TDMS Study 92013-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst 4-METHYLIMIDAZOLE DATE: 12/06/04
EXPERIMENT: 92013 TEST: 05 TIME: 08:46:08
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92013B
PATHOLOGIST: FARNELL, DANIEL R. CAS: 822-36-6
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FINAL #1 RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst 4-METHYLIMIDAZOLE DATE: 12/06/04
EXPERIMENT: 92013 TEST: 05 TIME: 08:46:08
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92013B
PATHOLOGIST: FARNELL, DANIEL R. CAS: 822-36-6
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF 4-METHYLIMIDAZOLE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Hyperplasia Focal
Eye: Retina Degeneration
Kidney Infarct
Nephropathy
Liver Congestion
Eosinophilic Focus
Histiocytosis
Infiltration Cellular Mixed Cell
Inflammation Chronic
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Fatty Change Focal
Lung Congestion
Hemorrhage Focal
Lymph Node: Mediastinal Hyperplasia
Mammary Gland Dilatation
Nose: Nasolacrimal Duct Inflammation
Pituitary Gland: Pars Distalis Hemorrhage Focal
Hypertrophy Focal
Preputial Gland Hyperplasia Cystic
Inflammation Chronic
Prostate Inflammation Chronic
Prostate: Epithelium Hyperplasia Focal
Spleen Atrophy
Stomach, Forestomach Edema
Stomach, Glandular Edema
Erosion
Testes: Interstitial Cell Hyperplasia Focal
Thymus Hemorrhage
Thyroid Gland: C-Cell Hyperplasia
Thyroid Gland: Follicle Cyst
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Bone Marrow Atrophy
Hyperplasia Focal Histiocytic
Brain Compression Focal
Clitoral Gland Hyperplasia Cystic
Eye Atrophy
Heart Cardiomyopathy
Thrombosis
Kidney Nephropathy
Kidney: Renal Tubule Pigmentation
Liver Basophilic Focus
Clear Cell Focus
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst 4-METHYLIMIDAZOLE DATE: 12/06/04
EXPERIMENT: 92013 TEST: 05 TIME: 08:46:08
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92013B
PATHOLOGIST: FARNELL, DANIEL R. CAS: 822-36-6
Eosinophilic Focus
Hepatodiaphragmatic Nodule
Histiocytosis
Hyperplasia Focal Histiocytic
Infiltration Cellular Mixed Cell
Inflammation Chronic
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Fatty Change Focal
Vacuolization Cytoplasmic
Lung Inflammation Chronic Focal
Lymph Node, Mesenteric Hyperplasia
Lymph Node: Deep Cervical Hemorrhage
Lymph Node: Mediastinal Ectasia
Mammary Gland Dilatation
Hyperplasia
Mesentery: Fat Necrosis Focal
Ovary Angiectasis
Cyst
Pancreas: Acinus Atrophy Focal
Pancreas: Duct Cyst Focal
Pituitary Gland Cyst
Pituitary Gland: Pars Distalis Degeneration Cystic Focal
Hypertrophy Focal
Spinal Cord Hemorrhage Focal
Spleen Hematopoietic Cell Proliferation
Inflammation Granulomatous
Stomach, Forestomach: Epithelium Hyperplasia
Thymus Cyst
Thyroid Gland: C-Cell Hyperplasia
Thyroid Gland: Follicle Mineralization
===============================================================
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 6/50 (12%) 5/50 (10%) 9/50 (18%) |8/49 (16%) 6/50 (12%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 9/45.67 6/43.74 5/44.41 9/43.64 |8/45.90 6/46.30 3/43.76 2/44.39 |
|POLY-3 PERCENT (g) | 19.7% 13.7% 11.3% 20.6% |17.4% 13.0% 6.9% 4.5% |
|TERMINAL (d) | 7/31 (23%) 4/34 (12%) 5/33 (15%) 9/32 (28%) |7/43 (16%) 4/39 (10%) 3/34 (9%) 2/35 (6%) |
|FIRST INCIDENCE | 653 567 729 (T) 729 (T) |667 636 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482 P=0.253N P=0.169N P=0.593N |P=0.049N* P=0.454N P=0.189N P=0.091N |
|POLY 3 | P=0.463 P=0.318N P=0.207N P=0.562 |P=0.025N* P=0.380N P=0.114N P=0.051N |
|POLY 1.5 | P=0.475 P=0.312N P=0.202N P=0.578 |P=0.023N* P=0.369N P=0.103N P=0.045N* |
|POLY 6 | P=0.443 P=0.316N P=0.214N P=0.539 |P=0.029N* P=0.392N P=0.132N P=0.059N |
|LOGISTIC REGRESSION| P=0.445 P=0.317N P=0.203N P=0.538 |P=0.026N* P=0.374N P=0.132N P=0.058N |
|COCH-ARM / FISHERS | P=0.486 P=0.288N P=0.194N P=0.602N |P=0.021N* P=0.371N P=0.094N P=0.043N* |
|ORDER RESTRICTED | P=0.370 (e) (e) (e) |P=0.030N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |4/49 (8%) 2/50 (4%) 7/50 (14%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/45.22 1/43.15 0/44.41 0/43.64 |4/46.67 2/46.50 7/43.88 4/44.39 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |8.6% 4.3% 16.0% 9.0% |
|TERMINAL (d) | 0/31 (0%) 1/34 (3%) 0/33 (0%) 0/32 (0%) |3/43 (7%) 1/39 (3%) 5/34 (15%) 4/35 (11%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |16 421 700 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.567N P=0.518 (e) (e) |P=0.309 P=0.366N P=0.163 P=0.541 |
|POLY 3 | P=0.575N P=0.491 (e) (e) |P=0.375 P=0.339N P=0.227 P=0.615 |
|POLY 1.5 | P=0.573N P=0.493 (e) (e) |P=0.395 P=0.333N P=0.244 P=0.632 |
|POLY 6 | P=0.575N P=0.491 (e) (e) |P=0.350 P=0.347N P=0.203 P=0.593 |
|LOGISTIC REGRESSION| (e) P=0.518 (e) (e) |P=0.429 P=0.417N P=0.282 P=0.645 |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.425 P=0.329N P=0.274 P=0.631N |
|ORDER RESTRICTED | P=0.379N (e) (e) (e) |P=0.256 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |1/49 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/45.71 2/43.15 1/44.41 2/44.01 |1/45.67 2/45.69 2/43.76 2/44.98 |
|POLY-3 PERCENT (g) | 6.6% 4.6% 2.3% 4.5% |2.2% 4.4% 4.6% 4.5% |
|TERMINAL (d) | 2/31 (7%) 2/34 (6%) 1/33 (3%) 1/32 (3%) |1/43 (2%) 2/39 (5%) 2/34 (6%) 1/35 (3%) |
|FIRST INCIDENCE | 582 729 (T) 729 (T) 628 |729 (T) 729 (T) 729 (T) 541 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.400N P=0.476N P=0.294N P=0.493N |P=0.355 P=0.466 P=0.418 P=0.452 |
|POLY 3 | P=0.408N P=0.526N P=0.316N P=0.517N |P=0.412 P=0.500 P=0.485 P=0.495 |
|POLY 1.5 | P=0.406N P=0.520N P=0.312N P=0.511N |P=0.423 P=0.506 P=0.496 P=0.503 |
|POLY 6 | P=0.413N P=0.529N P=0.319N P=0.525N |P=0.397 P=0.492 P=0.469 P=0.483 |
|LOGISTIC REGRESSION| P=0.406N P=0.511N P=0.301N P=0.480N |P=0.424 P=0.466 P=0.418 P=0.505 |
|COCH-ARM / FISHERS | P=0.404N P=0.500N P=0.309N P=0.500N |P=0.429 P=0.508 P=0.508 P=0.508 |
|ORDER RESTRICTED | P=0.373N (e) (e) (e) |P=0.450 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/45.71 0/43.15 0/44.41 0/43.64 |0/45.67 0/45.69 2/44.26 1/44.44 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |0.0% 0.0% 4.5% 2.3% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 0/39 (0%) 1/34 (3%) 0/35 (0%) |
|FIRST INCIDENCE | 582 --- --- --- |--- --- 581 717 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.305N P=0.522N P=0.508N P=0.500N |P=0.220 (e) P=0.210 P=0.465 |
|POLY 3 | P=0.297N P=0.512N P=0.506N P=0.509N |P=0.234 (e) P=0.230 P=0.495 |
|POLY 1.5 | P=0.300N P=0.509N P=0.503N P=0.506N |P=0.242 (e) P=0.236 P=0.500 |
|POLY 6 | P=0.295N P=0.513N P=0.508N P=0.514N |P=0.223 (e) P=0.222 P=0.487 |
|LOGISTIC REGRESSION| P=0.297N P=0.405N P=0.463N P=0.410N |P=0.250 (e) P=0.245 P=0.494 |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.249 (e) P=0.253 P=0.505 |
|ORDER RESTRICTED | P=0.129N (e) (e) (e) |P=0.162 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 13/50 (26%) 7/50 (14%) |8/49 (16%) 9/50 (18%) 13/50 (26%) 12/50 (24%) |
|POLY-3 RATE (b) | 6/45.39 5/43.15 13/46.97 7/44.16 |8/46.35 9/45.96 13/44.26 12/45.33 |
|POLY-3 PERCENT (g) | 13.2% 11.6% 27.7% 15.9% |17.3% 19.6% 29.4% 26.5% |
|TERMINAL (d) | 5/31 (16%) 5/34 (15%) 7/33 (21%) 5/32 (16%) |7/43 (16%) 7/39 (18%) 12/34 (35%) 8/35 (23%) |
|FIRST INCIDENCE | 685 729 (T) 493 650 |498 677 581 628 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.310 P=0.444N P=0.084 P=0.499 |P=0.072 P=0.422 P=0.061 P=0.128 |
|POLY 3 | P=0.296 P=0.536N P=0.070 P=0.479 |P=0.138 P=0.492 P=0.131 P=0.208 |
|POLY 1.5 | P=0.302 P=0.527N P=0.066 P=0.486 |P=0.154 P=0.511 P=0.152 P=0.227 |
|POLY 6 | P=0.288 P=0.538N P=0.076 P=0.472 |P=0.121 P=0.473 P=0.106 P=0.188 |
|LOGISTIC REGRESSION| P=0.305 P=0.511N P=0.068 P=0.461 |P=0.144 P=0.516 P=0.150 P=0.233 |
|COCH-ARM / FISHERS | P=0.310 P=0.500N P=0.062 P=0.500 |P=0.170 P=0.518 P=0.176 P=0.242 |
|ORDER RESTRICTED | P=0.178 (e) (e) (e) |P=0.173 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |2/48 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 7/45.32 1/43.15 3/44.73 0/43.64 |2/44.67 0/45.69 2/43.76 0/44.39 |
|POLY-3 PERCENT (g) | 15.5% 2.3% 6.7% 0.0% |4.5% 0.0% 4.6% 0.0% |
|TERMINAL (d) | 5/31 (16%) 1/34 (3%) 2/33 (6%) 0/32 (0%) |2/42 (5%) 0/39 (0%) 2/34 (6%) 0/35 (0%) |
|FIRST INCIDENCE | 712 729 (T) 642 --- |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009N** P=0.026N* P=0.147N P=0.010N* |P=0.294N P=0.255N P=0.617 P=0.279N |
|POLY 3 | P=0.008N** P=0.035N* P=0.162N P=0.009N** |P=0.247N P=0.232N P=0.687 P=0.239N |
|POLY 1.5 | P=0.008N** P=0.034N* P=0.161N P=0.008N** |P=0.243N P=0.228N P=0.690N P=0.232N |
|POLY 6 | P=0.008N** P=0.035N* P=0.161N P=0.009N** |P=0.253N P=0.237N P=0.670 P=0.247N |
|LOGISTIC REGRESSION| P=0.010N* P=0.031N* P=0.166N P=0.011N* |P=0.294N (e) P=0.617 (e) |
|COCH-ARM / FISHERS | P=0.009N** P=0.030N* P=0.159N P=0.006N** |P=0.239N P=0.237N P=0.676N P=0.237N |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.116N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 1/43.95 0/43.15 0/42.86 0/43.64 |0/46.53 0/44.39 0/43.76 2/42.90 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.7% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 0/39 (0%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 642 --- --- --- |--- --- --- 654 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312N P=0.523N P=0.509N P=0.514N |P=0.043 * (e) (e) P=0.217 |
|POLY 3 | P=0.288N P=0.504N P=0.505N P=0.501N |P=0.042 * (e) (e) P=0.219 |
|POLY 1.5 | P=0.292N P=0.499N P=0.501N P=0.496N |P=0.043 * (e) (e) P=0.225 |
|POLY 6 | P=0.284N P=0.508N P=0.509N P=0.509N |P=0.041 * (e) (e) P=0.213 |
|LOGISTIC REGRESSION| P=0.291N P=0.441N P=0.457N P=0.437N |P=0.045 * (e) (e) P=0.226 |
|COCH-ARM / FISHERS | P=0.300N P=0.485N P=0.495N P=0.485N |P=0.045 * (e) (e) P=0.237 |
|ORDER RESTRICTED | P=0.122N (e) (e) (e) |P=0.024 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/47 (4%) 3/50 (6%) 2/48 (4%) 4/50 (8%) |3/50 (6%) 2/48 (4%) 1/49 (2%) 2/48 (4%) |
|POLY-3 RATE (b) | 2/44.04 3/44.21 2/43.60 4/43.89 |3/46.53 2/44.51 1/43.88 2/42.39 |
|POLY-3 PERCENT (g) | 4.5% 6.8% 4.6% 9.1% |6.5% 4.5% 2.3% 4.7% |
|TERMINAL (d) | 0/31 (0%) 1/34 (3%) 0/33 (0%) 3/32 (9%) |3/43 (7%) 1/39 (3%) 0/34 (0%) 2/33 (6%) |
|FIRST INCIDENCE | 667 275 538 663 |729 (T) 700 700 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.258 P=0.490 P=0.675 P=0.313 |P=0.505N P=0.540N P=0.387N P=0.620N |
|POLY 3 | P=0.279 P=0.502 P=0.690 P=0.335 |P=0.433N P=0.520N P=0.327N P=0.542N |
|POLY 1.5 | P=0.289 P=0.511 P=0.693N P=0.348 |P=0.424N P=0.516N P=0.316N P=0.529N |
|POLY 6 | P=0.265 P=0.494 P=0.686 P=0.319 |P=0.446N P=0.525N P=0.342N P=0.560N |
|LOGISTIC REGRESSION| P=0.321 P=0.689N P=0.622N P=0.360 |P=0.459N P=0.526N P=0.342N P=0.620N |
|COCH-ARM / FISHERS | P=0.302 P=0.530 P=0.684N P=0.369 |P=0.416N P=0.520N P=0.316N P=0.520N |
|ORDER RESTRICTED | P=0.299 (e) (e) (e) |P=0.399N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia Focal Histiocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |0/50 (0%) 1/48 (2%) 2/49 (4%) 3/48 (6%) |
|POLY-3 RATE (b) | 0/43.63 0/43.15 0/42.86 0/43.64 |0/46.53 1/44.39 2/43.76 3/42.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.3% 4.6% 7.1% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 1/39 (3%) 2/34 (6%) 3/33 (9%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.035 * P=0.481 P=0.188 P=0.079 |
|POLY 3 | (e) (e) (e) (e) |P=0.051 P=0.491 P=0.224 P=0.103 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.055 P=0.493 P=0.230 P=0.108 |
|POLY 6 | (e) (e) (e) (e) |P=0.046 * P=0.488 P=0.214 P=0.096 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.481 P=0.188 P=0.079 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.058 P=0.490 P=0.242 P=0.114 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.046 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Compression Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 1/50 (2%) 1/50 (2%) |13/50 (26%) 8/50 (16%) 8/50 (16%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/46.10 6/44.37 1/44.41 1/43.64 |13/47.02 8/46.34 8/43.76 2/44.44 |
|POLY-3 PERCENT (g) | 8.7% 13.5% 2.3% 2.3% |27.7% 17.3% 18.3% 4.5% |
|TERMINAL (d) | 1/31 (3%) 4/34 (12%) 1/33 (3%) 1/32 (3%) |10/43 (23%) 5/39 (13%) 8/34 (24%) 1/35 (3%) |
|FIRST INCIDENCE | 464 477 729 (T) 729 (T) |667 653 729 (T) 717 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.057N P=0.392 P=0.179N P=0.195N |P=0.010N* P=0.233N P=0.345N P=0.010N* |
|POLY 3 | P=0.059N P=0.345 P=0.190N P=0.196N |P=0.003N** P=0.170N P=0.209N P=0.002N** |
|POLY 1.5 | P=0.057N P=0.350 P=0.186N P=0.190N |P=0.003N** P=0.161N P=0.185N P=0.002N** |
|POLY 6 | P=0.063N P=0.348 P=0.194N P=0.203N |P=0.004N** P=0.181N P=0.251N P=0.003N** |
|LOGISTIC REGRESSION| P=0.050N P=0.437 P=0.162N P=0.154N |P=0.004N** P=0.166N P=0.244N P=0.003N** |
|COCH-ARM / FISHERS | P=0.054N P=0.370 P=0.181N P=0.181N |P=0.002N** P=0.163N P=0.163N P=0.002N** |
|ORDER RESTRICTED | P=0.069N (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 3/50 (6%) 3/50 (6%) |1/50 (2%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/45.31 4/44.51 3/46.10 3/44.56 |1/46.53 2/47.23 4/44.32 2/45.86 |
|POLY-3 PERCENT (g) | 2.2% 9.0% 6.5% 6.7% |2.2% 4.2% 9.0% 4.4% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |1/43 (2%) 0/39 (0%) 1/34 (3%) 0/35 (0%) |
|FIRST INCIDENCE | 705 567 493 607 |729 (T) 434 635 368 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.340 P=0.170 P=0.306 P=0.286 |P=0.353 P=0.491 P=0.136 P=0.481 |
|POLY 3 | P=0.349 P=0.173 P=0.311 P=0.299 |P=0.375 P=0.505 P=0.164 P=0.495 |
|POLY 1.5 | P=0.351 P=0.172 P=0.309 P=0.301 |P=0.385 P=0.507 P=0.172 P=0.501 |
|POLY 6 | P=0.346 P=0.178 P=0.315 P=0.298 |P=0.359 P=0.501 P=0.154 P=0.486 |
|LOGISTIC REGRESSION| P=0.371 P=0.222 P=0.374 P=0.341 |P=0.359 P=0.393 P=0.176 P=0.437 |
|COCH-ARM / FISHERS | P=0.357 P=0.181 P=0.309 P=0.309 |P=0.387 P=0.500 P=0.181 P=0.500 |
|ORDER RESTRICTED | P=0.242 (e) (e) (e) |P=0.250 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 0/50 (0%) 5/50 (10%) 3/50 (6%) |
|POLY-3 RATE (b) | |4/46.53 0/45.69 5/43.88 3/44.46 |
|POLY-3 PERCENT (g) | |8.6% 0.0% 11.4% 6.8% |
|TERMINAL (d) | |4/43 (9%) 0/39 (0%) 4/34 (12%) 2/35 (6%) |
|FIRST INCIDENCE | |729 (T) --- 700 712 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.396 P=0.076N P=0.360 P=0.606N |
|POLY 3 | |P=0.477 P=0.063N P=0.463 P=0.525N |
|POLY 1.5 | |P=0.488 P=0.061N P=0.482 P=0.510N |
|POLY 6 | |P=0.461 P=0.065N P=0.437 P=0.544N |
|LOGISTIC REGRESSION| |P=0.434 (e) P=0.402 P=0.575N |
|COCH-ARM / FISHERS | |P=0.500 P=0.059N P=0.500 P=0.500N |
|ORDER RESTRICTED | |P=0.288 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |7/50 (14%) 4/50 (8%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | |7/46.53 4/45.96 1/44.10 1/44.39 |
|POLY-3 PERCENT (g) | |15.0% 8.7% 2.3% 2.3% |
|TERMINAL (d) | |7/43 (16%) 3/39 (8%) 0/34 (0%) 1/35 (3%) |
|FIRST INCIDENCE | |729 (T) 657 635 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.023N* P=0.318N P=0.063N P=0.060N |
|POLY 3 | |P=0.012N* P=0.268N P=0.036N* P=0.035N* |
|POLY 1.5 | |P=0.011N* P=0.260N P=0.033N* P=0.032N* |
|POLY 6 | |P=0.013N* P=0.277N P=0.041N* P=0.040N* |
|LOGISTIC REGRESSION| |P=0.013N* P=0.278N P=0.039N* P=0.060N |
|COCH-ARM / FISHERS | |P=0.011N* P=0.262N P=0.030N* P=0.030N* |
|ORDER RESTRICTED | |P=0.011N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 2/50 (4%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | |2/46.53 2/45.69 0/43.76 3/44.39 |
|POLY-3 PERCENT (g) | |4.3% 4.4% 0.0% 6.8% |
|TERMINAL (d) | |2/43 (5%) 2/39 (5%) 0/34 (0%) 3/35 (9%) |
|FIRST INCIDENCE | |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.343 P=0.659 P=0.291N P=0.406 |
|POLY 3 | |P=0.407 P=0.687 P=0.251N P=0.479 |
|POLY 1.5 | |P=0.415 P=0.693 P=0.244N P=0.491 |
|POLY 6 | |P=0.395 P=0.680 P=0.261N P=0.462 |
|LOGISTIC REGRESSION| |P=0.343 P=0.659 (e) P=0.406 |
|COCH-ARM / FISHERS | |P=0.423 P=0.691N P=0.247N P=0.500 |
|ORDER RESTRICTED | |P=0.274 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) |0/48 (0%) 0/45 (0%) 3/40 (8%) 4/45 (9%) |
|POLY-3 RATE (b) | 0/43.79 0/41.81 0/42.89 0/40.07 |0/45.04 0/42.88 3/38.47 4/39.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 7.8% 10.1% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 0/39 (0%) 3/34 (9%) 4/33 (12%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.005 ** (e) P=0.083 P=0.035 * |
|POLY 3 | (e) (e) (e) (e) |P=0.007 ** (e) P=0.091 P=0.045 * |
|POLY 1.5 | (e) (e) (e) (e) |P=0.008 ** (e) P=0.092 P=0.049 * |
|POLY 6 | (e) (e) (e) (e) |P=0.006 ** (e) P=0.089 P=0.041 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.083 P=0.035 * |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.010 * (e) P=0.090 P=0.051 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.012 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/47 (2%) 0/48 (0%) 2/45 (4%) |4/48 (8%) 0/45 (0%) 1/40 (3%) 1/45 (2%) |
|POLY-3 RATE (b) | 2/44.24 1/42.75 0/42.89 2/40.36 |4/45.04 0/42.88 1/38.47 1/39.76 |
|POLY-3 PERCENT (g) | 4.5% 2.3% 0.0% 5.0% |8.9% 0.0% 2.6% 2.5% |
|TERMINAL (d) | 1/31 (3%) 0/34 (0%) 0/33 (0%) 1/32 (3%) |4/43 (9%) 0/39 (0%) 1/34 (3%) 1/33 (3%) |
|FIRST INCIDENCE | 597 275 --- 650 |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.591 P=0.502N P=0.235N P=0.691N |P=0.228N P=0.076N P=0.256N P=0.267N |
|POLY 3 | P=0.566 P=0.512N P=0.244N P=0.661 |P=0.189N P=0.066N P=0.229N P=0.218N |
|POLY 1.5 | P=0.568 P=0.511N P=0.241N P=0.663 |P=0.186N P=0.066N P=0.228N P=0.207N |
|POLY 6 | P=0.564 P=0.511N P=0.246N P=0.660 |P=0.191N P=0.068N P=0.234N P=0.233N |
|LOGISTIC REGRESSION| P=0.622N P=0.280N P=0.219N P=0.696 |P=0.228N (e) P=0.256N P=0.267N |
|COCH-ARM / FISHERS | P=0.572 P=0.508N P=0.247N P=0.667 |P=0.182N P=0.067N P=0.242N P=0.201N |
|ORDER RESTRICTED | P=0.378 (e) (e) (e) |P=0.051N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Synechia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) |1/48 (2%) 0/45 (0%) 0/40 (0%) 2/45 (4%) |
|POLY-3 RATE (b) | 0/43.79 0/41.81 0/42.89 0/40.07 |1/45.04 0/42.88 0/38.47 2/39.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |1/43 (2%) 0/39 (0%) 0/34 (0%) 2/33 (6%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.193 P=0.519N P=0.547N P=0.408 |
|POLY 3 | (e) (e) (e) (e) |P=0.228 P=0.510N P=0.531N P=0.457 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.231 P=0.509N P=0.531N P=0.468 |
|POLY 6 | (e) (e) (e) (e) |P=0.224 P=0.512N P=0.534N P=0.442 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.193 (e) (e) P=0.408 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.236 P=0.516N P=0.545N P=0.476 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.107 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Anterior Chamber |
| Exudate |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 1/47 (2%) 0/48 (0%) 2/45 (4%) |0/48 (0%) 1/45 (2%) 0/40 (0%) 1/45 (2%) |
|POLY-3 RATE (b) | 0/43.79 1/41.81 0/42.89 2/41.23 |0/45.04 1/42.88 0/38.47 1/39.76 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 4.9% |0.0% 2.3% 0.0% 2.5% |
|TERMINAL (d) | 0/31 (0%) 1/34 (3%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 1/39 (3%) 0/34 (0%) 1/33 (3%) |
|FIRST INCIDENCE | --- 729 (T) --- 369 |--- 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140 P=0.518 (e) P=0.232 |P=0.351 P=0.481 (e) P=0.447 |
|POLY 3 | P=0.129 P=0.491 (e) P=0.224 |P=0.378 P=0.490 (e) P=0.475 |
|POLY 1.5 | P=0.129 P=0.492 (e) P=0.223 |P=0.387 P=0.491 (e) P=0.482 |
|POLY 6 | P=0.130 P=0.492 (e) P=0.225 |P=0.367 P=0.488 (e) P=0.467 |
|LOGISTIC REGRESSION| P=0.147 P=0.518 (e) P=0.388 |(e) P=0.481 (e) P=0.447 |
|COCH-ARM / FISHERS | P=0.129 P=0.495 (e) P=0.231 |P=0.393 P=0.484 (e) P=0.484 |
|ORDER RESTRICTED | P=0.066 (e) (e) (e) |P=0.227 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Cornea |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/45 (0%) |0/48 (0%) 1/45 (2%) 1/40 (3%) 2/45 (4%) |
|POLY-3 RATE (b) | 0/43.79 0/41.81 0/42.89 0/40.07 |0/45.04 1/42.88 1/38.47 2/39.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.3% 2.6% 5.0% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 1/39 (3%) 1/34 (3%) 2/33 (6%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.108 P=0.481 P=0.453 P=0.182 |
|POLY 3 | (e) (e) (e) (e) |P=0.132 P=0.490 P=0.468 P=0.210 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.139 P=0.491 P=0.469 P=0.217 |
|POLY 6 | (e) (e) (e) (e) |P=0.124 P=0.488 P=0.466 P=0.201 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.481 P=0.453 P=0.182 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.145 P=0.484 P=0.455 P=0.231 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.099 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/47 (0%) 0/48 (0%) 0/45 (0%) |4/48 (8%) 1/45 (2%) 0/40 (0%) 3/45 (7%) |
|POLY-3 RATE (b) | 2/44.24 0/41.81 0/42.89 0/40.07 |4/45.04 1/42.88 0/38.47 3/39.76 |
|POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |8.9% 2.3% 0.0% 7.6% |
|TERMINAL (d) | 1/31 (3%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |4/43 (9%) 1/39 (3%) 0/34 (0%) 3/33 (9%) |
|FIRST INCIDENCE | 597 --- --- --- |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113N P=0.239N P=0.235N P=0.234N |P=0.582 P=0.210N P=0.097N P=0.643N |
|POLY 3 | P=0.115N P=0.250N P=0.244N P=0.259N |P=0.534N P=0.194N P=0.081N P=0.568N |
|POLY 1.5 | P=0.115N P=0.248N P=0.241N P=0.257N |P=0.532N P=0.192N P=0.081N P=0.550N |
|POLY 6 | P=0.115N P=0.250N P=0.246N P=0.261N |P=0.537N P=0.197N P=0.084N P=0.590N |
|LOGISTIC REGRESSION| P=0.113N P=0.215N P=0.219N P=0.224N |P=0.582 P=0.210N (e) P=0.643N |
|COCH-ARM / FISHERS | P=0.119N P=0.253N P=0.247N P=0.264N |P=0.528N P=0.201N P=0.083N P=0.536N |
|ORDER RESTRICTED | P=0.037N* (e) (e) (e) |P=0.175N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia Focal Histiocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 4/50 (8%) 5/50 (10%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.22 0/43.15 0/44.41 0/43.64 |1/46.53 4/45.69 5/43.76 0/44.39 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |2.2% 8.8% 11.4% 0.0% |
|TERMINAL (d) | 1/31 (3%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |1/43 (2%) 4/39 (10%) 5/34 (15%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.303N P=0.482N P=0.488N P=0.494N |P=0.382N P=0.151 P=0.058 P=0.541N |
|POLY 3 | P=0.299N P=0.509N P=0.504N P=0.507N |P=0.320N P=0.173 P=0.088 P=0.509N |
|POLY 1.5 | P=0.301N P=0.507N P=0.502N P=0.505N |P=0.303N P=0.179 P=0.095 P=0.504N |
|POLY 6 | P=0.298N P=0.509N P=0.505N P=0.510N |P=0.345N P=0.167 P=0.079 P=0.517N |
|LOGISTIC REGRESSION| P=0.303N (e) (e) (e) |P=0.382N P=0.151 P=0.058 (e) |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.292N P=0.181 P=0.102 P=0.500N |
|ORDER RESTRICTED | P=0.127N (e) (e) (e) |P=0.092N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.22 0/43.15 2/44.52 0/43.64 |1/46.53 1/45.69 0/43.76 0/44.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% |2.2% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 1/33 (3%) 0/32 (0%) |1/43 (2%) 1/39 (3%) 0/34 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 700 --- |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.581 (e) P=0.244 (e) |P=0.271N P=0.740 P=0.547N P=0.541N |
|POLY 3 | P=0.583 (e) P=0.234 (e) |P=0.242N P=0.756 P=0.512N P=0.509N |
|POLY 1.5 | P=0.588 (e) P=0.235 (e) |P=0.239N P=0.760 P=0.506N P=0.504N |
|POLY 6 | P=0.573 (e) P=0.233 (e) |P=0.246N P=0.752 P=0.521N P=0.517N |
|LOGISTIC REGRESSION| P=0.588 (e) P=0.233 (e) |P=0.271N P=0.740 (e) (e) |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.236N P=0.753N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.244 (e) (e) (e) |P=0.257N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 40/50 (80%) 38/50 (76%) 36/50 (72%) 39/50 (78%) |30/50 (60%) 43/50 (86%) 38/48 (79%) 44/50 (88%) |
|POLY-3 RATE (b) | 40/48.09 38/44.61 36/46.50 39/48.66 |30/47.88 43/48.40 38/43.65 44/47.67 |
|POLY-3 PERCENT (g) | 83.2% 85.2% 77.4% 80.2% |62.7% 88.9% 87.1% 92.3% |
|TERMINAL (d) | 29/31 (94%) 32/34 (94%) 27/33 (82%) 27/32 (84%) |27/43 (63%) 35/39 (90%) 32/33 (97%) 34/35 (97%) |
|FIRST INCIDENCE | 582 547 538 369 |16 421 552 323 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.497N P=0.234N P=0.195N P=0.485N |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.320N P=0.509 P=0.319N P=0.450N |P<0.001 ** P=0.002 ** P=0.005 ** P<0.001 ** |
|POLY 1.5 | P=0.365N P=0.607 P=0.281N P=0.465N |P<0.001 ** P=0.002 ** P=0.010 * P<0.001 ** |
|POLY 6 | P=0.290N P=0.408 P=0.374N P=0.449N |P<0.001 ** P=0.002 ** P=0.002 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.516N P=0.573 P=0.293N P=0.533N |P=0.002 ** P=0.004 ** P=0.018 * P<0.001 ** |
|COCH-ARM / FISHERS | P=0.466N P=0.405N P=0.241N P=0.500N |P=0.004 ** P=0.003 ** P=0.032 * P<0.001 ** |
|ORDER RESTRICTED | P=0.371N (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 2/48 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 1/45.54 3/44.32 1/44.73 4/44.47 |0/46.53 0/45.69 2/42.77 5/44.55 |
|POLY-3 PERCENT (g) | 2.2% 6.8% 2.2% 9.0% |0.0% 0.0% 4.7% 11.2% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 1/32 (3%) |0/43 (0%) 0/39 (0%) 0/33 (0%) 4/35 (11%) |
|FIRST INCIDENCE | 642 593 642 584 |--- --- 635 688 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.164 P=0.278 P=0.751 P=0.171 |P=0.002 ** (e) P=0.220 P=0.020 * |
|POLY 3 | P=0.157 P=0.296 P=0.757 P=0.171 |P=0.002 ** (e) P=0.219 P=0.027 * |
|POLY 1.5 | P=0.160 P=0.296 P=0.758 P=0.174 |P=0.002 ** (e) P=0.223 P=0.029 * |
|POLY 6 | P=0.154 P=0.300 P=0.756 P=0.169 |P=0.002 ** (e) P=0.212 P=0.024 * |
|LOGISTIC REGRESSION| P=0.167 P=0.392 P=0.744N P=0.203 |P=0.003 ** (e) P=0.231 P=0.026 * |
|COCH-ARM / FISHERS | P=0.164 P=0.309 P=0.753N P=0.181 |P=0.003 ** (e) P=0.237 P=0.028 * |
|ORDER RESTRICTED | P=0.105 (e) (e) (e) |P=0.003 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/49 (2%) 0/48 (0%) 0/50 (0%) |0/48 (0%) 0/48 (0%) 2/43 (5%) 0/43 (0%) |
|POLY-3 RATE (b) | 2/44.18 1/42.48 0/42.84 0/43.64 |0/44.67 0/44.39 2/40.28 0/38.77 |
|POLY-3 PERCENT (g) | 4.5% 2.4% 0.0% 0.0% |0.0% 0.0% 5.0% 0.0% |
|TERMINAL (d) | 2/31 (7%) 1/34 (3%) 0/33 (0%) 0/32 (0%) |0/42 (0%) 0/39 (0%) 2/34 (6%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.097N P=0.468N P=0.224N P=0.231N |P=0.544 (e) P=0.193 (e) |
|POLY 3 | P=0.098N P=0.514N P=0.244N P=0.240N |P=0.551 (e) P=0.214 (e) |
|POLY 1.5 | P=0.097N P=0.508N P=0.241N P=0.235N |P=0.563 (e) P=0.216 (e) |
|POLY 6 | P=0.098N P=0.516N P=0.246N P=0.246N |P=0.534 (e) P=0.211 (e) |
|LOGISTIC REGRESSION| P=0.097N P=0.468N (e) (e) |(e) (e) P=0.193 (e) |
|COCH-ARM / FISHERS | P=0.098N P=0.492N P=0.247N P=0.237N |P=0.570 (e) P=0.221 (e) |
|ORDER RESTRICTED | P=0.076N (e) (e) (e) |P=0.228 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/49 (4%) 1/48 (2%) 4/50 (8%) |1/48 (2%) 1/48 (2%) 1/43 (2%) 2/43 (5%) |
|POLY-3 RATE (b) | 0/44.18 2/42.94 1/43.13 4/44.50 |1/44.67 1/44.59 1/40.28 2/38.77 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 2.3% 9.0% |2.2% 2.2% 2.5% 5.2% |
|TERMINAL (d) | 0/31 (0%) 1/34 (3%) 0/33 (0%) 0/32 (0%) |1/42 (2%) 0/39 (0%) 1/34 (3%) 2/33 (6%) |
|FIRST INCIDENCE | --- 593 650 622 |729 (T) 677 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.039 * P=0.242 P=0.486 P=0.056 |P=0.281 P=0.747 P=0.714 P=0.416 |
|POLY 3 | P=0.040 * P=0.231 P=0.495 P=0.061 |P=0.303 P=0.760 P=0.738 P=0.451 |
|POLY 1.5 | P=0.041 * P=0.233 P=0.497 P=0.063 |P=0.310 P=0.759N P=0.739 P=0.459 |
|POLY 6 | P=0.039 * P=0.231 P=0.494 P=0.059 |P=0.294 P=0.758 P=0.734 P=0.439 |
|LOGISTIC REGRESSION| P=0.045 * P=0.263 P=0.528 P=0.078 |P=0.301 P=0.762N P=0.714 P=0.416 |
|COCH-ARM / FISHERS | P=0.043 * P=0.253 P=0.500 P=0.064 |P=0.312 P=0.753N P=0.725 P=0.458 |
|ORDER RESTRICTED | P=0.019 * (e) (e) (e) |P=0.351 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 47/48 (98%) 43/49 (88%) 47/48 (98%) 46/50 (92%) |45/48 (94%) 37/48 (77%) 36/43 (84%) 38/43 (88%) |
|POLY-3 RATE (b) | 47/47.26 43/47.55 47/47.86 46/48.73 |45/45.70 37/45.83 36/41.42 38/40.42 |
|POLY-3 PERCENT (g) | 99.5% 90.4% 98.2% 94.4% |98.5% 80.7% 86.9% 94.0% |
|TERMINAL (d) | 31/31 (100%) 32/34 (94%) 33/33 (100%) 32/32 (100%)|42/42 (100%) 33/39 (85%) 31/34 (91%) 33/33 (100%) |
|FIRST INCIDENCE | 547 275 493 369 |498 434 581 541 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.468 P=0.159N P=0.458N P=0.518N |P=0.183 P=0.125N P=0.525N P=0.322 |
|POLY 3 | P=0.356N P=0.043N* P=0.672N P=0.154N |P=0.551N P=0.004N** P=0.033N* P=0.248N |
|POLY 1.5 | P=0.341N P=0.044N* P=0.709N P=0.157N |P=0.479N P=0.004N** P=0.036N* P=0.189N |
|POLY 6 | P=0.434N P=0.054N P=0.669N P=0.205N |P=0.510 P=0.004N** P=0.033N* P=0.422N |
|LOGISTIC REGRESSION| P=0.386N P=0.102N P=0.706 P=0.302N |P=0.561N P=0.009N** P=0.040N* P=0.318N |
|COCH-ARM / FISHERS | P=0.361N P=0.059N P=0.753N P=0.194N |P=0.484N P=0.020N* P=0.117N P=0.297N |
|ORDER RESTRICTED | P=0.129N (e) (e) (e) |P=0.036N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 3/49 (6%) 2/48 (4%) 2/50 (4%) |3/48 (6%) 0/48 (0%) 2/43 (5%) 1/43 (2%) |
|POLY-3 RATE (b) | 1/44.28 3/42.48 2/43.51 2/43.98 |3/45.35 0/44.39 2/40.56 1/38.77 |
|POLY-3 PERCENT (g) | 2.3% 7.1% 4.6% 4.6% |6.6% 0.0% 4.9% 2.6% |
|TERMINAL (d) | 0/31 (0%) 3/34 (9%) 0/33 (0%) 0/32 (0%) |2/42 (5%) 0/39 (0%) 1/34 (3%) 1/33 (3%) |
|FIRST INCIDENCE | 705 729 (T) 538 666 |498 --- 653 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.480 P=0.329 P=0.495 P=0.459 |P=0.400N P=0.135N P=0.569N P=0.373N |
|POLY 3 | P=0.492 P=0.290 P=0.494 P=0.498 |P=0.387N P=0.123N P=0.551N P=0.363N |
|POLY 1.5 | P=0.501 P=0.296 P=0.496 P=0.504 |P=0.383N P=0.119N P=0.546N P=0.352N |
|POLY 6 | P=0.481 P=0.287 P=0.492 P=0.490 |P=0.393N P=0.126N P=0.558N P=0.378N |
|LOGISTIC REGRESSION| P=0.518 P=0.292 P=0.549 P=0.522 |P=0.389N P=0.129N P=0.579N P=0.351N |
|COCH-ARM / FISHERS | P=0.515 P=0.316 P=0.500 P=0.515 |P=0.379N P=0.121N P=0.553N P=0.351N |
|ORDER RESTRICTED | P=0.383 (e) (e) (e) |P=0.241N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 1/49 (2%) 2/48 (4%) 0/50 (0%) |0/48 (0%) 0/48 (0%) 0/43 (0%) 2/43 (5%) |
|POLY-3 RATE (b) | 1/44.30 1/42.48 2/43.45 0/43.64 |0/44.67 0/44.39 0/40.28 2/39.16 |
|POLY-3 PERCENT (g) | 2.3% 2.4% 4.6% 0.0% |0.0% 0.0% 0.0% 5.1% |
|TERMINAL (d) | 0/31 (0%) 1/34 (3%) 0/33 (0%) 0/32 (0%) |0/42 (0%) 0/39 (0%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 700 729 (T) 642 --- |--- --- --- 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.382N P=0.756N P=0.484 P=0.533N |P=0.042 * (e) (e) P=0.216 |
|POLY 3 | P=0.372N P=0.751 P=0.493 P=0.503N |P=0.038 * (e) (e) P=0.208 |
|POLY 1.5 | P=0.365N P=0.755 P=0.496 P=0.499N |P=0.038 * (e) (e) P=0.212 |
|POLY 6 | P=0.381N P=0.750 P=0.493 P=0.509N |P=0.037 * (e) (e) P=0.203 |
|LOGISTIC REGRESSION| P=0.352N P=0.754 P=0.537 P=0.494N |P=0.038 * (e) (e) P=0.210 |
|COCH-ARM / FISHERS | P=0.357N P=0.747N P=0.500 P=0.490N |P=0.039 * (e) (e) P=0.221 |
|ORDER RESTRICTED | P=0.267N (e) (e) (e) |P=0.021 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 26/50 (52%) 30/50 (60%) 36/50 (72%) |46/50 (92%) 43/50 (86%) 31/48 (65%) 25/50 (50%) |
|POLY-3 RATE (b) | 31/46.54 26/43.76 30/46.16 36/46.55 |46/47.95 43/47.57 31/45.14 25/45.95 |
|POLY-3 PERCENT (g) | 66.6% 59.4% 65.0% 77.3% |95.9% 90.4% 68.7% 54.4% |
|TERMINAL (d) | 27/31 (87%) 24/34 (71%) 26/33 (79%) 30/32 (94%) |42/43 (98%) 37/39 (95%) 27/34 (79%) 20/35 (57%) |
|FIRST INCIDENCE | 464 577 531 369 |302 421 552 538 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.055 P=0.068N P=0.358N P=0.183 |P<0.001N** P=0.499 P=0.078N P=0.002N** |
|POLY 3 | P=0.084 P=0.305N P=0.522N P=0.163 |P<0.001N** P=0.230N P<0.001N** P<0.001N** |
|POLY 1.5 | P=0.090 P=0.280N P=0.515N P=0.181 |P<0.001N** P=0.201N P<0.001N** P<0.001N** |
|POLY 6 | P=0.068 P=0.310N P=0.524N P=0.132 |P<0.001N** P=0.265N P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.057 P=0.291N P=0.564N P=0.135 |P<0.001N** P=0.218N P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P=0.088 P=0.210N P=0.500N P=0.198 |P<0.001N** P=0.262N P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P=0.091 (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 28/50 (56%) 29/50 (58%) 31/50 (62%) |20/50 (40%) 32/50 (64%) 23/48 (48%) 27/50 (54%) |
|POLY-3 RATE (b) | 31/46.03 28/43.26 29/44.52 31/43.93 |20/46.53 32/45.98 23/43.62 27/45.66 |
|POLY-3 PERCENT (g) | 67.4% 64.7% 65.1% 70.6% |43.0% 69.6% 52.7% 59.1% |
|TERMINAL (d) | 27/31 (87%) 27/34 (79%) 28/33 (85%) 30/32 (94%) |20/43 (47%) 31/39 (80%) 23/34 (68%) 25/35 (71%) |
|FIRST INCIDENCE | 667 700 700 653 |729 (T) 653 729 (T) 323 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.450 P=0.126N P=0.237N P=0.560N |P=0.024 * P<0.001 ** P=0.053 P=0.010 * |
|POLY 3 | P=0.379 P=0.484N P=0.500N P=0.457 |P=0.206 P=0.007 ** P=0.235 P=0.085 |
|POLY 1.5 | P=0.426 P=0.440N P=0.462N P=0.511 |P=0.246 P=0.009 ** P=0.274 P=0.106 |
|POLY 6 | P=0.294 P=0.520N P=0.555N P=0.367 |P=0.149 P=0.004 ** P=0.175 P=0.061 |
|LOGISTIC REGRESSION| P=0.176 P=0.380N P=0.458N P=0.275 |P=0.107 P=0.003 ** P=0.053 P=0.069 |
|COCH-ARM / FISHERS | P=0.471 P=0.342N P=0.419N P=0.582N |P=0.259 P=0.014 * P=0.279 P=0.115 |
|ORDER RESTRICTED | P=0.477 (e) (e) (e) |P=0.053 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 0/48 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.22 0/43.15 0/44.41 0/43.64 |2/47.53 2/45.89 0/43.62 1/44.55 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% |4.2% 4.4% 0.0% 2.2% |
|TERMINAL (d) | 2/31 (7%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |1/43 (2%) 1/39 (3%) 0/34 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |16 677 --- 688 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.112N P=0.218N P=0.224N P=0.231N |P=0.339N P=0.671 P=0.268N P=0.540N |
|POLY 3 | P=0.109N P=0.248N P=0.241N P=0.245N |P=0.310N P=0.681 P=0.257N P=0.523N |
|POLY 1.5 | P=0.110N P=0.246N P=0.240N P=0.242N |P=0.305N P=0.686 P=0.251N P=0.513N |
|POLY 6 | P=0.109N P=0.247N P=0.242N P=0.248N |P=0.318N P=0.675 P=0.267N P=0.534N |
|LOGISTIC REGRESSION| P=0.112N (e) (e) (e) |P=0.360N P=0.599 P=0.479N P=0.608N |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.298N P=0.691N P=0.258N P=0.500N |
|ORDER RESTRICTED | P=0.032N* (e) (e) (e) |P=0.282N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 1/50 (2%) 7/50 (14%) |1/50 (2%) 0/50 (0%) 1/48 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 4/45.22 3/43.33 1/44.41 7/45.23 |1/46.53 0/45.69 1/43.62 3/44.55 |
|POLY-3 PERCENT (g) | 8.9% 6.9% 2.3% 15.5% |2.2% 0.0% 2.3% 6.7% |
|TERMINAL (d) | 4/31 (13%) 1/34 (3%) 1/33 (3%) 4/32 (13%) |1/43 (2%) 0/39 (0%) 1/34 (3%) 2/35 (6%) |
|FIRST INCIDENCE | 729 (T) 700 729 (T) 384 |729 (T) --- 729 (T) 688 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.147 P=0.466N P=0.159N P=0.275 |P=0.073 P=0.519N P=0.709 P=0.242 |
|POLY 3 | P=0.150 P=0.523N P=0.184N P=0.260 |P=0.092 P=0.504N P=0.746 P=0.290 |
|POLY 1.5 | P=0.150 P=0.519N P=0.182N P=0.261 |P=0.095 P=0.500N P=0.752 P=0.299 |
|POLY 6 | P=0.148 P=0.521N P=0.185N P=0.260 |P=0.089 P=0.508N P=0.737 P=0.278 |
|LOGISTIC REGRESSION| P=0.149 P=0.517N P=0.159N P=0.285 |P=0.085 (e) P=0.709 P=0.283 |
|COCH-ARM / FISHERS | P=0.148 P=0.500N P=0.181N P=0.262 |P=0.097 P=0.500N P=0.742 P=0.309 |
|ORDER RESTRICTED | P=0.075 (e) (e) (e) |P=0.074 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 7/50 (14%) 12/50 (24%) |1/50 (2%) 2/50 (4%) 5/48 (10%) 11/50 (22%) |
|POLY-3 RATE (b) | 4/45.39 3/43.15 7/44.41 12/43.64 |1/46.53 2/46.03 5/43.62 11/45.81 |
|POLY-3 PERCENT (g) | 8.8% 7.0% 15.8% 27.5% |2.2% 4.3% 11.5% 24.0% |
|TERMINAL (d) | 3/31 (10%) 3/34 (9%) 7/33 (21%) 12/32 (38%) |1/43 (2%) 1/39 (3%) 5/34 (15%) 8/35 (23%) |
|FIRST INCIDENCE | 685 729 (T) 729 (T) 729 (T) |729 (T) 636 729 (T) 538 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.461N P=0.290 P=0.027 * |P<0.001 ** P=0.477 P=0.058 P<0.001 ** |
|POLY 3 | P=0.003 ** P=0.528N P=0.248 P=0.019 * |P<0.001 ** P=0.496 P=0.087 P=0.002 ** |
|POLY 1.5 | P=0.003 ** P=0.521N P=0.254 P=0.022 * |P<0.001 ** P=0.501 P=0.092 P=0.002 ** |
|POLY 6 | P=0.002 ** P=0.529N P=0.242 P=0.016 * |P<0.001 ** P=0.491 P=0.078 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.002 ** P=0.517N P=0.252 P=0.016 * |P<0.001 ** P=0.500 P=0.058 P=0.003 ** |
|COCH-ARM / FISHERS | P=0.004 ** P=0.500N P=0.262 P=0.027 * |P<0.001 ** P=0.500 P=0.093 P=0.002 ** |
|ORDER RESTRICTED | P=0.005 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 5/50 (10%) 4/50 (8%) |5/50 (10%) 4/50 (8%) 6/48 (13%) 11/50 (22%) |
|POLY-3 RATE (b) | 5/47.01 2/43.87 5/45.69 4/43.64 |5/46.53 4/46.23 6/44.57 11/46.66 |
|POLY-3 PERCENT (g) | 10.6% 4.6% 10.9% 9.2% |10.8% 8.7% 13.5% 23.6% |
|TERMINAL (d) | 2/31 (7%) 1/34 (3%) 1/33 (3%) 4/32 (13%) |5/43 (12%) 2/39 (5%) 3/34 (9%) 5/35 (14%) |
|FIRST INCIDENCE | 464 477 531 729 (T) |729 (T) 636 578 368 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.563 P=0.220N P=0.620N P=0.491N |P=0.016 * P=0.550N P=0.368 P=0.052 |
|POLY 3 | P=0.540 P=0.245N P=0.612 P=0.546N |P=0.027 * P=0.504N P=0.470 P=0.084 |
|POLY 1.5 | P=0.554 P=0.237N P=0.618 P=0.529N |P=0.028 * P=0.497N P=0.480 P=0.088 |
|POLY 6 | P=0.521 P=0.250N P=0.609 P=0.567N |P=0.025 * P=0.511N P=0.451 P=0.080 |
|LOGISTIC REGRESSION| P=0.555N P=0.099N P=0.552N P=0.443N |P=0.028 * P=0.503N P=0.473 P=0.087 |
|COCH-ARM / FISHERS | P=0.570 P=0.218N P=0.630N P=0.500N |P=0.027 * P=0.500N P=0.471 P=0.086 |
|ORDER RESTRICTED | P=0.542N (e) (e) (e) |P=0.035 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Histiocytosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 38/50 (76%) 45/50 (90%) 50/50 (100%) 50/50 (100%)|40/50 (80%) 50/50 (100%) 48/48 (100%) 50/50 (100%) |
|POLY-3 RATE (b) | 38/48.44 45/48.87 50/50.00 50/50.00 |40/48.18 50/50.00 48/48.00 50/50.00 |
|POLY-3 PERCENT (g) | 78.5% 92.1% 100.0% 100.0% |83.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 26/31 (84%) 32/34 (94%) 33/33 (100%) 32/32 (100%)|36/43 (84%) 39/39 (100%) 34/34 (100%) 35/35 (100%) |
|FIRST INCIDENCE | 547 275 493 369 |302 421 552 323 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.019 * P=0.238 P=0.050 P=0.029 * |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.044 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P=0.003 ** P=0.002 ** |
|POLY 1.5 | P<0.001 ** P=0.048 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P=0.002 ** P=0.002 ** |
|POLY 6 | P<0.001 ** P=0.041 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.003 ** P=0.004 ** P=0.003 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.046 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P=0.002 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.054 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia Focal Histiocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/48 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/45.22 0/43.15 1/44.41 3/43.93 |0/46.53 0/45.69 0/43.62 2/44.39 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.3% 6.8% |0.0% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 1/31 (3%) 0/34 (0%) 1/33 (3%) 2/32 (6%) |0/43 (0%) 0/39 (0%) 0/34 (0%) 2/35 (6%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 653 |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.093 P=0.482N P=0.748N P=0.304 |P=0.037 * (e) (e) P=0.194 |
|POLY 3 | P=0.096 P=0.509N P=0.757 P=0.295 |P=0.044 * (e) (e) P=0.227 |
|POLY 1.5 | P=0.097 P=0.507N P=0.758 P=0.298 |P=0.045 * (e) (e) P=0.233 |
|POLY 6 | P=0.094 P=0.509N P=0.756 P=0.291 |P=0.043 * (e) (e) P=0.219 |
|LOGISTIC REGRESSION| P=0.091 (e) P=0.748N P=0.291 |(e) (e) (e) P=0.194 |
|COCH-ARM / FISHERS | P=0.097 P=0.500N P=0.753N P=0.309 |P=0.047 * (e) (e) P=0.247 |
|ORDER RESTRICTED | P=0.077 (e) (e) (e) |P=0.026 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 5/50 (10%) 5/50 (10%) 17/50 (34%) |5/50 (10%) 5/50 (10%) 0/48 (0%) 5/50 (10%) |
|POLY-3 RATE (b) | 15/45.69 5/44.09 5/45.02 17/43.89 |5/46.53 5/45.69 0/43.62 5/44.75 |
|POLY-3 PERCENT (g) | 32.8% 11.3% 11.1% 38.7% |10.8% 10.9% 0.0% 11.2% |
|TERMINAL (d) | 13/31 (42%) 4/34 (12%) 4/33 (12%) 16/32 (50%) |5/43 (12%) 5/39 (13%) 0/34 (0%) 4/35 (11%) |
|FIRST INCIDENCE | 667 275 531 663 |729 (T) 729 (T) --- 628 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.148 P=0.007N** P=0.009N** P=0.429 |P=0.546 P=0.568 P=0.057N P=0.509 |
|POLY 3 | P=0.138 P=0.012N* P=0.010N* P=0.357 |P=0.498N P=0.619 P=0.036N* P=0.605 |
|POLY 1.5 | P=0.145 P=0.012N* P=0.010N* P=0.380 |P=0.489N P=0.629 P=0.034N* P=0.620 |
|POLY 6 | P=0.128 P=0.012N* P=0.010N* P=0.328 |P=0.513N P=0.606 P=0.040N* P=0.586 |
|LOGISTIC REGRESSION| P=0.143 P=0.014N* P=0.013N* P=0.304 |P=0.538N P=0.568 (e) P=0.595 |
|COCH-ARM / FISHERS | P=0.159 P=0.011N* P=0.011N* P=0.415 |P=0.485N P=0.630N P=0.031N* P=0.630N |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) |P=0.290N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 32/50 (64%) 31/50 (62%) 36/50 (72%) |17/50 (34%) 28/50 (56%) 34/48 (71%) 35/50 (70%) |
|POLY-3 RATE (b) | 18/45.97 32/46.65 31/46.19 36/46.64 |17/46.88 28/46.16 34/44.85 35/46.23 |
|POLY-3 PERCENT (g) | 39.2% 68.6% 67.1% 77.2% |36.3% 60.7% 75.8% 75.7% |
|TERMINAL (d) | 16/31 (52%) 26/34 (77%) 27/33 (82%) 29/32 (91%) |15/43 (35%) 25/39 (64%) 31/34 (91%) 30/35 (86%) |
|FIRST INCIDENCE | 547 275 531 369 |667 653 552 323 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.010 * P=0.009 ** P<0.001 ** |P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.003 ** P=0.004 ** P<0.001 ** |P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.003 ** P=0.005 ** P<0.001 ** |P<0.001 ** P=0.017 * P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.003 ** P=0.003 ** P<0.001 ** |P<0.001 ** P=0.010 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.003 ** P=0.005 ** P<0.001 ** |P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.004 ** P=0.008 ** P<0.001 ** |P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 7/50 (14%) 11/50 (22%) 27/50 (54%) |10/50 (20%) 7/50 (14%) 6/48 (13%) 18/50 (36%) |
|POLY-3 RATE (b) | 5/45.39 7/43.15 11/45.62 27/44.01 |10/46.88 7/46.03 6/43.62 18/45.06 |
|POLY-3 PERCENT (g) | 11.0% 16.2% 24.1% 61.4% |21.3% 15.2% 13.8% 39.9% |
|TERMINAL (d) | 4/31 (13%) 7/34 (21%) 9/33 (27%) 26/32 (81%) |8/43 (19%) 6/39 (15%) 6/34 (18%) 16/35 (46%) |
|FIRST INCIDENCE | 685 729 (T) 531 628 |667 636 729 (T) 628 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.436 P=0.103 P<0.001 ** |P=0.004 ** P=0.371N P=0.372N P=0.017 * |
|POLY 3 | P<0.001 ** P=0.343 P=0.084 P<0.001 ** |P=0.010 * P=0.311N P=0.253N P=0.041 * |
|POLY 1.5 | P<0.001 ** P=0.352 P=0.084 P<0.001 ** |P=0.012 * P=0.298N P=0.234N P=0.050 |
|POLY 6 | P<0.001 ** P=0.340 P=0.084 P<0.001 ** |P=0.008 ** P=0.328N P=0.287N P=0.032 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.368 P=0.084 P<0.001 ** |P=0.008 ** P=0.308N P=0.286N P=0.038 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.380 P=0.086 P<0.001 ** |P=0.015 * P=0.298N P=0.233N P=0.059 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.004 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Dilatation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 2/48 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.22 2/43.15 2/44.41 2/43.64 |0/46.53 0/45.69 2/43.62 1/44.39 |
|POLY-3 PERCENT (g) | 4.4% 4.6% 4.5% 4.6% |0.0% 0.0% 4.6% 2.3% |
|TERMINAL (d) | 2/31 (7%) 2/34 (6%) 2/33 (6%) 2/32 (6%) |0/43 (0%) 0/39 (0%) 2/34 (6%) 1/35 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.595N P=0.662N P=0.673N P=0.684N |P=0.206 (e) P=0.188 P=0.459 |
|POLY 3 | P=0.585 P=0.677 P=0.688 P=0.681 |P=0.230 (e) P=0.223 P=0.491 |
|POLY 1.5 | P=0.590 P=0.680 P=0.690 P=0.686 |P=0.238 (e) P=0.228 P=0.496 |
|POLY 6 | P=0.577 P=0.678 P=0.686 P=0.676 |P=0.219 (e) P=0.214 P=0.483 |
|LOGISTIC REGRESSION| P=0.595N P=0.662N P=0.673N P=0.684N |(e) (e) P=0.188 P=0.459 |
|COCH-ARM / FISHERS | P=0.596 P=0.691N P=0.691N P=0.691N |P=0.246 (e) P=0.237 P=0.500 |
|ORDER RESTRICTED | P=0.732 (e) (e) (e) |P=0.156 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 48/50 (96%) 49/50 (98%) 42/50 (84%) |31/50 (62%) 38/50 (76%) 43/48 (90%) 35/50 (70%) |
|POLY-3 RATE (b) | 48/49.26 48/48.11 49/49.32 42/47.28 |31/47.70 38/47.85 43/46.49 35/45.98 |
|POLY-3 PERCENT (g) | 97.5% 99.8% 99.4% 88.8% |65.0% 79.4% 92.5% 76.1% |
|TERMINAL (d) | 30/31 (97%) 34/34 (100%) 33/33 (100%) 29/32 (91%) |27/43 (63%) 31/39 (80%) 32/34 (94%) 28/35 (80%) |
|FIRST INCIDENCE | 547 477 493 584 |498 434 578 541 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.182N P=0.420N P=0.532N P=0.214N |P=0.029 * P=0.044 * P<0.001 ** P=0.039 * |
|POLY 3 | P=0.005N** P=0.448 P=0.522 P=0.081N |P=0.119 P=0.085 P<0.001 ** P=0.166 |
|POLY 1.5 | P=0.003N** P=0.492 P=0.518 P=0.061N |P=0.179 P=0.100 P<0.001 ** P=0.216 |
|POLY 6 | P=0.011N* P=0.480 P=0.514 P=0.118N |P=0.068 P=0.071 P<0.001 ** P=0.117 |
|LOGISTIC REGRESSION| P=0.004N** P=0.228 P=0.401 P=0.068N |P=0.174 P=0.091 P<0.001 ** P=0.175 |
|COCH-ARM / FISHERS | P=0.009N** P=0.691N P=0.500 P=0.046N* |P=0.252 P=0.097 P<0.001 ** P=0.263 |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.011 * (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Fatty Change Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 24/50 (48%) 37/50 (74%) 33/50 (66%) |16/50 (32%) 29/50 (58%) 29/48 (60%) 32/50 (64%) |
|POLY-3 RATE (b) | 21/46.34 24/44.48 37/47.38 33/44.41 |16/47.02 29/46.59 29/44.57 32/46.13 |
|POLY-3 PERCENT (g) | 45.3% 54.0% 78.1% 74.3% |34.0% 62.2% 65.1% 69.4% |
|TERMINAL (d) | 17/31 (55%) 21/34 (62%) 29/33 (88%) 31/32 (97%) |13/43 (30%) 25/39 (64%) 25/34 (74%) 26/35 (74%) |
|FIRST INCIDENCE | 547 477 531 584 |667 636 578 323 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.465 P=0.003 ** P=0.006 ** |P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.267 P<0.001 ** P=0.003 ** |P<0.001 ** P=0.004 ** P=0.002 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.285 P<0.001 ** P=0.005 ** |P=0.002 ** P=0.006 ** P=0.003 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.259 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.260 P<0.001 ** P=0.002 ** |P<0.001 ** P=0.005 ** P=0.002 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.004 ** P=0.344 P<0.001 ** P=0.013 * |P=0.003 ** P=0.008 ** P=0.004 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/48 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.22 2/43.87 1/44.87 0/43.64 |1/46.53 0/45.69 0/43.62 1/44.66 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 2.2% 0.0% |2.2% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/31 (0%) 1/34 (3%) 0/33 (0%) 0/32 (0%) |1/43 (2%) 0/39 (0%) 0/34 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- 477 594 --- |729 (T) --- --- 654 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.457N P=0.248 P=0.500 (e) |P=0.563 P=0.519N P=0.547N P=0.727 |
|POLY 3 | P=0.474N P=0.230 P=0.498 (e) |P=0.589 P=0.504N P=0.513N P=0.751 |
|POLY 1.5 | P=0.470N P=0.231 P=0.499 (e) |P=0.591 P=0.500N P=0.508N P=0.757 |
|POLY 6 | P=0.479N P=0.232 P=0.499 (e) |P=0.585 P=0.508N P=0.521N P=0.744 |
|LOGISTIC REGRESSION| P=0.453N P=0.302 P=0.534 (e) |P=0.594 (e) (e) P=0.762N |
|COCH-ARM / FISHERS | P=0.461N P=0.247 P=0.500 (e) |P=0.594 P=0.500N P=0.510N P=0.753N |
|ORDER RESTRICTED | P=0.322 (e) (e) (e) |P=0.392 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 14/50 (28%) 12/50 (24%) 18/50 (36%) |6/50 (12%) 12/50 (24%) 17/48 (35%) 11/50 (22%) |
|POLY-3 RATE (b) | 11/47.28 14/45.41 12/47.92 18/49.09 |6/48.46 12/49.35 17/45.92 11/46.90 |
|POLY-3 PERCENT (g) | 23.3% 30.8% 25.0% 36.7% |12.4% 24.3% 37.0% 23.5% |
|TERMINAL (d) | 1/31 (3%) 6/34 (18%) 2/33 (6%) 3/32 (9%) |4/43 (9%) 4/39 (10%) 8/34 (24%) 4/35 (11%) |
|FIRST INCIDENCE | 464 567 493 369 |16 421 581 538 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095 P=0.333 P=0.488 P=0.098 |P=0.114 P=0.095 P=0.005 ** P=0.107 |
|POLY 3 | P=0.112 P=0.279 P=0.515 P=0.112 |P=0.127 P=0.103 P=0.004 ** P=0.126 |
|POLY 1.5 | P=0.102 P=0.286 P=0.508 P=0.103 |P=0.136 P=0.100 P=0.005 ** P=0.130 |
|POLY 6 | P=0.126 P=0.284 P=0.524 P=0.125 |P=0.121 P=0.106 P=0.004 ** P=0.123 |
|LOGISTIC REGRESSION| P=0.095 P=0.359 P=0.591 P=0.135 |P=0.208 P=0.096 P=0.004 ** P=0.144 |
|COCH-ARM / FISHERS | P=0.086 P=0.322 P=0.500 P=0.093 |P=0.165 P=0.096 P=0.006 ** P=0.143 |
|ORDER RESTRICTED | P=0.108 (e) (e) (e) |P=0.027 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte, Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/48 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.22 0/43.15 0/44.41 0/43.64 |2/47.53 0/45.69 1/43.95 1/44.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.2% 0.0% 2.3% 2.3% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |1/43 (2%) 0/39 (0%) 0/34 (0%) 1/35 (3%) |
|FIRST INCIDENCE | --- --- --- --- |16 --- 638 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.535N P=0.250N P=0.543N P=0.548N |
|POLY 3 | (e) (e) (e) (e) |P=0.506N P=0.246N P=0.527N P=0.524N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.504N P=0.242N P=0.520N P=0.514N |
|POLY 6 | (e) (e) (e) (e) |P=0.510N P=0.251N P=0.540N P=0.537N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.601N P=0.403N P=0.763N P=0.599N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.501N P=0.247N P=0.515N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.297N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/48 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.22 0/43.15 0/44.41 0/43.64 |1/46.53 0/45.69 0/43.62 2/44.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |1/43 (2%) 0/39 (0%) 0/34 (0%) 2/35 (6%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.206 P=0.519N P=0.547N P=0.428 |
|POLY 3 | (e) (e) (e) (e) |P=0.241 P=0.504N P=0.513N P=0.484 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.243 P=0.500N P=0.508N P=0.493 |
|POLY 6 | (e) (e) (e) (e) |P=0.237 P=0.508N P=0.521N P=0.471 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.206 (e) (e) P=0.428 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.246 P=0.500N P=0.510N P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.122 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 5/50 (10%) 3/50 (6%) 5/50 (10%) |
|POLY-3 RATE (b) | 4/46.19 1/43.15 0/44.41 2/44.09 |1/46.53 5/46.93 3/45.74 5/45.79 |
|POLY-3 PERCENT (g) | 8.7% 2.3% 0.0% 4.5% |2.2% 10.7% 6.6% 10.9% |
|TERMINAL (d) | 2/31 (7%) 1/34 (3%) 0/33 (0%) 0/32 (0%) |1/43 (2%) 2/39 (5%) 0/34 (0%) 1/35 (3%) |
|FIRST INCIDENCE | 464 729 (T) --- 651 |729 (T) 421 383 323 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.297N P=0.175N P=0.065N P=0.368N |P=0.126 P=0.098 P=0.292 P=0.082 |
|POLY 3 | P=0.274N P=0.200N P=0.065N P=0.359N |P=0.143 P=0.104 P=0.299 P=0.098 |
|POLY 1.5 | P=0.274N P=0.194N P=0.064N P=0.352N |P=0.151 P=0.105 P=0.304 P=0.102 |
|POLY 6 | P=0.275N P=0.203N P=0.067N P=0.366N |P=0.133 P=0.101 P=0.289 P=0.092 |
|LOGISTIC REGRESSION| P=0.272N P=0.147N P=0.049N* P=0.278N |P=0.138 P=0.091 P=0.296 P=0.095 |
|COCH-ARM / FISHERS | P=0.279N P=0.181N P=0.059N P=0.339N |P=0.151 P=0.102 P=0.309 P=0.102 |
|ORDER RESTRICTED | P=0.086N (e) (e) (e) |P=0.084 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/46.45 1/43.53 3/45.52 0/43.64 |1/47.21 0/45.69 2/45.18 2/45.90 |
|POLY-3 PERCENT (g) | 8.6% 2.3% 6.6% 0.0% |2.1% 0.0% 4.4% 4.4% |
|TERMINAL (d) | 2/31 (7%) 0/34 (0%) 1/33 (3%) 0/32 (0%) |0/43 (0%) 0/39 (0%) 0/34 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 464 621 498 --- |498 --- 383 323 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.073N P=0.187N P=0.489N P=0.065N |P=0.249 P=0.504N P=0.502 P=0.507 |
|POLY 3 | P=0.074N P=0.199N P=0.511N P=0.069N |P=0.242 P=0.507N P=0.485 P=0.490 |
|POLY 1.5 | P=0.072N P=0.194N P=0.507N P=0.066N |P=0.246 P=0.502N P=0.493 P=0.498 |
|POLY 6 | P=0.078N P=0.200N P=0.513N P=0.072N |P=0.234 P=0.511N P=0.471 P=0.479 |
|LOGISTIC REGRESSION| P=0.061N P=0.103N P=0.410N P=0.032N* |P=0.160 P=0.595N P=0.482 P=0.376 |
|COCH-ARM / FISHERS | P=0.072N P=0.181N P=0.500N P=0.059N |P=0.245 P=0.500N P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.032N* (e) (e) (e) |P=0.257 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia Focal Histiocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.22 0/43.15 0/44.41 0/43.64 |0/46.53 1/45.69 0/43.76 2/44.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 0.0% 4.5% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 1/39 (3%) 0/34 (0%) 1/35 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) --- 712 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.116 P=0.481 (e) P=0.202 |
|POLY 3 | (e) (e) (e) (e) |P=0.132 P=0.496 (e) P=0.227 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.136 P=0.500 (e) P=0.233 |
|POLY 6 | (e) (e) (e) (e) |P=0.127 P=0.492 (e) P=0.220 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.125 P=0.481 (e) P=0.221 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.140 P=0.500 (e) P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.068 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/45.45 0/43.15 1/45.02 2/45.37 |3/46.53 1/46.50 0/43.76 1/45.30 |
|POLY-3 PERCENT (g) | 6.6% 0.0% 2.2% 4.4% |6.5% 2.2% 0.0% 2.2% |
|TERMINAL (d) | 2/31 (7%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |3/43 (7%) 0/39 (0%) 0/34 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 667 --- 531 369 |729 (T) 421 --- 323 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.564N P=0.118N P=0.307N P=0.512N |P=0.232N P=0.329N P=0.166N P=0.359N |
|POLY 3 | P=0.544N P=0.128N P=0.309N P=0.501N |P=0.205N P=0.306N P=0.130N P=0.315N |
|POLY 1.5 | P=0.546N P=0.126N P=0.307N P=0.499N |P=0.203N P=0.302N P=0.124N P=0.307N |
|POLY 6 | P=0.545N P=0.129N P=0.309N P=0.506N |P=0.209N P=0.311N P=0.139N P=0.327N |
|LOGISTIC REGRESSION| P=0.542N P=0.127N P=0.282N P=0.318N |P=0.213N P=0.323N (e) P=0.318N |
|COCH-ARM / FISHERS | P=0.556N P=0.121N P=0.309N P=0.500N |P=0.200N P=0.309N P=0.121N P=0.309N |
|ORDER RESTRICTED | P=0.191N (e) (e) (e) |P=0.089N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 2/50 (4%) |25/50 (50%) 40/50 (80%) 39/50 (78%) 43/50 (86%) |
|POLY-3 RATE (b) | 3/45.22 3/43.68 4/45.09 2/43.93 |25/46.78 40/47.33 39/46.64 43/46.98 |
|POLY-3 PERCENT (g) | 6.6% 6.9% 8.9% 4.6% |53.4% 84.5% 83.6% 91.5% |
|TERMINAL (d) | 3/31 (10%) 2/34 (6%) 3/33 (9%) 1/32 (3%) |23/43 (54%) 34/39 (87%) 30/34 (88%) 33/35 (94%) |
|FIRST INCIDENCE | 729 (T) 567 498 651 |694 421 555 541 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.420N P=0.632N P=0.529 P=0.497N |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.431N P=0.646 P=0.498 P=0.513N |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.426N P=0.648 P=0.499 P=0.509N |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.438N P=0.650 P=0.499 P=0.518N |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.419N P=0.650 P=0.502 P=0.521N |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.420N P=0.661N P=0.500 P=0.500N |P<0.001 ** P=0.002 ** P=0.003 ** P<0.001 ** |
|ORDER RESTRICTED | P=0.462N (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 0/50 (0%) |4/50 (8%) 3/50 (6%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/45.22 4/43.72 3/44.41 0/43.64 |4/46.53 3/45.69 0/43.76 2/44.39 |
|POLY-3 PERCENT (g) | 4.4% 9.2% 6.8% 0.0% |8.6% 6.6% 0.0% 4.5% |
|TERMINAL (d) | 2/31 (7%) 3/34 (9%) 3/33 (9%) 0/32 (0%) |4/43 (9%) 3/39 (8%) 0/34 (0%) 2/35 (6%) |
|FIRST INCIDENCE | 729 (T) 547 729 (T) --- |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.133N P=0.368 P=0.529 P=0.231N |P=0.264N P=0.553N P=0.097N P=0.435N |
|POLY 3 | P=0.146N P=0.322 P=0.492 P=0.245N |P=0.204N P=0.510N P=0.068N P=0.359N |
|POLY 1.5 | P=0.142N P=0.324 P=0.495 P=0.242N |P=0.198N P=0.501N P=0.064N P=0.346N |
|POLY 6 | P=0.151N P=0.324 P=0.489 P=0.248N |P=0.212N P=0.521N P=0.075N P=0.376N |
|LOGISTIC REGRESSION| P=0.142N P=0.327 P=0.529 (e) |P=0.264N P=0.553N (e) P=0.435N |
|COCH-ARM / FISHERS | P=0.137N P=0.339 P=0.500 P=0.247N |P=0.194N P=0.500N P=0.059N P=0.339N |
|ORDER RESTRICTED | P=0.111N (e) (e) (e) |P=0.127N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/48 (2%) 0/48 (0%) 0/49 (0%) |0/49 (0%) 0/49 (0%) 2/49 (4%) 0/47 (0%) |
|POLY-3 RATE (b) | 1/45.67 1/42.81 0/43.18 0/43.07 |0/45.67 0/45.30 2/43.76 0/41.44 |
|POLY-3 PERCENT (g) | 2.2% 2.3% 0.0% 0.0% |0.0% 0.0% 4.6% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 0/39 (0%) 2/34 (6%) 0/33 (0%) |
|FIRST INCIDENCE | 597 275 --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236N P=0.748 P=0.509N P=0.500N |P=0.540 (e) P=0.188 (e) |
|POLY 3 | P=0.242N P=0.746 P=0.511N P=0.512N |P=0.560 (e) P=0.228 (e) |
|POLY 1.5 | P=0.241N P=0.747 P=0.510N P=0.509N |P=0.574 (e) P=0.235 (e) |
|POLY 6 | P=0.242N P=0.748 P=0.512N P=0.515N |P=0.542 (e) P=0.218 (e) |
|LOGISTIC REGRESSION| P=0.211N P=0.476N P=0.480N P=0.431N |(e) (e) P=0.188 (e) |
|COCH-ARM / FISHERS | P=0.239N P=0.742 P=0.510N P=0.505N |P=0.587 (e) P=0.247 (e) |
|ORDER RESTRICTED | P=0.250N (e) (e) (e) |P=0.240 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/48 (2%) 0/48 (0%) 2/49 (4%) |7/49 (14%) 0/49 (0%) 1/49 (2%) 2/47 (4%) |
|POLY-3 RATE (b) | 2/45.77 1/41.98 0/43.18 2/43.43 |7/46.35 0/45.30 1/43.76 2/41.44 |
|POLY-3 PERCENT (g) | 4.4% 2.4% 0.0% 4.6% |15.1% 0.0% 2.3% 4.8% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 1/32 (3%) |6/43 (14%) 0/39 (0%) 1/34 (3%) 2/33 (6%) |
|FIRST INCIDENCE | 642 700 --- 628 |498 --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.568 P=0.531N P=0.256N P=0.670 |P=0.125N P=0.014N* P=0.062N P=0.151N |
|POLY 3 | P=0.584 P=0.530N P=0.250N P=0.675 |P=0.081N P=0.008N** P=0.036N* P=0.108N |
|POLY 1.5 | P=0.586 P=0.527N P=0.249N P=0.679 |P=0.080N P=0.008N** P=0.032N* P=0.098N |
|POLY 6 | P=0.580 P=0.529N P=0.251N P=0.670 |P=0.083N P=0.009N** P=0.043N* P=0.123N |
|LOGISTIC REGRESSION| P=0.591 P=0.490N P=0.232N P=0.676N |P=0.085N P=0.009N** P=0.033N* P=0.093N |
|COCH-ARM / FISHERS | P=0.587 P=0.515N P=0.258N P=0.684 |P=0.083N P=0.006N** P=0.030N* P=0.090N |
|ORDER RESTRICTED | P=0.403 (e) (e) (e) |P=0.005N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Deep Cervical |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/19 (0%) 0/18 (0%) 0/26 (0%) 0/27 (0%) |3/24 (13%) 0/11 (0%) 0/24 (0%) 0/35 (0%) |
|POLY-3 RATE (b) | 0/15.75 0/14.68 0/21.00 0/22.83 |3/21.83 0/8.51 0/20.74 0/30.55 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |13.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/4 (0%) 0/8 (0%) 0/12 (0%) 0/13 (0%) |3/20 (15%) 0/4 (0%) 0/12 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.041N* P=0.500N P=0.220N P=0.095N |
|POLY 3 | (e) (e) (e) (e) |P=0.020N* P=0.329N P=0.121N P=0.061N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.021N* P=0.305N P=0.113N P=0.057N |
|POLY 6 | (e) (e) (e) (e) |P=0.019N* P=0.362N P=0.137N P=0.066N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.041N* (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.026N* P=0.309N P=0.117N P=0.062N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.002N** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/19 (11%) 2/18 (11%) 0/26 (0%) 3/27 (11%) |3/24 (13%) 1/11 (9%) 0/24 (0%) 1/35 (3%) |
|POLY-3 RATE (b) | 2/16.37 2/15.25 0/21.00 3/22.83 |3/21.83 1/8.51 0/20.74 1/30.55 |
|POLY-3 PERCENT (g) | 12.2% 13.1% 0.0% 13.1% |13.7% 11.8% 0.0% 3.3% |
|TERMINAL (d) | 0/4 (0%) 1/8 (13%) 0/12 (0%) 3/13 (23%) |3/20 (15%) 1/4 (25%) 0/12 (0%) 1/23 (4%) |
|FIRST INCIDENCE | 597 547 --- 729 (T) |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.577N P=0.652N P=0.248N P=0.596N |P=0.132N P=0.595 P=0.220N P=0.253N |
|POLY 3 | P=0.583 P=0.674 P=0.176N P=0.654 |P=0.094N P=0.665N P=0.121N P=0.188N |
|POLY 1.5 | P=0.587 P=0.670 P=0.173N P=0.657 |P=0.094N P=0.636N P=0.113N P=0.179N |
|POLY 6 | P=0.575 P=0.686 P=0.179N P=0.648 |P=0.097N P=0.700N P=0.137N P=0.202N |
|LOGISTIC REGRESSION| P=0.589 P=0.690N P=0.139N P=0.671 |P=0.132N P=0.595 (e) P=0.253N |
|COCH-ARM / FISHERS | P=0.588 P=0.677 P=0.173N P=0.698N |P=0.096N P=0.628N P=0.117N P=0.179N |
|ORDER RESTRICTED | P=0.426N (e) (e) (e) |P=0.035N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/19 (16%) 2/18 (11%) 2/26 (8%) 3/27 (11%) |5/24 (21%) 3/11 (27%) 5/24 (21%) 3/35 (9%) |
|POLY-3 RATE (b) | 3/16.67 2/14.68 2/21.07 3/23.12 |5/22.95 3/8.79 5/21.00 3/30.60 |
|POLY-3 PERCENT (g) | 18.0% 13.6% 9.5% 13.0% |21.8% 34.1% 23.8% 9.8% |
|TERMINAL (d) | 0/4 (0%) 2/8 (25%) 1/12 (8%) 2/13 (15%) |3/20 (15%) 2/4 (50%) 3/12 (25%) 2/23 (9%) |
|FIRST INCIDENCE | 547 729 (T) 712 651 |16 653 693 717 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.423N P=0.392N P=0.421N P=0.527N |P=0.237N P=0.438 P=0.400 P=0.332N |
|POLY 3 | P=0.429N P=0.560N P=0.389N P=0.505N |P=0.114N P=0.403 P=0.578 P=0.202N |
|POLY 1.5 | P=0.428N P=0.552N P=0.377N P=0.499N |P=0.103N P=0.443 P=0.607 P=0.187N |
|POLY 6 | P=0.436N P=0.564N P=0.399N P=0.515N |P=0.131N P=0.356 P=0.527 P=0.224N |
|LOGISTIC REGRESSION| P=0.420N P=0.528N P=0.350N P=0.510N |P=0.094N P=0.537 P=0.611 P=0.185N |
|COCH-ARM / FISHERS | P=0.431N P=0.527N P=0.350N P=0.484N |P=0.091N P=0.492 P=0.638N P=0.167N |
|ORDER RESTRICTED | P=0.429N (e) (e) (e) |P=0.086N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/19 (32%) 3/18 (17%) 4/26 (15%) 4/27 (15%) |4/24 (17%) 1/11 (9%) 2/24 (8%) 6/35 (17%) |
|POLY-3 RATE (b) | 6/16.88 3/15.74 4/21.43 4/22.83 |4/21.83 1/8.78 2/21.23 6/30.92 |
|POLY-3 PERCENT (g) | 35.6% 19.1% 18.7% 17.5% |18.3% 11.4% 9.4% 19.4% |
|TERMINAL (d) | 3/4 (75%) 1/8 (13%) 3/12 (25%) 4/13 (31%) |4/20 (20%) 0/4 (0%) 1/12 (8%) 5/23 (22%) |
|FIRST INCIDENCE | 547 275 605 729 (T) |729 (T) 657 581 628 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.087N P=0.125N P=0.070N P=0.032N* |P=0.328 P=0.656N P=0.548N P=0.447 |
|POLY 3 | P=0.167N P=0.253N P=0.205N P=0.173N |P=0.467 P=0.527N P=0.345N P=0.601 |
|POLY 1.5 | P=0.161N P=0.255N P=0.195N P=0.167N |P=0.474 P=0.498N P=0.328N P=0.619 |
|POLY 6 | P=0.178N P=0.245N P=0.210N P=0.185N |P=0.455 P=0.561N P=0.376N P=0.576 |
|LOGISTIC REGRESSION| P=0.158N P=0.197N P=0.184N P=0.148N |P=0.462 P=0.560N P=0.337N P=0.568 |
|COCH-ARM / FISHERS | P=0.156N P=0.252N P=0.177N P=0.160N |P=0.465 P=0.491N P=0.333N P=0.650N |
|ORDER RESTRICTED | P=0.136N (e) (e) (e) |P=0.416 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/19 (0%) 1/18 (6%) 3/26 (12%) 1/27 (4%) |1/24 (4%) 0/11 (0%) 2/24 (8%) 2/35 (6%) |
|POLY-3 RATE (b) | 0/15.75 1/15.14 3/21.36 1/22.83 |1/22.83 0/8.51 2/20.74 2/30.55 |
|POLY-3 PERCENT (g) | 0.0% 6.6% 14.1% 4.4% |4.4% 0.0% 9.6% 6.6% |
|TERMINAL (d) | 0/4 (0%) 0/8 (0%) 1/12 (8%) 1/13 (8%) |0/20 (0%) 0/4 (0%) 2/12 (17%) 2/23 (9%) |
|FIRST INCIDENCE | --- 593 650 729 (T) |16 --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.471 P=0.487 P=0.179 P=0.734 |P=0.380 P=0.496N P=0.383 P=0.532 |
|POLY 3 | P=0.497 P=0.492 P=0.170 P=0.574 |P=0.436 P=0.687N P=0.466 P=0.602 |
|POLY 1.5 | P=0.494 P=0.487 P=0.171 P=0.572 |P=0.445 P=0.674N P=0.483 P=0.614 |
|POLY 6 | P=0.498 P=0.504 P=0.176 P=0.577 |P=0.423 P=0.702N P=0.437 P=0.586 |
|LOGISTIC REGRESSION| P=0.490 P=0.555 P=0.172 P=0.734 |P=0.354 (e) P=0.324 P=0.495 |
|COCH-ARM / FISHERS | P=0.486 P=0.486 P=0.183 P=0.587 |P=0.453 P=0.686N P=0.500 P=0.641 |
|ORDER RESTRICTED | P=0.217 (e) (e) (e) |P=0.351 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/19 (11%) 0/18 (0%) 1/26 (4%) 4/27 (15%) |7/24 (29%) 1/11 (9%) 7/24 (29%) 7/35 (20%) |
|POLY-3 RATE (b) | 2/16.15 0/14.68 1/21.61 4/22.83 |7/21.83 1/8.62 7/21.56 7/31.19 |
|POLY-3 PERCENT (g) | 12.4% 0.0% 4.6% 17.5% |32.1% 11.6% 32.5% 22.4% |
|TERMINAL (d) | 0/4 (0%) 0/8 (0%) 0/12 (0%) 4/13 (31%) |7/20 (35%) 0/4 (0%) 5/12 (42%) 5/23 (22%) |
|FIRST INCIDENCE | 667 --- 531 729 (T) |729 (T) 700 581 628 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223 P=0.253N P=0.517N P=0.678 |P=0.551N P=0.437N P=0.247 P=0.527N |
|POLY 3 | P=0.206 P=0.254N P=0.397N P=0.505 |P=0.329N P=0.249N P=0.616 P=0.321N |
|POLY 1.5 | P=0.208 P=0.253N P=0.395N P=0.507 |P=0.327N P=0.216N P=0.611N P=0.304N |
|POLY 6 | P=0.199 P=0.249N P=0.394N P=0.498 |P=0.333N P=0.295N P=0.570 P=0.344N |
|LOGISTIC REGRESSION| P=0.209 P=0.246N P=0.318N P=0.540 |P=0.361N P=0.393N P=0.574 P=0.351N |
|COCH-ARM / FISHERS | P=0.204 P=0.257N P=0.382N P=0.516 |P=0.349N P=0.193N P=0.624N P=0.306N |
|ORDER RESTRICTED | P=0.165 (e) (e) (e) |P=0.309N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/47 (26%) 7/46 (15%) 1/41 (2%) 2/45 (4%) |37/50 (74%) 16/49 (33%) 8/50 (16%) 1/50 (2%) |
|POLY-3 RATE (b) | 12/44.09 7/41.81 1/36.55 2/39.96 |37/47.39 16/46.48 8/44.35 1/44.44 |
|POLY-3 PERCENT (g) | 27.2% 16.7% 2.7% 5.0% |78.1% 34.4% 18.0% 2.3% |
|TERMINAL (d) | 6/30 (20%) 4/32 (13%) 1/27 (4%) 1/30 (3%) |33/43 (77%) 11/39 (28%) 5/34 (15%) 0/35 (0%) |
|FIRST INCIDENCE | 464 477 729 (T) 663 |624 636 638 717 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002N** P=0.159N P=0.003N** P=0.009N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P=0.181N P=0.003N** P=0.006N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.178N P=0.002N** P=0.005N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P=0.181N P=0.003N** P=0.006N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.145N P=0.003N** P=0.006N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.165N P=0.002N** P=0.005N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/46 (0%) 0/41 (0%) 0/45 (0%) |6/50 (12%) 3/49 (6%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/42.88 0/40.47 0/36.55 0/39.72 |6/46.67 3/45.30 3/44.15 1/44.70 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |12.9% 6.6% 6.8% 2.2% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/27 (0%) 0/30 (0%) |5/43 (12%) 3/39 (8%) 2/34 (6%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- --- --- |694 729 (T) 619 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.076N P=0.292N P=0.358N P=0.095N |
|POLY 3 | (e) (e) (e) (e) |P=0.049N* P=0.257N P=0.270N P=0.063N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.046N* P=0.251N P=0.256N P=0.059N |
|POLY 6 | (e) (e) (e) (e) |P=0.053N P=0.266N P=0.292N P=0.069N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.048N* P=0.264N P=0.263N P=0.062N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.044N* P=0.254N P=0.243N P=0.056N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.033N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/13 (69%) 4/10 (40%) 6/11 (55%) 5/10 (50%) |8/9 (89%) 3/7 (43%) 0/11 (0%) 1/8 (13%) |
|POLY-3 RATE (b) | 9/12.86 4/8.81 6/9.38 5/8.70 |8/8.32 3/5.27 0/9.00 1/5.29 |
|POLY-3 PERCENT (g) | 70.0% 45.4% 64.0% 57.5% |96.2% 57.0% 0.0% 18.9% |
|TERMINAL (d) | 5/7 (71%) 3/5 (60%) 3/3 (100%) 4/5 (80%) |6/6 (100%) 3/4 (75%) 0/4 (0%) 1/2 (50%) |
|FIRST INCIDENCE | 582 477 653 670 |694 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.380N P=0.186N P=0.597 P=0.321N |P=0.010N* P=0.108N P=0.004N** P=0.078N |
|POLY 3 | P=0.423N P=0.241N P=0.563N P=0.445N |P<0.001N** P=0.096N P<0.001N** P<0.001N** |
|POLY 1.5 | P=0.371N P=0.204N P=0.480N P=0.378N |P<0.001N** P=0.073N P<0.001N** P<0.001N** |
|POLY 6 | P=0.525N P=0.301N P=0.676N P=0.563N |P<0.001N** P=0.143N P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.352N P=0.145N P=0.476N P=0.347N |P=0.003N** P=0.140N P<0.001N** P=0.030N* |
|COCH-ARM / FISHERS | P=0.321N P=0.164N P=0.375N P=0.306N |P<0.001N** P=0.077N P<0.001N** P=0.003N** |
|ORDER RESTRICTED | P=0.393N (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.19 0/43.15 1/44.87 1/43.64 |0/45.90 2/45.69 0/43.76 0/44.39 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.2% 2.3% |0.0% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 1/32 (3%) |0/43 (0%) 2/39 (5%) 0/34 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 464 --- 594 729 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.542 P=0.508N P=0.760 P=0.759 |P=0.448N P=0.217 (e) (e) |
|POLY 3 | P=0.536 P=0.509N P=0.759 P=0.753 |P=0.418N P=0.236 (e) (e) |
|POLY 1.5 | P=0.540 P=0.506N P=0.760N P=0.757 |P=0.408N P=0.241 (e) (e) |
|POLY 6 | P=0.530 P=0.511N P=0.758 P=0.748 |P=0.432N P=0.231 (e) (e) |
|LOGISTIC REGRESSION| P=0.552 P=0.251N P=0.728N P=0.689N |(e) P=0.217 (e) (e) |
|COCH-ARM / FISHERS | P=0.543 P=0.495N P=0.747N P=0.747N |P=0.402N P=0.253 (e) (e) |
|ORDER RESTRICTED | P=0.529 (e) (e) (e) |P=0.253N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 4/50 (8%) 2/50 (4%) |0/49 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.51 1/43.15 4/45.01 2/43.64 |0/45.90 3/45.79 1/43.76 0/44.39 |
|POLY-3 PERCENT (g) | 4.4% 2.3% 8.9% 4.6% |0.0% 6.6% 2.3% 0.0% |
|TERMINAL (d) | 0/31 (0%) 1/34 (3%) 2/33 (6%) 2/32 (6%) |0/43 (0%) 2/39 (5%) 1/34 (3%) 0/35 (0%) |
|FIRST INCIDENCE | 464 729 (T) 594 729 (T) |--- 705 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.470 P=0.508N P=0.347 P=0.688 |P=0.422N P=0.109 P=0.453 (e) |
|POLY 3 | P=0.462 P=0.519N P=0.332 P=0.679 |P=0.386N P=0.118 P=0.490 (e) |
|POLY 1.5 | P=0.472 P=0.511N P=0.338 P=0.687 |P=0.371N P=0.122 P=0.497 (e) |
|POLY 6 | P=0.446 P=0.523N P=0.327 P=0.668 |P=0.406N P=0.114 P=0.481 (e) |
|LOGISTIC REGRESSION| P=0.491 P=0.382N P=0.392 P=0.629N |P=0.393N P=0.118 P=0.453 (e) |
|COCH-ARM / FISHERS | P=0.484 P=0.492N P=0.349 P=0.684N |P=0.362N P=0.125 P=0.505 (e) |
|ORDER RESTRICTED | P=0.371 (e) (e) (e) |P=0.227N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 4/50 (8%) |2/49 (4%) 5/50 (10%) 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 0/44.45 0/43.15 0/44.41 4/43.89 |2/45.90 5/45.69 4/43.76 5/44.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 9.1% |4.4% 10.9% 9.1% 11.3% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 3/32 (9%) |2/43 (5%) 5/39 (13%) 4/34 (12%) 5/35 (14%) |
|FIRST INCIDENCE | --- --- --- 663 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** (e) (e) P=0.063 |P=0.150 P=0.179 P=0.235 P=0.141 |
|POLY 3 | P=0.003 ** (e) (e) P=0.058 |P=0.217 P=0.214 P=0.315 P=0.203 |
|POLY 1.5 | P=0.003 ** (e) (e) P=0.060 |P=0.234 P=0.223 P=0.331 P=0.215 |
|POLY 6 | P=0.003 ** (e) (e) P=0.056 |P=0.195 P=0.204 P=0.293 P=0.187 |
|LOGISTIC REGRESSION| P=0.003 ** (e) (e) P=0.059 |P=0.150 P=0.179 P=0.235 P=0.141 |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) P=0.061 |P=0.248 P=0.226 P=0.349 P=0.226 |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) |P=0.195 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 0/48 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/46.53 0/45.69 0/43.10 2/44.70 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 0.0% 4.5% |
|TERMINAL (d) | |0/43 (0%) 0/39 (0%) 0/34 (0%) 1/35 (3%) |
|FIRST INCIDENCE | |--- --- --- 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.042 * (e) (e) P=0.213 |
|POLY 3 | |P=0.044 * (e) (e) P=0.228 |
|POLY 1.5 | |P=0.045 * (e) (e) P=0.234 |
|POLY 6 | |P=0.043 * (e) (e) P=0.222 |
|LOGISTIC REGRESSION| |P=0.047 * (e) (e) P=0.238 |
|COCH-ARM / FISHERS | |P=0.047 * (e) (e) P=0.247 |
|ORDER RESTRICTED | |P=0.026 * (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |7/50 (14%) 3/50 (6%) 5/48 (10%) 0/50 (0%) |
|POLY-3 RATE (b) | |7/46.53 3/45.69 5/43.21 0/44.39 |
|POLY-3 PERCENT (g) | |15.0% 6.6% 11.6% 0.0% |
|TERMINAL (d) | |7/43 (16%) 3/39 (8%) 4/34 (12%) 0/35 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 700 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.027N* P=0.199N P=0.546N P=0.018N* |
|POLY 3 | |P=0.015N* P=0.165N P=0.432N P=0.009N** |
|POLY 1.5 | |P=0.014N* P=0.158N P=0.414N P=0.008N** |
|POLY 6 | |P=0.017N* P=0.173N P=0.459N P=0.010N* |
|LOGISTIC REGRESSION| |P=0.022N* P=0.199N P=0.501N (e) |
|COCH-ARM / FISHERS | |P=0.014N* P=0.159N P=0.409N P=0.006N** |
|ORDER RESTRICTED | |P=0.005N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 24/48 (50%) 24/48 (50%) 25/49 (51%) |13/49 (27%) 22/49 (45%) 26/47 (55%) 30/47 (64%) |
|POLY-3 RATE (b) | 23/48.15 24/42.54 24/44.70 25/45.06 |13/45.90 22/45.51 26/44.81 30/45.28 |
|POLY-3 PERCENT (g) | 47.8% 56.4% 53.7% 55.5% |28.3% 48.3% 58.0% 66.3% |
|TERMINAL (d) | 13/31 (42%) 19/34 (56%) 19/33 (58%) 19/32 (59%) |13/43 (30%) 20/39 (51%) 18/34 (53%) 21/33 (64%) |
|FIRST INCIDENCE | 547 665 498 384 |729 (T) 700 555 368 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.367 P=0.567N P=0.556 P=0.421 |P<0.001 ** P=0.020 * P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.302 P=0.268 P=0.357 P=0.294 |P<0.001 ** P=0.037 * P=0.003 ** P<0.001 ** |
|POLY 1.5 | P=0.334 P=0.313 P=0.385 P=0.330 |P<0.001 ** P=0.043 * P=0.003 ** P<0.001 ** |
|POLY 6 | P=0.252 P=0.238 P=0.326 P=0.245 |P<0.001 ** P=0.032 * P=0.003 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.340 P=0.360 P=0.421 P=0.375 |P<0.001 ** P=0.023 * P=0.003 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.364 P=0.423 P=0.423 P=0.383 |P<0.001 ** P=0.046 * P=0.004 ** P<0.001 ** |
|ORDER RESTRICTED | P=0.353 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Cyst Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 12/48 (25%) 16/48 (33%) 10/49 (20%) |10/49 (20%) 18/49 (37%) 11/47 (23%) 9/47 (19%) |
|POLY-3 RATE (b) | 15/46.05 12/42.69 16/43.96 10/43.30 |10/45.90 18/45.30 11/42.80 9/42.58 |
|POLY-3 PERCENT (g) | 32.6% 28.1% 36.4% 23.1% |21.8% 39.7% 25.7% 21.1% |
|TERMINAL (d) | 12/31 (39%) 9/34 (27%) 12/33 (36%) 9/32 (28%) |10/43 (23%) 18/39 (46%) 9/34 (27%) 5/33 (15%) |
|FIRST INCIDENCE | 642 547 642 666 |729 (T) 729 (T) 693 628 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.214N P=0.271N P=0.549 P=0.170N |P=0.477N P=0.026 * P=0.277 P=0.487 |
|POLY 3 | P=0.237N P=0.411N P=0.436 P=0.222N |P=0.291N P=0.049 * P=0.427 P=0.573N |
|POLY 1.5 | P=0.224N P=0.406N P=0.438 P=0.211N |P=0.269N P=0.056 P=0.452 P=0.553N |
|POLY 6 | P=0.259N P=0.400N P=0.442 P=0.237N |P=0.318N P=0.042 * P=0.392 P=0.595N |
|LOGISTIC REGRESSION| P=0.231N P=0.410N P=0.438 P=0.224N |P=0.354N P=0.026 * P=0.338 P=0.579N |
|COCH-ARM / FISHERS | P=0.211N P=0.372N P=0.445 P=0.193N |P=0.258N P=0.058 P=0.457 P=0.541N |
|ORDER RESTRICTED | P=0.256N (e) (e) (e) |P=0.243N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/50 (0%) 0/48 (0%) 2/50 (4%) |0/50 (0%) 0/49 (0%) 0/48 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/43.54 0/43.15 0/42.41 2/43.64 |0/46.53 0/44.69 0/42.76 1/43.55 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 4.6% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/29 (0%) 0/34 (0%) 0/31 (0%) 2/32 (6%) |0/43 (0%) 0/38 (0%) 0/33 (0%) 1/35 (3%) |
|FIRST INCIDENCE | 642 --- --- 729 (T) |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.250 P=0.523N P=0.509N P=0.515 |P=0.180 (e) (e) P=0.459 |
|POLY 3 | P=0.252 P=0.502N P=0.505N P=0.501 |P=0.193 (e) (e) P=0.487 |
|POLY 1.5 | P=0.253 P=0.500N P=0.503N P=0.506 |P=0.195 (e) (e) P=0.492 |
|POLY 6 | P=0.250 P=0.502N P=0.507N P=0.494 |P=0.189 (e) (e) P=0.480 |
|LOGISTIC REGRESSION| P=0.250 P=0.457N P=0.481N P=0.510 |(e) (e) (e) P=0.459 |
|COCH-ARM / FISHERS | P=0.252 P=0.490N P=0.500N P=0.515 |P=0.197 (e) (e) P=0.495 |
|ORDER RESTRICTED | P=0.132 (e) (e) (e) |P=0.108 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/49 (0%) 4/48 (8%) 1/48 (2%) |6/48 (13%) 4/50 (8%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/44.45 0/42.15 4/43.07 1/42.61 |6/46.21 4/45.69 3/44.27 4/44.39 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 9.3% 2.4% |13.0% 8.8% 6.8% 9.0% |
|TERMINAL (d) | 1/31 (3%) 0/33 (0%) 2/32 (6%) 1/32 (3%) |5/42 (12%) 4/39 (10%) 1/34 (3%) 4/35 (11%) |
|FIRST INCIDENCE | 729 (T) --- 700 729 (T) |498 729 (T) 619 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.425 P=0.488N P=0.185 P=0.755N |P=0.419N P=0.414N P=0.334N P=0.476N |
|POLY 3 | P=0.434 P=0.511N P=0.169 P=0.751 |P=0.334N P=0.377N P=0.264N P=0.395N |
|POLY 1.5 | P=0.437 P=0.508N P=0.170 P=0.753 |P=0.320N P=0.363N P=0.248N P=0.374N |
|POLY 6 | P=0.424 P=0.511N P=0.168 P=0.748 |P=0.352N P=0.392N P=0.285N P=0.422N |
|LOGISTIC REGRESSION| P=0.424 (e) P=0.167 P=0.755N |P=0.317N P=0.344N P=0.207N P=0.353N |
|COCH-ARM / FISHERS | P=0.436 P=0.500N P=0.175 P=0.747 |P=0.300N P=0.344N P=0.223N P=0.344N |
|ORDER RESTRICTED | P=0.177 (e) (e) (e) |P=0.324N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 2/49 (4%) 6/48 (13%) 1/48 (2%) |0/48 (0%) 4/50 (8%) 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 4/44.57 2/42.15 6/42.93 1/42.61 |0/45.53 4/45.81 2/43.76 5/45.30 |
|POLY-3 PERCENT (g) | 9.0% 4.8% 14.0% 2.4% |0.0% 8.7% 4.6% 11.0% |
|TERMINAL (d) | 3/31 (10%) 2/33 (6%) 5/32 (16%) 1/32 (3%) |0/42 (0%) 3/39 (8%) 2/34 (6%) 3/35 (9%) |
|FIRST INCIDENCE | 700 729 (T) 706 729 (T) |--- 700 729 (T) 538 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.235N P=0.318N P=0.386 P=0.185N |P=0.036 * P=0.057 P=0.193 P=0.026 * |
|POLY 3 | P=0.243N P=0.363N P=0.346 P=0.192N |P=0.047 * P=0.061 P=0.228 P=0.030 * |
|POLY 1.5 | P=0.240N P=0.357N P=0.350 P=0.189N |P=0.050 P=0.063 P=0.235 P=0.032 * |
|POLY 6 | P=0.252N P=0.366N P=0.342 P=0.197N |P=0.043 * P=0.059 P=0.219 P=0.028 * |
|LOGISTIC REGRESSION| P=0.263N P=0.355N P=0.344 P=0.202N |P=0.054 P=0.061 P=0.193 P=0.042 * |
|COCH-ARM / FISHERS | P=0.243N P=0.339N P=0.357 P=0.187N |P=0.056 P=0.064 P=0.258 P=0.031 * |
|ORDER RESTRICTED | P=0.168N (e) (e) (e) |P=0.017 * (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/48 (0%) |1/48 (2%) 2/50 (4%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.45 0/42.15 0/42.84 0/42.61 |1/45.53 2/45.69 3/43.76 0/44.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 4.4% 6.9% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/33 (0%) 0/32 (0%) 0/32 (0%) |1/42 (2%) 2/39 (5%) 3/34 (9%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.402N P=0.474 P=0.233 P=0.536N |
|POLY 3 | (e) (e) (e) (e) |P=0.356N P=0.501 P=0.291 P=0.505N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.343N P=0.507 P=0.302 P=0.500N |
|POLY 6 | (e) (e) (e) (e) |P=0.373N P=0.494 P=0.276 P=0.512N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.402N P=0.474 P=0.233 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.326N P=0.515 P=0.324 P=0.490N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.187N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 2/48 (4%) 0/48 (0%) |0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.45 0/42.15 2/42.84 0/42.61 |0/45.53 0/45.69 0/43.76 0/44.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/33 (0%) 2/32 (6%) 0/32 (0%) |0/42 (0%) 0/39 (0%) 0/34 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.598 (e) P=0.245 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.587 (e) P=0.229 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.590 (e) P=0.230 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.579 (e) P=0.228 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.245 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.590 (e) P=0.242 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.240 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 0/48 (0%) 0/48 (0%) |9/48 (19%) 6/50 (12%) 5/50 (10%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/44.45 1/42.26 0/42.84 0/42.61 |9/45.53 6/45.69 5/43.88 3/44.39 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 0.0% |19.8% 13.1% 11.4% 6.8% |
|TERMINAL (d) | 0/31 (0%) 0/33 (0%) 0/32 (0%) 0/32 (0%) |9/42 (21%) 6/39 (15%) 4/34 (12%) 3/35 (9%) |
|FIRST INCIDENCE | --- 700 --- --- |729 (T) 729 (T) 700 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.596N P=0.489 (e) (e) |P=0.089N P=0.341N P=0.326N P=0.110N |
|POLY 3 | P=0.578N P=0.490 (e) (e) |P=0.049N* P=0.284N P=0.213N P=0.065N |
|POLY 1.5 | P=0.576N P=0.492 (e) (e) |P=0.045N* P=0.273N P=0.197N P=0.059N |
|POLY 6 | P=0.579N P=0.490 (e) (e) |P=0.055N P=0.298N P=0.237N P=0.073N |
|LOGISTIC REGRESSION| P=0.571N P=0.495 (e) (e) |P=0.075N P=0.341N P=0.282N P=0.110N |
|COCH-ARM / FISHERS | P=0.571N P=0.500 (e) (e) |P=0.040N* P=0.259N P=0.172N P=0.052N |
|ORDER RESTRICTED | P=0.379N (e) (e) (e) |P=0.045N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/49 (0%) 0/48 (0%) 0/48 (0%) |0/48 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.45 0/42.15 0/42.84 0/42.61 |0/45.53 0/45.69 1/43.76 0/44.39 |
|POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 2/31 (7%) 0/33 (0%) 0/32 (0%) 0/32 (0%) |0/42 (0%) 0/39 (0%) 1/34 (3%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113N P=0.224N P=0.231N P=0.231N |P=0.669 (e) P=0.458 (e) |
|POLY 3 | P=0.111N P=0.249N P=0.245N P=0.246N |P=0.679 (e) P=0.492 (e) |
|POLY 1.5 | P=0.112N P=0.246N P=0.244N P=0.245N |P=0.687 (e) P=0.498 (e) |
|POLY 6 | P=0.111N P=0.250N P=0.246N P=0.250N |P=0.669 (e) P=0.483 (e) |
|LOGISTIC REGRESSION| P=0.113N (e) (e) (e) |(e) (e) P=0.458 (e) |
|COCH-ARM / FISHERS | P=0.117N P=0.247N P=0.253N P=0.253N |P=0.699 (e) P=0.510 (e) |
|ORDER RESTRICTED | P=0.033N* (e) (e) (e) |P=0.373 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 1/49 (2%) 1/48 (2%) 1/48 (2%) |4/48 (8%) 4/50 (8%) 5/50 (10%) 4/50 (8%) |
|POLY-3 RATE (b) | 3/44.45 1/42.15 1/42.84 1/42.61 |4/45.53 4/45.69 5/43.76 4/44.39 |
|POLY-3 PERCENT (g) | 6.8% 2.4% 2.3% 2.4% |8.8% 8.8% 11.4% 9.0% |
|TERMINAL (d) | 3/31 (10%) 1/33 (3%) 1/32 (3%) 1/32 (3%) |4/42 (10%) 4/39 (10%) 5/34 (15%) 4/35 (11%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236N P=0.282N P=0.293N P=0.293N |P=0.431 P=0.603 P=0.368 P=0.540 |
|POLY 3 | P=0.246N P=0.324N P=0.318N P=0.320N |P=0.528 P=0.641N P=0.475 P=0.629 |
|POLY 1.5 | P=0.246N P=0.320N P=0.316N P=0.317N |P=0.546 P=0.632N P=0.494 P=0.642N |
|POLY 6 | P=0.248N P=0.326N P=0.320N P=0.326N |P=0.503 P=0.635 P=0.448 P=0.609 |
|LOGISTIC REGRESSION| P=0.236N P=0.282N P=0.293N P=0.293N |P=0.431 P=0.603 P=0.368 P=0.540 |
|COCH-ARM / FISHERS | P=0.248N P=0.309N P=0.316N P=0.316N |P=0.565N P=0.619N P=0.526 P=0.619N |
|ORDER RESTRICTED | P=0.205N (e) (e) (e) |P=0.634 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/49 (16%) 9/49 (18%) 20/48 (42%) 22/48 (46%) |1/48 (2%) 0/50 (0%) 1/50 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 8/45.12 9/44.13 20/46.38 22/44.97 |1/45.53 0/45.69 1/43.76 4/44.98 |
|POLY-3 PERCENT (g) | 17.7% 20.4% 43.1% 48.9% |2.2% 0.0% 2.3% 8.9% |
|TERMINAL (d) | 5/31 (16%) 6/33 (18%) 12/32 (38%) 16/32 (50%) |1/42 (2%) 0/39 (0%) 1/34 (3%) 2/35 (6%) |
|FIRST INCIDENCE | 547 275 493 384 |729 (T) --- 729 (T) 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.530 P=0.013 * P=0.004 ** |P=0.026 * P=0.515N P=0.714 P=0.145 |
|POLY 3 | P<0.001 ** P=0.480 P=0.006 ** P<0.001 ** |P=0.033 * P=0.499N P=0.752 P=0.175 |
|POLY 1.5 | P<0.001 ** P=0.483 P=0.005 ** P<0.001 ** |P=0.034 * P=0.496N P=0.758 P=0.182 |
|POLY 6 | P<0.001 ** P=0.483 P=0.007 ** P<0.001 ** |P=0.032 * P=0.503N P=0.742 P=0.167 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.558 P=0.006 ** P=0.002 ** |P=0.035 * (e) P=0.714 P=0.194 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.005 ** P=0.002 ** |P=0.036 * P=0.490N P=0.742N P=0.194 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.025 * (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 2/50 (4%) 3/49 (6%) | |
|POLY-3 RATE (b) | 5/45.75 3/43.87 2/44.41 3/44.21 | |
|POLY-3 PERCENT (g) | 10.9% 6.8% 4.5% 6.8% | |
|TERMINAL (d) | 2/31 (7%) 2/34 (6%) 2/33 (6%) 1/32 (3%) | |
|FIRST INCIDENCE | 653 477 729 (T) 384 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309N P=0.347N P=0.216N P=0.379N | |
|POLY 3 | P=0.306N P=0.380N P=0.228N P=0.375N | |
|POLY 1.5 | P=0.305N P=0.375N P=0.223N P=0.372N | |
|POLY 6 | P=0.311N P=0.381N P=0.234N P=0.381N | |
|LOGISTIC REGRESSION| P=0.295N P=0.336N P=0.222N P=0.292N | |
|COCH-ARM / FISHERS | P=0.306N P=0.357N P=0.218N P=0.369N | |
|ORDER RESTRICTED | P=0.266N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | |
|POLY-3 RATE (b) | 3/45.45 1/43.26 0/44.41 0/42.87 | |
|POLY-3 PERCENT (g) | 6.6% 2.3% 0.0% 0.0% | |
|TERMINAL (d) | 2/31 (7%) 0/34 (0%) 0/33 (0%) 0/32 (0%) | |
|FIRST INCIDENCE | 667 700 --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.049N* P=0.305N P=0.121N P=0.131N | |
|POLY 3 | P=0.043N* P=0.323N P=0.123N P=0.129N | |
|POLY 1.5 | P=0.043N* P=0.319N P=0.121N P=0.127N | |
|POLY 6 | P=0.043N* P=0.323N P=0.124N P=0.132N | |
|LOGISTIC REGRESSION| P=0.046N* P=0.318N P=0.123N P=0.129N | |
|COCH-ARM / FISHERS | P=0.045N* P=0.309N P=0.121N P=0.125N | |
|ORDER RESTRICTED | P=0.024N* (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 28/50 (56%) 21/50 (42%) 23/49 (47%) | |
|POLY-3 RATE (b) | 30/47.22 28/45.01 21/45.67 23/45.91 | |
|POLY-3 PERCENT (g) | 63.5% 62.2% 46.0% 50.1% | |
|TERMINAL (d) | 25/31 (81%) 20/34 (59%) 16/33 (49%) 12/32 (38%) | |
|FIRST INCIDENCE | 464 577 498 607 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.102N P=0.300N P=0.034N* P=0.145N | |
|POLY 3 | P=0.067N P=0.534N P=0.062N P=0.131N | |
|POLY 1.5 | P=0.075N P=0.513N P=0.059N P=0.140N | |
|POLY 6 | P=0.054N P=0.515N P=0.062N P=0.106N | |
|LOGISTIC REGRESSION| P=0.092N P=0.531N P=0.062N P=0.152N | |
|COCH-ARM / FISHERS | P=0.084N P=0.420N P=0.055N P=0.135N | |
|ORDER RESTRICTED | P=0.092N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 24/50 (48%) 28/50 (56%) 36/49 (73%) | |
|POLY-3 RATE (b) | 27/48.10 24/46.04 28/47.60 36/46.40 | |
|POLY-3 PERCENT (g) | 56.1% 52.1% 58.8% 77.6% | |
|TERMINAL (d) | 15/31 (48%) 16/34 (47%) 19/33 (58%) 26/32 (81%) | |
|FIRST INCIDENCE | 464 477 493 384 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033 * P=0.309N P=0.553 P=0.086 | |
|POLY 3 | P=0.008 ** P=0.427N P=0.476 P=0.019 * | |
|POLY 1.5 | P=0.009 ** P=0.410N P=0.485 P=0.023 * | |
|POLY 6 | P=0.006 ** P=0.428N P=0.470 P=0.015 * | |
|LOGISTIC REGRESSION| P=0.012 * P=0.364N P=0.509 P=0.032 * | |
|COCH-ARM / FISHERS | P=0.012 * P=0.345N P=0.500 P=0.035 * | |
|ORDER RESTRICTED | P=0.010 * (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate: Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 5/50 (10%) 0/49 (0%) | |
|POLY-3 RATE (b) | 4/46.45 6/45.09 5/46.24 0/42.80 | |
|POLY-3 PERCENT (g) | 8.6% 13.3% 10.8% 0.0% | |
|TERMINAL (d) | 2/31 (7%) 3/34 (9%) 2/33 (6%) 0/32 (0%) | |
|FIRST INCIDENCE | 464 477 493 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.050N P=0.385 P=0.515 P=0.065N | |
|POLY 3 | P=0.059N P=0.351 P=0.497 P=0.071N | |
|POLY 1.5 | P=0.055N P=0.353 P=0.498 P=0.068N | |
|POLY 6 | P=0.064N P=0.355 P=0.498 P=0.075N | |
|LOGISTIC REGRESSION| P=0.035N* P=0.526 P=0.615 P=0.034N* | |
|COCH-ARM / FISHERS | P=0.049N* P=0.370 P=0.500 P=0.061N | |
|ORDER RESTRICTED | P=0.043N* (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.39 0/43.15 0/44.41 0/43.64 |0/46.53 0/45.69 2/43.76 0/44.39 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |0.0% 0.0% 4.6% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 0/39 (0%) 2/34 (6%) 0/35 (0%) |
|FIRST INCIDENCE | 685 --- --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.323N P=0.510N P=0.510N P=0.532N |P=0.552 (e) P=0.188 (e) |
|POLY 3 | P=0.298N P=0.510N P=0.504N P=0.508N |P=0.576 (e) P=0.224 (e) |
|POLY 1.5 | P=0.300N P=0.508N P=0.503N P=0.505N |P=0.587 (e) P=0.230 (e) |
|POLY 6 | P=0.297N P=0.511N P=0.506N P=0.512N |P=0.561 (e) P=0.214 (e) |
|LOGISTIC REGRESSION| P=0.305N P=0.496N P=0.496N P=0.494N |(e) (e) P=0.188 (e) |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.595 (e) P=0.247 (e) |
|ORDER RESTRICTED | P=0.128N (e) (e) (e) |P=0.236 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.67 1/43.15 2/45.34 1/43.64 |0/46.53 0/45.69 0/43.76 0/44.39 |
|POLY-3 PERCENT (g) | 2.2% 2.3% 4.4% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 1/34 (3%) 0/33 (0%) 1/32 (3%) |0/43 (0%) 0/39 (0%) 0/34 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 597 729 (T) 531 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.591 P=0.760N P=0.490 P=0.754N |(e) (e) (e) (e) |
|POLY 3 | P=0.576 P=0.748 P=0.497 P=0.751 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.582 P=0.751 P=0.498 P=0.754 |(e) (e) (e) (e) |
|POLY 6 | P=0.566 P=0.747 P=0.498 P=0.746 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.600 P=0.747N P=0.573 P=0.744N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.591 P=0.753N P=0.500 P=0.753N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.577 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.22 1/43.21 1/44.41 0/43.64 |0/46.53 0/45.69 1/43.76 2/44.83 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.3% 0.0% |0.0% 0.0% 2.3% 4.5% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 1/33 (3%) 0/32 (0%) |0/43 (0%) 0/39 (0%) 1/34 (3%) 0/35 (0%) |
|FIRST INCIDENCE | --- 712 729 (T) --- |--- --- 729 (T) 654 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.602N P=0.506 P=0.512 (e) |P=0.061 (e) P=0.453 P=0.217 |
|POLY 3 | P=0.605N P=0.491 P=0.496 (e) |P=0.067 (e) P=0.488 P=0.229 |
|POLY 1.5 | P=0.601N P=0.493 P=0.498 (e) |P=0.068 (e) P=0.494 P=0.234 |
|POLY 6 | P=0.609N P=0.491 P=0.495 (e) |P=0.064 (e) P=0.479 P=0.223 |
|LOGISTIC REGRESSION| P=0.606N P=0.491 P=0.512 (e) |P=0.070 (e) P=0.453 P=0.236 |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.070 (e) P=0.500 P=0.247 |
|ORDER RESTRICTED | P=0.395 (e) (e) (e) |P=0.069 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spinal Cord |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 1/3 (33%) 0/2 (0%) 1/3 (33%) |0/7 (0%) 0/3 (0%) 0/24 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/1.38 1/1.85 0/1.71 1/1.86 |0/5.32 0/2.72 0/20.93 2/45.35 |
|POLY-3 PERCENT (g) | 0.0% 54.0% 0.0% 53.9% |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |0/5 (0%) 0/2 (0%) 0/17 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- 567 --- 689 |--- --- --- 368 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.411 P=0.487 (e) P=0.512 |P=0.045 * (e) (e) P=0.228 |
|POLY 3 | P=0.429 P=0.568 (e) P=0.567 |P=0.315 (e) (e) P=0.735 |
|POLY 1.5 | P=0.432 P=0.569 (e) P=0.563 |P=0.312 (e) (e) P=0.734 |
|POLY 6 | P=0.465 P=0.592 (e) P=0.610 |P=0.317 (e) (e) P=0.734 |
|LOGISTIC REGRESSION| P=0.449 P=0.823 (e) (e) |P=0.149 (e) (e) P=0.488 |
|COCH-ARM / FISHERS | P=0.458 P=0.600 (e) P=0.600 |P=0.291 (e) (e) P=0.768 |
|ORDER RESTRICTED | P=0.264 (e) (e) (e) |P=0.579 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/48 (0%) 1/48 (2%) 3/49 (6%) |3/50 (6%) 0/48 (0%) 1/47 (2%) 1/48 (2%) |
|POLY-3 RATE (b) | 3/45.31 0/42.47 1/43.18 3/42.93 |3/46.65 0/43.79 1/43.00 1/42.39 |
|POLY-3 PERCENT (g) | 6.6% 0.0% 2.3% 7.0% |6.4% 0.0% 2.3% 2.4% |
|TERMINAL (d) | 2/31 (7%) 0/34 (0%) 1/33 (3%) 3/32 (9%) |2/43 (5%) 0/38 (0%) 0/34 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 705 --- 729 (T) 729 (T) |700 --- 700 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.418 P=0.114N P=0.290N P=0.660N |P=0.362N P=0.141N P=0.382N P=0.393N |
|POLY 3 | P=0.414 P=0.130N P=0.323N P=0.637 |P=0.311N P=0.130N P=0.335N P=0.340N |
|POLY 1.5 | P=0.417 P=0.130N P=0.322N P=0.643 |P=0.309N P=0.127N P=0.327N P=0.329N |
|POLY 6 | P=0.410 P=0.129N P=0.321N P=0.631 |P=0.314N P=0.135N P=0.347N P=0.356N |
|LOGISTIC REGRESSION| P=0.393 P=0.127N P=0.313N P=0.630 |P=0.323N P=0.131N P=0.330N P=0.350N |
|COCH-ARM / FISHERS | P=0.418 P=0.129N P=0.324N P=0.651 |P=0.307N P=0.129N P=0.332N P=0.324N |
|ORDER RESTRICTED | P=0.273 (e) (e) (e) |P=0.127N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/48 (0%) 0/48 (0%) 0/49 (0%) |0/50 (0%) 0/48 (0%) 2/47 (4%) 0/48 (0%) |
|POLY-3 RATE (b) | 3/46.09 0/42.47 0/43.18 0/42.93 |0/46.53 0/43.79 2/43.36 0/42.39 |
|POLY-3 PERCENT (g) | 6.5% 0.0% 0.0% 0.0% |0.0% 0.0% 4.6% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 0/38 (0%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 589 --- --- --- |--- --- 638 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.051N P=0.137N P=0.128N P=0.134N |P=0.572 (e) P=0.209 (e) |
|POLY 3 | P=0.045N* P=0.134N P=0.131N P=0.132N |P=0.560 (e) P=0.222 (e) |
|POLY 1.5 | P=0.045N* P=0.132N P=0.129N P=0.128N |P=0.574 (e) P=0.225 (e) |
|POLY 6 | P=0.044N* P=0.135N P=0.132N P=0.136N |P=0.541 (e) P=0.216 (e) |
|LOGISTIC REGRESSION| P=0.044N* P=0.096N P=0.112N P=0.093N |P=0.585 (e) P=0.211 (e) |
|COCH-ARM / FISHERS | P=0.049N* P=0.129N P=0.129N P=0.125N |P=0.587 (e) P=0.232 (e) |
|ORDER RESTRICTED | P=0.010N* (e) (e) (e) |P=0.235 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/48 (4%) 2/48 (4%) 0/49 (0%) |1/50 (2%) 0/48 (0%) 1/47 (2%) 1/48 (2%) |
|POLY-3 RATE (b) | 2/45.25 2/42.59 2/43.46 0/42.93 |1/46.53 0/43.79 1/43.38 1/42.39 |
|POLY-3 PERCENT (g) | 4.4% 4.7% 4.6% 0.0% |2.2% 0.0% 2.3% 2.4% |
|TERMINAL (d) | 1/31 (3%) 1/34 (3%) 1/33 (3%) 0/32 (0%) |1/43 (2%) 0/38 (0%) 0/34 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 722 700 653 --- |729 (T) --- 581 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.174N P=0.678N P=0.690N P=0.240N |P=0.491 P=0.525N P=0.729 P=0.702 |
|POLY 3 | P=0.175N P=0.672 P=0.679 P=0.249N |P=0.516 P=0.512N P=0.745 P=0.740 |
|POLY 1.5 | P=0.172N P=0.673 P=0.679 P=0.247N |P=0.523 P=0.509N P=0.748 P=0.746 |
|POLY 6 | P=0.178N P=0.676 P=0.683 P=0.252N |P=0.506 P=0.516N P=0.739 P=0.730 |
|LOGISTIC REGRESSION| P=0.172N P=0.679 P=0.679 P=0.253N |P=0.530 (e) P=0.737 P=0.702 |
|COCH-ARM / FISHERS | P=0.167N P=0.676 P=0.676 P=0.253N |P=0.530 P=0.510N P=0.737 P=0.742 |
|ORDER RESTRICTED | P=0.186N (e) (e) (e) |P=0.511 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 47
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/48 (2%) 1/48 (2%) 1/49 (2%) |6/50 (12%) 2/48 (4%) 0/47 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/45.45 1/42.59 1/43.77 1/42.93 |6/48.14 2/43.79 0/42.89 0/42.39 |
|POLY-3 PERCENT (g) | 2.2% 2.4% 2.3% 2.3% |12.5% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 1/32 (3%) |4/43 (9%) 2/38 (5%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 667 700 538 729 (T) |302 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.611 P=0.744 P=0.745 P=0.744 |P=0.007N** P=0.170N P=0.030N* P=0.031N* |
|POLY 3 | P=0.618 P=0.746 P=0.752 P=0.748 |P=0.004N** P=0.166N P=0.022N* P=0.023N* |
|POLY 1.5 | P=0.622 P=0.747 P=0.752 P=0.751 |P=0.004N** P=0.156N P=0.020N* P=0.021N* |
|POLY 6 | P=0.612 P=0.747 P=0.754 P=0.744 |P=0.004N** P=0.176N P=0.025N* P=0.027N* |
|LOGISTIC REGRESSION| P=0.621N P=0.762 P=0.749N P=0.757 |P=0.005N** P=0.162N P=0.026N* P=0.020N* |
|COCH-ARM / FISHERS | P=0.630 P=0.742 P=0.742 P=0.747 |P=0.004N** P=0.148N P=0.016N* P=0.015N* |
|ORDER RESTRICTED | P=0.729 (e) (e) (e) |P=0.002N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/48 (2%) 0/48 (0%) 2/49 (4%) |0/50 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/45.22 1/42.59 0/43.18 2/43.52 |0/46.53 0/43.79 0/42.89 0/42.39 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 4.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 0/38 (0%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 700 --- 632 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.126 P=0.489 (e) P=0.218 |(e) (e) (e) (e) |
|POLY 3 | P=0.137 P=0.488 (e) P=0.229 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.137 P=0.488 (e) P=0.230 |(e) (e) (e) (e) |
|POLY 6 | P=0.136 P=0.490 (e) P=0.228 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.145 P=0.490 (e) P=0.260 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.139 P=0.490 (e) P=0.242 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.069 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 48
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/48 (4%) 1/48 (2%) 2/49 (4%) |0/50 (0%) 3/48 (6%) 10/47 (21%) 3/48 (6%) |
|POLY-3 RATE (b) | 0/45.22 2/42.59 1/43.77 2/42.93 |0/46.53 3/43.91 10/42.89 3/42.39 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 2.3% 4.7% |0.0% 6.8% 23.3% 7.1% |
|TERMINAL (d) | 0/31 (0%) 1/34 (3%) 0/33 (0%) 2/32 (6%) |0/43 (0%) 2/38 (5%) 10/34 (29%) 3/33 (9%) |
|FIRST INCIDENCE | --- 700 538 729 (T) |--- 700 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.238 P=0.244 P=0.492 P=0.245 |P=0.072 P=0.106 P<0.001 ** P=0.079 |
|POLY 3 | P=0.234 P=0.224 P=0.494 P=0.226 |P=0.098 P=0.108 P<0.001 ** P=0.103 |
|POLY 1.5 | P=0.237 P=0.224 P=0.493 P=0.228 |P=0.112 P=0.111 P<0.001 ** P=0.108 |
|POLY 6 | P=0.230 P=0.226 P=0.496 P=0.223 |P=0.081 P=0.106 P<0.001 ** P=0.096 |
|LOGISTIC REGRESSION| P=0.247 P=0.225 P=0.534 P=0.245 |P=0.084 P=0.109 P<0.001 ** P=0.079 |
|COCH-ARM / FISHERS | P=0.243 P=0.237 P=0.490 P=0.242 |P=0.134 P=0.114 P<0.001 ** P=0.114 |
|ORDER RESTRICTED | P=0.147 (e) (e) (e) |P=0.006 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen: Capsule |
| Infiltration Cellular Focal Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/48 (0%) 0/49 (0%) |0/50 (0%) 0/48 (0%) 2/47 (4%) 1/48 (2%) |
|POLY-3 RATE (b) | 0/45.22 0/42.47 0/43.18 0/42.93 |0/46.53 0/43.79 2/42.89 1/42.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.7% 2.4% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 0/38 (0%) 2/34 (6%) 1/33 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.195 (e) P=0.188 P=0.447 |
|POLY 3 | (e) (e) (e) (e) |P=0.222 (e) P=0.219 P=0.481 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.231 (e) P=0.224 P=0.487 |
|POLY 6 | (e) (e) (e) (e) |P=0.210 (e) P=0.212 P=0.474 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.188 P=0.447 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.239 (e) P=0.232 P=0.490 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.153 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 49
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |1/50 (2%) 1/50 (2%) 2/49 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/45.66 0/43.15 0/44.41 0/43.07 |1/46.53 1/45.69 2/44.40 1/44.70 |
|POLY-3 PERCENT (g) | 6.6% 0.0% 0.0% 0.0% |2.2% 2.2% 4.5% 2.2% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |1/43 (2%) 1/39 (3%) 0/34 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 642 --- --- --- |729 (T) 729 (T) 581 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.052N P=0.131N P=0.127N P=0.137N |P=0.545 P=0.740 P=0.449 P=0.733 |
|POLY 3 | P=0.043N* P=0.129N P=0.124N P=0.129N |P=0.572 P=0.756 P=0.484 P=0.752 |
|POLY 1.5 | P=0.044N* P=0.126N P=0.122N P=0.127N |P=0.582 P=0.760 P=0.492 P=0.757 |
|POLY 6 | P=0.043N* P=0.130N P=0.126N P=0.133N |P=0.560 P=0.752 P=0.472 P=0.745 |
|LOGISTIC REGRESSION| P=0.048N* P=0.118N P=0.118N P=0.120N |P=0.589 P=0.740 P=0.484 P=0.762N |
|COCH-ARM / FISHERS | P=0.048N* P=0.121N P=0.121N P=0.125N |P=0.590 P=0.753N P=0.492 P=0.753N |
|ORDER RESTRICTED | P=0.010N* (e) (e) (e) |P=0.566 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/49 (6%) |0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.39 0/43.15 1/45.10 3/43.60 |0/46.53 0/45.69 2/44.58 0/44.39 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.2% 6.9% |0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 1/32 (3%) |0/43 (0%) 0/39 (0%) 0/34 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 685 --- 493 651 |--- --- 581 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.089 P=0.510N P=0.757 P=0.279 |P=0.585 (e) P=0.222 (e) |
|POLY 3 | P=0.094 P=0.510N P=0.759 P=0.291 |P=0.572 (e) P=0.228 (e) |
|POLY 1.5 | P=0.094 P=0.508N P=0.760 P=0.293 |P=0.584 (e) P=0.232 (e) |
|POLY 6 | P=0.093 P=0.511N P=0.759 P=0.289 |P=0.556 (e) P=0.221 (e) |
|LOGISTIC REGRESSION| P=0.092 P=0.496N P=0.731N P=0.309 |P=0.569 (e) P=0.195 (e) |
|COCH-ARM / FISHERS | P=0.093 P=0.500N P=0.753N P=0.301 |P=0.594 (e) P=0.242 (e) |
|ORDER RESTRICTED | P=0.075 (e) (e) (e) |P=0.239 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 50
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 2/50 (4%) 3/49 (6%) |1/50 (2%) 1/50 (2%) 3/49 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 5/46.03 2/43.39 2/45.04 3/43.88 |1/47.21 1/45.96 3/44.73 2/44.86 |
|POLY-3 PERCENT (g) | 10.9% 4.6% 4.4% 6.8% |2.1% 2.2% 6.7% 4.5% |
|TERMINAL (d) | 0/31 (0%) 1/34 (3%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 0/39 (0%) 0/34 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 642 665 642 632 |498 657 581 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.391N P=0.241N P=0.237N P=0.430N |P=0.299 P=0.753 P=0.284 P=0.478 |
|POLY 3 | P=0.351N P=0.241N P=0.225N P=0.383N |P=0.303 P=0.755 P=0.286 P=0.482 |
|POLY 1.5 | P=0.351N P=0.234N P=0.222N P=0.378N |P=0.314 P=0.759 P=0.295 P=0.492 |
|POLY 6 | P=0.353N P=0.245N P=0.228N P=0.389N |P=0.290 P=0.750 P=0.275 P=0.471 |
|LOGISTIC REGRESSION| P=0.348N P=0.213N P=0.198N P=0.336N |P=0.301 P=0.724 P=0.239 P=0.475 |
|COCH-ARM / FISHERS | P=0.353N P=0.218N P=0.218N P=0.369N |P=0.324 P=0.753N P=0.301 P=0.500 |
|ORDER RESTRICTED | P=0.230N (e) (e) (e) |P=0.306 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 2/50 (4%) 4/49 (8%) |0/50 (0%) 1/50 (2%) 6/49 (12%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/45.63 3/43.77 2/45.42 4/43.68 |0/46.53 1/45.79 6/44.40 1/44.70 |
|POLY-3 PERCENT (g) | 8.8% 6.9% 4.4% 9.2% |0.0% 2.2% 13.5% 2.2% |
|TERMINAL (d) | 0/31 (0%) 1/34 (3%) 0/33 (0%) 2/32 (6%) |0/43 (0%) 0/39 (0%) 4/34 (12%) 0/35 (0%) |
|FIRST INCIDENCE | 685 621 493 622 |--- 705 581 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.530 P=0.511N P=0.349N P=0.602 |P=0.260 P=0.490 P=0.010 * P=0.491 |
|POLY 3 | P=0.543 P=0.523N P=0.339N P=0.619 |P=0.281 P=0.497 P=0.013 * P=0.492 |
|POLY 1.5 | P=0.545 P=0.518N P=0.339N P=0.623 |P=0.296 P=0.500 P=0.014 * P=0.497 |
|POLY 6 | P=0.539 P=0.521N P=0.340N P=0.615 |P=0.263 P=0.493 P=0.011 * P=0.486 |
|LOGISTIC REGRESSION| P=0.553 P=0.498N P=0.301N P=0.635 |P=0.313 P=0.500 P=0.016 * P=0.494 |
|COCH-ARM / FISHERS | P=0.547 P=0.500N P=0.339N P=0.631 |P=0.312 P=0.500 P=0.012 * P=0.500 |
|ORDER RESTRICTED | P=0.514 (e) (e) (e) |P=0.043 * (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 51
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/45.43 0/43.15 0/43.75 0/43.07 |0/46.53 0/45.69 0/43.76 0/43.39 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 0/39 (0%) 0/34 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 700 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.125N P=0.249N P=0.243N P=0.272N |(e) (e) (e) (e) |
|POLY 3 | P=0.111N P=0.249N P=0.246N P=0.249N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.112N P=0.246N P=0.244N P=0.247N |(e) (e) (e) (e) |
|POLY 6 | P=0.110N P=0.250N P=0.247N P=0.252N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.118N P=0.244N P=0.243N P=0.245N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.117N P=0.247N P=0.253N P=0.253N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.034N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/49 (2%) 6/49 (12%) |2/50 (4%) 1/50 (2%) 1/49 (2%) 4/49 (8%) |
|POLY-3 RATE (b) | 3/45.69 1/43.39 1/43.89 6/44.21 |2/46.53 1/46.48 1/44.15 4/44.84 |
|POLY-3 PERCENT (g) | 6.6% 2.3% 2.3% 13.6% |4.3% 2.2% 2.3% 8.9% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |2/43 (5%) 0/39 (0%) 0/34 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 653 665 694 651 |729 (T) 434 619 368 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.062 P=0.328N P=0.319N P=0.198 |P=0.144 P=0.520N P=0.562N P=0.288 |
|POLY 3 | P=0.074 P=0.324N P=0.320N P=0.225 |P=0.154 P=0.500N P=0.518N P=0.320 |
|POLY 1.5 | P=0.074 P=0.320N P=0.317N P=0.227 |P=0.157 P=0.497N P=0.509N P=0.328 |
|POLY 6 | P=0.074 P=0.325N P=0.322N P=0.226 |P=0.149 P=0.506N P=0.532N P=0.310 |
|LOGISTIC REGRESSION| P=0.075 P=0.293N P=0.307N P=0.248 |P=0.137 P=0.535N P=0.507N P=0.317 |
|COCH-ARM / FISHERS | P=0.074 P=0.309N P=0.316N P=0.233 |P=0.158 P=0.500N P=0.508N P=0.329 |
|ORDER RESTRICTED | P=0.035 * (e) (e) (e) |P=0.124 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 52
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/49 (4%) 0/49 (0%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/45.33 1/43.61 2/44.55 0/43.07 |0/46.53 1/45.79 0/43.76 0/43.39 |
|POLY-3 PERCENT (g) | 2.2% 2.3% 4.5% 0.0% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 0/39 (0%) 0/34 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 700 593 493 --- |--- 705 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.385N P=0.747 P=0.496 P=0.533N |P=0.586N P=0.490 (e) (e) |
|POLY 3 | P=0.380N P=0.752 P=0.494 P=0.510N |P=0.577N P=0.497 (e) (e) |
|POLY 1.5 | P=0.377N P=0.753 P=0.493 P=0.508N |P=0.572N P=0.500 (e) (e) |
|POLY 6 | P=0.385N P=0.753 P=0.496 P=0.513N |P=0.584N P=0.493 (e) (e) |
|LOGISTIC REGRESSION| P=0.364N P=0.735N P=0.532 P=0.506N |P=0.573N P=0.500 (e) (e) |
|COCH-ARM / FISHERS | P=0.373N P=0.753N P=0.492 P=0.505N |P=0.571N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.274N (e) (e) (e) |P=0.391N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 10/50 (20%) 8/50 (16%) 10/50 (20%) | |
|POLY-3 RATE (b) | 15/46.51 10/43.35 8/45.36 10/44.51 | |
|POLY-3 PERCENT (g) | 32.3% 23.1% 17.6% 22.5% | |
|TERMINAL (d) | 10/31 (32%) 8/34 (24%) 4/33 (12%) 8/32 (25%) | |
|FIRST INCIDENCE | 589 694 594 584 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.185N P=0.150N P=0.080N P=0.183N | |
|POLY 3 | P=0.174N P=0.230N P=0.082N P=0.208N | |
|POLY 1.5 | P=0.170N P=0.214N P=0.080N P=0.196N | |
|POLY 6 | P=0.184N P=0.243N P=0.085N P=0.226N | |
|LOGISTIC REGRESSION| P=0.181N P=0.212N P=0.079N P=0.195N | |
|COCH-ARM / FISHERS | P=0.169N P=0.178N P=0.077N P=0.178N | |
|ORDER RESTRICTED | P=0.129N (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 53
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 6/50 (12%) 7/50 (14%) | |
|POLY-3 RATE (b) | 4/46.23 0/43.15 6/45.80 7/45.95 | |
|POLY-3 PERCENT (g) | 8.7% 0.0% 13.1% 15.2% | |
|TERMINAL (d) | 1/31 (3%) 0/34 (0%) 2/33 (6%) 2/32 (6%) | |
|FIRST INCIDENCE | 547 --- 493 384 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060 P=0.071N P=0.376 P=0.261 | |
|POLY 3 | P=0.060 P=0.069N P=0.364 P=0.257 | |
|POLY 1.5 | P=0.059 P=0.067N P=0.366 P=0.259 | |
|POLY 6 | P=0.060 P=0.071N P=0.363 P=0.255 | |
|LOGISTIC REGRESSION| P=0.058 P=0.043N* P=0.415 P=0.354 | |
|COCH-ARM / FISHERS | P=0.056 P=0.059N P=0.370 P=0.262 | |
|ORDER RESTRICTED | P=0.050 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/46 (0%) 0/45 (0%) |2/47 (4%) 0/50 (0%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/43.45 0/43.09 0/40.87 0/40.12 |2/43.67 0/45.69 0/43.10 0/42.55 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/34 (0%) 0/30 (0%) 0/31 (0%) |2/41 (5%) 0/39 (0%) 0/34 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.135N P=0.249N P=0.280N P=0.280N |
|POLY 3 | (e) (e) (e) (e) |P=0.110N P=0.227N P=0.240N P=0.243N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.112N P=0.223N P=0.234N P=0.237N |
|POLY 6 | (e) (e) (e) (e) |P=0.109N P=0.232N P=0.249N P=0.251N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.135N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.113N P=0.232N P=0.242N P=0.242N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.031N* (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 54
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/49 (0%) 0/46 (0%) 0/45 (0%) |0/47 (0%) 1/50 (2%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/44.22 0/43.09 0/40.87 0/40.12 |0/43.67 1/46.50 0/43.10 0/42.55 |
|POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/34 (0%) 0/30 (0%) 0/31 (0%) |0/41 (0%) 0/39 (0%) 0/34 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 582 --- --- --- |--- 421 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123N P=0.263N P=0.255N P=0.258N |P=0.569N P=0.508 (e) (e) |
|POLY 3 | P=0.116N P=0.243N P=0.255N P=0.259N |P=0.571N P=0.513 (e) (e) |
|POLY 1.5 | P=0.117N P=0.240N P=0.251N P=0.257N |P=0.567N P=0.515 (e) (e) |
|POLY 6 | P=0.116N P=0.245N P=0.259N P=0.262N |P=0.578N P=0.509 (e) (e) |
|LOGISTIC REGRESSION| P=0.108N P=0.167N P=0.211N P=0.189N |P=0.695N P=0.357 (e) (e) |
|COCH-ARM / FISHERS | P=0.121N P=0.242N P=0.258N P=0.264N |P=0.567N P=0.515 (e) (e) |
|ORDER RESTRICTED | P=0.037N* (e) (e) (e) |P=0.396N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 41/47 (87%) 28/46 (61%) 26/48 (54%) 29/44 (66%) |45/47 (96%) 42/44 (95%) 36/40 (90%) 35/45 (78%) |
|POLY-3 RATE (b) | 41/45.75 28/43.27 26/45.54 29/41.58 |45/47.00 42/43.93 36/39.50 35/44.27 |
|POLY-3 PERCENT (g) | 89.6% 64.7% 57.1% 69.7% |95.7% 95.6% 91.1% 79.1% |
|TERMINAL (d) | 29/31 (94%) 24/34 (71%) 20/33 (61%) 24/32 (75%) |40/42 (95%) 37/38 (97%) 31/34 (91%) 27/34 (79%) |
|FIRST INCIDENCE | 547 275 493 384 |16 434 581 368 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.034N* P=0.003N** P=0.002N** P=0.015N* |P=0.282N P=0.502 P=0.500N P=0.362N |
|POLY 3 | P=0.036N* P=0.003N** P<0.001N** P=0.014N* |P=0.002N** P=0.685N P=0.331N P=0.014N* |
|POLY 1.5 | P=0.037N* P=0.003N** P<0.001N** P=0.014N* |P=0.002N** P=0.677N P=0.301N P=0.012N* |
|POLY 6 | P=0.036N* P=0.003N** P<0.001N** P=0.014N* |P=0.003N** P=0.699N P=0.371N P=0.018N* |
|LOGISTIC REGRESSION| P=0.048N* P=0.006N** P<0.001N** P=0.023N* |P=0.002N** P=0.678N P=0.260N P=0.011N* |
|COCH-ARM / FISHERS | P=0.042N* P=0.003N** P<0.001N** P=0.015N* |P=0.002N** P=0.666N P=0.264N P=0.011N* |
|ORDER RESTRICTED | P=0.002N** (e) (e) (e) |P=0.002N** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 55
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 3/46 (7%) 1/48 (2%) 5/44 (11%) |0/47 (0%) 1/44 (2%) 0/40 (0%) 0/45 (0%) |
|POLY-3 RATE (b) | 0/43.51 3/41.52 1/43.18 5/39.55 |0/44.04 1/42.14 0/38.35 0/40.67 |
|POLY-3 PERCENT (g) | 0.0% 7.2% 2.3% 12.6% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 2/34 (6%) 1/33 (3%) 5/32 (16%) |0/42 (0%) 1/38 (3%) 0/34 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 547 729 (T) 729 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * P=0.130 P=0.512 P=0.035 * |P=0.598N P=0.480 (e) (e) |
|POLY 3 | P=0.020 * P=0.110 P=0.498 P=0.023 * |P=0.569N P=0.491 (e) (e) |
|POLY 1.5 | P=0.020 * P=0.111 P=0.500 P=0.023 * |P=0.568N P=0.492 (e) (e) |
|POLY 6 | P=0.019 * P=0.111 P=0.497 P=0.022 * |P=0.573N P=0.489 (e) (e) |
|LOGISTIC REGRESSION| P=0.022 * P=0.132 P=0.512 P=0.035 * |(e) P=0.480 (e) (e) |
|COCH-ARM / FISHERS | P=0.023 * P=0.117 P=0.505 P=0.023 * |P=0.572N P=0.484 (e) (e) |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) |P=0.388N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Degeneration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/47 (13%) 4/46 (9%) 8/48 (17%) 4/44 (9%) |0/47 (0%) 0/44 (0%) 1/40 (3%) 1/45 (2%) |
|POLY-3 RATE (b) | 6/43.51 4/41.08 8/43.49 4/40.17 |0/44.04 0/42.14 1/38.35 1/40.67 |
|POLY-3 PERCENT (g) | 13.8% 9.7% 18.4% 10.0% |0.0% 0.0% 2.6% 2.5% |
|TERMINAL (d) | 6/31 (19%) 3/34 (9%) 7/33 (21%) 2/32 (6%) |0/42 (0%) 0/38 (0%) 1/34 (3%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 694 642 622 |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.414N P=0.319N P=0.428 P=0.362N |P=0.203 (e) P=0.458 P=0.458 |
|POLY 3 | P=0.451N P=0.406N P=0.385 P=0.420N |P=0.221 (e) P=0.472 P=0.484 |
|POLY 1.5 | P=0.453N P=0.401N P=0.391 P=0.421N |P=0.228 (e) P=0.473 P=0.490 |
|POLY 6 | P=0.444N P=0.401N P=0.385 P=0.413N |P=0.211 (e) P=0.470 P=0.477 |
|LOGISTIC REGRESSION| P=0.465N P=0.377N P=0.379 P=0.427N |(e) (e) P=0.458 P=0.458 |
|COCH-ARM / FISHERS | P=0.450N P=0.384N P=0.403 P=0.413N |P=0.233 (e) P=0.460 P=0.489 |
|ORDER RESTRICTED | P=0.458N (e) (e) (e) |P=0.223 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 56
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/47 (6%) 3/46 (7%) 5/48 (10%) 6/44 (14%) |2/47 (4%) 7/44 (16%) 6/40 (15%) 19/45 (42%) |
|POLY-3 RATE (b) | 3/43.51 3/41.44 5/43.18 6/40.31 |2/44.04 7/42.14 6/38.35 19/41.06 |
|POLY-3 PERCENT (g) | 6.9% 7.2% 11.6% 14.9% |4.5% 16.6% 15.6% 46.3% |
|TERMINAL (d) | 3/31 (10%) 2/34 (6%) 5/33 (15%) 4/32 (13%) |2/42 (5%) 7/38 (18%) 6/34 (18%) 17/34 (50%) |
|FIRST INCIDENCE | 729 (T) 577 729 (T) 622 |729 (T) 729 (T) 729 (T) 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.146 P=0.633N P=0.389 P=0.258 |P<0.001 ** P=0.059 P=0.076 P<0.001 ** |
|POLY 3 | P=0.117 P=0.640 P=0.352 P=0.204 |P<0.001 ** P=0.068 P=0.091 P<0.001 ** |
|POLY 1.5 | P=0.117 P=0.641 P=0.358 P=0.204 |P<0.001 ** P=0.069 P=0.093 P<0.001 ** |
|POLY 6 | P=0.119 P=0.645 P=0.348 P=0.209 |P<0.001 ** P=0.065 P=0.087 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.115 P=0.648 P=0.389 P=0.205 |P<0.001 ** P=0.059 P=0.076 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.119 P=0.651 P=0.369 P=0.210 |P<0.001 ** P=0.064 P=0.087 P<0.001 ** |
|ORDER RESTRICTED | P=0.176 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 1/46 (2%) 1/48 (2%) 0/44 (0%) |1/47 (2%) 1/44 (2%) 1/40 (3%) 2/45 (4%) |
|POLY-3 RATE (b) | 1/43.51 1/41.59 1/43.87 0/39.55 |1/44.04 1/42.14 1/38.35 2/40.67 |
|POLY-3 PERCENT (g) | 2.3% 2.4% 2.3% 0.0% |2.3% 2.4% 2.6% 4.9% |
|TERMINAL (d) | 1/31 (3%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |1/42 (2%) 1/38 (3%) 1/34 (3%) 2/34 (6%) |
|FIRST INCIDENCE | 729 (T) 516 493 --- |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.313N P=0.755N P=0.751N P=0.494N |P=0.288 P=0.739 P=0.714 P=0.426 |
|POLY 3 | P=0.329N P=0.751 P=0.759N P=0.519N |P=0.328 P=0.751 P=0.730 P=0.472 |
|POLY 1.5 | P=0.328N P=0.751 P=0.758N P=0.518N |P=0.337 P=0.752 P=0.731 P=0.482 |
|POLY 6 | P=0.330N P=0.753 P=0.759N P=0.519N |P=0.316 P=0.749 P=0.726 P=0.459 |
|LOGISTIC REGRESSION| P=0.256N P=0.700N P=0.642N (e) |P=0.288 P=0.739 P=0.714 P=0.426 |
|COCH-ARM / FISHERS | P=0.323N P=0.747 P=0.747N P=0.516N |P=0.341 P=0.736 P=0.711 P=0.484 |
|ORDER RESTRICTED | P=0.338N (e) (e) (e) |P=0.378 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 57
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 1/1 (100%) 2/2 (100%) 0/0 (0%) |
|POLY-3 RATE (b) | 0/0.42 0/1.00 0/0.00 0/0.00 |0/1.00 1/1.00 2/2.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 100.0% 100.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 383 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.464 P=0.500 P=0.202 (e) |
|POLY 3 | (e) (e) (e) (e) |(e) P=1.000N P=0.333 (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) P=1.000N P=0.333 (e) |
|POLY 6 | (e) (e) (e) (e) |(e) P=1.000N P=0.333 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.250 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.364 P=0.500 P=0.333 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 1/49 (2%) 2/48 (4%) |
|POLY-3 RATE (b) | 1/44.48 1/43.39 0/44.41 1/43.93 |0/45.67 0/45.69 1/43.76 2/43.52 |
|POLY-3 PERCENT (g) | 2.3% 2.3% 0.0% 2.3% |0.0% 0.0% 2.3% 4.6% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/33 (0%) 0/32 (0%) |0/43 (0%) 0/39 (0%) 1/34 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 705 665 --- 651 |--- --- 729 (T) 368 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.642N P=0.749 P=0.500N P=0.737 |P=0.062 (e) P=0.453 P=0.228 |
|POLY 3 | P=0.613N P=0.755 P=0.500N P=0.758 |P=0.064 (e) P=0.491 P=0.226 |
|POLY 1.5 | P=0.612N P=0.757 P=0.499N P=0.760 |P=0.066 (e) P=0.498 P=0.231 |
|POLY 6 | P=0.615N P=0.756 P=0.502N P=0.755 |P=0.062 (e) P=0.482 P=0.220 |
|LOGISTIC REGRESSION| P=0.609N P=0.756N P=0.498N P=0.749N |P=0.055 (e) P=0.453 P=0.179 |
|COCH-ARM / FISHERS | P=0.612N P=0.747N P=0.495N P=0.747N |P=0.067 (e) P=0.500 P=0.242 |
|ORDER RESTRICTED | P=0.533N (e) (e) (e) |P=0.067 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/06/04 EXPERIMENT: 92013 TEST: 05 Page 58
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2500 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |25/50 (50%) 26/50 (52%) 18/48 (38%) 26/50 (52%) |
|POLY-3 RATE (b) | |25/46.88 26/46.48 18/44.64 26/46.05 |
|POLY-3 PERCENT (g) | |53.3% 55.9% 40.3% 56.5% |
|TERMINAL (d) | |23/43 (54%) 25/39 (64%) 14/34 (41%) 21/35 (60%) |
|FIRST INCIDENCE | |667 434 383 541 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.199 P=0.310 P=0.395N P=0.173 |
|POLY 3 | |P=0.508 P=0.482 P=0.147N P=0.462 |
|POLY 1.5 | |P=0.532 P=0.513 P=0.132N P=0.493 |
|POLY 6 | |P=0.476 P=0.435 P=0.181N P=0.424 |
|LOGISTIC REGRESSION| |P=0.468 P=0.451 P=0.163N P=0.406 |
|COCH-ARM / FISHERS | |P=0.538N P=0.500 P=0.148N P=0.500 |
|ORDER RESTRICTED | |P=0.415 (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).