TDMS Study 92012-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst 2-METHYLIMIDAZOLE DATE: 08/06/04
EXPERIMENT: 92012 TEST: 06 TIME: 09:39:30
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; REVISION #2 MICE
REASONS FOR REMOVAL: 25019 Moribund Sacrifice
25020 Natural Death
25026 Other
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst 2-METHYLIMIDAZOLE DATE: 08/06/04
EXPERIMENT: 92012 TEST: 06 TIME: 09:39:30
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
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Bone Marrow Hyperplasia
Epididymis Granuloma Sperm
Inflammation Chronic
Heart: Perivascular Inflammation Chronic
Kidney Cyst
Infarct
Nephropathy
Kidney: Renal Tubule Pigmentation
Liver: Hepatocyte Cytoplasmic Alteration
Karyomegaly
Liver: Kupffer Cell Pigmentation
Lymph Node, Mandibular Atrophy
Lymph Node, Mesenteric Hemorrhage
Hyperplasia Lymphoid
Prostate Inflammation Chronic
Spleen Atrophy
Hematopoietic Cell Proliferation
Pigmentation
Spleen: Lymphoid Follicle Atrophy
Hyperplasia
Testes: Germinal Epithelium Atrophy
Thyroid Gland Degeneration Cystic
Thyroid Gland: Follicular Cell Hyperplasia
Hypertrophy
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia Focal
Adrenal Cortex: Capsule Hyperplasia
Bone Marrow Hyperplasia
Heart Cardiomyopathy
Kidney Hyperplasia Lymphoid
Nephropathy
Liver Clear Cell Focus
Infiltration Cellular Mixed Cell
Mixed Cell Focus
Lymph Node, Mandibular Hematopoietic Cell Proliferation
Lymph Node, Mesenteric Hematopoietic Cell Proliferation
Mesentery: Fat Necrosis
Ovary Inflammation Chronic
Salivary Glands Hyperplasia Lymphoid
Spleen Congestion
Hematopoietic Cell Proliferation
Pigmentation
Stomach, Forestomach Diverticulum
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst 2-METHYLIMIDAZOLE DATE: 08/06/04
EXPERIMENT: 92012 TEST: 06 TIME: 09:39:30
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
Thymus Hyperplasia Lymphoid
Thyroid Gland: Follicular Cell Hyperplasia
Hypertrophy
Urinary Bladder Hyperplasia Lymphoid
Uterus Metaplasia
===============================================================
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions 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 |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 8/50 (16%) 6/50 (12%) |7/50 (14%) 5/49 (10%) 4/49 (8%) 6/50 (12%) |
|POLY-3 RATE (b) | 2/47.43 6/48.86 8/41.44 6/45.45 |7/48.25 5/46.83 4/46.63 6/48.64 |
|POLY-3 PERCENT (g) | 4.2% 12.3% 19.3% 13.2% |14.5% 10.7% 8.6% 12.3% |
|TERMINAL (d) | 2/43 (5%) 5/46 (11%) 8/36 (22%) 5/40 (13%) |7/46 (15%) 5/43 (12%) 4/43 (9%) 6/45 (13%) |
|FIRST INCIDENCE | 729 (T) 657 729 (T) 21 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.114 P=0.158 P=0.023 * P=0.115 |P=0.475N P=0.427N P=0.301N P=0.517N |
|POLY 3 | P=0.128 P=0.144 P=0.027 * P=0.120 |P=0.460N P=0.401N P=0.282N P=0.494N |
|POLY 1.5 | P=0.130 P=0.139 P=0.029 * P=0.120 |P=0.462N P=0.397N P=0.281N P=0.495N |
|POLY 6 | P=0.126 P=0.151 P=0.025 * P=0.120 |P=0.460N P=0.407N P=0.285N P=0.495N |
|LOGISTIC REGRESSION| P=0.146 P=0.137 P=0.023 * P=0.156 |P=0.475N P=0.427N P=0.301N P=0.517N |
|COCH-ARM / FISHERS | P=0.160 P=0.134 P=0.046 * P=0.134 |P=0.466N P=0.394N P=0.274N P=0.500N |
|ORDER RESTRICTED | P=0.053 (e) (e) (e) |P=0.424N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/47.43 4/48.59 3/41.44 1/44.45 |0/48.25 0/46.83 0/46.63 2/48.64 |
|POLY-3 PERCENT (g) | 4.2% 8.2% 7.2% 2.3% |0.0% 0.0% 0.0% 4.1% |
|TERMINAL (d) | 2/43 (5%) 4/46 (9%) 3/36 (8%) 1/40 (3%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 2/45 (4%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.342N P=0.369 P=0.419 P=0.525N |P=0.048 * (e) (e) P=0.234 |
|POLY 3 | P=0.333N P=0.349 P=0.439 P=0.523N |P=0.047 * (e) (e) P=0.239 |
|POLY 1.5 | P=0.332N P=0.344 P=0.447 P=0.523N |P=0.047 * (e) (e) P=0.239 |
|POLY 6 | P=0.335N P=0.357 P=0.432 P=0.522N |P=0.047 * (e) (e) P=0.239 |
|LOGISTIC REGRESSION| P=0.342N P=0.369 P=0.419 P=0.525N |(e) (e) (e) P=0.234 |
|COCH-ARM / FISHERS | P=0.292N P=0.339 P=0.500 P=0.500N |P=0.047 * (e) (e) P=0.247 |
|ORDER RESTRICTED | P=0.291N (e) (e) (e) |P=0.030 * (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 18/50 (36%) 10/50 (20%) 10/50 (20%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 13/47.43 18/48.59 10/41.48 10/44.45 |0/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 27.4% 37.0% 24.1% 22.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 13/43 (30%) 18/46 (39%) 9/36 (25%) 10/40 (25%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 718 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.218N P=0.257 P=0.502N P=0.388N |(e) (e) (e) (e) |
|POLY 3 | P=0.195N P=0.215 P=0.456N P=0.382N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.191N P=0.205 P=0.437N P=0.382N |(e) (e) (e) (e) |
|POLY 6 | P=0.198N P=0.231 P=0.471N P=0.379N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.214N P=0.257 P=0.480N P=0.388N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.130N P=0.194 P=0.318N P=0.318N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.233N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex: Capsule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |3/50 (6%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.43 2/48.59 3/41.44 2/44.45 |3/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 2.1% 4.1% 7.2% 4.5% |6.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/43 (2%) 2/46 (4%) 3/36 (8%) 2/40 (5%) |3/46 (7%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355 P=0.524 P=0.244 P=0.475 |P=0.050N P=0.134N P=0.134N P=0.125N |
|POLY 3 | P=0.362 P=0.508 P=0.259 P=0.477 |P=0.045N* P=0.124N P=0.125N P=0.118N |
|POLY 1.5 | P=0.364 P=0.505 P=0.265 P=0.477 |P=0.046N* P=0.123N P=0.125N P=0.118N |
|POLY 6 | P=0.361 P=0.514 P=0.254 P=0.478 |P=0.045N* P=0.126N P=0.126N P=0.118N |
|LOGISTIC REGRESSION| P=0.355 P=0.524 P=0.244 P=0.475 |P=0.050N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.404 P=0.500 P=0.309 P=0.500 |P=0.048N* P=0.125N P=0.125N P=0.121N |
|ORDER RESTRICTED | P=0.306 (e) (e) (e) |P=0.008N** (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions 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 Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 2/41.44 0/44.45 |0/48.25 0/46.83 1/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 2/36 (6%) 0/40 (0%) |0/46 (0%) 0/43 (0%) 1/43 (2%) 0/45 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.570 (e) P=0.200 (e) |P=0.691 (e) P=0.487 (e) |
|POLY 3 | P=0.567 (e) P=0.209 (e) |P=0.699 (e) P=0.493 (e) |
|POLY 1.5 | P=0.567 (e) P=0.212 (e) |P=0.698 (e) P=0.493 (e) |
|POLY 6 | P=0.568 (e) P=0.205 (e) |P=0.699 (e) P=0.492 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.200 (e) |(e) (e) P=0.487 (e) |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.694 (e) P=0.495 (e) |
|ORDER RESTRICTED | P=0.220 (e) (e) (e) |P=0.374 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Hyperostosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |9/50 (18%) 13/49 (27%) 10/49 (20%) 11/50 (22%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 0/41.44 0/44.45 |9/48.27 13/46.83 10/46.63 11/48.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |18.6% 27.8% 21.5% 22.6% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 0/40 (0%) |8/46 (17%) 13/43 (30%) 10/43 (23%) 11/45 (24%) |
|FIRST INCIDENCE | --- --- --- --- |723 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.457 P=0.183 P=0.434 P=0.381 |
|POLY 3 | (e) (e) (e) (e) |P=0.480 P=0.209 P=0.467 P=0.409 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.478 P=0.214 P=0.468 P=0.408 |
|POLY 6 | (e) (e) (e) (e) |P=0.480 P=0.201 P=0.461 P=0.406 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.476 P=0.182 P=0.440 P=0.399 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.470 P=0.218 P=0.480 P=0.402 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.421 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 10/50 (20%) 20/50 (40%) 42/50 (84%) |10/50 (20%) 5/49 (10%) 13/48 (27%) 16/50 (32%) |
|POLY-3 RATE (b) | 4/48.07 10/48.99 20/42.09 42/46.00 |10/48.25 5/47.38 13/47.56 16/49.11 |
|POLY-3 PERCENT (g) | 8.3% 20.4% 47.5% 91.3% |20.7% 10.6% 27.3% 32.6% |
|TERMINAL (d) | 2/43 (5%) 8/46 (17%) 18/36 (50%) 36/40 (90%) |10/46 (22%) 3/43 (7%) 10/42 (24%) 13/45 (29%) |
|FIRST INCIDENCE | 611 657 531 531 |729 (T) 620 128 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.102 P<0.001 ** P<0.001 ** |P=0.030 * P=0.166N P=0.248 P=0.123 |
|POLY 3 | P<0.001 ** P=0.079 P<0.001 ** P<0.001 ** |P=0.028 * P=0.138N P=0.303 P=0.137 |
|POLY 1.5 | P<0.001 ** P=0.076 P<0.001 ** P<0.001 ** |P=0.027 * P=0.139N P=0.296 P=0.134 |
|POLY 6 | P<0.001 ** P=0.083 P<0.001 ** P<0.001 ** |P=0.028 * P=0.139N P=0.308 P=0.140 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.074 P<0.001 ** P<0.001 ** |P=0.023 * P=0.142N P=0.306 P=0.131 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.074 P<0.001 ** P<0.001 ** |P=0.026 * P=0.140N P=0.278 P=0.127 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.030 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Granuloma Sperm |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 6/50 (12%) | |
|POLY-3 RATE (b) | 0/47.43 0/48.59 3/41.44 6/44.45 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.2% 13.5% | |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 3/36 (8%) 6/40 (15%) | |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.092 P=0.014 * | |
|POLY 3 | P<0.001 ** (e) P=0.097 P=0.012 * | |
|POLY 1.5 | P<0.001 ** (e) P=0.099 P=0.012 * | |
|POLY 6 | P<0.001 ** (e) P=0.094 P=0.012 * | |
|LOGISTIC REGRESSION| (e) (e) P=0.092 P=0.014 * | |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.121 P=0.013 * | |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |
|POLY-3 RATE (b) | 0/47.43 0/48.59 2/41.44 1/44.45 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 2.3% | |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 2/36 (6%) 1/40 (3%) | |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223 (e) P=0.200 P=0.486 | |
|POLY 3 | P=0.223 (e) P=0.209 P=0.487 | |
|POLY 1.5 | P=0.223 (e) P=0.212 P=0.487 | |
|POLY 6 | P=0.222 (e) P=0.205 P=0.487 | |
|LOGISTIC REGRESSION| (e) (e) P=0.200 P=0.486 | |
|COCH-ARM / FISHERS | P=0.246 (e) P=0.247 P=0.500 | |
|ORDER RESTRICTED | P=0.144 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 7/50 (14%) 8/50 (16%) | |
|POLY-3 RATE (b) | 1/47.84 3/48.59 7/41.44 8/44.45 | |
|POLY-3 PERCENT (g) | 2.1% 6.2% 16.9% 18.0% | |
|TERMINAL (d) | 0/43 (0%) 3/46 (7%) 7/36 (19%) 8/40 (20%) | |
|FIRST INCIDENCE | 611 729 (T) 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** P=0.325 P=0.018 * P=0.014 * | |
|POLY 3 | P=0.004 ** P=0.311 P=0.018 * P=0.011 * | |
|POLY 1.5 | P=0.004 ** P=0.309 P=0.019 * P=0.012 * | |
|POLY 6 | P=0.004 ** P=0.315 P=0.016 * P=0.011 * | |
|LOGISTIC REGRESSION| P=0.005 ** P=0.303 P=0.021 * P=0.014 * | |
|COCH-ARM / FISHERS | P=0.008 ** P=0.309 P=0.030 * P=0.015 * | |
|ORDER RESTRICTED | P=0.007 ** (e) (e) (e) | |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 1/49 (2%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 1/41.81 1/44.45 |0/48.25 1/47.16 2/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 2.3% |0.0% 2.1% 4.3% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 1/40 (3%) |0/46 (0%) 0/43 (0%) 2/43 (5%) 0/45 (0%) |
|FIRST INCIDENCE | --- --- 623 729 (T) |--- 639 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.221 (e) P=0.469 P=0.486 |P=0.615N P=0.492 P=0.224 (e) |
|POLY 3 | P=0.219 (e) P=0.475 P=0.487 |P=0.611N P=0.495 P=0.230 (e) |
|POLY 1.5 | P=0.219 (e) P=0.478 P=0.487 |P=0.612N P=0.496 P=0.230 (e) |
|POLY 6 | P=0.218 (e) P=0.473 P=0.487 |P=0.612N P=0.495 P=0.229 (e) |
|LOGISTIC REGRESSION| P=0.235 (e) P=0.523 P=0.486 |P=0.619N P=0.497 P=0.224 (e) |
|COCH-ARM / FISHERS | P=0.236 (e) P=0.500 P=0.500 |P=0.614N P=0.495 P=0.242 (e) |
|ORDER RESTRICTED | P=0.226 (e) (e) (e) |P=0.317N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 0/49 (0%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.43 2/48.59 2/41.81 2/44.45 |1/48.25 0/46.83 2/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 2.1% 4.1% 4.8% 4.5% |2.1% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 1/43 (2%) 2/46 (4%) 1/36 (3%) 2/40 (5%) |1/46 (2%) 0/43 (0%) 2/43 (5%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 623 729 (T) |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.379 P=0.524 P=0.441 P=0.475 |P=0.463N P=0.513N P=0.476 P=0.504N |
|POLY 3 | P=0.385 P=0.508 P=0.456 P=0.477 |P=0.455N P=0.506N P=0.488 P=0.498N |
|POLY 1.5 | P=0.387 P=0.505 P=0.461 P=0.477 |P=0.457N P=0.505N P=0.489 P=0.499N |
|POLY 6 | P=0.384 P=0.514 P=0.453 P=0.478 |P=0.454N P=0.508N P=0.486 P=0.499N |
|LOGISTIC REGRESSION| P=0.395 P=0.524 P=0.479 P=0.475 |P=0.463N (e) P=0.476 (e) |
|COCH-ARM / FISHERS | P=0.423 P=0.500 P=0.500 P=0.500 |P=0.460N P=0.505N P=0.492 P=0.500N |
|ORDER RESTRICTED | P=0.420 (e) (e) (e) |P=0.316N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/48 (4%) 0/50 (0%) |0/50 (0%) 3/49 (6%) 2/49 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/47.43 0/48.59 2/40.53 0/44.45 |0/48.25 3/46.83 2/46.63 1/48.64 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 4.9% 0.0% |0.0% 6.4% 4.3% 2.1% |
|TERMINAL (d) | 1/43 (2%) 0/46 (0%) 2/36 (6%) 0/40 (0%) |0/46 (0%) 3/43 (7%) 2/43 (5%) 1/45 (2%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491N P=0.487N P=0.438 P=0.514N |P=0.552 P=0.110 P=0.224 P=0.496 |
|POLY 3 | P=0.487N P=0.495N P=0.445 P=0.513N |P=0.562 P=0.114 P=0.230 P=0.502 |
|POLY 1.5 | P=0.485N P=0.497N P=0.451 P=0.513N |P=0.561 P=0.115 P=0.230 P=0.501 |
|POLY 6 | P=0.489N P=0.492N P=0.441 P=0.513N |P=0.561 P=0.112 P=0.229 P=0.501 |
|LOGISTIC REGRESSION| P=0.491N (e) P=0.438 (e) |(e) P=0.110 P=0.224 P=0.496 |
|COCH-ARM / FISHERS | P=0.462N P=0.500N P=0.485 P=0.500N |P=0.557 P=0.117 P=0.242 P=0.500 |
|ORDER RESTRICTED | P=0.322N (e) (e) (e) |P=0.179 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 0/48 (0%) 2/50 (4%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/47.43 4/48.59 0/40.53 2/44.45 |0/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 6.3% 8.2% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/43 (7%) 4/46 (9%) 0/36 (0%) 2/40 (5%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309N P=0.537 P=0.154N P=0.533N |(e) (e) (e) (e) |
|POLY 3 | P=0.295N P=0.513 P=0.149N P=0.529N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.292N P=0.507 P=0.146N P=0.529N |(e) (e) (e) (e) |
|POLY 6 | P=0.297N P=0.522 P=0.152N P=0.529N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.309N P=0.537 (e) P=0.533N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.266N P=0.500 P=0.129N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.215N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/47.57 0/48.59 0/41.44 1/44.45 |0/48.25 0/46.83 0/46.63 2/48.64 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 2.3% |0.0% 0.0% 0.0% 4.1% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 1/40 (3%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 2/45 (4%) |
|FIRST INCIDENCE | 694 --- --- 729 (T) |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.573 P=0.483N P=0.529N P=0.747 |P=0.048 * (e) (e) P=0.234 |
|POLY 3 | P=0.578 P=0.496N P=0.527N P=0.745 |P=0.047 * (e) (e) P=0.239 |
|POLY 1.5 | P=0.580 P=0.498N P=0.524N P=0.746 |P=0.047 * (e) (e) P=0.239 |
|POLY 6 | P=0.575 P=0.493N P=0.531N P=0.745 |P=0.047 * (e) (e) P=0.239 |
|LOGISTIC REGRESSION| P=0.581 P=0.502N P=0.512N P=0.753 |(e) (e) (e) P=0.234 |
|COCH-ARM / FISHERS | P=0.595 P=0.500N P=0.500N P=0.753N |P=0.047 * (e) (e) P=0.247 |
|ORDER RESTRICTED | P=0.384 (e) (e) (e) |P=0.030 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Perivascular |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/47.66 0/48.59 0/41.44 0/44.45 |0/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 6.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/43 (5%) 0/46 (0%) 0/36 (0%) 0/40 (0%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 668 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.057N P=0.113N P=0.157N P=0.136N |(e) (e) (e) (e) |
|POLY 3 | P=0.049N* P=0.116N P=0.146N P=0.132N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.048N* P=0.117N P=0.142N P=0.132N |(e) (e) (e) (e) |
|POLY 6 | P=0.050N P=0.113N P=0.150N P=0.132N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.051N P=0.121N P=0.136N P=0.127N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.047N* P=0.121N P=0.121N P=0.121N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.010N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/49 (2%) 1/47 (2%) 1/50 (2%) |2/50 (4%) 0/48 (0%) 2/48 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/46.72 1/47.60 1/41.44 1/44.45 |2/48.25 0/46.26 2/45.67 2/48.88 |
|POLY-3 PERCENT (g) | 4.3% 2.1% 2.4% 2.3% |4.2% 0.0% 4.4% 4.1% |
|TERMINAL (d) | 2/43 (5%) 1/46 (2%) 1/36 (3%) 1/40 (3%) |2/46 (4%) 0/43 (0%) 2/43 (5%) 1/45 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) --- 729 (T) 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.448N P=0.476N P=0.562N P=0.525N |P=0.445 P=0.253N P=0.670 P=0.689 |
|POLY 3 | P=0.428N P=0.494N P=0.542N P=0.517N |P=0.454 P=0.247N P=0.674 P=0.689N |
|POLY 1.5 | P=0.425N P=0.496N P=0.535N P=0.516N |P=0.452 P=0.247N P=0.674 P=0.690N |
|POLY 6 | P=0.432N P=0.489N P=0.548N P=0.518N |P=0.456 P=0.248N P=0.672 P=0.688N |
|LOGISTIC REGRESSION| P=0.448N P=0.476N P=0.562N P=0.525N |P=0.449 (e) P=0.670 P=0.691 |
|COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.516N P=0.492N |P=0.448 P=0.258N P=0.676 P=0.691N |
|ORDER RESTRICTED | P=0.440N (e) (e) (e) |P=0.434 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) |1/50 (2%) 1/48 (2%) 0/48 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/47.43 2/48.59 0/41.44 1/44.45 |1/48.27 1/45.83 0/45.67 1/48.64 |
|POLY-3 PERCENT (g) | 0.0% 4.1% 0.0% 2.3% |2.1% 2.2% 0.0% 2.1% |
|TERMINAL (d) | 0/43 (0%) 2/46 (4%) 0/36 (0%) 1/40 (3%) |0/46 (0%) 1/42 (2%) 0/43 (0%) 1/45 (2%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |723 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.509 P=0.253 (e) P=0.486 |P=0.614N P=0.740 P=0.518N P=0.755 |
|POLY 3 | P=0.513 P=0.243 (e) P=0.487 |P=0.612N P=0.749 P=0.511N P=0.759N |
|POLY 1.5 | P=0.513 P=0.240 (e) P=0.487 |P=0.612N P=0.750 P=0.511N P=0.759N |
|POLY 6 | P=0.513 P=0.247 (e) P=0.487 |P=0.612N P=0.747 P=0.512N P=0.759N |
|LOGISTIC REGRESSION| (e) P=0.253 (e) P=0.486 |P=0.610N P=0.749 P=0.511N P=0.761N |
|COCH-ARM / FISHERS | P=0.538 P=0.247 (e) P=0.500 |P=0.613N P=0.742 P=0.510N P=0.753N |
|ORDER RESTRICTED | P=0.314 (e) (e) (e) |P=0.528N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 10
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 11/50 (22%) 12/50 (24%) 19/50 (38%) |1/50 (2%) 2/49 (4%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 13/47.43 11/48.59 12/41.44 19/44.45 |1/48.25 2/47.16 1/46.63 1/48.64 |
|POLY-3 PERCENT (g) | 27.4% 22.6% 29.0% 42.7% |2.1% 4.2% 2.1% 2.1% |
|TERMINAL (d) | 13/43 (30%) 11/46 (24%) 12/36 (33%) 19/40 (48%) |1/46 (2%) 1/43 (2%) 1/43 (2%) 1/45 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 639 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027 * P=0.334N P=0.479 P=0.084 |P=0.531N P=0.479 P=0.747 P=0.757 |
|POLY 3 | P=0.036 * P=0.381N P=0.529 P=0.091 |P=0.527N P=0.492 P=0.753 P=0.759N |
|POLY 1.5 | P=0.038 * P=0.393N P=0.550 P=0.093 |P=0.527N P=0.493 P=0.753 P=0.759N |
|POLY 6 | P=0.033 * P=0.363N P=0.511 P=0.091 |P=0.528N P=0.491 P=0.752 P=0.759N |
|LOGISTIC REGRESSION| P=0.027 * P=0.334N P=0.479 P=0.084 |P=0.530N P=0.495 P=0.747 P=0.757 |
|COCH-ARM / FISHERS | P=0.070 P=0.408N P=0.500N P=0.142 |P=0.529N P=0.492 P=0.747 P=0.753N |
|ORDER RESTRICTED | P=0.043 * (e) (e) (e) |P=0.577N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 3/50 (6%) |8/50 (16%) 16/49 (33%) 8/49 (16%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/47.66 3/48.59 3/41.44 3/44.45 |8/48.25 16/47.16 8/46.63 4/48.64 |
|POLY-3 PERCENT (g) | 2.1% 6.2% 7.2% 6.8% |16.6% 33.9% 17.2% 8.2% |
|TERMINAL (d) | 0/43 (0%) 3/46 (7%) 3/36 (8%) 3/40 (8%) |8/46 (17%) 15/43 (35%) 8/43 (19%) 4/45 (9%) |
|FIRST INCIDENCE | 668 729 (T) 729 (T) 729 (T) |729 (T) 639 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.246 P=0.329 P=0.245 P=0.282 |P=0.043N* P=0.034 * P=0.550 P=0.188N |
|POLY 3 | P=0.251 P=0.313 P=0.257 P=0.281 |P=0.035N* P=0.041 * P=0.578 P=0.174N |
|POLY 1.5 | P=0.253 P=0.309 P=0.264 P=0.282 |P=0.036N* P=0.042 * P=0.579 P=0.175N |
|POLY 6 | P=0.248 P=0.317 P=0.251 P=0.280 |P=0.035N* P=0.040 * P=0.574 P=0.175N |
|LOGISTIC REGRESSION| P=0.255 P=0.306 P=0.264 P=0.286 |P=0.038N* P=0.040 * P=0.550 P=0.188N |
|COCH-ARM / FISHERS | P=0.292 P=0.309 P=0.309 P=0.309 |P=0.040N* P=0.044 * P=0.590 P=0.178N |
|ORDER RESTRICTED | P=0.241 (e) (e) (e) |P=0.019N* (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 11
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 6/50 (12%) 6/50 (12%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 2/49 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 6/48.43 6/48.59 6/41.44 1/44.45 |0/48.25 0/46.83 2/46.63 2/48.64 |
|POLY-3 PERCENT (g) | 12.4% 12.4% 14.5% 2.3% |0.0% 0.0% 4.3% 4.1% |
|TERMINAL (d) | 5/43 (12%) 6/46 (13%) 6/36 (17%) 1/40 (3%) |0/46 (0%) 0/43 (0%) 2/43 (5%) 2/45 (4%) |
|FIRST INCIDENCE | 24 729 (T) 729 (T) 729 (T) |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.070N P=0.576N P=0.497 P=0.073N |P=0.088 (e) P=0.224 P=0.234 |
|POLY 3 | P=0.069N P=0.618N P=0.508 P=0.071N |P=0.089 (e) P=0.230 P=0.239 |
|POLY 1.5 | P=0.068N P=0.615 P=0.521 P=0.072N |P=0.089 (e) P=0.230 P=0.239 |
|POLY 6 | P=0.070N P=0.606N P=0.496 P=0.071N |P=0.090 (e) P=0.229 P=0.239 |
|LOGISTIC REGRESSION| P=0.051N P=0.610 P=0.623N P=0.040N* |(e) (e) P=0.224 P=0.234 |
|COCH-ARM / FISHERS | P=0.047N* P=0.620N P=0.620N P=0.056N |P=0.087 (e) P=0.242 P=0.247 |
|ORDER RESTRICTED | P=0.064N (e) (e) (e) |P=0.111 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 1/49 (2%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 5/47.66 3/48.59 2/41.44 3/44.45 |0/48.25 1/46.83 0/46.63 2/49.07 |
|POLY-3 PERCENT (g) | 10.5% 6.2% 4.8% 6.8% |0.0% 2.1% 0.0% 4.1% |
|TERMINAL (d) | 4/43 (9%) 3/46 (7%) 2/36 (6%) 3/40 (8%) |0/46 (0%) 1/43 (2%) 0/43 (0%) 1/45 (2%) |
|FIRST INCIDENCE | 668 729 (T) 729 (T) 729 (T) |--- 729 (T) --- 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.356N P=0.323N P=0.296N P=0.397N |P=0.143 P=0.487 (e) P=0.240 |
|POLY 3 | P=0.340N P=0.346N P=0.277N P=0.396N |P=0.144 P=0.494 (e) P=0.241 |
|POLY 1.5 | P=0.335N P=0.351N P=0.268N P=0.394N |P=0.143 P=0.495 (e) P=0.240 |
|POLY 6 | P=0.345N P=0.339N P=0.286N P=0.397N |P=0.144 P=0.492 (e) P=0.242 |
|LOGISTIC REGRESSION| P=0.344N P=0.349N P=0.274N P=0.390N |P=0.134 P=0.487 (e) P=0.190 |
|COCH-ARM / FISHERS | P=0.297N P=0.357N P=0.218N P=0.357N |P=0.141 P=0.495 (e) P=0.247 |
|ORDER RESTRICTED | P=0.305N (e) (e) (e) |P=0.077 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 12
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 43/50 (86%) 32/50 (64%) 31/50 (62%) |27/50 (54%) 17/49 (35%) 21/49 (43%) 19/50 (38%) |
|POLY-3 RATE (b) | 34/48.03 43/48.99 32/42.15 31/44.73 |27/50.00 17/48.38 21/48.01 19/49.28 |
|POLY-3 PERCENT (g) | 70.8% 87.8% 75.9% 69.3% |54.0% 35.1% 43.8% 38.6% |
|TERMINAL (d) | 31/43 (72%) 41/46 (89%) 29/36 (81%) 29/40 (73%) |23/46 (50%) 14/43 (33%) 16/43 (37%) 18/45 (40%) |
|FIRST INCIDENCE | 668 657 611 693 |402 400 555 517 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.331N P=0.106 P=0.267 P=0.524N |P=0.167N P=0.078N P=0.264N P=0.107N |
|POLY 3 | P=0.253N P=0.031 * P=0.377 P=0.529N |P=0.149N P=0.045N* P=0.209N P=0.089N |
|POLY 1.5 | P=0.235N P=0.027 * P=0.427 P=0.519N |P=0.145N P=0.043N* P=0.207N P=0.085N |
|POLY 6 | P=0.275N P=0.040 * P=0.332 P=0.538N |P=0.155N P=0.049N* P=0.209N P=0.096N |
|LOGISTIC REGRESSION| P=0.256N P=0.044 * P=0.304 P=0.493N |P=0.146N P=0.031N* P=0.173N P=0.084N |
|COCH-ARM / FISHERS | P=0.088N P=0.028 * P=0.417N P=0.338N |P=0.139N P=0.041N* P=0.182N P=0.080N |
|ORDER RESTRICTED | P=0.188N (e) (e) (e) |P=0.088N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.43 1/48.59 2/41.44 3/44.59 |0/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 4.8% 6.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/43 (2%) 1/46 (2%) 2/36 (6%) 2/40 (5%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 695 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.139 P=0.747N P=0.438 P=0.286 |(e) (e) (e) (e) |
|POLY 3 | P=0.144 P=0.755N P=0.453 P=0.284 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.145 P=0.757N P=0.459 P=0.283 |(e) (e) (e) (e) |
|POLY 6 | P=0.143 P=0.751N P=0.448 P=0.285 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.142 P=0.747N P=0.438 P=0.283 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.165 P=0.753N P=0.500 P=0.309 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.192 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 13
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 45/50 (90%) |0/50 (0%) 2/49 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.66 0/48.59 2/41.70 45/46.00 |0/48.25 2/47.25 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 4.8% 97.8% |0.0% 4.2% 0.0% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 1/36 (3%) 39/40 (98%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 668 --- 659 531 |--- 620 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.492N P=0.439 P<0.001 ** |P=0.404N P=0.230 (e) (e) |
|POLY 3 | P<0.001 ** P=0.496N P=0.454 P<0.001 ** |P=0.404N P=0.233 (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.498N P=0.460 P<0.001 ** |P=0.404N P=0.233 (e) (e) |
|POLY 6 | P<0.001 ** P=0.493N P=0.449 P<0.001 ** |P=0.405N P=0.232 (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.503N P=0.487 P<0.001 ** |P=0.407N P=0.233 (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.500 P<0.001 ** |P=0.405N P=0.242 (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/47.43 0/48.59 1/42.27 0/44.45 |1/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 4.2% 0.0% 2.4% 0.0% |2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/43 (5%) 0/46 (0%) 0/36 (0%) 0/40 (0%) |1/46 (2%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) --- 400 --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.208N P=0.224N P=0.551N P=0.254N |P=0.309N P=0.513N P=0.513N P=0.504N |
|POLY 3 | P=0.201N P=0.232N P=0.540N P=0.252N |P=0.307N P=0.506N P=0.507N P=0.498N |
|POLY 1.5 | P=0.199N P=0.234N P=0.536N P=0.252N |P=0.307N P=0.505N P=0.507N P=0.499N |
|POLY 6 | P=0.204N P=0.228N P=0.544N P=0.252N |P=0.306N P=0.508N P=0.508N P=0.499N |
|LOGISTIC REGRESSION| P=0.163N (e) P=0.457N (e) |P=0.309N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.188N P=0.247N P=0.500N P=0.247N |P=0.306N P=0.505N P=0.505N P=0.500N |
|ORDER RESTRICTED | P=0.084N (e) (e) (e) |P=0.119N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 14
Statistical Analysis of Non-neoplastic Lesions 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 |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 4/49 (8%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/47.43 3/48.59 1/41.44 3/44.56 |0/48.25 4/47.67 1/46.63 1/48.64 |
|POLY-3 PERCENT (g) | 4.2% 6.2% 2.4% 6.7% |0.0% 8.4% 2.1% 2.1% |
|TERMINAL (d) | 2/43 (5%) 3/46 (7%) 1/36 (3%) 2/40 (5%) |0/46 (0%) 3/43 (7%) 1/43 (2%) 1/45 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 701 |--- 400 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.425 P=0.531 P=0.562N P=0.470 |P=0.557N P=0.058 P=0.487 P=0.496 |
|POLY 3 | P=0.438 P=0.511 P=0.547N P=0.472 |P=0.551N P=0.059 P=0.493 P=0.502 |
|POLY 1.5 | P=0.440 P=0.506 P=0.541N P=0.471 |P=0.551N P=0.059 P=0.493 P=0.501 |
|POLY 6 | P=0.436 P=0.519 P=0.552N P=0.473 |P=0.553N P=0.058 P=0.492 P=0.501 |
|LOGISTIC REGRESSION| P=0.432 P=0.531 P=0.562N P=0.471 |P=0.566N P=0.054 P=0.487 P=0.496 |
|COCH-ARM / FISHERS | P=0.477 P=0.500 P=0.500N P=0.500 |P=0.554N P=0.056 P=0.495 P=0.500 |
|ORDER RESTRICTED | P=0.457 (e) (e) (e) |P=0.178 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 9/50 (18%) 6/50 (12%) 8/50 (16%) |1/50 (2%) 0/49 (0%) 1/49 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 6/47.43 9/48.59 6/41.44 8/44.45 |1/48.25 0/46.83 1/46.63 4/48.64 |
|POLY-3 PERCENT (g) | 12.7% 18.5% 14.5% 18.0% |2.1% 0.0% 2.1% 8.2% |
|TERMINAL (d) | 6/43 (14%) 9/46 (20%) 6/36 (17%) 8/40 (20%) |1/46 (2%) 0/43 (0%) 1/43 (2%) 4/45 (9%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.333 P=0.337 P=0.492 P=0.330 |P=0.035 * P=0.513N P=0.747 P=0.174 |
|POLY 3 | P=0.356 P=0.306 P=0.523 P=0.337 |P=0.035 * P=0.506N P=0.753 P=0.182 |
|POLY 1.5 | P=0.360 P=0.298 P=0.536 P=0.338 |P=0.035 * P=0.505N P=0.753 P=0.181 |
|POLY 6 | P=0.351 P=0.318 P=0.512 P=0.338 |P=0.035 * P=0.508N P=0.752 P=0.181 |
|LOGISTIC REGRESSION| P=0.333 P=0.337 P=0.492 P=0.330 |P=0.035 * (e) P=0.747 P=0.174 |
|COCH-ARM / FISHERS | P=0.433 P=0.288 P=0.620N P=0.387 |P=0.035 * P=0.505N P=0.747 P=0.181 |
|ORDER RESTRICTED | P=0.385 (e) (e) (e) |P=0.027 * (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 15
Statistical Analysis of Non-neoplastic Lesions 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 |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 6/50 (12%) |0/50 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/47.43 3/48.59 2/41.44 6/44.73 |0/48.25 0/46.83 1/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 6.3% 6.2% 4.8% 13.4% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 3/43 (7%) 3/46 (7%) 2/36 (6%) 5/40 (13%) |0/46 (0%) 0/43 (0%) 1/43 (2%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 654 |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.116 P=0.631N P=0.581N P=0.211 |P=0.691 (e) P=0.487 (e) |
|POLY 3 | P=0.125 P=0.651N P=0.561N P=0.214 |P=0.699 (e) P=0.493 (e) |
|POLY 1.5 | P=0.127 P=0.656N P=0.553N P=0.213 |P=0.698 (e) P=0.493 (e) |
|POLY 6 | P=0.124 P=0.643N P=0.568N P=0.217 |P=0.699 (e) P=0.492 (e) |
|LOGISTIC REGRESSION| P=0.122 P=0.631N P=0.581N P=0.212 |(e) (e) P=0.487 (e) |
|COCH-ARM / FISHERS | P=0.151 P=0.661N P=0.500N P=0.243 |P=0.694 (e) P=0.495 (e) |
|ORDER RESTRICTED | P=0.131 (e) (e) (e) |P=0.374 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |3/50 (6%) 3/49 (6%) 5/49 (10%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/47.66 0/48.59 2/41.44 2/44.45 |3/48.25 3/47.41 5/47.19 3/49.10 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 4.8% 4.5% |6.2% 6.3% 10.6% 6.1% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 2/36 (6%) 2/40 (5%) |3/46 (7%) 0/43 (0%) 4/43 (9%) 1/45 (2%) |
|FIRST INCIDENCE | 668 --- 729 (T) 729 (T) |729 (T) 620 555 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.217 P=0.492N P=0.437 P=0.475 |P=0.537 P=0.634 P=0.326 P=0.655 |
|POLY 3 | P=0.220 P=0.496N P=0.451 P=0.476 |P=0.552 P=0.654 P=0.345 P=0.654N |
|POLY 1.5 | P=0.222 P=0.498N P=0.458 P=0.477 |P=0.548 P=0.653 P=0.343 P=0.656N |
|POLY 6 | P=0.218 P=0.493N P=0.445 P=0.475 |P=0.555 P=0.654 P=0.345 P=0.652N |
|LOGISTIC REGRESSION| P=0.225 P=0.503N P=0.465 P=0.485 |P=0.530 P=0.657 P=0.350 P=0.650 |
|COCH-ARM / FISHERS | P=0.245 P=0.500N P=0.500 P=0.500 |P=0.540 P=0.651 P=0.346 P=0.661N |
|ORDER RESTRICTED | P=0.226 (e) (e) (e) |P=0.542 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 16
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 1/49 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 0/41.44 1/44.45 |0/48.25 0/46.83 1/46.63 2/48.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.3% |0.0% 0.0% 2.1% 4.1% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 1/40 (3%) |0/46 (0%) 0/43 (0%) 1/43 (2%) 2/45 (4%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.187 (e) (e) P=0.486 |P=0.072 (e) P=0.487 P=0.234 |
|POLY 3 | P=0.189 (e) (e) P=0.487 |P=0.073 (e) P=0.493 P=0.239 |
|POLY 1.5 | P=0.190 (e) (e) P=0.487 |P=0.072 (e) P=0.493 P=0.239 |
|POLY 6 | P=0.188 (e) (e) P=0.487 |P=0.073 (e) P=0.492 P=0.239 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.486 |(e) (e) P=0.487 P=0.234 |
|COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.071 (e) P=0.495 P=0.247 |
|ORDER RESTRICTED | P=0.109 (e) (e) (e) |P=0.075 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 3/49 (6%) 0/49 (0%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 0/41.44 0/44.45 |3/48.25 3/46.83 0/46.63 6/48.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.2% 6.4% 0.0% 12.3% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 0/40 (0%) |3/46 (7%) 3/43 (7%) 0/43 (0%) 6/45 (13%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.157 P=0.631 P=0.134N P=0.232 |
|POLY 3 | (e) (e) (e) (e) |P=0.159 P=0.648 P=0.125N P=0.247 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.159 P=0.650 P=0.125N P=0.246 |
|POLY 6 | (e) (e) (e) (e) |P=0.159 P=0.644 P=0.126N P=0.246 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.157 P=0.631 (e) P=0.232 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.160 P=0.651 P=0.125N P=0.243 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.071 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 17
Statistical Analysis of Non-neoplastic Lesions 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 |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 7/50 (14%) 7/50 (14%) 7/50 (14%) |13/50 (26%) 5/49 (10%) 12/49 (24%) 10/50 (20%) |
|POLY-3 RATE (b) | 5/47.43 7/48.59 7/41.53 7/44.56 |13/48.25 5/46.83 12/46.63 10/48.64 |
|POLY-3 PERCENT (g) | 10.5% 14.4% 16.9% 15.7% |27.0% 10.7% 25.7% 20.6% |
|TERMINAL (d) | 5/43 (12%) 7/46 (15%) 6/36 (17%) 6/40 (15%) |13/46 (28%) 5/43 (12%) 12/43 (28%) 10/45 (22%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 706 701 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.276 P=0.427 P=0.265 P=0.332 |P=0.508N P=0.047N* P=0.578N P=0.338N |
|POLY 3 | P=0.294 P=0.397 P=0.290 P=0.336 |P=0.483N P=0.037N* P=0.539N P=0.310N |
|POLY 1.5 | P=0.297 P=0.389 P=0.301 P=0.336 |P=0.487N P=0.036N* P=0.538N P=0.311N |
|POLY 6 | P=0.292 P=0.409 P=0.281 P=0.339 |P=0.481N P=0.039N* P=0.546N P=0.311N |
|LOGISTIC REGRESSION| P=0.285 P=0.427 P=0.272 P=0.337 |P=0.508N P=0.047N* P=0.578N P=0.338N |
|COCH-ARM / FISHERS | P=0.361 P=0.380 P=0.380 P=0.380 |P=0.495N P=0.037N* P=0.523N P=0.318N |
|ORDER RESTRICTED | P=0.345 (e) (e) (e) |P=0.262N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 4/50 (8%) 4/50 (8%) |4/50 (8%) 1/49 (2%) 3/49 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/47.43 3/48.60 4/41.44 4/44.45 |4/48.25 1/46.83 3/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 8.4% 6.2% 9.7% 9.0% |8.3% 2.1% 6.4% 0.0% |
|TERMINAL (d) | 4/43 (9%) 2/46 (4%) 4/36 (11%) 4/40 (10%) |4/46 (9%) 1/43 (2%) 3/43 (7%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 726 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.447 P=0.462N P=0.543 P=0.604 |P=0.075N P=0.201N P=0.537N P=0.066N |
|POLY 3 | P=0.463 P=0.487N P=0.567 P=0.607 |P=0.069N P=0.188N P=0.519N P=0.060N |
|POLY 1.5 | P=0.467 P=0.493N P=0.577 P=0.607 |P=0.070N P=0.187N P=0.518N P=0.060N |
|POLY 6 | P=0.459 P=0.477N P=0.558 P=0.608 |P=0.069N P=0.191N P=0.522N P=0.060N |
|LOGISTIC REGRESSION| P=0.448 P=0.455N P=0.543 P=0.604 |P=0.075N P=0.201N P=0.537N (e) |
|COCH-ARM / FISHERS | P=0.518 P=0.500N P=0.643N P=0.643N |P=0.072N P=0.187N P=0.511N P=0.059N |
|ORDER RESTRICTED | P=0.567 (e) (e) (e) |P=0.027N* (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 18
Statistical Analysis of Non-neoplastic Lesions 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 |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 2/50 (4%) 6/50 (12%) |5/50 (10%) 2/49 (4%) 3/49 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/47.66 6/48.86 2/41.44 6/44.56 |5/48.25 2/47.67 3/47.89 4/49.31 |
|POLY-3 PERCENT (g) | 4.2% 12.3% 4.8% 13.5% |10.4% 4.2% 6.3% 8.1% |
|TERMINAL (d) | 1/43 (2%) 5/46 (11%) 2/36 (6%) 5/40 (13%) |5/46 (11%) 1/43 (2%) 1/43 (2%) 2/45 (4%) |
|FIRST INCIDENCE | 668 657 729 (T) 701 |729 (T) 400 128 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.147 P=0.160 P=0.627 P=0.118 |P=0.535N P=0.244N P=0.389N P=0.508N |
|POLY 3 | P=0.151 P=0.142 P=0.642 P=0.113 |P=0.526N P=0.222N P=0.361N P=0.486N |
|POLY 1.5 | P=0.153 P=0.138 P=0.650 P=0.113 |P=0.529N P=0.222N P=0.363N P=0.491N |
|POLY 6 | P=0.148 P=0.148 P=0.635 P=0.112 |P=0.521N P=0.224N P=0.361N P=0.482N |
|LOGISTIC REGRESSION| P=0.156 P=0.135 P=0.655 P=0.116 |P=0.563 P=0.217N P=0.298N P=0.517N |
|COCH-ARM / FISHERS | P=0.189 P=0.134 P=0.691N P=0.134 |P=0.535N P=0.226N P=0.369N P=0.500N |
|ORDER RESTRICTED | P=0.086 (e) (e) (e) |P=0.341N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Tension Lipidosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.43 2/48.59 1/41.44 0/44.45 |0/48.25 0/46.83 2/47.00 0/48.64 |
|POLY-3 PERCENT (g) | 0.0% 4.1% 2.4% 0.0% |0.0% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 0/43 (0%) 2/46 (4%) 1/36 (3%) 0/40 (0%) |0/46 (0%) 0/43 (0%) 1/43 (2%) 0/45 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |--- --- 623 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491N P=0.253 P=0.465 (e) |P=0.594 (e) P=0.230 (e) |
|POLY 3 | P=0.487N P=0.243 P=0.473 (e) |P=0.602 (e) P=0.232 (e) |
|POLY 1.5 | P=0.487N P=0.240 P=0.477 (e) |P=0.601 (e) P=0.231 (e) |
|POLY 6 | P=0.487N P=0.247 P=0.470 (e) |P=0.603 (e) P=0.231 (e) |
|LOGISTIC REGRESSION| (e) P=0.253 P=0.465 (e) |P=0.593 (e) P=0.246 (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.247 P=0.500 (e) |P=0.595 (e) P=0.242 (e) |
|ORDER RESTRICTED | P=0.317 (e) (e) (e) |P=0.242 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 19
Statistical Analysis of Non-neoplastic Lesions 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: Hepatocyte |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 11/50 (22%) 37/50 (74%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 11/41.44 37/44.45 |0/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 26.6% 83.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 11/36 (31%) 37/40 (93%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (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: Hepatocyte |
| Karyomegaly |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 10/50 (20%) 29/50 (58%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 10/41.44 29/44.45 |0/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 24.1% 65.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 10/36 (28%) 29/40 (73%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 20
Statistical Analysis of Non-neoplastic Lesions 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: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 19/50 (38%) |0/50 (0%) 2/49 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.43 1/48.72 1/41.44 19/45.62 |0/48.25 2/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 2.4% 41.7% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 1/36 (3%) 15/40 (38%) |0/46 (0%) 2/43 (5%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | --- 696 729 (T) 531 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.522 P=0.465 P<0.001 ** |P=0.408N P=0.224 (e) (e) |
|POLY 3 | P<0.001 ** P=0.505 P=0.473 P<0.001 ** |P=0.405N P=0.231 (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.503 P=0.477 P<0.001 ** |P=0.404N P=0.232 (e) (e) |
|POLY 6 | P<0.001 ** P=0.509 P=0.470 P<0.001 ** |P=0.407N P=0.229 (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.499 P=0.465 P<0.001 ** |(e) P=0.224 (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 P<0.001 ** |P=0.405N P=0.242 (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.240N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |2/50 (4%) 0/49 (0%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/47.43 3/48.59 1/41.44 3/44.45 |2/48.27 0/46.83 0/46.63 1/48.64 |
|POLY-3 PERCENT (g) | 2.1% 6.2% 2.4% 6.8% |4.1% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 1/43 (2%) 3/46 (7%) 1/36 (3%) 3/40 (8%) |1/46 (2%) 0/43 (0%) 0/43 (0%) 1/45 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |723 --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.269 P=0.330 P=0.722 P=0.280 |P=0.463N P=0.257N P=0.257N P=0.508N |
|POLY 3 | P=0.279 P=0.314 P=0.730 P=0.283 |P=0.459N P=0.244N P=0.245N P=0.497N |
|POLY 1.5 | P=0.281 P=0.310 P=0.734 P=0.283 |P=0.460N P=0.243N P=0.245N P=0.498N |
|POLY 6 | P=0.277 P=0.320 P=0.726 P=0.283 |P=0.458N P=0.246N P=0.246N P=0.498N |
|LOGISTIC REGRESSION| P=0.269 P=0.330 P=0.722 P=0.280 |P=0.458N P=0.246N P=0.246N P=0.498N |
|COCH-ARM / FISHERS | P=0.313 P=0.309 P=0.753N P=0.309 |P=0.460N P=0.253N P=0.253N P=0.500N |
|ORDER RESTRICTED | P=0.218 (e) (e) (e) |P=0.132N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 21
Statistical Analysis of Non-neoplastic Lesions 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 |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/49 (4%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 0/41.44 0/44.45 |2/48.27 2/46.83 2/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.1% 4.3% 4.3% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 0/40 (0%) |1/46 (2%) 2/43 (5%) 2/43 (5%) 0/45 (0%) |
|FIRST INCIDENCE | --- --- --- --- |723 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.169N P=0.667 P=0.667 P=0.245N |
|POLY 3 | (e) (e) (e) (e) |P=0.162N P=0.683 P=0.681 P=0.236N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.163N P=0.685 P=0.682 P=0.236N |
|POLY 6 | (e) (e) (e) (e) |P=0.162N P=0.679 P=0.679 P=0.236N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.163N P=0.678 P=0.679 P=0.236N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.163N P=0.684 P=0.684 P=0.247N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.179N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/50 (16%) 4/50 (8%) 2/50 (4%) |4/50 (8%) 3/49 (6%) 1/49 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 4/47.43 8/48.72 4/41.44 2/44.72 |4/48.25 3/46.83 1/46.63 4/49.07 |
|POLY-3 PERCENT (g) | 8.4% 16.4% 9.7% 4.5% |8.3% 6.4% 2.1% 8.2% |
|TERMINAL (d) | 4/43 (9%) 7/46 (15%) 4/36 (11%) 1/40 (3%) |4/46 (9%) 3/43 (7%) 1/43 (2%) 3/45 (7%) |
|FIRST INCIDENCE | 729 (T) 696 729 (T) 656 |729 (T) 729 (T) 729 (T) 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.187N P=0.216 P=0.543 P=0.371N |P=0.576 P=0.537N P=0.201N P=0.633 |
|POLY 3 | P=0.172N P=0.191 P=0.567 P=0.365N |P=0.571N P=0.516N P=0.190N P=0.633N |
|POLY 1.5 | P=0.172N P=0.185 P=0.577 P=0.366N |P=0.573N P=0.513N P=0.189N P=0.636N |
|POLY 6 | P=0.171N P=0.201 P=0.558 P=0.362N |P=0.569N P=0.521N P=0.191N P=0.632N |
|LOGISTIC REGRESSION| P=0.175N P=0.199 P=0.543 P=0.363N |P=0.575N P=0.537N P=0.201N P=0.638 |
|COCH-ARM / FISHERS | P=0.139N P=0.178 P=0.643N P=0.339N |P=0.577N P=0.511N P=0.187N P=0.643N |
|ORDER RESTRICTED | P=0.151N (e) (e) (e) |P=0.420N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 22
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 4/50 (8%) |9/50 (18%) 6/49 (12%) 3/49 (6%) 7/50 (14%) |
|POLY-3 RATE (b) | 1/47.43 2/48.59 2/41.44 4/44.45 |9/48.25 6/46.83 3/46.63 7/48.67 |
|POLY-3 PERCENT (g) | 2.1% 4.1% 4.8% 9.0% |18.7% 12.8% 6.4% 14.4% |
|TERMINAL (d) | 1/43 (2%) 2/46 (4%) 2/36 (6%) 4/40 (10%) |9/46 (20%) 6/43 (14%) 3/43 (7%) 6/45 (13%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 720 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.089 P=0.524 P=0.438 P=0.159 |P=0.352N P=0.337N P=0.078N P=0.411N |
|POLY 3 | P=0.094 P=0.508 P=0.453 P=0.160 |P=0.337N P=0.310N P=0.068N P=0.386N |
|POLY 1.5 | P=0.096 P=0.505 P=0.459 P=0.160 |P=0.339N P=0.306N P=0.068N P=0.387N |
|POLY 6 | P=0.093 P=0.514 P=0.448 P=0.160 |P=0.336N P=0.316N P=0.069N P=0.386N |
|LOGISTIC REGRESSION| P=0.089 P=0.524 P=0.438 P=0.159 |P=0.338N P=0.337N P=0.078N P=0.392N |
|COCH-ARM / FISHERS | P=0.113 P=0.500 P=0.500 P=0.181 |P=0.343N P=0.303N P=0.065N P=0.393N |
|ORDER RESTRICTED | P=0.097 (e) (e) (e) |P=0.179N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 4/50 (8%) 2/50 (4%) |2/50 (4%) 2/49 (4%) 3/49 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/47.43 4/48.59 4/41.44 2/44.45 |2/48.25 2/47.16 3/46.67 0/48.64 |
|POLY-3 PERCENT (g) | 8.4% 8.2% 9.7% 4.5% |4.2% 4.2% 6.4% 0.0% |
|TERMINAL (d) | 4/43 (9%) 4/46 (9%) 4/36 (11%) 2/40 (5%) |2/46 (4%) 1/43 (2%) 2/43 (5%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 639 720 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.313N P=0.606N P=0.543 P=0.371N |P=0.204N P=0.671 P=0.470 P=0.243N |
|POLY 3 | P=0.301N P=0.629N P=0.567 P=0.368N |P=0.196N P=0.685 P=0.485 P=0.236N |
|POLY 1.5 | P=0.299N P=0.635N P=0.577 P=0.368N |P=0.197N P=0.686 P=0.485 P=0.236N |
|POLY 6 | P=0.304N P=0.620N P=0.558 P=0.367N |P=0.196N P=0.684 P=0.483 P=0.236N |
|LOGISTIC REGRESSION| P=0.313N P=0.606N P=0.543 P=0.371N |P=0.199N P=0.690 P=0.479 (e) |
|COCH-ARM / FISHERS | P=0.256N P=0.643N P=0.643N P=0.339N |P=0.199N P=0.684 P=0.490 P=0.247N |
|ORDER RESTRICTED | P=0.356N (e) (e) (e) |P=0.150N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 23
Statistical Analysis of Non-neoplastic Lesions 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 |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 1/42.27 2/44.45 |0/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 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 | --- --- 400 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.063 (e) P=0.483 P=0.223 |(e) (e) (e) (e) |
|POLY 3 | P=0.062 (e) P=0.477 P=0.223 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.062 (e) P=0.479 P=0.223 |(e) (e) (e) (e) |
|POLY 6 | P=0.061 (e) P=0.475 P=0.223 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.077 (e) P=0.634 P=0.223 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.070 (e) P=0.500 P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.066 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 2/41.44 0/44.45 |0/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 2/36 (6%) 0/40 (0%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.570 (e) P=0.200 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.567 (e) P=0.209 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.567 (e) P=0.212 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.568 (e) P=0.205 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.200 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.220 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 24
Statistical Analysis of Non-neoplastic Lesions 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 Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |1/50 (2%) 2/49 (4%) 3/49 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 5/47.43 3/48.59 1/41.44 3/44.45 |1/48.25 2/46.83 3/46.63 2/48.64 |
|POLY-3 PERCENT (g) | 10.5% 6.2% 2.4% 6.8% |2.1% 4.3% 6.4% 4.1% |
|TERMINAL (d) | 5/43 (12%) 3/46 (7%) 1/36 (3%) 3/40 (8%) |1/46 (2%) 2/43 (5%) 3/43 (7%) 2/45 (4%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.327N P=0.320N P=0.148N P=0.396N |P=0.401 P=0.476 P=0.282 P=0.492 |
|POLY 3 | P=0.309N P=0.344N P=0.136N P=0.393N |P=0.412 P=0.490 P=0.293 P=0.503 |
|POLY 1.5 | P=0.305N P=0.350N P=0.131N P=0.393N |P=0.411 P=0.491 P=0.294 P=0.502 |
|POLY 6 | P=0.313N P=0.334N P=0.140N P=0.392N |P=0.412 P=0.486 P=0.291 P=0.502 |
|LOGISTIC REGRESSION| P=0.327N P=0.320N P=0.148N P=0.396N |P=0.401 P=0.476 P=0.282 P=0.492 |
|COCH-ARM / FISHERS | P=0.273N P=0.357N P=0.102N P=0.357N |P=0.406 P=0.492 P=0.301 P=0.500 |
|ORDER RESTRICTED | P=0.200N (e) (e) (e) |P=0.346 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/46 (0%) 2/45 (4%) 4/50 (8%) |0/48 (0%) 0/48 (0%) 2/46 (4%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/46.11 0/45.59 2/37.94 4/47.72 |0/46.25 0/46.26 2/45.36 0/47.07 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 5.3% 8.4% |0.0% 0.0% 4.4% 0.0% |
|TERMINAL (d) | 0/42 (0%) 0/43 (0%) 0/32 (0%) 0/40 (0%) |0/44 (0%) 0/43 (0%) 0/42 (0%) 0/44 (0%) |
|FIRST INCIDENCE | 611 --- 7 7 |--- --- 128 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * P=0.500N P=0.464 P=0.173 |P=0.595 (e) P=0.238 (e) |
|POLY 3 | P=0.043 * P=0.502N P=0.433 P=0.190 |P=0.603 (e) P=0.233 (e) |
|POLY 1.5 | P=0.044 * P=0.503N P=0.440 P=0.190 |P=0.600 (e) P=0.231 (e) |
|POLY 6 | P=0.042 * P=0.501N P=0.426 P=0.189 |P=0.605 (e) P=0.234 (e) |
|LOGISTIC REGRESSION| P=0.170 P=0.578N P=0.709 P=0.494 |P=0.547 (e) P=0.273 (e) |
|COCH-ARM / FISHERS | P=0.047 * P=0.511N P=0.476 P=0.194 |P=0.594 (e) P=0.237 (e) |
|ORDER RESTRICTED | P=0.043 * (e) (e) (e) |P=0.243 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 25
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/46 (0%) 0/45 (0%) 0/50 (0%) |3/48 (6%) 0/48 (0%) 0/46 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/45.70 0/45.59 0/36.53 0/44.45 |3/46.25 0/46.26 0/43.81 0/47.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/42 (0%) 0/43 (0%) 0/32 (0%) 0/40 (0%) |3/44 (7%) 0/43 (0%) 0/42 (0%) 0/44 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.049N* P=0.125N P=0.130N P=0.121N |
|POLY 3 | (e) (e) (e) (e) |P=0.046N* P=0.119N P=0.129N P=0.116N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.046N* P=0.119N P=0.129N P=0.117N |
|POLY 6 | (e) (e) (e) (e) |P=0.046N* P=0.119N P=0.129N P=0.115N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.049N* (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.048N* P=0.121N P=0.129N P=0.121N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.007N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/46 (0%) 0/45 (0%) 0/50 (0%) |2/48 (4%) 1/48 (2%) 4/46 (9%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/45.70 0/45.59 0/36.53 0/44.45 |2/46.25 1/46.26 4/44.18 0/47.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.3% 2.2% 9.1% 0.0% |
|TERMINAL (d) | 0/42 (0%) 0/43 (0%) 0/32 (0%) 0/40 (0%) |2/44 (5%) 1/43 (2%) 3/42 (7%) 0/44 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 623 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.280N P=0.508N P=0.319 P=0.238N |
|POLY 3 | (e) (e) (e) (e) |P=0.272N P=0.500N P=0.316 P=0.233N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.275N P=0.500N P=0.315 P=0.235N |
|POLY 6 | (e) (e) (e) (e) |P=0.270N P=0.501N P=0.318 P=0.233N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.282N P=0.508N P=0.317 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.282N P=0.500N P=0.318 P=0.247N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.147N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 26
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/48 (21%) 14/46 (30%) 9/45 (20%) 13/50 (26%) |11/48 (23%) 12/48 (25%) 10/46 (22%) 15/48 (31%) |
|POLY-3 RATE (b) | 10/45.70 14/45.86 9/36.95 13/44.70 |11/46.25 12/46.64 10/43.81 15/47.10 |
|POLY-3 PERCENT (g) | 21.9% 30.5% 24.4% 29.1% |23.8% 25.7% 22.8% 31.8% |
|TERMINAL (d) | 10/42 (24%) 13/43 (30%) 7/32 (22%) 11/40 (28%) |11/44 (25%) 11/43 (26%) 10/42 (24%) 14/44 (32%) |
|FIRST INCIDENCE | 729 (T) 657 623 693 |729 (T) 620 729 (T) 720 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.296 P=0.262 P=0.454 P=0.273 |P=0.219 P=0.475 P=0.549N P=0.246 |
|POLY 3 | P=0.337 P=0.242 P=0.499 P=0.294 |P=0.224 P=0.509 P=0.556N P=0.263 |
|POLY 1.5 | P=0.342 P=0.232 P=0.516 P=0.294 |P=0.220 P=0.506 P=0.556N P=0.258 |
|POLY 6 | P=0.333 P=0.257 P=0.485 P=0.297 |P=0.227 P=0.511 P=0.559N P=0.267 |
|LOGISTIC REGRESSION| P=0.328 P=0.243 P=0.471 P=0.285 |P=0.230 P=0.500 P=0.549N P=0.263 |
|COCH-ARM / FISHERS | P=0.445 P=0.203 P=0.563N P=0.358 |P=0.212 P=0.500 P=0.544N P=0.246 |
|ORDER RESTRICTED | P=0.341 (e) (e) (e) |P=0.297 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/48 (17%) 6/46 (13%) 9/45 (20%) 6/50 (12%) |24/48 (50%) 20/48 (42%) 21/46 (46%) 21/48 (44%) |
|POLY-3 RATE (b) | 8/46.11 6/45.72 9/37.59 6/44.72 |24/47.17 20/46.97 21/45.74 21/47.31 |
|POLY-3 PERCENT (g) | 17.4% 13.1% 23.9% 13.4% |50.9% 42.6% 45.9% 44.4% |
|TERMINAL (d) | 7/42 (17%) 5/43 (12%) 7/32 (22%) 5/40 (13%) |21/44 (48%) 18/43 (42%) 18/42 (43%) 20/44 (46%) |
|FIRST INCIDENCE | 611 696 512 656 |533 620 128 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.485N P=0.367N P=0.289 P=0.429N |P=0.367N P=0.319N P=0.425N P=0.348N |
|POLY 3 | P=0.454N P=0.393N P=0.320 P=0.410N |P=0.364N P=0.275N P=0.394N P=0.336N |
|POLY 1.5 | P=0.447N P=0.398N P=0.333 P=0.408N |P=0.365N P=0.272N P=0.398N P=0.336N |
|POLY 6 | P=0.460N P=0.385N P=0.309 P=0.412N |P=0.366N P=0.280N P=0.396N P=0.341N |
|LOGISTIC REGRESSION| P=0.423N P=0.414N P=0.354 P=0.397N |P=0.385N P=0.269N P=0.395N P=0.332N |
|COCH-ARM / FISHERS | P=0.366N P=0.420N P=0.441 P=0.355N |P=0.374N P=0.270N P=0.415N P=0.341N |
|ORDER RESTRICTED | P=0.451N (e) (e) (e) |P=0.412N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 27
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 1/47 (2%) 2/46 (4%) 2/48 (4%) |0/48 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/44.84 1/46.72 2/41.81 2/44.86 |0/46.25 0/45.83 0/44.67 0/47.07 |
|POLY-3 PERCENT (g) | 2.2% 2.1% 4.8% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/36 (0%) 0/40 (0%) |0/44 (0%) 0/42 (0%) 0/42 (0%) 0/44 (0%) |
|FIRST INCIDENCE | 611 696 7 7 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.313 P=0.748N P=0.461 P=0.480 |(e) (e) (e) (e) |
|POLY 3 | P=0.330 P=0.751N P=0.476 P=0.500 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.331 P=0.753N P=0.481 P=0.500 |(e) (e) (e) (e) |
|POLY 6 | P=0.330 P=0.748N P=0.471 P=0.502 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.571 P=0.727 P=0.620 P=0.659 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.344 P=0.753N P=0.492 P=0.508 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.415 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/47 (0%) 0/46 (0%) 0/48 (0%) |5/48 (10%) 3/48 (6%) 0/47 (0%) 3/48 (6%) |
|POLY-3 RATE (b) | 0/44.43 0/46.59 0/40.71 0/43.59 |5/46.25 3/45.83 0/44.67 3/47.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |10.8% 6.6% 0.0% 6.4% |
|TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/36 (0%) 0/40 (0%) |5/44 (11%) 3/42 (7%) 0/42 (0%) 3/44 (7%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.245N P=0.382N P=0.038N* P=0.356N |
|POLY 3 | (e) (e) (e) (e) |P=0.245N P=0.362N P=0.033N* P=0.347N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.247N P=0.359N P=0.033N* P=0.350N |
|POLY 6 | (e) (e) (e) (e) |P=0.243N P=0.366N P=0.034N* P=0.345N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.245N P=0.382N (e) P=0.356N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.249N P=0.357N P=0.030N* P=0.357N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.092N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 28
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/47 (9%) 2/47 (4%) 2/46 (4%) 0/48 (0%) |0/48 (0%) 1/48 (2%) 0/47 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 4/44.43 2/46.59 2/40.71 0/43.59 |0/46.25 1/46.16 0/44.67 1/47.07 |
|POLY-3 PERCENT (g) | 9.0% 4.3% 4.9% 0.0% |0.0% 2.2% 0.0% 2.1% |
|TERMINAL (d) | 4/40 (10%) 2/44 (5%) 2/36 (6%) 0/40 (0%) |0/44 (0%) 0/42 (0%) 0/42 (0%) 1/44 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- 639 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.049N* P=0.294N P=0.386N P=0.063N |P=0.408 P=0.492 (e) P=0.500 |
|POLY 3 | P=0.049N* P=0.316N P=0.378N P=0.063N |P=0.410 P=0.500 (e) P=0.504 |
|POLY 1.5 | P=0.049N* P=0.321N P=0.372N P=0.063N |P=0.408 P=0.500 (e) P=0.502 |
|POLY 6 | P=0.050N P=0.307N P=0.383N P=0.062N |P=0.410 P=0.499 (e) P=0.504 |
|LOGISTIC REGRESSION| P=0.049N* P=0.294N P=0.386N (e) |P=0.396 P=0.500 (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.043N* P=0.339N P=0.349N P=0.056N |P=0.405 P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.029N* (e) (e) (e) |P=0.255 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/47 (15%) 7/47 (15%) 15/46 (33%) 10/48 (21%) |3/48 (6%) 7/48 (15%) 4/47 (9%) 6/48 (13%) |
|POLY-3 RATE (b) | 7/44.70 7/46.59 15/40.71 10/43.59 |3/46.25 7/46.22 4/44.67 6/47.10 |
|POLY-3 PERCENT (g) | 15.7% 15.0% 36.8% 22.9% |6.5% 15.2% 9.0% 12.7% |
|TERMINAL (d) | 6/40 (15%) 7/44 (16%) 15/36 (42%) 10/40 (25%) |3/44 (7%) 6/42 (14%) 4/42 (10%) 5/44 (11%) |
|FIRST INCIDENCE | 657 729 (T) 729 (T) 729 (T) |729 (T) 620 729 (T) 720 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.141 P=0.541N P=0.021 * P=0.292 |P=0.325 P=0.144 P=0.475 P=0.245 |
|POLY 3 | P=0.132 P=0.581N P=0.021 * P=0.276 |P=0.327 P=0.157 P=0.481 P=0.252 |
|POLY 1.5 | P=0.136 P=0.588N P=0.024 * P=0.277 |P=0.323 P=0.158 P=0.482 P=0.249 |
|POLY 6 | P=0.128 P=0.570N P=0.019 * P=0.276 |P=0.330 P=0.156 P=0.478 P=0.254 |
|LOGISTIC REGRESSION| P=0.142 P=0.583N P=0.022 * P=0.285 |P=0.326 P=0.157 P=0.475 P=0.252 |
|COCH-ARM / FISHERS | P=0.188 P=0.613N P=0.038 * P=0.314 |P=0.315 P=0.158 P=0.488 P=0.243 |
|ORDER RESTRICTED | P=0.075 (e) (e) (e) |P=0.261 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 29
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Bronchial |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 1/3 (33%) 0/0 (0%) 0/1 (0%) |1/12 (8%) 0/6 (0%) 0/8 (0%) 2/9 (22%) |
|POLY-3 RATE (b) | 0/1.71 1/3.00 0/0.00 0/0.87 |1/12.00 0/5.84 0/7.18 2/9.00 |
|POLY-3 PERCENT (g) | 0.0% 33.3% 0.0% 0.0% |8.3% 0.0% 0.0% 22.2% |
|TERMINAL (d) | 0/1 (0%) 1/3 (33%) 0/0 (0%) 0/0 (0%) |1/12 (8%) 0/5 (0%) 0/6 (0%) 1/8 (13%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |729 (T) --- --- 720 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.958 P=0.718 (e) (e) |P=0.219 P=0.674N P=0.638N P=0.406 |
|POLY 3 | (e) P=0.604 (e) (e) |P=0.218 P=0.641N P=0.600N P=0.397 |
|POLY 1.5 | (e) P=0.591 (e) (e) |P=0.218 P=0.639N P=0.592N P=0.397 |
|POLY 6 | (e) P=0.625 (e) (e) |P=0.217 P=0.645N P=0.611N P=0.397 |
|LOGISTIC REGRESSION| (e) P=0.718 (e) (e) |P=0.217 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.752N P=0.600 (e) (e) |P=0.217 P=0.667N P=0.600N P=0.388 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.088 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 0/3 (0%) 0/0 (0%) 0/1 (0%) |2/12 (17%) 1/6 (17%) 1/8 (13%) 0/9 (0%) |
|POLY-3 RATE (b) | 0/1.71 0/3.00 0/0.00 0/0.87 |2/12.00 1/5.84 1/7.18 0/8.96 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |16.7% 17.1% 13.9% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) |2/12 (17%) 1/5 (20%) 1/6 (17%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.222N P=0.698 P=0.743 P=0.328N |
|POLY 3 | (e) (e) (e) (e) |P=0.198N P=0.729 P=0.677N P=0.298N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.197N P=0.733 P=0.662N P=0.298N |
|POLY 6 | (e) (e) (e) (e) |P=0.200N P=0.723 P=0.696N P=0.299N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.222N P=0.698 P=0.743 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.186N P=0.730 P=0.656N P=0.314N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.161N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 30
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 0/3 (0%) 0/0 (0%) 0/1 (0%) |5/12 (42%) 3/6 (50%) 4/8 (50%) 2/9 (22%) |
|POLY-3 RATE (b) | 0/1.71 0/3.00 0/0.00 0/0.87 |5/12.00 3/5.84 4/7.74 2/8.96 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |41.7% 51.4% 51.7% 22.3% |
|TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) |5/12 (42%) 3/5 (60%) 3/6 (50%) 2/8 (25%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 555 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.311N P=0.440 P=0.385 P=0.390N |
|POLY 3 | (e) (e) (e) (e) |P=0.248N P=0.545 P=0.510 P=0.327N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.248N P=0.554 P=0.521 P=0.326N |
|POLY 6 | (e) (e) (e) (e) |P=0.249N P=0.530 P=0.490 P=0.329N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.230N P=0.440 P=0.653 P=0.390N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.240N P=0.563 P=0.535 P=0.324N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.178N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Lumbar |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 0/3 (0%) 0/0 (0%) 0/1 (0%) |1/12 (8%) 1/6 (17%) 2/8 (25%) 2/9 (22%) |
|POLY-3 RATE (b) | 0/1.71 0/3.00 0/0.00 0/0.87 |1/12.00 1/5.84 2/7.18 2/8.96 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |8.3% 17.1% 27.9% 22.3% |
|TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) |1/12 (8%) 1/5 (20%) 2/6 (33%) 2/8 (25%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.241 P=0.556 P=0.257 P=0.354 |
|POLY 3 | (e) (e) (e) (e) |P=0.284 P=0.593 P=0.317 P=0.395 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.285 P=0.596 P=0.333 P=0.396 |
|POLY 6 | (e) (e) (e) (e) |P=0.283 P=0.587 P=0.297 P=0.394 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.241 P=0.556 P=0.257 P=0.354 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.278 P=0.569 P=0.344 P=0.388 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.237 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 31
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 0/3 (0%) 0/0 (0%) 0/1 (0%) |3/12 (25%) 1/6 (17%) 2/8 (25%) 0/9 (0%) |
|POLY-3 RATE (b) | 0/1.71 0/3.00 0/0.00 0/0.87 |3/12.00 1/5.84 2/7.18 0/8.96 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |25.0% 17.1% 27.9% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) |3/12 (25%) 1/5 (20%) 2/6 (33%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.165N P=0.653N P=0.572 P=0.192N |
|POLY 3 | (e) (e) (e) (e) |P=0.134N P=0.586N P=0.646 P=0.158N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.134N P=0.581N P=0.666 P=0.157N |
|POLY 6 | (e) (e) (e) (e) |P=0.134N P=0.595N P=0.618 P=0.159N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.165N P=0.653N P=0.572 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.129N P=0.593N P=0.693 P=0.165N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.082N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 2/49 (4%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 0/41.44 0/44.45 |0/48.08 2/47.64 0/46.63 2/48.67 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.2% 0.0% 4.1% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 0/40 (0%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 1/45 (2%) |
|FIRST INCIDENCE | --- --- --- --- |--- 606 --- 720 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.252 P=0.237 (e) P=0.237 |
|POLY 3 | (e) (e) (e) (e) |P=0.249 P=0.235 (e) P=0.240 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.251 P=0.236 (e) P=0.241 |
|POLY 6 | (e) (e) (e) (e) |P=0.248 P=0.235 (e) P=0.239 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.250 P=0.341 (e) P=0.240 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.253 P=0.247 (e) P=0.253 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.119 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 32
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/6 (67%) 1/2 (50%) 3/5 (60%) 2/2 (100%) |2/3 (67%) 3/4 (75%) 6/6 (100%) 6/6 (100%) |
|POLY-3 RATE (b) | 4/6.00 1/2.00 3/5.00 2/2.00 |2/3.00 3/4.00 6/6.00 6/6.00 |
|POLY-3 PERCENT (g) | 66.7% 50.0% 60.0% 100.0% |66.7% 75.0% 100.0% 100.0% |
|TERMINAL (d) | 4/6 (67%) 1/2 (50%) 2/4 (50%) 2/2 (100%) |2/3 (67%) 3/4 (75%) 5/5 (100%) 3/3 (100%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 718 729 (T) |729 (T) 729 (T) 128 517 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.401 P=0.653N P=0.650 P=0.500 |P=0.008 ** P=0.712 P=0.185 P=0.068 |
|POLY 3 | P=0.404 P=0.644N P=0.642N P=0.500 |P=0.127 P=0.696 P=0.351 P=0.351 |
|POLY 1.5 | P=0.404 P=0.644N P=0.642N P=0.500 |P=0.127 P=0.696 P=0.351 P=0.351 |
|POLY 6 | P=0.404 P=0.644N P=0.642N P=0.500 |P=0.127 P=0.696 P=0.351 P=0.351 |
|LOGISTIC REGRESSION| P=0.401 P=0.653N (e) P=0.500 |P=0.008 ** P=0.712 (e) (e) |
|COCH-ARM / FISHERS | P=0.393 P=0.643N P=0.652N P=0.536 |P=0.127 P=0.714 P=0.333 P=0.333 |
|ORDER RESTRICTED | P=0.363 (e) (e) (e) |P=0.144 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 1/49 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.43 3/48.59 3/41.70 2/44.45 |0/48.25 1/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 2.1% 6.2% 7.2% 4.5% |0.0% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 1/43 (2%) 3/46 (7%) 2/36 (6%) 2/40 (5%) |0/46 (0%) 1/43 (2%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 659 729 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.425 P=0.330 P=0.247 P=0.475 |P=0.568N P=0.487 (e) (e) |
|POLY 3 | P=0.431 P=0.314 P=0.261 P=0.477 |P=0.568N P=0.494 (e) (e) |
|POLY 1.5 | P=0.433 P=0.310 P=0.266 P=0.477 |P=0.567N P=0.495 (e) (e) |
|POLY 6 | P=0.430 P=0.320 P=0.257 P=0.478 |P=0.569N P=0.492 (e) (e) |
|LOGISTIC REGRESSION| P=0.437 P=0.330 P=0.266 P=0.475 |(e) P=0.487 (e) (e) |
|COCH-ARM / FISHERS | P=0.477 P=0.309 P=0.309 P=0.500 |P=0.566N P=0.495 (e) (e) |
|ORDER RESTRICTED | P=0.316 (e) (e) (e) |P=0.374N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 33
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.43 4/48.59 3/41.70 2/44.45 |0/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 2.1% 8.2% 7.2% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/43 (2%) 4/46 (9%) 2/36 (6%) 2/40 (5%) |0/46 (0%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 659 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.488 P=0.201 P=0.247 P=0.475 |(e) (e) (e) (e) |
|POLY 3 | P=0.494 P=0.187 P=0.261 P=0.477 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.496 P=0.183 P=0.266 P=0.477 |(e) (e) (e) (e) |
|POLY 6 | P=0.494 P=0.192 P=0.257 P=0.478 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.501 P=0.201 P=0.266 P=0.475 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.544 P=0.181 P=0.309 P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.268 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |12/50 (24%) 7/49 (14%) 8/49 (16%) 8/48 (17%) |
|POLY-3 RATE (b) | |12/48.53 7/47.16 8/46.89 8/46.64 |
|POLY-3 PERCENT (g) | |24.7% 14.8% 17.1% 17.2% |
|TERMINAL (d) | |11/46 (24%) 6/43 (14%) 7/43 (16%) 8/43 (19%) |
|FIRST INCIDENCE | |651 639 658 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.295N P=0.199N P=0.281N P=0.278N |
|POLY 3 | |P=0.281N P=0.170N P=0.253N P=0.257N |
|POLY 1.5 | |P=0.281N P=0.168N P=0.252N P=0.256N |
|POLY 6 | |P=0.284N P=0.175N P=0.257N P=0.263N |
|LOGISTIC REGRESSION| |P=0.278N P=0.168N P=0.250N P=0.253N |
|COCH-ARM / FISHERS | |P=0.283N P=0.166N P=0.242N P=0.259N |
|ORDER RESTRICTED | |P=0.233N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 34
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |10/50 (20%) 11/49 (22%) 15/49 (31%) 10/48 (21%) |
|POLY-3 RATE (b) | |10/48.25 11/46.87 15/46.89 10/47.28 |
|POLY-3 PERCENT (g) | |20.7% 23.5% 32.0% 21.2% |
|TERMINAL (d) | |10/46 (22%) 10/43 (23%) 14/43 (33%) 9/43 (21%) |
|FIRST INCIDENCE | |729 (T) 720 658 517 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.466 P=0.431 P=0.133 P=0.537 |
|POLY 3 | |P=0.511 P=0.470 P=0.155 P=0.579 |
|POLY 1.5 | |P=0.501 P=0.475 P=0.155 P=0.573 |
|POLY 6 | |P=0.518 P=0.462 P=0.154 P=0.581 |
|LOGISTIC REGRESSION| |P=0.488 P=0.437 P=0.148 P=0.559 |
|COCH-ARM / FISHERS | |P=0.480 P=0.479 P=0.163 P=0.558 |
|ORDER RESTRICTED | |P=0.401 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 0/49 (0%) 2/49 (4%) 0/48 (0%) |
|POLY-3 RATE (b) | |3/48.25 0/46.83 2/46.63 0/46.64 |
|POLY-3 PERCENT (g) | |6.2% 0.0% 4.3% 0.0% |
|TERMINAL (d) | |3/46 (7%) 0/43 (0%) 2/43 (5%) 0/43 (0%) |
|FIRST INCIDENCE | |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.136N P=0.134N P=0.531N P=0.134N |
|POLY 3 | |P=0.128N P=0.124N P=0.515N P=0.125N |
|POLY 1.5 | |P=0.129N P=0.123N P=0.515N P=0.125N |
|POLY 6 | |P=0.127N P=0.126N P=0.518N P=0.125N |
|LOGISTIC REGRESSION| |P=0.136N (e) P=0.531N (e) |
|COCH-ARM / FISHERS | |P=0.131N P=0.125N P=0.510N P=0.129N |
|ORDER RESTRICTED | |P=0.040N* (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 35
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/49 (6%) 2/50 (4%) |1/50 (2%) 1/49 (2%) 1/48 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/47.43 0/48.59 3/41.48 2/44.45 |1/48.25 1/46.83 1/45.67 2/48.64 |
|POLY-3 PERCENT (g) | 4.2% 0.0% 7.2% 4.5% |2.1% 2.1% 2.2% 4.1% |
|TERMINAL (d) | 2/43 (5%) 0/46 (0%) 2/36 (6%) 2/40 (5%) |1/46 (2%) 1/43 (2%) 1/43 (2%) 2/45 (4%) |
|FIRST INCIDENCE | 729 (T) --- 718 729 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.377 P=0.224N P=0.422 P=0.669 |P=0.350 P=0.747 P=0.747 P=0.492 |
|POLY 3 | P=0.385 P=0.232N P=0.439 P=0.670 |P=0.357 P=0.754 P=0.748 P=0.503 |
|POLY 1.5 | P=0.387 P=0.234N P=0.447 P=0.670 |P=0.356 P=0.755 P=0.748 P=0.502 |
|POLY 6 | P=0.381 P=0.228N P=0.433 P=0.671 |P=0.357 P=0.752 P=0.747 P=0.502 |
|LOGISTIC REGRESSION| P=0.382 (e) P=0.428 P=0.669 |P=0.350 P=0.747 P=0.747 P=0.492 |
|COCH-ARM / FISHERS | P=0.422 P=0.247N P=0.490 P=0.691N |P=0.353 P=0.747 P=0.742 P=0.500 |
|ORDER RESTRICTED | P=0.279 (e) (e) (e) |P=0.419 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 2/48 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 2/41.44 1/45.07 |0/48.25 0/46.83 2/45.67 1/49.28 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 2.2% |0.0% 0.0% 4.4% 2.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 2/36 (6%) 0/40 (0%) |0/46 (0%) 0/43 (0%) 2/43 (5%) 0/45 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 531 |--- --- 729 (T) 517 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.226 (e) P=0.200 P=0.487 |P=0.250 (e) P=0.224 P=0.504 |
|POLY 3 | P=0.227 (e) P=0.208 P=0.490 |P=0.258 (e) P=0.225 P=0.504 |
|POLY 1.5 | P=0.225 (e) P=0.212 P=0.489 |P=0.255 (e) P=0.225 P=0.503 |
|POLY 6 | P=0.228 (e) P=0.205 P=0.491 |P=0.260 (e) P=0.224 P=0.505 |
|LOGISTIC REGRESSION| P=0.252 (e) P=0.200 P=0.559 |P=0.233 (e) P=0.224 P=0.268 |
|COCH-ARM / FISHERS | P=0.246 (e) P=0.242 P=0.500 |P=0.248 (e) P=0.237 P=0.500 |
|ORDER RESTRICTED | P=0.144 (e) (e) (e) |P=0.158 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 36
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 1/47 (2%) 2/45 (4%) 1/48 (2%) |0/48 (0%) 1/46 (2%) 1/45 (2%) 1/48 (2%) |
|POLY-3 RATE (b) | 3/46.66 1/45.59 2/37.37 1/43.00 |0/46.25 1/44.58 1/42.89 1/47.07 |
|POLY-3 PERCENT (g) | 6.4% 2.2% 5.4% 2.3% |0.0% 2.2% 2.3% 2.1% |
|TERMINAL (d) | 3/43 (7%) 1/43 (2%) 2/33 (6%) 1/40 (3%) |0/44 (0%) 0/41 (0%) 1/40 (3%) 1/44 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- 639 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.318N P=0.305N P=0.620N P=0.331N |P=0.389 P=0.492 P=0.481 P=0.500 |
|POLY 3 | P=0.315N P=0.314N P=0.600N P=0.335N |P=0.395 P=0.493 P=0.485 P=0.504 |
|POLY 1.5 | P=0.314N P=0.317N P=0.593N P=0.336N |P=0.393 P=0.492 P=0.485 P=0.502 |
|POLY 6 | P=0.316N P=0.309N P=0.605N P=0.333N |P=0.396 P=0.493 P=0.485 P=0.504 |
|LOGISTIC REGRESSION| P=0.318N P=0.305N P=0.620N P=0.331N |P=0.381 P=0.488 P=0.481 P=0.500 |
|COCH-ARM / FISHERS | P=0.287N P=0.324N P=0.541N P=0.316N |P=0.387 P=0.489 P=0.484 P=0.500 |
|ORDER RESTRICTED | P=0.254N (e) (e) (e) |P=0.313 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) |0/50 (0%) 3/49 (6%) 1/47 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/47.43 0/47.59 0/40.85 0/44.45 |0/48.25 3/46.83 1/44.81 1/47.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 6.4% 2.2% 2.1% |
|TERMINAL (d) | 0/43 (0%) 0/45 (0%) 0/36 (0%) 0/40 (0%) |0/46 (0%) 3/43 (7%) 1/43 (2%) 1/44 (2%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.580 P=0.110 P=0.487 P=0.491 |
|POLY 3 | (e) (e) (e) (e) |P=0.587 P=0.114 P=0.485 P=0.497 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.586 P=0.115 P=0.485 P=0.497 |
|POLY 6 | (e) (e) (e) (e) |P=0.585 P=0.112 P=0.485 P=0.497 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.110 P=0.487 P=0.491 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.583 P=0.117 P=0.485 P=0.495 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.211 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 37
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/48 (2%) 2/48 (4%) 2/50 (4%) |1/50 (2%) 3/49 (6%) 1/47 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/47.43 1/47.59 2/40.85 2/44.45 |1/48.25 3/46.83 1/44.81 0/47.64 |
|POLY-3 PERCENT (g) | 4.2% 2.1% 4.9% 4.5% |2.1% 6.4% 2.2% 0.0% |
|TERMINAL (d) | 2/43 (5%) 1/45 (2%) 2/36 (6%) 2/40 (5%) |1/46 (2%) 3/43 (7%) 1/43 (2%) 0/44 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482 P=0.484N P=0.629 P=0.669 |P=0.209N P=0.282 P=0.747 P=0.509N |
|POLY 3 | P=0.490 P=0.499N P=0.639 P=0.670 |P=0.205N P=0.295 P=0.744 P=0.503N |
|POLY 1.5 | P=0.492 P=0.503N P=0.644 P=0.670 |P=0.205N P=0.297 P=0.744 P=0.503N |
|POLY 6 | P=0.487 P=0.493N P=0.635 P=0.671 |P=0.206N P=0.292 P=0.743 P=0.503N |
|LOGISTIC REGRESSION| P=0.482 P=0.484N P=0.629 P=0.669 |P=0.209N P=0.282 P=0.747 (e) |
|COCH-ARM / FISHERS | P=0.536 P=0.508N P=0.684 P=0.684N |P=0.206N P=0.301 P=0.737 P=0.505N |
|ORDER RESTRICTED | P=0.552 (e) (e) (e) |P=0.151N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/48 (2%) 0/48 (0%) 0/50 (0%) |1/50 (2%) 2/49 (4%) 1/47 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/47.43 1/47.59 0/40.85 0/44.45 |1/48.25 2/46.83 1/44.81 2/47.64 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 0.0% |2.1% 4.3% 2.2% 4.2% |
|TERMINAL (d) | 0/43 (0%) 1/45 (2%) 0/36 (0%) 0/40 (0%) |1/46 (2%) 2/43 (5%) 1/43 (2%) 2/44 (5%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.583N P=0.509 (e) (e) |P=0.433 P=0.476 P=0.747 P=0.484 |
|POLY 3 | P=0.575N P=0.501 (e) (e) |P=0.441 P=0.490 P=0.744 P=0.496 |
|POLY 1.5 | P=0.575N P=0.498 (e) (e) |P=0.440 P=0.491 P=0.744 P=0.495 |
|POLY 6 | P=0.574N P=0.504 (e) (e) |P=0.440 P=0.486 P=0.743 P=0.495 |
|LOGISTIC REGRESSION| (e) P=0.509 (e) (e) |P=0.433 P=0.476 P=0.747 P=0.484 |
|COCH-ARM / FISHERS | P=0.563N P=0.495 (e) (e) |P=0.437 P=0.492 P=0.737 P=0.492 |
|ORDER RESTRICTED | P=0.393N (e) (e) (e) |P=0.438 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 38
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 23/50 (46%) 16/50 (32%) 21/50 (42%) | |
|POLY-3 RATE (b) | 18/47.95 23/48.99 16/41.94 21/44.72 | |
|POLY-3 PERCENT (g) | 37.5% 47.0% 38.2% 47.0% | |
|TERMINAL (d) | 16/43 (37%) 21/46 (46%) 14/36 (39%) 20/40 (50%) | |
|FIRST INCIDENCE | 650 657 611 656 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.261 P=0.301 P=0.501 P=0.242 | |
|POLY 3 | P=0.287 P=0.233 P=0.562 P=0.240 | |
|POLY 1.5 | P=0.300 P=0.221 P=0.583N P=0.244 | |
|POLY 6 | P=0.273 P=0.252 P=0.540 P=0.236 | |
|LOGISTIC REGRESSION| P=0.292 P=0.224 P=0.555 P=0.247 | |
|COCH-ARM / FISHERS | P=0.442 P=0.208 P=0.417N P=0.341 | |
|ORDER RESTRICTED | P=0.284 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 10/50 (20%) 14/50 (28%) 7/50 (14%) | |
|POLY-3 RATE (b) | 14/48.07 10/48.59 14/41.48 7/44.45 | |
|POLY-3 PERCENT (g) | 29.1% 20.6% 33.8% 15.8% | |
|TERMINAL (d) | 12/43 (28%) 10/46 (22%) 13/36 (36%) 7/40 (18%) | |
|FIRST INCIDENCE | 611 729 (T) 718 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.155N P=0.192N P=0.372 P=0.101N | |
|POLY 3 | P=0.142N P=0.232N P=0.405 P=0.099N | |
|POLY 1.5 | P=0.136N P=0.236N P=0.434 P=0.096N | |
|POLY 6 | P=0.149N P=0.224N P=0.376 P=0.101N | |
|LOGISTIC REGRESSION| P=0.139N P=0.229N P=0.407 P=0.092N | |
|COCH-ARM / FISHERS | P=0.089N P=0.241N P=0.588N P=0.070N | |
|ORDER RESTRICTED | P=0.100N (e) (e) (e) | |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 39
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) | |
|POLY-3 RATE (b) | 0/46.43 0/48.59 0/40.44 2/45.07 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.4% | |
|TERMINAL (d) | 0/42 (0%) 0/46 (0%) 0/35 (0%) 1/40 (3%) | |
|FIRST INCIDENCE | --- --- --- 531 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043 * (e) (e) P=0.228 | |
|POLY 3 | P=0.043 * (e) (e) P=0.231 | |
|POLY 1.5 | P=0.043 * (e) (e) P=0.229 | |
|POLY 6 | P=0.042 * (e) (e) P=0.232 | |
|LOGISTIC REGRESSION| P=0.050 (e) (e) P=0.259 | |
|COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.253 | |
|ORDER RESTRICTED | P=0.027 * (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/49 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 0/41.44 0/44.45 |2/49.08 0/46.83 0/46.63 1/48.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.1% 0.0% 0.0% 2.1% |
|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 | --- --- --- --- |402 --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.462N P=0.252N P=0.252N P=0.505N |
|POLY 3 | (e) (e) (e) (e) |P=0.463N P=0.248N P=0.249N P=0.507N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.464N P=0.246N P=0.247N P=0.507N |
|POLY 6 | (e) (e) (e) (e) |P=0.461N P=0.251N P=0.251N P=0.507N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.478N P=0.221N P=0.149N P=0.660N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.465N P=0.253N P=0.253N P=0.508N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.138N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 40
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 5/49 (10%) 3/49 (6%) 2/49 (4%) |
|POLY-3 RATE (b) | 2/47.43 2/48.59 0/41.44 0/44.45 |0/48.25 5/46.83 3/46.63 2/48.07 |
|POLY-3 PERCENT (g) | 4.2% 4.1% 0.0% 0.0% |0.0% 10.7% 6.4% 4.2% |
|TERMINAL (d) | 2/43 (5%) 2/46 (4%) 0/36 (0%) 0/40 (0%) |0/46 (0%) 5/43 (12%) 3/43 (7%) 2/45 (4%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.101N P=0.670N P=0.278N P=0.254N |P=0.453 P=0.028 * P=0.110 P=0.234 |
|POLY 3 | P=0.096N P=0.685N P=0.269N P=0.252N |P=0.460 P=0.028 * P=0.113 P=0.237 |
|POLY 1.5 | P=0.095N P=0.689N P=0.264N P=0.252N |P=0.456 P=0.029 * P=0.113 P=0.235 |
|POLY 6 | P=0.097N P=0.679N P=0.272N P=0.252N |P=0.462 P=0.027 * P=0.112 P=0.237 |
|LOGISTIC REGRESSION| P=0.101N P=0.670N (e) (e) |(e) P=0.028 * P=0.110 P=0.234 |
|COCH-ARM / FISHERS | P=0.086N P=0.691N P=0.247N P=0.247N |P=0.449 P=0.027 * P=0.117 P=0.242 |
|ORDER RESTRICTED | P=0.129N (e) (e) (e) |P=0.088 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/49 (8%) 3/50 (6%) |0/50 (0%) 1/49 (2%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.43 1/49.59 4/44.71 3/47.45 |0/48.25 1/46.83 1/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 9.0% 6.3% |0.0% 2.1% 2.1% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 0/40 (0%) |0/46 (0%) 1/43 (2%) 1/43 (2%) 0/45 (0%) |
|FIRST INCIDENCE | --- 40 7 7 |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.070 P=0.504 P=0.063 P=0.120 |P=0.595N P=0.487 P=0.487 (e) |
|POLY 3 | P=0.068 P=0.509 P=0.053 P=0.119 |P=0.591N P=0.494 P=0.493 (e) |
|POLY 1.5 | P=0.069 P=0.507 P=0.055 P=0.119 |P=0.592N P=0.495 P=0.493 (e) |
|POLY 6 | P=0.068 P=0.512 P=0.052 P=0.119 |P=0.592N P=0.492 P=0.492 (e) |
|LOGISTIC REGRESSION| P=0.521 P=0.470 (e) P=0.588 |(e) P=0.487 P=0.487 (e) |
|COCH-ARM / FISHERS | P=0.072 P=0.500 P=0.056 P=0.121 |P=0.594N P=0.495 P=0.495 (e) |
|ORDER RESTRICTED | P=0.045 * (e) (e) (e) |P=0.392N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 41
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |2/50 (4%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 0/40.71 0/44.45 |2/48.25 0/46.83 0/46.63 0/48.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 0/40 (0%) |2/46 (4%) 0/43 (0%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.119N P=0.253N P=0.253N P=0.243N |
|POLY 3 | (e) (e) (e) (e) |P=0.114N P=0.244N P=0.245N P=0.236N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.114N P=0.243N P=0.245N P=0.236N |
|POLY 6 | (e) (e) (e) (e) |P=0.113N P=0.246N P=0.246N P=0.236N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.119N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.253N P=0.253N P=0.247N |
|ORDER RESTRICTED | (e) (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 |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 21/50 (42%) 38/49 (78%) 45/50 (90%) |15/50 (30%) 20/49 (41%) 24/49 (49%) 39/50 (78%) |
|POLY-3 RATE (b) | 10/48.21 21/49.00 38/43.50 45/45.89 |15/48.27 20/48.42 24/48.96 39/49.36 |
|POLY-3 PERCENT (g) | 20.7% 42.9% 87.4% 98.1% |31.1% 41.3% 49.0% 79.0% |
|TERMINAL (d) | 7/43 (16%) 18/46 (39%) 32/36 (89%) 40/40 (100%)|14/46 (30%) 16/43 (37%) 19/43 (44%) 35/45 (78%) |
|FIRST INCIDENCE | 611 657 400 531 |723 400 128 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.034 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.153 P=0.038 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.202 P=0.054 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.195 P=0.049 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.017 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.206 P=0.059 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.181 P=0.046 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.180 P=0.042 * P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 42
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 16/50 (32%) 33/49 (67%) 43/50 (86%) |0/50 (0%) 4/49 (8%) 11/49 (22%) 34/50 (68%) |
|POLY-3 RATE (b) | 1/47.43 16/48.59 33/44.00 43/45.86 |0/48.25 4/47.67 11/47.62 34/49.32 |
|POLY-3 PERCENT (g) | 2.1% 32.9% 75.0% 93.8% |0.0% 8.4% 23.1% 68.9% |
|TERMINAL (d) | 1/43 (2%) 16/46 (35%) 25/36 (69%) 38/40 (95%) |0/46 (0%) 3/43 (7%) 10/43 (23%) 31/45 (69%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 400 531 |--- 400 128 517 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.058 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.059 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.059 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.058 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.054 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.056 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 14/49 (29%) 30/50 (60%) |1/50 (2%) 3/49 (6%) 5/49 (10%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/47.43 4/49.73 14/43.93 30/46.89 |1/48.25 3/48.05 5/48.70 4/49.36 |
|POLY-3 PERCENT (g) | 0.0% 8.0% 31.9% 64.0% |2.1% 6.2% 10.3% 8.1% |
|TERMINAL (d) | 0/43 (0%) 1/46 (2%) 8/36 (22%) 24/40 (60%) |1/46 (2%) 1/43 (2%) 1/43 (2%) 0/45 (0%) |
|FIRST INCIDENCE | --- 40 22 7 |729 (T) 400 128 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.076 P<0.001 ** P<0.001 ** |P=0.167 P=0.293 P=0.102 P=0.187 |
|POLY 3 | P<0.001 ** P=0.067 P<0.001 ** P<0.001 ** |P=0.167 P=0.304 P=0.104 P=0.186 |
|POLY 1.5 | P<0.001 ** P=0.065 P<0.001 ** P<0.001 ** |P=0.163 P=0.303 P=0.102 P=0.184 |
|POLY 6 | P<0.001 ** P=0.070 P<0.001 ** P<0.001 ** |P=0.171 P=0.304 P=0.106 P=0.189 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.048 * P<0.001 ** P<0.001 ** |P=0.077 P=0.282 P=0.100 P=0.149 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.059 P<0.001 ** P<0.001 ** |P=0.157 P=0.301 P=0.098 P=0.181 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.123 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 43
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 2/49 (4%) 0/50 (0%) |12/50 (24%) 14/49 (29%) 13/49 (27%) 16/50 (32%) |
|POLY-3 RATE (b) | 5/47.43 2/48.59 2/41.13 0/44.45 |12/48.25 14/46.83 13/46.63 16/48.64 |
|POLY-3 PERCENT (g) | 10.5% 4.1% 4.9% 0.0% |24.9% 29.9% 27.9% 32.9% |
|TERMINAL (d) | 5/43 (12%) 2/46 (4%) 1/36 (3%) 0/40 (0%) |12/46 (26%) 14/43 (33%) 13/43 (30%) 16/45 (36%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 611 --- |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030N* P=0.191N P=0.294N P=0.040N* |P=0.225 P=0.332 P=0.422 P=0.227 |
|POLY 3 | P=0.027N* P=0.207N P=0.278N P=0.037N* |P=0.249 P=0.376 P=0.461 P=0.260 |
|POLY 1.5 | P=0.026N* P=0.212N P=0.273N P=0.037N* |P=0.247 P=0.381 P=0.462 P=0.259 |
|POLY 6 | P=0.027N* P=0.200N P=0.280N P=0.036N* |P=0.249 P=0.365 P=0.454 P=0.257 |
|LOGISTIC REGRESSION| P=0.027N* P=0.191N P=0.268N (e) |P=0.225 P=0.332 P=0.422 P=0.227 |
|COCH-ARM / FISHERS | P=0.022N* P=0.218N P=0.226N P=0.028N* |P=0.240 P=0.387 P=0.477 P=0.252 |
|ORDER RESTRICTED | P=0.012N* (e) (e) (e) |P=0.302 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Diverticulum |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/49 (0%) 0/49 (0%) 5/50 (10%) |
|POLY-3 RATE (b) | 0/47.43 2/47.60 0/41.44 0/44.45 |1/48.25 0/46.83 0/46.63 5/48.64 |
|POLY-3 PERCENT (g) | 0.0% 4.2% 0.0% 0.0% |2.1% 0.0% 0.0% 10.3% |
|TERMINAL (d) | 0/43 (0%) 1/45 (2%) 0/36 (0%) 0/40 (0%) |1/46 (2%) 0/43 (0%) 0/43 (0%) 5/45 (11%) |
|FIRST INCIDENCE | --- 726 --- --- |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.430N P=0.255 (e) (e) |P=0.009 ** P=0.513N P=0.513N P=0.099 |
|POLY 3 | P=0.422N P=0.238 (e) (e) |P=0.008 ** P=0.506N P=0.507N P=0.104 |
|POLY 1.5 | P=0.422N P=0.236 (e) (e) |P=0.008 ** P=0.505N P=0.507N P=0.104 |
|POLY 6 | P=0.422N P=0.242 (e) (e) |P=0.008 ** P=0.508N P=0.508N P=0.103 |
|LOGISTIC REGRESSION| P=0.425N P=0.247 (e) (e) |P=0.009 ** (e) (e) P=0.099 |
|COCH-ARM / FISHERS | P=0.404N P=0.242 (e) (e) |P=0.009 ** P=0.505N P=0.505N P=0.102 |
|ORDER RESTRICTED | P=0.261N (e) (e) (e) |P=0.003 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 44
Statistical Analysis of Non-neoplastic Lesions 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 |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/49 (2%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.70 1/47.59 0/41.44 0/44.45 |1/48.25 1/47.67 2/47.19 0/48.64 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 0.0% 0.0% |2.1% 2.1% 4.2% 0.0% |
|TERMINAL (d) | 0/43 (0%) 1/45 (2%) 0/36 (0%) 0/40 (0%) |1/46 (2%) 0/43 (0%) 1/43 (2%) 0/45 (0%) |
|FIRST INCIDENCE | 657 729 (T) --- --- |729 (T) 400 555 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.257N P=0.751N P=0.537N P=0.518N |P=0.368N P=0.751 P=0.484 P=0.504N |
|POLY 3 | P=0.248N P=0.760 P=0.528N P=0.514N |P=0.364N P=0.758 P=0.492 P=0.498N |
|POLY 1.5 | P=0.247N P=0.758 P=0.524N P=0.514N |P=0.365N P=0.758 P=0.491 P=0.499N |
|POLY 6 | P=0.250N P=0.758N P=0.532N P=0.515N |P=0.364N P=0.756 P=0.492 P=0.499N |
|LOGISTIC REGRESSION| P=0.238N P=0.756 P=0.493N P=0.490N |P=0.373N P=0.780 P=0.523 (e) |
|COCH-ARM / FISHERS | P=0.235N P=0.747 P=0.500N P=0.500N |P=0.366N P=0.747 P=0.492 P=0.500N |
|ORDER RESTRICTED | P=0.265N (e) (e) (e) |P=0.266N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/49 (4%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 0/49 (0%) 4/49 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/47.70 2/47.59 1/41.85 1/44.45 |1/48.25 0/46.83 4/47.19 1/48.64 |
|POLY-3 PERCENT (g) | 4.2% 4.2% 2.4% 2.3% |2.1% 0.0% 8.5% 2.1% |
|TERMINAL (d) | 1/43 (2%) 2/45 (4%) 0/36 (0%) 1/40 (3%) |1/46 (2%) 0/43 (0%) 3/43 (7%) 1/45 (2%) |
|FIRST INCIDENCE | 657 729 (T) 611 729 (T) |729 (T) --- 555 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.377N P=0.677N P=0.560N P=0.527N |P=0.444 P=0.513N P=0.166 P=0.757 |
|POLY 3 | P=0.366N P=0.693 P=0.545N P=0.525N |P=0.454 P=0.506N P=0.172 P=0.759N |
|POLY 1.5 | P=0.363N P=0.690 P=0.540N P=0.524N |P=0.452 P=0.505N P=0.172 P=0.759N |
|POLY 6 | P=0.369N P=0.690N P=0.550N P=0.525N |P=0.455 P=0.508N P=0.172 P=0.759N |
|LOGISTIC REGRESSION| P=0.347N P=0.688 P=0.496N P=0.513N |P=0.441 (e) P=0.181 P=0.757 |
|COCH-ARM / FISHERS | P=0.335N P=0.684 P=0.500N P=0.500N |P=0.446 P=0.505N P=0.175 P=0.753N |
|ORDER RESTRICTED | P=0.474N (e) (e) (e) |P=0.181 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 45
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 8/50 (16%) 14/50 (28%) | |
|POLY-3 RATE (b) | 1/47.84 4/48.72 8/41.53 14/45.34 | |
|POLY-3 PERCENT (g) | 2.1% 8.2% 19.3% 30.9% | |
|TERMINAL (d) | 0/43 (0%) 3/46 (7%) 7/36 (19%) 11/40 (28%) | |
|FIRST INCIDENCE | 611 696 706 531 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.203 P=0.010 * P<0.001 ** | |
|POLY 3 | P<0.001 ** P=0.185 P=0.008 ** P<0.001 ** | |
|POLY 1.5 | P<0.001 ** P=0.182 P=0.009 ** P<0.001 ** | |
|POLY 6 | P<0.001 ** P=0.189 P=0.008 ** P<0.001 ** | |
|LOGISTIC REGRESSION| P<0.001 ** P=0.177 P=0.011 * P<0.001 ** | |
|COCH-ARM / FISHERS | P<0.001 ** P=0.181 P=0.015 * P<0.001 ** | |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/47 (15%) 5/46 (11%) 9/46 (20%) 8/47 (17%) |5/50 (10%) 2/48 (4%) 7/48 (15%) 3/50 (6%) |
|POLY-3 RATE (b) | 7/46.48 5/45.73 9/44.18 8/46.59 |5/49.71 2/46.22 7/47.36 3/49.35 |
|POLY-3 PERCENT (g) | 15.1% 10.9% 20.4% 17.2% |10.1% 4.3% 14.8% 6.1% |
|TERMINAL (d) | 4/42 (10%) 3/43 (7%) 0/34 (0%) 1/38 (3%) |2/46 (4%) 1/42 (2%) 3/42 (7%) 0/45 (0%) |
|FIRST INCIDENCE | 24 696 7 7 |402 620 128 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.279 P=0.362N P=0.307 P=0.453 |P=0.447N P=0.250N P=0.345 P=0.363N |
|POLY 3 | P=0.332 P=0.391N P=0.350 P=0.502 |P=0.439N P=0.248N P=0.346 P=0.361N |
|POLY 1.5 | P=0.333 P=0.393N P=0.358 P=0.501 |P=0.441N P=0.243N P=0.349 P=0.360N |
|POLY 6 | P=0.332 P=0.388N P=0.346 P=0.503 |P=0.436N P=0.253N P=0.343 P=0.362N |
|LOGISTIC REGRESSION| P=0.317N P=0.615 P=0.265N P=0.484N |P=0.530N P=0.207N P=0.393 P=0.421N |
|COCH-ARM / FISHERS | P=0.333 P=0.395N P=0.374 P=0.500 |P=0.443N P=0.235N P=0.351 P=0.357N |
|ORDER RESTRICTED | P=0.357 (e) (e) (e) |P=0.380N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 46
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 1/46 (2%) 0/46 (0%) 0/47 (0%) |0/50 (0%) 0/48 (0%) 0/48 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/44.84 1/45.59 0/38.11 0/42.07 |0/48.25 0/45.83 0/45.63 4/48.65 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |0.0% 0.0% 0.0% 8.2% |
|TERMINAL (d) | 0/42 (0%) 1/43 (2%) 0/34 (0%) 0/38 (0%) |0/46 (0%) 0/42 (0%) 0/42 (0%) 3/45 (7%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- --- --- 727 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.587N P=0.505 (e) (e) |P=0.004 ** (e) (e) P=0.063 |
|POLY 3 | P=0.577N P=0.503 (e) (e) |P=0.003 ** (e) (e) P=0.062 |
|POLY 1.5 | P=0.576N P=0.502 (e) (e) |P=0.003 ** (e) (e) P=0.062 |
|POLY 6 | P=0.577N P=0.506 (e) (e) |P=0.003 ** (e) (e) P=0.061 |
|LOGISTIC REGRESSION| (e) P=0.505 (e) (e) |P=0.004 ** (e) (e) P=0.063 |
|COCH-ARM / FISHERS | P=0.566N P=0.495 (e) (e) |P=0.003 ** (e) (e) P=0.059 |
|ORDER RESTRICTED | P=0.395N (e) (e) (e) |P=0.002 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |15/49 (31%) 14/48 (29%) 12/48 (25%) 9/50 (18%) |
|POLY-3 RATE (b) | 10/47.66 2/48.59 3/41.44 4/44.45 |15/47.25 14/46.22 12/46.89 9/48.64 |
|POLY-3 PERCENT (g) | 21.0% 4.1% 7.2% 9.0% |31.8% 30.3% 25.6% 18.5% |
|TERMINAL (d) | 9/43 (21%) 2/46 (4%) 3/36 (8%) 4/40 (10%) |15/45 (33%) 13/42 (31%) 11/43 (26%) 9/45 (20%) |
|FIRST INCIDENCE | 668 729 (T) 729 (T) 729 (T) |729 (T) 620 128 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.126N P=0.012N* P=0.074N P=0.098N |P=0.077N P=0.586N P=0.376N P=0.118N |
|POLY 3 | P=0.109N P=0.012N* P=0.062N P=0.094N |P=0.068N P=0.528N P=0.334N P=0.103N |
|POLY 1.5 | P=0.106N P=0.013N* P=0.057N P=0.094N |P=0.069N P=0.527N P=0.337N P=0.104N |
|POLY 6 | P=0.113N P=0.011N* P=0.066N P=0.094N |P=0.067N P=0.533N P=0.334N P=0.103N |
|LOGISTIC REGRESSION| P=0.119N P=0.014N* P=0.065N P=0.093N |P=0.073N P=0.546N P=0.338N P=0.118N |
|COCH-ARM / FISHERS | P=0.089N P=0.014N* P=0.036N* P=0.074N |P=0.073N P=0.527N P=0.349N P=0.109N |
|ORDER RESTRICTED | P=0.014N* (e) (e) (e) |P=0.105N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 47
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 33/50 (66%) |1/49 (2%) 1/48 (2%) 1/48 (2%) 9/50 (18%) |
|POLY-3 RATE (b) | 0/47.43 2/48.59 3/41.44 33/44.56 |1/47.25 1/45.83 1/45.89 9/48.67 |
|POLY-3 PERCENT (g) | 0.0% 4.1% 7.2% 74.1% |2.1% 2.2% 2.2% 18.5% |
|TERMINAL (d) | 0/43 (0%) 2/46 (4%) 3/36 (8%) 32/40 (80%) |1/45 (2%) 1/42 (2%) 1/43 (2%) 8/45 (18%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 701 |729 (T) 729 (T) 729 (T) 720 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.253 P=0.092 P<0.001 ** |P<0.001 ** P=0.746 P=0.751 P=0.010 * |
|POLY 3 | P<0.001 ** P=0.243 P=0.097 P<0.001 ** |P<0.001 ** P=0.754 P=0.754 P=0.009 ** |
|POLY 1.5 | P<0.001 ** P=0.240 P=0.099 P<0.001 ** |P<0.001 ** P=0.755 P=0.754 P=0.009 ** |
|POLY 6 | P<0.001 ** P=0.247 P=0.094 P<0.001 ** |P<0.001 ** P=0.752 P=0.754 P=0.009 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.253 P=0.092 P<0.001 ** |P<0.001 ** P=0.746 P=0.751 P=0.011 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.247 P=0.121 P<0.001 ** |P<0.001 ** P=0.747 P=0.747 P=0.009 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 6/50 (12%) 25/50 (50%) |6/49 (12%) 3/48 (6%) 23/48 (48%) 46/50 (92%) |
|POLY-3 RATE (b) | 1/47.57 0/48.59 6/42.69 25/45.00 |6/47.25 3/45.83 23/46.03 46/48.68 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 14.1% 55.6% |12.7% 6.6% 50.0% 94.5% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 3/36 (8%) 22/40 (55%) |6/45 (13%) 3/42 (7%) 22/43 (51%) 44/45 (98%) |
|FIRST INCIDENCE | 694 --- 531 654 |729 (T) 729 (T) 693 720 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.483N P=0.041 * P<0.001 ** |P<0.001 ** P=0.277N P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.496N P=0.041 * P<0.001 ** |P<0.001 ** P=0.258N P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.498N P=0.041 * P<0.001 ** |P<0.001 ** P=0.255N P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.493N P=0.040 * P<0.001 ** |P<0.001 ** P=0.262N P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.502N P=0.054 P<0.001 ** |P<0.001 ** P=0.277N P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.056 P<0.001 ** |P<0.001 ** P=0.254N P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 48
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |16/50 (32%) 16/49 (33%) 6/49 (12%) 11/50 (22%) |
|POLY-3 RATE (b) | 0/47.43 0/48.59 0/41.44 0/44.45 |16/48.25 16/46.87 6/46.63 11/48.67 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |33.2% 34.1% 12.9% 22.6% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/36 (0%) 0/40 (0%) |16/46 (35%) 15/43 (35%) 6/43 (14%) 10/45 (22%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 720 729 (T) 720 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.083N P=0.493 P=0.022N* P=0.202N |
|POLY 3 | (e) (e) (e) (e) |P=0.070N P=0.546 P=0.016N* P=0.176N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.072N P=0.552 P=0.016N* P=0.177N |
|POLY 6 | (e) (e) (e) (e) |P=0.069N P=0.535 P=0.017N* P=0.176N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.072N P=0.498 P=0.022N* P=0.182N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.077N P=0.558 P=0.016N* P=0.184N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.049N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 2/49 (4%) 2/49 (4%) 6/50 (12%) |
|POLY-3 RATE (b) | |3/48.25 2/46.83 2/46.63 6/48.64 |
|POLY-3 PERCENT (g) | |6.2% 4.3% 4.3% 12.3% |
|TERMINAL (d) | |3/46 (7%) 2/43 (5%) 2/43 (5%) 6/45 (13%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.113 P=0.531N P=0.531N P=0.232 |
|POLY 3 | |P=0.117 P=0.514N P=0.515N P=0.247 |
|POLY 1.5 | |P=0.117 P=0.511N P=0.515N P=0.246 |
|POLY 6 | |P=0.117 P=0.518N P=0.518N P=0.246 |
|LOGISTIC REGRESSION| |P=0.113 P=0.531N P=0.531N P=0.232 |
|COCH-ARM / FISHERS | |P=0.115 P=0.510N P=0.510N P=0.243 |
|ORDER RESTRICTED | |P=0.111 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 49
Statistical Analysis of Non-neoplastic Lesions 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 |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |6/50 (12%) 2/49 (4%) 9/49 (18%) 4/50 (8%) |
|POLY-3 RATE (b) | |6/48.25 2/46.83 9/47.19 4/48.64 |
|POLY-3 PERCENT (g) | |12.4% 4.3% 19.1% 8.2% |
|TERMINAL (d) | |6/46 (13%) 2/43 (5%) 8/43 (19%) 4/45 (9%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 555 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.520N P=0.157N P=0.246 P=0.383N |
|POLY 3 | |P=0.502N P=0.143N P=0.272 P=0.365N |
|POLY 1.5 | |P=0.505N P=0.142N P=0.270 P=0.366N |
|POLY 6 | |P=0.500N P=0.146N P=0.272 P=0.366N |
|LOGISTIC REGRESSION| |P=0.508N P=0.157N P=0.268 P=0.383N |
|COCH-ARM / FISHERS | |P=0.512N P=0.141N P=0.274 P=0.370N |
|ORDER RESTRICTED | |P=0.326 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0PPM 625 PPM 1250 PPM 2500 PPM |0PPM 625 PPM 1250 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |5/50 (10%) 0/49 (0%) 5/49 (10%) 1/50 (2%) |
|POLY-3 RATE (b) | |5/48.25 0/46.83 5/46.63 1/48.64 |
|POLY-3 PERCENT (g) | |10.4% 0.0% 10.7% 2.1% |
|TERMINAL (d) | |5/46 (11%) 0/43 (0%) 5/43 (12%) 1/45 (2%) |
|FIRST INCIDENCE | |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.191N P=0.040N* P=0.588 P=0.109N |
|POLY 3 | |P=0.178N P=0.033N* P=0.608 P=0.100N |
|POLY 1.5 | |P=0.179N P=0.033N* P=0.609 P=0.100N |
|POLY 6 | |P=0.176N P=0.034N* P=0.605 P=0.100N |
|LOGISTIC REGRESSION| |P=0.191N (e) P=0.588 P=0.109N |
|COCH-ARM / FISHERS | |P=0.186N P=0.030N* P=0.617 P=0.102N |
|ORDER RESTRICTED | |P=0.052N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/06/04 EXPERIMENT: 92012 TEST: 06 Page 50
Statistical Analysis of Non-neoplastic Lesions 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: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |48/50 (96%) 47/49 (96%) 46/49 (94%) 45/50 (90%) |
|POLY-3 RATE (b) | |48/49.39 47/48.80 46/47.74 45/49.56 |
|POLY-3 PERCENT (g) | |97.2% 96.3% 96.4% 90.8% |
|TERMINAL (d) | |45/46 (98%) 43/43 (100%) 42/43 (98%) 42/45 (93%) |
|FIRST INCIDENCE | |402 400 555 517 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.226N P=0.348 P=0.489 P=0.369N |
|POLY 3 | |P=0.084N P=0.634N P=0.642N P=0.171N |
|POLY 1.5 | |P=0.095N P=0.653N P=0.640N P=0.186N |
|POLY 6 | |P=0.076N P=0.628N P=0.646N P=0.164N |
|LOGISTIC REGRESSION| |P=0.081N P=0.694N P=0.585N P=0.171N |
|COCH-ARM / FISHERS | |P=0.116N P=0.684N P=0.490N P=0.218N |
|ORDER RESTRICTED | |P=0.092N (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).