TDMS Study 05162-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus DIETHANOLAMINE DATE: 06/19/97
EXPERIMENT: 05162 TEST: 09 TIME: 12:11:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55174D
PATHOLOGIST: RYAN, M. CAS: 111-42-2
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 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: 09 TIME: 12:11:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55174D
PATHOLOGIST: RYAN, M. CAS: 111-42-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DIETHANOLAMINE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Pituitary Gland: Pars Distalis or UnspeAdenomaSite
Carcinoma or Adenoma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Clitoral/Preputial Gland Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
===============================================================
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.8% 0.0% |0.0% 2.3% 0.0% 2.5% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 1/29 (3%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- --- 663 --- |--- 730 (T) --- 703 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.584 (e) P=0.252 (e) |P=0.392 P=0.530 (e) P=0.515 |
|POLY 3 | P=0.603 (e) P=0.257 (e) |P=0.405 P=0.516 (e) P=0.499 |
|POLY 1.5 | P=0.598 (e) P=0.250 (e) |P=0.404 P=0.509 (e) P=0.499 |
|POLY 6 | P=0.626 (e) P=0.270 (e) |P=0.408 P=0.527 (e) P=0.500 |
|LOGISTIC REGRESSION| P=0.596 (e) P=0.235 (e) |P=0.394 P=0.530 (e) P=0.499 |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.405 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 7/50 (14%) 7/50 (14%) 12/50 (24%) |0/49 (0%) 1/50 (2%) 2/49 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 22.3% 18.5% 16.3% 29.6% |0.0% 2.3% 4.8% 5.0% |
|TERMINAL (d) | 2/14 (14%) 2/10 (20%) 2/21 (10%) 5/22 (23%) |0/25 (0%) 1/29 (3%) 1/29 (3%) 2/24 (8%) |
|FIRST INCIDENCE | 561 463 533 533 |--- 730 (T) 665 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.488 P=0.596 P=0.223N P=0.529 |P=0.139 P=0.530 P=0.279 P=0.228 |
|POLY 3 | P=0.214 P=0.447N P=0.340N P=0.309 |P=0.154 P=0.520 P=0.250 P=0.239 |
|POLY 1.5 | P=0.205 P=0.407N P=0.354N P=0.313 |P=0.158 P=0.513 P=0.243 P=0.239 |
|POLY 6 | P=0.241 P=0.526N P=0.318N P=0.317 |P=0.151 P=0.530 P=0.261 P=0.239 |
|LOGISTIC REGRESSION| P=0.210 P=0.412N P=0.369N P=0.316 |P=0.146 P=0.530 P=0.247 P=0.228 |
|COCH-ARM / FISHERS | P=0.198 P=0.393N P=0.393N P=0.312 |P=0.163 P=0.505 P=0.247 P=0.253 |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 7/50 (14%) 7/50 (14%) 12/50 (24%) |0/49 (0%) 1/50 (2%) 2/49 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 24.8% 18.5% 16.3% 29.6% |0.0% 2.3% 4.8% 5.0% |
|TERMINAL (d) | 2/14 (14%) 2/10 (20%) 2/21 (10%) 5/22 (23%) |0/25 (0%) 1/29 (3%) 1/29 (3%) 2/24 (8%) |
|FIRST INCIDENCE | 561 463 533 533 |--- 730 (T) 665 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.510N P=0.516N P=0.151N P=0.542N |P=0.139 P=0.530 P=0.279 P=0.228 |
|POLY 3 | P=0.289 P=0.346N P=0.247N P=0.404 |P=0.154 P=0.520 P=0.250 P=0.239 |
|POLY 1.5 | P=0.277 P=0.309N P=0.261N P=0.408 |P=0.158 P=0.513 P=0.243 P=0.239 |
|POLY 6 | P=0.323 P=0.423N P=0.227N P=0.415 |P=0.151 P=0.530 P=0.261 P=0.239 |
|LOGISTIC REGRESSION| P=0.283 P=0.321N P=0.270N P=0.411 |P=0.146 P=0.530 P=0.247 P=0.228 |
|COCH-ARM / FISHERS | P=0.267 P=0.298N P=0.298N P=0.405 |P=0.163 P=0.505 P=0.247 P=0.253 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.1% 2.7% 0.0% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 302 463 --- --- |--- --- --- 728 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.525N P=0.198N P=0.222N |P=0.185 (e) (e) P=0.492 |
|POLY 3 | P=0.096N P=0.523N P=0.225N P=0.241N |P=0.193 (e) (e) P=0.498 |
|POLY 1.5 | P=0.098N P=0.508N P=0.229N P=0.240N |P=0.195 (e) (e) P=0.498 |
|POLY 6 | P=0.092N P=0.550N P=0.218N P=0.238N |P=0.191 (e) (e) P=0.499 |
|LOGISTIC REGRESSION| P=0.145N P=0.668N P=0.355N P=0.273N |P=0.184 (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |P=0.199 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/49 (2%) 4/50 (8%) |4/50 (8%) 6/50 (12%) 2/49 (4%) 0/47 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 2.7% 2.5% 10.3% |10.0% 13.5% 4.8% 0.0% |
|TERMINAL (d) | 1/14 (7%) 0/10 (0%) 1/20 (5%) 3/22 (14%) |4/25 (16%) 3/29 (10%) 1/29 (3%) 0/22 (0%) |
|FIRST INCIDENCE | 729 (T) 688 729 (T) 701 |730 (T) 544 561 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.176 P=0.689 P=0.682N P=0.320 |P=0.026N* P=0.480 P=0.278N P=0.077N |
|POLY 3 | P=0.071 P=0.749 P=0.749N P=0.180 |P=0.025N* P=0.432 P=0.316N P=0.068N |
|POLY 1.5 | P=0.069 P=0.758 P=0.754N P=0.180 |P=0.025N* P=0.403 P=0.332N P=0.069N |
|POLY 6 | P=0.077 P=0.733 P=0.740N P=0.186 |P=0.024N* P=0.475 P=0.291N P=0.067N |
|LOGISTIC REGRESSION| P=0.114 P=0.709 P=0.682N P=0.258 |P=0.026N* P=0.436 P=0.316N (e) |
|COCH-ARM / FISHERS | P=0.068 P=0.753N P=0.747 P=0.181 |P=0.026N* P=0.370 P=0.349N P=0.066N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.8% 2.7% 2.4% 5.1% |0.0% 2.3% 2.4% 0.0% |
|TERMINAL (d) | 2/14 (14%) 0/10 (0%) 1/21 (5%) 1/22 (5%) |0/25 (0%) 1/29 (3%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 687 638 729 (T) 653 |--- 730 (T) 648 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.330N P=0.423N P=0.186N P=0.382N |P=0.615N P=0.530 P=0.521 (e) |
|POLY 3 | P=0.456N P=0.324N P=0.278N P=0.495N |P=0.596N P=0.516 P=0.512 (e) |
|POLY 1.5 | P=0.466N P=0.310N P=0.287N P=0.496N |P=0.596N P=0.509 P=0.505 (e) |
|POLY 6 | P=0.436N P=0.351N P=0.264N P=0.484N |P=0.593N P=0.527 P=0.522 (e) |
|LOGISTIC REGRESSION| P=0.437N P=0.364N P=0.210N P=0.478N |P=0.600N P=0.530 P=0.497 (e) |
|COCH-ARM / FISHERS | P=0.474N P=0.309N P=0.309N P=0.500N |P=0.595N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.2% 2.7% 2.4% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 2/14 (14%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 1/24 (4%) |
|FIRST INCIDENCE | 729 (T) 688 663 --- |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099N P=0.611N P=0.400N P=0.144N |P=0.182 (e) (e) P=0.492 |
|POLY 3 | P=0.146N P=0.519N P=0.471N P=0.235N |P=0.193 (e) (e) P=0.498 |
|POLY 1.5 | P=0.150N P=0.505N P=0.481N P=0.235N |P=0.195 (e) (e) P=0.498 |
|POLY 6 | P=0.137N P=0.545N P=0.453N P=0.229N |P=0.191 (e) (e) P=0.499 |
|LOGISTIC REGRESSION| P=0.132N P=0.598N P=0.448N (e) |(e) (e) (e) P=0.492 |
|COCH-ARM / FISHERS | P=0.153N P=0.500N P=0.500N P=0.247N |P=0.199 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 12.9% 5.4% 4.8% 5.1% |0.0% 2.3% 2.4% 2.5% |
|TERMINAL (d) | 4/14 (29%) 0/10 (0%) 1/21 (5%) 1/22 (5%) |0/25 (0%) 1/29 (3%) 0/29 (0%) 1/24 (4%) |
|FIRST INCIDENCE | 687 638 663 653 |--- 730 (T) 648 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.089N P=0.359N P=0.104N P=0.107N |P=0.360 P=0.530 P=0.521 P=0.492 |
|POLY 3 | P=0.170N P=0.233N P=0.183N P=0.209N |P=0.376 P=0.516 P=0.512 P=0.498 |
|POLY 1.5 | P=0.179N P=0.219N P=0.194N P=0.212N |P=0.379 P=0.509 P=0.505 P=0.498 |
|POLY 6 | P=0.152N P=0.261N P=0.165N P=0.197N |P=0.375 P=0.527 P=0.522 P=0.499 |
|LOGISTIC REGRESSION| P=0.152N P=0.309N P=0.137N P=0.176N |P=0.374 P=0.530 P=0.497 P=0.492 |
|COCH-ARM / FISHERS | P=0.186N P=0.218N P=0.218N P=0.218N |P=0.384 P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.5% 0.0% 2.5% |2.5% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |1/25 (4%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- 673 --- 465 |730 (T) 724 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.576 P=0.166 (e) P=0.500 |P=0.240N P=0.728N P=0.470N P=0.508N |
|POLY 3 | P=0.548 P=0.225 (e) P=0.505 |P=0.235N P=0.743N P=0.490N P=0.502N |
|POLY 1.5 | P=0.546 P=0.234 (e) P=0.504 |P=0.236N P=0.751N P=0.495N P=0.502N |
|POLY 6 | P=0.553 P=0.210 (e) P=0.511 |P=0.233N P=0.730N P=0.481N P=0.501N |
|LOGISTIC REGRESSION| P=0.525 P=0.214 (e) P=0.441 |P=0.234N P=0.719N (e) (e) |
|COCH-ARM / FISHERS | P=0.539 P=0.247 (e) P=0.500 |P=0.236N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.5% 0.0% 2.5% |2.5% 2.3% 0.0% 2.5% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |1/25 (4%) 0/29 (0%) 0/29 (0%) 1/24 (4%) |
|FIRST INCIDENCE | --- 673 --- 465 |730 (T) 724 --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.576 P=0.166 (e) P=0.500 |P=0.638N P=0.728N P=0.470N P=0.754 |
|POLY 3 | P=0.548 P=0.225 (e) P=0.505 |P=0.616N P=0.743N P=0.490N P=0.759 |
|POLY 1.5 | P=0.546 P=0.234 (e) P=0.504 |P=0.616N P=0.751N P=0.495N P=0.759 |
|POLY 6 | P=0.553 P=0.210 (e) P=0.511 |P=0.615N P=0.730N P=0.481N P=0.761 |
|LOGISTIC REGRESSION| P=0.525 P=0.214 (e) P=0.441 |P=0.633N P=0.719N (e) P=0.754 |
|COCH-ARM / FISHERS | P=0.539 P=0.247 (e) P=0.500 |P=0.616N P=0.753N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.5% 0.0% 2.5% |2.5% 2.3% 0.0% 2.5% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |1/25 (4%) 0/29 (0%) 0/29 (0%) 1/24 (4%) |
|FIRST INCIDENCE | --- 673 --- 465 |730 (T) 724 --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.576 P=0.166 (e) P=0.500 |P=0.638N P=0.728N P=0.470N P=0.754 |
|POLY 3 | P=0.548 P=0.225 (e) P=0.505 |P=0.616N P=0.743N P=0.490N P=0.759 |
|POLY 1.5 | P=0.546 P=0.234 (e) P=0.504 |P=0.616N P=0.751N P=0.495N P=0.759 |
|POLY 6 | P=0.553 P=0.210 (e) P=0.511 |P=0.615N P=0.730N P=0.481N P=0.761 |
|LOGISTIC REGRESSION| P=0.525 P=0.214 (e) P=0.441 |P=0.633N P=0.719N (e) P=0.754 |
|COCH-ARM / FISHERS | P=0.539 P=0.247 (e) P=0.500 |P=0.616N P=0.753N P=0.500N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.6% |4.9% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 1/22 (5%) |1/25 (4%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |460 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.274 (e) (e) P=0.590 |P=0.116N P=0.223N P=0.228N P=0.247N |
|POLY 3 | P=0.203 (e) (e) P=0.502 |P=0.116N P=0.223N P=0.230N P=0.243N |
|POLY 1.5 | P=0.201 (e) (e) P=0.501 |P=0.115N P=0.230N P=0.234N P=0.241N |
|POLY 6 | P=0.211 (e) (e) P=0.506 |P=0.118N P=0.213N P=0.221N P=0.243N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.590 |P=0.105N P=0.254N P=0.226N P=0.215N |
|COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 0.0% 2.6% |4.9% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 1/22 (5%) |1/25 (4%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- 702 --- 729 (T) |460 --- 634 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.507 P=0.433 (e) P=0.590 |P=0.194N P=0.223N P=0.476N P=0.247N |
|POLY 3 | P=0.409 P=0.489 (e) P=0.502 |P=0.197N P=0.223N P=0.486N P=0.243N |
|POLY 1.5 | P=0.408 P=0.497 (e) P=0.501 |P=0.193N P=0.230N P=0.494N P=0.241N |
|POLY 6 | P=0.413 P=0.474 (e) P=0.506 |P=0.202N P=0.213N P=0.470N P=0.243N |
|LOGISTIC REGRESSION| P=0.455 P=0.458 (e) P=0.590 |P=0.173N P=0.254N P=0.496N P=0.215N |
|COCH-ARM / FISHERS | P=0.405 P=0.500 (e) P=0.500 |P=0.188N P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |14/50 (28%) 8/50 (16%) 9/50 (18%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 0.0% 0.0% |33.9% 18.2% 20.8% 12.6% |
|TERMINAL (d) | 1/14 (7%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |9/25 (36%) 5/29 (17%) 5/29 (17%) 4/24 (17%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |648 638 606 728 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236N P=0.567N P=0.419N P=0.410N |P=0.031N* P=0.051N P=0.095N P=0.025N* |
|POLY 3 | P=0.297N P=0.512N P=0.484N P=0.498N |P=0.027N* P=0.075N P=0.130N P=0.019N* |
|POLY 1.5 | P=0.302N P=0.503N P=0.489N P=0.499N |P=0.025N* P=0.091N P=0.150N P=0.019N* |
|POLY 6 | P=0.290N P=0.528N P=0.476N P=0.494N |P=0.030N* P=0.058N P=0.104N P=0.020N* |
|LOGISTIC REGRESSION| P=0.236N (e) (e) (e) |P=0.024N* P=0.057N P=0.121N P=0.016N* |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.023N* P=0.114N P=0.171N P=0.020N* |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |14/50 (28%) 9/50 (18%) 9/50 (18%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 0.0% 2.6% |33.9% 20.1% 20.8% 12.6% |
|TERMINAL (d) | 1/14 (7%) 0/10 (0%) 0/21 (0%) 1/22 (5%) |9/25 (36%) 5/29 (17%) 5/29 (17%) 4/24 (17%) |
|FIRST INCIDENCE | 729 (T) --- --- 729 (T) |648 492 606 728 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.650N P=0.567N P=0.419N P=0.659N |P=0.027N* P=0.085N P=0.095N P=0.025N* |
|POLY 3 | P=0.606 P=0.512N P=0.484N P=0.760N |P=0.024N* P=0.112N P=0.130N P=0.019N* |
|POLY 1.5 | P=0.599 P=0.503N P=0.489N P=0.759N |P=0.022N* P=0.136N P=0.150N P=0.019N* |
|POLY 6 | P=0.621 P=0.528N P=0.476N P=0.755N |P=0.027N* P=0.086N P=0.104N P=0.020N* |
|LOGISTIC REGRESSION| P=0.650N (e) (e) P=0.659N |P=0.021N* P=0.118N P=0.121N P=0.016N* |
|COCH-ARM / FISHERS | P=0.595 P=0.500N P=0.500N P=0.753N |P=0.020N* P=0.171N P=0.171N P=0.020N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |14/50 (28%) 9/50 (18%) 10/50 (20%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 2.4% 2.6% |33.9% 20.1% 23.0% 15.1% |
|TERMINAL (d) | 1/14 (7%) 0/10 (0%) 1/21 (5%) 1/22 (5%) |9/25 (36%) 5/29 (17%) 5/29 (17%) 5/24 (21%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |648 492 606 728 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.612N P=0.567N P=0.670N P=0.659N |P=0.058N P=0.085N P=0.140N P=0.046N* |
|POLY 3 | P=0.552 P=0.512N P=0.743N P=0.760N |P=0.053N P=0.112N P=0.187N P=0.040N* |
|POLY 1.5 | P=0.544 P=0.503N P=0.749N P=0.759N |P=0.048N* P=0.136N P=0.214N P=0.039N* |
|POLY 6 | P=0.573 P=0.528N P=0.734N P=0.755N |P=0.060N P=0.086N P=0.151N P=0.041N* |
|LOGISTIC REGRESSION| P=0.612N (e) P=0.670N P=0.659N |P=0.046N* P=0.118N P=0.184N P=0.033N* |
|COCH-ARM / FISHERS | P=0.539 P=0.500N P=0.753N P=0.753N |P=0.043N* P=0.171N P=0.241N P=0.039N* |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.6% 5.4% 0.0% 0.0% |0.0% 2.3% 0.0% 2.5% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 1/29 (3%) 0/29 (0%) 1/24 (4%) |
|FIRST INCIDENCE | 702 666 --- --- |--- 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.167N P=0.374 P=0.416N P=0.457N |P=0.386 P=0.530 (e) P=0.492 |
|POLY 3 | P=0.185N P=0.483 P=0.485N P=0.499N |P=0.404 P=0.516 (e) P=0.498 |
|POLY 1.5 | P=0.185N P=0.496 P=0.490N P=0.499N |P=0.404 P=0.509 (e) P=0.498 |
|POLY 6 | P=0.184N P=0.459 P=0.477N P=0.495N |P=0.407 P=0.527 (e) P=0.499 |
|LOGISTIC REGRESSION| P=0.182N P=0.473 P=0.476N P=0.492N |(e) P=0.530 (e) P=0.492 |
|COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.405 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 39/50 (78%) 39/50 (78%) 32/49 (65%) |27/49 (55%) 31/50 (62%) 31/50 (62%) 34/50 (68%) |
|POLY-3 ADJUSTED (b)| 72.5% 83.1% 79.9% 70.6% |61.7% 66.5% 68.6% 72.4% |
|TERMINAL (d) | 10/14 (71%) 8/10 (80%) 15/21 (71%) 12/21 (57%) |15/25 (60%) 19/29 (66%) 19/29 (66%) 16/24 (67%) |
|FIRST INCIDENCE | 479 463 471 431 |460 492 579 430 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066N P=0.025 * P=0.404N P=0.249N |P=0.097 P=0.519N P=0.558N P=0.155 |
|POLY 3 | P=0.308N P=0.146 P=0.265 P=0.516N |P=0.158 P=0.395 P=0.314 P=0.184 |
|POLY 1.5 | P=0.364N P=0.135 P=0.195 P=0.559N |P=0.139 P=0.352 P=0.297 P=0.156 |
|POLY 6 | P=0.220N P=0.163 P=0.377 P=0.437N |P=0.192 P=0.457 P=0.362 P=0.231 |
|LOGISTIC REGRESSION| P=0.447N P=0.088 P=0.130 P=0.537 |P=0.102 P=0.387 P=0.366 P=0.129 |
|COCH-ARM / FISHERS | P=0.462N P=0.093 P=0.093 P=0.530 |P=0.125 P=0.311 P=0.311 P=0.133 |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |2/49 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.8% 0.0% 0.0% |5.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/21 (0%) |1/25 (4%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- 722 --- --- |632 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482N P=0.471 (e) (e) |P=0.116N P=0.210N P=0.215N P=0.250N |
|POLY 3 | P=0.571N P=0.488 (e) (e) |P=0.115N P=0.217N P=0.224N P=0.237N |
|POLY 1.5 | P=0.568N P=0.497 (e) (e) |P=0.113N P=0.224N P=0.229N P=0.236N |
|POLY 6 | P=0.579N P=0.473 (e) (e) |P=0.117N P=0.209N P=0.216N P=0.238N |
|LOGISTIC REGRESSION| P=0.518N P=0.443 (e) (e) |P=0.113N P=0.230N P=0.231N P=0.235N |
|COCH-ARM / FISHERS | P=0.571N P=0.500 (e) (e) |P=0.113N P=0.242N P=0.242N P=0.242N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 40/50 (80%) 39/50 (78%) 32/49 (65%) |29/49 (59%) 31/50 (62%) 31/50 (62%) 34/50 (68%) |
|POLY-3 ADJUSTED (b)| 72.5% 85.2% 79.9% 70.6% |65.7% 66.5% 68.6% 72.4% |
|TERMINAL (d) | 10/14 (71%) 8/10 (80%) 15/21 (71%) 12/21 (57%) |16/25 (64%) 19/29 (66%) 19/29 (66%) 16/24 (67%) |
|FIRST INCIDENCE | 479 463 471 431 |460 492 579 430 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.059N P=0.018 * P=0.404N P=0.249N |P=0.153 P=0.381N P=0.420N P=0.239 |
|POLY 3 | P=0.272N P=0.089 P=0.265 P=0.516N |P=0.252 P=0.559 P=0.471 P=0.315 |
|POLY 1.5 | P=0.329N P=0.085 P=0.195 P=0.559N |P=0.229 P=0.515 P=0.454 P=0.278 |
|POLY 6 | P=0.187N P=0.096 P=0.377 P=0.437N |P=0.289 P=0.575N P=0.516 P=0.369 |
|LOGISTIC REGRESSION| P=0.415N P=0.055 P=0.130 P=0.537 |P=0.177 P=0.554 P=0.533 P=0.235 |
|COCH-ARM / FISHERS | P=0.431N P=0.059 P=0.093 P=0.530 |P=0.209 P=0.468 P=0.468 P=0.241 |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 8.2% 4.8% 0.0% |0.0% 4.6% 2.3% 0.0% |
|TERMINAL (d) | 0/14 (0%) 1/10 (10%) 2/21 (10%) 0/22 (0%) |0/25 (0%) 2/29 (7%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 702 610 729 (T) --- |--- 730 (T) 490 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066N P=0.368 P=0.538N P=0.192N |P=0.476N P=0.271 P=0.500 (e) |
|POLY 3 | P=0.129N P=0.477 P=0.668N P=0.236N |P=0.458N P=0.255 P=0.513 (e) |
|POLY 1.5 | P=0.131N P=0.495 P=0.676N P=0.236N |P=0.461N P=0.247 P=0.507 (e) |
|POLY 6 | P=0.122N P=0.444 P=0.655N P=0.232N |P=0.451N P=0.268 P=0.524 (e) |
|LOGISTIC REGRESSION| P=0.112N P=0.442 P=0.614N P=0.228N |P=0.453N P=0.271 P=0.591 (e) |
|COCH-ARM / FISHERS | P=0.134N P=0.500 P=0.691N P=0.247N |P=0.462N P=0.247 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.4% 0.0% 2.6% |2.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |1/25 (4%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- 542 --- 709 |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.622 P=0.218 (e) P=0.573 |P=0.308N P=0.470N P=0.470N P=0.508N |
|POLY 3 | P=0.543 P=0.227 (e) P=0.502 |P=0.309N P=0.484N P=0.490N P=0.502N |
|POLY 1.5 | P=0.543 P=0.235 (e) P=0.501 |P=0.308N P=0.491N P=0.495N P=0.502N |
|POLY 6 | P=0.547 P=0.212 (e) P=0.507 |P=0.312N P=0.473N P=0.481N P=0.501N |
|LOGISTIC REGRESSION| P=0.539 P=0.235 (e) P=0.514 |P=0.308N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.539 P=0.247 (e) P=0.500 |P=0.305N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 5.4% 0.0% 0.0% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 702 610 --- --- |--- --- 490 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058N P=0.589 P=0.151N P=0.192N |P=0.691 (e) P=0.500 (e) |
|POLY 3 | P=0.082N P=0.677 P=0.221N P=0.236N |P=0.677 (e) P=0.513 (e) |
|POLY 1.5 | P=0.083N P=0.690 P=0.226N P=0.236N |P=0.684 (e) P=0.507 (e) |
|POLY 6 | P=0.079N P=0.652 P=0.213N P=0.232N |P=0.669 (e) P=0.524 (e) |
|LOGISTIC REGRESSION| P=0.082N P=0.672 P=0.210N P=0.228N |P=0.734 (e) P=0.591 (e) |
|COCH-ARM / FISHERS | P=0.086N P=0.691N P=0.247N P=0.247N |P=0.695 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% 5.0% |0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 2/29 (7%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- --- 710 577 |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.085 (e) P=0.592 P=0.222 |P=0.418N P=0.271 (e) (e) |
|POLY 3 | P=0.076 (e) P=0.516 P=0.243 |P=0.393N P=0.255 (e) (e) |
|POLY 1.5 | P=0.073 (e) P=0.511 P=0.241 |P=0.399N P=0.247 (e) (e) |
|POLY 6 | P=0.085 (e) P=0.525 P=0.251 |P=0.381N P=0.268 (e) (e) |
|LOGISTIC REGRESSION| P=0.070 (e) P=0.534 P=0.230 |(e) P=0.271 (e) (e) |
|COCH-ARM / FISHERS | P=0.070 (e) P=0.500 P=0.247 |P=0.406N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 8.2% 4.8% 0.0% |0.0% 2.3% 2.3% 0.0% |
|TERMINAL (d) | 0/14 (0%) 1/10 (10%) 2/21 (10%) 0/22 (0%) |0/25 (0%) 1/29 (3%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 702 610 729 (T) --- |--- 730 (T) 490 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066N P=0.368 P=0.538N P=0.192N |P=0.608N P=0.530 P=0.500 (e) |
|POLY 3 | P=0.129N P=0.477 P=0.668N P=0.236N |P=0.595N P=0.516 P=0.513 (e) |
|POLY 1.5 | P=0.131N P=0.495 P=0.676N P=0.236N |P=0.596N P=0.509 P=0.507 (e) |
|POLY 6 | P=0.122N P=0.444 P=0.655N P=0.232N |P=0.593N P=0.527 P=0.524 (e) |
|LOGISTIC REGRESSION| P=0.112N P=0.442 P=0.614N P=0.228N |P=0.575N P=0.530 P=0.591 (e) |
|COCH-ARM / FISHERS | P=0.134N P=0.500 P=0.691N P=0.247N |P=0.595N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 8.2% 2.4% 0.0% |0.0% 2.3% 2.3% 0.0% |
|TERMINAL (d) | 0/14 (0%) 1/10 (10%) 1/21 (5%) 0/22 (0%) |0/25 (0%) 1/29 (3%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 702 610 729 (T) --- |--- 730 (T) 490 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.055N P=0.368 P=0.357N P=0.192N |P=0.608N P=0.530 P=0.500 (e) |
|POLY 3 | P=0.099N P=0.477 P=0.475N P=0.236N |P=0.595N P=0.516 P=0.513 (e) |
|POLY 1.5 | P=0.101N P=0.495 P=0.482N P=0.236N |P=0.596N P=0.509 P=0.507 (e) |
|POLY 6 | P=0.095N P=0.444 P=0.462N P=0.232N |P=0.593N P=0.527 P=0.524 (e) |
|LOGISTIC REGRESSION| P=0.090N P=0.442 P=0.437N P=0.228N |P=0.575N P=0.530 P=0.591 (e) |
|COCH-ARM / FISHERS | P=0.104N P=0.500 P=0.500N P=0.247N |P=0.595N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.1% 0.0% 2.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 610 --- 694 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.168N P=0.298N P=0.439N P=0.249N |(e) (e) (e) (e) |
|POLY 3 | P=0.177N P=0.253N P=0.477N P=0.238N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.184N P=0.242N P=0.484N P=0.237N |(e) (e) (e) (e) |
|POLY 6 | P=0.165N P=0.276N P=0.466N P=0.236N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.188N P=0.238N P=0.505N P=0.238N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.188N P=0.247N P=0.500N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 19/50 (38%) 28/50 (56%) 26/50 (52%) | |
|POLY-3 ADJUSTED (b)| 74.4% 48.6% 63.6% 62.4% | |
|TERMINAL (d) | 11/14 (79%) 8/10 (80%) 18/21 (86%) 17/22 (77%) | |
|FIRST INCIDENCE | 561 542 499 465 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010N* P=0.234N P=0.021N* P=0.019N* | |
|POLY 3 | P=0.306N P=0.007N** P=0.180N P=0.153N | |
|POLY 1.5 | P=0.326N P=0.005N** P=0.191N P=0.139N | |
|POLY 6 | P=0.274N P=0.022N* P=0.184N P=0.183N | |
|LOGISTIC REGRESSION| P=0.261N P=0.019N* P=0.123N P=0.139N | |
|COCH-ARM / FISHERS | P=0.360N P=0.008N** P=0.270N P=0.156N | |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 5/50 (10%) 7/49 (14%) |8/50 (16%) 9/50 (18%) 6/50 (12%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 15.2% 5.5% 11.9% 17.8% |19.7% 20.5% 13.8% 12.4% |
|TERMINAL (d) | 2/14 (14%) 1/10 (10%) 3/21 (14%) 2/22 (9%) |6/25 (24%) 7/29 (24%) 3/29 (10%) 4/24 (17%) |
|FIRST INCIDENCE | 595 625 568 465 |638 597 490 515 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.514 P=0.258N P=0.303N P=0.554N |P=0.199N P=0.577N P=0.295N P=0.294N |
|POLY 3 | P=0.281 P=0.154N P=0.452N P=0.500 |P=0.173N P=0.573 P=0.334N P=0.275N |
|POLY 1.5 | P=0.265 P=0.139N P=0.466N P=0.496 |P=0.172N P=0.539 P=0.361N P=0.277N |
|POLY 6 | P=0.318 P=0.186N P=0.431N P=0.516 |P=0.173N P=0.598N P=0.296N P=0.270N |
|LOGISTIC REGRESSION| P=0.259 P=0.162N P=0.449N P=0.486 |P=0.179N P=0.580N P=0.353N P=0.276N |
|COCH-ARM / FISHERS | P=0.250 P=0.134N P=0.500N P=0.484 |P=0.168N P=0.500 P=0.387N P=0.277N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 0.0% 0.0% |0.0% 2.3% 0.0% 4.9% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 1/29 (3%) 0/29 (0%) 1/24 (4%) |
|FIRST INCIDENCE | --- 625 --- --- |--- 730 (T) --- 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.563N P=0.472 (e) (e) |P=0.127 P=0.530 (e) P=0.235 |
|POLY 3 | P=0.570N P=0.490 (e) (e) |P=0.140 P=0.516 (e) P=0.239 |
|POLY 1.5 | P=0.568N P=0.498 (e) (e) |P=0.139 P=0.509 (e) P=0.238 |
|POLY 6 | P=0.576N P=0.476 (e) (e) |P=0.141 P=0.527 (e) P=0.241 |
|LOGISTIC REGRESSION| P=0.574N P=0.496 (e) (e) |P=0.149 P=0.530 (e) P=0.254 |
|COCH-ARM / FISHERS | P=0.571N P=0.500 (e) (e) |P=0.140 P=0.500 (e) P=0.247 |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 5/50 (10%) 7/49 (14%) |8/50 (16%) 10/50 (20%) 6/50 (12%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 15.2% 5.5% 11.9% 17.8% |19.7% 22.7% 13.8% 17.0% |
|TERMINAL (d) | 2/14 (14%) 1/10 (10%) 3/21 (14%) 2/22 (9%) |6/25 (24%) 8/29 (28%) 3/29 (10%) 5/24 (21%) |
|FIRST INCIDENCE | 595 625 568 465 |638 597 490 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.514 P=0.258N P=0.303N P=0.554N |P=0.386N P=0.536 P=0.295N P=0.524N |
|POLY 3 | P=0.281 P=0.154N P=0.452N P=0.500 |P=0.331N P=0.470 P=0.334N P=0.488N |
|POLY 1.5 | P=0.265 P=0.139N P=0.466N P=0.496 |P=0.333N P=0.436 P=0.361N P=0.495N |
|POLY 6 | P=0.318 P=0.186N P=0.431N P=0.516 |P=0.326N P=0.518 P=0.296N P=0.479N |
|LOGISTIC REGRESSION| P=0.259 P=0.162N P=0.449N P=0.486 |P=0.352N P=0.541 P=0.353N P=0.507N |
|COCH-ARM / FISHERS | P=0.250 P=0.134N P=0.500N P=0.484 |P=0.334N P=0.398 P=0.387N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 5.5% 0.0% 0.0% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 1/29 (3%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 694 670 --- --- |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.155N P=0.388 P=0.428N P=0.468N |P=0.582N P=0.530 (e) (e) |
|POLY 3 | P=0.188N P=0.482 P=0.485N P=0.504N |P=0.556N P=0.516 (e) (e) |
|POLY 1.5 | P=0.188N P=0.495 P=0.490N P=0.504N |P=0.562N P=0.509 (e) (e) |
|POLY 6 | P=0.187N P=0.457 P=0.477N P=0.502N |P=0.547N P=0.527 (e) (e) |
|LOGISTIC REGRESSION| P=0.184N P=0.466 P=0.483N P=0.501N |(e) P=0.530 (e) (e) |
|COCH-ARM / FISHERS | P=0.191N P=0.500 P=0.500N P=0.505N |P=0.568N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 5.5% 0.0% 0.0% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 1/29 (3%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 673 670 --- --- |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.068N P=0.565 P=0.186N P=0.226N |P=0.582N P=0.530 (e) (e) |
|POLY 3 | P=0.084N P=0.674 P=0.222N P=0.242N |P=0.556N P=0.516 (e) (e) |
|POLY 1.5 | P=0.085N P=0.689 P=0.226N P=0.242N |P=0.562N P=0.509 (e) (e) |
|POLY 6 | P=0.082N P=0.647 P=0.214N P=0.240N |P=0.547N P=0.527 (e) (e) |
|LOGISTIC REGRESSION| P=0.083N P=0.668 P=0.225N P=0.241N |(e) P=0.530 (e) (e) |
|COCH-ARM / FISHERS | P=0.088N P=0.691N P=0.247N P=0.253N |P=0.568N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |7.5% 2.3% 2.3% 4.9% |
|TERMINAL (d) | |3/25 (12%) 1/29 (3%) 0/29 (0%) 1/24 (4%) |
|FIRST INCIDENCE | |730 (T) 730 (T) 365 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.494N P=0.252N P=0.269N P=0.515N |
|POLY 3 | |P=0.482N P=0.276N P=0.279N P=0.495N |
|POLY 1.5 | |P=0.478N P=0.290N P=0.292N P=0.498N |
|POLY 6 | |P=0.487N P=0.258N P=0.262N P=0.489N |
|LOGISTIC REGRESSION| |P=0.448N P=0.252N P=0.310N P=0.499N |
|COCH-ARM / FISHERS | |P=0.474N P=0.309N P=0.309N P=0.500N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| |10.0% 2.3% 4.6% 7.4% |
|TERMINAL (d) | |4/25 (16%) 1/29 (3%) 0/29 (0%) 1/24 (4%) |
|FIRST INCIDENCE | |730 (T) 730 (T) 365 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.568N P=0.134N P=0.286N P=0.513N |
|POLY 3 | |P=0.555N P=0.154N P=0.304N P=0.492N |
|POLY 1.5 | |P=0.550N P=0.166N P=0.320N P=0.497N |
|POLY 6 | |P=0.562N P=0.139N P=0.281N P=0.484N |
|LOGISTIC REGRESSION| |P=0.531N P=0.134N P=0.340N P=0.503N |
|COCH-ARM / FISHERS | |P=0.543N P=0.181N P=0.339N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.4% 2.4% 2.5% |4.8% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 1/29 (3%) 0/24 (0%) |
|FIRST INCIDENCE | --- 541 702 533 |522 --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.518 P=0.239 P=0.584 P=0.500 |P=0.196N P=0.233N P=0.480N P=0.252N |
|POLY 3 | P=0.512 P=0.230 P=0.516 P=0.505 |P=0.197N P=0.225N P=0.492N P=0.245N |
|POLY 1.5 | P=0.508 P=0.237 P=0.511 P=0.503 |P=0.193N P=0.231N P=0.497N P=0.242N |
|POLY 6 | P=0.526 P=0.217 P=0.525 P=0.511 |P=0.202N P=0.217N P=0.482N P=0.247N |
|LOGISTIC REGRESSION| P=0.473 P=0.186 P=0.524 P=0.471 |P=0.174N P=0.239N P=0.497N P=0.190N |
|COCH-ARM / FISHERS | P=0.500 P=0.247 P=0.500 P=0.500 |P=0.188N P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 14/50 (28%) 13/50 (26%) 18/50 (36%) |11/50 (22%) 13/50 (26%) 10/50 (20%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| 52.4% 35.5% 29.5% 41.7% |25.6% 28.6% 22.6% 30.8% |
|TERMINAL (d) | 6/14 (43%) 3/10 (30%) 4/21 (19%) 4/22 (18%) |3/25 (12%) 3/29 (10%) 3/29 (10%) 7/24 (29%) |
|FIRST INCIDENCE | 394 554 499 379 |438 556 579 565 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.293N P=0.010N* P=0.130N |P=0.371 P=0.578N P=0.405N P=0.385 |
|POLY 3 | P=0.223N P=0.083N P=0.021N* P=0.211N |P=0.383 P=0.467 P=0.468N P=0.383 |
|POLY 1.5 | P=0.243N P=0.057N P=0.021N* P=0.203N |P=0.396 P=0.437 P=0.488N P=0.389 |
|POLY 6 | P=0.188N P=0.149N P=0.021N* P=0.210N |P=0.374 P=0.514 P=0.431N P=0.382 |
|LOGISTIC REGRESSION| P=0.270N P=0.051N P=0.031N* P=0.207N |P=0.426 P=0.383 P=0.515N P=0.410 |
|COCH-ARM / FISHERS | P=0.272N P=0.048N* P=0.030N* P=0.208N |P=0.422 P=0.408 P=0.500N P=0.408 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.1% 2.8% 2.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 1/10 (10%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 653 729 (T) 715 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.103N P=0.609N P=0.402N P=0.237N |(e) (e) (e) (e) |
|POLY 3 | P=0.146N P=0.524N P=0.476N P=0.237N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.150N P=0.507N P=0.483N P=0.237N |(e) (e) (e) (e) |
|POLY 6 | P=0.138N P=0.556N P=0.464N P=0.234N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.136N P=0.551N P=0.478N P=0.236N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.153N P=0.500N P=0.500N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.1% 2.7% 0.0% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 302 463 --- --- |--- --- --- 728 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.525N P=0.198N P=0.222N |P=0.185 (e) (e) P=0.492 |
|POLY 3 | P=0.096N P=0.523N P=0.225N P=0.241N |P=0.193 (e) (e) P=0.498 |
|POLY 1.5 | P=0.098N P=0.508N P=0.229N P=0.240N |P=0.195 (e) (e) P=0.498 |
|POLY 6 | P=0.092N P=0.550N P=0.218N P=0.238N |P=0.191 (e) (e) P=0.499 |
|LOGISTIC REGRESSION| P=0.145N P=0.668N P=0.355N P=0.273N |P=0.184 (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |P=0.199 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.1% 2.7% 0.0% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 302 463 --- --- |--- --- --- 728 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.525N P=0.198N P=0.222N |P=0.185 (e) (e) P=0.492 |
|POLY 3 | P=0.096N P=0.523N P=0.225N P=0.241N |P=0.193 (e) (e) P=0.498 |
|POLY 1.5 | P=0.098N P=0.508N P=0.229N P=0.240N |P=0.195 (e) (e) P=0.498 |
|POLY 6 | P=0.092N P=0.550N P=0.218N P=0.238N |P=0.191 (e) (e) P=0.499 |
|LOGISTIC REGRESSION| P=0.145N P=0.668N P=0.355N P=0.273N |P=0.184 (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |P=0.199 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 46/50 (92%) 48/50 (96%) 45/50 (90%) |38/50 (76%) 39/50 (78%) 40/50 (80%) 41/50 (82%) |
|POLY-3 ADJUSTED (b)| 99.5% 95.9% 97.2% 95.2% |84.2% 82.6% 83.8% 84.4% |
|TERMINAL (d) | 14/14 (100%) 10/10 (100%) 20/21 (95%) 21/22 (96%) |24/25 (96%) 24/29 (83%) 23/29 (79%) 19/24 (79%) |
|FIRST INCIDENCE | 479 463 471 431 |460 492 365 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.018N* P=0.115 P=0.079N P=0.083N |P=0.213 P=0.231N P=0.351N P=0.329 |
|POLY 3 | P=0.188N P=0.241N P=0.459N P=0.206N |P=0.513 P=0.534N P=0.598N P=0.610 |
|POLY 1.5 | P=0.204N P=0.242N P=0.546N P=0.196N |P=0.399 P=0.600 P=0.517 P=0.473 |
|POLY 6 | P=0.186N P=0.467N P=0.466N P=0.285N |P=0.478N P=0.398N P=0.422N P=0.479N |
|LOGISTIC REGRESSION| P=0.306N P=0.185N P=0.489N P=0.282N |P=0.213 P=0.493N P=0.455 P=0.287 |
|COCH-ARM / FISHERS | P=0.320N P=0.500N P=0.500 P=0.357N |P=0.259 P=0.500 P=0.405 P=0.312 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 23/50 (46%) 19/50 (38%) 22/50 (44%) |17/50 (34%) 16/50 (32%) 15/50 (30%) 22/50 (44%) |
|POLY-3 ADJUSTED (b)| 68.2% 53.3% 42.1% 48.8% |38.3% 35.3% 32.8% 49.9% |
|TERMINAL (d) | 8/14 (57%) 3/10 (30%) 6/21 (29%) 5/22 (23%) |6/25 (24%) 6/29 (21%) 4/29 (14%) 11/24 (46%) |
|FIRST INCIDENCE | 101 463 499 379 |438 556 434 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014N* P=0.407N P=0.003N** P=0.032N* |P=0.134 P=0.318N P=0.315N P=0.212 |
|POLY 3 | P=0.034N* P=0.096N P=0.007N** P=0.041N* |P=0.126 P=0.469N P=0.373N P=0.181 |
|POLY 1.5 | P=0.039N* P=0.071N P=0.007N** P=0.039N* |P=0.132 P=0.487N P=0.398N P=0.189 |
|POLY 6 | P=0.026N* P=0.151N P=0.008N** P=0.039N* |P=0.121 P=0.438N P=0.332N P=0.178 |
|LOGISTIC REGRESSION| P=0.046N* P=0.046N* P=0.013N* P=0.035N* |P=0.153 P=0.520N P=0.442N P=0.209 |
|COCH-ARM / FISHERS | P=0.042N* P=0.054N P=0.008N** P=0.035N* |P=0.146 P=0.500N P=0.415N P=0.206 |
|=================================================================================================================================|
Date: 06/19/97 EXPERIMENT: 05162 TEST: 09 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG |0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 49/50 (98%) 49/50 (98%) 47/50 (94%) |46/50 (92%) 42/50 (84%) 43/50 (86%) 45/50 (90%) |
|POLY-3 ADJUSTED (b)| 100.0% 99.3% 98.0% 96.4% |95.3% 87.5% 87.6% 90.8% |
|TERMINAL (d) | 14/14 (100%) 10/10 (100%) 20/21 (95%) 21/22 (96%) |24/25 (96%) 24/29 (83%) 23/29 (79%) 21/24 (88%) |
|FIRST INCIDENCE | 101 463 471 379 |438 492 365 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.015N* P=0.122 P=0.052N P=0.074N |P=0.377 P=0.070N P=0.136N P=0.551 |
|POLY 3 | P=0.107N P=0.972N P=0.500N P=0.264N |P=0.372N P=0.138N P=0.147N P=0.304N |
|POLY 1.5 | P=0.088N P=0.760N P=0.500N P=0.204N |P=0.441N P=0.159N P=0.198N P=0.382N |
|POLY 6 | P=0.127N P=1.000N P=0.500N P=0.328N |P=0.316N P=0.114N P=0.096N P=0.235N |
|LOGISTIC REGRESSION| P=0.047N* P=0.420N (e) P=0.098N |P=0.537 P=0.112N P=0.249N P=0.505N |
|COCH-ARM / FISHERS | P=0.054N P=0.500N P=0.500N P=0.121N |P=0.558N P=0.178N P=0.262N P=0.500N |
|=================================================================================================================================|
(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).