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: 09:17:33
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
------------------------------------------------------------------------------------------------------------------------------------
STOP 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 009 300 MG/KG
INCLUDE 010 300 MG/KG
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus METHYLEUGENOL DATE: 07/20/98
EXPERIMENT: 05187 TEST: 09 TIME: 09:17:33
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: Atrium Thrombosis
Heart: Myocardium Degeneration
Mineralization
Intestine Large, Colon Mineralization
Kidney Nephropathy
Kidney: Renal Tubule Hyperplasia Focal
Liver Basophilic Focus
Degeneration Cystic Focal
Eosinophilic Focus
Liver: Bile Duct Hyperplasia
Liver: Centrilobular Degeneration
Liver: Hepatocyte Hypertrophy
Liver: Oval Cell Hyperplasia
Lung: Interstitium Mineralization
Mammary Gland Dilatation
Nose Inflammation
Pancreas Hyperplasia Focal
Pancreas: Acinus Atrophy
Parathyroid Gland Hyperplasia
Pituitary Gland: Pars Distalis Hyperplasia Focal
Preputial Gland Cyst
Hyperplasia Focal
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
Ulcer
Stomach, Glandular: Neuroendocrine Cell
Hyperplasia
Testes: Tunic Hyperplasia Mesothelium
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia Focal
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus METHYLEUGENOL DATE: 07/20/98
EXPERIMENT: 05187 TEST: 09 TIME: 09:17:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B
PATHOLOGIST: MISSING CAS: 93-15-2
Bone Marrow Hyperplasia
Kidney Nephropathy
Liver Basophilic Focus
Degeneration Cystic Focal
Eosinophilic Focus
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Hypertrophy
Liver: Oval Cell Hyperplasia
Mammary Gland Dilatation
Hyperplasia Focal
Salivary Glands: Submandibular Gland Cytoplasmic Alteration
Spleen Fibrosis
Hematopoietic Cell Proliferation
Stomach, Glandular Atrophy
===============================================================
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 5/50 (10%) | 13/50 (26%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 30.5% 20.0% | 31.3% 13.4% |
|TERMINAL (d) | 9/20 (45%) 0/0 (0%) | 6/22 (27%) 3/16 (19%) |
|FIRST INCIDENCE | 610 517 | 459 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * | P=0.102N |
|POLY 3 | P=0.303N | P=0.050N |
|POLY 1.5 | P=0.132N | P=0.043N* |
|POLY 6 | P=0.686N | P=0.061N |
|LOGISTIC REGRESSION| P=0.518N | P=0.042N* |
|COCH-ARM / FISHERS | P=0.033N* | P=0.033N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 14/50 (28%) | 4/50 (8%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 36.1% 46.7% | 10.0% 15.7% |
|TERMINAL (d) | 6/20 (30%) 0/0 (0%) | 2/22 (9%) 0/16 (0%) |
|FIRST INCIDENCE | 553 498 | 609 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.297 |
|POLY 3 | P=0.271 | P=0.341 |
|POLY 1.5 | P=0.464 | P=0.349 |
|POLY 6 | P=0.090 | P=0.333 |
|LOGISTIC REGRESSION| P=0.540 | P=0.344 |
|COCH-ARM / FISHERS | P=0.414N | P=0.370 |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Blood Vessel |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 9/50 (18%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 32.6% | 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 662 502 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | (e) |
|POLY 3 | P<0.001 ** | (e) |
|POLY 1.5 | P=0.002 ** | (e) |
|POLY 6 | P<0.001 ** | (e) |
|LOGISTIC REGRESSION| P=0.016 * | (e) |
|COCH-ARM / FISHERS | P=0.008 ** | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 10/50 (20%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 11.8% 37.6% | 0.0% 2.7% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 626 553 | --- 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.493 |
|POLY 3 | P=0.018 * | P=0.501 |
|POLY 1.5 | P=0.044 * | P=0.500 |
|POLY 6 | P=0.004 ** | P=0.501 |
|LOGISTIC REGRESSION| P=0.009 ** | P=0.497 |
|COCH-ARM / FISHERS | P=0.131 | P=0.500 |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 21/50 (42%) | 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 18.7% 64.0% | 0.0% 8.0% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 626 502 | --- 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.111 |
|POLY 3 | P<0.001 ** | P=0.113 |
|POLY 1.5 | P<0.001 ** | P=0.114 |
|POLY 6 | P<0.001 ** | P=0.111 |
|LOGISTIC REGRESSION| P<0.001 ** | P=0.116 |
|COCH-ARM / FISHERS | P=0.004 ** | P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone |
| Hyperostosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% | 2.5% 5.3% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | --- --- | 555 459 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.489 |
|POLY 3 | (e) | P=0.490 |
|POLY 1.5 | (e) | P=0.492 |
|POLY 6 | (e) | P=0.486 |
|LOGISTIC REGRESSION| (e) | P=0.561 |
|COCH-ARM / FISHERS | (e) | P=0.500 |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) | 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 7.1% 0.0% | 5.1% 10.7% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 1/22 (5%) 1/16 (6%) |
|FIRST INCIDENCE | 521 --- | 641 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.551N | P=0.265 |
|POLY 3 | P=0.379N | P=0.316 |
|POLY 1.5 | P=0.230N | P=0.322 |
|POLY 6 | P=0.731N | P=0.308 |
|LOGISTIC REGRESSION| P=0.189N | P=0.309 |
|COCH-ARM / FISHERS | P=0.121N | P=0.339 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 18/50 (36%) | 4/50 (8%) 25/50 (50%) |
|POLY-3 ADJUSTED (b)| 41.4% 55.3% | 10.1% 63.1% |
|TERMINAL (d) | 10/20 (50%) 0/0 (0%) | 3/22 (14%) 14/16 (88%) |
|FIRST INCIDENCE | 564 380 | 549 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P<0.001 ** |
|POLY 3 | P=0.168 | P<0.001 ** |
|POLY 1.5 | P=0.314 | P<0.001 ** |
|POLY 6 | P=0.045 * | P<0.001 ** |
|LOGISTIC REGRESSION| P=0.324 | P<0.001 ** |
|COCH-ARM / FISHERS | P=0.582N | P<0.001 ** |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Brain |
| Hydrocephalus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 4/50 (8%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 4.8% 4.3% | 10.1% 23.2% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 1/22 (5%) 2/16 (13%) |
|FIRST INCIDENCE | 668 502 | 597 477 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.531 | P=0.078 |
|POLY 3 | P=0.778N | P=0.101 |
|POLY 1.5 | P=0.655N | P=0.104 |
|POLY 6 | P=0.850 | P=0.097 |
|LOGISTIC REGRESSION| P=0.618N | P=0.102 |
|COCH-ARM / FISHERS | P=0.500N | P=0.117 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Brain: Hypothalamus |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 9/50 (18%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% | 22.4% 13.1% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 6/22 (27%) 2/16 (13%) |
|FIRST INCIDENCE | --- --- | 597 477 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.339N |
|POLY 3 | (e) | P=0.220N |
|POLY 1.5 | (e) | P=0.213N |
|POLY 6 | (e) | P=0.234N |
|LOGISTIC REGRESSION| (e) | P=0.223N |
|COCH-ARM / FISHERS | (e) | P=0.194N |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 2/48 (4%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| | 5.2% 0.0% |
|TERMINAL (d) | | 0/21 (0%) 0/15 (0%) |
|FIRST INCIDENCE | | 597 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.266N |
|POLY 3 | | P=0.271N |
|POLY 1.5 | | P=0.259N |
|POLY 6 | | P=0.289N |
|LOGISTIC REGRESSION| | P=0.236N |
|COCH-ARM / FISHERS | | P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 2/48 (4%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| | 5.3% 2.9% |
|TERMINAL (d) | | 1/21 (5%) 1/15 (7%) |
|FIRST INCIDENCE | | 717 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.609N |
|POLY 3 | | P=0.539N |
|POLY 1.5 | | P=0.526N |
|POLY 6 | | P=0.556N |
|LOGISTIC REGRESSION| | P=0.582N |
|COCH-ARM / FISHERS | | P=0.500N |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Epididymis: Serosa |
| Hyperplasia Mesothelium |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 0.0% 8.4% | |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | --- 437 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.124 | |
|POLY 3 | P=0.226 | |
|POLY 1.5 | P=0.217 | |
|POLY 6 | P=0.323 | |
|LOGISTIC REGRESSION| P=0.360 | |
|COCH-ARM / FISHERS | P=0.247 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 14.1% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 553 --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.411N | (e) |
|POLY 3 | P=0.147N | (e) |
|POLY 1.5 | P=0.059N | (e) |
|POLY 6 | P=0.484N | (e) |
|LOGISTIC REGRESSION| P=0.044N* | (e) |
|COCH-ARM / FISHERS | P=0.014N* | (e) |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 25/49 (51%) | 35/50 (70%) 27/50 (54%) |
|POLY-3 ADJUSTED (b)| 92.7% 71.3% | 77.5% 64.0% |
|TERMINAL (d) | 19/20 (95%) 0/0 (0%) | 16/22 (73%) 9/16 (56%) |
|FIRST INCIDENCE | 521 380 | 459 331 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.420N |
|POLY 3 | P=0.003N** | P=0.111N |
|POLY 1.5 | P<0.001N** | P=0.093N |
|POLY 6 | P=0.088N | P=0.145N |
|LOGISTIC REGRESSION| P=0.012N* | P=0.104N |
|COCH-ARM / FISHERS | P<0.001N** | P=0.074N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 15/49 (31%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 11.8% 51.3% | 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 626 526 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | (e) |
|POLY 3 | P<0.001 ** | (e) |
|POLY 1.5 | P<0.001 ** | (e) |
|POLY 6 | P<0.001 ** | (e) |
|LOGISTIC REGRESSION| P<0.001 ** | (e) |
|COCH-ARM / FISHERS | P=0.010 * | (e) |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 16.1% | 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | --- 526 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.022 * | (e) |
|POLY 3 | P=0.032 * | (e) |
|POLY 1.5 | P=0.039 * | (e) |
|POLY 6 | P=0.033 * | (e) |
|LOGISTIC REGRESSION| P=0.091 | (e) |
|COCH-ARM / FISHERS | P=0.059 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 4.3% | 5.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 1/22 (5%) 0/16 (0%) |
|FIRST INCIDENCE | 730 (T) 556 | 619 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.401 | P=0.275N |
|POLY 3 | P=0.741 | P=0.261N |
|POLY 1.5 | P=0.738 | P=0.253N |
|POLY 6 | P=0.817 | P=0.273N |
|LOGISTIC REGRESSION| P=0.722 | P=0.245N |
|COCH-ARM / FISHERS | P=0.747N | P=0.247N |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 722 --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N | (e) |
|POLY 3 | P=0.378N | (e) |
|POLY 1.5 | P=0.234N | (e) |
|POLY 6 | P=0.722N | (e) |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | P=0.125N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 47/50 (94%) | 35/50 (70%) 45/50 (90%) |
|POLY-3 ADJUSTED (b)| 99.8% 99.8% | 80.5% 99.0% |
|TERMINAL (d) | 20/20 (100%) 0/0 (0%) | 22/22 (100%) 16/16 (100%) |
|FIRST INCIDENCE | 521 219 | 459 477 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.004 ** |
|POLY 3 | P=1.000 | P<0.001 ** |
|POLY 1.5 | P=0.984N | P<0.001 ** |
|POLY 6 | P=1.000 | P=0.002 ** |
|LOGISTIC REGRESSION| P=0.346 | P<0.001 ** |
|COCH-ARM / FISHERS | P=0.309N | P=0.011 * |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.4% | 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | --- 528 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.118 | (e) |
|POLY 3 | P=0.227 | (e) |
|POLY 1.5 | P=0.217 | (e) |
|POLY 6 | P=0.326 | (e) |
|LOGISTIC REGRESSION| P=0.292 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 11.9% 12.5% | 0.0% 0.0% |
|TERMINAL (d) | 2/20 (10%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 642 540 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.045 * | (e) |
|POLY 3 | P=0.683 | (e) |
|POLY 1.5 | P=0.565N | (e) |
|POLY 6 | P=0.580 | (e) |
|LOGISTIC REGRESSION| P=0.684 | (e) |
|COCH-ARM / FISHERS | P=0.357N | (e) |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 6/50 (12%) | 36/50 (72%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 52.4% 22.4% | 80.9% 24.9% |
|TERMINAL (d) | 14/20 (70%) 0/0 (0%) | 21/22 (96%) 2/16 (13%) |
|FIRST INCIDENCE | 564 299 | 241 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.081 | P<0.001N** |
|POLY 3 | P=0.013N* | P<0.001N** |
|POLY 1.5 | P=0.002N** | P<0.001N** |
|POLY 6 | P=0.189N | P<0.001N** |
|LOGISTIC REGRESSION| P=0.004N** | P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** | P<0.001N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) | 3/50 (6%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 9.5% 12.3% | 7.5% 17.3% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 1/22 (5%) 0/16 (0%) |
|FIRST INCIDENCE | 610 495 | 549 281 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091 | P=0.141 |
|POLY 3 | P=0.592 | P=0.156 |
|POLY 1.5 | P=0.674 | P=0.156 |
|POLY 6 | P=0.506 | P=0.155 |
|LOGISTIC REGRESSION| P=0.646N | P=0.204 |
|COCH-ARM / FISHERS | P=0.500N | P=0.159 |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 41/50 (82%) | 0/50 (0%) 29/50 (58%) |
|POLY-3 ADJUSTED (b)| 9.5% 93.5% | 0.0% 66.8% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 9/16 (56%) |
|FIRST INCIDENCE | 626 380 | --- 477 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P<0.001 ** |
|POLY 3 | P<0.001 ** | P<0.001 ** |
|POLY 1.5 | P<0.001 ** | P<0.001 ** |
|POLY 6 | P<0.001 ** | P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** | P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** | P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 39/50 (78%) | 10/50 (20%) 37/50 (74%) |
|POLY-3 ADJUSTED (b)| 26.4% 90.3% | 25.1% 77.9% |
|TERMINAL (d) | 7/20 (35%) 0/0 (0%) | 6/22 (27%) 13/16 (81%) |
|FIRST INCIDENCE | 704 219 | 679 281 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P<0.001 ** |
|POLY 3 | P<0.001 ** | P<0.001 ** |
|POLY 1.5 | P<0.001 ** | P<0.001 ** |
|POLY 6 | P<0.001 ** | P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** | P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** | P<0.001 ** |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) | 7/50 (14%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 9.4% 0.0% | 17.0% 7.9% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 2/22 (9%) 1/16 (6%) |
|FIRST INCIDENCE | 614 --- | 459 528 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.457N | P=0.230N |
|POLY 3 | P=0.277N | P=0.195N |
|POLY 1.5 | P=0.145N | P=0.182N |
|POLY 6 | P=0.649N | P=0.215N |
|LOGISTIC REGRESSION| P=0.054N | P=0.153N |
|COCH-ARM / FISHERS | P=0.059N | P=0.159N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 6/50 (12%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 2.4% 8.2% | 15.1% 18.1% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 2/22 (9%) 3/16 (19%) |
|FIRST INCIDENCE | 730 (T) 299 | 683 477 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.216 | P=0.356 |
|POLY 3 | P=0.423 | P=0.482 |
|POLY 1.5 | P=0.444 | P=0.484 |
|POLY 6 | P=0.465 | P=0.475 |
|LOGISTIC REGRESSION| P=0.745 | P=0.464 |
|COCH-ARM / FISHERS | P=0.500 | P=0.500 |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.8% 8.3% | 0.0% 2.7% |
|TERMINAL (d) | 2/20 (10%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 730 (T) 506 | --- 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199 | P=0.487 |
|POLY 3 | P=0.578 | P=0.501 |
|POLY 1.5 | P=0.620 | P=0.500 |
|POLY 6 | P=0.574 | P=0.501 |
|LOGISTIC REGRESSION| P=0.686 | P=0.497 |
|COCH-ARM / FISHERS | P=0.691N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.3% | 0.0% 5.4% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 1/16 (6%) |
|FIRST INCIDENCE | --- 553 | --- 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.404 | P=0.191 |
|POLY 3 | P=0.585 | P=0.231 |
|POLY 1.5 | P=0.523 | P=0.233 |
|POLY 6 | P=0.794 | P=0.228 |
|LOGISTIC REGRESSION| P=0.591 | P=0.217 |
|COCH-ARM / FISHERS | P=0.500 | P=0.247 |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 28/50 (56%) | 11/50 (22%) 30/50 (60%) |
|POLY-3 ADJUSTED (b)| 77.0% 76.0% | 27.0% 72.9% |
|TERMINAL (d) | 16/20 (80%) 0/0 (0%) | 6/22 (27%) 16/16 (100%) |
|FIRST INCIDENCE | 521 18 | 569 477 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P<0.001 ** |
|POLY 3 | P=0.585N | P<0.001 ** |
|POLY 1.5 | P=0.299N | P<0.001 ** |
|POLY 6 | P=0.328 | P<0.001 ** |
|LOGISTIC REGRESSION| P=0.451N | P<0.001 ** |
|COCH-ARM / FISHERS | P=0.072N | P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 14.1% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 553 --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.471N | (e) |
|POLY 3 | P=0.139N | (e) |
|POLY 1.5 | P=0.055N | (e) |
|POLY 6 | P=0.473N | (e) |
|LOGISTIC REGRESSION| P=0.065N | (e) |
|COCH-ARM / FISHERS | P=0.013N* | (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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration Fatty |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 626 --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.672N | (e) |
|POLY 3 | P=0.544N | (e) |
|POLY 1.5 | P=0.380N | (e) |
|POLY 6 | P=0.857N | (e) |
|LOGISTIC REGRESSION| P=0.249N | (e) |
|COCH-ARM / FISHERS | P=0.247N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 26/50 (52%) | 1/50 (2%) 31/50 (62%) |
|POLY-3 ADJUSTED (b)| 0.0% 68.9% | 2.5% 70.8% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 1/22 (5%) 15/16 (94%) |
|FIRST INCIDENCE | --- 18 | 730 (T) 281 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P<0.001 ** |
|POLY 3 | P<0.001 ** | P<0.001 ** |
|POLY 1.5 | P<0.001 ** | P<0.001 ** |
|POLY 6 | P<0.001 ** | P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** | P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** | P<0.001 ** |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 27/50 (54%) | 1/50 (2%) 34/50 (68%) |
|POLY-3 ADJUSTED (b)| 31.5% 69.5% | 2.5% 77.4% |
|TERMINAL (d) | 5/20 (25%) 0/0 (0%) | 1/22 (5%) 16/16 (100%) |
|FIRST INCIDENCE | 521 18 | 730 (T) 331 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P<0.001 ** |
|POLY 3 | P<0.001 ** | P<0.001 ** |
|POLY 1.5 | P<0.001 ** | P<0.001 ** |
|POLY 6 | P<0.001 ** | P<0.001 ** |
|LOGISTIC REGRESSION| P=0.304 | P<0.001 ** |
|COCH-ARM / FISHERS | P=0.007 ** | P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/49 (4%) | 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 4.8% 8.6% | 2.5% 5.3% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 668 528 | 641 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099 | P=0.474 |
|POLY 3 | P=0.572 | P=0.487 |
|POLY 1.5 | P=0.613 | P=0.491 |
|POLY 6 | P=0.578 | P=0.483 |
|LOGISTIC REGRESSION| P=0.588 | P=0.494 |
|COCH-ARM / FISHERS | P=0.684 | P=0.500 |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) | 2/50 (4%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.4% | 5.1% 13.3% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 1/22 (5%) 3/16 (19%) |
|FIRST INCIDENCE | --- 589 | 644 641 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.353 | P=0.144 |
|POLY 3 | P=0.589 | P=0.196 |
|POLY 1.5 | P=0.525 | P=0.202 |
|POLY 6 | P=0.800 | P=0.188 |
|LOGISTIC REGRESSION| P=0.533 | P=0.188 |
|COCH-ARM / FISHERS | P=0.495 | P=0.218 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.8% 4.5% | 0.0% 2.7% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 1/16 (6%) |
|FIRST INCIDENCE | 652 680 | --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.185 | P=0.436 |
|POLY 3 | P=0.795N | P=0.501 |
|POLY 1.5 | P=0.669N | P=0.500 |
|POLY 6 | P=0.858 | P=0.502 |
|LOGISTIC REGRESSION| P=0.699 | P=0.436 |
|COCH-ARM / FISHERS | P=0.508N | P=0.500 |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 18/49 (37%) | 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 9.5% 58.5% | 0.0% 5.4% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 1/16 (6%) |
|FIRST INCIDENCE | 626 502 | --- 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.205 |
|POLY 3 | P<0.001 ** | P=0.231 |
|POLY 1.5 | P<0.001 ** | P=0.233 |
|POLY 6 | P<0.001 ** | P=0.229 |
|LOGISTIC REGRESSION| P<0.001 ** | P=0.230 |
|COCH-ARM / FISHERS | P<0.001 ** | P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | 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%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 639 --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.916N | (e) |
|POLY 3 | P=0.539N | (e) |
|POLY 1.5 | P=0.378N | (e) |
|POLY 6 | P=0.850N | (e) |
|LOGISTIC REGRESSION| P=0.500N | (e) |
|COCH-ARM / FISHERS | P=0.247N | (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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 1/46 (2%) | 27/50 (54%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 29.6% 4.7% | 60.7% 25.6% |
|TERMINAL (d) | 4/20 (20%) 0/0 (0%) | 11/22 (50%) 5/16 (31%) |
|FIRST INCIDENCE | 521 589 | 407 459 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.444N | P=0.011N* |
|POLY 3 | P=0.050N | P<0.001N** |
|POLY 1.5 | P=0.010N* | P<0.001N** |
|POLY 6 | P=0.325N | P=0.002N** |
|LOGISTIC REGRESSION| P=0.008N** | P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** | P<0.001N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/46 (2%) | 10/50 (20%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.4% 4.6% | 25.1% 13.4% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 7/22 (32%) 3/16 (19%) |
|FIRST INCIDENCE | 642 502 | 598 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.541 | P=0.275N |
|POLY 3 | P=0.742 | P=0.155N |
|POLY 1.5 | P=0.732 | P=0.148N |
|POLY 6 | P=0.830 | P=0.167N |
|LOGISTIC REGRESSION| P=0.749N | P=0.174N |
|COCH-ARM / FISHERS | P=0.731 | P=0.131N |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/46 (0%) | 8/50 (16%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% | 19.7% 5.3% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 2/22 (9%) 0/16 (0%) |
|FIRST INCIDENCE | --- --- | 597 641 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.086N |
|POLY 3 | (e) | P=0.058N |
|POLY 1.5 | (e) | P=0.054N |
|POLY 6 | (e) | P=0.066N |
|LOGISTIC REGRESSION| (e) | P=0.053N |
|COCH-ARM / FISHERS | (e) | P=0.046N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/5 (100%) 0/1 (0%) | 5/6 (83%) 2/3 (67%) |
|POLY-3 ADJUSTED (b)| 100.0% 0.0% | 90.1% 81.6% |
|TERMINAL (d) | 2/2 (100%) 0/0 (0%) | 1/1 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 553 --- | 569 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.938N | P=0.230N |
|POLY 3 | P=1.000 | P=0.941N |
|POLY 1.5 | P=1.000N | P=0.831N |
|POLY 6 | P=1.000 | P=1.000N |
|LOGISTIC REGRESSION| (e) | P=0.700N |
|COCH-ARM / FISHERS | P=0.167N | P=0.583N |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 9/50 (18%) | 8/50 (16%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 25.4% 33.7% | 20.0% 7.8% |
|TERMINAL (d) | 2/20 (10%) 0/0 (0%) | 4/22 (18%) 0/16 (0%) |
|FIRST INCIDENCE | 603 517 | 609 331 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.177N |
|POLY 3 | P=0.362 | P=0.108N |
|POLY 1.5 | P=0.542 | P=0.106N |
|POLY 6 | P=0.163 | P=0.113N |
|LOGISTIC REGRESSION| P=0.390 | P=0.107N |
|COCH-ARM / FISHERS | P=0.402N | P=0.100N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| | 5.0% 10.6% |
|TERMINAL (d) | | 0/22 (0%) 3/16 (19%) |
|FIRST INCIDENCE | | 598 281 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.266 |
|POLY 3 | | P=0.315 |
|POLY 1.5 | | P=0.323 |
|POLY 6 | | P=0.300 |
|LOGISTIC REGRESSION| | P=0.361 |
|COCH-ARM / FISHERS | | P=0.339 |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/49 (4%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 7.2% 8.8% | 0.0% 2.7% |
|TERMINAL (d) | 2/20 (10%) 0/0 (0%) | 0/22 (0%) 1/16 (6%) |
|FIRST INCIDENCE | 652 638 | --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011 * | P=0.436 |
|POLY 3 | P=0.683 | P=0.501 |
|POLY 1.5 | P=0.688N | P=0.500 |
|POLY 6 | P=0.659 | P=0.502 |
|LOGISTIC REGRESSION| P=0.294 | P=0.436 |
|COCH-ARM / FISHERS | P=0.510N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 10/49 (20%) | 10/50 (20%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 45.6% 36.0% | 24.6% 10.4% |
|TERMINAL (d) | 9/20 (45%) 0/0 (0%) | 4/22 (18%) 1/16 (6%) |
|FIRST INCIDENCE | 553 299 | 555 331 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** | P=0.147N |
|POLY 3 | P=0.320N | P=0.084N |
|POLY 1.5 | P=0.132N | P=0.080N |
|POLY 6 | P=0.620 | P=0.093N |
|LOGISTIC REGRESSION| P=0.194N | P=0.077N |
|COCH-ARM / FISHERS | P=0.028N* | P=0.074N |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.7% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 4/20 (20%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 730 (T) --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N | (e) |
|POLY 3 | P=0.266N | (e) |
|POLY 1.5 | P=0.144N | (e) |
|POLY 6 | P=0.612N | (e) |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | P=0.061N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/48 (35%) 25/46 (54%) | 0/44 (0%) 3/45 (7%) |
|POLY-3 ADJUSTED (b)| 40.5% 74.9% | 0.0% 8.5% |
|TERMINAL (d) | 7/20 (35%) 0/0 (0%) | 0/18 (0%) 1/16 (6%) |
|FIRST INCIDENCE | 626 502 | --- 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.105 |
|POLY 3 | P<0.001 ** | P=0.122 |
|POLY 1.5 | P=0.007 ** | P=0.122 |
|POLY 6 | P<0.001 ** | P=0.120 |
|LOGISTIC REGRESSION| P<0.001 ** | P=0.122 |
|COCH-ARM / FISHERS | P=0.050 | P=0.125 |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/46 (2%) | 0/44 (0%) 0/45 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 4.6% | 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 0/18 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 668 674 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.200 | (e) |
|POLY 3 | P=0.800N | (e) |
|POLY 1.5 | P=0.674N | (e) |
|POLY 6 | P=0.859 | (e) |
|LOGISTIC REGRESSION| P=0.595 | (e) |
|COCH-ARM / FISHERS | P=0.516N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 4/50 (8%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% | 9.9% 5.4% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 1/22 (5%) 1/16 (6%) |
|FIRST INCIDENCE | 529 --- | 616 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.569N | P=0.412N |
|POLY 3 | P=0.543N | P=0.388N |
|POLY 1.5 | P=0.380N | P=0.374N |
|POLY 6 | P=0.854N | P=0.409N |
|LOGISTIC REGRESSION| P=0.231N | P=0.360N |
|COCH-ARM / FISHERS | P=0.247N | P=0.349N |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) | 3/50 (6%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.3% | 7.5% 8.1% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 2/22 (9%) 0/16 (0%) |
|FIRST INCIDENCE | --- 592 | 569 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311 | P=0.564 |
|POLY 3 | P=0.586 | P=0.635 |
|POLY 1.5 | P=0.524 | P=0.640 |
|POLY 6 | P=0.798 | P=0.630 |
|LOGISTIC REGRESSION| P=0.531 | P=0.633 |
|COCH-ARM / FISHERS | P=0.500 | P=0.651 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 1/50 (2%) | 11/50 (22%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 26.1% 4.3% | 27.0% 15.9% |
|TERMINAL (d) | 8/20 (40%) 0/0 (0%) | 6/22 (27%) 3/16 (19%) |
|FIRST INCIDENCE | 529 556 | 459 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.664 | P=0.268N |
|POLY 3 | P=0.055N | P=0.179N |
|POLY 1.5 | P=0.014N* | P=0.173N |
|POLY 6 | P=0.309N | P=0.188N |
|LOGISTIC REGRESSION| P=0.244N | P=0.172N |
|COCH-ARM / FISHERS | P=0.002N** | P=0.154N |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) | |
|POLY-3 ADJUSTED (b)| 12.0% 16.1% | |
|TERMINAL (d) | 3/20 (15%) 0/0 (0%) | |
|FIRST INCIDENCE | 668 517 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * | |
|POLY 3 | P=0.520 | |
|POLY 1.5 | P=0.622 | |
|POLY 6 | P=0.397 | |
|LOGISTIC REGRESSION| P=0.536 | |
|COCH-ARM / FISHERS | P=0.500N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) | |
|POLY-3 ADJUSTED (b)| 7.2% 20.1% | |
|TERMINAL (d) | 2/20 (10%) 0/0 (0%) | |
|FIRST INCIDENCE | 642 513 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | |
|POLY 3 | P=0.167 | |
|POLY 1.5 | P=0.233 | |
|POLY 6 | P=0.112 | |
|LOGISTIC REGRESSION| P=0.175 | |
|COCH-ARM / FISHERS | P=0.357 | |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 4/50 (8%) | |
|POLY-3 ADJUSTED (b)| 20.1% 16.1% | |
|TERMINAL (d) | 2/20 (10%) 0/0 (0%) | |
|FIRST INCIDENCE | 521 502 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.479 | |
|POLY 3 | P=0.526N | |
|POLY 1.5 | P=0.310N | |
|POLY 6 | P=0.640 | |
|LOGISTIC REGRESSION| P=0.055N | |
|COCH-ARM / FISHERS | P=0.117N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 9/49 (18%) | |
|POLY-3 ADJUSTED (b)| 35.3% 33.2% | |
|TERMINAL (d) | 4/20 (20%) 0/0 (0%) | |
|FIRST INCIDENCE | 521 502 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.020 * | |
|POLY 3 | P=0.569N | |
|POLY 1.5 | P=0.315N | |
|POLY 6 | P=0.411 | |
|LOGISTIC REGRESSION| P=0.153N | |
|COCH-ARM / FISHERS | P=0.091N | |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Salivary Glands: Submandibular Gland |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 48/48 (100%) | 1/50 (2%) 49/50 (98%) |
|POLY-3 ADJUSTED (b)| 9.2% 100.0% | 2.5% 100.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 16/16 (100%) |
|FIRST INCIDENCE | 344 18 | 555 281 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P<0.001 ** |
|POLY 3 | P<0.001 ** | P<0.001 ** |
|POLY 1.5 | P<0.001 ** | P<0.001 ** |
|POLY 6 | P<0.001 ** | P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** | P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** | P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 0.0% 12.5% | |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | --- 589 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.007 ** | |
|POLY 3 | P=0.086 | |
|POLY 1.5 | P=0.092 | |
|POLY 6 | P=0.112 | |
|LOGISTIC REGRESSION| P=0.079 | |
|COCH-ARM / FISHERS | P=0.121 | |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 0.0% 12.3% | |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | --- 526 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.069 | |
|POLY 3 | P=0.086 | |
|POLY 1.5 | P=0.093 | |
|POLY 6 | P=0.107 | |
|LOGISTIC REGRESSION| P=0.186 | |
|COCH-ARM / FISHERS | P=0.121 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.7% 4.4% | 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 564 674 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.574 | (e) |
|POLY 3 | P=0.793N | (e) |
|POLY 1.5 | P=0.664N | (e) |
|POLY 6 | P=0.860 | (e) |
|LOGISTIC REGRESSION| P=0.533N | (e) |
|COCH-ARM / FISHERS | P=0.500N | (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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 4/49 (8%) | 3/50 (6%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 19.3% 16.9% | 7.5% 38.5% |
|TERMINAL (d) | 4/20 (20%) 0/0 (0%) | 1/22 (5%) 6/16 (38%) |
|FIRST INCIDENCE | 714 528 | 641 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P<0.001 ** |
|POLY 3 | P=0.597N | P<0.001 ** |
|POLY 1.5 | P=0.395N | P<0.001 ** |
|POLY 6 | P=0.593 | P<0.001 ** |
|LOGISTIC REGRESSION| P=0.084 | P<0.001 ** |
|COCH-ARM / FISHERS | P=0.188N | P=0.002 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/49 (8%) | 0/50 (0%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 4.8% 16.2% | 0.0% 30.5% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 0/22 (0%) 4/16 (25%) |
|FIRST INCIDENCE | 729 506 | --- 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027 * | P<0.001 ** |
|POLY 3 | P=0.188 | P<0.001 ** |
|POLY 1.5 | P=0.236 | P<0.001 ** |
|POLY 6 | P=0.151 | P<0.001 ** |
|LOGISTIC REGRESSION| P=0.339 | P<0.001 ** |
|COCH-ARM / FISHERS | P=0.329 | P<0.001 ** |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/49 (10%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.1% 20.2% | 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 588 526 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * | (e) |
|POLY 3 | P=0.163 | (e) |
|POLY 1.5 | P=0.226 | (e) |
|POLY 6 | P=0.111 | (e) |
|LOGISTIC REGRESSION| P=0.353 | (e) |
|COCH-ARM / FISHERS | P=0.346 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 1/49 (2%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 16.7% 4.4% | 0.0% 0.0% |
|TERMINAL (d) | 3/20 (15%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 639 521 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.522 | (e) |
|POLY 3 | P=0.217N | (e) |
|POLY 1.5 | P=0.101N | (e) |
|POLY 6 | P=0.557N | (e) |
|LOGISTIC REGRESSION| P=0.338N | (e) |
|COCH-ARM / FISHERS | P=0.032N* | (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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 29/49 (59%) | 3/50 (6%) 33/49 (67%) |
|POLY-3 ADJUSTED (b)| 0.0% 76.8% | 7.3% 72.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 6/16 (38%) |
|FIRST INCIDENCE | --- 177 | 407 281 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P<0.001 ** |
|POLY 3 | P<0.001 ** | P<0.001 ** |
|POLY 1.5 | P<0.001 ** | P<0.001 ** |
|POLY 6 | P<0.001 ** | P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** | P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** | P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) | 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.7% 4.4% | 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 588 572 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.635 | (e) |
|POLY 3 | P=0.792N | (e) |
|POLY 1.5 | P=0.668N | (e) |
|POLY 6 | P=0.854 | (e) |
|LOGISTIC REGRESSION| P=0.511N | (e) |
|COCH-ARM / FISHERS | P=0.508N | (e) |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 20/49 (41%) | 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 23.1% 63.1% | 0.0% 0.0% |
|TERMINAL (d) | 2/20 (10%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 588 502 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | (e) |
|POLY 3 | P<0.001 ** | (e) |
|POLY 1.5 | P=0.002 ** | (e) |
|POLY 6 | P<0.001 ** | (e) |
|LOGISTIC REGRESSION| P=0.003 ** | (e) |
|COCH-ARM / FISHERS | P=0.021 * | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/49 (16%) | 3/50 (6%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 9.3% 29.7% | 7.5% 7.9% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 1/22 (5%) 0/16 (0%) |
|FIRST INCIDENCE | 521 437 | 598 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * | P=0.622 |
|POLY 3 | P=0.042 * | P=0.643 |
|POLY 1.5 | P=0.078 | P=0.647 |
|POLY 6 | P=0.016 * | P=0.637 |
|LOGISTIC REGRESSION| P=0.380 | P=0.655 |
|COCH-ARM / FISHERS | P=0.168 | P=0.651 |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Neuroendocrine Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 8/49 (16%) | 0/50 (0%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 30.9% | 0.0% 7.9% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 1/16 (6%) |
|FIRST INCIDENCE | --- 528 | --- 528 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.104 |
|POLY 3 | P<0.001 ** | P=0.114 |
|POLY 1.5 | P<0.001 ** | P=0.115 |
|POLY 6 | P<0.001 ** | P=0.112 |
|LOGISTIC REGRESSION| P=0.002 ** | P=0.121 |
|COCH-ARM / FISHERS | P=0.003 ** | P=0.117 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) | |
|POLY-3 ADJUSTED (b)| 7.1% 4.3% | |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | |
|FIRST INCIDENCE | 521 570 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.699 | |
|POLY 3 | P=0.637N | |
|POLY 1.5 | P=0.477N | |
|POLY 6 | P=0.876N | |
|LOGISTIC REGRESSION| P=0.298N | |
|COCH-ARM / FISHERS | P=0.309N | |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) | |
|POLY-3 ADJUSTED (b)| 7.0% 4.3% | |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | 521 502 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.689N | |
|POLY 3 | P=0.637N | |
|POLY 1.5 | P=0.477N | |
|POLY 6 | P=0.877N | |
|LOGISTIC REGRESSION| P=0.191N | |
|COCH-ARM / FISHERS | P=0.309N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes: Tunic |
| Hyperplasia Mesothelium |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 0.0% 12.3% | |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | --- 437 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.045 * | |
|POLY 3 | P=0.086 | |
|POLY 1.5 | P=0.093 | |
|POLY 6 | P=0.107 | |
|LOGISTIC REGRESSION| P=0.196 | |
|COCH-ARM / FISHERS | P=0.121 | |
|=================================================================================================================================|
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 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 17/48 (35%) | 32/50 (64%) 32/48 (67%) |
|POLY-3 ADJUSTED (b)| 50.8% 55.3% | 71.4% 73.2% |
|TERMINAL (d) | 14/20 (70%) 0/0 (0%) | 18/22 (82%) 10/16 (63%) |
|FIRST INCIDENCE | 610 437 | 407 459 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.240 |
|POLY 3 | P=0.461 | P=0.520 |
|POLY 1.5 | P=0.556N | P=0.496 |
|POLY 6 | P=0.199 | P=0.560 |
|LOGISTIC REGRESSION| P=0.356 | P=0.461 |
|COCH-ARM / FISHERS | P=0.254N | P=0.474 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| | 5.0% 0.0% |
|TERMINAL (d) | | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | | 549 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.278N |
|POLY 3 | | P=0.263N |
|POLY 1.5 | | P=0.254N |
|POLY 6 | | P=0.277N |
|LOGISTIC REGRESSION| | P=0.231N |
|COCH-ARM / FISHERS | | 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).