TDMS Study 92012-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst 2-METHYLIMIDAZOLE DATE: 02/25/03
EXPERIMENT: 92012 TEST: 06 TIME: 07:34:56
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92012B
PATHOLOGIST: HEATH, JAMES E. CAS: 693-98-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1/MICE
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: 02/25/03
EXPERIMENT: 92012 TEST: 06 TIME: 07:34:56
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92012B
PATHOLOGIST: HEATH, JAMES E. CAS: 693-98-1
Mice(B6C3F1)
-----------------------------
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
Bone Marrow
Brain
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Spleen
Testes
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst 2-METHYLIMIDAZOLE DATE: 02/25/03
EXPERIMENT: 92012 TEST: 06 TIME: 07:34:56
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92012B
PATHOLOGIST: HEATH, JAMES E. CAS: 693-98-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF 2-METHYLIMIDAZOLE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Harderian Gland Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Thyroid Gland: Follicular Cell Adenoma
All Organs Benign Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
===============================================================
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.43 2/48.59 0/41.44 1/44.45 |0/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 0.0% 4.1% 0.0% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/43 (0%) 2/46 (4%) 0/36 (0%) 1/40 (3%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.509 P=0.253 (e) P=0.486 |(e) (e) (e) (e) |
|POLY 3 | P=0.513 P=0.243 (e) P=0.487 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.513 P=0.240 (e) P=0.487 |(e) (e) (e) (e) |
|POLY 6 | P=0.513 P=0.247 (e) P=0.487 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.253 (e) P=0.486 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.539 P=0.247 (e) P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.314 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 6/50 (12%) 5/50 (10%) 3/50 (6%) |3/50 (6%) 2/49 (4%) 6/49 (12%) 6/50 (12%) |
|POLY-3 RATE (b) | 9/47.43 6/48.59 5/41.71 3/45.07 |3/48.25 2/46.83 6/46.63 6/48.64 |
|POLY-3 PERCENT (g) | 19.0% 12.4% 12.0% 6.7% |6.2% 4.3% 12.9% 12.3% |
|TERMINAL (d) | 9/43 (21%) 6/46 (13%) 4/36 (11%) 2/40 (5%) |3/46 (7%) 2/43 (5%) 6/43 (14%) 6/45 (13%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 654 531 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.072N P=0.240N P=0.304N P=0.081N |P=0.106 P=0.531N P=0.210 P=0.232 |
|POLY 3 | P=0.060N P=0.271N P=0.271N P=0.072N |P=0.113 P=0.514N P=0.226 P=0.247 |
|POLY 1.5 | P=0.060N P=0.279N P=0.262N P=0.074N |P=0.112 P=0.511N P=0.227 P=0.246 |
|POLY 6 | P=0.060N P=0.259N P=0.278N P=0.069N |P=0.113 P=0.518N P=0.223 P=0.246 |
|LOGISTIC REGRESSION| P=0.061N P=0.240N P=0.284N P=0.073N |P=0.106 P=0.531N P=0.210 P=0.232 |
|COCH-ARM / FISHERS | P=0.046N* P=0.288N P=0.194N P=0.061N |P=0.109 P=0.510N P=0.233 P=0.243 |
|ORDER RESTRICTED | P=0.052N (e) (e) (e) |P=0.156 (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 0/49 (0%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/47.70 3/48.59 1/41.81 2/44.45 |1/48.25 0/46.83 1/47.00 1/48.64 |
|POLY-3 PERCENT (g) | 2.1% 6.2% 2.4% 4.5% |2.1% 0.0% 2.1% 2.1% |
|TERMINAL (d) | 0/43 (0%) 3/46 (7%) 0/36 (0%) 2/40 (5%) |1/46 (2%) 0/43 (0%) 0/43 (0%) 1/45 (2%) |
|FIRST INCIDENCE | 657 729 (T) 623 729 (T) |729 (T) --- 623 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.480 P=0.329 P=0.722 P=0.473 |P=0.538 P=0.513N P=0.750 P=0.757 |
|POLY 3 | P=0.485 P=0.312 P=0.730 P=0.475 |P=0.544 P=0.506N P=0.755 P=0.759N |
|POLY 1.5 | P=0.488 P=0.309 P=0.734 P=0.476 |P=0.543 P=0.505N P=0.754 P=0.759N |
|POLY 6 | P=0.483 P=0.317 P=0.727 P=0.475 |P=0.545 P=0.508N P=0.755 P=0.759N |
|LOGISTIC REGRESSION| P=0.506 P=0.305 P=0.753N P=0.487 |P=0.536 (e) P=0.754N P=0.757 |
|COCH-ARM / FISHERS | P=0.526 P=0.309 P=0.753N P=0.500 |P=0.540 P=0.505N P=0.747 P=0.753N |
|ORDER RESTRICTED | P=0.435 (e) (e) (e) |P=0.534 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 9/50 (18%) 6/50 (12%) 5/50 (10%) |4/50 (8%) 2/49 (4%) 7/49 (14%) 7/50 (14%) |
|POLY-3 RATE (b) | 10/47.70 9/48.59 6/42.09 5/45.07 |4/48.25 2/46.83 7/47.00 7/48.64 |
|POLY-3 PERCENT (g) | 21.0% 18.5% 14.3% 11.1% |8.3% 4.3% 14.9% 14.4% |
|TERMINAL (d) | 9/43 (21%) 9/46 (20%) 4/36 (11%) 4/40 (10%) |4/46 (9%) 2/43 (5%) 6/43 (14%) 7/45 (16%) |
|FIRST INCIDENCE | 657 729 (T) 623 531 |729 (T) 729 (T) 623 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.128N P=0.437N P=0.334N P=0.170N |P=0.102 P=0.369N P=0.229 P=0.249 |
|POLY 3 | P=0.108N P=0.482N P=0.292N P=0.157N |P=0.107 P=0.351N P=0.247 P=0.267 |
|POLY 1.5 | P=0.107N P=0.490N P=0.282N P=0.159N |P=0.106 P=0.349N P=0.246 P=0.266 |
|POLY 6 | P=0.108N P=0.470N P=0.298N P=0.155N |P=0.108 P=0.356N P=0.247 P=0.265 |
|LOGISTIC REGRESSION| P=0.105N P=0.470N P=0.280N P=0.152N |P=0.107 P=0.369N P=0.245 P=0.249 |
|COCH-ARM / FISHERS | P=0.080N P=0.500N P=0.207N P=0.131N |P=0.103 P=0.349N P=0.251 P=0.262 |
|ORDER RESTRICTED | P=0.153N (e) (e) (e) |P=0.137 (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.66 0/48.59 0/41.44 2/44.45 |0/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 2/40 (5%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 668 --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225 P=0.492N P=0.538N P=0.475 |(e) (e) (e) (e) |
|POLY 3 | P=0.230 P=0.496N P=0.528N P=0.476 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.232 P=0.498N P=0.524N P=0.477 |(e) (e) (e) (e) |
|POLY 6 | P=0.227 P=0.493N P=0.532N P=0.475 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.233 P=0.503N P=0.499N P=0.485 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.116 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 14/50 (28%) 13/50 (26%) 18/50 (36%) |3/50 (6%) 4/49 (8%) 6/49 (12%) 10/50 (20%) |
|POLY-3 RATE (b) | 7/47.43 14/48.59 13/42.27 18/44.72 |3/48.27 4/46.99 6/46.63 10/48.88 |
|POLY-3 PERCENT (g) | 14.8% 28.8% 30.8% 40.3% |6.2% 8.5% 12.9% 20.5% |
|TERMINAL (d) | 7/43 (16%) 14/46 (30%) 10/36 (28%) 17/40 (43%) |2/46 (4%) 3/43 (7%) 6/43 (14%) 9/45 (20%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 611 656 |723 688 729 (T) 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** P=0.094 P=0.048 * P=0.005 ** |P=0.015 * P=0.464 P=0.212 P=0.037 * |
|POLY 3 | P=0.006 ** P=0.077 P=0.058 P=0.005 ** |P=0.015 * P=0.485 P=0.226 P=0.037 * |
|POLY 1.5 | P=0.006 ** P=0.073 P=0.061 P=0.005 ** |P=0.014 * P=0.487 P=0.227 P=0.037 * |
|POLY 6 | P=0.006 ** P=0.083 P=0.056 P=0.005 ** |P=0.015 * P=0.482 P=0.223 P=0.037 * |
|LOGISTIC REGRESSION| P=0.006 ** P=0.094 P=0.056 P=0.006 ** |P=0.015 * P=0.485 P=0.215 P=0.038 * |
|COCH-ARM / FISHERS | P=0.015 * P=0.070 P=0.105 P=0.010 * |P=0.014 * P=0.489 P=0.233 P=0.036 * |
|ORDER RESTRICTED | P=0.003 ** (e) (e) (e) |P=0.019 * (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/50 (16%) 14/50 (28%) 6/50 (12%) |2/50 (4%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/47.84 8/49.00 14/42.82 6/44.86 |2/48.27 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 8.4% 16.3% 32.7% 13.4% |4.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/43 (7%) 5/46 (11%) 9/36 (25%) 4/40 (10%) |1/46 (2%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 611 657 531 656 |723 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.267 P=0.219 P=0.005 ** P=0.332 |P=0.120N P=0.257N P=0.257N P=0.245N |
|POLY 3 | P=0.261 P=0.190 P=0.003 ** P=0.330 |P=0.114N P=0.244N P=0.245N P=0.236N |
|POLY 1.5 | P=0.264 P=0.184 P=0.003 ** P=0.330 |P=0.114N P=0.243N P=0.245N P=0.236N |
|POLY 6 | P=0.260 P=0.199 P=0.003 ** P=0.332 |P=0.113N P=0.246N P=0.246N P=0.236N |
|LOGISTIC REGRESSION| P=0.302 P=0.178 P=0.005 ** P=0.345 |P=0.115N P=0.246N P=0.246N P=0.236N |
|COCH-ARM / FISHERS | P=0.348 P=0.178 P=0.009 ** P=0.370 |P=0.115N P=0.253N P=0.253N P=0.247N |
|ORDER RESTRICTED | P=0.043 * (e) (e) (e) |P=0.029N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 22/50 (44%) 22/50 (44%) 22/50 (44%) |4/50 (8%) 4/49 (8%) 6/49 (12%) 10/50 (20%) |
|POLY-3 RATE (b) | 10/47.84 22/49.00 22/43.23 22/44.86 |4/48.27 4/46.99 6/46.63 10/48.88 |
|POLY-3 PERCENT (g) | 20.9% 44.9% 50.9% 49.0% |8.3% 8.5% 12.9% 20.5% |
|TERMINAL (d) | 9/43 (21%) 19/46 (41%) 16/36 (44%) 20/40 (50%) |3/46 (7%) 3/43 (7%) 6/43 (14%) 9/45 (20%) |
|FIRST INCIDENCE | 611 657 531 656 |723 688 729 (T) 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * P=0.020 * P=0.003 ** P=0.005 ** |P=0.030 * P=0.604 P=0.328 P=0.074 |
|POLY 3 | P=0.007 ** P=0.009 ** P=0.002 ** P=0.003 ** |P=0.030 * P=0.628 P=0.348 P=0.077 |
|POLY 1.5 | P=0.007 ** P=0.008 ** P=0.002 ** P=0.003 ** |P=0.030 * P=0.630 P=0.350 P=0.076 |
|POLY 6 | P=0.007 ** P=0.011 * P=0.002 ** P=0.003 ** |P=0.031 * P=0.624 P=0.345 P=0.077 |
|LOGISTIC REGRESSION| P=0.010 * P=0.010 * P=0.003 ** P=0.004 ** |P=0.030 * P=0.628 P=0.333 P=0.077 |
|COCH-ARM / FISHERS | P=0.024 * P=0.009 ** P=0.009 ** P=0.009 ** |P=0.029 * P=0.631 P=0.357 P=0.074 |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) |P=0.048 * (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 22/50 (44%) 22/50 (44%) 22/50 (44%) |4/50 (8%) 4/49 (8%) 6/49 (12%) 10/50 (20%) |
|POLY-3 RATE (b) | 10/47.84 22/49.00 22/43.23 22/44.86 |4/48.27 4/46.99 6/46.63 10/48.88 |
|POLY-3 PERCENT (g) | 20.9% 44.9% 50.9% 49.0% |8.3% 8.5% 12.9% 20.5% |
|TERMINAL (d) | 9/43 (21%) 19/46 (41%) 16/36 (44%) 20/40 (50%) |3/46 (7%) 3/43 (7%) 6/43 (14%) 9/45 (20%) |
|FIRST INCIDENCE | 611 657 531 656 |723 688 729 (T) 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * P=0.020 * P=0.003 ** P=0.005 ** |P=0.030 * P=0.604 P=0.328 P=0.074 |
|POLY 3 | P=0.007 ** P=0.009 ** P=0.002 ** P=0.003 ** |P=0.030 * P=0.628 P=0.348 P=0.077 |
|POLY 1.5 | P=0.007 ** P=0.008 ** P=0.002 ** P=0.003 ** |P=0.030 * P=0.630 P=0.350 P=0.076 |
|POLY 6 | P=0.007 ** P=0.011 * P=0.002 ** P=0.003 ** |P=0.031 * P=0.624 P=0.345 P=0.077 |
|LOGISTIC REGRESSION| P=0.010 * P=0.010 * P=0.003 ** P=0.004 ** |P=0.030 * P=0.628 P=0.333 P=0.077 |
|COCH-ARM / FISHERS | P=0.024 * P=0.009 ** P=0.009 ** P=0.009 ** |P=0.029 * P=0.631 P=0.357 P=0.074 |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) |P=0.048 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 7/50 (14%) 6/50 (12%) 5/50 (10%) |4/50 (8%) 2/49 (4%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 11/47.93 7/48.59 6/41.44 5/44.45 |4/48.25 2/47.22 0/46.63 1/48.64 |
|POLY-3 PERCENT (g) | 23.0% 14.4% 14.5% 11.3% |8.3% 4.2% 0.0% 2.1% |
|TERMINAL (d) | 9/43 (21%) 7/46 (15%) 6/36 (17%) 5/40 (13%) |4/46 (9%) 1/43 (2%) 0/43 (0%) 1/45 (2%) |
|FIRST INCIDENCE | 657 729 (T) 729 (T) 729 (T) |729 (T) 620 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.114N P=0.180N P=0.255N P=0.117N |P=0.090N P=0.366N P=0.072N P=0.187N |
|POLY 3 | P=0.103N P=0.208N P=0.229N P=0.113N |P=0.085N P=0.348N P=0.065N P=0.177N |
|POLY 1.5 | P=0.099N P=0.212N P=0.214N P=0.111N |P=0.085N P=0.347N P=0.065N P=0.177N |
|POLY 6 | P=0.108N P=0.201N P=0.245N P=0.115N |P=0.085N P=0.349N P=0.066N P=0.177N |
|LOGISTIC REGRESSION| P=0.104N P=0.208N P=0.224N P=0.108N |P=0.086N P=0.345N (e) P=0.187N |
|COCH-ARM / FISHERS | P=0.072N P=0.218N P=0.143N P=0.086N |P=0.086N P=0.349N P=0.061N P=0.181N |
|ORDER RESTRICTED | P=0.093N (e) (e) (e) |P=0.038N* (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 5/50 (10%) 5/50 (10%) |0/50 (0%) 2/49 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/47.43 3/48.59 5/41.71 5/44.45 |0/48.25 2/47.16 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 12.7% 6.2% 12.0% 11.3% |0.0% 4.2% 0.0% 0.0% |
|TERMINAL (d) | 6/43 (14%) 3/46 (7%) 4/36 (11%) 5/40 (13%) |0/46 (0%) 1/43 (2%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 654 729 (T) |--- 639 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.502 P=0.210N P=0.621N P=0.551N |P=0.406N P=0.228 (e) (e) |
|POLY 3 | P=0.521 P=0.231N P=0.589N P=0.545N |P=0.404N P=0.232 (e) (e) |
|POLY 1.5 | P=0.525 P=0.236N P=0.579N P=0.545N |P=0.404N P=0.233 (e) (e) |
|POLY 6 | P=0.516 P=0.223N P=0.596N P=0.544N |P=0.405N P=0.231 (e) (e) |
|LOGISTIC REGRESSION| P=0.516 P=0.210N P=0.601N P=0.551N |P=0.407N P=0.234 (e) (e) |
|COCH-ARM / FISHERS | P=0.549N P=0.243N P=0.500N P=0.500N |P=0.405N P=0.242 (e) (e) |
|ORDER RESTRICTED | P=0.502N (e) (e) (e) |P=0.241N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 9/50 (18%) 10/50 (20%) 9/50 (18%) |4/50 (8%) 4/49 (8%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 14/47.93 9/48.59 10/41.71 9/44.45 |4/48.25 4/47.54 0/46.63 1/48.64 |
|POLY-3 PERCENT (g) | 29.2% 18.5% 24.0% 20.3% |8.3% 8.4% 0.0% 2.1% |
|TERMINAL (d) | 12/43 (28%) 9/46 (20%) 9/36 (25%) 9/40 (23%) |4/46 (9%) 2/43 (5%) 0/43 (0%) 1/45 (2%) |
|FIRST INCIDENCE | 657 729 (T) 654 729 (T) |729 (T) 620 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.287N P=0.133N P=0.420N P=0.227N |P=0.064N P=0.609 P=0.072N P=0.187N |
|POLY 3 | P=0.264N P=0.160N P=0.376N P=0.226N |P=0.059N P=0.635 P=0.065N P=0.177N |
|POLY 1.5 | P=0.256N P=0.165N P=0.355N P=0.223N |P=0.059N P=0.634 P=0.065N P=0.177N |
|POLY 6 | P=0.275N P=0.154N P=0.395N P=0.231N |P=0.059N P=0.635 P=0.066N P=0.177N |
|LOGISTIC REGRESSION| P=0.264N P=0.158N P=0.373N P=0.216N |P=0.060N P=0.636 (e) P=0.187N |
|COCH-ARM / FISHERS | P=0.189N P=0.171N P=0.241N P=0.171N |P=0.060N P=0.631 P=0.061N P=0.181N |
|ORDER RESTRICTED | P=0.242N (e) (e) (e) |P=0.063N (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 0/41.44 0/44.45 |1/48.25 0/46.83 0/46.63 2/48.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.1% 0.0% 0.0% 4.1% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 0/40 (0%) |1/46 (2%) 0/43 (0%) 0/43 (0%) 1/45 (2%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- 727 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.249 P=0.513N P=0.513N P=0.495 |
|POLY 3 | (e) (e) (e) (e) |P=0.249 P=0.506N P=0.507N P=0.503 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.249 P=0.505N P=0.507N P=0.502 |
|POLY 6 | (e) (e) (e) (e) |P=0.250 P=0.508N P=0.508N P=0.502 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.251 (e) (e) P=0.500 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.247 P=0.505N P=0.505N P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.135 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 4/49 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/47.43 1/48.59 0/41.44 0/44.45 |0/48.25 0/46.83 4/46.77 1/48.67 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 0.0% 0.0% |0.0% 0.0% 8.6% 2.1% |
|TERMINAL (d) | 1/43 (2%) 1/46 (2%) 0/36 (0%) 0/40 (0%) |0/46 (0%) 0/43 (0%) 3/43 (7%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- 693 720 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256N P=0.747N P=0.535N P=0.514N |P=0.250 (e) P=0.058 P=0.500 |
|POLY 3 | P=0.249N P=0.755N P=0.527N P=0.513N |P=0.252 (e) P=0.057 P=0.502 |
|POLY 1.5 | P=0.247N P=0.757N P=0.523N P=0.513N |P=0.250 (e) P=0.057 P=0.501 |
|POLY 6 | P=0.250N P=0.751N P=0.530N P=0.513N |P=0.253 (e) P=0.056 P=0.502 |
|LOGISTIC REGRESSION| P=0.256N P=0.747N (e) (e) |P=0.249 (e) P=0.059 P=0.500 |
|COCH-ARM / FISHERS | P=0.236N P=0.753N P=0.500N P=0.500N |P=0.248 (e) P=0.056 P=0.500 |
|ORDER RESTRICTED | P=0.265N (e) (e) (e) |P=0.074 (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 3/49 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 0/41.44 0/44.45 |0/48.25 0/46.83 3/46.77 1/48.67 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 6.4% 2.1% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 0/40 (0%) |0/46 (0%) 0/43 (0%) 2/43 (5%) 0/45 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 693 720 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.253 (e) P=0.113 P=0.500 |
|POLY 3 | (e) (e) (e) (e) |P=0.254 (e) P=0.113 P=0.502 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.253 (e) P=0.113 P=0.501 |
|POLY 6 | (e) (e) (e) (e) |P=0.255 (e) P=0.113 P=0.502 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.250 (e) P=0.116 P=0.500 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.249 (e) P=0.117 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.109 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 4/49 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/47.43 1/48.59 0/41.44 0/44.45 |0/48.25 0/46.83 4/46.77 1/48.67 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 0.0% 0.0% |0.0% 0.0% 8.6% 2.1% |
|TERMINAL (d) | 1/43 (2%) 1/46 (2%) 0/36 (0%) 0/40 (0%) |0/46 (0%) 0/43 (0%) 3/43 (7%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- 693 720 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256N P=0.747N P=0.535N P=0.514N |P=0.250 (e) P=0.058 P=0.500 |
|POLY 3 | P=0.249N P=0.755N P=0.527N P=0.513N |P=0.252 (e) P=0.057 P=0.502 |
|POLY 1.5 | P=0.247N P=0.757N P=0.523N P=0.513N |P=0.250 (e) P=0.057 P=0.501 |
|POLY 6 | P=0.250N P=0.751N P=0.530N P=0.513N |P=0.253 (e) P=0.056 P=0.502 |
|LOGISTIC REGRESSION| P=0.256N P=0.747N (e) (e) |P=0.249 (e) P=0.059 P=0.500 |
|COCH-ARM / FISHERS | P=0.236N P=0.753N P=0.500N P=0.500N |P=0.248 (e) P=0.056 P=0.500 |
|ORDER RESTRICTED | P=0.265N (e) (e) (e) |P=0.074 (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 1/49 (2%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/47.43 1/48.59 0/41.44 1/44.45 |2/48.25 1/46.83 0/46.63 2/49.07 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 2.3% |4.2% 2.1% 0.0% 4.1% |
|TERMINAL (d) | 0/43 (0%) 1/46 (2%) 0/36 (0%) 1/40 (3%) |2/46 (4%) 1/43 (2%) 0/43 (0%) 1/45 (2%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |729 (T) 729 (T) --- 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.381 P=0.513 (e) P=0.486 |P=0.589 P=0.524N P=0.253N P=0.689 |
|POLY 3 | P=0.385 P=0.505 (e) P=0.487 |P=0.596 P=0.510N P=0.245N P=0.687N |
|POLY 1.5 | P=0.385 P=0.503 (e) P=0.487 |P=0.594 P=0.509N P=0.245N P=0.689N |
|POLY 6 | P=0.385 P=0.508 (e) P=0.487 |P=0.598 P=0.514N P=0.246N P=0.686N |
|LOGISTIC REGRESSION| (e) P=0.513 (e) P=0.486 |P=0.589 P=0.524N (e) P=0.676 |
|COCH-ARM / FISHERS | P=0.405 P=0.500 (e) P=0.500 |P=0.592 P=0.508N P=0.253N P=0.691N |
|ORDER RESTRICTED | P=0.239 (e) (e) (e) |P=0.414N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 7/50 (14%) |1/49 (2%) 0/48 (0%) 0/48 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/47.43 1/48.86 0/41.44 7/44.45 |1/47.25 0/45.83 0/45.89 1/48.64 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 15.8% |2.1% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 7/40 (18%) |1/45 (2%) 0/42 (0%) 0/43 (0%) 1/45 (2%) |
|FIRST INCIDENCE | --- 657 --- 729 (T) |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.508 (e) P=0.007 ** |P=0.597 P=0.514N P=0.509N P=0.761 |
|POLY 3 | P<0.001 ** P=0.506 (e) P=0.006 ** |P=0.602 P=0.506N P=0.506N P=0.754N |
|POLY 1.5 | P<0.001 ** P=0.503 (e) P=0.006 ** |P=0.601 P=0.505N P=0.506N P=0.754N |
|POLY 6 | P<0.001 ** P=0.510 (e) P=0.006 ** |P=0.603 P=0.508N P=0.506N P=0.754N |
|LOGISTIC REGRESSION| P<0.001 ** P=0.496 (e) P=0.007 ** |P=0.597 (e) (e) P=0.761 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 (e) P=0.006 ** |P=0.599 P=0.505N P=0.505N P=0.747N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.397N (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/49 (0%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | |0/48.25 0/46.83 2/47.00 0/48.64 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 4.3% 0.0% |
|TERMINAL (d) | |0/46 (0%) 0/43 (0%) 1/43 (2%) 0/45 (0%) |
|FIRST INCIDENCE | |--- --- 623 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.594 (e) P=0.230 (e) |
|POLY 3 | |P=0.602 (e) P=0.232 (e) |
|POLY 1.5 | |P=0.601 (e) P=0.231 (e) |
|POLY 6 | |P=0.603 (e) P=0.231 (e) |
|LOGISTIC REGRESSION| |P=0.593 (e) P=0.246 (e) |
|COCH-ARM / FISHERS | |P=0.595 (e) P=0.242 (e) |
|ORDER RESTRICTED | |P=0.242 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 0/49 (0%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | |1/48.25 0/46.83 2/47.00 0/48.64 |
|POLY-3 PERCENT (g) | |2.1% 0.0% 4.3% 0.0% |
|TERMINAL (d) | |1/46 (2%) 0/43 (0%) 1/43 (2%) 0/45 (0%) |
|FIRST INCIDENCE | |729 (T) --- 623 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.462N P=0.513N P=0.482 P=0.504N |
|POLY 3 | |P=0.455N P=0.506N P=0.491 P=0.498N |
|POLY 1.5 | |P=0.457N P=0.505N P=0.490 P=0.499N |
|POLY 6 | |P=0.455N P=0.508N P=0.491 P=0.499N |
|LOGISTIC REGRESSION| |P=0.464N (e) P=0.505 (e) |
|COCH-ARM / FISHERS | |P=0.460N P=0.505N P=0.492 P=0.500N |
|ORDER RESTRICTED | |P=0.317N (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |2/50 (4%) 2/49 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/47.66 1/48.60 1/41.44 2/44.45 |2/48.86 2/47.25 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 4.2% 2.1% 2.4% 4.5% |4.1% 4.2% 0.0% 0.0% |
|TERMINAL (d) | 1/43 (2%) 0/46 (0%) 1/36 (3%) 2/40 (5%) |1/46 (2%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 668 726 729 (T) 729 (T) |533 620 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.512 P=0.477N P=0.563N P=0.668 |P=0.089N P=0.676 P=0.249N P=0.242N |
|POLY 3 | P=0.522 P=0.493N P=0.548N P=0.668 |P=0.087N P=0.682 P=0.248N P=0.238N |
|POLY 1.5 | P=0.525 P=0.496N P=0.542N P=0.669 |P=0.087N P=0.684 P=0.246N P=0.238N |
|POLY 6 | P=0.518 P=0.488N P=0.555N P=0.668 |P=0.088N P=0.679 P=0.250N P=0.240N |
|LOGISTIC REGRESSION| P=0.526 P=0.500N P=0.535N P=0.677 |P=0.081N P=0.696 P=0.193N P=0.300N |
|COCH-ARM / FISHERS | P=0.556 P=0.500N P=0.500N P=0.691N |P=0.086N P=0.684 P=0.253N P=0.247N |
|ORDER RESTRICTED | P=0.526 (e) (e) (e) |P=0.111N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |2/50 (4%) 2/49 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/47.66 1/48.60 1/41.44 3/44.45 |2/48.86 2/47.25 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 4.2% 2.1% 2.4% 6.8% |4.1% 4.2% 0.0% 0.0% |
|TERMINAL (d) | 1/43 (2%) 0/46 (0%) 1/36 (3%) 3/40 (8%) |1/46 (2%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 668 726 729 (T) 729 (T) |533 620 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.285 P=0.477N P=0.563N P=0.468 |P=0.089N P=0.676 P=0.249N P=0.242N |
|POLY 3 | P=0.294 P=0.493N P=0.548N P=0.468 |P=0.087N P=0.682 P=0.248N P=0.238N |
|POLY 1.5 | P=0.297 P=0.496N P=0.542N P=0.469 |P=0.087N P=0.684 P=0.246N P=0.238N |
|POLY 6 | P=0.290 P=0.488N P=0.555N P=0.467 |P=0.088N P=0.679 P=0.250N P=0.240N |
|LOGISTIC REGRESSION| P=0.295 P=0.500N P=0.535N P=0.474 |P=0.081N P=0.696 P=0.193N P=0.300N |
|COCH-ARM / FISHERS | P=0.324 P=0.500N P=0.500N P=0.500 |P=0.086N P=0.684 P=0.253N P=0.247N |
|ORDER RESTRICTED | P=0.268 (e) (e) (e) |P=0.111N (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |6/50 (12%) 8/49 (16%) 6/49 (12%) 8/50 (16%) |
|POLY-3 RATE (b) | 2/47.43 3/48.59 0/41.44 1/44.45 |6/48.25 8/46.99 6/46.89 8/48.64 |
|POLY-3 PERCENT (g) | 4.2% 6.2% 0.0% 2.3% |12.4% 17.0% 12.8% 16.5% |
|TERMINAL (d) | 2/43 (5%) 3/46 (7%) 0/36 (0%) 1/40 (3%) |6/46 (13%) 7/43 (16%) 5/43 (12%) 8/45 (18%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |729 (T) 688 658 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.277N P=0.531 P=0.278N P=0.525N |P=0.389 P=0.338 P=0.575 P=0.369 |
|POLY 3 | P=0.266N P=0.511 P=0.269N P=0.523N |P=0.403 P=0.367 P=0.600 P=0.393 |
|POLY 1.5 | P=0.264N P=0.506 P=0.264N P=0.523N |P=0.402 P=0.369 P=0.599 P=0.392 |
|POLY 6 | P=0.268N P=0.519 P=0.272N P=0.522N |P=0.403 P=0.362 P=0.599 P=0.392 |
|LOGISTIC REGRESSION| P=0.277N P=0.531 (e) P=0.525N |P=0.404 P=0.356 P=0.598 P=0.369 |
|COCH-ARM / FISHERS | P=0.242N P=0.500 P=0.247N P=0.500N |P=0.396 P=0.371 P=0.606 P=0.387 |
|ORDER RESTRICTED | P=0.217N (e) (e) (e) |P=0.456 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 25/50 (50%) 24/50 (48%) 30/50 (60%) |13/50 (26%) 12/49 (24%) 14/49 (29%) 20/50 (40%) |
|POLY-3 RATE (b) | 23/48.07 25/48.86 24/42.55 30/45.48 |13/48.27 12/47.41 14/47.00 20/49.31 |
|POLY-3 PERCENT (g) | 47.9% 51.2% 56.4% 66.0% |26.9% 25.3% 29.8% 40.6% |
|TERMINAL (d) | 20/43 (47%) 24/46 (52%) 20/36 (56%) 27/40 (68%) |12/46 (26%) 9/43 (21%) 13/43 (30%) 18/45 (40%) |
|FIRST INCIDENCE | 657 657 611 531 |723 620 623 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030 * P=0.546 P=0.213 P=0.063 |P=0.054 P=0.572N P=0.421 P=0.095 |
|POLY 3 | P=0.037 * P=0.451 P=0.273 P=0.057 |P=0.058 P=0.521N P=0.468 P=0.113 |
|POLY 1.5 | P=0.038 * P=0.438 P=0.295 P=0.057 |P=0.055 P=0.521N P=0.465 P=0.109 |
|POLY 6 | P=0.035 * P=0.471 P=0.259 P=0.058 |P=0.060 P=0.521N P=0.467 P=0.117 |
|LOGISTIC REGRESSION| P=0.035 * P=0.454 P=0.260 P=0.057 |P=0.054 P=0.532N P=0.457 P=0.105 |
|COCH-ARM / FISHERS | P=0.098 P=0.421 P=0.500 P=0.115 |P=0.051 P=0.523N P=0.475 P=0.101 |
|ORDER RESTRICTED | P=0.053 (e) (e) (e) |P=0.090 (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/03 EXPERIMENT: 92012 TEST: 06 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 16/50 (32%) 21/50 (42%) 14/50 (28%) |12/50 (24%) 12/49 (24%) 15/49 (31%) 14/50 (28%) |
|POLY-3 RATE (b) | 20/48.77 16/49.00 21/43.75 14/45.00 |12/49.71 12/47.74 15/47.45 14/49.36 |
|POLY-3 PERCENT (g) | 41.0% 32.7% 48.0% 31.1% |24.1% 25.1% 31.6% 28.4% |
|TERMINAL (d) | 15/43 (35%) 13/46 (28%) 14/36 (39%) 11/40 (28%) |9/46 (20%) 8/43 (19%) 11/43 (26%) 10/45 (22%) |
|FIRST INCIDENCE | 611 657 512 656 |402 620 623 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.330N P=0.213N P=0.263 P=0.227N |P=0.334 P=0.523 P=0.276 P=0.400 |
|POLY 3 | P=0.291N P=0.260N P=0.322 P=0.218N |P=0.325 P=0.548 P=0.277 P=0.402 |
|POLY 1.5 | P=0.280N P=0.263N P=0.334 P=0.211N |P=0.326 P=0.554 P=0.281 P=0.405 |
|POLY 6 | P=0.306N P=0.255N P=0.314 P=0.227N |P=0.326 P=0.543 P=0.276 P=0.402 |
|LOGISTIC REGRESSION| P=0.247N P=0.260N P=0.364 P=0.189N |P=0.317 P=0.585 P=0.322 P=0.375 |
|COCH-ARM / FISHERS | P=0.178N P=0.266N P=0.500 P=0.146N |P=0.328 P=0.570 P=0.304 P=0.410 |
|ORDER RESTRICTED | P=0.256N (e) (e) (e) |P=0.407 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 34/50 (68%) 34/50 (68%) 38/50 (76%) |23/50 (46%) 20/49 (41%) 23/49 (47%) 29/50 (58%) |
|POLY-3 RATE (b) | 32/48.77 34/49.00 34/44.17 38/45.61 |23/49.71 20/47.74 23/47.45 29/49.36 |
|POLY-3 PERCENT (g) | 65.6% 69.4% 77.0% 83.3% |46.3% 41.9% 48.5% 58.8% |
|TERMINAL (d) | 27/43 (63%) 31/46 (67%) 26/36 (72%) 34/40 (85%) |20/46 (44%) 16/43 (37%) 19/43 (44%) 25/45 (56%) |
|FIRST INCIDENCE | 611 657 512 531 |402 620 623 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.031 * P=0.562N P=0.112 P=0.069 |P=0.096 P=0.454N P=0.466 P=0.158 |
|POLY 3 | P=0.023 * P=0.428 P=0.164 P=0.040 * |P=0.078 P=0.409N P=0.494 P=0.148 |
|POLY 1.5 | P=0.025 * P=0.423 P=0.172 P=0.042 * |P=0.079 P=0.399N P=0.501 P=0.152 |
|POLY 6 | P=0.020 * P=0.438 P=0.165 P=0.036 * |P=0.079 P=0.416N P=0.492 P=0.147 |
|LOGISTIC REGRESSION| P=0.027 * P=0.441 P=0.162 P=0.049 * |P=0.083 P=0.369N P=0.543 P=0.150 |
|COCH-ARM / FISHERS | P=0.117 P=0.417 P=0.417 P=0.138 |P=0.082 P=0.376N P=0.543 P=0.158 |
|ORDER RESTRICTED | P=0.034 * (e) (e) (e) |P=0.107 (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).