TDMS Study 05162-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus DIETHANOLAMINE DATE: 06/20/97
EXPERIMENT: 05162 TEST: 09 TIME: 09:19:29
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 NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus DIETHANOLAMINE DATE: 06/20/97
EXPERIMENT: 05162 TEST: 09 TIME: 09:19:29
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
----- ----------
Adrenal Cortex Hyperplasia
Blood Vessel Mineralization
Eye: Lens Cataract
Kidney Nephropathy
Liver Basophilic Focus
Lung Inflammation Granulomatous
Mineralization
Lung: Alveolar Epithelium Hyperplasia
Mammary Gland Hyperplasia Cystic
Nose Inflammation
Oral Mucosa Inflammation
Parathyroid Gland Hyperplasia
Seminal Vesicle Atrophy
Skin: Epidermis, Skin, Site of ApplicatAcanthosis
Degeneration
Exudate
Hyperkeratosis
Skin: Skin, Site of Application Ulcer
Spleen Fibrosis
Testes: Germinal Epithelium Atrophy
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Hyperplasia
Heart: Myocardium Mineralization
Intestine Large, Rectum Parasite Metazoan
Kidney Nephropathy
Liver Basophilic Focus
Cyst
Degeneration Cystic
Hepatodiaphragmatic Nodule
Mixed Cell Focus
Lung Inflammation Granulomatous
Mineralization
Pituitary Gland: Pars Distalis Hyperplasia
Inflammation Granulomatous
Skin: Epidermis, Skin, Site of ApplicatAcanthosis
Exudate
Hyperkeratosis
Stomach, Forestomach Inflammation Chronic
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus DIETHANOLAMINE DATE: 06/20/97
EXPERIMENT: 05162 TEST: 09 TIME: 09:19:29
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
Stomach, Glandular Mineralization
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 1
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 15/50 (30%) 15/50 (30%) 12/50 (24%) |13/50 (26%) 13/50 (26%) 11/50 (22%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 38.6% 38.4% 34.9% 29.2% |31.3% 29.5% 25.8% 26.9% |
|TERMINAL (d) | 6/14 (43%) 4/10 (40%) 6/21 (29%) 7/22 (32%) |7/25 (28%) 8/29 (28%) 9/29 (31%) 8/24 (33%) |
|FIRST INCIDENCE | 560 542 499 277 |638 689 677 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.034N* P=0.347 P=0.179N P=0.102N |P=0.392N P=0.375N P=0.264N P=0.438N |
|POLY 3 | P=0.185N P=0.587N P=0.449N P=0.249N |P=0.357N P=0.523N P=0.377N P=0.421N |
|POLY 1.5 | P=0.193N P=0.526N P=0.456N P=0.241N |P=0.344N P=0.554N P=0.395N P=0.416N |
|POLY 6 | P=0.169N P=0.498 P=0.436N P=0.256N |P=0.376N P=0.481N P=0.353N P=0.432N |
|LOGISTIC REGRESSION| P=0.190N P=0.571N P=0.414N P=0.247N |P=0.361N P=0.448N P=0.305N P=0.414N |
|COCH-ARM / FISHERS | P=0.215N P=0.500N P=0.500N P=0.252N |P=0.327N P=0.590N P=0.408N P=0.408N |
|=================================================================================================================================|
| | | |
| | 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 |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.8% 0.0% |2.5% 4.6% 0.0% 7.4% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 1/21 (5%) 0/22 (0%) |1/25 (4%) 1/29 (3%) 0/29 (0%) 1/24 (4%) |
|FIRST INCIDENCE | --- --- 702 --- |730 (T) 666 --- 572 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.676N (e) P=0.334 (e) |P=0.223 P=0.564 P=0.470N P=0.302 |
|POLY 3 | P=0.604 (e) P=0.255 (e) |P=0.241 P=0.530 P=0.490N P=0.308 |
|POLY 1.5 | P=0.598 (e) P=0.249 (e) |P=0.240 P=0.516 P=0.495N P=0.306 |
|POLY 6 | P=0.626 (e) P=0.266 (e) |P=0.244 P=0.550 P=0.481N P=0.315 |
|LOGISTIC REGRESSION| P=0.645 (e) P=0.285 (e) |P=0.239 P=0.542 (e) P=0.304 |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.242 P=0.500 P=0.500N P=0.309 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 2
Statistical Analysis of Non-neoplastic Lesions 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 |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.5% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 2/10 (20%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.289N P=0.164 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.406N P=0.223 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.402N P=0.233 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.415N P=0.206 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.164 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |(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 |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 9/50 (18%) 15/50 (30%) 8/50 (16%) |3/49 (6%) 10/50 (20%) 4/49 (8%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 26.8% 23.5% 35.0% 19.8% |7.6% 22.3% 9.5% 24.9% |
|TERMINAL (d) | 4/14 (29%) 2/10 (20%) 8/21 (38%) 4/22 (18%) |1/25 (4%) 5/29 (17%) 2/29 (7%) 7/24 (29%) |
|FIRST INCIDENCE | 302 562 499 431 |648 589 561 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.097N P=0.556 P=0.578N P=0.162N |P=0.067 P=0.077 P=0.566 P=0.037 * |
|POLY 3 | P=0.335N P=0.469N P=0.278 P=0.314N |P=0.079 P=0.055 P=0.533 P=0.033 * |
|POLY 1.5 | P=0.346N P=0.427N P=0.270 P=0.310N |P=0.082 P=0.047 * P=0.515 P=0.035 * |
|POLY 6 | P=0.295N P=0.539N P=0.298 P=0.303N |P=0.078 P=0.070 P=0.559 P=0.032 * |
|LOGISTIC REGRESSION| P=0.333N P=0.405N P=0.287 P=0.305N |P=0.075 P=0.049 * P=0.514 P=0.036 * |
|COCH-ARM / FISHERS | P=0.353N P=0.402N P=0.247 P=0.306N |P=0.091 P=0.039 * P=0.500 P=0.039 * |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 3
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/4 (100%) 3/3 (100%) 0/0 (0%) 0/1 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 2/2 (100%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 0.0% 0.0% |0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 610 678 --- --- |--- --- --- 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.021N* (e) (e) P=0.114N |(e) (e) (e) (e) |
|POLY 3 | P=1.000N (e) (e) P=1.000N |(e) (e) (e) (e) |
|POLY 1.5 | P=1.000N (e) (e) P=1.000N |(e) (e) (e) (e) |
|POLY 6 | P=1.000N (e) (e) P=1.000N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.114N (e) (e) P=0.317N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.037N* (e) (e) P=0.200N |(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 |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 4/50 (8%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 7.6% 10.9% 9.5% 0.0% |2.5% 0.0% 0.0% 5.0% |
|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 | 610 666 635 --- |730 (T) --- --- 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.057N P=0.357 P=0.622 P=0.122N |P=0.235 P=0.470N P=0.470N P=0.515 |
|POLY 3 | P=0.092N P=0.461 P=0.538 P=0.121N |P=0.237 P=0.484N P=0.490N P=0.500 |
|POLY 1.5 | P=0.093N P=0.488 P=0.526 P=0.119N |P=0.241 P=0.491N P=0.495N P=0.498 |
|POLY 6 | P=0.087N P=0.415 P=0.557 P=0.120N |P=0.233 P=0.473N P=0.481N P=0.505 |
|LOGISTIC REGRESSION| P=0.089N P=0.478 P=0.503 P=0.121N |P=0.236 (e) (e) P=0.498 |
|COCH-ARM / FISHERS | P=0.095N P=0.500 P=0.500 P=0.121N |P=0.246 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 4
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 4/50 (8%) 7/50 (14%) 9/50 (18%) |2/50 (4%) 6/50 (12%) 4/50 (8%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 24.7% 10.8% 16.5% 22.7% |5.0% 13.6% 9.2% 12.5% |
|TERMINAL (d) | 4/14 (29%) 2/10 (20%) 3/21 (14%) 4/22 (18%) |1/25 (4%) 3/29 (10%) 2/29 (7%) 4/24 (17%) |
|FIRST INCIDENCE | 561 554 635 632 |666 638 561 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.335N P=0.181N P=0.139N P=0.297N |P=0.256 P=0.211 P=0.393 P=0.213 |
|POLY 3 | P=0.498 P=0.094N P=0.258N P=0.521N |P=0.276 P=0.163 P=0.369 P=0.210 |
|POLY 1.5 | P=0.483 P=0.079N P=0.268N P=0.509N |P=0.280 P=0.148 P=0.353 P=0.212 |
|POLY 6 | P=0.539 P=0.130N P=0.241N P=0.520N |P=0.275 P=0.185 P=0.395 P=0.211 |
|LOGISTIC REGRESSION| P=0.508 P=0.082N P=0.259N P=0.492N |P=0.275 P=0.156 P=0.333 P=0.214 |
|COCH-ARM / FISHERS | P=0.473 P=0.074N P=0.298N P=0.500N |P=0.288 P=0.134 P=0.339 P=0.218 |
|=================================================================================================================================|
| | | |
| | 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 |
| | | |
|=================================================================================================================================|
| |
|Brain: Medulla |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.8% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 1/21 (5%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- --- 702 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.676N (e) P=0.334 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.604 (e) P=0.255 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.598 (e) P=0.249 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.626 (e) P=0.266 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.645 (e) P=0.285 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 5
Statistical Analysis of Non-neoplastic Lesions 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 Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 4/50 (8%) 1/49 (2%) 2/47 (4%) |
|POLY-3 ADJUSTED (b)| |9.8% 9.2% 2.4% 5.3% |
|TERMINAL (d) | |2/25 (8%) 2/29 (7%) 1/29 (3%) 0/22 (0%) |
|FIRST INCIDENCE | |600 703 730 (T) 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.212N P=0.535N P=0.147N P=0.360N |
|POLY 3 | |P=0.213N P=0.604N P=0.172N P=0.371N |
|POLY 1.5 | |P=0.211N P=0.622N P=0.180N P=0.370N |
|POLY 6 | |P=0.213N P=0.578N P=0.161N P=0.371N |
|LOGISTIC REGRESSION| |P=0.213N P=0.593N P=0.169N P=0.368N |
|COCH-ARM / FISHERS | |P=0.207N P=0.643N P=0.187N P=0.369N |
|=================================================================================================================================|
| | | |
| | 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 Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 4/50 (8%) 1/49 (2%) 1/47 (2%) |
|POLY-3 ADJUSTED (b)| |7.5% 9.2% 2.4% 2.7% |
|TERMINAL (d) | |2/25 (8%) 2/29 (7%) 0/29 (0%) 1/22 (5%) |
|FIRST INCIDENCE | |701 704 665 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.155N P=0.594 P=0.253N P=0.337N |
|POLY 3 | |P=0.153N P=0.544 P=0.293N P=0.330N |
|POLY 1.5 | |P=0.153N P=0.523 P=0.303N P=0.330N |
|POLY 6 | |P=0.151N P=0.573 P=0.275N P=0.329N |
|LOGISTIC REGRESSION| |P=0.153N P=0.602 P=0.282N P=0.325N |
|COCH-ARM / FISHERS | |P=0.152N P=0.500 P=0.316N P=0.332N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 6
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 1/2 (50%) 2/2 (100%) 0/2 (0%) |1/2 (50%) 0/0 (0%) 0/1 (0%) 1/2 (50%) |
|POLY-3 ADJUSTED (b)| 0.0% 56.3% 100.0% 0.0% |50.1% 0.0% 0.0% 50.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |1/1 (100%) 0/0 (0%) 0/0 (0%) 1/2 (50%) |
|FIRST INCIDENCE | --- 723 689 --- |730 (T) --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.430N P=1.000 P=1.000 P=0.638N |
|POLY 3 | (e) (e) (e) (e) |P=1.000N P=1.000 P=0.644N P=0.760N |
|POLY 1.5 | (e) (e) (e) (e) |P=1.000N P=1.000 P=0.630N P=0.760N |
|POLY 6 | (e) (e) (e) (e) |P=1.000N P=1.000 P=0.670N P=0.760N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.430N (e) (e) P=0.638N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.695 P=1.000 P=0.667N P=0.833N |
|=================================================================================================================================|
| | | |
| | 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 |
| | | |
|=================================================================================================================================|
| |
|Eye: Lens |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/2 (0%) 0/2 (0%) 2/2 (100%) |0/2 (0%) 0/0 (0%) 0/1 (0%) 0/2 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 100.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 0/0 (0%) 0/0 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- 277 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 7
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.1% 2.7% 2.4% 5.0% |2.5% 2.3% 9.2% 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 | 645 638 715 379 |597 589 490 699 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.606N P=0.599N P=0.429N P=0.686N |P=0.510 P=0.750N P=0.213 P=0.757N |
|POLY 3 | P=0.575 P=0.522N P=0.477N P=0.688N |P=0.496 P=0.743N P=0.200 P=0.757 |
|POLY 1.5 | P=0.566 P=0.506N P=0.484N P=0.689N |P=0.508 P=0.751N P=0.189 P=0.758 |
|POLY 6 | P=0.594 P=0.551N P=0.466N P=0.682N |P=0.483 P=0.731N P=0.219 P=0.758 |
|LOGISTIC REGRESSION| P=0.543 P=0.500N P=0.487N P=0.683 |P=0.555 P=0.746 P=0.175 P=0.760N |
|COCH-ARM / FISHERS | P=0.556 P=0.500N P=0.500N P=0.691N |P=0.526 P=0.753N P=0.181 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 |
| | | |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 41/50 (82%) 44/50 (88%) 45/50 (90%) |36/50 (72%) 33/50 (66%) 35/50 (70%) 36/50 (72%) |
|POLY-3 ADJUSTED (b)| 87.8% 87.4% 92.0% 93.3% |79.5% 73.1% 76.5% 78.7% |
|TERMINAL (d) | 14/14 (100%) 9/10 (90%) 21/21 (100%) 22/22 (100%)|23/25 (92%) 24/29 (83%) 23/29 (79%) 20/24 (83%) |
|FIRST INCIDENCE | 302 463 499 277 |460 541 490 430 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.101N P=0.120 P=0.137N P=0.278N |P=0.314 P=0.079N P=0.202N P=0.502 |
|POLY 3 | P=0.152 P=0.611N P=0.353 P=0.265 |P=0.499 P=0.303N P=0.457N P=0.570N |
|POLY 1.5 | P=0.153 P=0.560N P=0.357 P=0.263 |P=0.474 P=0.327N P=0.500N P=0.587N |
|POLY 6 | P=0.152 P=0.605 P=0.353 P=0.257 |P=0.555 P=0.251N P=0.351N P=0.520N |
|LOGISTIC REGRESSION| P=0.129 P=0.580N P=0.440 P=0.205 |P=0.369 P=0.145N P=0.419N P=0.558 |
|COCH-ARM / FISHERS | P=0.117 P=0.602N P=0.288 P=0.194 |P=0.459 P=0.333N P=0.500N P=0.588N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 8
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.6% 2.7% 2.4% 0.0% |0.0% 0.0% 0.0% 7.3% |
|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 | 687 695 635 --- |--- --- --- 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.269N P=0.678 P=0.729N P=0.479N |P=0.011 * (e) (e) P=0.134 |
|POLY 3 | P=0.305N P=0.748 P=0.743N P=0.499N |P=0.010 * (e) (e) P=0.121 |
|POLY 1.5 | P=0.309N P=0.757 P=0.748N P=0.499N |P=0.011 * (e) (e) P=0.120 |
|POLY 6 | P=0.297N P=0.730 P=0.732N P=0.496N |P=0.010 * (e) (e) P=0.124 |
|LOGISTIC REGRESSION| P=0.307N P=0.735 P=0.763 P=0.498N |P=0.015 * (e) (e) P=0.129 |
|COCH-ARM / FISHERS | P=0.311N P=0.753N P=0.753N P=0.500N |P=0.012 * (e) (e) P=0.121 |
|=================================================================================================================================|
| | | |
| | 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 |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) 3/50 (6%) |3/50 (6%) 3/50 (6%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 5.2% 0.0% 7.2% 7.6% |7.4% 6.9% 2.4% 2.6% |
|TERMINAL (d) | 1/14 (7%) 0/10 (0%) 1/21 (5%) 2/22 (9%) |2/25 (8%) 3/29 (10%) 1/29 (3%) 1/24 (4%) |
|FIRST INCIDENCE | 710 --- 689 533 |600 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.411 P=0.308N P=0.674N P=0.651 |P=0.174N P=0.601N P=0.263N P=0.321N |
|POLY 3 | P=0.253 P=0.250N P=0.537 P=0.510 |P=0.176N P=0.631N P=0.290N P=0.321N |
|POLY 1.5 | P=0.241 P=0.241N P=0.525 P=0.507 |P=0.174N P=0.645N P=0.299N P=0.318N |
|POLY 6 | P=0.282 P=0.269N P=0.559 P=0.523 |P=0.177N P=0.610N P=0.277N P=0.322N |
|LOGISTIC REGRESSION| P=0.255 P=0.300N P=0.598 P=0.505 |P=0.174N P=0.609N P=0.287N P=0.316N |
|COCH-ARM / FISHERS | P=0.232 P=0.247N P=0.500 P=0.500 |P=0.169N P=0.661N P=0.309N P=0.316N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 9
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 4/50 (8%) 3/49 (6%) |4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 10.3% 5.5% 9.6% 7.8% |9.8% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 3/14 (21%) 2/10 (20%) 4/21 (19%) 2/22 (9%) |3/25 (12%) 0/29 (0%) 1/29 (3%) 0/24 (0%) |
|FIRST INCIDENCE | 666 729 (T) 729 (T) 653 |522 --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.249N P=0.504N P=0.436N P=0.350N |P=0.039N* P=0.050N P=0.146N P=0.069N |
|POLY 3 | P=0.504N P=0.366N P=0.604N P=0.504N |P=0.040N* P=0.052N P=0.167N P=0.062N |
|POLY 1.5 | P=0.518N P=0.345N P=0.616N P=0.506N |P=0.039N* P=0.056N P=0.174N P=0.062N |
|POLY 6 | P=0.468N P=0.407N P=0.584N P=0.490N |P=0.042N* P=0.047N* P=0.155N P=0.062N |
|LOGISTIC REGRESSION| P=0.362N P=0.474N P=0.465N P=0.469N |P=0.039N* P=0.062N P=0.171N P=0.063N |
|COCH-ARM / FISHERS | P=0.531N P=0.339N P=0.643N P=0.511N |P=0.039N* P=0.059N P=0.181N P=0.059N |
|=================================================================================================================================|
| | | |
| | 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 |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 7.5% 0.0% 0.0% 2.6% |2.5% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 1/24 (4%) |
|FIRST INCIDENCE | 101 --- --- 643 |648 --- --- 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.229N P=0.170N P=0.096N P=0.310N |P=0.229 P=0.474N P=0.479N P=0.496 |
|POLY 3 | P=0.227N P=0.135N P=0.110N P=0.311N |P=0.233 P=0.485N P=0.491N P=0.495 |
|POLY 1.5 | P=0.236N P=0.126N P=0.114N P=0.311N |P=0.237 P=0.492N P=0.496N P=0.493 |
|POLY 6 | P=0.211N P=0.154N P=0.105N P=0.305N |P=0.229 P=0.476N P=0.484N P=0.498 |
|LOGISTIC REGRESSION| P=0.302N P=0.180N P=0.220N P=0.345N |P=0.241 P=0.513N P=0.503N P=0.493 |
|COCH-ARM / FISHERS | P=0.247N P=0.121N P=0.121N P=0.309N |P=0.241 P=0.500N P=0.500N P=0.492 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 10
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 5/50 (10%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.1% 10.7% 11.9% 10.1% |0.0% 0.0% 2.4% 2.5% |
|TERMINAL (d) | 0/14 (0%) 1/10 (10%) 1/21 (5%) 3/22 (14%) |0/25 (0%) 0/29 (0%) 1/29 (3%) 1/24 (4%) |
|FIRST INCIDENCE | 595 554 681 277 |--- --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.474 P=0.243 P=0.343 P=0.429 |P=0.215 (e) P=0.530 P=0.492 |
|POLY 3 | P=0.327 P=0.314 P=0.244 P=0.343 |P=0.225 (e) P=0.510 P=0.498 |
|POLY 1.5 | P=0.322 P=0.332 P=0.236 P=0.344 |P=0.230 (e) P=0.505 P=0.498 |
|POLY 6 | P=0.343 P=0.283 P=0.261 P=0.347 |P=0.220 (e) P=0.519 P=0.499 |
|LOGISTIC REGRESSION| P=0.308 P=0.337 P=0.238 P=0.328 |(e) (e) P=0.530 P=0.492 |
|COCH-ARM / FISHERS | P=0.309 P=0.339 P=0.218 P=0.339 |P=0.236 (e) P=0.500 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 |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.8% 8.2% 4.7% 5.2% |2.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/14 (21%) 2/10 (20%) 0/21 (0%) 2/22 (9%) |1/25 (4%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 729 (T) 695 599 729 (T) |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.189N P=0.502 P=0.382N P=0.294N |P=0.308N P=0.470N P=0.470N P=0.508N |
|POLY 3 | P=0.354N P=0.638 P=0.456N P=0.496N |P=0.309N P=0.484N P=0.490N P=0.502N |
|POLY 1.5 | P=0.362N P=0.656 P=0.471N P=0.497N |P=0.308N P=0.491N P=0.495N P=0.502N |
|POLY 6 | P=0.335N P=0.603 P=0.429N P=0.486N |P=0.312N P=0.473N P=0.481N P=0.501N |
|LOGISTIC REGRESSION| P=0.317N P=0.528 P=0.475N P=0.294N |P=0.308N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.371N P=0.661N P=0.500N P=0.500N |P=0.305N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 11
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.1% 0.0% 0.0% 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 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.117N P=0.298N P=0.231N P=0.259N |(e) (e) (e) (e) |
|POLY 3 | P=0.105N P=0.254N P=0.223N P=0.238N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.110N P=0.242N P=0.227N P=0.237N |(e) (e) (e) (e) |
|POLY 6 | P=0.098N P=0.276N P=0.217N P=0.236N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.118N P=0.238N P=0.249N P=0.239N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N 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 |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 48/50 (96%) 50/50 (100%) 48/50 (96%) |40/50 (80%) 47/50 (94%) 48/50 (96%) 48/50 (96%) |
|POLY-3 ADJUSTED (b)| 98.4% 96.5% 100.0% 96.3% |84.6% 96.5% 99.5% 96.5% |
|TERMINAL (d) | 14/14 (100%) 10/10 (100%) 21/21 (100%) 21/22 (96%) |22/25 (88%) 29/29 (100%) 29/29 (100%) 24/24 (100%) |
|FIRST INCIDENCE | 302 463 471 277 |460 492 434 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.038N* P=0.106 P=0.097N P=0.142N |P=0.067 P=0.546 P=0.419 P=0.115 |
|POLY 3 | P=0.441N P=0.517N P=0.607 P=0.490N |P=0.015 * P=0.035 * P=0.004 ** P=0.033 * |
|POLY 1.5 | P=0.469N P=0.524N P=0.526 P=0.510N |P=0.010 * P=0.029 * P=0.004 ** P=0.022 * |
|POLY 6 | P=0.406N P=0.534N P=0.740 P=0.475N |P=0.030 * P=0.051 P=0.007 ** P=0.055 |
|LOGISTIC REGRESSION| P=0.581 P=0.616N P=0.489 P=0.664N |P=0.005 ** P=0.054 P=0.012 * P=0.015 * |
|COCH-ARM / FISHERS | P=0.556 P=0.691N P=0.247 P=0.691N |P=0.009 ** P=0.036 * P=0.014 * P=0.014 * |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 12
Statistical Analysis of Non-neoplastic Lesions 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 |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 5/50 (10%) 1/50 (2%) 2/50 (4%) |40/50 (80%) 31/50 (62%) 20/50 (40%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 37.6% 13.5% 2.4% 5.1% |87.2% 67.7% 46.5% 17.5% |
|TERMINAL (d) | 11/14 (79%) 2/10 (20%) 1/21 (5%) 1/22 (5%) |25/25 (100%) 21/29 (72%) 17/29 (59%) 6/24 (25%) |
|FIRST INCIDENCE | 507 640 729 (T) 530 |460 544 606 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.049N* P<0.001N** P<0.001N** |P<0.001N** P=0.008N** P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P=0.012N* P<0.001N** P<0.001N** |P<0.001N** P=0.015N* P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.010N* P<0.001N** P<0.001N** |P<0.001N** P=0.023N* P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P=0.017N* P<0.001N** P<0.001N** |P<0.001N** P=0.008N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.029N* P<0.001N** P<0.001N** |P<0.001N** P=0.009N** P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.011N* P<0.001N** P<0.001N** |P<0.001N** P=0.038N* P<0.001N** P<0.001N** |
|=================================================================================================================================|
| | | |
| | 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 |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 7.2% 5.2% |0.0% 6.9% 4.7% 2.5% |
|TERMINAL (d) | 1/14 (7%) 0/10 (0%) 3/21 (14%) 2/22 (9%) |0/25 (0%) 1/29 (3%) 2/29 (7%) 1/24 (4%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |--- 702 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.448 P=0.567N P=0.457 P=0.658 |P=0.533 P=0.163 P=0.271 P=0.492 |
|POLY 3 | P=0.255 P=0.512N P=0.333 P=0.503 |P=0.549 P=0.134 P=0.248 P=0.498 |
|POLY 1.5 | P=0.247 P=0.503N P=0.324 P=0.502 |P=0.550 P=0.127 P=0.242 P=0.498 |
|POLY 6 | P=0.278 P=0.528N P=0.349 P=0.510 |P=0.552 P=0.145 P=0.259 P=0.499 |
|LOGISTIC REGRESSION| P=0.448 (e) P=0.457 P=0.658 |P=0.542 P=0.151 P=0.271 P=0.492 |
|COCH-ARM / FISHERS | P=0.242 P=0.500N P=0.309 P=0.500 |P=0.555 P=0.121 P=0.247 P=0.500 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 13
Statistical Analysis of Non-neoplastic Lesions 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 |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 5.0% |
|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 | --- --- --- --- |--- --- --- 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.257 |
|POLY 3 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.237 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.236 |
|POLY 6 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.241 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.237 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | 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 |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 5/50 (10%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 5.2% 5.5% 11.9% 5.2% |0.0% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 2/14 (14%) 2/10 (20%) 1/21 (5%) 2/22 (9%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 1/24 (4%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 681 729 (T) |--- --- --- 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.383N P=0.572 P=0.397 P=0.524N |P=0.040 * (e) (e) P=0.230 |
|POLY 3 | P=0.540 P=0.674 P=0.252 P=0.692N |P=0.044 * (e) (e) P=0.237 |
|POLY 1.5 | P=0.530 P=0.689 P=0.240 P=0.692N |P=0.044 * (e) (e) P=0.237 |
|POLY 6 | P=0.573 P=0.645 P=0.275 P=0.685N |P=0.043 * (e) (e) P=0.240 |
|LOGISTIC REGRESSION| P=0.492N P=0.572 P=0.300 P=0.524N |P=0.049 * (e) (e) P=0.239 |
|COCH-ARM / FISHERS | P=0.521 P=0.691N P=0.218 P=0.691N |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 14
Statistical Analysis of Non-neoplastic Lesions 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 |
| Degeneration Fatty |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 9/50 (18%) 7/50 (14%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 15.1% 13.1% 20.6% 17.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/14 (14%) 0/10 (0%) 1/21 (5%) 4/22 (18%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 507 572 533 541 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.537N P=0.618N P=0.482 P=0.537N |(e) (e) (e) (e) |
|POLY 3 | P=0.369 P=0.526N P=0.357 P=0.504 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.358 P=0.504N P=0.332 P=0.503 |(e) (e) (e) (e) |
|POLY 6 | P=0.405 P=0.565N P=0.402 P=0.519 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.350 P=0.501N P=0.280 P=0.504 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.350 P=0.500N P=0.288 P=0.500 |(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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 5/50 (10%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 10.4% 5.5% 4.8% 5.1% |2.5% 11.3% 4.7% 7.5% |
|TERMINAL (d) | 4/14 (29%) 2/10 (20%) 2/21 (10%) 1/22 (5%) |1/25 (4%) 4/29 (14%) 2/29 (7%) 2/24 (8%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 642 |730 (T) 544 730 (T) 706 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.109N P=0.500N P=0.160N P=0.184N |P=0.403 P=0.136 P=0.552 P=0.298 |
|POLY 3 | P=0.271N P=0.363N P=0.300N P=0.328N |P=0.432 P=0.123 P=0.518 P=0.302 |
|POLY 1.5 | P=0.282N P=0.344N P=0.313N P=0.332N |P=0.432 P=0.113 P=0.508 P=0.302 |
|POLY 6 | P=0.247N P=0.401N P=0.280N P=0.313N |P=0.437 P=0.139 P=0.534 P=0.304 |
|LOGISTIC REGRESSION| P=0.166N P=0.500N P=0.160N P=0.282N |P=0.416 P=0.118 P=0.552 P=0.306 |
|COCH-ARM / FISHERS | P=0.292N P=0.339N P=0.339N P=0.339N |P=0.437 P=0.102 P=0.500 P=0.309 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 15
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.9% 0.0% 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 | --- --- --- --- |506 --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.477N P=0.221N P=0.226N P=0.515N |
|POLY 3 | (e) (e) (e) (e) |P=0.468N P=0.223N P=0.229N P=0.509N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.465N P=0.230N P=0.234N P=0.506N |
|POLY 6 | (e) (e) (e) (e) |P=0.472N P=0.213N P=0.221N P=0.510N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.453N P=0.256N P=0.236N P=0.497N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.460N P=0.247N P=0.247N 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 |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/50 (2%) 8/50 (16%) 4/50 (8%) |2/50 (4%) 6/50 (12%) 6/50 (12%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 15.4% 2.7% 18.3% 10.1% |4.9% 13.7% 13.9% 19.8% |
|TERMINAL (d) | 3/14 (21%) 0/10 (0%) 2/21 (10%) 2/22 (9%) |1/25 (4%) 4/29 (14%) 4/29 (14%) 6/24 (25%) |
|FIRST INCIDENCE | 687 542 504 541 |632 699 434 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.369N P=0.123N P=0.572 P=0.211N |P=0.039 * P=0.201 P=0.181 P=0.043 * |
|POLY 3 | P=0.510N P=0.062N P=0.480 P=0.357N |P=0.048 * P=0.158 P=0.154 P=0.042 * |
|POLY 1.5 | P=0.532N P=0.057N P=0.446 P=0.361N |P=0.050 P=0.146 P=0.143 P=0.043 * |
|POLY 6 | P=0.459N P=0.075N P=0.536 P=0.341N |P=0.048 * P=0.175 P=0.170 P=0.043 * |
|LOGISTIC REGRESSION| P=0.542N P=0.074N P=0.408 P=0.356N |P=0.046 * P=0.176 P=0.133 P=0.045 * |
|COCH-ARM / FISHERS | P=0.549N P=0.056N P=0.387 P=0.370N |P=0.054 P=0.134 P=0.134 P=0.046 * |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 16
Statistical Analysis of Non-neoplastic Lesions 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 |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 3/50 (6%) 6/50 (12%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 0.0% 2.6% |0.0% 6.9% 14.1% 2.5% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 1/22 (5%) |0/25 (0%) 2/29 (7%) 5/29 (17%) 1/24 (4%) |
|FIRST INCIDENCE | 689 --- --- 729 (T) |--- 704 656 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.682N P=0.569N P=0.431N P=0.692N |P=0.425 P=0.154 P=0.028 * P=0.492 |
|POLY 3 | P=0.606 P=0.513N P=0.485N P=0.760N |P=0.433 P=0.134 P=0.018 * P=0.498 |
|POLY 1.5 | P=0.599 P=0.504N P=0.490N P=0.760N |P=0.441 P=0.127 P=0.016 * P=0.498 |
|POLY 6 | P=0.620 P=0.529N P=0.477N P=0.757N |P=0.427 P=0.145 P=0.021 * P=0.499 |
|LOGISTIC REGRESSION| P=0.629 P=0.525N P=0.486N P=0.749N |P=0.435 P=0.153 P=0.024 * P=0.492 |
|COCH-ARM / FISHERS | P=0.595 P=0.500N P=0.500N P=0.753N |P=0.456 P=0.121 P=0.013 * 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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.1% 0.0% 0.0% 2.6% |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 --- --- 722 |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.387N P=0.335N P=0.203N P=0.442N |P=0.582N P=0.530 (e) (e) |
|POLY 3 | P=0.444N P=0.252N P=0.222N P=0.500N |P=0.556N P=0.516 (e) (e) |
|POLY 1.5 | P=0.453N P=0.241N P=0.226N P=0.499N |P=0.562N P=0.509 (e) (e) |
|POLY 6 | P=0.428N P=0.273N P=0.214N P=0.496N |P=0.547N P=0.527 (e) (e) |
|LOGISTIC REGRESSION| P=0.444N P=0.250N P=0.228N P=0.494N |(e) P=0.530 (e) (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.247N P=0.247N P=0.500N |P=0.568N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 17
Statistical Analysis of Non-neoplastic Lesions 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: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.7% 2.7% 4.7% 2.5% |0.0% 2.3% 4.6% 0.0% |
|TERMINAL (d) | 1/14 (7%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 561 639 471 379 |--- 589 490 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.247N P=0.387N P=0.424N P=0.260N |P=0.629N P=0.509 P=0.254 (e) |
|POLY 3 | P=0.261N P=0.329N P=0.462N P=0.300N |P=0.625N P=0.518 P=0.253 (e) |
|POLY 1.5 | P=0.270N P=0.312N P=0.474N P=0.301N |P=0.622N P=0.510 P=0.245 (e) |
|POLY 6 | P=0.243N P=0.359N P=0.442N P=0.294N |P=0.627N P=0.530 P=0.266 (e) |
|LOGISTIC REGRESSION| P=0.308N P=0.306N P=0.556N P=0.320N |P=0.585N P=0.485 P=0.242 (e) |
|COCH-ARM / FISHERS | P=0.279N P=0.309N P=0.500N P=0.309N |P=0.616N P=0.500 P=0.247 (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 |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 2.4% 0.0% |4.9% 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%) 1/24 (4%) |
|FIRST INCIDENCE | --- 638 715 --- |597 --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.540N P=0.466 P=0.589 (e) |P=0.474N P=0.207N P=0.218N P=0.506N |
|POLY 3 | P=0.591N P=0.490 P=0.516 (e) |P=0.468N P=0.223N P=0.229N P=0.509N |
|POLY 1.5 | P=0.592N P=0.498 P=0.511 (e) |P=0.465N P=0.230N P=0.234N P=0.506N |
|POLY 6 | P=0.586N P=0.476 P=0.525 (e) |P=0.471N P=0.215N P=0.222N P=0.512N |
|LOGISTIC REGRESSION| P=0.591N P=0.499 P=0.545 (e) |P=0.457N P=0.255N P=0.239N P=0.499N |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.460N P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 18
Statistical Analysis of Non-neoplastic Lesions 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 |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |5/50 (10%) 2/50 (4%) 5/50 (10%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.6% 8.1% 0.0% 0.0% |11.9% 4.5% 11.4% 11.8% |
|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 | 479 661 --- --- |489 541 351 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140N P=0.239 P=0.492N P=0.504N |P=0.398 P=0.170N P=0.557N P=0.621 |
|POLY 3 | P=0.152N P=0.282 P=0.488N P=0.502N |P=0.403 P=0.194N P=0.604N P=0.628N |
|POLY 1.5 | P=0.150N P=0.298 P=0.492N P=0.501N |P=0.408 P=0.204N P=0.617N P=0.629N |
|POLY 6 | P=0.152N P=0.257 P=0.481N P=0.500N |P=0.396 P=0.180N P=0.584N P=0.625N |
|LOGISTIC REGRESSION| P=0.161N P=0.299 P=0.644N P=0.552N |P=0.491 P=0.262N P=0.623 P=0.580N |
|COCH-ARM / FISHERS | P=0.153N P=0.309 P=0.500N P=0.500N |P=0.416 P=0.218N P=0.630N P=0.630N |
|=================================================================================================================================|
| | | |
| | 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 |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |3/50 (6%) 3/50 (6%) 5/50 (10%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 12.8% 0.0% 4.8% 5.2% |7.4% 6.9% 11.8% 21.6% |
|TERMINAL (d) | 2/14 (14%) 0/10 (0%) 0/21 (0%) 2/22 (9%) |1/25 (4%) 3/29 (10%) 4/29 (14%) 4/24 (17%) |
|FIRST INCIDENCE | 582 --- 664 729 (T) |648 730 (T) 677 515 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.143N P=0.064N P=0.124N P=0.108N |P=0.014 * P=0.590N P=0.444 P=0.067 |
|POLY 3 | P=0.238N P=0.036N* P=0.187N P=0.217N |P=0.017 * P=0.632N P=0.378 P=0.061 |
|POLY 1.5 | P=0.252N P=0.032N* P=0.196N P=0.216N |P=0.017 * P=0.646N P=0.366 P=0.060 |
|POLY 6 | P=0.213N P=0.045N* P=0.171N P=0.212N |P=0.017 * P=0.614N P=0.398 P=0.065 |
|LOGISTIC REGRESSION| P=0.231N P=0.043N* P=0.189N P=0.201N |P=0.016 * P=0.621N P=0.393 P=0.061 |
|COCH-ARM / FISHERS | P=0.263N P=0.028N* P=0.218N P=0.218N |P=0.019 * P=0.661N P=0.357 P=0.061 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 19
Statistical Analysis of Non-neoplastic Lesions 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 |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 7.7% 2.7% 0.0% 0.0% |0.0% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 1/14 (7%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 680 678 --- --- |--- --- --- 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029N* P=0.451N P=0.079N P=0.091N |P=0.041 * (e) (e) P=0.259 |
|POLY 3 | P=0.039N* P=0.327N P=0.106N P=0.118N |P=0.044 * (e) (e) P=0.236 |
|POLY 1.5 | P=0.041N* P=0.311N P=0.110N P=0.118N |P=0.044 * (e) (e) P=0.236 |
|POLY 6 | P=0.036N* P=0.357N P=0.100N P=0.115N |P=0.043 * (e) (e) P=0.239 |
|LOGISTIC REGRESSION| P=0.038N* P=0.358N P=0.101N P=0.114N |P=0.045 * (e) (e) P=0.236 |
|COCH-ARM / FISHERS | P=0.044N* P=0.309N P=0.121N P=0.121N |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | 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 Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) 2/50 (4%) 2/50 (4%) |2/50 (4%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 13.1% 4.8% 5.2% |4.9% 6.9% 4.7% 5.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 1/21 (5%) 2/22 (9%) |1/25 (4%) 3/29 (10%) 2/29 (7%) 1/24 (4%) |
|FIRST INCIDENCE | --- 541 709 729 (T) |652 730 (T) 730 (T) 629 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.563N P=0.023 * P=0.337 P=0.341 |P=0.556N P=0.571 P=0.641N P=0.683 |
|POLY 3 | P=0.485 P=0.028 * P=0.255 P=0.238 |P=0.531N P=0.533 P=0.679N P=0.692 |
|POLY 1.5 | P=0.484 P=0.031 * P=0.249 P=0.238 |P=0.529N P=0.518 P=0.687N P=0.692 |
|POLY 6 | P=0.499 P=0.024 * P=0.265 P=0.242 |P=0.531N P=0.554 P=0.665N P=0.695 |
|LOGISTIC REGRESSION| P=0.481 P=0.030 * P=0.297 P=0.341 |P=0.541N P=0.568 P=0.662N P=0.693 |
|COCH-ARM / FISHERS | P=0.477 P=0.028 * P=0.247 P=0.247 |P=0.523N P=0.500 P=0.691N P=0.691N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 20
Statistical Analysis of Non-neoplastic Lesions 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: Interstitium |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.2% 2.4% 5.1% |0.0% 4.6% 4.7% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 1/21 (5%) 1/22 (5%) |0/25 (0%) 1/29 (3%) 1/29 (3%) 0/24 (0%) |
|FIRST INCIDENCE | --- 666 729 (T) 465 |--- 666 727 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.461 P=0.076 P=0.581 P=0.289 |P=0.517N P=0.285 P=0.272 (e) |
|POLY 3 | P=0.350 P=0.109 P=0.516 P=0.243 |P=0.505N P=0.257 P=0.248 (e) |
|POLY 1.5 | P=0.346 P=0.116 P=0.511 P=0.241 |P=0.504N P=0.247 P=0.242 (e) |
|POLY 6 | P=0.361 P=0.097 P=0.524 P=0.249 |P=0.502N P=0.270 P=0.259 (e) |
|LOGISTIC REGRESSION| P=0.340 P=0.091 P=0.581 P=0.227 |P=0.512N P=0.251 P=0.273 (e) |
|COCH-ARM / FISHERS | P=0.337 P=0.121 P=0.500 P=0.247 |P=0.500N P=0.247 P=0.247 (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 |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 0.0% 2.4% 2.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 1/21 (5%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 674 --- 729 (T) 653 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.410N P=0.309N P=0.392N P=0.470N |(e) (e) (e) (e) |
|POLY 3 | P=0.482N P=0.251N P=0.475N P=0.497N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.493N P=0.241N P=0.483N P=0.498N |(e) (e) (e) (e) |
|POLY 6 | P=0.461N P=0.271N P=0.462N P=0.490N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.480N P=0.272N P=0.449N P=0.497N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.247N P=0.500N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 21
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/46 (11%) 5/48 (10%) 5/45 (11%) 1/42 (2%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 13.4% 13.8% 13.2% 3.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/14 (7%) 0/9 (0%) 2/19 (11%) 0/20 (0%) |0/25 (0%) 0/29 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 507 576 664 688 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.041N* P=0.464 P=0.463N P=0.074N |(e) (e) (e) (e) |
|POLY 3 | P=0.095N P=0.613 P=0.625N P=0.124N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.099N P=0.625N P=0.631 P=0.123N |(e) (e) (e) (e) |
|POLY 6 | P=0.087N P=0.566 P=0.608N P=0.122N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.095N P=0.613N P=0.626N P=0.124N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.102N P=0.602N P=0.616 P=0.124N |(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 |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Artery |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/7 (29%) 0/4 (0%) 0/8 (0%) 0/3 (0%) |0/4 (0%) 0/7 (0%) 0/6 (0%) 0/5 (0%) |
|POLY-3 ADJUSTED (b)| 42.2% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/2 (0%) |0/2 (0%) 0/1 (0%) 0/1 (0%) 0/1 (0%) |
|FIRST INCIDENCE | 663 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095N P=0.333N P=0.198N P=0.216N |(e) (e) (e) (e) |
|POLY 3 | P=0.151N P=0.346N P=0.191N P=0.347N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.147N P=0.345N P=0.184N P=0.382N |(e) (e) (e) (e) |
|POLY 6 | P=0.143N P=0.374N P=0.226N P=0.306N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.103N P=0.356N P=0.247N P=0.289N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.139N P=0.382N P=0.200N P=0.467N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 22
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/7 (57%) 3/4 (75%) 4/8 (50%) 3/3 (100%) |4/4 (100%) 6/7 (86%) 4/6 (67%) 3/5 (60%) |
|POLY-3 ADJUSTED (b)| 63.6% 75.0% 67.1% 100.0% |100.0% 87.0% 83.0% 68.9% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 2/2 (100%) |2/2 (100%) 1/1 (100%) 1/1 (100%) 0/1 (0%) |
|FIRST INCIDENCE | 394 562 568 632 |506 655 490 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.251N P=0.577N P=0.543N P=0.171N |P=0.421N P=0.320 P=0.537 P=0.600N |
|POLY 3 | P=0.245 P=0.616 P=0.688 P=0.335 |P=0.194N P=0.651N P=0.652N P=0.384N |
|POLY 1.5 | P=0.258 P=0.570 P=0.694N P=0.303 |P=0.159N P=0.630N P=0.467N P=0.325N |
|POLY 6 | P=0.254 P=0.693 P=0.642 P=0.405 |P=0.244N P=0.695N P=0.935N P=0.457N |
|LOGISTIC REGRESSION| P=0.289 P=0.547 P=0.596N P=0.191 |P=0.176N P=0.629N P=0.477N P=0.286N |
|COCH-ARM / FISHERS | P=0.289 P=0.530 P=0.595N P=0.292 |P=0.124N P=0.636N P=0.333N P=0.278N |
|=================================================================================================================================|
| | | |
| | 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 |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 4/50 (8%) 9/49 (18%) |1/49 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.1% 13.4% 9.5% 21.9% |2.5% 2.3% 2.4% 0.0% |
|TERMINAL (d) | 0/14 (0%) 2/10 (20%) 2/21 (10%) 3/22 (14%) |0/24 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 663 572 635 277 |650 722 677 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.067 P=0.123 P=0.463 P=0.054 |P=0.321N P=0.723N P=0.721N P=0.506N |
|POLY 3 | P=0.023 * P=0.195 P=0.372 P=0.029 * |P=0.315N P=0.739N P=0.744N P=0.498N |
|POLY 1.5 | P=0.020 * P=0.211 P=0.361 P=0.027 * |P=0.313N P=0.747N P=0.751N P=0.498N |
|POLY 6 | P=0.028 * P=0.167 P=0.391 P=0.035 * |P=0.316N P=0.727N P=0.734N P=0.498N |
|LOGISTIC REGRESSION| P=0.017 * P=0.193 P=0.376 P=0.023 * |P=0.309N P=0.754N P=0.761N P=0.494N |
|COCH-ARM / FISHERS | P=0.017 * P=0.218 P=0.339 P=0.023 * |P=0.308N P=0.747N P=0.747N P=0.495N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 23
Statistical Analysis of Non-neoplastic Lesions 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 Mucosa |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/7 (57%) 1/2 (50%) 0/2 (0%) 0/0 (0%) |0/2 (0%) 0/2 (0%) 0/0 (0%) 0/1 (0%) |
|POLY-3 ADJUSTED (b)| 58.9% 56.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |0/1 (0%) 0/2 (0%) 0/0 (0%) 0/1 (0%) |
|FIRST INCIDENCE | 653 666 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014N* P=0.319N P=0.043N* P=0.056N |(e) (e) (e) (e) |
|POLY 3 | P=1.000 P=0.756N P=0.273N P=1.000 |(e) (e) (e) (e) |
|POLY 1.5 | P=1.000 P=0.734N P=0.268N P=1.000 |(e) (e) (e) (e) |
|POLY 6 | P=1.000 P=0.782 P=0.281N P=1.000 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.337N P=0.427N P=0.477N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.287N P=0.722N P=0.278N P=1.000 |(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 |
| | | |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/7 (29%) 0/2 (0%) 2/2 (100%) 0/0 (0%) |2/2 (100%) 1/2 (50%) 0/0 (0%) 0/1 (0%) |
|POLY-3 ADJUSTED (b)| 32.6% 0.0% 100.0% 0.0% |100.0% 50.0% 0.0% 0.0% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |1/1 (100%) 1/2 (50%) 0/0 (0%) 0/1 (0%) |
|FIRST INCIDENCE | 702 --- 694 --- |729 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.331N P=0.576N P=0.668N P=0.453N |P=0.115N P=0.300N (e) P=0.249N |
|POLY 3 | P=1.000 P=0.571N P=0.159 P=1.000 |P=1.000N P=0.500N (e) P=1.000N |
|POLY 1.5 | P=1.000 P=0.555N P=0.148 P=1.000 |P=1.000N P=0.500N (e) P=1.000N |
|POLY 6 | P=1.000 P=0.606N P=0.186 P=1.000 |P=1.000N P=0.500N (e) P=1.000N |
|LOGISTIC REGRESSION| P=0.305 (e) P=0.290 (e) |(e) P=0.300N (e) (e) |
|COCH-ARM / FISHERS | P=0.256 P=0.583N P=0.167 P=1.000 |P=0.160N P=0.500N (e) P=0.333N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 24
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 4/50 (8%) 5/50 (10%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| |9.7% 9.2% 11.7% 19.6% |
|TERMINAL (d) | |2/25 (8%) 3/29 (10%) 3/29 (10%) 5/24 (21%) |
|FIRST INCIDENCE | |460 703 656 490 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.080 P=0.551N P=0.584 P=0.175 |
|POLY 3 | |P=0.088 P=0.611N P=0.523 P=0.168 |
|POLY 1.5 | |P=0.092 P=0.627N P=0.509 P=0.171 |
|POLY 6 | |P=0.085 P=0.588N P=0.549 P=0.169 |
|LOGISTIC REGRESSION| |P=0.090 P=0.633N P=0.507 P=0.175 |
|COCH-ARM / FISHERS | |P=0.099 P=0.643N P=0.500 P=0.178 |
|=================================================================================================================================|
| | | |
| | 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 |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 18/50 (36%) 26/50 (52%) 24/50 (48%) |13/50 (26%) 21/50 (42%) 11/50 (22%) 14/50 (28%) |
|POLY-3 ADJUSTED (b)| 53.7% 45.9% 60.0% 56.1% |31.7% 46.2% 25.1% 33.2% |
|TERMINAL (d) | 9/14 (64%) 5/10 (50%) 15/21 (71%) 13/22 (59%) |9/25 (36%) 14/29 (48%) 8/29 (28%) 8/24 (33%) |
|FIRST INCIDENCE | 394 560 556 379 |638 541 365 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.159N P=0.538 P=0.251N P=0.254N |P=0.445N P=0.192 P=0.272N P=0.476 |
|POLY 3 | P=0.325 P=0.305N P=0.350 P=0.496 |P=0.342N P=0.118 P=0.332N P=0.537 |
|POLY 1.5 | P=0.308 P=0.238N P=0.363 P=0.505 |P=0.354N P=0.092 P=0.367N P=0.517 |
|POLY 6 | P=0.376 P=0.441N P=0.344 P=0.504 |P=0.322N P=0.165 P=0.285N P=0.570 |
|LOGISTIC REGRESSION| P=0.331 P=0.263N P=0.474 P=0.508 |P=0.397N P=0.127 P=0.355N P=0.489 |
|COCH-ARM / FISHERS | P=0.290 P=0.208N P=0.345 P=0.500 |P=0.368N P=0.069 P=0.408N P=0.500 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 25
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/46 (4%) 9/49 (18%) 1/48 (2%) 1/47 (2%) |0/43 (0%) 0/42 (0%) 1/42 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 5.6% 24.4% 2.5% 2.7% |0.0% 0.0% 2.8% 2.6% |
|TERMINAL (d) | 0/13 (0%) 1/10 (10%) 0/20 (0%) 0/20 (0%) |0/19 (0%) 0/25 (0%) 1/25 (4%) 0/23 (0%) |
|FIRST INCIDENCE | 610 584 710 640 |--- --- 730 (T) 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058N P=0.012 * P=0.442N P=0.515N |P=0.241 (e) P=0.555 P=0.519 |
|POLY 3 | P=0.080N P=0.024 * P=0.460N P=0.492N |P=0.260 (e) P=0.515 P=0.530 |
|POLY 1.5 | P=0.081N P=0.030 * P=0.467N P=0.491N |P=0.262 (e) P=0.505 P=0.528 |
|POLY 6 | P=0.078N P=0.017 * P=0.450N P=0.490N |P=0.258 (e) P=0.530 P=0.536 |
|LOGISTIC REGRESSION| P=0.086N P=0.028 * P=0.506N P=0.500N |P=0.259 (e) P=0.555 P=0.527 |
|COCH-ARM / FISHERS | P=0.092N P=0.032 * P=0.484N P=0.492N |P=0.265 (e) P=0.494 P=0.533 |
|=================================================================================================================================|
| | | |
| | 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 |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 2/49 (4%) |5/49 (10%) 3/50 (6%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 5.1% 0.0% 4.8% 5.2% |12.3% 6.8% 4.7% 10.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 1/21 (5%) 1/21 (5%) |2/25 (8%) 1/29 (3%) 1/29 (3%) 2/24 (8%) |
|FIRST INCIDENCE | 582 --- 715 379 |579 589 648 703 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.543 P=0.266N P=0.613N P=0.666N |P=0.500N P=0.294N P=0.185N P=0.520N |
|POLY 3 | P=0.457 P=0.255N P=0.674N P=0.688 |P=0.480N P=0.313N P=0.197N P=0.513N |
|POLY 1.5 | P=0.446 P=0.243N P=0.679N P=0.689 |P=0.469N P=0.328N P=0.204N P=0.503N |
|POLY 6 | P=0.482 P=0.278N P=0.665N P=0.691 |P=0.491N P=0.294N P=0.187N P=0.525N |
|LOGISTIC REGRESSION| P=0.426 P=0.250N P=0.692 P=0.670 |P=0.459N P=0.368N P=0.212N P=0.493N |
|COCH-ARM / FISHERS | P=0.437 P=0.247N P=0.691N P=0.684 |P=0.453N P=0.346N P=0.210N P=0.487N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 26
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/50 (16%) 7/50 (14%) 8/49 (16%) |3/49 (6%) 11/50 (22%) 12/50 (24%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 10.2% 20.8% 16.8% 20.6% |7.5% 25.1% 27.7% 12.4% |
|TERMINAL (d) | 1/14 (7%) 1/10 (10%) 5/21 (24%) 6/21 (29%) |2/25 (8%) 9/29 (31%) 9/29 (31%) 4/24 (17%) |
|FIRST INCIDENCE | 645 554 689 277 |622 666 490 589 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.466 P=0.090 P=0.478 P=0.319 |P=0.452 P=0.043 * P=0.026 * P=0.331 |
|POLY 3 | P=0.207 P=0.162 P=0.297 P=0.168 |P=0.502 P=0.029 * P=0.015 * P=0.361 |
|POLY 1.5 | P=0.207 P=0.176 P=0.287 P=0.172 |P=0.510 P=0.025 * P=0.013 * P=0.362 |
|POLY 6 | P=0.218 P=0.137 P=0.315 P=0.169 |P=0.497 P=0.035 * P=0.019 * P=0.361 |
|LOGISTIC REGRESSION| P=0.209 P=0.169 P=0.356 P=0.169 |P=0.490 P=0.043 * P=0.017 * P=0.361 |
|COCH-ARM / FISHERS | P=0.198 P=0.178 P=0.262 P=0.168 |P=0.527 P=0.022 * P=0.013 * P=0.369 |
|=================================================================================================================================|
| | | |
| | 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 |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/49 (2%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 0.0% 8.2% 2.5% 5.2% | |
|TERMINAL (d) | 0/14 (0%) 1/10 (10%) 1/20 (5%) 2/22 (9%) | |
|FIRST INCIDENCE | --- 670 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.515 P=0.073 P=0.571 P=0.341 | |
|POLY 3 | P=0.341 P=0.108 P=0.511 P=0.238 | |
|POLY 1.5 | P=0.341 P=0.116 P=0.506 P=0.238 | |
|POLY 6 | P=0.349 P=0.096 P=0.519 P=0.242 | |
|LOGISTIC REGRESSION| P=0.419 P=0.085 P=0.571 P=0.341 | |
|COCH-ARM / FISHERS | P=0.337 P=0.121 P=0.495 P=0.247 | |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 27
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 5/49 (10%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 5.2% 0.0% 12.1% 7.5% | |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/20 (0%) 0/22 (0%) | |
|FIRST INCIDENCE | 680 --- 542 533 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.337 P=0.326N P=0.369 P=0.552 | |
|POLY 3 | P=0.248 P=0.251N P=0.243 P=0.512 | |
|POLY 1.5 | P=0.232 P=0.241N P=0.231 P=0.508 | |
|POLY 6 | P=0.287 P=0.272N P=0.263 P=0.527 | |
|LOGISTIC REGRESSION| P=0.223 P=0.265N P=0.225 P=0.500 | |
|COCH-ARM / FISHERS | P=0.221 P=0.247N P=0.210 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 |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 3/50 (6%) 4/50 (8%) | |
|POLY-3 ADJUSTED (b)| 5.2% 16.0% 7.1% 9.8% | |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 1/22 (5%) | |
|FIRST INCIDENCE | 680 639 556 277 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.545 P=0.068 P=0.607 P=0.386 | |
|POLY 3 | P=0.490 P=0.118 P=0.542 P=0.361 | |
|POLY 1.5 | P=0.476 P=0.129 P=0.528 P=0.355 | |
|POLY 6 | P=0.516 P=0.099 P=0.565 P=0.375 | |
|LOGISTIC REGRESSION| P=0.428 P=0.108 P=0.496 P=0.303 | |
|COCH-ARM / FISHERS | P=0.446 P=0.134 P=0.500 P=0.339 | |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 28
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.1% | |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 0/22 (0%) | |
|FIRST INCIDENCE | --- --- --- 709 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.085 (e) (e) P=0.336 | |
|POLY 3 | P=0.047 * (e) (e) P=0.239 | |
|POLY 1.5 | P=0.046 * (e) (e) P=0.239 | |
|POLY 6 | P=0.050 (e) (e) P=0.244 | |
|LOGISTIC REGRESSION| P=0.059 (e) (e) P=0.262 | |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 | |
|=================================================================================================================================|
| | | |
| | 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: Epidermis, Skin, Site of Application |
| Acanthosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 4/50 (8%) 10/50 (20%) |1/50 (2%) 1/50 (2%) 4/50 (8%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.5% 9.5% 25.1% |2.5% 2.3% 9.5% 14.4% |
|TERMINAL (d) | 0/14 (0%) 1/10 (10%) 2/21 (10%) 7/22 (32%) |0/25 (0%) 1/29 (3%) 4/29 (14%) 1/24 (4%) |
|FIRST INCIDENCE | --- 695 659 577 |650 730 (T) 730 (T) 430 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.171 P=0.099 P=0.005 ** |P=0.010 * P=0.726N P=0.225 P=0.066 |
|POLY 3 | P<0.001 ** P=0.224 P=0.072 P<0.001 ** |P=0.012 * P=0.744N P=0.191 P=0.059 |
|POLY 1.5 | P<0.001 ** P=0.234 P=0.068 P<0.001 ** |P=0.012 * P=0.752N P=0.184 P=0.057 |
|POLY 6 | P<0.001 ** P=0.208 P=0.079 P<0.001 ** |P=0.012 * P=0.734N P=0.203 P=0.063 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.179 P=0.073 P<0.001 ** |P=0.013 * P=0.756N P=0.212 P=0.062 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.247 P=0.059 P<0.001 ** |P=0.013 * P=0.753N P=0.181 P=0.056 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 29
Statistical Analysis of Non-neoplastic Lesions 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: Epidermis, Skin, Site of Application |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.1% |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 | --- --- --- 577 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.045 * (e) (e) P=0.219 |(e) (e) (e) (e) |
|POLY 3 | P=0.048 * (e) (e) P=0.243 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.047 * (e) (e) P=0.241 |(e) (e) (e) (e) |
|POLY 6 | P=0.052 (e) (e) P=0.251 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.046 * (e) (e) P=0.231 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |(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 |
| | | |
|=================================================================================================================================|
| |
|Skin: Epidermis, Skin, Site of Application |
| Exudate |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) 7/50 (14%) |1/50 (2%) 7/50 (14%) 7/50 (14%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.2% 4.8% 17.9% |2.5% 16.1% 16.6% 17.6% |
|TERMINAL (d) | 0/14 (0%) 2/10 (20%) 2/21 (10%) 4/22 (18%) |0/25 (0%) 6/29 (21%) 7/29 (24%) 5/24 (21%) |
|FIRST INCIDENCE | --- 662 729 (T) 653 |638 702 730 (T) 700 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026 * P=0.069 P=0.330 P=0.030 * |P=0.049 * P=0.056 P=0.049 * P=0.032 * |
|POLY 3 | P=0.004 ** P=0.108 P=0.255 P=0.007 ** |P=0.061 P=0.038 * P=0.034 * P=0.027 * |
|POLY 1.5 | P=0.004 ** P=0.116 P=0.249 P=0.008 ** |P=0.065 P=0.034 * P=0.032 * P=0.028 * |
|POLY 6 | P=0.005 ** P=0.095 P=0.264 P=0.008 ** |P=0.058 P=0.043 * P=0.037 * P=0.026 * |
|LOGISTIC REGRESSION| P=0.009 ** P=0.080 P=0.330 P=0.011 * |P=0.052 P=0.050 P=0.046 * P=0.031 * |
|COCH-ARM / FISHERS | P=0.004 ** P=0.121 P=0.247 P=0.006 ** |P=0.073 P=0.030 * P=0.030 * P=0.030 * |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 30
Statistical Analysis of Non-neoplastic Lesions 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: Epidermis, Skin, Site of Application |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 5/50 (10%) 11/50 (22%) |3/50 (6%) 13/50 (26%) 23/50 (46%) 23/50 (46%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.1% 12.0% 27.2% |7.4% 29.0% 51.4% 53.2% |
|TERMINAL (d) | 0/14 (0%) 1/10 (10%) 3/21 (14%) 5/22 (23%) |2/25 (8%) 7/29 (24%) 13/29 (45%) 13/24 (54%) |
|FIRST INCIDENCE | --- 640 702 379 |650 589 579 515 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.075 P=0.082 P=0.005 ** |P<0.001 ** P=0.024 * P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.110 P=0.037 * P<0.001 ** |P<0.001 ** P=0.010 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.116 P=0.035 * P<0.001 ** |P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.098 P=0.042 * P<0.001 ** |P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.107 P=0.056 P<0.001 ** |P<0.001 ** P=0.010 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.121 P=0.028 * P<0.001 ** |P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | 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: Skin, Site of Application |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.1% |4.9% 2.3% 2.4% 2.5% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 1/22 (5%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- --- --- 701 |650 655 677 430 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.082 (e) (e) P=0.319 |P=0.418N P=0.428N P=0.440N P=0.502N |
|POLY 3 | P=0.047 * (e) (e) P=0.239 |P=0.418N P=0.475N P=0.485N P=0.501N |
|POLY 1.5 | P=0.046 * (e) (e) P=0.239 |P=0.415N P=0.486N P=0.493N P=0.501N |
|POLY 6 | P=0.050 (e) (e) P=0.244 |P=0.422N P=0.459N P=0.473N P=0.501N |
|LOGISTIC REGRESSION| P=0.059 (e) (e) P=0.261 |P=0.380N P=0.520N P=0.504N P=0.458N |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |P=0.409N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 31
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 2.7% 7.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/14 (7%) 0/10 (0%) 3/21 (14%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 729 (T) 625 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.261N P=0.707 P=0.457 P=0.410N |(e) (e) (e) (e) |
|POLY 3 | P=0.398N P=0.751 P=0.333 P=0.498N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.404N P=0.758 P=0.324 P=0.499N |(e) (e) (e) (e) |
|POLY 6 | P=0.378N P=0.735 P=0.349 P=0.494N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.358N P=0.751 P=0.457 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.409N P=0.753N P=0.309 P=0.500N |(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 |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 10/50 (20%) 9/50 (18%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 17.2% 26.4% 21.1% 5.1% |2.5% 0.0% 7.1% 5.0% |
|TERMINAL (d) | 2/14 (14%) 3/10 (30%) 3/21 (14%) 1/22 (5%) |0/25 (0%) 0/29 (0%) 2/29 (7%) 2/24 (8%) |
|FIRST INCIDENCE | 101 538 568 642 |648 --- 648 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014N* P=0.149 P=0.584N P=0.058N |P=0.213 P=0.474N P=0.353 P=0.484 |
|POLY 3 | P=0.048N* P=0.237 P=0.434 P=0.085N |P=0.221 P=0.485N P=0.323 P=0.494 |
|POLY 1.5 | P=0.050N P=0.270 P=0.417 P=0.084N |P=0.229 P=0.492N P=0.313 P=0.496 |
|POLY 6 | P=0.041N* P=0.186 P=0.465 P=0.082N |P=0.211 P=0.476N P=0.339 P=0.494 |
|LOGISTIC REGRESSION| P=0.047N* P=0.298 P=0.359 P=0.085N |P=0.229 P=0.513N P=0.314 P=0.498 |
|COCH-ARM / FISHERS | P=0.049N* P=0.298 P=0.393 P=0.080N |P=0.242 P=0.500N P=0.309 P=0.500 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 32
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.5% 7.1% 2.6% |2.5% 6.8% 9.3% 2.5% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 1/22 (5%) |0/25 (0%) 2/29 (7%) 1/29 (3%) 1/24 (4%) |
|FIRST INCIDENCE | --- 695 556 729 (T) |666 589 561 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.563 P=0.183 P=0.152 P=0.590 |P=0.547N P=0.362 P=0.237 P=0.758N |
|POLY 3 | P=0.453 P=0.224 P=0.137 P=0.502 |P=0.541N P=0.336 P=0.198 P=0.758 |
|POLY 1.5 | P=0.449 P=0.234 P=0.131 P=0.501 |P=0.535N P=0.322 P=0.188 P=0.758 |
|POLY 6 | P=0.471 P=0.208 P=0.149 P=0.506 |P=0.546N P=0.356 P=0.216 P=0.758 |
|LOGISTIC REGRESSION| P=0.452 P=0.182 P=0.101 P=0.590 |P=0.525N P=0.303 P=0.176 P=0.761 |
|COCH-ARM / FISHERS | P=0.444 P=0.247 P=0.121 P=0.500 |P=0.523N P=0.309 P=0.181 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 |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.1% 2.4% 2.5% |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 | --- 639 568 379 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.618 P=0.080 P=0.505 P=0.504 |(e) (e) (e) (e) |
|POLY 3 | P=0.606 P=0.110 P=0.518 P=0.506 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.603 P=0.117 P=0.512 P=0.504 |(e) (e) (e) (e) |
|POLY 6 | P=0.617 P=0.099 P=0.528 P=0.512 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.562 P=0.113 P=0.435 P=0.388 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.591 P=0.121 P=0.500 P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 33
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.6% 5.4% 0.0% 0.0% |4.9% 2.3% 0.0% 2.5% |
|TERMINAL (d) | 1/14 (7%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 729 (T) 625 --- --- |506 666 --- 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.142N P=0.411 P=0.419N P=0.410N |P=0.367N P=0.439N P=0.223N P=0.487N |
|POLY 3 | P=0.184N P=0.484 P=0.484N P=0.498N |P=0.372N P=0.478N P=0.230N P=0.509N |
|POLY 1.5 | P=0.185N P=0.497 P=0.489N P=0.499N |P=0.370N P=0.488N P=0.235N P=0.506N |
|POLY 6 | P=0.183N P=0.462 P=0.476N P=0.494N |P=0.374N P=0.463N P=0.223N P=0.510N |
|LOGISTIC REGRESSION| P=0.181N P=0.468 (e) (e) |P=0.348N P=0.535N P=0.222N P=0.479N |
|COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.366N P=0.500N P=0.247N 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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 7.6% 2.7% 4.8% 5.1% |0.0% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 1/22 (5%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 582 572 681 653 |--- --- --- 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.451N P=0.373N P=0.434N P=0.508N |P=0.040 * (e) (e) P=0.235 |
|POLY 3 | P=0.485N P=0.331N P=0.474N P=0.506N |P=0.044 * (e) (e) P=0.237 |
|POLY 1.5 | P=0.494N P=0.313N P=0.481N P=0.502N |P=0.044 * (e) (e) P=0.237 |
|POLY 6 | P=0.465N P=0.364N P=0.461N P=0.504N |P=0.043 * (e) (e) P=0.241 |
|LOGISTIC REGRESSION| P=0.502N P=0.316N P=0.515N P=0.500N |P=0.049 * (e) (e) P=0.240 |
|COCH-ARM / FISHERS | P=0.500N P=0.309N P=0.500N P=0.500N |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 34
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 8/50 (16%) 9/50 (18%) 10/50 (20%) |2/50 (4%) 3/50 (6%) 5/50 (10%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 17.7% 20.7% 20.7% 23.9% |4.9% 6.8% 11.4% 14.7% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 1/21 (5%) 1/22 (5%) |0/25 (0%) 0/29 (0%) 1/29 (3%) 3/24 (13%) |
|FIRST INCIDENCE | 663 610 527 379 |638 597 490 572 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.429 P=0.281 P=0.596 P=0.398 |P=0.069 P=0.582 P=0.272 P=0.133 |
|POLY 3 | P=0.296 P=0.477 P=0.470 P=0.337 |P=0.074 P=0.540 P=0.249 P=0.133 |
|POLY 1.5 | P=0.273 P=0.500 P=0.445 P=0.323 |P=0.076 P=0.521 P=0.232 P=0.132 |
|POLY 6 | P=0.343 P=0.437 P=0.508 P=0.366 |P=0.073 P=0.566 P=0.275 P=0.138 |
|LOGISTIC REGRESSION| P=0.240 P=0.483 P=0.418 P=0.297 |P=0.085 P=0.493 P=0.209 P=0.133 |
|COCH-ARM / FISHERS | P=0.242 P=0.500 P=0.393 P=0.298 |P=0.079 P=0.500 P=0.218 P=0.134 |
|=================================================================================================================================|
| | | |
| | 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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 2.4% 2.5% |2.5% 0.0% 4.7% 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 | --- 666 702 277 |506 --- 634 700 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.412 P=0.425 P=0.584 P=0.504 |P=0.489 P=0.496N P=0.525 P=0.757N |
|POLY 3 | P=0.400 P=0.490 P=0.516 P=0.506 |P=0.476 P=0.487N P=0.516 P=0.756 |
|POLY 1.5 | P=0.395 P=0.497 P=0.511 P=0.505 |P=0.486 P=0.493N P=0.507 P=0.757 |
|POLY 6 | P=0.413 P=0.475 P=0.525 P=0.512 |P=0.466 P=0.478N P=0.532 P=0.757 |
|LOGISTIC REGRESSION| P=0.344 P=0.495 P=0.524 P=0.296 |P=0.518 P=0.477N P=0.502 P=0.748N |
|COCH-ARM / FISHERS | P=0.384 P=0.500 P=0.500 P=0.500 |P=0.500 P=0.500N P=0.500 P=0.753N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 35
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 10.2% 8.2% 4.8% 2.6% |0.0% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 1/14 (7%) 0/10 (0%) 0/21 (0%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 610 678 681 643 |--- --- --- 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.069N P=0.628 P=0.233N P=0.162N |P=0.041 * (e) (e) P=0.259 |
|POLY 3 | P=0.106N P=0.537N P=0.307N P=0.178N |P=0.044 * (e) (e) P=0.236 |
|POLY 1.5 | P=0.110N P=0.511N P=0.316N P=0.178N |P=0.044 * (e) (e) P=0.236 |
|POLY 6 | P=0.097N P=0.583N P=0.293N P=0.173N |P=0.043 * (e) (e) P=0.239 |
|LOGISTIC REGRESSION| P=0.105N P=0.550N P=0.310N P=0.178N |P=0.045 * (e) (e) P=0.236 |
|COCH-ARM / FISHERS | P=0.114N P=0.500N P=0.339N P=0.181N |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | 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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 4/50 (8%) 5/50 (10%) 4/50 (8%) |3/50 (6%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 16.9% 10.8% 11.7% 9.9% |7.3% 4.6% 4.6% 5.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 1/21 (5%) 0/22 (0%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 2/24 (8%) |
|FIRST INCIDENCE | 101 638 471 379 |597 638 434 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.181N P=0.397N P=0.256N P=0.257N |P=0.458N P=0.435N P=0.461N P=0.516N |
|POLY 3 | P=0.246N P=0.326N P=0.356N P=0.274N |P=0.449N P=0.467N P=0.475N P=0.512N |
|POLY 1.5 | P=0.257N P=0.293N P=0.366N P=0.272N |P=0.442N P=0.483N P=0.487N P=0.508N |
|POLY 6 | P=0.221N P=0.386N P=0.338N P=0.267N |P=0.457N P=0.447N P=0.456N P=0.516N |
|LOGISTIC REGRESSION| P=0.287N P=0.296N P=0.542N P=0.281N |P=0.422N P=0.511N P=0.504N P=0.503N |
|COCH-ARM / FISHERS | P=0.262N P=0.262N P=0.380N P=0.262N |P=0.431N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 36
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 10/50 (20%) 11/50 (22%) 9/50 (18%) | |
|POLY-3 ADJUSTED (b)| 37.7% 25.6% 25.7% 22.1% | |
|TERMINAL (d) | 0/14 (0%) 1/10 (10%) 2/21 (10%) 2/22 (9%) | |
|FIRST INCIDENCE | 560 509 635 541 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.036N* P=0.369N P=0.067N P=0.063N | |
|POLY 3 | P=0.088N P=0.171N P=0.167N P=0.092N | |
|POLY 1.5 | P=0.091N P=0.137N P=0.165N P=0.084N | |
|POLY 6 | P=0.080N P=0.250N P=0.170N P=0.099N | |
|LOGISTIC REGRESSION| P=0.090N P=0.128N P=0.158N P=0.081N | |
|COCH-ARM / FISHERS | P=0.096N P=0.127N P=0.184N P=0.083N | |
|=================================================================================================================================|
| | | |
| | 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: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 5.1% 2.7% 0.0% 5.1% | |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 0/21 (0%) 1/22 (5%) | |
|FIRST INCIDENCE | 653 688 --- 641 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.571N P=0.615N P=0.209N P=0.664N | |
|POLY 3 | P=0.605 P=0.523N P=0.222N P=0.693N | |
|POLY 1.5 | P=0.597 P=0.507N P=0.227N P=0.692N | |
|POLY 6 | P=0.620 P=0.553N P=0.215N P=0.688N | |
|LOGISTIC REGRESSION| P=0.601 P=0.520N P=0.232N P=0.693N | |
|COCH-ARM / FISHERS | P=0.591 P=0.500N P=0.247N P=0.691N | |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 37
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 37/50 (74%) 42/50 (84%) 33/49 (67%) |31/50 (62%) 33/50 (66%) 39/50 (78%) 29/50 (58%) |
|POLY-3 ADJUSTED (b)| 76.6% 81.5% 86.4% 75.7% |67.8% 70.4% 84.9% 67.2% |
|TERMINAL (d) | 12/14 (86%) 9/10 (90%) 17/21 (81%) 20/22 (91%) |18/25 (72%) 20/29 (69%) 26/29 (90%) 18/24 (75%) |
|FIRST INCIDENCE | 560 463 471 277 |438 492 561 565 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033N* P=0.045 * P=0.455N P=0.125N |P=0.520 P=0.384N P=0.342 P=0.493N |
|POLY 3 | P=0.474N P=0.371 P=0.154 P=0.564N |P=0.493 P=0.480 P=0.035 * P=0.568N |
|POLY 1.5 | P=0.494N P=0.355 P=0.091 P=0.568N |P=0.512N P=0.445 P=0.038 * P=0.510N |
|POLY 6 | P=0.447N P=0.359 P=0.280 P=0.572N |P=0.413 P=0.539 P=0.042 * P=0.578 |
|LOGISTIC REGRESSION| P=0.527 P=0.189 P=0.064 P=0.518 |P=0.454N P=0.488 P=0.075 P=0.442N |
|COCH-ARM / FISHERS | P=0.505 P=0.257 P=0.032 * P=0.528 |P=0.381N P=0.418 P=0.063 P=0.419N |
|=================================================================================================================================|
| | | |
| | 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 |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 2/49 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.5% 2.4% 5.3% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/10 (0%) 1/21 (5%) 1/22 (5%) |0/25 (0%) 0/29 (0%) 0/29 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- 662 729 (T) 722 |--- 597 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.379 P=0.179 P=0.581 P=0.346 |P=0.582N P=0.509 (e) (e) |
|POLY 3 | P=0.243 P=0.225 P=0.516 P=0.233 |P=0.555N P=0.518 (e) (e) |
|POLY 1.5 | P=0.242 P=0.234 P=0.511 P=0.233 |P=0.562N P=0.510 (e) (e) |
|POLY 6 | P=0.250 P=0.210 P=0.524 P=0.236 |P=0.545N P=0.530 (e) (e) |
|LOGISTIC REGRESSION| P=0.280 P=0.215 P=0.581 P=0.299 |P=0.551N P=0.484 (e) (e) |
|COCH-ARM / FISHERS | P=0.239 P=0.247 P=0.500 P=0.242 |P=0.568N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 09 Page 38
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Vagina |
| Infiltration Cellular Polymorphonuclear |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |0/0 (0%) 2/2 (100%) 0/1 (0%) 0/1 (0%) |
|POLY-3 ADJUSTED (b)| |0.0% 100.0% 0.0% 0.0% |
|TERMINAL (d) | |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | |--- 556 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |(e) (e) (e) (e) |
|POLY 3 | |(e) (e) (e) (e) |
|POLY 1.5 | |(e) (e) (e) (e) |
|POLY 6 | |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | |(e) (e) (e) (e) |
|=================================================================================================================================|
(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).