TDMS Study 05162-10 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus DIETHANOLAMINE DATE: 06/19/97
EXPERIMENT: 05162 TEST: 10 TIME: 12:11:41
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55174D
PATHOLOGIST: PERSING, R. CAS: 111-42-2
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
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 DIETHANOLAMINE DATE: 06/19/97
EXPERIMENT: 05162 TEST: 10 TIME: 12:11:41
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55174D
PATHOLOGIST: PERSING, R. CAS: 111-42-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DIETHANOLAMINE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Adenoma
Kidney: Renal Tubule Adenoma
Carcinoma or Adenoma
Liver Hepatoblastoma
Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Pituitary Gland: Pars Distalis or UnspeAdenomaSite
Thyroid Gland: Follicular Cell Adenoma
All Organs Hemangiosarcoma or Hemangioma
Malignant Lymphoma And Histiocytic Sarcoma
Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 9/50 (18%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 10.9% 18.7% 2.2% 4.6% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 4/40 (10%) 9/43 (21%) 1/34 (3%) 2/30 (7%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 1/23 (4%) |
|FIRST INCIDENCE | 678 729 (T) 729 (T) 729 (T) |--- --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.110N P=0.237 P=0.141N P=0.330N |P=0.131 (e) (e) P=0.371 |
|POLY 3 | P=0.051N P=0.219 P=0.106N P=0.234N |P=0.192 (e) (e) P=0.478 |
|POLY 1.5 | P=0.048N* P=0.210 P=0.103N P=0.228N |P=0.196 (e) (e) P=0.488 |
|POLY 6 | P=0.055N P=0.228 P=0.111N P=0.243N |P=0.183 (e) (e) P=0.461 |
|LOGISTIC REGRESSION| P=0.069N P=0.237 P=0.112N P=0.242N |(e) (e) (e) P=0.371 |
|COCH-ARM / FISHERS | P=0.047N* P=0.194 P=0.102N P=0.218N |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.2% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |2/44 (5%) 0/33 (0%) 1/33 (3%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.293N P=0.304N P=0.600N P=0.390N |
|POLY 3 | (e) (e) (e) (e) |P=0.183N P=0.276N P=0.531N P=0.263N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.183N P=0.261N P=0.518N P=0.251N |
|POLY 6 | (e) (e) (e) (e) |P=0.188N P=0.291N P=0.549N P=0.284N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.293N (e) P=0.600N (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.188N P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 4.4% 0.0% |2.1% 2.4% 2.3% 4.6% |
|TERMINAL (d) | 0/40 (0%) 1/43 (2%) 1/34 (3%) 0/30 (0%) |1/44 (2%) 0/33 (0%) 1/33 (3%) 1/23 (4%) |
|FIRST INCIDENCE | --- 729 (T) 558 --- |731 (T) 649 731 (T) 726 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.638 P=0.514 P=0.224 (e) |P=0.205 P=0.701 P=0.696 P=0.285 |
|POLY 3 | P=0.634N P=0.510 P=0.237 (e) |P=0.328 P=0.724 P=0.740 P=0.461 |
|POLY 1.5 | P=0.628N P=0.506 P=0.238 (e) |P=0.341 P=0.738 P=0.749 P=0.479 |
|POLY 6 | P=0.642N P=0.514 P=0.233 (e) |P=0.303 P=0.711 P=0.728 P=0.433 |
|LOGISTIC REGRESSION| P=0.583N P=0.514 P=0.221 (e) |P=0.320 P=0.767N P=0.696 P=0.341 |
|COCH-ARM / FISHERS | P=0.616N P=0.500 P=0.247 (e) |P=0.351 P=0.753N P=0.753N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 4.4% 2.3% |2.1% 4.8% 2.3% 6.9% |
|TERMINAL (d) | 0/40 (0%) 1/43 (2%) 1/34 (3%) 1/30 (3%) |1/44 (2%) 0/33 (0%) 1/33 (3%) 1/23 (4%) |
|FIRST INCIDENCE | --- 729 (T) 558 729 (T) |731 (T) 424 731 (T) 606 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.293 P=0.514 P=0.224 P=0.443 |P=0.140 P=0.433 P=0.696 P=0.153 |
|POLY 3 | P=0.343 P=0.510 P=0.237 P=0.492 |P=0.212 P=0.452 P=0.740 P=0.270 |
|POLY 1.5 | P=0.351 P=0.506 P=0.238 P=0.495 |P=0.225 P=0.470 P=0.749 P=0.286 |
|POLY 6 | P=0.333 P=0.514 P=0.233 P=0.489 |P=0.190 P=0.435 P=0.728 P=0.245 |
|LOGISTIC REGRESSION| P=0.384 P=0.514 P=0.221 P=0.443 |P=0.240 P=0.760N P=0.696 P=0.326 |
|COCH-ARM / FISHERS | P=0.366 P=0.500 P=0.247 P=0.500 |P=0.237 P=0.500 P=0.753N P=0.309 |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 6.6% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 2/34 (6%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- 631 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.478 (e) P=0.106 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.505 (e) P=0.117 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.516 (e) P=0.119 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.490 (e) P=0.114 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.544 (e) P=0.121 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.539 (e) P=0.121 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 6.6% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 2/34 (6%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- 631 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.478 (e) P=0.106 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.505 (e) P=0.117 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.516 (e) P=0.119 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.490 (e) P=0.114 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.544 (e) P=0.121 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.539 (e) P=0.121 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 6/50 (12%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 8.3% 13.1% 13.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 3/43 (7%) 3/34 (9%) 2/30 (7%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) 692 654 540 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * P=0.207 P=0.047 * P=0.042 * |(e) (e) (e) (e) |
|POLY 3 | P=0.049 * P=0.196 P=0.056 P=0.053 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.051 P=0.189 P=0.057 P=0.054 |(e) (e) (e) (e) |
|POLY 6 | P=0.047 * P=0.202 P=0.054 P=0.053 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.058 P=0.197 P=0.058 P=0.061 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.056 P=0.181 P=0.056 P=0.056 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 2.1% 0.0% 4.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/40 (5%) 1/43 (2%) 0/34 (0%) 2/30 (7%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482 P=0.475N P=0.275N P=0.588 |(e) (e) (e) (e) |
|POLY 3 | P=0.574 P=0.483N P=0.240N P=0.680 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.580 P=0.489N P=0.238N P=0.684 |(e) (e) (e) (e) |
|POLY 6 | P=0.566 P=0.476N P=0.245N P=0.674 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.482 P=0.475N (e) P=0.588 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.591 P=0.500N P=0.247N P=0.691N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 6/50 (12%) 8/50 (16%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.6% 10.4% 13.1% 17.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/40 (8%) 4/43 (9%) 3/34 (9%) 4/30 (13%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) 692 654 540 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030 * P=0.400 P=0.193 P=0.056 |(e) (e) (e) (e) |
|POLY 3 | P=0.064 P=0.386 P=0.242 P=0.093 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.067 P=0.375 P=0.244 P=0.095 |(e) (e) (e) (e) |
|POLY 6 | P=0.061 P=0.398 P=0.237 P=0.092 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.068 P=0.396 P=0.238 P=0.096 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.073 P=0.357 P=0.243 P=0.100 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 1/43 (2%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 729 (T) 583 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.651N P=0.514 P=0.237 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.634N P=0.510 P=0.238 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.628N P=0.506 P=0.238 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.642N P=0.514 P=0.235 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.562N P=0.514 P=0.206 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.616N P=0.500 P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 8/50 (16%) 5/50 (10%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.2% 17.5% 11.3% |0.0% 4.8% 2.3% 2.3% |
|TERMINAL (d) | 0/40 (0%) 2/43 (5%) 4/34 (12%) 2/30 (7%) |0/44 (0%) 1/33 (3%) 1/33 (3%) 1/23 (4%) |
|FIRST INCIDENCE | --- 729 (T) 633 684 |--- 421 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * P=0.254 P=0.004 ** P=0.023 * |P=0.370 P=0.206 P=0.443 P=0.371 |
|POLY 3 | P=0.018 * P=0.249 P=0.004 ** P=0.028 * |P=0.446 P=0.207 P=0.482 P=0.478 |
|POLY 1.5 | P=0.019 * P=0.244 P=0.004 ** P=0.029 * |P=0.471 P=0.218 P=0.490 P=0.488 |
|POLY 6 | P=0.016 * P=0.253 P=0.003 ** P=0.027 * |P=0.407 P=0.196 P=0.472 P=0.461 |
|LOGISTIC REGRESSION| P=0.021 * P=0.254 P=0.005 ** P=0.030 * |P=0.509 P=0.451 P=0.443 P=0.371 |
|COCH-ARM / FISHERS | P=0.026 * P=0.247 P=0.003 ** P=0.028 * |P=0.500 P=0.247 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 42/50 (84%) 49/50 (98%) 45/50 (90%) |32/50 (64%) 50/50 (100%) 48/50 (96%) 48/50 (96%) |
|POLY-3 ADJUSTED (b)| 65.0% 86.5% 98.0% 93.5% |66.1% 100.0% 96.4% 96.4% |
|TERMINAL (d) | 28/40 (70%) 40/43 (93%) 33/34 (97%) 28/30 (93%) |30/44 (68%) 33/33 (100%) 33/33 (100%) 23/23 (100%) |
|FIRST INCIDENCE | 411 641 445 386 |674 418 474 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.037 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.010 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 17/50 (34%) 33/50 (66%) 34/50 (68%) |5/50 (10%) 19/50 (38%) 38/50 (76%) 42/50 (84%) |
|POLY-3 ADJUSTED (b)| 25.1% 34.9% 66.9% 72.3% |10.4% 43.4% 77.9% 84.9% |
|TERMINAL (d) | 6/40 (15%) 13/43 (30%) 20/34 (59%) 20/30 (67%) |4/44 (9%) 12/33 (36%) 26/33 (79%) 18/23 (78%) |
|FIRST INCIDENCE | 485 576 445 446 |729 423 474 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.275 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.206 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.201 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.208 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.147 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.189 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 18/50 (36%) 34/50 (68%) 34/50 (68%) |5/50 (10%) 20/50 (40%) 39/50 (78%) 43/50 (86%) |
|POLY-3 ADJUSTED (b)| 25.1% 36.9% 68.9% 72.3% |10.4% 44.9% 79.9% 86.9% |
|TERMINAL (d) | 6/40 (15%) 14/43 (33%) 20/34 (59%) 20/30 (67%) |4/44 (9%) 12/33 (36%) 27/33 (82%) 19/23 (83%) |
|FIRST INCIDENCE | 485 576 445 446 |729 421 474 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.217 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.151 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.147 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.152 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.106 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.138 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 47/50 (94%) 50/50 (100%) 49/50 (98%) |33/50 (66%) 50/50 (100%) 50/50 (100%) 50/50 (100%) |
|POLY-3 ADJUSTED (b)| 79.0% 95.3% 100.0% 99.9% |68.2% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 31/40 (78%) 41/43 (95%) 34/34 (100%) 30/30 (100%)|31/44 (71%) 33/33 (100%) 33/33 (100%) 23/23 (100%) |
|FIRST INCIDENCE | 411 576 445 386 |674 418 474 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.208 P=0.003 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.025 * P<0.001 ** P=0.002 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.020 * P<0.001 ** P=0.002 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 47/50 (94%) 50/50 (100%) 49/50 (98%) |33/50 (66%) 50/50 (100%) 50/50 (100%) 50/50 (100%) |
|POLY-3 ADJUSTED (b)| 79.0% 95.3% 100.0% 99.9% |68.2% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 31/40 (78%) 41/43 (95%) 34/34 (100%) 30/30 (100%)|31/44 (71%) 33/33 (100%) 33/33 (100%) 23/23 (100%) |
|FIRST INCIDENCE | 411 576 445 386 |674 418 474 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.208 P=0.003 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.025 * P<0.001 ** P=0.002 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.020 * P<0.001 ** P=0.002 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 15/50 (30%) 10/50 (20%) 4/50 (8%) |4/50 (8%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 24.1% 30.9% 21.8% 9.1% |8.3% 2.4% 4.5% 2.3% |
|TERMINAL (d) | 11/40 (28%) 12/43 (28%) 7/34 (21%) 4/30 (13%) |4/44 (9%) 1/33 (3%) 2/33 (6%) 1/23 (4%) |
|FIRST INCIDENCE | 729 (T) 670 641 729 (T) |731 (T) 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.076N P=0.325 P=0.548 P=0.130N |P=0.349N P=0.275N P=0.476N P=0.417N |
|POLY 3 | P=0.020N* P=0.304 P=0.496N P=0.051N |P=0.169N P=0.233N P=0.379N P=0.215N |
|POLY 1.5 | P=0.018N* P=0.281 P=0.495N P=0.049N* |P=0.164N P=0.212N P=0.361N P=0.198N |
|POLY 6 | P=0.024N* P=0.333 P=0.504N P=0.054N |P=0.183N P=0.256N P=0.405N P=0.244N |
|LOGISTIC REGRESSION| P=0.024N* P=0.317 P=0.532N P=0.130N |P=0.349N P=0.275N P=0.476N P=0.417N |
|COCH-ARM / FISHERS | P=0.016N* P=0.247 P=0.500N P=0.045N* |P=0.165N P=0.181N P=0.339N P=0.181N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 10.9% 2.1% 6.7% 0.0% |4.1% 2.4% 4.5% 0.0% |
|TERMINAL (d) | 4/40 (10%) 1/43 (2%) 3/34 (9%) 0/30 (0%) |1/44 (2%) 0/33 (0%) 1/33 (3%) 0/23 (0%) |
|FIRST INCIDENCE | 678 729 (T) 729 (T) --- |659 418 684 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.067N P=0.089N P=0.440N P=0.059N |P=0.279N P=0.566N P=0.605 P=0.342N |
|POLY 3 | P=0.042N* P=0.091N P=0.367N P=0.034N* |P=0.218N P=0.552N P=0.661 P=0.264N |
|POLY 1.5 | P=0.040N* P=0.095N P=0.361N P=0.033N* |P=0.208N P=0.532N P=0.675 P=0.252N |
|POLY 6 | P=0.045N* P=0.088N P=0.381N P=0.036N* |P=0.239N P=0.572N P=0.641 P=0.286N |
|LOGISTIC REGRESSION| P=0.045N* P=0.090N P=0.385N P=0.037N* |P=0.184N P=0.232N P=0.682N P=0.204N |
|COCH-ARM / FISHERS | P=0.037N* P=0.102N P=0.357N P=0.028N* |P=0.200N P=0.500N P=0.691N P=0.247N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 16/50 (32%) 12/50 (24%) 4/50 (8%) |6/50 (12%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 32.7% 33.0% 26.2% 9.1% |12.4% 4.8% 9.0% 2.3% |
|TERMINAL (d) | 14/40 (35%) 13/43 (30%) 9/34 (27%) 4/30 (13%) |5/44 (11%) 1/33 (3%) 3/33 (9%) 1/23 (4%) |
|FIRST INCIDENCE | 678 670 641 729 (T) |659 418 684 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.020N* P=0.570N P=0.494N P=0.025N* |P=0.189N P=0.232N P=0.543N P=0.208N |
|POLY 3 | P=0.003N** P=0.574 P=0.324N P=0.005N** |P=0.075N P=0.187N P=0.428N P=0.078N |
|POLY 1.5 | P=0.003N** P=0.546 P=0.322N P=0.005N** |P=0.069N P=0.165N P=0.403N P=0.067N |
|POLY 6 | P=0.004N** P=0.568N P=0.335N P=0.006N** |P=0.089N P=0.213N P=0.463N P=0.097N |
|LOGISTIC REGRESSION| P=0.004N** P=0.582N P=0.359N P=0.009N** |P=0.068N P=0.094N P=0.433N P=0.090N |
|COCH-ARM / FISHERS | P=0.002N** P=0.500 P=0.326N P=0.005N** |P=0.066N P=0.134N P=0.370N P=0.056N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.1% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |1/44 (2%) 0/33 (0%) 1/33 (3%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) --- 626 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.572N P=0.557N P=0.418 P=0.629N |
|POLY 3 | (e) (e) (e) (e) |P=0.472N P=0.532N P=0.472 P=0.522N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.464N P=0.520N P=0.484 P=0.512N |
|POLY 6 | (e) (e) (e) (e) |P=0.493N P=0.545N P=0.456 P=0.539N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.462N (e) P=0.533 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.461N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |2/49 (4%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| |4.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | |2/43 (5%) 0/33 (0%) 0/32 (0%) 0/22 (0%) |
|FIRST INCIDENCE | |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.172N P=0.298N P=0.306N P=0.395N |
|POLY 3 | |P=0.102N P=0.271N P=0.258N P=0.264N |
|POLY 1.5 | |P=0.106N P=0.256N P=0.249N P=0.251N |
|POLY 6 | |P=0.099N P=0.286N P=0.271N P=0.285N |
|LOGISTIC REGRESSION| |P=0.172N (e) (e) (e) |
|COCH-ARM / FISHERS | |P=0.115N P=0.242N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |3/49 (6%) 0/50 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| |6.4% 0.0% 0.0% 2.4% |
|TERMINAL (d) | |3/43 (7%) 0/33 (0%) 0/32 (0%) 0/22 (0%) |
|FIRST INCIDENCE | |731 (T) --- --- 721 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.392N P=0.172N P=0.178N P=0.550N |
|POLY 3 | |P=0.228N P=0.147N P=0.136N P=0.347N |
|POLY 1.5 | |P=0.234N P=0.134N P=0.128N P=0.328N |
|POLY 6 | |P=0.226N P=0.160N P=0.147N P=0.380N |
|LOGISTIC REGRESSION| |P=0.331N (e) (e) P=0.462N |
|COCH-ARM / FISHERS | |P=0.249N P=0.117N P=0.121N P=0.309N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/46 (0%) 0/43 (0%) |7/50 (14%) 0/50 (0%) 3/47 (6%) 1/44 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |14.5% 0.0% 7.3% 2.6% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/31 (0%) 0/27 (0%) |6/44 (14%) 0/33 (0%) 3/31 (10%) 1/20 (5%) |
|FIRST INCIDENCE | --- --- --- --- |674 --- 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.165N P=0.024N* P=0.325N P=0.188N |
|POLY 3 | (e) (e) (e) (e) |P=0.052N P=0.015N* P=0.231N P=0.065N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.051N P=0.012N* P=0.210N P=0.056N |
|POLY 6 | (e) (e) (e) (e) |P=0.057N P=0.019N* P=0.262N P=0.083N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.096N P=0.018N* P=0.265N P=0.086N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.057N P=0.006N** P=0.185N P=0.044N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/47 (0%) 0/46 (0%) 2/43 (5%) |1/50 (2%) 0/50 (0%) 0/47 (0%) 0/44 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 0.0% 0.0% 5.3% |2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/31 (0%) 2/27 (7%) |0/44 (0%) 0/33 (0%) 0/31 (0%) 0/20 (0%) |
|FIRST INCIDENCE | 716 --- --- 729 (T) |659 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.176 P=0.486N P=0.532N P=0.397 |P=0.334N P=0.557N P=0.541N P=0.552N |
|POLY 3 | P=0.210 P=0.497N P=0.513N P=0.442 |P=0.302N P=0.534N P=0.532N P=0.549N |
|POLY 1.5 | P=0.214 P=0.500N P=0.511N P=0.448 |P=0.309N P=0.521N P=0.524N P=0.538N |
|POLY 6 | P=0.206 P=0.495N P=0.519N P=0.435 |P=0.294N P=0.546N P=0.544N P=0.565N |
|LOGISTIC REGRESSION| P=0.194 P=0.500N P=0.515N P=0.428 |P=0.311N P=0.442N P=0.437N P=0.448N |
|COCH-ARM / FISHERS | P=0.221 P=0.505N P=0.511N P=0.458 |P=0.321N P=0.500N P=0.515N P=0.532N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 2.1% 2.2% 2.3% |2.1% 7.3% 4.5% 0.0% |
|TERMINAL (d) | 2/40 (5%) 1/43 (2%) 1/34 (3%) 0/30 (0%) |1/44 (2%) 2/33 (6%) 1/33 (3%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 660 |731 (T) 691 684 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500N P=0.475N P=0.557N P=0.569N |P=0.386N P=0.212 P=0.415 P=0.629N |
|POLY 3 | P=0.425N P=0.483N P=0.505N P=0.511N |P=0.287N P=0.251 P=0.470 P=0.522N |
|POLY 1.5 | P=0.419N P=0.489N P=0.502N P=0.508N |P=0.265N P=0.271 P=0.483 P=0.512N |
|POLY 6 | P=0.432N P=0.476N P=0.513N P=0.516N |P=0.324N P=0.233 P=0.454 P=0.539N |
|LOGISTIC REGRESSION| P=0.427N P=0.475N P=0.557N P=0.508N |P=0.277N P=0.232 P=0.476 (e) |
|COCH-ARM / FISHERS | P=0.409N P=0.500N P=0.500N P=0.500N |P=0.242N P=0.309 P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 2.2% 0.0% |0.0% 7.3% 2.3% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/43 (0%) 1/34 (3%) 0/30 (0%) |0/44 (0%) 2/33 (6%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- 691 684 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.472N P=0.486N P=0.725 P=0.557N |P=0.482N P=0.078 P=0.467 (e) |
|POLY 3 | P=0.419N P=0.490N P=0.757 P=0.508N |P=0.426N P=0.093 P=0.483 (e) |
|POLY 1.5 | P=0.414N P=0.494N P=0.759 P=0.505N |P=0.399N P=0.102 P=0.490 (e) |
|POLY 6 | P=0.425N P=0.486N P=0.753 P=0.511N |P=0.465N P=0.085 P=0.473 (e) |
|LOGISTIC REGRESSION| P=0.472N (e) P=0.725 (e) |P=0.385N P=0.087 P=0.537 (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.753N P=0.500N |P=0.366N P=0.121 P=0.500 (e) |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 2.2% 0.0% |2.1% 7.3% 2.3% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/43 (0%) 1/34 (3%) 0/30 (0%) |1/44 (2%) 2/33 (6%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |731 (T) 691 684 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.472N P=0.486N P=0.725 P=0.557N |P=0.312N P=0.212 P=0.709 P=0.629N |
|POLY 3 | P=0.419N P=0.490N P=0.757 P=0.508N |P=0.237N P=0.251 P=0.741 P=0.522N |
|POLY 1.5 | P=0.414N P=0.494N P=0.759 P=0.505N |P=0.219N P=0.271 P=0.750 P=0.512N |
|POLY 6 | P=0.425N P=0.486N P=0.753 P=0.511N |P=0.265N P=0.233 P=0.730 P=0.539N |
|LOGISTIC REGRESSION| P=0.472N (e) P=0.725 (e) |P=0.223N P=0.232 P=0.768N (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.753N P=0.500N |P=0.200N P=0.309 P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 8.2% 0.0% 0.0% |4.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 2/43 (5%) 0/34 (0%) 0/30 (0%) |2/44 (5%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 678 499 --- --- |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.154N P=0.209 P=0.510N P=0.510N |P=0.170N P=0.304N P=0.304N P=0.390N |
|POLY 3 | P=0.127N P=0.200 P=0.504N P=0.509N |P=0.102N P=0.276N P=0.258N P=0.263N |
|POLY 1.5 | P=0.125N P=0.192 P=0.501N P=0.506N |P=0.106N P=0.261N P=0.249N P=0.251N |
|POLY 6 | P=0.131N P=0.208 P=0.509N P=0.513N |P=0.099N P=0.291N P=0.270N P=0.284N |
|LOGISTIC REGRESSION| P=0.092N P=0.096 P=0.502N P=0.493N |P=0.170N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.125N P=0.181 P=0.500N P=0.500N |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 4.3% 0.0% 4.4% 4.6% | |
|TERMINAL (d) | 1/40 (3%) 0/43 (0%) 2/34 (6%) 2/30 (7%) | |
|FIRST INCIDENCE | 596 --- 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.343 P=0.227N P=0.649 P=0.615 | |
|POLY 3 | P=0.415 P=0.228N P=0.685 P=0.676 | |
|POLY 1.5 | P=0.425 P=0.232N P=0.690 P=0.682 | |
|POLY 6 | P=0.403 P=0.226N P=0.675 P=0.668 | |
|LOGISTIC REGRESSION| P=0.435 P=0.282N P=0.695N P=0.694 | |
|COCH-ARM / FISHERS | P=0.444 P=0.247N P=0.691N P=0.691N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/49 (10%) 4/50 (8%) 2/50 (4%) |4/50 (8%) 9/50 (18%) 7/50 (14%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 8.8% 10.6% 8.8% 4.6% |8.3% 22.0% 15.7% 7.1% |
|TERMINAL (d) | 4/40 (10%) 5/42 (12%) 3/34 (9%) 2/30 (7%) |4/44 (9%) 9/33 (27%) 6/33 (18%) 3/23 (13%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 667 729 (T) |731 (T) 731 (T) 600 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.370N P=0.531 P=0.560 P=0.476N |P=0.457 P=0.037 * P=0.132 P=0.468 |
|POLY 3 | P=0.243N P=0.518 P=0.638 P=0.355N |P=0.355N P=0.063 P=0.217 P=0.571N |
|POLY 1.5 | P=0.234N P=0.507 P=0.642 P=0.349N |P=0.314N P=0.080 P=0.236 P=0.543N |
|POLY 6 | P=0.255N P=0.530 P=0.629 P=0.363N |P=0.429N P=0.049 * P=0.194 P=0.614N |
|LOGISTIC REGRESSION| P=0.271N P=0.531 P=0.619 P=0.476N |P=0.434N P=0.037 * P=0.202 P=0.468 |
|COCH-ARM / FISHERS | P=0.218N P=0.487 P=0.643N P=0.339N |P=0.274N P=0.117 P=0.262 P=0.511N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |6.2% 4.8% 4.5% 0.0% |
|TERMINAL (d) | |3/44 (7%) 1/33 (3%) 2/33 (6%) 0/23 (0%) |
|FIRST INCIDENCE | |731 (T) 418 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.179N P=0.603N P=0.630N P=0.256N |
|POLY 3 | |P=0.098N P=0.565N P=0.541N P=0.140N |
|POLY 1.5 | |P=0.092N P=0.540N P=0.523N P=0.130N |
|POLY 6 | |P=0.112N P=0.590N P=0.564N P=0.158N |
|LOGISTIC REGRESSION| |P=0.082N P=0.404N P=0.630N (e) |
|COCH-ARM / FISHERS | |P=0.086N P=0.500N P=0.500N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.2% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |3/44 (7%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) --- --- 701 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.552 P=0.176N P=0.176N P=0.618 |
|POLY 3 | (e) (e) (e) (e) |P=0.509N P=0.151N P=0.136N P=0.549N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.515N P=0.138N P=0.128N P=0.526N |
|POLY 6 | (e) (e) (e) (e) |P=0.507N P=0.165N P=0.146N P=0.585N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.599N (e) (e) P=0.619N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.531N P=0.121N P=0.121N P=0.500N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 8.2% 6.5% 2.3% |4.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 2/43 (5%) 0/34 (0%) 1/30 (3%) |2/44 (5%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 674 499 583 729 (T) |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.352N P=0.376 P=0.487 P=0.544N |P=0.170N P=0.304N P=0.304N P=0.390N |
|POLY 3 | P=0.320N P=0.366 P=0.500 P=0.516N |P=0.102N P=0.276N P=0.258N P=0.263N |
|POLY 1.5 | P=0.310N P=0.356 P=0.502 P=0.511N |P=0.106N P=0.261N P=0.249N P=0.251N |
|POLY 6 | P=0.335N P=0.376 P=0.495 P=0.526N |P=0.099N P=0.291N P=0.270N P=0.284N |
|LOGISTIC REGRESSION| P=0.211N P=0.217 P=0.476 P=0.500N |P=0.170N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.292N P=0.339 P=0.500 P=0.500N |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |5/50 (10%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 4.3% 8.2% 6.5% 2.3% |10.4% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 0/40 (0%) 2/43 (5%) 0/34 (0%) 1/30 (3%) |5/44 (11%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 674 499 583 729 (T) |731 (T) --- --- 701 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.352N P=0.376 P=0.487 P=0.544N |P=0.364N P=0.064N P=0.064N P=0.498N |
|POLY 3 | P=0.320N P=0.366 P=0.500 P=0.516N |P=0.176N P=0.047N* P=0.039N* P=0.263N |
|POLY 1.5 | P=0.310N P=0.356 P=0.502 P=0.511N |P=0.181N P=0.040N* P=0.035N* P=0.241N |
|POLY 6 | P=0.335N P=0.376 P=0.495 P=0.526N |P=0.175N P=0.055N P=0.045N* P=0.300N |
|LOGISTIC REGRESSION| P=0.211N P=0.217 P=0.476 P=0.500N |P=0.270N (e) (e) P=0.348N |
|COCH-ARM / FISHERS | P=0.292N P=0.339 P=0.500 P=0.500N |P=0.199N P=0.028N* P=0.028N* P=0.218N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.1% 2.4% 0.0% 4.6% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 1/33 (3%) 0/33 (0%) 2/23 (9%) |
|FIRST INCIDENCE | --- --- --- --- |692 731 (T) --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.233 P=0.693 P=0.543N P=0.323 |
|POLY 3 | (e) (e) (e) (e) |P=0.349 P=0.722 P=0.518N P=0.460 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.359 P=0.737 P=0.510N P=0.479 |
|POLY 6 | (e) (e) (e) (e) |P=0.331 P=0.706 P=0.529N P=0.430 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.315 P=0.739 P=0.475N P=0.440 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.366 P=0.753N P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |13/50 (26%) 6/50 (12%) 11/50 (22%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 2.3% |26.5% 14.4% 24.7% 9.2% |
|TERMINAL (d) | 0/40 (0%) 1/43 (2%) 0/34 (0%) 1/30 (3%) |9/44 (21%) 4/33 (12%) 9/33 (27%) 3/23 (13%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |576 599 614 606 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.334 P=0.514 (e) P=0.443 |P=0.229N P=0.201N P=0.489 P=0.165N |
|POLY 3 | P=0.395 P=0.510 (e) P=0.492 |P=0.043N* P=0.124N P=0.516N P=0.028N* |
|POLY 1.5 | P=0.399 P=0.506 (e) P=0.495 |P=0.035N* P=0.097N P=0.469N P=0.021N* |
|POLY 6 | P=0.390 P=0.514 (e) P=0.489 |P=0.063N P=0.156N P=0.580N P=0.045N* |
|LOGISTIC REGRESSION| (e) P=0.514 (e) P=0.443 |P=0.044N* P=0.080N P=0.480N P=0.016N* |
|COCH-ARM / FISHERS | P=0.405 P=0.500 (e) P=0.500 |P=0.032N* P=0.062N P=0.408N P=0.016N* |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |12/50 (24%) 6/50 (12%) 11/50 (22%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 2.3% |24.5% 14.4% 24.7% 4.6% |
|TERMINAL (d) | 0/40 (0%) 1/43 (2%) 0/34 (0%) 1/30 (3%) |9/44 (21%) 4/33 (12%) 9/33 (27%) 1/23 (4%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |576 599 614 606 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.334 P=0.514 (e) P=0.443 |P=0.106N P=0.259N P=0.407 P=0.057N |
|POLY 3 | P=0.395 P=0.510 (e) P=0.492 |P=0.015N* P=0.173N P=0.586 P=0.007N** |
|POLY 1.5 | P=0.399 P=0.506 (e) P=0.495 |P=0.012N* P=0.140N P=0.559N P=0.005N** |
|POLY 6 | P=0.390 P=0.514 (e) P=0.489 |P=0.024N* P=0.210N P=0.527 P=0.012N* |
|LOGISTIC REGRESSION| (e) P=0.514 (e) P=0.443 |P=0.015N* P=0.123N P=0.583N P=0.004N** |
|COCH-ARM / FISHERS | P=0.405 P=0.500 (e) P=0.500 |P=0.011N* P=0.096N P=0.500N P=0.004N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 38/50 (76%) 45/50 (90%) 49/50 (98%) 45/50 (90%) |40/50 (80%) 50/50 (100%) 49/50 (98%) 48/50 (96%) |
|POLY-3 ADJUSTED (b)| 78.5% 92.2% 98.0% 93.5% |82.2% 100.0% 98.3% 96.4% |
|TERMINAL (d) | 32/40 (80%) 41/43 (95%) 33/34 (97%) 28/30 (93%) |37/44 (84%) 33/33 (100%) 33/33 (100%) 23/23 (100%) |
|FIRST INCIDENCE | 411 641 445 386 |659 418 474 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.242 P=0.002 ** P=0.003 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.012 * P=0.044 * P=0.002 ** P=0.028 * |P=0.013 * P<0.001 ** P=0.006 ** P=0.019 * |
|POLY 1.5 | P=0.013 * P=0.046 * P<0.001 ** P=0.029 * |P=0.011 * P<0.001 ** P=0.005 ** P=0.016 * |
|POLY 6 | P=0.016 * P=0.046 * P=0.003 ** P=0.033 * |P=0.015 * P=0.002 ** P=0.007 ** P=0.022 * |
|LOGISTIC REGRESSION| P=0.013 * P=0.095 P<0.001 ** P=0.033 * |P=0.011 * P<0.001 ** P=0.002 ** P=0.005 ** |
|COCH-ARM / FISHERS | P=0.033 * P=0.054 P<0.001 ** P=0.054 |P=0.011 * P<0.001 ** P=0.004 ** P=0.014 * |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 10 Page 20
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 22/50 (44%) 38/50 (76%) 35/50 (70%) |22/50 (44%) 26/50 (52%) 44/50 (88%) 44/50 (88%) |
|POLY-3 ADJUSTED (b)| 43.8% 44.2% 76.0% 74.5% |44.0% 56.3% 89.4% 88.9% |
|TERMINAL (d) | 14/40 (35%) 16/43 (37%) 22/34 (65%) 21/30 (70%) |16/44 (36%) 16/33 (49%) 30/33 (91%) 20/23 (87%) |
|FIRST INCIDENCE | 485 499 445 446 |508 418 474 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.532N P<0.001 ** P<0.001 ** |P<0.001 ** P=0.061 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.563 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.158 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.542 P<0.001 ** P=0.002 ** |P<0.001 ** P=0.198 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.578 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.122 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.428 P<0.001 ** P=0.003 ** |P<0.001 ** P=0.447 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P<0.001 ** P=0.004 ** |P<0.001 ** P=0.274 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 49/50 (98%) 50/50 (100%) 49/50 (98%) |47/50 (94%) 50/50 (100%) 50/50 (100%) 50/50 (100%) |
|POLY-3 ADJUSTED (b)| 92.0% 98.0% 100.0% 99.9% |94.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 36/40 (90%) 42/43 (98%) 34/34 (100%) 30/30 (100%)|41/44 (93%) 33/33 (100%) 33/33 (100%) 23/23 (100%) |
|FIRST INCIDENCE | 411 499 445 386 |508 418 474 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.555N P=0.048 * P=0.015 * |P<0.001 ** P=0.002 ** P=0.003 ** P<0.001 ** |
|POLY 3 | P=0.019 * P=0.180 P=0.061 P=0.065 |P=0.045 * P=0.119 P=0.119 P=0.119 |
|POLY 1.5 | P=0.025 * P=0.180 P=0.061 P=0.076 |P=0.045 * P=0.119 P=0.119 P=0.119 |
|POLY 6 | P=0.018 * P=0.180 P=0.061 P=0.063 |P=0.045 * P=0.119 P=0.119 P=0.119 |
|LOGISTIC REGRESSION| P=0.066 (e) (e) P=0.132 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.104 P=0.181 P=0.059 P=0.181 |P=0.047 * P=0.121 P=0.121 P=0.121 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(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.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers 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).