TDMS Study 05187-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus METHYLEUGENOL DATE: 07/20/98
EXPERIMENT: 05187 TEST: 09 TIME: 09:12:12
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B
PATHOLOGIST: MISSING CAS: 93-15-2
------------------------------------------------------------------------------------------------------------------------------------
CORE STUDY
REASONS FOR REMOVAL: 25022 Accidently Killed
25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/KG
INCLUDE 002 0 MG/KG
INCLUDE 003 37 MG/KG
INCLUDE 004 37 MG/KG
INCLUDE 005 75 MG/KG
INCLUDE 006 75 MG/KG
INCLUDE 007 150 MG/KG
INCLUDE 008 150 MG/KG
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus METHYLEUGENOL DATE: 07/20/98
EXPERIMENT: 05187 TEST: 09 TIME: 09:12:12
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B
PATHOLOGIST: MISSING CAS: 93-15-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF METHYLEUGENOL
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia Focal
Adrenal Medulla Hyperplasia Focal
Blood Vessel Mineralization
Blood Vessel: Aorta Mineralization
Bone Fibrous Osteodystrophy
Bone Marrow Hyperplasia
Heart: Myocardium Degeneration
Mineralization
Intestine Large, Rectum Parasite Metazoan
Intestine Small, Duodenum Ulcer
Islets, Pancreatic Hyperplasia
Kidney Inflammation Focal
Nephropathy
Kidney: Renal Tubule Hyperplasia Focal
Hyperplasia Oncocytic
Liver Basophilic Focus
Degeneration Cystic Focal
Eosinophilic Focus
Hepatodiaphragmatic Nodule
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Hyperplasia Atypical Focal
Liver: Centrilobular Degeneration
Liver: Hepatocyte Hypertrophy
Liver: Oval Cell Hyperplasia
Lung: Interstitium Mineralization
Mammary Gland Dilatation
Mesentery: Fat Necrosis
Nose Inflammation
Pancreas: Acinus Atrophy
Pancreas: Artery Inflammation Chronic
Parathyroid Gland Hyperplasia
Pituitary Gland: Pars Distalis Hyperplasia Focal
Preputial Gland Cyst
Prostate Inflammation Chronic
Salivary Glands: Submandibular Gland Cytoplasmic Alteration
Seminal Vesicle Inflammation
Spleen Fibrosis
Hematopoietic Cell Proliferation
Stomach, Forestomach Mineralization
Ulcer
Stomach, Glandular Atrophy
Mineralization
Stomach, Glandular: Neuroendocrine Cell
Hyperplasia
Testes: Interstitial Cell Hyperplasia
Thyroid Gland: C-Cell Hyperplasia
===============================================================
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus METHYLEUGENOL DATE: 07/20/98
EXPERIMENT: 05187 TEST: 09 TIME: 09:12:12
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B
PATHOLOGIST: MISSING CAS: 93-15-2
Female Rats
------------
Organ Morphology
----- ----------
Bone Marrow Hyperplasia
Heart: Myocardium Degeneration
Kidney Nephropathy
Liver Basophilic Focus
Clear Cell Focus
Degeneration Cystic Focal
Eosinophilic Focus
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Hypertrophy
Liver: Oval Cell Hyperplasia
Mammary Gland Hyperplasia Focal
Pituitary Gland Angiectasis
Pituitary Gland: Pars Distalis Hyperplasia Focal
Salivary Glands: Submandibular Gland Cytoplasmic Alteration
Spleen Fibrosis
Hematopoietic Cell Proliferation
Spleen: Red Pulp Necrosis
Stomach, Glandular Atrophy
Stomach, Glandular: Neuroendocrine Cell
Hyperplasia
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 12/50 (24%) 6/50 (12%) 4/50 (8%) |13/50 (26%) 11/50 (22%) 7/50 (14%) 9/49 (18%) |
|POLY-3 ADJUSTED (b)| 30.5% 30.2% 16.0% 12.4% |31.3% 26.7% 16.7% 24.2% |
|TERMINAL (d) | 9/20 (45%) 6/16 (38%) 5/15 (33%) 0/0 (0%) |6/22 (27%) 8/25 (32%) 3/22 (14%) 3/11 (27%) |
|FIRST INCIDENCE | 610 639 659 642 |459 683 637 572 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.445 P=0.456 P=0.171N P=0.275 |P=0.488 P=0.316N P=0.111N P=0.515 |
|POLY 3 | P=0.019N* P=0.584N P=0.099N P=0.055N |P=0.224N P=0.412N P=0.091N P=0.325N |
|POLY 1.5 | P=0.010N* P=0.548N P=0.082N P=0.030N* |P=0.199N P=0.406N P=0.095N P=0.279N |
|POLY 6 | P=0.053N P=0.565 P=0.136N P=0.140N |P=0.275N P=0.427N P=0.089N P=0.423N |
|LOGISTIC REGRESSION| P=0.112N P=0.558 P=0.142N P=0.176N |P=0.259N P=0.362N P=0.089N P=0.306N |
|COCH-ARM / FISHERS | P=0.005N** P=0.500N P=0.062N P=0.016N* |P=0.183N P=0.408N P=0.105N P=0.251N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.6% 0.0% 0.0% |0.0% 4.9% 0.0% 2.8% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 1/25 (4%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 588 650 --- --- |--- 724 --- 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.286N P=0.740 P=0.519N P=0.539N |P=0.415 P=0.268 (e) P=0.457 |
|POLY 3 | P=0.251N P=0.744 P=0.523N P=0.557N |P=0.520 P=0.246 (e) P=0.484 |
|POLY 1.5 | P=0.245N P=0.751 P=0.514N P=0.530N |P=0.530 P=0.243 (e) P=0.492 |
|POLY 6 | P=0.266N P=0.734 P=0.538N P=0.604N |P=0.497 P=0.249 (e) P=0.468 |
|LOGISTIC REGRESSION| P=0.208N P=0.740N P=0.456N P=0.426N |P=0.491 P=0.255 (e) P=0.495 |
|COCH-ARM / FISHERS | P=0.236N P=0.753N P=0.500N P=0.500N |P=0.534 P=0.247 (e) P=0.495 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 20/50 (40%) 21/50 (42%) 21/50 (42%) |4/50 (8%) 9/50 (18%) 4/50 (8%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 36.1% 46.9% 50.8% 54.9% |10.0% 20.6% 9.6% 8.3% |
|TERMINAL (d) | 6/20 (30%) 6/16 (38%) 9/15 (60%) 0/0 (0%) |2/22 (9%) 3/25 (12%) 2/22 (9%) 2/11 (18%) |
|FIRST INCIDENCE | 553 535 521 457 |609 443 627 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.136 P=0.064 P<0.001 ** |P=0.439N P=0.164 P=0.622N P=0.551 |
|POLY 3 | P=0.049 * P=0.204 P=0.117 P=0.059 |P=0.265N P=0.150 P=0.620N P=0.556N |
|POLY 1.5 | P=0.102 P=0.230 P=0.145 P=0.112 |P=0.238N P=0.137 P=0.628N P=0.528N |
|POLY 6 | P=0.011 * P=0.172 P=0.081 P=0.016 * |P=0.319N P=0.165 P=0.614N P=0.609N |
|LOGISTIC REGRESSION| P=0.098 P=0.249 P=0.153 P=0.144 |P=0.222N P=0.101 P=0.622N P=0.581N |
|COCH-ARM / FISHERS | P=0.202 P=0.266 P=0.204 P=0.204 |P=0.223N P=0.117 P=0.643N P=0.511N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Blood Vessel |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 7/50 (14%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 5.1% 7.8% 21.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 662 596 568 568 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.454 P=0.273 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.003 ** P=0.481 P=0.278 P=0.012 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.005 ** P=0.489 P=0.288 P=0.019 * |(e) (e) (e) (e) |
|POLY 6 | P=0.002 ** P=0.469 P=0.262 P=0.005 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.012 * P=0.538 P=0.350 P=0.024 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.009 ** P=0.500 P=0.309 P=0.030 * |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 9/50 (18%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 11.8% 0.0% 23.4% 18.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 2/15 (13%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 626 --- 664 650 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.059N P=0.073 P=0.003 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.070 P=0.038N* P=0.139 P=0.319 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.108 P=0.035N* P=0.159 P=0.403 |(e) (e) (e) (e) |
|POLY 6 | P=0.030 * P=0.044N* P=0.113 P=0.194 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.028 * P=0.037N* P=0.130 P=0.193 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.169 P=0.028N* P=0.194 P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 2/50 (4%) 12/50 (24%) 14/50 (28%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 18.7% 5.1% 30.5% 39.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/16 (0%) 3/15 (20%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 626 596 568 568 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.100N P=0.086 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.002 ** P=0.060N P=0.159 P=0.030 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.005 ** P=0.053N P=0.183 P=0.059 |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.072N P=0.125 P=0.008 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.002 ** P=0.050N P=0.171 P=0.028 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.013 * P=0.046N* P=0.227 P=0.114 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone |
| Hyperostosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 5/50 (10%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.5% 2.4% 11.5% 10.6% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- --- --- |555 673 515 553 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.052 P=0.748N P=0.129 P=0.153 |
|POLY 3 | (e) (e) (e) (e) |P=0.062 P=0.754N P=0.121 P=0.162 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.071 P=0.756N P=0.113 P=0.173 |
|POLY 6 | (e) (e) (e) (e) |P=0.049 * P=0.752N P=0.131 P=0.142 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.079 P=0.746 P=0.073 P=0.166 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.078 P=0.753N P=0.102 P=0.181 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 5.2% 0.0% 0.0% |0.0% 2.5% 4.8% 0.0% |
|TERMINAL (d) | 0/20 (0%) 1/16 (6%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 1/25 (4%) 2/22 (9%) 0/11 (0%) |
|FIRST INCIDENCE | 521 673 --- --- |--- 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.342N P=0.458 P=0.513N P=0.521N |P=0.543 P=0.525 P=0.237 (e) |
|POLY 3 | P=0.227N P=0.472 P=0.524N P=0.558N |P=0.640 P=0.508 P=0.249 (e) |
|POLY 1.5 | P=0.209N P=0.484 P=0.514N P=0.530N |P=0.630N P=0.505 P=0.245 (e) |
|POLY 6 | P=0.265N P=0.455 P=0.539N P=0.605N |P=0.581 P=0.511 P=0.253 (e) |
|LOGISTIC REGRESSION| P=0.174N P=0.523 P=0.413N P=0.386N |(e) P=0.525 P=0.237 (e) |
|COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.616N P=0.500 P=0.247 (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 2/49 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 7.1% 0.0% 5.3% 0.0% |5.1% 0.0% 4.9% 5.5% |
|TERMINAL (d) | 1/20 (5%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |1/22 (5%) 0/25 (0%) 1/22 (5%) 1/11 (9%) |
|FIRST INCIDENCE | 521 --- 610 --- |641 --- 613 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.273N P=0.157N P=0.579N P=0.521N |P=0.280 P=0.226N P=0.681N P=0.508 |
|POLY 3 | P=0.159N P=0.134N P=0.545N P=0.181N |P=0.405 P=0.230N P=0.680N P=0.665 |
|POLY 1.5 | P=0.141N P=0.127N P=0.528N P=0.148N |P=0.426 P=0.232N P=0.688N P=0.683 |
|POLY 6 | P=0.199N P=0.144N P=0.572N P=0.250N |P=0.372 P=0.228N P=0.671N P=0.629 |
|LOGISTIC REGRESSION| P=0.115N P=0.115N P=0.477N P=0.123N |P=0.414 P=0.231N P=0.695N P=0.640 |
|COCH-ARM / FISHERS | P=0.125N P=0.121N P=0.500N P=0.121N |P=0.444 P=0.247N P=0.684 P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 14/50 (28%) 22/50 (44%) 23/50 (46%) |4/50 (8%) 15/50 (30%) 11/49 (22%) 20/50 (40%) |
|POLY-3 ADJUSTED (b)| 41.4% 33.7% 53.6% 56.2% |10.1% 34.0% 26.8% 49.6% |
|TERMINAL (d) | 10/20 (50%) 7/16 (44%) 10/15 (67%) 0/0 (0%) |3/22 (14%) 8/25 (32%) 8/22 (36%) 8/11 (73%) |
|FIRST INCIDENCE | 564 406 522 409 |549 347 676 508 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.490N P=0.065 P<0.001 ** |P<0.001 ** P=0.013 * P=0.048 * P<0.001 ** |
|POLY 3 | P=0.035 * P=0.304N P=0.174 P=0.115 |P<0.001 ** P=0.007 ** P=0.046 * P<0.001 ** |
|POLY 1.5 | P=0.053 P=0.282N P=0.206 P=0.156 |P<0.001 ** P=0.006 ** P=0.044 * P<0.001 ** |
|POLY 6 | P=0.015 * P=0.347N P=0.131 P=0.059 |P<0.001 ** P=0.009 ** P=0.049 * P<0.001 ** |
|LOGISTIC REGRESSION| P=0.045 * P=0.302N P=0.150 P=0.234 |P<0.001 ** P=0.005 ** P=0.058 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.081 P=0.260N P=0.270 P=0.208 |P<0.001 ** P=0.005 ** P=0.041 * P<0.001 ** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 2/25 (8%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.539N P=0.266 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.406N P=0.245 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.404N P=0.243 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.412N P=0.248 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.266 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.406N P=0.247 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.1% 5.3% 3.2% |0.0% 2.4% 0.0% 5.4% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- 575 661 659 |--- 637 --- 589 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.188 P=0.219 P=0.164 P=0.367 |P=0.102 P=0.505 (e) P=0.194 |
|POLY 3 | P=0.324 P=0.225 P=0.216 P=0.446 |P=0.132 P=0.509 (e) P=0.223 |
|POLY 1.5 | P=0.392 P=0.230 P=0.224 P=0.472 |P=0.137 P=0.506 (e) P=0.232 |
|POLY 6 | P=0.216 P=0.218 P=0.204 P=0.402 |P=0.124 P=0.514 (e) P=0.206 |
|LOGISTIC REGRESSION| P=0.448 P=0.257 P=0.216 P=0.472 |P=0.145 P=0.491 (e) P=0.240 |
|COCH-ARM / FISHERS | P=0.469 P=0.247 P=0.247 P=0.500 |P=0.140 P=0.500 (e) P=0.247 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow: Myeloid Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.5% 4.8% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- --- --- |641 606 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.213N P=0.522 P=0.495N P=0.550N |
|POLY 3 | (e) (e) (e) (e) |P=0.192N P=0.517 P=0.494N P=0.518N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.190N P=0.511 P=0.497N P=0.507N |
|POLY 6 | (e) (e) (e) (e) |P=0.196N P=0.524 P=0.490N P=0.538N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.190N P=0.481 P=0.514N P=0.498N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.189N P=0.500 P=0.505N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Brain |
| Hydrocephalus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |4/50 (8%) 9/50 (18%) 3/50 (6%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 4.8% 7.6% 7.9% 3.1% |10.1% 21.8% 7.1% 20.9% |
|TERMINAL (d) | 1/20 (5%) 1/16 (6%) 2/15 (13%) 0/0 (0%) |1/22 (5%) 7/25 (28%) 0/22 (0%) 1/11 (9%) |
|FIRST INCIDENCE | 668 572 601 523 |597 637 557 541 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.452 P=0.442 P=0.390 P=0.643 |P=0.078 P=0.166 P=0.463N P=0.066 |
|POLY 3 | P=0.475N P=0.476 P=0.456 P=0.592N |P=0.255 P=0.125 P=0.466N P=0.154 |
|POLY 1.5 | P=0.411N P=0.487 P=0.473 P=0.548N |P=0.271 P=0.123 P=0.479N P=0.169 |
|POLY 6 | P=0.540 P=0.462 P=0.426 P=0.667N |P=0.226 P=0.126 P=0.452N P=0.125 |
|LOGISTIC REGRESSION| P=0.348N P=0.513 P=0.445 P=0.481N |P=0.245 P=0.134 P=0.500N P=0.167 |
|COCH-ARM / FISHERS | P=0.343N P=0.500 P=0.500 P=0.500N |P=0.278 P=0.117 P=0.500N P=0.178 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Brain |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.1% 2.7% 3.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- 650 658 684 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.255 P=0.220 P=0.469 P=0.202 |(e) (e) (e) (e) |
|POLY 3 | P=0.375 P=0.224 P=0.481 P=0.446 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.434 P=0.229 P=0.488 P=0.472 |(e) (e) (e) (e) |
|POLY 6 | P=0.279 P=0.217 P=0.469 P=0.401 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.454 P=0.240 P=0.502 P=0.384 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500 P=0.247 P=0.500 P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Brain: Hypothalamus |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |9/50 (18%) 12/50 (24%) 6/50 (12%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 2.6% 0.0% |22.4% 28.5% 14.0% 18.5% |
|TERMINAL (d) | 0/20 (0%) 1/16 (6%) 0/15 (0%) 0/0 (0%) |6/22 (27%) 8/25 (32%) 1/22 (5%) 1/11 (9%) |
|FIRST INCIDENCE | --- 730 (T) 601 --- |597 609 541 541 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.624 P=0.455 P=0.476 (e) |P=0.546 P=0.415 P=0.269N P=0.442 |
|POLY 3 | P=0.648 P=0.486 P=0.482 (e) |P=0.233N P=0.352 P=0.236N P=0.443N |
|POLY 1.5 | P=0.633N P=0.492 P=0.489 (e) |P=0.213N P=0.338 P=0.256N P=0.410N |
|POLY 6 | P=0.530 P=0.477 P=0.470 (e) |P=0.273N P=0.372 P=0.215N P=0.510N |
|LOGISTIC REGRESSION| P=0.630N P=0.455 P=0.536 (e) |P=0.240N P=0.349 P=0.270N P=0.476N |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.204N P=0.312 P=0.288N P=0.393N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/48 (4%) 1/46 (2%) 2/49 (4%) 1/46 (2%) |
|POLY-3 ADJUSTED (b)| |5.2% 2.7% 4.8% 3.0% |
|TERMINAL (d) | |0/21 (0%) 1/22 (5%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | |597 730 (T) 557 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.555N P=0.492N P=0.679N P=0.579N |
|POLY 3 | |P=0.479N P=0.515N P=0.670N P=0.547N |
|POLY 1.5 | |P=0.465N P=0.514N P=0.676N P=0.528N |
|POLY 6 | |P=0.501N P=0.518N P=0.663N P=0.579N |
|LOGISTIC REGRESSION| |P=0.448N P=0.513N P=0.689 P=0.509N |
|COCH-ARM / FISHERS | |P=0.454N P=0.516N P=0.684N P=0.516N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/48 (4%) 3/46 (7%) 1/49 (2%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| |5.3% 8.1% 2.5% 0.0% |
|TERMINAL (d) | |1/21 (5%) 3/22 (14%) 1/22 (5%) 0/11 (0%) |
|FIRST INCIDENCE | |717 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.190N P=0.527 P=0.485N P=0.374N |
|POLY 3 | |P=0.117N P=0.486 P=0.476N P=0.267N |
|POLY 1.5 | |P=0.111N P=0.485 P=0.483N P=0.255N |
|POLY 6 | |P=0.128N P=0.487 P=0.469N P=0.290N |
|LOGISTIC REGRESSION| |P=0.167N P=0.503 P=0.464N P=0.340N |
|COCH-ARM / FISHERS | |P=0.107N P=0.480 P=0.492N P=0.258N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 4/50 (8%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 1/49 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 14.1% 12.7% 10.5% 6.2% |0.0% 4.8% 2.5% 0.0% |
|TERMINAL (d) | 1/20 (5%) 1/16 (6%) 1/15 (7%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 553 575 596 502 |--- 520 712 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.542 P=0.614 P=0.561N P=0.660N |P=0.546N P=0.258 P=0.523 (e) |
|POLY 3 | P=0.175N P=0.556N P=0.443N P=0.241N |P=0.483N P=0.249 P=0.508 (e) |
|POLY 1.5 | P=0.131N P=0.531N P=0.414N P=0.184N |P=0.471N P=0.245 P=0.503 (e) |
|POLY 6 | P=0.273N P=0.589N P=0.492N P=0.366N |P=0.507N P=0.254 P=0.513 (e) |
|LOGISTIC REGRESSION| P=0.113N P=0.508N P=0.393N P=0.110N |P=0.465N P=0.220 P=0.513 (e) |
|COCH-ARM / FISHERS | P=0.092N P=0.500N P=0.370N P=0.134N |P=0.467N P=0.247 P=0.495 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 41/50 (82%) 34/50 (68%) 37/50 (74%) |35/50 (70%) 30/50 (60%) 26/49 (53%) 20/49 (41%) |
|POLY-3 ADJUSTED (b)| 92.7% 85.4% 72.4% 81.0% |77.5% 68.9% 59.3% 49.8% |
|TERMINAL (d) | 19/20 (95%) 14/16 (88%) 9/15 (60%) 0/0 (0%) |16/22 (73%) 20/25 (80%) 15/22 (68%) 7/11 (64%) |
|FIRST INCIDENCE | 521 403 438 409 |459 450 515 508 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.367 P=0.469N P<0.001 ** |P=0.333N P=0.121N P=0.074N P=0.331N |
|POLY 3 | P=0.047N* P=0.187N P=0.005N** P=0.059N |P=0.002N** P=0.234N P=0.043N* P=0.003N** |
|POLY 1.5 | P=0.033N* P=0.175N P=0.006N** P=0.040N* |P<0.001N** P=0.201N P=0.045N* P=0.002N** |
|POLY 6 | P=0.093N P=0.228N P=0.007N** P=0.131N |P=0.006N** P=0.316N P=0.049N* P=0.012N* |
|LOGISTIC REGRESSION| P=0.029N* P=0.219N P=0.009N** P=0.062N |P=0.003N** P=0.127N P=0.035N* P=0.004N** |
|COCH-ARM / FISHERS | P=0.026N* P=0.194N P=0.006N** P=0.033N* |P=0.002N** P=0.201N P=0.063N P=0.003N** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 11/50 (22%) 9/50 (18%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 11.8% 5.1% 27.8% 26.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 2/15 (13%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 626 596 568 598 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.316N P=0.031 * P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.013 * P=0.247N P=0.059 P=0.084 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.024 * P=0.233N P=0.067 P=0.128 |(e) (e) (e) (e) |
|POLY 6 | P=0.004 ** P=0.268N P=0.048 * P=0.037 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.018 * P=0.223N P=0.068 P=0.069 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.050 P=0.218N P=0.086 P=0.194 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 5/50 (10%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 5.1% 12.6% 3.1% |2.5% 0.0% 0.0% 2.8% |
|TERMINAL (d) | 1/20 (5%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 1/11 (9%) |
|FIRST INCIDENCE | 730 (T) 638 502 568 |719 --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.322 P=0.445 P=0.081 P=0.481 |P=0.476 P=0.484N P=0.500N P=0.618 |
|POLY 3 | P=0.372 P=0.480 P=0.090 P=0.698 |P=0.579 P=0.492N P=0.490N P=0.743 |
|POLY 1.5 | P=0.468 P=0.488 P=0.094 P=0.730 |P=0.587 P=0.495N P=0.493N P=0.754 |
|POLY 6 | P=0.221 P=0.469 P=0.083 P=0.637 |P=0.568 P=0.490N P=0.486N P=0.721 |
|LOGISTIC REGRESSION| P=0.534N P=0.485 P=0.135 P=0.774 |P=0.515 P=0.487N P=0.484N P=0.664 |
|COCH-ARM / FISHERS | P=0.569 P=0.500 P=0.102 P=0.753N |P=0.595 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 3/49 (6%) 5/49 (10%) 4/50 (8%) |2/50 (4%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 7.7% 13.0% 12.1% |5.0% 9.8% 4.7% 5.4% |
|TERMINAL (d) | 1/20 (5%) 1/16 (6%) 2/15 (13%) 0/0 (0%) |1/22 (5%) 4/25 (16%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 730 (T) 403 521 502 |619 730 (T) 541 548 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * P=0.246 P=0.071 P=0.030 * |P=0.549 P=0.388 P=0.665N P=0.605 |
|POLY 3 | P=0.079 P=0.291 P=0.087 P=0.121 |P=0.480N P=0.350 P=0.672N P=0.672 |
|POLY 1.5 | P=0.113 P=0.298 P=0.092 P=0.150 |P=0.465N P=0.347 P=0.680N P=0.686 |
|POLY 6 | P=0.039 * P=0.280 P=0.079 P=0.081 |P=0.508N P=0.352 P=0.664N P=0.643 |
|LOGISTIC REGRESSION| P=0.210 P=0.323 P=0.110 P=0.223 |P=0.458N P=0.362 P=0.680 P=0.692N |
|COCH-ARM / FISHERS | P=0.162 P=0.309 P=0.102 P=0.187 |P=0.456N P=0.339 P=0.691N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 2.6% 0.0% 0.0% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 722 680 --- --- |--- 520 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.159N P=0.397N P=0.193N P=1.000 |P=0.562N P=0.509 (e) (e) |
|POLY 3 | P=0.046N* P=0.329N P=0.138N P=0.177N |P=0.559N P=0.511 (e) (e) |
|POLY 1.5 | P=0.045N* P=0.319N P=0.130N P=0.146N |P=0.562N P=0.507 (e) (e) |
|POLY 6 | P=0.048N* P=0.344N P=0.151N P=0.244N |P=0.553N P=0.515 (e) (e) |
|LOGISTIC REGRESSION| P=0.103N P=0.365N P=0.199N P=0.961N |P=0.621N P=0.437 (e) (e) |
|COCH-ARM / FISHERS | P=0.044N* P=0.309N P=0.121N P=0.121N |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.2% 2.6% 0.0% |2.5% 0.0% 0.0% 2.8% |
|TERMINAL (d) | 0/20 (0%) 2/16 (13%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 1/11 (9%) |
|FIRST INCIDENCE | --- 589 568 --- |616 --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.580N P=0.047 * P=0.496 (e) |P=0.515 P=0.495N P=0.485N P=0.664 |
|POLY 3 | P=0.416N P=0.053 P=0.482 (e) |P=0.579 P=0.494N P=0.492N P=0.741 |
|POLY 1.5 | P=0.356N P=0.056 P=0.489 (e) |P=0.587 P=0.496N P=0.494N P=0.753 |
|POLY 6 | P=0.534N P=0.049 * P=0.471 (e) |P=0.567 P=0.493N P=0.489N P=0.717 |
|LOGISTIC REGRESSION| P=0.304N P=0.058 P=0.556 (e) |P=0.591 P=0.517N P=0.518N P=0.754 |
|COCH-ARM / FISHERS | P=0.296N P=0.059 P=0.500 (e) |P=0.595 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.3% 0.0% |0.0% 4.8% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 1/25 (4%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- 664 --- |--- 450 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.293 (e) P=0.165 (e) |P=0.460N P=0.256 (e) (e) |
|POLY 3 | P=0.443 (e) P=0.216 (e) |P=0.406N P=0.250 (e) (e) |
|POLY 1.5 | P=0.520 (e) P=0.224 (e) |P=0.404N P=0.246 (e) (e) |
|POLY 6 | P=0.307 (e) P=0.204 (e) |P=0.411N P=0.254 (e) (e) |
|LOGISTIC REGRESSION| P=0.516 (e) P=0.216 (e) |P=0.429N P=0.204 (e) (e) |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.409N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 3/50 (6%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 7.2% 2.4% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 1/22 (5%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 520 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.449N P=0.136 P=0.500 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.386N P=0.130 P=0.510 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.374N P=0.126 P=0.507 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.412N P=0.136 P=0.514 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.370N P=0.106 P=0.500 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.372N P=0.121 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 2.7% 6.3% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- 650 712 575 |--- --- 690 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032 * P=0.483 P=0.388 P=0.129 |P=0.662 (e) P=0.520 (e) |
|POLY 3 | P=0.104 P=0.487 P=0.480 P=0.184 |P=0.652 (e) P=0.511 (e) |
|POLY 1.5 | P=0.126 P=0.493 P=0.488 P=0.208 |P=0.676 (e) P=0.507 (e) |
|POLY 6 | P=0.074 P=0.480 P=0.467 P=0.148 |P=0.603 (e) P=0.516 (e) |
|LOGISTIC REGRESSION| P=0.142 P=0.509 P=0.449 P=0.268 |P=0.687 (e) P=0.508 (e) |
|COCH-ARM / FISHERS | P=0.153 P=0.500 P=0.500 P=0.247 |P=0.692 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 46/50 (92%) 48/50 (96%) 50/50 (100%)|35/50 (70%) 42/50 (84%) 41/50 (82%) 44/49 (90%) |
|POLY-3 ADJUSTED (b)| 99.8% 95.8% 98.5% 100.0% |80.5% 90.4% 87.7% 94.3% |
|TERMINAL (d) | 20/20 (100%) 16/16 (100%) 15/15 (100%) 0/0 (0%) |22/22 (100%) 25/25 (100%) 22/22 (100%) 11/11 (100%) |
|FIRST INCIDENCE | 521 403 438 337 |459 347 444 508 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.268 P=0.095 P<0.001 ** |P<0.001 ** P=0.349 P=0.244 P<0.001 ** |
|POLY 3 | P=0.387 P=0.192N P=0.707N P=1.000 |P=0.029 * P=0.112 P=0.229 P=0.022 * |
|POLY 1.5 | P=0.277 P=0.155N P=0.699N P=0.981 |P=0.023 * P=0.099 P=0.174 P=0.017 * |
|POLY 6 | P=0.558 P=0.374N P=0.841N P=1.000 |P=0.044 * P=0.133 P=0.330 P=0.033 * |
|LOGISTIC REGRESSION| P=0.066 P=0.255N P=0.773N P=0.431 |P=0.009 ** P=0.102 P=0.192 P=0.006 ** |
|COCH-ARM / FISHERS | P=0.199 P=0.181N P=0.500N P=0.500 |P=0.016 * P=0.077 P=0.121 P=0.013 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 1/16 (6%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- 725 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.752 P=0.193 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.464N P=0.221 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.437N P=0.228 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.516N P=0.211 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.746 P=0.180 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 7/50 (14%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 11.9% 2.6% 18.6% 12.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/20 (10%) 1/16 (6%) 5/15 (33%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 642 730 (T) 673 646 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.158N P=0.195 P=0.064 |(e) (e) (e) (e) |
|POLY 3 | P=0.312 P=0.121N P=0.301 P=0.611 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.392 P=0.112N P=0.332 P=0.587N |(e) (e) (e) (e) |
|POLY 6 | P=0.193 P=0.136N P=0.251 P=0.471 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.103 P=0.125N P=0.235 P=0.508 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.483 P=0.102N P=0.380 P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia Oncocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 6.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- --- 642 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.019 * (e) (e) P=0.132 |(e) (e) (e) (e) |
|POLY 3 | P=0.037 * (e) (e) P=0.183 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.041 * (e) (e) P=0.208 |(e) (e) (e) (e) |
|POLY 6 | P=0.034 * (e) (e) P=0.147 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.041 * (e) (e) P=0.209 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation Lipofuscin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 4/50 (8%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.5% 2.4% 9.3% 8.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- --- --- |569 569 515 534 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.143 P=0.751N P=0.212 P=0.304 |
|POLY 3 | (e) (e) (e) (e) |P=0.139 P=0.752N P=0.202 P=0.285 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.151 P=0.755N P=0.193 P=0.295 |
|POLY 6 | (e) (e) (e) (e) |P=0.116 P=0.750N P=0.213 P=0.262 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.123 P=0.728 P=0.137 P=0.209 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.157 P=0.753N P=0.181 P=0.301 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 21/50 (42%) 22/50 (44%) 7/50 (14%) |36/50 (72%) 36/50 (72%) 29/49 (59%) 17/49 (35%) |
|POLY-3 ADJUSTED (b)| 52.4% 47.5% 52.6% 20.3% |80.9% 78.1% 66.5% 41.8% |
|TERMINAL (d) | 14/20 (70%) 9/16 (56%) 11/15 (73%) 0/0 (0%) |21/22 (96%) 23/25 (92%) 20/22 (91%) 5/11 (46%) |
|FIRST INCIDENCE | 564 403 467 337 |241 347 444 483 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.359 P=0.443 P=0.247 P=0.277 |P=0.079N P=0.321N P=0.097N P=0.120N |
|POLY 3 | P=0.005N** P=0.398N P=0.583 P=0.002N** |P<0.001N** P=0.465N P=0.076N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.402N P=0.560N P<0.001N** |P<0.001N** P=0.519N P=0.100N P<0.001N** |
|POLY 6 | P=0.036N* P=0.408N P=0.520 P=0.013N* |P<0.001N** P=0.393N P=0.052N P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.438N P=0.526 P=0.003N** |P<0.001N** P=0.523N P=0.071N P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.420N P=0.500N P<0.001N** |P<0.001N** P=0.588N P=0.129N P<0.001N** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 7/50 (14%) 3/50 (6%) |3/50 (6%) 10/50 (20%) 12/49 (24%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 9.5% 7.5% 18.0% 9.2% |7.5% 23.6% 29.3% 10.5% |
|TERMINAL (d) | 1/20 (5%) 0/16 (0%) 2/15 (13%) 0/0 (0%) |1/22 (5%) 7/25 (28%) 9/22 (41%) 0/11 (0%) |
|FIRST INCIDENCE | 610 579 595 583 |549 347 690 508 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.166 P=0.589N P=0.140 P=0.246 |P=0.229 P=0.060 P=0.015 * P=0.426 |
|POLY 3 | P=0.422 P=0.526N P=0.214 P=0.635N |P=0.526 P=0.041 * P=0.010 * P=0.472 |
|POLY 1.5 | P=0.516 P=0.515N P=0.231 P=0.571N |P=0.547N P=0.039 * P=0.010 * P=0.486 |
|POLY 6 | P=0.269 P=0.542N P=0.189 P=0.559 |P=0.442 P=0.042 * P=0.010 * P=0.438 |
|LOGISTIC REGRESSION| P=0.509N P=0.469N P=0.225 P=0.515N |P=0.551N P=0.037 * P=0.015 * P=0.454 |
|COCH-ARM / FISHERS | P=0.517N P=0.500N P=0.262 P=0.500N |P=0.533N P=0.036 * P=0.010 * P=0.489 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 25/50 (50%) 38/50 (76%) |0/50 (0%) 0/50 (0%) 1/49 (2%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 9.5% 5.1% 59.1% 84.5% |0.0% 0.0% 2.5% 10.8% |
|TERMINAL (d) | 0/20 (0%) 1/16 (6%) 8/15 (53%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 626 650 502 409 |--- --- 717 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.421N P<0.001 ** P<0.001 ** |P=0.002 ** (e) P=0.508 P=0.039 * |
|POLY 3 | P<0.001 ** P=0.375N P<0.001 ** P<0.001 ** |P=0.004 ** (e) P=0.508 P=0.052 |
|POLY 1.5 | P<0.001 ** P=0.358N P<0.001 ** P<0.001 ** |P=0.005 ** (e) P=0.503 P=0.056 |
|POLY 6 | P<0.001 ** P=0.400N P<0.001 ** P<0.001 ** |P=0.004 ** (e) P=0.513 P=0.045 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.357N P<0.001 ** P<0.001 ** |P=0.005 ** (e) P=0.514 P=0.060 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.339N P<0.001 ** P<0.001 ** |P=0.005 ** (e) P=0.495 P=0.056 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 28/50 (56%) 43/50 (86%) 47/50 (94%) |10/50 (20%) 20/50 (40%) 27/49 (55%) 31/49 (63%) |
|POLY-3 ADJUSTED (b)| 26.4% 62.9% 92.8% 96.6% |25.1% 47.9% 62.8% 71.2% |
|TERMINAL (d) | 7/20 (35%) 11/16 (69%) 15/15 (100%) 0/0 (0%) |6/22 (27%) 16/25 (64%) 18/22 (82%) 6/11 (55%) |
|FIRST INCIDENCE | 704 406 467 337 |679 618 444 508 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.049 * P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.023 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.024 * P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.027 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.024 * P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |7/50 (14%) 2/50 (4%) 6/49 (12%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 9.4% 2.6% 0.0% 0.0% |17.0% 4.8% 14.2% 5.4% |
|TERMINAL (d) | 0/20 (0%) 1/16 (6%) 0/15 (0%) 0/0 (0%) |2/22 (9%) 1/25 (4%) 2/22 (9%) 0/11 (0%) |
|FIRST INCIDENCE | 614 730 (T) --- --- |459 450 541 508 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043N* P=0.229N P=0.085N P=0.142N |P=0.226N P=0.076N P=0.474N P=0.164N |
|POLY 3 | P=0.020N* P=0.211N P=0.079N P=0.111N |P=0.157N P=0.074N P=0.479N P=0.104N |
|POLY 1.5 | P=0.019N* P=0.196N P=0.071N P=0.083N |P=0.141N P=0.075N P=0.492N P=0.091N |
|POLY 6 | P=0.023N* P=0.235N P=0.095N P=0.179N |P=0.189N P=0.076N P=0.466N P=0.134N |
|LOGISTIC REGRESSION| P=0.017N* P=0.166N P=0.049N* P=0.041N* |P=0.131N P=0.092N P=0.546N P=0.085N |
|COCH-ARM / FISHERS | P=0.019N* P=0.181N P=0.059N P=0.059N |P=0.131N P=0.080N P=0.516N P=0.085N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 7/50 (14%) 14/50 (28%) 8/50 (16%) |6/50 (12%) 4/50 (8%) 19/49 (39%) 9/49 (18%) |
|POLY-3 ADJUSTED (b)| 2.4% 17.2% 34.1% 22.2% |15.1% 9.6% 44.0% 23.3% |
|TERMINAL (d) | 1/20 (5%) 3/16 (19%) 5/15 (33%) 0/0 (0%) |2/22 (9%) 2/25 (8%) 12/22 (55%) 3/11 (27%) |
|FIRST INCIDENCE | 730 (T) 535 438 337 |683 564 444 527 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.022 * P<0.001 ** P=0.003 ** |P=0.007 ** P=0.316N P=0.005 ** P=0.096 |
|POLY 3 | P=0.008 ** P=0.027 * P<0.001 ** P=0.007 ** |P=0.062 P=0.337N P=0.003 ** P=0.263 |
|POLY 1.5 | P=0.017 * P=0.028 * P<0.001 ** P=0.011 * |P=0.075 P=0.348N P=0.002 ** P=0.276 |
|POLY 6 | P=0.002 ** P=0.025 * P<0.001 ** P=0.003 ** |P=0.040 * P=0.324N P=0.004 ** P=0.229 |
|LOGISTIC REGRESSION| P=0.082 P=0.036 * P<0.001 ** P=0.081 |P=0.076 P=0.345N P=0.003 ** P=0.256 |
|COCH-ARM / FISHERS | P=0.035 * P=0.030 * P<0.001 ** P=0.015 * |P=0.090 P=0.370N P=0.002 ** P=0.274 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 5/50 (10%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 1/49 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 5.1% 12.9% 9.2% |0.0% 2.5% 2.5% 0.0% |
|TERMINAL (d) | 2/20 (10%) 0/16 (0%) 1/15 (7%) 0/0 (0%) |0/22 (0%) 1/25 (4%) 1/22 (5%) 0/11 (0%) |
|FIRST INCIDENCE | 730 (T) 650 595 546 |--- 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.052 P=0.636 P=0.138 P=0.063 |P=0.678 P=0.525 P=0.500 (e) |
|POLY 3 | P=0.211 P=0.674 P=0.188 P=0.392 |P=0.615N P=0.508 P=0.507 (e) |
|POLY 1.5 | P=0.271 P=0.682 P=0.198 P=0.444 |P=0.604N P=0.505 P=0.503 (e) |
|POLY 6 | P=0.126 P=0.663 P=0.172 P=0.306 |P=0.634N P=0.511 P=0.512 (e) |
|LOGISTIC REGRESSION| P=0.344 P=0.668 P=0.202 P=0.508 |(e) P=0.525 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.344 P=0.691N P=0.218 P=0.500 |P=0.600N P=0.500 P=0.495 (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 17/50 (34%) 16/50 (32%) 17/50 (34%) |11/50 (22%) 11/50 (22%) 17/49 (35%) 22/49 (45%) |
|POLY-3 ADJUSTED (b)| 77.0% 40.8% 39.3% 46.4% |27.0% 26.2% 39.4% 54.3% |
|TERMINAL (d) | 16/20 (80%) 6/16 (38%) 6/15 (40%) 0/0 (0%) |6/22 (27%) 7/25 (28%) 8/22 (36%) 9/11 (82%) |
|FIRST INCIDENCE | 521 575 572 583 |569 609 444 508 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.135 P=0.020N* P=0.024N* P=0.014 * |P<0.001 ** P=0.491N P=0.180 P<0.001 ** |
|POLY 3 | P=0.002N** P<0.001N** P<0.001N** P<0.001N** |P=0.002 ** P=0.568N P=0.160 P=0.008 ** |
|POLY 1.5 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |P=0.002 ** P=0.575N P=0.143 P=0.010 * |
|POLY 6 | P=0.008N** P<0.001N** P<0.001N** P=0.013N* |P<0.001 ** P=0.565N P=0.180 P=0.004 ** |
|LOGISTIC REGRESSION| P=0.008N** P<0.001N** P<0.001N** P=0.004N** |P=0.002 ** P=0.557N P=0.143 P=0.008 ** |
|COCH-ARM / FISHERS | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |P=0.003 ** P=0.595N P=0.119 P=0.013 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia Atypical Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 6.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- 438 502 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047 * (e) P=0.500 P=0.155 |(e) (e) (e) (e) |
|POLY 3 | P=0.048 * (e) P=0.483 P=0.185 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.058 (e) P=0.490 P=0.209 |(e) (e) (e) (e) |
|POLY 6 | P=0.036 * (e) P=0.472 P=0.149 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.099 (e) P=0.645 P=0.321 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.070 (e) P=0.500 P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 14.1% 2.6% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 553 703 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.022N* P=0.105N P=0.043N* P=0.268N |(e) (e) (e) (e) |
|POLY 3 | P=0.003N** P=0.071N P=0.023N* P=0.039N* |(e) (e) (e) (e) |
|POLY 1.5 | P=0.003N** P=0.064N P=0.019N* P=0.025N* |(e) (e) (e) (e) |
|POLY 6 | P=0.004N** P=0.083N P=0.029N* P=0.083N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.005N** P=0.063N P=0.019N* P=0.027N* |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.004N** P=0.056N P=0.013N* P=0.013N* |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration Fatty |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 3/50 (6%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 2.6% 0.0% |0.0% 7.2% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 626 --- 596 --- |--- 606 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.233N P=0.264N P=0.533N P=0.321N |P=0.343N P=0.140 (e) (e) |
|POLY 3 | P=0.208N P=0.257N P=0.538N P=0.309N |P=0.313N P=0.130 (e) (e) |
|POLY 1.5 | P=0.198N P=0.248N P=0.523N P=0.273N |P=0.311N P=0.126 (e) (e) |
|POLY 6 | P=0.232N P=0.271N P=0.563N P=0.380N |P=0.322N P=0.137 (e) (e) |
|LOGISTIC REGRESSION| P=0.160N P=0.217N P=0.457N P=0.199N |P=0.322N P=0.106 (e) (e) |
|COCH-ARM / FISHERS | P=0.188N P=0.247N P=0.500N P=0.247N |P=0.317N P=0.121 (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/49 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 10.1% 0.0% 3.2% |0.0% 0.0% 2.5% 2.8% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 1/11 (9%) |
|FIRST INCIDENCE | 715 575 --- 575 |--- --- 712 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.621 P=0.136 P=0.610N P=0.477 |P=0.126 (e) P=0.523 P=0.362 |
|POLY 3 | P=0.418N P=0.165 P=0.521N P=0.698 |P=0.208 (e) P=0.508 P=0.482 |
|POLY 1.5 | P=0.379N P=0.171 P=0.513N P=0.729 |P=0.222 (e) P=0.503 P=0.491 |
|POLY 6 | P=0.482N P=0.158 P=0.535N P=0.636 |P=0.183 (e) P=0.513 P=0.465 |
|LOGISTIC REGRESSION| P=0.318N P=0.188 P=0.556N P=0.777N |P=0.161 (e) P=0.513 P=0.362 |
|COCH-ARM / FISHERS | P=0.337N P=0.181 P=0.500N P=0.753N |P=0.232 (e) P=0.495 P=0.495 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 13/50 (26%) 25/50 (50%) 30/50 (60%) |1/50 (2%) 13/50 (26%) 16/49 (33%) 26/49 (53%) |
|POLY-3 ADJUSTED (b)| 0.0% 30.1% 58.8% 70.4% |2.5% 30.6% 37.9% 61.1% |
|TERMINAL (d) | 0/20 (0%) 4/16 (25%) 14/15 (93%) 0/0 (0%) |1/22 (5%) 10/25 (40%) 12/22 (55%) 7/11 (64%) |
|FIRST INCIDENCE | --- 403 438 337 |730 (T) 347 444 483 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 17/50 (34%) 24/50 (48%) 34/50 (68%) |1/50 (2%) 15/50 (30%) 19/49 (39%) 35/49 (71%) |
|POLY-3 ADJUSTED (b)| 31.5% 38.1% 52.9% 76.1% |2.5% 36.0% 44.3% 77.7% |
|TERMINAL (d) | 5/20 (25%) 2/16 (13%) 6/15 (40%) 0/0 (0%) |1/22 (5%) 14/25 (56%) 12/22 (55%) 10/11 (91%) |
|FIRST INCIDENCE | 521 431 438 337 |730 (T) 347 444 483 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.217 P=0.017 * P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.333 P=0.028 * P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.332 P=0.027 * P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.340 P=0.029 * P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.427 P=0.051 P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.333 P=0.032 * P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 7.6% 5.2% 3.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 639 542 568 699 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.444 P=0.264 P=0.467 P=0.512 |(e) (e) (e) (e) |
|POLY 3 | P=0.574 P=0.284 P=0.468 P=0.693 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.541N P=0.294 P=0.480 P=0.727 |(e) (e) (e) (e) |
|POLY 6 | P=0.443 P=0.272 P=0.448 P=0.627 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.451N P=0.329 P=0.542 P=0.727 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.474N P=0.309 P=0.500 P=0.753N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/49 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.5% 0.0% 4.9% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- --- --- |700 --- 690 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.552N P=0.493N P=0.531 P=0.577N |
|POLY 3 | (e) (e) (e) (e) |P=0.496N P=0.493N P=0.515 P=0.518N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.479N P=0.495N P=0.506 P=0.509N |
|POLY 6 | (e) (e) (e) (e) |P=0.526N P=0.491N P=0.525 P=0.537N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.490N P=0.491N P=0.510 P=0.539N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.467N P=0.500N P=0.492 P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 1/49 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 5.3% 9.3% |2.5% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 668 --- 610 502 |641 --- 724 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.052 P=0.288N P=0.610 P=0.071 |P=0.484N P=0.500N P=0.757N P=0.550N |
|POLY 3 | P=0.179 P=0.254N P=0.662 P=0.386 |P=0.424N P=0.494N P=0.754N P=0.519N |
|POLY 1.5 | P=0.205 P=0.247N P=0.674 P=0.440 |P=0.417N P=0.496N P=0.758N P=0.510N |
|POLY 6 | P=0.142 P=0.266N P=0.641 P=0.295 |P=0.435N P=0.492N P=0.751N P=0.538N |
|LOGISTIC REGRESSION| P=0.248 P=0.255N P=0.696N P=0.494 |P=0.417N P=0.508N P=0.761N P=0.503N |
|COCH-ARM / FISHERS | P=0.237 P=0.247N P=0.691N P=0.500 |P=0.410N P=0.500N P=0.747 P=0.505N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |2/50 (4%) 3/50 (6%) 7/49 (14%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 2.6% 6.2% |5.1% 7.3% 17.2% 8.0% |
|TERMINAL (d) | 0/20 (0%) 1/16 (6%) 0/15 (0%) 0/0 (0%) |1/22 (5%) 2/25 (8%) 6/22 (27%) 0/11 (0%) |
|FIRST INCIDENCE | --- 730 (T) 522 575 |644 588 717 527 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.059 P=0.455 P=0.487 P=0.190 |P=0.142 P=0.547 P=0.083 P=0.393 |
|POLY 3 | P=0.105 P=0.486 P=0.483 P=0.185 |P=0.319 P=0.520 P=0.083 P=0.473 |
|POLY 1.5 | P=0.126 P=0.492 P=0.489 P=0.209 |P=0.347 P=0.513 P=0.080 P=0.487 |
|POLY 6 | P=0.075 P=0.477 P=0.471 P=0.149 |P=0.263 P=0.527 P=0.086 P=0.441 |
|LOGISTIC REGRESSION| P=0.181 P=0.455 P=0.586 P=0.289 |P=0.329 P=0.512 P=0.095 P=0.489 |
|COCH-ARM / FISHERS | P=0.153 P=0.500 P=0.500 P=0.247 |P=0.362 P=0.500 P=0.075 P=0.490 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 2.6% 5.3% 3.2% |0.0% 2.5% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 1/15 (7%) 0/0 (0%) |0/22 (0%) 1/25 (4%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 652 703 712 584 |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312 P=0.575N P=0.544 P=0.696 |P=0.678N P=0.525 (e) (e) |
|POLY 3 | P=0.527N P=0.527N P=0.654 P=0.594N |P=0.563N P=0.508 (e) (e) |
|POLY 1.5 | P=0.488N P=0.515N P=0.670 P=0.549N |P=0.566N P=0.505 (e) (e) |
|POLY 6 | P=0.566 P=0.545N P=0.626 P=0.671N |P=0.558N P=0.511 (e) (e) |
|LOGISTIC REGRESSION| P=0.569N P=0.519N P=0.638 P=0.502N |(e) P=0.525 (e) (e) |
|COCH-ARM / FISHERS | P=0.444N P=0.500N P=0.691N P=0.500N |P=0.571N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 8/50 (16%) 10/50 (20%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 9.5% 2.6% 20.7% 29.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 2/15 (13%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 626 596 595 646 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.245N P=0.081 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.002 ** P=0.202N P=0.134 P=0.022 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.004 ** P=0.192N P=0.150 P=0.040 * |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.219N P=0.111 P=0.007 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.002 ** P=0.172N P=0.143 P=0.011 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.009 ** P=0.181N P=0.178 P=0.074 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION 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)| 4.8% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 639 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.193N P=0.286N P=0.300N P=0.576N |(e) (e) (e) (e) |
|POLY 3 | P=0.101N P=0.255N P=0.263N P=0.307N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.107N P=0.247N P=0.252N P=0.272N |(e) (e) (e) (e) |
|POLY 6 | P=0.091N P=0.267N P=0.281N P=0.376N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.127N P=0.244N P=0.250N P=0.314N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 13/49 (27%) 4/49 (8%) 7/45 (16%) |27/50 (54%) 22/50 (44%) 34/50 (68%) 20/50 (40%) |
|POLY-3 ADJUSTED (b)| 29.6% 32.2% 10.6% 23.2% |60.7% 49.4% 74.3% 47.5% |
|TERMINAL (d) | 4/20 (20%) 5/16 (31%) 1/15 (7%) 0/0 (0%) |11/22 (50%) 13/25 (52%) 18/22 (82%) 5/11 (46%) |
|FIRST INCIDENCE | 521 572 467 575 |407 450 444 527 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.414 P=0.391 P=0.065N P=0.166 |P=0.183 P=0.156N P=0.225 P=0.479 |
|POLY 3 | P=0.131N P=0.490 P=0.030N* P=0.367N |P=0.260N P=0.188N P=0.112 P=0.145N |
|POLY 1.5 | P=0.089N P=0.522 P=0.024N* P=0.258N |P=0.209N P=0.188N P=0.113 P=0.119N |
|POLY 6 | P=0.228N P=0.448 P=0.044N* P=0.571N |P=0.371N P=0.206N P=0.106 P=0.214N |
|LOGISTIC REGRESSION| P=0.077N P=0.549 P=0.017N* P=0.225N |P=0.216N P=0.195N P=0.139 P=0.122N |
|COCH-ARM / FISHERS | P=0.056N P=0.567 P=0.017N* P=0.160N |P=0.188N P=0.212N P=0.109 P=0.115N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/45 (0%) |10/50 (20%) 10/50 (20%) 7/50 (14%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 0.0% |25.1% 23.4% 16.2% 15.7% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |7/22 (32%) 4/25 (16%) 2/22 (9%) 0/11 (0%) |
|FIRST INCIDENCE | 642 --- --- --- |598 606 541 541 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.344N P=0.523N P=0.523N P=0.570N |P=0.395N P=0.497N P=0.287N P=0.550N |
|POLY 3 | P=0.280N P=0.519N P=0.527N P=0.578N |P=0.148N P=0.531N P=0.231N P=0.226N |
|POLY 1.5 | P=0.300N P=0.512N P=0.518N P=0.551N |P=0.135N P=0.558N P=0.257N P=0.210N |
|POLY 6 | P=0.254N P=0.528N P=0.542N P=0.623N |P=0.176N P=0.492N P=0.204N P=0.266N |
|LOGISTIC REGRESSION| P=0.306N P=0.492N P=0.492N P=0.514N |P=0.140N P=0.564N P=0.269N P=0.262N |
|COCH-ARM / FISHERS | P=0.317N P=0.505N P=0.505N P=0.526N |P=0.130N P=0.598N P=0.298N P=0.207N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/45 (0%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.9% 4.8% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 1/25 (4%) 1/22 (5%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 665 625 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.635N P=0.264 P=0.254 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.535N P=0.247 P=0.251 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.514N P=0.244 P=0.246 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.575N P=0.251 P=0.256 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.524N P=0.246 P=0.241 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.500N P=0.247 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/49 (0%) 1/45 (2%) |8/50 (16%) 7/50 (14%) 9/50 (18%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 0.0% 3.6% |19.7% 16.8% 21.2% 5.4% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |2/22 (9%) 5/25 (20%) 3/22 (14%) 1/11 (9%) |
|FIRST INCIDENCE | --- 703 --- 660 |597 569 627 553 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.146 P=0.451 (e) P=0.356 |P=0.205N P=0.424N P=0.532 P=0.161N |
|POLY 3 | P=0.314 P=0.483 (e) P=0.425 |P=0.076N P=0.479N P=0.539 P=0.060N |
|POLY 1.5 | P=0.346 P=0.489 (e) P=0.450 |P=0.060N P=0.484N P=0.526 P=0.051N |
|POLY 6 | P=0.268 P=0.476 (e) P=0.382 |P=0.114N P=0.479N P=0.551 P=0.085N |
|LOGISTIC REGRESSION| P=0.302 P=0.476 (e) P=0.447 |P=0.063N P=0.476N P=0.536 P=0.054N |
|COCH-ARM / FISHERS | P=0.383 P=0.495 (e) P=0.474 |P=0.051N P=0.500N P=0.500 P=0.046N* |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/5 (100%) 6/6 (100%) 0/0 (0%) 0/1 (0%) |5/6 (83%) 5/5 (100%) 2/3 (67%) 3/3 (100%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 0.0% 0.0% |90.1% 100.0% 85.1% 100.0% |
|TERMINAL (d) | 2/2 (100%) 5/5 (100%) 0/0 (0%) 0/0 (0%) |1/1 (100%) 3/3 (100%) 1/1 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 553 639 --- --- |569 564 613 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.124N (e) (e) P=0.566N |P=0.374N P=0.312N P=0.176N P=0.481N |
|POLY 3 | (e) (e) (e) P<0.001N** |P=0.711 P=0.797 P=0.885N P=0.861 |
|POLY 1.5 | (e) (e) (e) P<0.001N** |P=0.615 P=0.658 P=0.750N P=0.745 |
|POLY 6 | (e) (e) (e) P=1.000 |P=0.941 P=0.985 P=0.997N P=0.993 |
|LOGISTIC REGRESSION| P=0.039N* (e) (e) P=0.205N |P=0.675 P=0.667 P=0.906 P=0.858 |
|COCH-ARM / FISHERS | P=0.017N* (e) (e) P=0.167N |P=0.562 P=0.545 P=0.583N P=0.667 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 14/50 (28%) 20/50 (40%) 11/50 (22%) |8/50 (16%) 10/50 (20%) 14/50 (28%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 25.4% 33.0% 47.7% 31.3% |20.0% 23.0% 31.8% 8.1% |
|TERMINAL (d) | 2/20 (10%) 3/16 (19%) 6/15 (40%) 0/0 (0%) |4/22 (18%) 3/25 (12%) 6/22 (27%) 1/11 (9%) |
|FIRST INCIDENCE | 603 431 438 337 |609 520 515 590 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.194 P=0.013 * P=0.002 ** |P=0.343N P=0.480 P=0.153 P=0.321N |
|POLY 3 | P=0.225 P=0.294 P=0.024 * P=0.373 |P=0.149N P=0.474 P=0.162 P=0.119N |
|POLY 1.5 | P=0.369 P=0.308 P=0.028 * P=0.483 |P=0.116N P=0.444 P=0.141 P=0.106N |
|POLY 6 | P=0.070 P=0.273 P=0.018 * P=0.203 |P=0.227N P=0.515 P=0.191 P=0.153N |
|LOGISTIC REGRESSION| P=0.513 P=0.339 P=0.033 * P=0.574 |P=0.106N P=0.410 P=0.128 P=0.146N |
|COCH-ARM / FISHERS | P=0.542 P=0.322 P=0.041 * P=0.595N |P=0.099N P=0.398 P=0.114 P=0.100N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 7/50 (14%) 2/49 (4%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| |5.0% 16.4% 4.8% 5.5% |
|TERMINAL (d) | |0/22 (0%) 3/25 (12%) 1/22 (5%) 1/11 (9%) |
|FIRST INCIDENCE | |598 520 683 553 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.458N P=0.111 P=0.669N P=0.604 |
|POLY 3 | |P=0.335N P=0.093 P=0.682N P=0.661 |
|POLY 1.5 | |P=0.315N P=0.088 P=0.687N P=0.677 |
|POLY 6 | |P=0.377N P=0.098 P=0.680N P=0.626 |
|LOGISTIC REGRESSION| |P=0.305N P=0.070 P=0.674 P=0.686 |
|COCH-ARM / FISHERS | |P=0.308N P=0.080 P=0.684 P=0.684 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 5.2% 2.7% 6.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/20 (10%) 2/16 (13%) 1/15 (7%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 652 730 (T) 730 (T) 660 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.156 P=0.593N P=0.402N P=0.130 |(e) (e) (e) (e) |
|POLY 3 | P=0.470N P=0.536N P=0.345N P=0.624N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.440N P=0.520N P=0.329N P=0.565N |(e) (e) (e) (e) |
|POLY 6 | P=0.516N P=0.560N P=0.373N P=0.626 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.390 P=0.576N P=0.391N P=0.530 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.404N P=0.500N P=0.309N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 15/50 (30%) 13/50 (26%) 9/50 (18%) |10/50 (20%) 11/50 (22%) 8/50 (16%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 45.6% 36.4% 32.1% 25.5% |24.6% 25.8% 18.7% 16.2% |
|TERMINAL (d) | 9/20 (45%) 5/16 (31%) 5/15 (33%) 0/0 (0%) |4/22 (18%) 8/25 (32%) 3/22 (14%) 1/11 (9%) |
|FIRST INCIDENCE | 553 575 502 502 |555 450 515 576 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.234 P=0.455N P=0.371N P=0.090 |P=0.430N P=0.584 P=0.371N P=0.542N |
|POLY 3 | P=0.035N* P=0.256N P=0.141N P=0.048N* |P=0.166N P=0.548 P=0.350N P=0.262N |
|POLY 1.5 | P=0.020N* P=0.232N P=0.125N P=0.025N* |P=0.145N P=0.534 P=0.366N P=0.233N |
|POLY 6 | P=0.088N P=0.288N P=0.177N P=0.131N |P=0.212N P=0.554 P=0.335N P=0.328N |
|LOGISTIC REGRESSION| P=0.026N* P=0.262N P=0.139N P=0.033N* |P=0.145N P=0.522 P=0.372N P=0.265N |
|COCH-ARM / FISHERS | P=0.011N* P=0.201N P=0.101N P=0.013N* |P=0.132N P=0.500 P=0.398N P=0.220N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 9.7% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/20 (20%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 730 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.051N P=0.089N P=0.099N P=1.000N |(e) (e) (e) (e) |
|POLY 3 | P=0.016N* P=0.069N P=0.073N P=0.104N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.017N* P=0.065N P=0.068N P=0.080N |(e) (e) (e) (e) |
|POLY 6 | P=0.014N* P=0.075N P=0.083N P=0.163N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.051N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.020N* P=0.059N P=0.059N P=0.059N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/48 (35%) 8/49 (16%) 22/48 (46%) 21/45 (47%) |0/44 (0%) 0/45 (0%) 1/41 (2%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 40.5% 20.6% 57.5% 63.4% |0.0% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 7/20 (35%) 2/16 (13%) 12/15 (80%) 0/0 (0%) |0/18 (0%) 0/24 (0%) 0/19 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 626 596 568 568 |--- --- 515 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.132N P=0.030 * P<0.001 ** |P=0.700 (e) P=0.513 (e) |
|POLY 3 | P=0.002 ** P=0.041N* P=0.086 P=0.032 * |P=0.655 (e) P=0.510 (e) |
|POLY 1.5 | P=0.006 ** P=0.033N* P=0.125 P=0.080 |P=0.680 (e) P=0.501 (e) |
|POLY 6 | P<0.001 ** P=0.056N P=0.045 * P=0.006 ** |P=0.602 (e) P=0.519 (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.052N P=0.045 * P=0.002 ** |P=0.621 (e) P=0.337 (e) |
|COCH-ARM / FISHERS | P=0.026 * P=0.027N* P=0.203 P=0.186 |P=0.696 (e) P=0.482 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/49 (0%) 0/48 (0%) 0/45 (0%) |0/44 (0%) 0/45 (0%) 0/41 (0%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/18 (0%) 0/24 (0%) 0/19 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 668 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.216N P=0.279N P=0.299N P=0.718N |(e) (e) (e) (e) |
|POLY 3 | P=0.103N P=0.253N P=0.265N P=0.327N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.111N P=0.244N P=0.254N P=0.290N |(e) (e) (e) (e) |
|POLY 6 | P=0.094N P=0.267N P=0.284N P=0.398N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.154N P=0.256N P=0.271N P=0.439N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.119N P=0.242N P=0.247N P=0.264N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |4/50 (8%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 0.0% 6.3% |9.9% 4.8% 4.8% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |1/22 (5%) 0/25 (0%) 1/22 (5%) 0/11 (0%) |
|FIRST INCIDENCE | 529 --- --- 658 |616 611 595 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.228 P=0.275N P=0.297N P=0.276 |P=0.071N P=0.313N P=0.321N P=0.115N |
|POLY 3 | P=0.473 P=0.257N P=0.264N P=0.588 |P=0.052N P=0.323N P=0.319N P=0.074N |
|POLY 1.5 | P=0.484 P=0.248N P=0.253N P=0.640 |P=0.047N* P=0.327N P=0.325N P=0.066N |
|POLY 6 | P=0.463 P=0.269N P=0.283N P=0.493 |P=0.062N P=0.320N P=0.316N P=0.092N |
|LOGISTIC REGRESSION| P=0.503 P=0.214N P=0.209N P=0.703 |P=0.043N* P=0.345N P=0.342N P=0.063N |
|COCH-ARM / FISHERS | P=0.500 P=0.247N P=0.247N P=0.691N |P=0.044N* P=0.339N P=0.339N P=0.059N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |7.5% 4.8% 9.5% 5.5% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |2/22 (9%) 0/25 (0%) 1/22 (5%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- --- --- |569 450 515 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.529 P=0.467N P=0.516 P=0.668 |
|POLY 3 | (e) (e) (e) (e) |P=0.533N P=0.474N P=0.532 P=0.539N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.505N P=0.483N P=0.520 P=0.516N |
|POLY 6 | (e) (e) (e) (e) |P=0.565 P=0.465N P=0.543 P=0.582N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.470N P=0.543N P=0.505 P=0.541N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.479N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 9/50 (18%) 8/50 (16%) 2/50 (4%) |11/50 (22%) 17/50 (34%) 14/50 (28%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 26.1% 22.7% 20.9% 6.3% |27.0% 40.3% 32.5% 37.5% |
|TERMINAL (d) | 8/20 (40%) 5/16 (31%) 6/15 (40%) 0/0 (0%) |6/22 (27%) 11/25 (44%) 7/22 (32%) 6/11 (55%) |
|FIRST INCIDENCE | 529 575 521 584 |459 606 515 483 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.490 P=0.592 P=0.574N P=0.387 |P=0.026 * P=0.221 P=0.366 P=0.035 * |
|POLY 3 | P=0.025N* P=0.459N P=0.386N P=0.026N* |P=0.287 P=0.142 P=0.376 P=0.213 |
|POLY 1.5 | P=0.013N* P=0.434N P=0.354N P=0.014N* |P=0.317 P=0.139 P=0.356 P=0.238 |
|POLY 6 | P=0.068N P=0.492N P=0.444N P=0.068N |P=0.227 P=0.146 P=0.395 P=0.164 |
|LOGISTIC REGRESSION| P=0.061N P=0.507N P=0.462N P=0.093N |P=0.254 P=0.157 P=0.361 P=0.222 |
|COCH-ARM / FISHERS | P=0.007N** P=0.402N P=0.306N P=0.007N** |P=0.326 P=0.133 P=0.322 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 0/49 (0%) 6/50 (12%) | |
|POLY-3 ADJUSTED (b)| 12.0% 5.2% 0.0% 18.4% | |
|TERMINAL (d) | 3/20 (15%) 0/16 (0%) 0/15 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | 668 703 --- 638 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.322N P=0.071N P<0.001 ** | |
|POLY 3 | P=0.276 P=0.246N P=0.042N* P=0.330 | |
|POLY 1.5 | P=0.298 P=0.233N P=0.038N* P=0.409 | |
|POLY 6 | P=0.247 P=0.267N P=0.049N* P=0.210 | |
|LOGISTIC REGRESSION| P=0.097 P=0.281N P=0.057N P=0.116 | |
|COCH-ARM / FISHERS | P=0.331 P=0.218N P=0.030N* P=0.500 | |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 6/49 (12%) 4/50 (8%) | |
|POLY-3 ADJUSTED (b)| 7.2% 10.1% 15.8% 12.0% | |
|TERMINAL (d) | 2/20 (10%) 0/16 (0%) 2/15 (13%) 0/0 (0%) | |
|FIRST INCIDENCE | 642 625 521 467 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.056 P=0.432 P=0.132 P=0.134 | |
|POLY 3 | P=0.255 P=0.473 P=0.194 P=0.379 | |
|POLY 1.5 | P=0.328 P=0.484 P=0.208 P=0.437 | |
|POLY 6 | P=0.150 P=0.461 P=0.171 P=0.282 | |
|LOGISTIC REGRESSION| P=0.427 P=0.498 P=0.197 P=0.608 | |
|COCH-ARM / FISHERS | P=0.414 P=0.500 P=0.233 P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 15/50 (30%) 8/49 (16%) 12/50 (24%) | |
|POLY-3 ADJUSTED (b)| 20.1% 34.4% 20.1% 31.3% | |
|TERMINAL (d) | 2/20 (10%) 1/16 (6%) 2/15 (13%) 0/0 (0%) | |
|FIRST INCIDENCE | 521 406 467 409 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.093 P=0.095 P=0.586 P=0.091 | |
|POLY 3 | P=0.273 P=0.099 P=0.604N P=0.177 | |
|POLY 1.5 | P=0.357 P=0.107 P=0.571N P=0.239 | |
|POLY 6 | P=0.149 P=0.093 P=0.560 P=0.090 | |
|LOGISTIC REGRESSION| P=0.281N P=0.186 P=0.392N P=0.301N | |
|COCH-ARM / FISHERS | P=0.452 P=0.121 P=0.518N P=0.312 | |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 18/50 (36%) 13/49 (27%) 15/49 (31%) | |
|POLY-3 ADJUSTED (b)| 35.3% 40.2% 31.2% 42.3% | |
|TERMINAL (d) | 4/20 (20%) 5/16 (31%) 1/15 (7%) 0/0 (0%) | |
|FIRST INCIDENCE | 521 403 438 467 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026 * P=0.265 P=0.571N P=0.003 ** | |
|POLY 3 | P=0.389 P=0.395 P=0.427N P=0.341 | |
|POLY 1.5 | P=0.524 P=0.411 P=0.399N P=0.482 | |
|POLY 6 | P=0.209 P=0.363 P=0.479N P=0.153 | |
|LOGISTIC REGRESSION| P=0.218N P=0.547 P=0.264N P=0.516N | |
|COCH-ARM / FISHERS | P=0.389N P=0.417 P=0.353N P=0.527N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Salivary Glands: Submandibular Gland |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 50/50 (100%) 49/50 (98%) 48/48 (100%)|1/50 (2%) 48/48 (100%) 49/49 (100%) 49/49 (100%) |
|POLY-3 ADJUSTED (b)| 9.2% 100.0% 98.0% 100.0% |2.5% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/20 (0%) 16/16 (100%) 14/15 (93%) 0/0 (0%) |0/22 (0%) 25/25 (100%) 22/22 (100%) 11/11 (100%) |
|FIRST INCIDENCE | 344 403 15 337 |555 347 297 483 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 6/50 (12%) | |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 5.3% 18.2% | |
|TERMINAL (d) | 0/20 (0%) 1/16 (6%) 0/15 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | --- 730 (T) 664 568 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.455 P=0.184 P<0.001 ** | |
|POLY 3 | P<0.001 ** P=0.486 P=0.216 P=0.006 ** | |
|POLY 1.5 | P<0.001 ** P=0.492 P=0.224 P=0.010 * | |
|POLY 6 | P<0.001 ** P=0.477 P=0.204 P=0.003 ** | |
|LOGISTIC REGRESSION| P<0.001 ** P=0.455 P=0.221 P=0.011 * | |
|COCH-ARM / FISHERS | P=0.002 ** P=0.500 P=0.247 P=0.013 * | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.7% 0.0% 0.0% 0.0% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 564 --- --- --- |--- --- 595 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.132N P=0.262N P=0.258N P=0.286N |P=0.682 (e) P=0.509 (e) |
|POLY 3 | P=0.100N P=0.258N P=0.266N P=0.311N |P=0.648 (e) P=0.513 (e) |
|POLY 1.5 | P=0.107N P=0.249N P=0.254N P=0.274N |P=0.675 (e) P=0.508 (e) |
|POLY 6 | P=0.093N P=0.273N P=0.286N P=0.382N |P=0.595 (e) P=0.518 (e) |
|LOGISTIC REGRESSION| P=0.088N P=0.199N P=0.182N P=0.153N |P=0.686 (e) P=0.474 (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 11/50 (22%) 12/50 (24%) 12/50 (24%) |3/50 (6%) 3/50 (6%) 5/50 (10%) 12/49 (24%) |
|POLY-3 ADJUSTED (b)| 19.3% 27.7% 31.1% 35.4% |7.5% 7.3% 12.0% 32.4% |
|TERMINAL (d) | 4/20 (20%) 6/16 (38%) 8/15 (53%) 0/0 (0%) |1/22 (5%) 1/25 (4%) 4/22 (18%) 6/11 (55%) |
|FIRST INCIDENCE | 714 596 522 642 |641 618 690 600 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.156 P=0.063 P<0.001 ** |P<0.001 ** P=0.622N P=0.376 P<0.001 ** |
|POLY 3 | P=0.071 P=0.258 P=0.163 P=0.088 |P<0.001 ** P=0.647N P=0.378 P=0.005 ** |
|POLY 1.5 | P=0.125 P=0.278 P=0.187 P=0.143 |P<0.001 ** P=0.652N P=0.371 P=0.007 ** |
|POLY 6 | P=0.023 * P=0.235 P=0.128 P=0.033 * |P<0.001 ** P=0.644N P=0.382 P=0.002 ** |
|LOGISTIC REGRESSION| P=0.003 ** P=0.181 P=0.084 P<0.001 ** |P<0.001 ** P=0.653N P=0.391 P=0.003 ** |
|COCH-ARM / FISHERS | P=0.216 P=0.306 P=0.227 P=0.227 |P<0.001 ** P=0.661N P=0.357 P=0.010 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 9/50 (18%) 2/50 (4%) 13/50 (26%) |0/50 (0%) 7/50 (14%) 6/50 (12%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 4.8% 21.4% 5.3% 34.6% |0.0% 16.3% 14.2% 5.4% |
|TERMINAL (d) | 1/20 (5%) 1/16 (6%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 1/25 (4%) 3/22 (14%) 0/11 (0%) |
|FIRST INCIDENCE | 729 406 619 409 |--- 606 444 534 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.021 * P=0.623 P<0.001 ** |P=0.343 P=0.015 * P=0.022 * P=0.229 |
|POLY 3 | P<0.001 ** P=0.025 * P=0.664 P<0.001 ** |P=0.465 P=0.010 * P=0.019 * P=0.223 |
|POLY 1.5 | P=0.002 ** P=0.025 * P=0.675 P<0.001 ** |P=0.495 P=0.009 ** P=0.018 * P=0.230 |
|POLY 6 | P<0.001 ** P=0.025 * P=0.646 P<0.001 ** |P=0.398 P=0.012 * P=0.021 * P=0.208 |
|LOGISTIC REGRESSION| P=0.015 * P=0.037 * P=0.675 P=0.013 * |P=0.512 P=0.008 ** P=0.018 * P=0.195 |
|COCH-ARM / FISHERS | P=0.004 ** P=0.026 * P=0.691N P=0.002 ** |P=0.506 P=0.006 ** P=0.013 * P=0.242 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.9% 2.4% 2.8% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 2/25 (8%) 1/22 (5%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 730 (T) 730 (T) 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.339 P=0.266 P=0.500 P=0.477 |
|POLY 3 | (e) (e) (e) (e) |P=0.469 P=0.245 P=0.510 P=0.485 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.486 P=0.243 P=0.507 P=0.492 |
|POLY 6 | (e) (e) (e) (e) |P=0.435 P=0.248 P=0.514 P=0.469 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.446 P=0.266 P=0.500 P=0.492 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.494 P=0.247 P=0.500 P=0.495 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen: Red Pulp |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 5.5% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 553 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.032 * (e) (e) P=0.197 |
|POLY 3 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.221 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.229 |
|POLY 6 | (e) (e) (e) (e) |P=0.039 * (e) (e) P=0.206 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.229 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.242 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 6/50 (12%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.1% 0.0% 2.7% 18.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 1/15 (7%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 588 --- 730 (T) 568 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.151N P=0.400N P=0.027 * |(e) (e) (e) (e) |
|POLY 3 | P=0.035 * P=0.135N P=0.350N P=0.134 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.040 * P=0.128N P=0.332N P=0.181 |(e) (e) (e) (e) |
|POLY 6 | P=0.028 * P=0.147N P=0.382N P=0.076 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.039 * P=0.110N P=0.312N P=0.222 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.050 P=0.121N P=0.309N P=0.243 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 16.7% 2.6% 0.0% 0.0% |0.0% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 3/20 (15%) 1/16 (6%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 639 730 (T) --- --- |--- 609 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014N* P=0.069N P=0.032N* P=0.484N |P=0.464N P=0.261 (e) (e) |
|POLY 3 | P<0.001N** P=0.038N* P=0.011N* P=0.022N* |P=0.403N P=0.243 (e) (e) |
|POLY 1.5 | P<0.001N** P=0.035N* P=0.010N* P=0.013N* |P=0.401N P=0.239 (e) (e) |
|POLY 6 | P<0.001N** P=0.045N* P=0.015N* P=0.053N |P=0.409N P=0.248 (e) (e) |
|LOGISTIC REGRESSION| P=0.005N** P=0.048N* P=0.017N* P=0.086N |P=0.404N P=0.232 (e) (e) |
|COCH-ARM / FISHERS | P=0.002N** P=0.030N* P=0.006N** P=0.006N** |P=0.404N P=0.242 (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 14/50 (28%) 32/50 (64%) 37/50 (74%) |3/50 (6%) 41/50 (82%) 45/50 (90%) 39/48 (81%) |
|POLY-3 ADJUSTED (b)| 0.0% 34.6% 72.3% 81.2% |7.3% 86.0% 93.2% 84.1% |
|TERMINAL (d) | 0/20 (0%) 7/16 (44%) 12/15 (80%) 0/0 (0%) |0/22 (0%) 21/25 (84%) 20/22 (91%) 8/11 (73%) |
|FIRST INCIDENCE | --- 431 438 337 |407 347 444 508 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 4.7% 7.6% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 1/16 (6%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 588 606 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.155N P=0.439 P=0.277N P=0.372N |(e) (e) (e) (e) |
|POLY 3 | P=0.101N P=0.468 P=0.265N P=0.309N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.086N P=0.482 P=0.253N P=0.273N |(e) (e) (e) (e) |
|POLY 6 | P=0.134N P=0.449 P=0.284N P=0.380N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.066N P=0.523 P=0.211N P=0.193N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.073N P=0.500 P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 4/50 (8%) 15/50 (30%) 14/50 (28%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 23.1% 10.1% 37.7% 39.5% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 2/20 (10%) 0/16 (0%) 4/15 (27%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 588 596 568 523 |--- --- 690 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.160N P=0.058 P<0.001 ** |P=0.662 (e) P=0.520 (e) |
|POLY 3 | P=0.012 * P=0.097N P=0.109 P=0.087 |P=0.656 (e) P=0.511 (e) |
|POLY 1.5 | P=0.025 * P=0.086N P=0.132 P=0.147 |P=0.677 (e) P=0.507 (e) |
|POLY 6 | P=0.003 ** P=0.118N P=0.079 P=0.031 * |P=0.609 (e) P=0.516 (e) |
|LOGISTIC REGRESSION| P=0.015 * P=0.077N P=0.126 P=0.124 |P=0.686 (e) P=0.508 (e) |
|COCH-ARM / FISHERS | P=0.055 P=0.074N P=0.178 P=0.241 |P=0.690 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |3/50 (6%) 4/50 (8%) 4/50 (8%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 9.3% 5.1% 7.9% 6.3% |7.5% 9.7% 9.5% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 1/15 (7%) 0/0 (0%) |1/22 (5%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 521 664 596 658 |598 650 557 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.535 P=0.401N P=0.571N P=0.525N |P=0.179N P=0.547 P=0.529 P=0.189N |
|POLY 3 | P=0.431N P=0.386N P=0.569N P=0.486N |P=0.123N P=0.519 P=0.528 P=0.139N |
|POLY 1.5 | P=0.377N P=0.364N P=0.541N P=0.413N |P=0.109N P=0.513 P=0.518 P=0.130N |
|POLY 6 | P=0.526N P=0.417N P=0.612N P=0.609N |P=0.154N P=0.526 P=0.537 P=0.159N |
|LOGISTIC REGRESSION| P=0.295N P=0.290N P=0.442N P=0.236N |P=0.105N P=0.510 P=0.502 P=0.128N |
|COCH-ARM / FISHERS | P=0.319N P=0.339N P=0.500N P=0.339N |P=0.103N P=0.500 P=0.500 P=0.129N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Neuroendocrine Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 8/50 (16%) |0/50 (0%) 5/50 (10%) 11/50 (22%) 9/48 (19%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.7% 24.1% |0.0% 12.3% 25.6% 22.9% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 1/15 (7%) 0/0 (0%) |0/22 (0%) 5/25 (20%) 5/22 (23%) 1/11 (9%) |
|FIRST INCIDENCE | --- --- 730 (T) 598 |--- 730 (T) 527 508 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.443 P<0.001 ** |P<0.001 ** P=0.042 * P<0.001 ** P=0.002 ** |
|POLY 3 | P<0.001 ** (e) P=0.479 P<0.001 ** |P=0.003 ** P=0.033 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.487 P=0.002 ** |P=0.003 ** P=0.032 * P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.466 P<0.001 ** |P=0.002 ** P=0.033 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.443 P<0.001 ** |P=0.003 ** P=0.042 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P=0.003 ** |P=0.003 ** P=0.028 * P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/49 (2%) 0/49 (0%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 7.1% 2.6% 0.0% 9.2% | |
|TERMINAL (d) | 1/20 (5%) 1/16 (6%) 0/15 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | 521 730 (T) --- 502 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.285 P=0.362N P=0.153N P=0.409 | |
|POLY 3 | P=0.480 P=0.343N P=0.145N P=0.538 | |
|POLY 1.5 | P=0.501 P=0.330N P=0.136N P=0.599 | |
|POLY 6 | P=0.449 P=0.363N P=0.161N P=0.430 | |
|LOGISTIC REGRESSION| P=0.588 P=0.300N P=0.103N P=0.525N | |
|COCH-ARM / FISHERS | P=0.528 P=0.316N P=0.125N P=0.661N | |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 7.0% 0.0% 0.0% 0.0% | |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | 521 --- --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.065N P=0.141N P=0.146N P=0.191N | |
|POLY 3 | P=0.041N* P=0.139N P=0.147N P=0.184N | |
|POLY 1.5 | P=0.043N* P=0.132N P=0.137N P=0.150N | |
|POLY 6 | P=0.038N* P=0.151N P=0.164N P=0.258N | |
|LOGISTIC REGRESSION| P=0.034N* P=0.100N P=0.089N P=0.067N | |
|COCH-ARM / FISHERS | P=0.048N* P=0.125N P=0.125N P=0.121N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 25/50 (50%) 25/50 (50%) 10/48 (21%) |32/50 (64%) 33/49 (67%) 30/49 (61%) 32/50 (64%) |
|POLY-3 ADJUSTED (b)| 50.8% 58.3% 60.1% 30.3% |71.4% 73.4% 67.0% 73.1% |
|TERMINAL (d) | 14/20 (70%) 12/16 (75%) 13/15 (87%) 0/0 (0%) |18/22 (82%) 19/25 (76%) 15/22 (68%) 10/11 (91%) |
|FIRST INCIDENCE | 610 431 502 502 |407 443 444 534 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * P=0.111 P=0.062 P=0.011 * |P=0.016 * P=0.424N P=0.374N P=0.030 * |
|POLY 3 | P=0.051N P=0.308 P=0.250 P=0.051N |P=0.524 P=0.508 P=0.411N P=0.523 |
|POLY 1.5 | P=0.018N* P=0.324 P=0.281 P=0.025N* |P=0.512N P=0.488 P=0.429N P=0.568 |
|POLY 6 | P=0.207N P=0.285 P=0.198 P=0.151N |P=0.441 P=0.532 P=0.395N P=0.445 |
|LOGISTIC REGRESSION| P=0.084N P=0.232 P=0.165 P=0.209N |P=0.530 P=0.512 P=0.399N P=0.530 |
|COCH-ARM / FISHERS | P=0.006N** P=0.344 P=0.344 P=0.012N* |P=0.477N P=0.445 P=0.469N P=0.582N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 09 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 2/49 (4%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.6% 5.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/16 (0%) 0/15 (0%) 0/0 (0%) |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 617 660 664 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.631N P=0.739 P=0.410 P=0.557N |(e) (e) (e) (e) |
|POLY 3 | P=0.470N P=0.747 P=0.463 P=0.559N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.421N P=0.755 P=0.478 P=0.531N |(e) (e) (e) (e) |
|POLY 6 | P=0.569N P=0.736 P=0.441 P=0.606N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.391N P=0.742N P=0.501 P=0.454N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.368N P=0.747N P=0.500 P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |5.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | |0/22 (0%) 0/25 (0%) 0/22 (0%) 0/11 (0%) |
|FIRST INCIDENCE | |549 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.131N P=0.225N P=0.235N P=0.301N |
|POLY 3 | |P=0.109N P=0.231N P=0.229N P=0.258N |
|POLY 1.5 | |P=0.113N P=0.233N P=0.233N P=0.246N |
|POLY 6 | |P=0.102N P=0.230N P=0.226N P=0.284N |
|LOGISTIC REGRESSION| |P=0.119N P=0.247N P=0.265N P=0.235N |
|COCH-ARM / FISHERS | |P=0.116N P=0.247N P=0.253N P=0.247N |
|=================================================================================================================================|
(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).