TDMS Study 05187-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus METHYLEUGENOL DATE: 09/16/98
EXPERIMENT: 05187 TEST: 09 TIME: 09:30:17
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 PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus METHYLEUGENOL DATE: 09/16/98
EXPERIMENT: 05187 TEST: 09 TIME: 09:30:17
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B
PATHOLOGIST: MISSING CAS: 93-15-2
Rats(FISCHER 344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Medulla
Brain
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Pancreas
Parathyroid Gland
Pituitary Gland
Salivary Glands
Spleen
Testes
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus METHYLEUGENOL DATE: 09/16/98
EXPERIMENT: 05187 TEST: 09 TIME: 09:30:17
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 Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Kidney: Renal Tubule Adenoma
Carcinoma or Adenoma
Liver Cholangioma
Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Hepatocholangiocarcinoma
Hepatocholangioma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Skin
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
Fibroma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
Squamous Cell Papilloma, Papilloma, or Keratoacanthoma
Stomach, Glandular Neuroendocrine Tumor, Benign
Neuroendocrine Tumor, Malignant
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Mesothelioma: Benign, Malignant, NOS
Mesothelioma: Malignant
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Hepatocholangiocarcinoma
Hepatocholangioma
Stomach, Glandular Neuroendocrine Tumor, Benign
Neuroendocrine Tumor, Malignant
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus METHYLEUGENOL DATE: 09/16/98
EXPERIMENT: 05187 TEST: 09 TIME: 09:30:17
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B
PATHOLOGIST: MISSING CAS: 93-15-2
Uterus Polyp Stromal
All Organs Malignant Tumors
===============================================================
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 1
Statistical Analysis of Primary Tumors 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 Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 9/50 (18%) | 1/50 (2%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 54.5% 33.4% | 2.5% 16.0% |
|TERMINAL (d) | 9/20 (45%) 0/0 (0%) | 0/22 (0%) 4/16 (25%) |
|FIRST INCIDENCE | 588 495 | 698 641 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.031 * |
|POLY 3 | P=0.078N | P=0.047 * |
|POLY 1.5 | P=0.014N* | P=0.050 |
|POLY 6 | P=0.447N | P=0.044 * |
|LOGISTIC REGRESSION| P=0.303N | P=0.044 * |
|COCH-ARM / FISHERS | P<0.001N** | P=0.056 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 9/50 (18%) | 1/50 (2%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 56.8% 33.4% | 2.5% 16.0% |
|TERMINAL (d) | 10/20 (50%) 0/0 (0%) | 0/22 (0%) 4/16 (25%) |
|FIRST INCIDENCE | 588 495 | 698 641 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.031 * |
|POLY 3 | P=0.052N | P=0.047 * |
|POLY 1.5 | P=0.008N** | P=0.050 |
|POLY 6 | P=0.381N | P=0.044 * |
|LOGISTIC REGRESSION| P=0.291N | P=0.044 * |
|COCH-ARM / FISHERS | P<0.001N** | P=0.056 |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 2
Statistical Analysis of Primary Tumors 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/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 6/50 (12%) | 5/48 (10%) 4/48 (8%) |
|POLY-3 ADJUSTED (b)| 21.2% 23.2% | 13.1% 11.3% |
|TERMINAL (d) | 4/20 (20%) 0/0 (0%) | 3/21 (14%) 3/15 (20%) |
|FIRST INCIDENCE | 610 437 | 679 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.007 ** | P=0.618 |
|POLY 3 | P=0.586 | P=0.556N |
|POLY 1.5 | P=0.532N | P=0.538N |
|POLY 6 | P=0.380 | P=0.580N |
|LOGISTIC REGRESSION| P=0.564N | P=0.584N |
|COCH-ARM / FISHERS | P=0.288N | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) | 1/48 (2%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 11.9% 0.0% | 2.6% 0.0% |
|TERMINAL (d) | 2/20 (10%) 0/0 (0%) | 1/21 (5%) 0/15 (0%) |
|FIRST INCIDENCE | 564 --- | 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.622N | P=0.567N |
|POLY 3 | P=0.190N | P=0.534N |
|POLY 1.5 | P=0.087N | P=0.523N |
|POLY 6 | P=0.534N | P=0.548N |
|LOGISTIC REGRESSION| P=0.215N | (e) |
|COCH-ARM / FISHERS | P=0.028N* | P=0.500N |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 3
Statistical Analysis of Primary Tumors 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/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 6/50 (12%) | 6/48 (13%) 4/48 (8%) |
|POLY-3 ADJUSTED (b)| 32.4% 23.2% | 15.7% 11.3% |
|TERMINAL (d) | 6/20 (30%) 0/0 (0%) | 4/21 (19%) 3/15 (20%) |
|FIRST INCIDENCE | 564 437 | 679 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.020 * | P=0.543N |
|POLY 3 | P=0.337N | P=0.424N |
|POLY 1.5 | P=0.152N | P=0.406N |
|POLY 6 | P=0.686 | P=0.447N |
|LOGISTIC REGRESSION| P=0.252N | P=0.458N |
|COCH-ARM / FISHERS | P=0.039N* | P=0.370N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR 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 | 704 --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N | (e) |
|POLY 3 | P=0.380N | (e) |
|POLY 1.5 | P=0.235N | (e) |
|POLY 6 | P=0.726N | (e) |
|LOGISTIC REGRESSION| P=0.821N | (e) |
|COCH-ARM / FISHERS | P=0.125N | (e) |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 4
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/49 (0%) | 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 0.0% | 2.5% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 1/22 (5%) 0/16 (0%) |
|FIRST INCIDENCE | 704 --- | 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N | P=0.564N |
|POLY 3 | P=0.380N | P=0.524N |
|POLY 1.5 | P=0.235N | P=0.517N |
|POLY 6 | P=0.726N | P=0.536N |
|LOGISTIC REGRESSION| P=0.821N | (e) |
|COCH-ARM / FISHERS | P=0.125N | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 8/50 (16%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 31.2% | 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 712 528 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | (e) |
|POLY 3 | P=0.018 * | (e) |
|POLY 1.5 | P=0.039 * | (e) |
|POLY 6 | P=0.006 ** | (e) |
|LOGISTIC REGRESSION| P=0.002 ** | (e) |
|COCH-ARM / FISHERS | P=0.100 | (e) |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 5
Statistical Analysis of Primary Tumors 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 |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/50 (16%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.6% 31.2% | 0.0% 0.0% |
|TERMINAL (d) | 2/20 (10%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 712 528 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | (e) |
|POLY 3 | P=0.039 * | (e) |
|POLY 1.5 | P=0.078 | (e) |
|POLY 6 | P=0.014 * | (e) |
|LOGISTIC REGRESSION| P=0.003 ** | (e) |
|COCH-ARM / FISHERS | P=0.178 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Cholangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.5% | 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | --- 592 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * | (e) |
|POLY 3 | P=0.228 | (e) |
|POLY 1.5 | P=0.217 | (e) |
|POLY 6 | P=0.334 | (e) |
|LOGISTIC REGRESSION| P=0.185 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 6
Statistical Analysis of Primary Tumors 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 |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 32/50 (64%) | 1/50 (2%) 43/50 (86%) |
|POLY-3 ADJUSTED (b)| 12.0% 83.0% | 2.5% 96.5% |
|TERMINAL (d) | 2/20 (10%) 0/0 (0%) | 1/22 (5%) 16/16 (100%) |
|FIRST INCIDENCE | 715 437 | 730 (T) 459 |
|-------------------| | |
|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 |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 36/50 (72%) | 0/50 (0%) 22/50 (44%) |
|POLY-3 ADJUSTED (b)| 4.8% 89.1% | 0.0% 53.8% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 0/22 (0%) 8/16 (50%) |
|FIRST INCIDENCE | 529 437 | --- 459 |
|-------------------| | |
|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: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 7
Statistical Analysis of Primary Tumors 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 |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 45/50 (90%) | 1/50 (2%) 43/50 (86%) |
|POLY-3 ADJUSTED (b)| 16.6% 99.4% | 2.5% 96.5% |
|TERMINAL (d) | 3/20 (15%) 0/0 (0%) | 1/22 (5%) 16/16 (100%) |
|FIRST INCIDENCE | 529 437 | 730 (T) 459 |
|-------------------| | |
|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 |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 45/50 (90%) | 1/50 (2%) 43/50 (86%) |
|POLY-3 ADJUSTED (b)| 16.6% 99.4% | 2.5% 96.5% |
|TERMINAL (d) | 3/20 (15%) 0/0 (0%) | 1/22 (5%) 16/16 (100%) |
|FIRST INCIDENCE | 529 437 | 730 (T) 459 |
|-------------------| | |
|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: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 8
Statistical Analysis of Primary Tumors 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 |
| Hepatocholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 7/50 (14%) | 0/50 (0%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 0.0% 27.1% | 0.0% 23.6% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 3/16 (19%) |
|FIRST INCIDENCE | --- 506 | --- 641 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P<0.001 ** |
|POLY 3 | P<0.001 ** | P<0.001 ** |
|POLY 1.5 | P=0.003 ** | P<0.001 ** |
|POLY 6 | P<0.001 ** | P<0.001 ** |
|LOGISTIC REGRESSION| P=0.006 ** | P=0.002 ** |
|COCH-ARM / FISHERS | P=0.006 ** | P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocholangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 6/50 (12%) | 0/50 (0%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 0.0% 23.1% | 0.0% 20.9% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 3/16 (19%) |
|FIRST INCIDENCE | --- 502 | --- 609 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** | P=0.003 ** |
|POLY 3 | P=0.004 ** | P=0.003 ** |
|POLY 1.5 | P=0.007 ** | P=0.003 ** |
|POLY 6 | P=0.003 ** | P=0.003 ** |
|LOGISTIC REGRESSION| P=0.029 * | P=0.004 ** |
|COCH-ARM / FISHERS | P=0.013 * | P=0.003 ** |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 9
Statistical Analysis of Primary Tumors 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 |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) | 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% | 5.1% 10.6% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 2/22 (9%) 1/16 (6%) |
|FIRST INCIDENCE | 730 (T) --- | 730 (T) 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N | P=0.246 |
|POLY 3 | P=0.787N | P=0.320 |
|POLY 1.5 | P=0.649N | P=0.324 |
|POLY 6 | P=0.967N | P=0.315 |
|LOGISTIC REGRESSION| (e) | P=0.304 |
|COCH-ARM / FISHERS | P=0.500N | P=0.339 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) | 2/50 (4%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% | 5.1% 13.3% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 2/22 (9%) 2/16 (13%) |
|FIRST INCIDENCE | 730 (T) --- | 730 (T) 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N | P=0.137 |
|POLY 3 | P=0.787N | P=0.199 |
|POLY 1.5 | P=0.649N | P=0.204 |
|POLY 6 | P=0.967N | P=0.194 |
|LOGISTIC REGRESSION| (e) | P=0.183 |
|COCH-ARM / FISHERS | P=0.500N | P=0.218 |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 10
Statistical Analysis of Primary Tumors 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 |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) | 36/50 (72%) 30/50 (60%) |
|POLY-3 ADJUSTED (b)| 12.0% 23.4% | 78.7% 74.3% |
|TERMINAL (d) | 4/20 (20%) 0/0 (0%) | 15/22 (68%) 14/16 (88%) |
|FIRST INCIDENCE | 610 380 | 407 609 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.535 |
|POLY 3 | P=0.231 | P=0.412N |
|POLY 1.5 | P=0.332 | P=0.288N |
|POLY 6 | P=0.132 | P=0.593N |
|LOGISTIC REGRESSION| P=0.291 | P=0.209N |
|COCH-ARM / FISHERS | P=0.500 | P=0.146N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) | 36/50 (72%) 30/50 (60%) |
|POLY-3 ADJUSTED (b)| 12.0% 23.4% | 78.7% 74.3% |
|TERMINAL (d) | 4/20 (20%) 0/0 (0%) | 15/22 (68%) 14/16 (88%) |
|FIRST INCIDENCE | 610 380 | 407 609 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.535 |
|POLY 3 | P=0.231 | P=0.412N |
|POLY 1.5 | P=0.332 | P=0.288N |
|POLY 6 | P=0.132 | P=0.593N |
|LOGISTIC REGRESSION| P=0.291 | P=0.209N |
|COCH-ARM / FISHERS | P=0.500 | P=0.146N |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 11
Statistical Analysis of Primary Tumors 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 |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) | 37/50 (74%) 31/50 (62%) |
|POLY-3 ADJUSTED (b)| 12.0% 23.4% | 80.9% 75.8% |
|TERMINAL (d) | 4/20 (20%) 0/0 (0%) | 16/22 (73%) 14/16 (88%) |
|FIRST INCIDENCE | 610 380 | 407 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.524 |
|POLY 3 | P=0.231 | P=0.374N |
|POLY 1.5 | P=0.332 | P=0.268N |
|POLY 6 | P=0.132 | P=0.531N |
|LOGISTIC REGRESSION| P=0.291 | P=0.205N |
|COCH-ARM / FISHERS | P=0.500 | P=0.142N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) | 22/50 (44%) 19/49 (39%) |
|POLY-3 ADJUSTED (b)| 16.3% 12.3% | 51.8% 48.8% |
|TERMINAL (d) | 3/20 (15%) 0/0 (0%) | 10/22 (46%) 9/16 (56%) |
|FIRST INCIDENCE | 521 502 | 549 477 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.305 | P=0.484 |
|POLY 3 | P=0.530N | P=0.483N |
|POLY 1.5 | P=0.340N | P=0.446N |
|POLY 6 | P=0.703 | P=0.537N |
|LOGISTIC REGRESSION| P=0.208N | P=0.447N |
|COCH-ARM / FISHERS | P=0.159N | P=0.373N |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 12
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 7.2% 12.4% | 0.0% 2.7% |
|TERMINAL (d) | 3/20 (15%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 730 (T) 528 | --- 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046 * | P=0.494 |
|POLY 3 | P=0.480 | P=0.501 |
|POLY 1.5 | P=0.552 | P=0.500 |
|POLY 6 | P=0.419 | P=0.501 |
|LOGISTIC REGRESSION| P=0.430 | P=0.499 |
|COCH-ARM / FISHERS | P=0.661N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) | 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 16.3% | 2.5% 2.7% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 730 (T) 548 | 724 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** | P=0.732 |
|POLY 3 | P=0.096 | P=0.756 |
|POLY 1.5 | P=0.121 | P=0.757 |
|POLY 6 | P=0.084 | P=0.754 |
|LOGISTIC REGRESSION| P=0.124 | P=0.749 |
|COCH-ARM / FISHERS | P=0.181 | P=0.753N |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 13
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) | 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.4% 16.3% | 2.5% 5.3% |
|TERMINAL (d) | 1/20 (5%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 730 (T) 548 | 724 641 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** | P=0.464 |
|POLY 3 | P=0.096 | P=0.490 |
|POLY 1.5 | P=0.121 | P=0.492 |
|POLY 6 | P=0.084 | P=0.487 |
|LOGISTIC REGRESSION| P=0.124 | P=0.486 |
|COCH-ARM / FISHERS | P=0.181 | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 8.4% | 0.0% 0.0% |
|TERMINAL (d) | 3/20 (15%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 730 (T) 528 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.146 | (e) |
|POLY 3 | P=0.692 | (e) |
|POLY 1.5 | P=0.670N | (e) |
|POLY 6 | P=0.658 | (e) |
|LOGISTIC REGRESSION| P=0.623 | (e) |
|COCH-ARM / FISHERS | P=0.500N | (e) |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 14
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 12.4% | 0.0% 0.0% |
|TERMINAL (d) | 3/20 (15%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 730 (T) 528 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046 * | (e) |
|POLY 3 | P=0.480 | (e) |
|POLY 1.5 | P=0.552 | (e) |
|POLY 6 | P=0.419 | (e) |
|LOGISTIC REGRESSION| P=0.430 | (e) |
|COCH-ARM / FISHERS | P=0.661N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 12.4% | 0.0% 0.0% |
|TERMINAL (d) | 3/20 (15%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 730 (T) 528 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046 * | (e) |
|POLY 3 | P=0.480 | (e) |
|POLY 1.5 | P=0.552 | (e) |
|POLY 6 | P=0.419 | (e) |
|LOGISTIC REGRESSION| P=0.430 | (e) |
|COCH-ARM / FISHERS | P=0.661N | (e) |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 15
Statistical Analysis of Primary Tumors 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 Tumor, Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.6% | 0.0% 12.8% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | --- 556 | --- 477 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * | P=0.034 * |
|POLY 3 | P=0.228 | P=0.029 * |
|POLY 1.5 | P=0.217 | P=0.029 * |
|POLY 6 | P=0.339 | P=0.029 * |
|LOGISTIC REGRESSION| P=0.162 | P=0.039 * |
|COCH-ARM / FISHERS | P=0.247 | P=0.028 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Neuroendocrine Tumor, Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 36/50 (72%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.5% | 0.0% 86.8% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 16/16 (100%) |
|FIRST INCIDENCE | --- 517 | --- 560 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035 * | P<0.001 ** |
|POLY 3 | P=0.228 | P<0.001 ** |
|POLY 1.5 | P=0.217 | P<0.001 ** |
|POLY 6 | P=0.336 | P<0.001 ** |
|LOGISTIC REGRESSION| P=0.216 | P<0.001 ** |
|COCH-ARM / FISHERS | P=0.247 | P<0.001 ** |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 16
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 43/50 (86%) | |
|POLY-3 ADJUSTED (b)| 96.1% 97.6% | |
|TERMINAL (d) | 20/20 (100%) 0/0 (0%) | |
|FIRST INCIDENCE | 529 437 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | |
|POLY 3 | P=0.615 | |
|POLY 1.5 | P=0.681 | |
|POLY 6 | P=0.680 | |
|LOGISTIC REGRESSION| P=0.053 | |
|COCH-ARM / FISHERS | P=0.262N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/48 (2%) | 2/50 (4%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 14.5% 4.6% | 5.1% 5.4% |
|TERMINAL (d) | 5/20 (25%) 0/0 (0%) | 1/22 (5%) 1/16 (6%) |
|FIRST INCIDENCE | 704 634 | 711 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.145 | P=0.604 |
|POLY 3 | P=0.309N | P=0.680 |
|POLY 1.5 | P=0.164N | P=0.681 |
|POLY 6 | P=0.656N | P=0.676 |
|LOGISTIC REGRESSION| P=0.582 | P=0.661 |
|COCH-ARM / FISHERS | P=0.062N | P=0.676 |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 17
Statistical Analysis of Primary Tumors 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 |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) | 0/50 (0%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% | 0.0% 5.4% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 1/16 (6%) |
|FIRST INCIDENCE | --- --- | --- 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.191 |
|POLY 3 | (e) | P=0.230 |
|POLY 1.5 | (e) | P=0.231 |
|POLY 6 | (e) | P=0.228 |
|LOGISTIC REGRESSION| (e) | P=0.217 |
|COCH-ARM / FISHERS | (e) | P=0.237 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/48 (2%) | 2/50 (4%) 4/48 (8%) |
|POLY-3 ADJUSTED (b)| 14.5% 4.6% | 5.1% 10.7% |
|TERMINAL (d) | 5/20 (25%) 0/0 (0%) | 1/22 (5%) 2/16 (13%) |
|FIRST INCIDENCE | 704 634 | 711 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.145 | P=0.238 |
|POLY 3 | P=0.309N | P=0.316 |
|POLY 1.5 | P=0.164N | P=0.319 |
|POLY 6 | P=0.656N | P=0.310 |
|LOGISTIC REGRESSION| P=0.582 | P=0.292 |
|COCH-ARM / FISHERS | P=0.062N | P=0.319 |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 18
Statistical Analysis of Primary Tumors 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: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/48 (6%) | 1/50 (2%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| 4.8% 13.0% | 2.5% 2.7% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 1/16 (6%) |
|FIRST INCIDENCE | 626 513 | 717 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.050 | P=0.693 |
|POLY 3 | P=0.335 | P=0.755 |
|POLY 1.5 | P=0.386 | P=0.755 |
|POLY 6 | P=0.319 | P=0.752 |
|LOGISTIC REGRESSION| P=0.469 | P=0.724 |
|COCH-ARM / FISHERS | P=0.480 | P=0.742 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | | 4/50 (8%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| | 10.0% 25.2% |
|TERMINAL (d) | | 1/22 (5%) 4/16 (25%) |
|FIRST INCIDENCE | | 641 331 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.048 * |
|POLY 3 | | P=0.065 |
|POLY 1.5 | | P=0.067 |
|POLY 6 | | P=0.062 |
|LOGISTIC REGRESSION| | P=0.074 |
|COCH-ARM / FISHERS | | P=0.074 |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 19
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) | 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.4% 4.3% | 0.0% 7.8% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 712 517 | --- 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.454 | P=0.112 |
|POLY 3 | P=0.741 | P=0.115 |
|POLY 1.5 | P=0.737 | P=0.116 |
|POLY 6 | P=0.820 | P=0.114 |
|LOGISTIC REGRESSION| P=0.793 | P=0.139 |
|COCH-ARM / FISHERS | P=0.753N | P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 1/50 (2%) | 17/50 (34%) 17/50 (34%) |
|POLY-3 ADJUSTED (b)| 56.0% 4.3% | 38.3% 42.3% |
|TERMINAL (d) | 8/20 (40%) 0/0 (0%) | 5/22 (23%) 4/16 (25%) |
|FIRST INCIDENCE | 521 572 | 448 459 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.163N | P=0.395 |
|POLY 3 | P<0.001N** | P=0.442 |
|POLY 1.5 | P<0.001N** | P=0.490 |
|POLY 6 | P=0.033N* | P=0.387 |
|LOGISTIC REGRESSION| P<0.001N** | P=0.572 |
|COCH-ARM / FISHERS | P<0.001N** | P=0.583N |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 20
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 19.8% | 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 564 556 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * | (e) |
|POLY 3 | P=0.041 * | (e) |
|POLY 1.5 | P=0.058 | (e) |
|POLY 6 | P=0.030 * | (e) |
|LOGISTIC REGRESSION| P=0.141 | (e) |
|COCH-ARM / FISHERS | P=0.102 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 19.8% | 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/0 (0%) | 0/22 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 564 556 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * | (e) |
|POLY 3 | P=0.041 * | (e) |
|POLY 1.5 | P=0.058 | (e) |
|POLY 6 | P=0.030 * | (e) |
|LOGISTIC REGRESSION| P=0.141 | (e) |
|COCH-ARM / FISHERS | P=0.102 | (e) |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 21
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 46/50 (92%) | 43/50 (86%) 46/50 (92%) |
|POLY-3 ADJUSTED (b)| 99.8% 99.8% | 91.9% 98.9% |
|TERMINAL (d) | 20/20 (100%) 0/0 (0%) | 20/22 (91%) 16/16 (100%) |
|FIRST INCIDENCE | 521 380 | 407 331 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.087 |
|POLY 3 | P=1.000N | P=0.095 |
|POLY 1.5 | P=0.951N | P=0.109 |
|POLY 6 | P=1.000 | P=0.119 |
|LOGISTIC REGRESSION| (e) | P=0.083 |
|COCH-ARM / FISHERS | P=0.181N | P=0.262 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 300 | 0 MG/KG 300 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 43/50 (86%) | 22/50 (44%) 39/50 (78%) |
|POLY-3 ADJUSTED (b)| 68.9% 96.8% | 48.5% 87.9% |
|TERMINAL (d) | 12/20 (60%) 0/0 (0%) | 7/22 (32%) 13/16 (81%) |
|FIRST INCIDENCE | 344 380 | 407 459 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.002 ** |
|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=0.017 * | P<0.001 ** |
|=================================================================================================================================|
Date: 09/16/98 EXPERIMENT: 05187 TEST: 09 Page 22
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 46/50 (92%) | 47/50 (94%) 47/50 (94%) |
|POLY-3 ADJUSTED (b)| 100.0% 99.8% | 95.8% 99.7% |
|TERMINAL (d) | 20/20 (100%) 0/0 (0%) | 20/22 (91%) 16/16 (100%) |
|FIRST INCIDENCE | 344 380 | 407 331 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.179 |
|POLY 3 | P=1.000N | P=0.275 |
|POLY 1.5 | P=0.920N | P=0.363 |
|POLY 6 | P=1.000N | P=0.253 |
|LOGISTIC REGRESSION| (e) | P=0.434 |
|COCH-ARM / FISHERS | P=0.059N | P=0.661N |
|=================================================================================================================================|
(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).