TDMS Study 92012-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst 2-METHYLIMIDAZOLE DATE: 02/24/03
EXPERIMENT: 92012 TEST: 05 TIME: 14:27:17
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92012B
PATHOLOGIST: FARNELL, DANIEL R. CAS: 693-98-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1/RATS
REASONS FOR REMOVAL: 25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst 2-METHYLIMIDAZOLE DATE: 02/24/03
EXPERIMENT: 92012 TEST: 05 TIME: 14:27:17
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92012B
PATHOLOGIST: FARNELL, DANIEL R. CAS: 693-98-1
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 Cortex
Adrenal Medulla
Brain
Clitoral/Preputial Gland
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Pituitary Gland
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst 2-METHYLIMIDAZOLE DATE: 02/24/03
EXPERIMENT: 92012 TEST: 05 TIME: 14:27:17
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92012B
PATHOLOGIST: FARNELL, DANIEL R. CAS: 693-98-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF 2-METHYLIMIDAZOLE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Bone Osteoma
Osteosarcoma
Clitoral/Preputial Gland Carcinoma or Adenoma
Islets, Pancreatic Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Skin Basal Cell Carcinoma
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor (malignant or NOS), or Carcinoma
Testes Adenoma
Thyroid Gland: C-Cell Carcinoma
Thyroid Gland: Follicular Cell Carcinoma or Adenoma
All Organs Osteoma
Osteosarcoma
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Adenoma
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Islets, Pancreatic Carcinoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin
Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, malignant or NOS), or Trichoepithelioma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
Thyroid Gland: Follicular Cell Adenoma
Carcinoma
Carcinoma or Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |5/50 (10%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.13 1/45.93 0/44.49 0/43.91 |5/46.87 0/44.59 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |10.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 0/36 (0%) 0/35 (0%) |3/40 (8%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |588 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.586N P=0.527 (e) (e) |P=0.015N* P=0.039N* P=0.065N P=0.031N* |
|POLY 3 | P=0.579N P=0.499 (e) (e) |P=0.010N* P=0.035N* P=0.044N* P=0.029N* |
|POLY 1.5 | P=0.578N P=0.500 (e) (e) |P=0.010N* P=0.034N* P=0.038N* P=0.029N* |
|POLY 6 | P=0.579N P=0.499 (e) (e) |P=0.010N* P=0.036N* P=0.053N P=0.028N* |
|LOGISTIC REGRESSION| (e) P=0.527 (e) (e) |P=0.011N* P=0.033N* P=0.028N* P=0.040N* |
|COCH-ARM / FISHERS | P=0.576N P=0.500 (e) (e) |P=0.012N* P=0.030N* P=0.028N* P=0.028N* |
|ORDER RESTRICTED | P=0.389N (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 3/50 (6%) 6/50 (12%) 6/50 (12%) |0/49 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 8/46.55 3/45.93 6/44.98 6/44.15 |0/45.00 2/44.59 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 17.2% 6.5% 13.3% 13.6% |0.0% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 5/35 (14%) 3/40 (8%) 5/36 (14%) 4/35 (11%) |0/39 (0%) 2/39 (5%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 689 729 (T) 583 689 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.515 P=0.079N P=0.382N P=0.407N |P=0.351N P=0.238 (e) (e) |
|POLY 3 | P=0.526 P=0.102N P=0.413N P=0.428N |P=0.350N P=0.235 (e) (e) |
|POLY 1.5 | P=0.537 P=0.101N P=0.403N P=0.414N |P=0.350N P=0.236 (e) (e) |
|POLY 6 | P=0.517 P=0.104N P=0.421N P=0.441N |P=0.349N P=0.235 (e) (e) |
|LOGISTIC REGRESSION| P=0.522 P=0.101N P=0.407N P=0.430N |(e) P=0.238 (e) (e) |
|COCH-ARM / FISHERS | P=0.562 P=0.100N P=0.387N P=0.387N |P=0.348N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.304N (e) (e) (e) |P=0.233N (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |0/49 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.13 1/45.93 3/44.49 1/43.91 |0/45.00 0/44.59 1/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 6.7% 2.3% |0.0% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 3/36 (8%) 1/35 (3%) |0/39 (0%) 0/39 (0%) 1/28 (4%) 0/42 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491 P=0.527 P=0.126 P=0.500 |P=0.677 (e) P=0.434 (e) |
|POLY 3 | P=0.483 P=0.499 P=0.112 P=0.490 |P=0.709 (e) P=0.480 (e) |
|POLY 1.5 | P=0.492 P=0.500 P=0.115 P=0.493 |P=0.699 (e) P=0.490 (e) |
|POLY 6 | P=0.475 P=0.499 P=0.111 P=0.487 |P=0.720 (e) P=0.469 (e) |
|LOGISTIC REGRESSION| (e) P=0.527 P=0.126 P=0.500 |(e) (e) P=0.434 (e) |
|COCH-ARM / FISHERS | P=0.512 P=0.500 P=0.121 P=0.500 |P=0.682 (e) P=0.505 (e) |
|ORDER RESTRICTED | P=0.148 (e) (e) (e) |P=0.364 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 4/50 (8%) 9/50 (18%) 7/50 (14%) |0/49 (0%) 2/49 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 8/46.55 4/45.93 9/44.98 7/44.15 |0/45.00 2/44.59 1/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 17.2% 8.7% 20.0% 15.9% |0.0% 4.5% 2.5% 0.0% |
|TERMINAL (d) | 5/35 (14%) 4/40 (10%) 8/36 (22%) 5/35 (14%) |0/39 (0%) 2/39 (5%) 1/28 (4%) 0/42 (0%) |
|FIRST INCIDENCE | 689 729 (T) 583 689 |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.440 P=0.140N P=0.512 P=0.517N |P=0.416N P=0.238 P=0.434 (e) |
|POLY 3 | P=0.448 P=0.183N P=0.469 P=0.544N |P=0.408N P=0.235 P=0.480 (e) |
|POLY 1.5 | P=0.462 P=0.180N P=0.481 P=0.529N |P=0.412N P=0.236 P=0.490 (e) |
|POLY 6 | P=0.435 P=0.186N P=0.459 P=0.558N |P=0.402N P=0.235 P=0.469 (e) |
|LOGISTIC REGRESSION| P=0.442 P=0.178N P=0.469 P=0.549N |(e) P=0.238 P=0.434 (e) |
|COCH-ARM / FISHERS | P=0.493 P=0.178N P=0.500 P=0.500N |P=0.418N P=0.247 P=0.505 (e) |
|ORDER RESTRICTED | P=0.405 (e) (e) (e) |P=0.299N (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.14 0/45.93 0/44.49 0/43.91 |0/46.00 0/44.99 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/40 (0%) 0/36 (0%) 0/35 (0%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 726 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252N P=0.214N P=0.237N P=0.243N |(e) (e) (e) (e) |
|POLY 3 | P=0.241N P=0.238N P=0.245N P=0.248N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.241N P=0.238N P=0.242N P=0.245N |(e) (e) (e) (e) |
|POLY 6 | P=0.242N P=0.238N P=0.247N P=0.251N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.253N P=0.226N P=0.241N P=0.248N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.242N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.033N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.13 0/45.93 0/44.49 2/44.60 |0/46.00 0/44.99 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/36 (0%) 1/35 (3%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- 491 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.039 * (e) (e) P=0.237 |(e) (e) (e) (e) |
|POLY 3 | P=0.039 * (e) (e) P=0.230 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.040 * (e) (e) P=0.232 |(e) (e) (e) (e) |
|POLY 6 | P=0.039 * (e) (e) P=0.228 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.061 (e) (e) P=0.277 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.027 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.14 0/45.93 0/44.49 2/44.60 |0/46.00 0/44.99 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/40 (0%) 0/36 (0%) 1/35 (3%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 726 --- --- 491 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364 P=0.214N P=0.237N P=0.688 |(e) (e) (e) (e) |
|POLY 3 | P=0.375 P=0.238N P=0.245N P=0.682 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.376 P=0.238N P=0.242N P=0.685 |(e) (e) (e) (e) |
|POLY 6 | P=0.373 P=0.238N P=0.247N P=0.679 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.410 P=0.226N P=0.241N P=0.673N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.381 P=0.247N P=0.247N P=0.691N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.259 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |5/50 (10%) 4/49 (8%) 6/50 (12%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.13 1/45.93 3/44.75 0/43.91 |5/46.10 4/43.99 6/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 6.7% 0.0% |10.9% 9.1% 14.7% 0.0% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 1/36 (3%) 0/35 (0%) |4/40 (10%) 4/38 (11%) 6/28 (21%) 0/42 (0%) |
|FIRST INCIDENCE | --- 729 (T) 673 --- |703 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.520N P=0.527 P=0.123 (e) |P=0.051N P=0.532N P=0.263 P=0.030N* |
|POLY 3 | P=0.524N P=0.499 P=0.113 (e) |P=0.037N* P=0.529N P=0.414 P=0.027N* |
|POLY 1.5 | P=0.516N P=0.500 P=0.115 (e) |P=0.041N* P=0.523N P=0.448 P=0.029N* |
|POLY 6 | P=0.531N P=0.499 P=0.113 (e) |P=0.033N* P=0.535N P=0.372 P=0.026N* |
|LOGISTIC REGRESSION| P=0.513N P=0.527 P=0.117 (e) |P=0.043N* P=0.530N P=0.304 P=0.027N* |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.121 (e) |P=0.048N* P=0.513N P=0.500 P=0.028N* |
|ORDER RESTRICTED | P=0.214 (e) (e) (e) |P=0.025N* (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |3/50 (6%) 2/49 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.13 2/46.50 2/44.63 3/44.07 |3/46.00 2/44.59 1/40.77 1/48.02 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 4.5% 6.8% |6.5% 4.5% 2.5% 2.1% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 1/36 (3%) 2/35 (6%) |3/40 (8%) 1/38 (3%) 1/28 (4%) 1/42 (2%) |
|FIRST INCIDENCE | --- 548 694 687 |729 (T) 538 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.143 P=0.252 P=0.240 P=0.122 |P=0.203N P=0.522N P=0.439N P=0.288N |
|POLY 3 | P=0.142 P=0.239 P=0.230 P=0.111 |P=0.194N P=0.514N P=0.350N P=0.290N |
|POLY 1.5 | P=0.146 P=0.239 P=0.233 P=0.113 |P=0.197N P=0.512N P=0.332N P=0.296N |
|POLY 6 | P=0.138 P=0.240 P=0.229 P=0.109 |P=0.191N P=0.514N P=0.373N P=0.283N |
|LOGISTIC REGRESSION| P=0.159 P=0.209 P=0.231 P=0.111 |P=0.196N P=0.504N P=0.439N P=0.288N |
|COCH-ARM / FISHERS | P=0.156 P=0.247 P=0.247 P=0.121 |P=0.198N P=0.510N P=0.309N P=0.309N |
|ORDER RESTRICTED | P=0.070 (e) (e) (e) |P=0.202N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 5/50 (10%) 3/50 (6%) |8/50 (16%) 6/49 (12%) 7/50 (14%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.13 3/46.50 5/44.89 3/44.07 |8/46.10 6/44.59 7/40.77 1/48.02 |
|POLY-3 PERCENT (g) | 0.0% 6.5% 11.1% 6.8% |17.4% 13.5% 17.2% 2.1% |
|TERMINAL (d) | 0/35 (0%) 2/40 (5%) 2/36 (6%) 2/35 (6%) |7/40 (18%) 5/38 (13%) 7/28 (25%) 1/42 (2%) |
|FIRST INCIDENCE | --- 548 673 687 |703 538 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.267 P=0.138 P=0.036 * P=0.122 |P=0.022N* P=0.427N P=0.426 P=0.015N* |
|POLY 3 | P=0.259 P=0.120 P=0.028 * P=0.111 |P=0.015N* P=0.412N P=0.603N P=0.013N* |
|POLY 1.5 | P=0.269 P=0.120 P=0.029 * P=0.113 |P=0.017N* P=0.409N P=0.562N P=0.014N* |
|POLY 6 | P=0.252 P=0.121 P=0.028 * P=0.109 |P=0.013N* P=0.413N P=0.569 P=0.012N* |
|LOGISTIC REGRESSION| P=0.287 P=0.112 P=0.031 * P=0.111 |P=0.017N* P=0.418N P=0.478 P=0.013N* |
|COCH-ARM / FISHERS | P=0.291 P=0.121 P=0.028 * P=0.121 |P=0.020N* P=0.403N P=0.500N P=0.015N* |
|ORDER RESTRICTED | P=0.052 (e) (e) (e) |P=0.012N* (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.13 0/45.35 1/44.49 3/43.91 |0/46.00 0/44.59 1/40.77 1/48.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 6.8% |0.0% 0.0% 2.5% 2.1% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 1/36 (3%) 3/35 (9%) |0/40 (0%) 0/39 (0%) 1/28 (4%) 1/42 (2%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.018 * (e) P=0.506 P=0.121 |P=0.240 (e) P=0.429 P=0.510 |
|POLY 3 | P=0.019 * (e) P=0.493 P=0.110 |P=0.244 (e) P=0.476 P=0.509 |
|POLY 1.5 | P=0.019 * (e) P=0.495 P=0.113 |P=0.238 (e) P=0.485 P=0.505 |
|POLY 6 | P=0.018 * (e) P=0.491 P=0.108 |P=0.252 (e) P=0.464 P=0.513 |
|LOGISTIC REGRESSION| (e) (e) P=0.506 P=0.121 |(e) (e) P=0.429 P=0.510 |
|COCH-ARM / FISHERS | P=0.022 * (e) P=0.500 P=0.121 |P=0.227 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.018 * (e) (e) (e) |P=0.229 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/49 (6%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.13 3/45.35 0/44.49 0/43.91 |2/46.22 0/44.59 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 0.0% 6.6% 0.0% 0.0% |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 3/40 (8%) 0/36 (0%) 0/35 (0%) |1/40 (3%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |671 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.265N P=0.146 (e) (e) |P=0.134N P=0.243N P=0.307N P=0.222N |
|POLY 3 | P=0.257N P=0.116 (e) (e) |P=0.130N P=0.245N P=0.266N P=0.229N |
|POLY 1.5 | P=0.255N P=0.116 (e) (e) |P=0.129N P=0.244N P=0.254N P=0.232N |
|POLY 6 | P=0.259N P=0.116 (e) (e) |P=0.131N P=0.246N P=0.282N P=0.225N |
|LOGISTIC REGRESSION| (e) P=0.146 (e) (e) |P=0.128N P=0.242N P=0.250N P=0.244N |
|COCH-ARM / FISHERS | P=0.253N P=0.117 (e) (e) |P=0.128N P=0.253N P=0.247N P=0.247N |
|ORDER RESTRICTED | P=0.169N (e) (e) (e) |P=0.027N* (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/49 (6%) 1/50 (2%) 3/50 (6%) |2/50 (4%) 0/49 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.13 3/45.35 1/44.49 3/43.91 |2/46.22 0/44.59 1/40.77 1/48.02 |
|POLY-3 PERCENT (g) | 0.0% 6.6% 2.3% 6.8% |4.3% 0.0% 2.5% 2.1% |
|TERMINAL (d) | 0/35 (0%) 3/40 (8%) 1/36 (3%) 3/35 (9%) |1/40 (3%) 0/39 (0%) 1/28 (4%) 1/42 (2%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |671 --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.195 P=0.146 P=0.506 P=0.121 |P=0.514N P=0.243N P=0.609N P=0.476N |
|POLY 3 | P=0.203 P=0.116 P=0.493 P=0.110 |P=0.519N P=0.245N P=0.544N P=0.487N |
|POLY 1.5 | P=0.209 P=0.116 P=0.495 P=0.113 |P=0.522N P=0.244N P=0.526N P=0.492N |
|POLY 6 | P=0.199 P=0.116 P=0.491 P=0.108 |P=0.517N P=0.246N P=0.565N P=0.481N |
|LOGISTIC REGRESSION| (e) P=0.146 P=0.506 P=0.121 |P=0.513N P=0.242N P=0.547N P=0.501N |
|COCH-ARM / FISHERS | P=0.220 P=0.117 P=0.500 P=0.121 |P=0.524N P=0.253N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.069 (e) (e) (e) |P=0.272N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Cholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.13 2/45.93 2/44.49 1/43.91 |1/46.00 0/44.59 0/40.77 1/48.02 |
|POLY-3 PERCENT (g) | 2.2% 4.4% 4.5% 2.3% |2.2% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 1/35 (3%) 2/40 (5%) 2/36 (6%) 1/35 (3%) |1/40 (3%) 0/39 (0%) 0/28 (0%) 1/42 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.545N P=0.547 P=0.510 P=0.762 |P=0.576 P=0.505N P=0.571N P=0.751N |
|POLY 3 | P=0.541N P=0.498 P=0.487 P=0.750 |P=0.583 P=0.506N P=0.524N P=0.751N |
|POLY 1.5 | P=0.534N P=0.500 P=0.492 P=0.753 |P=0.580 P=0.505N P=0.515N P=0.755N |
|POLY 6 | P=0.546N P=0.499 P=0.485 P=0.747 |P=0.586 P=0.506N P=0.536N P=0.746N |
|LOGISTIC REGRESSION| P=0.545N P=0.547 P=0.510 P=0.762 |P=0.576 (e) (e) P=0.751N |
|COCH-ARM / FISHERS | P=0.521N P=0.500 P=0.500 P=0.753N |P=0.576 P=0.505N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.536 (e) (e) (e) |P=0.399N (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Cholangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.13 2/45.93 0/44.49 0/43.91 |0/46.00 0/44.59 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 2/40 (5%) 0/36 (0%) 0/35 (0%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.380N P=0.268 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.375N P=0.236 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.373N P=0.237 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.377N P=0.236 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.268 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.369N P=0.247 (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.256N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 0/49 (0%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/46.13 1/45.93 3/44.62 2/44.01 |1/46.00 0/44.59 2/40.77 4/48.02 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 6.7% 4.5% |2.2% 0.0% 4.9% 8.3% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 2/36 (6%) 1/35 (3%) |1/40 (3%) 0/39 (0%) 2/28 (7%) 4/42 (10%) |
|FIRST INCIDENCE | --- 729 (T) 696 702 |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.237 P=0.527 P=0.126 P=0.237 |P=0.043 * P=0.505N P=0.376 P=0.194 |
|POLY 3 | P=0.235 P=0.499 P=0.113 P=0.227 |P=0.039 * P=0.506N P=0.458 P=0.192 |
|POLY 1.5 | P=0.241 P=0.500 P=0.115 P=0.230 |P=0.037 * P=0.505N P=0.475 P=0.187 |
|POLY 6 | P=0.229 P=0.499 P=0.112 P=0.224 |P=0.041 * P=0.506N P=0.437 P=0.199 |
|LOGISTIC REGRESSION| P=0.236 P=0.527 P=0.113 P=0.226 |P=0.043 * (e) P=0.376 P=0.194 |
|COCH-ARM / FISHERS | P=0.256 P=0.500 P=0.121 P=0.247 |P=0.036 * P=0.505N P=0.500 P=0.181 |
|ORDER RESTRICTED | P=0.103 (e) (e) (e) |P=0.044 * (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.13 0/45.93 1/44.49 2/43.91 |0/46.00 0/44.59 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 4.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 1/36 (3%) 2/35 (6%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075 (e) P=0.506 P=0.238 |(e) (e) (e) (e) |
|POLY 3 | P=0.077 (e) P=0.493 P=0.226 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.079 (e) P=0.495 P=0.230 |(e) (e) (e) (e) |
|POLY 6 | P=0.075 (e) P=0.491 P=0.223 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.506 P=0.238 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.084 (e) P=0.500 P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.067 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 3/50 (6%) |1/50 (2%) 0/49 (0%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/46.13 1/45.93 3/44.62 3/44.01 |1/46.00 0/44.59 2/40.77 4/48.02 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 6.7% 6.8% |2.2% 0.0% 4.9% 8.3% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 2/36 (6%) 2/35 (6%) |1/40 (3%) 0/39 (0%) 2/28 (7%) 4/42 (10%) |
|FIRST INCIDENCE | --- 729 (T) 696 702 |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095 P=0.527 P=0.126 P=0.121 |P=0.043 * P=0.505N P=0.376 P=0.194 |
|POLY 3 | P=0.095 P=0.499 P=0.113 P=0.110 |P=0.039 * P=0.506N P=0.458 P=0.192 |
|POLY 1.5 | P=0.098 P=0.500 P=0.115 P=0.113 |P=0.037 * P=0.505N P=0.475 P=0.187 |
|POLY 6 | P=0.092 P=0.499 P=0.112 P=0.108 |P=0.041 * P=0.506N P=0.437 P=0.199 |
|LOGISTIC REGRESSION| P=0.093 P=0.527 P=0.113 P=0.109 |P=0.043 * (e) P=0.376 P=0.194 |
|COCH-ARM / FISHERS | P=0.107 P=0.500 P=0.121 P=0.121 |P=0.036 * P=0.505N P=0.500 P=0.181 |
|ORDER RESTRICTED | P=0.069 (e) (e) (e) |P=0.044 * (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 3/50 (6%) |1/50 (2%) 0/49 (0%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/46.13 1/45.93 3/44.62 3/44.01 |1/46.00 0/44.59 2/40.77 4/48.02 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 6.7% 6.8% |2.2% 0.0% 4.9% 8.3% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 2/36 (6%) 2/35 (6%) |1/40 (3%) 0/39 (0%) 2/28 (7%) 4/42 (10%) |
|FIRST INCIDENCE | --- 729 (T) 696 702 |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095 P=0.527 P=0.126 P=0.121 |P=0.043 * P=0.505N P=0.376 P=0.194 |
|POLY 3 | P=0.095 P=0.499 P=0.113 P=0.110 |P=0.039 * P=0.506N P=0.458 P=0.192 |
|POLY 1.5 | P=0.098 P=0.500 P=0.115 P=0.113 |P=0.037 * P=0.505N P=0.475 P=0.187 |
|POLY 6 | P=0.092 P=0.499 P=0.112 P=0.108 |P=0.041 * P=0.506N P=0.437 P=0.199 |
|LOGISTIC REGRESSION| P=0.093 P=0.527 P=0.113 P=0.109 |P=0.043 * (e) P=0.376 P=0.194 |
|COCH-ARM / FISHERS | P=0.107 P=0.500 P=0.121 P=0.121 |P=0.036 * P=0.505N P=0.500 P=0.181 |
|ORDER RESTRICTED | P=0.069 (e) (e) (e) |P=0.044 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/49 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.13 2/46.44 2/44.49 1/43.91 |0/46.00 1/44.59 1/40.77 1/48.05 |
|POLY-3 PERCENT (g) | 4.3% 4.3% 4.5% 2.3% |0.0% 2.2% 2.5% 2.1% |
|TERMINAL (d) | 2/35 (6%) 1/40 (3%) 2/36 (6%) 1/35 (3%) |0/40 (0%) 1/39 (3%) 1/28 (4%) 0/42 (0%) |
|FIRST INCIDENCE | 729 (T) 572 729 (T) 729 (T) |--- 729 (T) 729 (T) 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.403N P=0.661N P=0.685N P=0.500N |P=0.409 P=0.495 P=0.429 P=0.519 |
|POLY 3 | P=0.402N P=0.691N P=0.681 P=0.517N |P=0.415 P=0.494 P=0.476 P=0.509 |
|POLY 1.5 | P=0.395N P=0.692N P=0.685 P=0.511N |P=0.407 P=0.495 P=0.485 P=0.505 |
|POLY 6 | P=0.408N P=0.689N P=0.678 P=0.522N |P=0.424 P=0.494 P=0.464 P=0.513 |
|LOGISTIC REGRESSION| P=0.391N P=0.693 P=0.685N P=0.500N |P=0.415 P=0.495 P=0.429 P=0.512 |
|COCH-ARM / FISHERS | P=0.380N P=0.691N P=0.691N P=0.500N |P=0.396 P=0.495 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.480N (e) (e) (e) |P=0.306 (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.13 1/45.93 3/45.22 0/43.91 |0/46.00 0/44.59 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 4.3% 2.2% 6.6% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/35 (6%) 1/40 (3%) 2/36 (6%) 0/35 (0%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 471 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.237N P=0.453N P=0.508 P=0.238N |(e) (e) (e) (e) |
|POLY 3 | P=0.240N P=0.502N P=0.491 P=0.248N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.234N P=0.500N P=0.494 P=0.245N |(e) (e) (e) (e) |
|POLY 6 | P=0.244N P=0.501N P=0.490 P=0.251N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.212N P=0.453N P=0.519 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.223N P=0.500N P=0.500 P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.193N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 5/50 (10%) 1/50 (2%) |0/50 (0%) 1/49 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/46.13 3/46.44 5/45.22 1/43.91 |0/46.00 1/44.59 1/40.77 1/48.05 |
|POLY-3 PERCENT (g) | 8.7% 6.5% 11.1% 2.3% |0.0% 2.2% 2.5% 2.1% |
|TERMINAL (d) | 4/35 (11%) 2/40 (5%) 4/36 (11%) 1/35 (3%) |0/40 (0%) 1/39 (3%) 1/28 (4%) 0/42 (0%) |
|FIRST INCIDENCE | 729 (T) 572 471 729 (T) |--- 729 (T) 729 (T) 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.177N P=0.441N P=0.514 P=0.178N |P=0.409 P=0.495 P=0.429 P=0.519 |
|POLY 3 | P=0.180N P=0.496N P=0.488 P=0.194N |P=0.415 P=0.494 P=0.476 P=0.509 |
|POLY 1.5 | P=0.173N P=0.497N P=0.492 P=0.189N |P=0.407 P=0.495 P=0.485 P=0.505 |
|POLY 6 | P=0.187N P=0.493N P=0.486 P=0.198N |P=0.424 P=0.494 P=0.464 P=0.513 |
|LOGISTIC REGRESSION| P=0.158N P=0.500N P=0.498 P=0.178N |P=0.415 P=0.495 P=0.429 P=0.512 |
|COCH-ARM / FISHERS | P=0.159N P=0.500N P=0.500 P=0.181N |P=0.396 P=0.495 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.186N (e) (e) (e) |P=0.306 (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |4/50 (8%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.13 0/45.93 0/44.49 0/43.91 |4/46.42 1/44.99 3/41.98 1/48.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |8.6% 2.2% 7.2% 2.1% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/36 (0%) 0/35 (0%) |3/40 (8%) 1/39 (3%) 1/28 (4%) 1/42 (2%) |
|FIRST INCIDENCE | --- --- --- --- |605 729 (T) 332 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.216N P=0.191N P=0.633N P=0.167N |
|POLY 3 | (e) (e) (e) (e) |P=0.198N P=0.188N P=0.555N P=0.169N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.205N P=0.185N P=0.532N P=0.173N |
|POLY 6 | (e) (e) (e) (e) |P=0.192N P=0.191N P=0.584N P=0.164N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.224N P=0.181N P=0.404N P=0.184N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.214N P=0.181N P=0.500N P=0.181N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.103N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |26/50 (52%) 23/50 (46%) 24/50 (48%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/46.13 0/45.93 0/44.49 2/43.91 |26/47.63 23/47.19 24/42.36 6/48.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% |54.6% 48.7% 56.7% 12.5% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/36 (0%) 2/35 (6%) |21/40 (53%) 19/39 (49%) 16/28 (57%) 5/42 (12%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |602 483 598 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * (e) (e) P=0.238 |P<0.001N** P=0.399N P=0.181 P<0.001N** |
|POLY 3 | P=0.038 * (e) (e) P=0.226 |P<0.001N** P=0.357N P=0.506 P<0.001N** |
|POLY 1.5 | P=0.039 * (e) (e) P=0.230 |P<0.001N** P=0.349N P=0.568N P<0.001N** |
|POLY 6 | P=0.038 * (e) (e) P=0.223 |P<0.001N** P=0.370N P=0.396 P<0.001N** |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.238 |P<0.001N** P=0.357N P=0.463 P<0.001N** |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |P<0.001N** P=0.345N P=0.421N P<0.001N** |
|ORDER RESTRICTED | P=0.026 * (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |28/50 (56%) 24/50 (48%) 26/50 (52%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/46.13 0/45.93 0/44.49 2/43.91 |28/47.63 24/47.19 26/43.57 6/48.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% |58.8% 50.9% 59.7% 12.5% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/36 (0%) 2/35 (6%) |23/40 (58%) 20/39 (51%) 16/28 (57%) 5/42 (12%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |602 483 332 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * (e) (e) P=0.238 |P<0.001N** P=0.331N P=0.167 P<0.001N** |
|POLY 3 | P=0.038 * (e) (e) P=0.226 |P<0.001N** P=0.283N P=0.551 P<0.001N** |
|POLY 1.5 | P=0.039 * (e) (e) P=0.230 |P<0.001N** P=0.276N P=0.538N P<0.001N** |
|POLY 6 | P=0.038 * (e) (e) P=0.223 |P<0.001N** P=0.295N P=0.454 P<0.001N** |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.238 |P<0.001N** P=0.289N P=0.549 P<0.001N** |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |P<0.001N** P=0.274N P=0.421N P<0.001N** |
|ORDER RESTRICTED | P=0.026 * (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 6/50 (12%) 8/50 (16%) 9/50 (18%) |23/50 (46%) 24/48 (50%) 21/50 (42%) 13/50 (26%) |
|POLY-3 RATE (b) | 9/46.40 6/45.93 8/46.05 9/44.06 |23/46.48 24/46.25 21/44.42 13/48.36 |
|POLY-3 PERCENT (g) | 19.4% 13.1% 17.4% 20.4% |49.5% 51.9% 47.3% 26.9% |
|TERMINAL (d) | 7/35 (20%) 6/40 (15%) 5/36 (14%) 8/35 (23%) |21/40 (53%) 18/39 (46%) 10/28 (36%) 11/42 (26%) |
|FIRST INCIDENCE | 694 729 (T) 392 689 |658 425 532 644 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.354 P=0.214N P=0.489N P=0.589 |P=0.017N* P=0.458 P=0.252 P=0.020N* |
|POLY 3 | P=0.363 P=0.294N P=0.507N P=0.556 |P=0.006N** P=0.490 P=0.500N P=0.018N* |
|POLY 1.5 | P=0.378 P=0.291N P=0.504N P=0.572 |P=0.007N** P=0.463 P=0.477N P=0.021N* |
|POLY 6 | P=0.351 P=0.297N P=0.508N P=0.541 |P=0.004N** P=0.532 P=0.515N P=0.014N* |
|LOGISTIC REGRESSION| P=0.378 P=0.279N P=0.488N P=0.544 |P=0.009N** P=0.413 P=0.565N P=0.015N* |
|COCH-ARM / FISHERS | P=0.409 P=0.288N P=0.500N P=0.602N |P=0.010N* P=0.423 P=0.420N P=0.030N* |
|ORDER RESTRICTED | P=0.476 (e) (e) (e) |P=0.010N* (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/48 (2%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.13 0/45.93 0/44.49 0/43.91 |2/46.71 1/43.78 3/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.3% 2.3% 7.4% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/36 (0%) 0/35 (0%) |0/40 (0%) 1/39 (3%) 3/28 (11%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- --- |602 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.256N P=0.516N P=0.371 P=0.228N |
|POLY 3 | (e) (e) (e) (e) |P=0.236N P=0.523N P=0.438 P=0.231N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.242N P=0.519N P=0.463 P=0.233N |
|POLY 6 | (e) (e) (e) (e) |P=0.231N P=0.525N P=0.407 P=0.229N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.251N P=0.509N P=0.493 P=0.292N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.250N P=0.515N P=0.500 P=0.247N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.157N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 6/50 (12%) 8/50 (16%) 9/50 (18%) |25/50 (50%) 25/48 (52%) 24/50 (48%) 13/50 (26%) |
|POLY-3 RATE (b) | 9/46.40 6/45.93 8/46.05 9/44.06 |25/47.20 25/46.25 24/44.42 13/48.36 |
|POLY-3 PERCENT (g) | 19.4% 13.1% 17.4% 20.4% |53.0% 54.1% 54.0% 26.9% |
|TERMINAL (d) | 7/35 (20%) 6/40 (15%) 5/36 (14%) 8/35 (23%) |21/40 (53%) 19/39 (49%) 13/28 (46%) 11/42 (26%) |
|FIRST INCIDENCE | 694 729 (T) 392 689 |602 425 532 644 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.354 P=0.214N P=0.489N P=0.589 |P=0.009N** P=0.527 P=0.170 P=0.009N** |
|POLY 3 | P=0.363 P=0.294N P=0.507N P=0.556 |P=0.002N** P=0.541 P=0.543 P=0.007N** |
|POLY 1.5 | P=0.378 P=0.291N P=0.504N P=0.572 |P=0.003N** P=0.525 P=0.582 P=0.008N** |
|POLY 6 | P=0.351 P=0.297N P=0.508N P=0.541 |P=0.002N** P=0.564 P=0.506 P=0.006N** |
|LOGISTIC REGRESSION| P=0.378 P=0.279N P=0.488N P=0.544 |P=0.004N** P=0.492 P=0.517 P=0.008N** |
|COCH-ARM / FISHERS | P=0.409 P=0.288N P=0.500N P=0.602N |P=0.004N** P=0.498 P=0.500N P=0.011N* |
|ORDER RESTRICTED | P=0.476 (e) (e) (e) |P=0.004N** (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.13 0/45.93 0/44.49 2/43.91 |1/46.22 0/44.99 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/36 (0%) 2/35 (6%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |671 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * (e) (e) P=0.238 |P=0.316N P=0.500N P=0.548N P=0.478N |
|POLY 3 | P=0.038 * (e) (e) P=0.226 |P=0.328N P=0.505N P=0.525N P=0.492N |
|POLY 1.5 | P=0.039 * (e) (e) P=0.230 |P=0.326N P=0.503N P=0.515N P=0.495N |
|POLY 6 | P=0.038 * (e) (e) P=0.223 |P=0.330N P=0.507N P=0.538N P=0.489N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.238 |P=0.321N P=0.494N P=0.487N P=0.528N |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |P=0.321N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.026 * (e) (e) (e) |P=0.113N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.13 0/45.93 1/44.80 3/43.91 |2/46.22 0/44.99 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.2% 6.8% |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/40 (0%) 0/36 (0%) 3/35 (9%) |1/40 (3%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 729 (T) --- 644 729 (T) |671 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.070 P=0.473N P=0.758 P=0.305 |P=0.134N P=0.243N P=0.307N P=0.222N |
|POLY 3 | P=0.073 P=0.501N P=0.754 P=0.288 |P=0.129N P=0.243N P=0.266N P=0.229N |
|POLY 1.5 | P=0.075 P=0.500N P=0.756 P=0.294 |P=0.129N P=0.241N P=0.254N P=0.232N |
|POLY 6 | P=0.072 P=0.501N P=0.754 P=0.283 |P=0.130N P=0.245N P=0.282N P=0.225N |
|LOGISTIC REGRESSION| P=0.073 (e) P=0.758N P=0.305 |P=0.129N P=0.237N P=0.250N P=0.244N |
|COCH-ARM / FISHERS | P=0.080 P=0.500N P=0.753N P=0.309 |P=0.129N P=0.247N P=0.247N P=0.247N |
|ORDER RESTRICTED | P=0.073 (e) (e) (e) |P=0.027N* (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 7/50 (14%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.13 2/45.93 2/44.80 7/44.67 |2/46.22 0/44.99 1/41.26 1/48.02 |
|POLY-3 PERCENT (g) | 4.3% 4.4% 4.5% 15.7% |4.3% 0.0% 2.4% 2.1% |
|TERMINAL (d) | 2/35 (6%) 2/40 (5%) 1/36 (3%) 4/35 (11%) |1/40 (3%) 0/39 (0%) 0/28 (0%) 1/42 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 644 598 |671 --- 580 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014 * P=0.646N P=0.690N P=0.082 |P=0.514N P=0.243N P=0.586N P=0.476N |
|POLY 3 | P=0.015 * P=0.692 P=0.683 P=0.071 |P=0.518N P=0.243N P=0.539N P=0.487N |
|POLY 1.5 | P=0.015 * P=0.693 P=0.687 P=0.073 |P=0.522N P=0.241N P=0.524N P=0.492N |
|POLY 6 | P=0.014 * P=0.693 P=0.683 P=0.070 |P=0.514N P=0.245N P=0.559N P=0.481N |
|LOGISTIC REGRESSION| P=0.015 * P=0.646N P=0.688 P=0.074 |P=0.537N P=0.237N P=0.462N P=0.501N |
|COCH-ARM / FISHERS | P=0.017 * P=0.691N P=0.691N P=0.080 |P=0.527N P=0.247N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.023 * (e) (e) (e) |P=0.271N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/46.36 4/45.93 0/44.49 2/43.91 |1/46.00 0/44.99 2/41.11 2/48.35 |
|POLY-3 PERCENT (g) | 4.3% 8.7% 0.0% 4.6% |2.2% 0.0% 4.9% 4.1% |
|TERMINAL (d) | 1/35 (3%) 4/40 (10%) 0/36 (0%) 2/35 (6%) |1/40 (3%) 0/39 (0%) 0/28 (0%) 1/42 (2%) |
|FIRST INCIDENCE | 668 729 (T) --- 729 (T) |729 (T) --- 668 638 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.477N P=0.388 P=0.242N P=0.687 |P=0.253 P=0.505N P=0.403 P=0.524 |
|POLY 3 | P=0.467N P=0.333 P=0.246N P=0.674 |P=0.249 P=0.504N P=0.461 P=0.517 |
|POLY 1.5 | P=0.461N P=0.336 P=0.243N P=0.681 |P=0.240 P=0.503N P=0.476 P=0.510 |
|POLY 6 | P=0.472N P=0.331 P=0.249N P=0.668 |P=0.260 P=0.505N P=0.443 P=0.526 |
|LOGISTIC REGRESSION| P=0.480N P=0.335 P=0.237N P=0.678 |P=0.224 (e) P=0.475 P=0.485 |
|COCH-ARM / FISHERS | P=0.451N P=0.339 P=0.247N P=0.691N |P=0.226 P=0.500N P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.259N (e) (e) (e) |P=0.245 (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 1/50 (2%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/46.36 4/45.93 1/44.49 3/43.91 |1/46.00 0/44.99 2/41.11 2/48.35 |
|POLY-3 PERCENT (g) | 4.3% 8.7% 2.3% 6.8% |2.2% 0.0% 4.9% 4.1% |
|TERMINAL (d) | 1/35 (3%) 4/40 (10%) 1/36 (3%) 3/35 (9%) |1/40 (3%) 0/39 (0%) 0/28 (0%) 1/42 (2%) |
|FIRST INCIDENCE | 668 729 (T) 729 (T) 729 (T) |729 (T) --- 668 638 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.531 P=0.388 P=0.499N P=0.494 |P=0.253 P=0.505N P=0.403 P=0.524 |
|POLY 3 | P=0.536 P=0.333 P=0.514N P=0.475 |P=0.249 P=0.504N P=0.461 P=0.517 |
|POLY 1.5 | P=0.544 P=0.336 P=0.509N P=0.484 |P=0.240 P=0.503N P=0.476 P=0.510 |
|POLY 6 | P=0.528 P=0.331 P=0.519N P=0.467 |P=0.260 P=0.505N P=0.443 P=0.526 |
|LOGISTIC REGRESSION| P=0.527 P=0.335 P=0.508N P=0.474 |P=0.224 (e) P=0.475 P=0.485 |
|COCH-ARM / FISHERS | P=0.561 P=0.339 P=0.500N P=0.500 |P=0.226 P=0.500N P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.475 (e) (e) (e) |P=0.245 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.13 2/45.93 1/44.49 4/44.67 |0/46.00 0/44.99 0/40.77 1/48.02 |
|POLY-3 PERCENT (g) | 2.2% 4.4% 2.3% 9.0% |0.0% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 1/35 (3%) 2/40 (5%) 1/36 (3%) 1/35 (3%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 1/42 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 598 |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099 P=0.547 P=0.756N P=0.177 |P=0.208 (e) (e) P=0.510 |
|POLY 3 | P=0.102 P=0.498 P=0.753 P=0.169 |P=0.202 (e) (e) P=0.509 |
|POLY 1.5 | P=0.104 P=0.500 P=0.755 P=0.172 |P=0.199 (e) (e) P=0.505 |
|POLY 6 | P=0.102 P=0.499 P=0.751 P=0.169 |P=0.205 (e) (e) P=0.513 |
|LOGISTIC REGRESSION| P=0.104 P=0.547 P=0.756N P=0.185 |(e) (e) (e) P=0.510 |
|COCH-ARM / FISHERS | P=0.108 P=0.500 P=0.753N P=0.181 |P=0.194 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.087 (e) (e) (e) |P=0.129 (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous |
| Tumor (malignant or NOS), or Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.13 0/45.93 0/44.49 2/43.91 |1/46.22 0/44.99 1/41.26 0/48.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% |2.2% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/36 (0%) 2/35 (6%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |671 --- 580 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * (e) (e) P=0.238 |P=0.417N P=0.500N P=0.716 P=0.478N |
|POLY 3 | P=0.038 * (e) (e) P=0.226 |P=0.416N P=0.505N P=0.735 P=0.492N |
|POLY 1.5 | P=0.039 * (e) (e) P=0.230 |P=0.420N P=0.503N P=0.745 P=0.495N |
|POLY 6 | P=0.038 * (e) (e) P=0.223 |P=0.412N P=0.507N P=0.721 P=0.489N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.238 |P=0.440N P=0.494N P=0.718N P=0.528N |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |P=0.425N P=0.500N P=0.753N P=0.500N |
|ORDER RESTRICTED | P=0.026 * (e) (e) (e) |P=0.243N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.13 2/45.93 1/44.49 4/44.67 |0/46.00 0/44.99 1/41.26 1/48.02 |
|POLY-3 PERCENT (g) | 2.2% 4.4% 2.3% 9.0% |0.0% 0.0% 2.4% 2.1% |
|TERMINAL (d) | 1/35 (3%) 2/40 (5%) 1/36 (3%) 1/35 (3%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 1/42 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 598 |--- --- 580 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099 P=0.547 P=0.756N P=0.177 |P=0.237 (e) P=0.469 P=0.510 |
|POLY 3 | P=0.102 P=0.498 P=0.753 P=0.169 |P=0.243 (e) P=0.478 P=0.509 |
|POLY 1.5 | P=0.104 P=0.500 P=0.755 P=0.172 |P=0.237 (e) P=0.487 P=0.505 |
|POLY 6 | P=0.102 P=0.499 P=0.751 P=0.169 |P=0.251 (e) P=0.468 P=0.513 |
|LOGISTIC REGRESSION| P=0.104 P=0.547 P=0.756N P=0.185 |P=0.205 (e) P=0.579 P=0.510 |
|COCH-ARM / FISHERS | P=0.108 P=0.500 P=0.753N P=0.181 |P=0.225 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.087 (e) (e) (e) |P=0.231 (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 45/50 (90%) 42/50 (84%) 43/50 (86%) | |
|POLY-3 RATE (b) | 48/48.94 45/48.27 42/46.44 43/47.50 | |
|POLY-3 PERCENT (g) | 98.1% 93.2% 90.4% 90.5% | |
|TERMINAL (d) | 35/35 (100%) 38/40 (95%) 34/36 (94%) 31/35 (89%) | |
|FIRST INCIDENCE | 572 548 538 562 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.453N P=0.075N P=0.123N P=0.277N | |
|POLY 3 | P=0.144N P=0.225N P=0.090N P=0.109N | |
|POLY 1.5 | P=0.146N P=0.193N P=0.055N P=0.091N | |
|POLY 6 | P=0.124N P=0.298N P=0.163N P=0.119N | |
|LOGISTIC REGRESSION| P=0.300N P=0.235N P=0.111N P=0.153N | |
|COCH-ARM / FISHERS | P=0.129N P=0.218N P=0.046N* P=0.080N | |
|ORDER RESTRICTED | P=0.078N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/48 (19%) 5/46 (11%) 9/43 (21%) 7/50 (14%) |9/49 (18%) 9/48 (19%) 8/42 (19%) 3/48 (6%) |
|POLY-3 RATE (b) | 9/45.06 5/43.50 9/40.29 7/44.17 |9/45.71 9/44.22 8/36.31 3/46.81 |
|POLY-3 PERCENT (g) | 20.0% 11.5% 22.3% 15.9% |19.7% 20.4% 22.0% 6.4% |
|TERMINAL (d) | 9/35 (26%) 5/39 (13%) 9/35 (26%) 5/35 (14%) |8/40 (20%) 7/39 (18%) 5/28 (18%) 3/41 (7%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 689 |602 638 638 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.562N P=0.134N P=0.607 P=0.396N |P=0.047N* P=0.577 P=0.429 P=0.057N |
|POLY 3 | P=0.521N P=0.211N P=0.499 P=0.409N |P=0.036N* P=0.573 P=0.505 P=0.054N |
|POLY 1.5 | P=0.501N P=0.215N P=0.498 P=0.395N |P=0.040N* P=0.576 P=0.528 P=0.058N |
|POLY 6 | P=0.538N P=0.202N P=0.510 P=0.415N |P=0.033N* P=0.574 P=0.483 P=0.051N |
|LOGISTIC REGRESSION| P=0.562N P=0.134N P=0.607 P=0.424N |P=0.042N* P=0.574 P=0.508 P=0.056N |
|COCH-ARM / FISHERS | P=0.455N P=0.218N P=0.500 P=0.359N |P=0.049N* P=0.584 P=0.572 P=0.065N |
|ORDER RESTRICTED | P=0.474N (e) (e) (e) |P=0.039N* (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/46 (0%) 0/43 (0%) 3/50 (6%) |0/49 (0%) 1/48 (2%) 0/42 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 1/45.06 0/43.50 0/40.29 3/44.06 |0/45.28 1/44.11 0/35.57 1/46.81 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 6.8% |0.0% 2.3% 0.0% 2.1% |
|TERMINAL (d) | 1/35 (3%) 0/39 (0%) 0/35 (0%) 2/35 (6%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 729 (T) --- --- 689 |--- 638 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.051 P=0.478N P=0.500N P=0.302 |P=0.438 P=0.500 (e) P=0.505 |
|POLY 3 | P=0.059 P=0.507N P=0.522N P=0.297 |P=0.433 P=0.495 (e) P=0.507 |
|POLY 1.5 | P=0.061 P=0.508N P=0.523N P=0.304 |P=0.428 P=0.495 (e) P=0.503 |
|POLY 6 | P=0.057 P=0.504N P=0.520N P=0.293 |P=0.439 P=0.496 (e) P=0.511 |
|LOGISTIC REGRESSION| P=0.054 (e) (e) P=0.291 |P=0.407 P=0.498 (e) P=0.505 |
|COCH-ARM / FISHERS | P=0.066 P=0.511N P=0.527N P=0.324 |P=0.420 P=0.495 (e) P=0.495 |
|ORDER RESTRICTED | P=0.036 * (e) (e) (e) |P=0.258 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/48 (21%) 5/46 (11%) 9/43 (21%) 10/50 (20%) |9/49 (18%) 10/48 (21%) 8/42 (19%) 3/48 (6%) |
|POLY-3 RATE (b) | 10/45.06 5/43.50 9/40.29 10/44.33 |9/45.71 10/44.55 8/36.31 3/46.81 |
|POLY-3 PERCENT (g) | 22.2% 11.5% 22.3% 22.6% |19.7% 22.5% 22.0% 6.4% |
|TERMINAL (d) | 10/35 (29%) 5/39 (13%) 9/35 (26%) 7/35 (20%) |8/40 (20%) 7/39 (18%) 5/28 (18%) 3/41 (7%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 689 |602 638 638 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.273 P=0.083N P=0.500N P=0.593 |P=0.039N* P=0.477 P=0.429 P=0.057N |
|POLY 3 | P=0.318 P=0.144N P=0.596 P=0.584 |P=0.030N* P=0.475 P=0.505 P=0.054N |
|POLY 1.5 | P=0.337 P=0.148N P=0.594 P=0.598 |P=0.033N* P=0.476 P=0.528 P=0.058N |
|POLY 6 | P=0.304 P=0.136N P=0.599N P=0.579 |P=0.027N* P=0.481 P=0.483 P=0.051N |
|LOGISTIC REGRESSION| P=0.274 P=0.083N P=0.500N P=0.559 |P=0.035N* P=0.472 P=0.508 P=0.056N |
|COCH-ARM / FISHERS | P=0.382 P=0.150N P=0.596 P=0.558N |P=0.040N* P=0.480 P=0.572 P=0.065N |
|ORDER RESTRICTED | P=0.394 (e) (e) (e) |P=0.033N* (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/46 (0%) 1/43 (2%) 3/50 (6%) |0/49 (0%) 0/48 (0%) 0/42 (0%) 5/48 (10%) |
|POLY-3 RATE (b) | 1/45.06 0/43.50 1/40.29 3/43.91 |0/45.28 0/43.78 0/35.57 5/47.14 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.5% 6.8% |0.0% 0.0% 0.0% 10.6% |
|TERMINAL (d) | 1/35 (3%) 0/39 (0%) 1/35 (3%) 3/35 (9%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 4/41 (10%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |--- --- --- 638 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.072 P=0.478N P=0.762 P=0.305 |P<0.001 ** (e) (e) P=0.038 * |
|POLY 3 | P=0.083 P=0.507N P=0.736 P=0.296 |P<0.001 ** (e) (e) P=0.034 * |
|POLY 1.5 | P=0.087 P=0.508N P=0.735 P=0.303 |P<0.001 ** (e) (e) P=0.032 * |
|POLY 6 | P=0.080 P=0.504N P=0.738 P=0.291 |P<0.001 ** (e) (e) P=0.036 * |
|LOGISTIC REGRESSION| P=0.072 (e) P=0.762 P=0.305 |P<0.001 ** (e) (e) P=0.028 * |
|COCH-ARM / FISHERS | P=0.095 P=0.511N P=0.725 P=0.324 |P<0.001 ** (e) (e) P=0.027 * |
|ORDER RESTRICTED | P=0.077 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/46 (4%) 0/43 (0%) 2/50 (4%) |1/49 (2%) 1/48 (2%) 1/42 (2%) 7/48 (15%) |
|POLY-3 RATE (b) | 0/45.06 2/43.64 0/40.29 2/44.75 |1/45.77 1/44.38 1/35.57 7/46.84 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 4.5% |2.2% 2.3% 2.8% 14.9% |
|TERMINAL (d) | 0/35 (0%) 1/39 (3%) 0/35 (0%) 1/35 (3%) |0/40 (0%) 0/39 (0%) 1/28 (4%) 6/41 (15%) |
|FIRST INCIDENCE | --- 693 --- 395 |583 538 729 (T) 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.273 P=0.252 (e) P=0.240 |P=0.005 ** P=0.744 P=0.700 P=0.039 * |
|POLY 3 | P=0.296 P=0.230 (e) P=0.236 |P=0.003 ** P=0.754 P=0.703 P=0.033 * |
|POLY 1.5 | P=0.300 P=0.229 (e) P=0.239 |P=0.003 ** P=0.754 P=0.711 P=0.031 * |
|POLY 6 | P=0.293 P=0.234 (e) P=0.233 |P=0.003 ** P=0.754 P=0.692 P=0.034 * |
|LOGISTIC REGRESSION| P=0.473 P=0.228 (e) P=0.403 |P=0.002 ** P=0.767 P=0.761 P=0.026 * |
|COCH-ARM / FISHERS | P=0.310 P=0.237 (e) P=0.258 |P=0.003 ** P=0.747 P=0.713 P=0.028 * |
|ORDER RESTRICTED | P=0.115 (e) (e) (e) |P=0.003 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 2/46 (4%) 1/43 (2%) 5/50 (10%) |1/49 (2%) 1/48 (2%) 1/42 (2%) 11/48 (23%) |
|POLY-3 RATE (b) | 1/45.06 2/43.64 1/40.29 5/44.75 |1/45.77 1/44.38 1/35.57 11/47.17 |
|POLY-3 PERCENT (g) | 2.2% 4.6% 2.5% 11.2% |2.2% 2.3% 2.8% 23.3% |
|TERMINAL (d) | 1/35 (3%) 1/39 (3%) 1/35 (3%) 4/35 (11%) |0/40 (0%) 0/39 (0%) 1/28 (4%) 9/41 (22%) |
|FIRST INCIDENCE | 729 (T) 693 729 (T) 395 |583 538 729 (T) 638 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * P=0.525 P=0.762 P=0.105 |P<0.001 ** P=0.744 P=0.700 P=0.004 ** |
|POLY 3 | P=0.046 * P=0.489 P=0.736 P=0.099 |P<0.001 ** P=0.754 P=0.703 P=0.002 ** |
|POLY 1.5 | P=0.049 * P=0.486 P=0.735 P=0.103 |P<0.001 ** P=0.754 P=0.711 P=0.002 ** |
|POLY 6 | P=0.044 * P=0.495 P=0.738 P=0.097 |P<0.001 ** P=0.754 P=0.692 P=0.003 ** |
|LOGISTIC REGRESSION| P=0.069 P=0.487 P=0.762 P=0.136 |P<0.001 ** P=0.767 P=0.761 P=0.002 ** |
|COCH-ARM / FISHERS | P=0.054 P=0.484 P=0.725 P=0.112 |P<0.001 ** P=0.747 P=0.713 P=0.002 ** |
|ORDER RESTRICTED | P=0.035 * (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |8/50 (16%) 6/50 (12%) 7/50 (14%) 3/50 (6%) |
|POLY-3 RATE (b) | |8/46.00 6/45.70 7/41.86 3/48.02 |
|POLY-3 PERCENT (g) | |17.4% 13.1% 16.7% 6.3% |
|TERMINAL (d) | |8/40 (20%) 5/39 (13%) 5/28 (18%) 3/42 (7%) |
|FIRST INCIDENCE | |729 (T) 483 332 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.099N P=0.405N P=0.454 P=0.085N |
|POLY 3 | |P=0.082N P=0.391N P=0.579N P=0.086N |
|POLY 1.5 | |P=0.088N P=0.390N P=0.546N P=0.091N |
|POLY 6 | |P=0.075N P=0.390N P=0.602 P=0.079N |
|LOGISTIC REGRESSION| |P=0.095N P=0.399N P=0.559N P=0.085N |
|COCH-ARM / FISHERS | |P=0.097N P=0.387N P=0.500N P=0.100N |
|ORDER RESTRICTED | |P=0.078N (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.13 1/46.59 2/44.70 0/43.91 |0/46.00 0/44.99 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 1/36 (3%) 0/35 (0%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- 507 673 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.528N P=0.504 P=0.238 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.535N P=0.502 P=0.230 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.528N P=0.502 P=0.233 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.541N P=0.503 P=0.229 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.456N P=0.357 P=0.236 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.515N P=0.500 P=0.247 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.319 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 14/50 (28%) 21/50 (42%) 10/50 (20%) |6/50 (12%) 4/50 (8%) 9/50 (18%) 10/50 (20%) |
|POLY-3 RATE (b) | 15/48.70 14/48.08 21/47.64 10/45.67 |6/47.21 4/45.63 9/42.95 10/49.18 |
|POLY-3 PERCENT (g) | 30.8% 29.1% 44.1% 21.9% |12.7% 8.8% 21.0% 20.3% |
|TERMINAL (d) | 4/35 (11%) 8/40 (20%) 11/36 (31%) 4/35 (11%) |2/40 (5%) 2/39 (5%) 3/28 (11%) 6/42 (14%) |
|FIRST INCIDENCE | 572 521 439 574 |583 598 548 434 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222N P=0.449N P=0.182 P=0.245N |P=0.111 P=0.392N P=0.157 P=0.261 |
|POLY 3 | P=0.193N P=0.516N P=0.127 P=0.228N |P=0.090 P=0.391N P=0.222 P=0.233 |
|POLY 1.5 | P=0.172N P=0.506N P=0.136 P=0.209N |P=0.083 P=0.383N P=0.246 P=0.224 |
|POLY 6 | P=0.217N P=0.530N P=0.120 P=0.251N |P=0.097 P=0.399N P=0.196 P=0.242 |
|LOGISTIC REGRESSION| P=0.099N P=0.485N P=0.179 P=0.146N |P=0.058 P=0.351N P=0.354 P=0.144 |
|COCH-ARM / FISHERS | P=0.137N P=0.500N P=0.149 P=0.178N |P=0.073 P=0.370N P=0.288 P=0.207 |
|ORDER RESTRICTED | P=0.141N (e) (e) (e) |P=0.135 (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 24
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.44 4/46.60 2/44.49 0/43.91 |0/46.00 0/44.99 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 4.3% 8.6% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 2/40 (5%) 2/36 (6%) 0/35 (0%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 643 608 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.100N P=0.364 P=0.692N P=0.252N |(e) (e) (e) (e) |
|POLY 3 | P=0.097N P=0.339 P=0.678 P=0.250N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.094N P=0.339 P=0.684 P=0.245N |(e) (e) (e) (e) |
|POLY 6 | P=0.101N P=0.341 P=0.674 P=0.254N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.085N P=0.330 P=0.689 P=0.230N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.087N P=0.339 P=0.691N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.103N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.44 4/46.60 2/44.49 0/43.91 |0/46.00 0/44.99 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 4.3% 8.6% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 2/40 (5%) 2/36 (6%) 0/35 (0%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 643 608 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.100N P=0.364 P=0.692N P=0.252N |(e) (e) (e) (e) |
|POLY 3 | P=0.097N P=0.339 P=0.678 P=0.250N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.094N P=0.339 P=0.684 P=0.245N |(e) (e) (e) (e) |
|POLY 6 | P=0.101N P=0.341 P=0.674 P=0.254N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.085N P=0.330 P=0.689 P=0.230N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.087N P=0.339 P=0.691N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.103N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 25
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.14 0/45.93 0/44.49 0/43.91 |0/46.00 0/44.99 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/40 (0%) 0/36 (0%) 0/35 (0%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 726 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252N P=0.214N P=0.237N P=0.243N |(e) (e) (e) (e) |
|POLY 3 | P=0.241N P=0.238N P=0.245N P=0.248N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.241N P=0.238N P=0.242N P=0.245N |(e) (e) (e) (e) |
|POLY 6 | P=0.242N P=0.238N P=0.247N P=0.251N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.253N P=0.226N P=0.241N P=0.248N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.242N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.033N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.13 0/45.93 0/44.49 2/44.60 |0/46.00 0/44.99 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/36 (0%) 1/35 (3%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- 491 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.039 * (e) (e) P=0.237 |(e) (e) (e) (e) |
|POLY 3 | P=0.039 * (e) (e) P=0.230 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.040 * (e) (e) P=0.232 |(e) (e) (e) (e) |
|POLY 6 | P=0.039 * (e) (e) P=0.228 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.061 (e) (e) P=0.277 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.027 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 26
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.14 0/45.93 0/44.49 2/44.60 |0/46.00 0/44.99 0/40.77 0/48.02 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/40 (0%) 0/36 (0%) 1/35 (3%) |0/40 (0%) 0/39 (0%) 0/28 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 726 --- --- 491 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364 P=0.214N P=0.237N P=0.688 |(e) (e) (e) (e) |
|POLY 3 | P=0.375 P=0.238N P=0.245N P=0.682 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.376 P=0.238N P=0.242N P=0.685 |(e) (e) (e) (e) |
|POLY 6 | P=0.373 P=0.238N P=0.247N P=0.679 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.410 P=0.226N P=0.241N P=0.673N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.381 P=0.247N P=0.247N P=0.691N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.259 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 46/50 (92%) 47/50 (94%) 45/50 (90%) |43/50 (86%) 43/50 (86%) 40/50 (80%) 27/50 (54%) |
|POLY-3 RATE (b) | 49/49.08 46/48.27 47/48.49 45/47.50 |43/48.60 43/49.21 40/45.84 27/48.69 |
|POLY-3 PERCENT (g) | 99.8% 95.3% 96.9% 94.7% |88.5% 87.4% 87.3% 55.5% |
|TERMINAL (d) | 35/35 (100%) 39/40 (98%) 35/36 (97%) 33/35 (94%) |35/40 (88%) 34/39 (87%) 25/28 (89%) 24/42 (57%) |
|FIRST INCIDENCE | 572 548 392 562 |588 425 332 638 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.545N P=0.073N P=0.387N P=0.344N |P<0.001N** P=0.495 P=0.055 P<0.001N** |
|POLY 3 | P=0.220N P=0.165N P=0.347N P=0.154N |P<0.001N** P=0.558N P=0.557N P<0.001N** |
|POLY 1.5 | P=0.201N P=0.135N P=0.284N P=0.113N |P<0.001N** P=0.567N P=0.441N P<0.001N** |
|POLY 6 | P=0.215N P=0.289N P=0.451N P=0.205N |P<0.001N** P=0.566N P=0.579 P<0.001N** |
|LOGISTIC REGRESSION| P=0.361N P=0.193N P=0.458N P=0.205N |P<0.001N** P=0.588 P=0.591N P<0.001N** |
|COCH-ARM / FISHERS | P=0.150N P=0.181N P=0.309N P=0.102N |P<0.001N** P=0.613N P=0.298N P<0.001N** |
|ORDER RESTRICTED | P=0.082N (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/03 EXPERIMENT: 92012 TEST: 05 Page 27
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 26/50 (52%) 30/50 (60%) 25/50 (50%) |19/50 (38%) 10/50 (20%) 21/50 (42%) 20/50 (40%) |
|POLY-3 RATE (b) | 22/49.63 26/50.00 30/48.58 25/47.52 |19/49.74 10/46.66 21/46.62 20/49.18 |
|POLY-3 PERCENT (g) | 44.3% 52.0% 61.8% 52.6% |38.2% 21.4% 45.0% 40.7% |
|TERMINAL (d) | 9/35 (26%) 16/40 (40%) 18/36 (50%) 15/35 (43%) |10/40 (25%) 5/39 (13%) 10/28 (36%) 16/42 (38%) |
|FIRST INCIDENCE | 315 507 439 395 |328 538 244 434 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.354 P=0.410 P=0.137 P=0.334 |P=0.236 P=0.070N P=0.153 P=0.569N |
|POLY 3 | P=0.335 P=0.287 P=0.062 P=0.270 |P=0.172 P=0.056N P=0.318 P=0.482 |
|POLY 1.5 | P=0.371 P=0.281 P=0.066 P=0.293 |P=0.170 P=0.049N* P=0.362 P=0.490 |
|POLY 6 | P=0.300 P=0.296 P=0.060 P=0.248 |P=0.168 P=0.065N P=0.259 P=0.469 |
|LOGISTIC REGRESSION| P=0.548 P=0.196 P=0.108 P=0.419 |P=0.106 P=0.023N* P=0.401N P=0.308 |
|COCH-ARM / FISHERS | P=0.448 P=0.274 P=0.080 P=0.344 |P=0.163 P=0.038N* P=0.419 P=0.500 |
|ORDER RESTRICTED | P=0.157 (e) (e) (e) |P=0.137 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 300 PPM 1000 PPM 3000 PPM |0PPM 1000 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 49/50 (98%) 49/50 (98%) 48/50 (96%) |45/50 (90%) 44/50 (88%) 48/50 (96%) 38/50 (76%) |
|POLY-3 RATE (b) | 50/50.00 49/50.00 49/50.00 48/49.04 |45/50.00 44/49.40 48/49.76 38/49.82 |
|POLY-3 PERCENT (g) | 100.0% 98.0% 98.0% 97.9% |90.0% 89.1% 96.5% 76.3% |
|TERMINAL (d) | 35/35 (100%) 39/40 (98%) 35/36 (97%) 34/35 (97%) |35/40 (88%) 34/39 (87%) 27/28 (96%) 32/42 (76%) |
|FIRST INCIDENCE | 315 507 392 395 |328 425 244 434 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.440 P=0.173N P=0.465N P=0.493N |P=0.096N P=0.567 P=0.005 ** P=0.062N |
|POLY 3 | P=0.463N P=0.500N P=0.500N P=0.480N |P=0.024N* P=0.570N P=0.185 P=0.057N |
|POLY 1.5 | P=0.405N P=0.500N P=0.500N P=0.419N |P=0.025N* P=0.542N P=0.200 P=0.055N |
|POLY 6 | P=0.477N P=0.500N P=0.500N P=0.495N |P=0.024N* P=0.598N P=0.163 P=0.060N |
|LOGISTIC REGRESSION| P=0.269N (e) (e) P=0.325N |P=0.040N* P=0.489N P=0.305 P=0.077N |
|COCH-ARM / FISHERS | P=0.194N P=0.500N P=0.500N P=0.247N |P=0.030N* P=0.500N P=0.218 P=0.054N |
|ORDER RESTRICTED | P=0.310N (e) (e) (e) |P=0.009N** (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(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.
(g) Poly-3 adjusted lifetime tumor incidence.
(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).