/18 (0%) 0/19 (0%) | 0/25 (0%) 0/29 (0%) 0/25 (0%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 456 (I) --- 456 (I) 456 (I) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.583N P=0.153N P=0.506N P=0.522N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.595 P=0.085N P=0.477N P=0.525N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.589N P=0.120N P=0.513N P=0.508N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.578N | (e) |
|FISHER EXACT | P=0.122N P=0.508N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 49/60 (82%) 58/60 (97%) 56/59 (95%) 53/60 (88%) | 45/60 (75%) 39/60 (65%) 42/60 (70%) 37/60 (62%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 95.6% 90.4% 93.2% 88.9% |
|INTERIM SACRIFICE 1 (c)| 5/10 (50%) 9/10 (90%) 9/10 (90%) 5/10 (50%) | 2/10 (20%) 2/10 (20%) 3/10 (30%) 7/10 (70%) |
|TERMINAL (d) | 21/21 (100%) 11/11 (100%) 18/18 (100%) 19/19 (100%)| 23/25 (92%) 25/29 (86%) 22/25 (88%) 14/18 (78%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 416 353 404 | 390 457 (I) 457 (I) 353 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.415 P=0.002 ** P=0.104 P=0.167 | P=0.168 P=0.089N P=0.386N P=0.338 |
|INCIDENTAL TUMOR | P=0.226 P=0.005 ** P=0.010 ** P=0.148 | P=0.492N P=0.086N P=0.367N P=0.248N |
|LOGISTIC REGRESSION | P=0.249 P=0.002 ** P=0.006 ** P=0.095 | P=0.522N P=0.135N P=0.355N P=0.310N |
|COCHRAN-ARMITAGE | P=0.317 | P=0.108N |
|FISHER EXACT | P=0.008 ** P=0.023 * P=0.222 | P=0.160N P=0.342N P=0.085N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 32 MG/KG 63 MG/KG 125 | 0 MG/KG 63 MG/KG 125 250 |
| | MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 27/60 (45%) 24/60 (40%) 27/59 (46%) 26/60 (43%) | 17/60 (28%) 17/60 (28%) 13/60 (22%) 18/60 (30%) |
|ADJUSTED (b) | 77.1% 68.9% 72.2% 82.4% | 47.4% 45.8% 36.2% 56.4% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 14/21 (67%) 2/11 (18%) 9/18 (50%) 14/19 (74%) | 8/25 (32%) 10/29 (34%) 5/25 (20%) 6/18 (33%) |
|FIRST INCIDENCE (DAYS) | 452 467 379 424 | 457 (I) 443 484 439 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.525 P=0.270 P=0.428 P=0.467 | P=0.126 P=0.469N P=0.280N P=0.148 |
|INCIDENTAL TUMOR | P=0.525N P=0.292N P=0.466 P=0.518N | P=0.347 P=0.557 P=0.276N P=0.321 |
|LOGISTIC REGRESSION | P=0.487 P=0.451N P=0.530 P=0.563 | P=0.272 P=0.574 P=0.270N P=0.285 |
|COCHRAN-ARMITAGE | P=0.531 | P=0.490 |
|FISHER EXACT | P=0.356N P=0.540 P=0.500N | P=0.580N P=0.264N P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 53/60 (88%) 58/60 (97%) 57/59 (97%) 55/60 (92%) | 50/60 (83%) 44/60 (73%) 47/60 (78%) 44/60 (73%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 98.0% 93.5% 95.9% 95.2% |
|INTERIM SACRIFICE 1 (c)| 6/10 (60%) 9/10 (90%) 9/10 (90%) 5/10 (50%) | 3/10 (30%) 2/10 (20%) 3/10 (30%) 7/10 (70%) |
|TERMINAL (d) | 21/21 (100%) 11/11 (100%) 18/18 (100%) 19/19 (100%)| 24/25 (96%) 26/29 (90%) 23/25 (92%) 16/18 (89%) |
|FIRST INCIDENCE (DAYS) | 452 416 353 404 | 390 443 457 (I) 353 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.467 P=0.010 * P=0.199 P=0.247 | P=0.072 P=0.101N P=0.396N P=0.180 |
|INCIDENTAL TUMOR | P=0.409 P=0.097 P=0.041 * P=0.414 | P=0.479 P=0.065N P=0.313N P=0.390N |
|LOGISTIC REGRESSION | P=0.399 P=0.043 * P=0.027 * P=0.277 | P=0.355 P=0.100N P=0.328N P=0.507N |
|COCHRAN-ARMITAGE | P=0.432 | P=0.182N |
|FISHER EXACT | P=0.081 P=0.085 P=0.381 | P=0.134N P=0.322N P=0.134N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05109 TEST: 11 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIETHANOLAMINE
TERMINAL SACRIFICE AT 105 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(c) Observed incidence at interim kill.
Male interim sacrifices(days): 456
Female interim sacrifices(days): 457
(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).