TDMS Study 05211-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst EMODIN DATE: 04/07/99
EXPERIMENT: 05211 TEST: 06 TIME: 10:51:38
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-85216 ROUTE: DOSED FEED NTP C#: C62408
PATHOLOGIST: FARNELL, D. CAS: 518-82-1
------------------------------------------------------------------------------------------------------------------------------------
CORE STUDY; FINAL#1,REVISION#1
REASONS FOR REMOVAL: 25022 Accidently Killed
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst EMODIN DATE: 04/07/99
EXPERIMENT: 05211 TEST: 06 TIME: 10:51:38
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-85216 ROUTE: DOSED FEED NTP C#: C62408
PATHOLOGIST: FARNELL, D. CAS: 518-82-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF EMODIN
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia Focal
Kidney: Renal Tubule Dilatation
Pigmentation
Liver Eosinophilic Focus
Liver: Hepatocyte Vacuolization Cytoplasmic Focal
Preputial Gland Inflammation Chronic
Seminal Vesicle Dilatation
Thyroid Gland: Follicular Cell Hyperplasia
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Cyst
Kidney Nephropathy
Kidney: Renal Tubule Pigmentation
Liver Inflammation Focal
Lymph Node, Mesenteric Hemorrhage
Lymph Node: Iliac Angiectasis
Thyroid Gland Degeneration Cystic Focal
Thyroid Gland: Follicular Cell Hyperplasia
Uterus Cyst
===============================================================
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 2.2% 0.0% 2.1% |2.2% 2.2% 2.1% 0.0% |
|TERMINAL (d) | 1/41 (2%) 1/37 (3%) 0/40 (0%) 1/43 (2%) |0/37 (0%) 0/39 (0%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 728 729 (T) --- 729 (T) |681 727 90 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.349N P=0.538N P=0.248N P=0.486N |P=0.312N P=0.746N P=0.750N P=0.495N |
|POLY 3 | P=0.364N P=0.514N P=0.242N P=0.499N |P=0.310N P=0.759N P=0.747N P=0.499N |
|POLY 1.5 | P=0.366N P=0.509N P=0.240N P=0.501N |P=0.311N P=0.760 P=0.753N P=0.499N |
|POLY 6 | P=0.362N P=0.520N P=0.243N P=0.494N |P=0.309N P=0.756N P=0.739N P=0.499N |
|LOGISTIC REGRESSION| P=0.344N P=0.538N P=0.239N P=0.481N |P=0.275N P=0.762N P=0.593N P=0.501N |
|COCH-ARM / FISHERS | P=0.367N P=0.500N P=0.247N P=0.500N |P=0.311N P=0.753N P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.1% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 1/41 (2%) 0/37 (0%) 0/40 (0%) 0/43 (0%) |0/37 (0%) 0/39 (0%) 0/40 (0%) 2/36 (6%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.298N P=0.520N P=0.505N P=0.490N |P=0.042 * (e) (e) P=0.232 |
|POLY 3 | P=0.302N P=0.508N P=0.504N P=0.499N |P=0.046 * (e) (e) P=0.239 |
|POLY 1.5 | P=0.303N P=0.505N P=0.503N P=0.501N |P=0.046 * (e) (e) P=0.238 |
|POLY 6 | P=0.302N P=0.511N P=0.505N P=0.496N |P=0.046 * (e) (e) P=0.240 |
|LOGISTIC REGRESSION| P=0.298N (e) (e) (e) |(e) (e) (e) P=0.232 |
|COCH-ARM / FISHERS | P=0.304N P=0.500N P=0.500N P=0.500N |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.8% 2.1% 6.3% |0.0% 2.2% 4.2% 0.0% |
|TERMINAL (d) | 0/41 (0%) 4/37 (11%) 1/40 (3%) 3/43 (7%) |0/37 (0%) 1/39 (3%) 2/40 (5%) 0/36 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |--- 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.259 P=0.051 P=0.495 P=0.130 |P=0.627N P=0.511 P=0.256 (e) |
|POLY 3 | P=0.227 P=0.055 P=0.496 P=0.120 |P=0.613N P=0.502 P=0.247 (e) |
|POLY 1.5 | P=0.225 P=0.057 P=0.497 P=0.119 |P=0.614N P=0.500 P=0.241 (e) |
|POLY 6 | P=0.231 P=0.053 P=0.495 P=0.122 |P=0.611N P=0.506 P=0.256 (e) |
|LOGISTIC REGRESSION| (e) P=0.051 P=0.495 P=0.130 |(e) P=0.511 P=0.256 (e) |
|COCH-ARM / FISHERS | P=0.228 P=0.059 P=0.500 P=0.121 |P=0.616N P=0.500 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.3% 0.0% 0.0% 0.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/41 (7%) 0/37 (0%) 0/40 (0%) 0/43 (0%) |1/37 (3%) 0/39 (0%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.045N* P=0.140N P=0.126N P=0.113N |P=0.307N P=0.489N P=0.484N P=0.505N |
|POLY 3 | P=0.043N* P=0.126N P=0.123N P=0.118N |P=0.305N P=0.498N P=0.491N P=0.498N |
|POLY 1.5 | P=0.043N* P=0.124N P=0.121N P=0.119N |P=0.306N P=0.500N P=0.497N P=0.499N |
|POLY 6 | P=0.042N* P=0.129N P=0.123N P=0.116N |P=0.306N P=0.494N P=0.484N P=0.497N |
|LOGISTIC REGRESSION| P=0.045N* (e) (e) (e) |P=0.307N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.046N* P=0.121N P=0.121N P=0.121N |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 2.2% 4.3% 2.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/41 (5%) 1/37 (3%) 2/40 (5%) 1/43 (2%) |0/37 (0%) 0/39 (0%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.415N P=0.536N P=0.686 P=0.483N |(e) (e) (e) (e) |
|POLY 3 | P=0.436N P=0.514N P=0.686 P=0.499N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.441N P=0.509N P=0.689 P=0.501N |(e) (e) (e) (e) |
|POLY 6 | P=0.429N P=0.520N P=0.685 P=0.494N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.415N P=0.536N P=0.686 P=0.483N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.443N P=0.500N P=0.691N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex: Capsule |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.2% 2.2% 2.1% 2.1% |2.2% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 2/41 (5%) 1/37 (3%) 1/40 (3%) 1/43 (2%) |1/37 (3%) 0/39 (0%) 0/40 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |731 (T) --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.384N P=0.536N P=0.509N P=0.483N |P=0.589 P=0.489N P=0.484N P=0.756 |
|POLY 3 | P=0.404N P=0.514N P=0.507N P=0.499N |P=0.596 P=0.498N P=0.491N P=0.759N |
|POLY 1.5 | P=0.407N P=0.509N P=0.505N P=0.501N |P=0.595 P=0.500N P=0.497N P=0.759N |
|POLY 6 | P=0.399N P=0.520N P=0.509N P=0.494N |P=0.594 P=0.494N P=0.484N P=0.757N |
|LOGISTIC REGRESSION| P=0.384N P=0.536N P=0.509N P=0.483N |P=0.589 (e) (e) P=0.756 |
|COCH-ARM / FISHERS | P=0.409N P=0.500N P=0.500N P=0.500N |P=0.595 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.1% 4.4% 0.0% 2.1% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/41 (0%) 1/37 (3%) 0/40 (0%) 1/43 (2%) |0/37 (0%) 0/39 (0%) 0/40 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 636 639 --- 729 (T) |--- --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.496N P=0.471 P=0.517N P=0.759 |P=0.191 (e) (e) P=0.495 |
|POLY 3 | P=0.505N P=0.480 P=0.506N P=0.760 |P=0.200 (e) (e) P=0.502 |
|POLY 1.5 | P=0.504N P=0.485 P=0.504N P=0.759 |P=0.200 (e) (e) P=0.501 |
|POLY 6 | P=0.504N P=0.475 P=0.507N P=0.759N |P=0.199 (e) (e) P=0.503 |
|LOGISTIC REGRESSION| P=0.486N P=0.579 P=0.399N P=0.748N |(e) (e) (e) P=0.495 |
|COCH-ARM / FISHERS | P=0.502N P=0.492 P=0.500N P=0.753N |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Blood Vessel: Pulmonary Artery, Media |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) |0/0 (0%) 3/4 (75%) 0/2 (0%) 1/2 (50%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 95.1% 0.0% 54.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |0/0 (0%) 3/3 (100%) 0/1 (0%) 1/1 (100%) |
|FIRST INCIDENCE | --- --- --- --- |--- 731 (T) --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.753N P=1.000 (e) P=1.000N |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=1.000 (e) P=1.000N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.500N P=1.000 (e) P=1.000 |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |3/48 (6%) 1/50 (2%) 1/49 (2%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.1% 0.0% 0.0% 2.1% |6.8% 2.2% 2.1% 10.7% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/40 (0%) 1/43 (2%) |1/37 (3%) 0/39 (0%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 680 --- --- 729 (T) |684 633 698 608 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.610 P=0.514N P=0.500N P=0.750N |P=0.166 P=0.287N P=0.269N P=0.368 |
|POLY 3 | P=0.603 P=0.509N P=0.505N P=0.760 |P=0.175 P=0.292N P=0.283N P=0.387 |
|POLY 1.5 | P=0.600 P=0.505N P=0.503N P=0.759 |P=0.173 P=0.293N P=0.292N P=0.383 |
|POLY 6 | P=0.607 P=0.513N P=0.506N P=0.758N |P=0.176 P=0.288N P=0.274N P=0.392 |
|LOGISTIC REGRESSION| P=0.598 P=0.466N P=0.467N P=0.760N |P=0.169 P=0.282N P=0.299N P=0.383 |
|COCH-ARM / FISHERS | P=0.597 P=0.500N P=0.500N P=0.753N |P=0.171 P=0.293N P=0.301N P=0.381 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Brain |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/49 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 2.2% 6.6% |
|TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/40 (0%) 0/43 (0%) |0/37 (0%) 0/39 (0%) 1/40 (3%) 2/36 (6%) |
|FIRST INCIDENCE | --- --- --- --- |484 --- 731 (T) 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.091 P=0.508N P=0.756N P=0.301 |
|POLY 3 | (e) (e) (e) (e) |P=0.097 P=0.501N P=0.759N P=0.304 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.097 P=0.502N P=0.757 P=0.304 |
|POLY 6 | (e) (e) (e) (e) |P=0.096 P=0.499N P=0.752N P=0.304 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.094 P=0.264N P=0.739N P=0.303 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.097 P=0.500N P=0.747 P=0.309 |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/46 (0%) 0/49 (0%) 2/50 (4%) |0/45 (0%) 0/48 (0%) 0/45 (0%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/40 (0%) 2/43 (5%) |0/37 (0%) 0/39 (0%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.055 (e) (e) P=0.249 |(e) (e) (e) (e) |
|POLY 3 | P=0.050 (e) (e) P=0.249 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.050 (e) (e) P=0.249 |(e) (e) (e) (e) |
|POLY 6 | P=0.051 (e) (e) P=0.250 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.249 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.052 (e) (e) P=0.263 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 4/50 (8%) 3/50 (6%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.8% 6.4% 6.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/41 (0%) 4/37 (11%) 3/40 (8%) 3/43 (7%) |0/37 (0%) 0/39 (0%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252 P=0.051 P=0.117 P=0.130 |(e) (e) (e) (e) |
|POLY 3 | P=0.226 P=0.058 P=0.118 P=0.123 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.223 P=0.060 P=0.120 P=0.122 |(e) (e) (e) (e) |
|POLY 6 | P=0.232 P=0.055 P=0.117 P=0.125 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.051 P=0.117 P=0.130 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.224 P=0.061 P=0.125 P=0.125 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Focal Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/49 (0%) 2/50 (4%) 2/50 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.3% 2.1% |0.0% 4.4% 4.2% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 2/40 (5%) 0/43 (0%) |0/37 (0%) 2/39 (5%) 2/40 (5%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 633 |--- 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.262 (e) P=0.233 P=0.492 |P=0.511N P=0.250 P=0.256 (e) |
|POLY 3 | P=0.261 (e) P=0.237 P=0.506 |P=0.492N P=0.243 P=0.251 (e) |
|POLY 1.5 | P=0.255 (e) P=0.239 P=0.504 |P=0.495N P=0.241 P=0.245 (e) |
|POLY 6 | P=0.271 (e) P=0.235 P=0.509 |P=0.489N P=0.246 P=0.258 (e) |
|LOGISTIC REGRESSION| P=0.253 (e) P=0.233 P=0.564 |(e) P=0.250 P=0.256 (e) |
|COCH-ARM / FISHERS | P=0.251 (e) P=0.253 P=0.505 |P=0.501N P=0.253 P=0.253 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 49/49 (100%) 49/50 (98%) 50/50 (100%) 49/50 (98%) |22/49 (45%) 46/50 (92%) 41/50 (82%) 48/49 (98%) |
|POLY-3 ADJUSTED (b)| 100.0% 98.7% 100.0% 98.0% |48.6% 92.6% 85.0% 98.4% |
|TERMINAL (d) | 41/41 (100%) 37/37 (100%) 40/40 (100%) 42/43 (98%) |19/37 (51%) 36/39 (92%) 34/40 (85%) 36/36 (100%) |
|FIRST INCIDENCE | 556 446 497 281 |587 391 625 515 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.243N P=0.209 (e) P=0.402N |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.338N P=0.695N (e) P=0.504N |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.370N P=0.593N (e) P=0.504N |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.287N P=0.897N (e) P=0.504N |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.416N P=0.604N (e) (e) |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.406N P=0.505N (e) P=0.505N |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 3/50 (6%) 1/50 (2%) 6/50 (12%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 6.4% 6.5% 2.1% 12.6% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 2/41 (5%) 1/37 (3%) 1/40 (3%) 6/43 (14%) |0/37 (0%) 0/39 (0%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 636 639 729 (T) 729 (T) |--- 490 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.182 P=0.621 P=0.321N P=0.262 |P=0.566N P=0.496 (e) (e) |
|POLY 3 | P=0.159 P=0.653 P=0.309N P=0.250 |P=0.563N P=0.508 (e) (e) |
|POLY 1.5 | P=0.158 P=0.660 P=0.305N P=0.249 |P=0.566N P=0.506 (e) (e) |
|POLY 6 | P=0.162 P=0.647 P=0.312N P=0.254 |P=0.558N P=0.512 (e) (e) |
|LOGISTIC REGRESSION| P=0.160 P=0.616N P=0.288N P=0.252 |P=0.580N P=0.723 (e) (e) |
|COCH-ARM / FISHERS | P=0.159 P=0.651N P=0.301N P=0.254 |P=0.568N P=0.505 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/49 (2%) 3/50 (6%) 1/50 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.1% |2.2% 6.4% 2.1% 4.4% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/40 (0%) 1/43 (2%) |0/37 (0%) 0/39 (0%) 0/40 (0%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |608 490 730 608 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.213 (e) (e) P=0.510 |P=0.529 P=0.322 P=0.736N P=0.507 |
|POLY 3 | P=0.204 (e) (e) P=0.504 |P=0.534 P=0.319 P=0.749N P=0.507 |
|POLY 1.5 | P=0.202 (e) (e) P=0.503 |P=0.530 P=0.315 P=0.754N P=0.504 |
|POLY 6 | P=0.207 (e) (e) P=0.507 |P=0.536 P=0.326 P=0.744N P=0.509 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.510 |P=0.507 P=0.377 P=0.753N P=0.449 |
|COCH-ARM / FISHERS | P=0.201 (e) (e) P=0.505 |P=0.524 P=0.316 P=0.747N P=0.500 |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 6.3% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/40 (0%) 3/43 (7%) |0/37 (0%) 0/39 (0%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- --- 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.015 * (e) (e) P=0.130 |P=0.192 (e) (e) P=0.500 |
|POLY 3 | P=0.012 * (e) (e) P=0.123 |P=0.200 (e) (e) P=0.504 |
|POLY 1.5 | P=0.011 * (e) (e) P=0.122 |P=0.199 (e) (e) P=0.503 |
|POLY 6 | P=0.012 * (e) (e) P=0.125 |P=0.200 (e) (e) P=0.506 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.130 |P=0.197 (e) (e) P=0.501 |
|COCH-ARM / FISHERS | P=0.012 * (e) (e) P=0.125 |P=0.197 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 46/50 (92%) 50/50 (100%) 50/50 (100%)|0/49 (0%) 37/50 (74%) 48/50 (96%) 49/49 (100%) |
|POLY-3 ADJUSTED (b)| 0.0% 92.7% 100.0% 100.0% |0.0% 78.3% 98.0% 100.0% |
|TERMINAL (d) | 0/41 (0%) 34/37 (92%) 40/40 (100%) 43/43 (100%)|0/37 (0%) 32/39 (82%) 39/40 (98%) 36/36 (100%) |
|FIRST INCIDENCE | --- 446 497 281 |--- 461 461 515 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% 0.0% |0.0% 2.2% 4.2% 2.2% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 1/40 (3%) 0/43 (0%) |0/37 (0%) 1/39 (3%) 2/40 (5%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.704 (e) P=0.495 (e) |P=0.354 P=0.511 P=0.256 P=0.495 |
|POLY 3 | P=0.703 (e) P=0.496 (e) |P=0.370 P=0.502 P=0.247 P=0.502 |
|POLY 1.5 | P=0.699 (e) P=0.497 (e) |P=0.369 P=0.500 P=0.241 P=0.501 |
|POLY 6 | P=0.711 (e) P=0.495 (e) |P=0.371 P=0.506 P=0.256 P=0.503 |
|LOGISTIC REGRESSION| (e) (e) P=0.495 (e) |(e) P=0.511 P=0.256 P=0.495 |
|COCH-ARM / FISHERS | P=0.697 (e) P=0.500 (e) |P=0.366 P=0.500 P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 0.0% 0.0% 4.2% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 1/41 (2%) 0/37 (0%) 0/40 (0%) 2/43 (5%) |0/37 (0%) 0/39 (0%) 1/40 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 639 --- --- 729 (T) |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.520 P=0.258N P=0.247N P=0.682N |P=0.693 (e) P=0.516 (e) |
|POLY 3 | P=0.511 P=0.248N P=0.244N P=0.692 |P=0.694 (e) P=0.509 (e) |
|POLY 1.5 | P=0.507 P=0.244N P=0.241N P=0.691 |P=0.695 (e) P=0.503 (e) |
|POLY 6 | P=0.516 P=0.253N P=0.245N P=0.691N |P=0.693 (e) P=0.516 (e) |
|LOGISTIC REGRESSION| P=0.503 P=0.200N P=0.203N P=0.691N |(e) (e) P=0.516 (e) |
|COCH-ARM / FISHERS | P=0.503 P=0.247N P=0.247N P=0.691N |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 4/50 (8%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 2.2% 0.0% 8.4% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 2/41 (5%) 1/37 (3%) 0/40 (0%) 4/43 (9%) |0/37 (0%) 1/39 (3%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.190 P=0.536N P=0.244N P=0.359 |P=0.573N P=0.511 (e) (e) |
|POLY 3 | P=0.168 P=0.514N P=0.242N P=0.339 |P=0.563N P=0.502 (e) (e) |
|POLY 1.5 | P=0.166 P=0.509N P=0.240N P=0.336 |P=0.565N P=0.500 (e) (e) |
|POLY 6 | P=0.171 P=0.520N P=0.243N P=0.346 |P=0.558N P=0.506 (e) (e) |
|LOGISTIC REGRESSION| P=0.190 P=0.536N (e) P=0.359 |(e) P=0.511 (e) (e) |
|COCH-ARM / FISHERS | P=0.165 P=0.500N P=0.247N P=0.339 |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Congestion Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.1% |2.2% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/40 (0%) 1/43 (2%) |1/37 (3%) 0/39 (0%) 2/40 (5%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |731 (T) --- 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.213 (e) (e) P=0.510 |P=0.489 P=0.489N P=0.527 P=0.756 |
|POLY 3 | P=0.202 (e) (e) P=0.501 |P=0.502 P=0.498N P=0.515 P=0.759N |
|POLY 1.5 | P=0.201 (e) (e) P=0.499 |P=0.502 P=0.500N P=0.506 P=0.759N |
|POLY 6 | P=0.205 (e) (e) P=0.504 |P=0.500 P=0.494N P=0.528 P=0.757N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.510 |P=0.489 (e) P=0.527 P=0.756 |
|COCH-ARM / FISHERS | P=0.199 (e) (e) P=0.500 |P=0.500 P=0.500N P=0.500 P=0.753N |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 14.7% 0.0% 2.1% 4.2% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 6/41 (15%) 0/37 (0%) 1/40 (3%) 2/43 (5%) |0/37 (0%) 0/39 (0%) 0/40 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 699 --- 729 (T) 729 (T) |--- --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066N P=0.014N* P=0.036N* P=0.072N |P=0.191 (e) (e) P=0.495 |
|POLY 3 | P=0.066N P=0.009N** P=0.033N* P=0.079N |P=0.200 (e) (e) P=0.502 |
|POLY 1.5 | P=0.068N P=0.008N** P=0.032N* P=0.080N |P=0.200 (e) (e) P=0.501 |
|POLY 6 | P=0.063N P=0.010N* P=0.033N* P=0.076N |P=0.199 (e) (e) P=0.503 |
|LOGISTIC REGRESSION| P=0.067N P=0.012N* P=0.034N* P=0.073N |(e) (e) (e) P=0.495 |
|COCH-ARM / FISHERS | P=0.075N P=0.006N** P=0.030N* P=0.080N |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 2.1% 4.4% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/40 (0%) 0/43 (0%) |1/37 (3%) 0/39 (0%) 1/40 (3%) 2/36 (6%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) --- 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.234 P=0.489N P=0.744N P=0.490 |
|POLY 3 | (e) (e) (e) (e) |P=0.250 P=0.498N P=0.751N P=0.503 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.249 P=0.500N P=0.757N P=0.502 |
|POLY 6 | (e) (e) (e) (e) |P=0.248 P=0.494N P=0.742N P=0.505 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.234 (e) P=0.744N P=0.490 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.247 P=0.500N P=0.753N P=0.500 |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia Focal Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.2% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/40 (0%) 0/43 (0%) |0/37 (0%) 0/39 (0%) 2/40 (5%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.589 (e) P=0.256 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.596 (e) P=0.247 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.597 (e) P=0.241 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.594 (e) P=0.256 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.256 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |5/50 (10%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.1% 0.0% 0.0% 0.0% |11.1% 6.5% 0.0% 0.0% |
|TERMINAL (d) | 1/41 (2%) 0/37 (0%) 0/40 (0%) 0/43 (0%) |5/37 (14%) 2/39 (5%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |731 (T) 391 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.298N P=0.520N P=0.505N P=0.490N |P=0.007N** P=0.332N P=0.027N* P=0.035N* |
|POLY 3 | P=0.302N P=0.508N P=0.504N P=0.499N |P=0.006N** P=0.341N P=0.027N* P=0.030N* |
|POLY 1.5 | P=0.303N P=0.505N P=0.503N P=0.501N |P=0.007N** P=0.349N P=0.029N* P=0.030N* |
|POLY 6 | P=0.302N P=0.511N P=0.505N P=0.496N |P=0.006N** P=0.329N P=0.024N* P=0.029N* |
|LOGISTIC REGRESSION| P=0.298N (e) (e) (e) |P=0.007N** P=0.352N (e) (e) |
|COCH-ARM / FISHERS | P=0.304N P=0.500N P=0.500N P=0.500N |P=0.007N** P=0.357N P=0.028N* P=0.028N* |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.5% 4.2% 4.1% |0.0% 2.2% 0.0% 4.4% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/40 (0%) 0/43 (0%) |0/37 (0%) 0/39 (0%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 446 579 604 |--- 681 --- 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.412 P=0.062 P=0.228 P=0.247 |P=0.140 P=0.510 (e) P=0.245 |
|POLY 3 | P=0.408 P=0.060 P=0.237 P=0.241 |P=0.143 P=0.503 (e) P=0.241 |
|POLY 1.5 | P=0.401 P=0.060 P=0.237 P=0.238 |P=0.141 P=0.501 (e) P=0.239 |
|POLY 6 | P=0.422 P=0.060 P=0.239 P=0.246 |P=0.145 P=0.507 (e) P=0.243 |
|LOGISTIC REGRESSION| P=0.489 P=0.156 P=0.462 P=0.278 |P=0.139 P=0.504 (e) P=0.237 |
|COCH-ARM / FISHERS | P=0.399 P=0.059 P=0.247 P=0.247 |P=0.140 P=0.500 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 2.1% 2.2% 2.1% 2.1% |2.2% 6.5% 4.2% 8.6% |
|TERMINAL (d) | 1/41 (2%) 1/37 (3%) 1/40 (3%) 1/43 (2%) |1/37 (3%) 1/39 (3%) 1/40 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |731 (T) 552 673 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.609N P=0.739 P=0.756 P=0.751N |P=0.165 P=0.322 P=0.531 P=0.186 |
|POLY 3 | P=0.630N P=0.751 P=0.756 P=0.760N |P=0.171 P=0.315 P=0.517 P=0.187 |
|POLY 1.5 | P=0.632N P=0.755 P=0.757 P=0.760 |P=0.167 P=0.309 P=0.507 P=0.183 |
|POLY 6 | P=0.625N P=0.748 P=0.755 P=0.757N |P=0.176 P=0.326 P=0.531 P=0.192 |
|LOGISTIC REGRESSION| P=0.609N P=0.739 P=0.756 P=0.751N |P=0.159 P=0.318 P=0.504 P=0.177 |
|COCH-ARM / FISHERS | P=0.634 P=0.753N P=0.753N P=0.753N |P=0.162 P=0.309 P=0.500 P=0.181 |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 10/50 (20%) 7/50 (14%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 27.3% 21.9% 15.0% 12.6% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 13/41 (32%) 10/37 (27%) 7/40 (18%) 6/43 (14%) |0/37 (0%) 0/39 (0%) 1/40 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026N* P=0.420N P=0.112N P=0.047N* |P=0.693 (e) P=0.516 (e) |
|POLY 3 | P=0.036N* P=0.356N P=0.112N P=0.059N |P=0.694 (e) P=0.509 (e) |
|POLY 1.5 | P=0.039N* P=0.342N P=0.110N P=0.062N |P=0.695 (e) P=0.503 (e) |
|POLY 6 | P=0.032N* P=0.372N P=0.113N P=0.054N |P=0.693 (e) P=0.516 (e) |
|LOGISTIC REGRESSION| P=0.026N* P=0.420N P=0.112N P=0.047N* |(e) (e) P=0.516 (e) |
|COCH-ARM / FISHERS | P=0.041N* P=0.318N P=0.105N P=0.062N |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.5% 0.0% 4.2% |0.0% 0.0% 4.2% 0.0% |
|TERMINAL (d) | 0/41 (0%) 1/37 (3%) 0/40 (0%) 2/43 (5%) |0/37 (0%) 0/39 (0%) 2/40 (5%) 0/36 (0%) |
|FIRST INCIDENCE | --- 636 --- 729 (T) |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.367 P=0.109 (e) P=0.249 |P=0.589 (e) P=0.256 (e) |
|POLY 3 | P=0.343 P=0.113 (e) P=0.238 |P=0.596 (e) P=0.247 (e) |
|POLY 1.5 | P=0.342 P=0.115 (e) P=0.237 |P=0.597 (e) P=0.241 (e) |
|POLY 6 | P=0.348 P=0.112 (e) P=0.241 |P=0.594 (e) P=0.256 (e) |
|LOGISTIC REGRESSION| P=0.346 P=0.133 (e) P=0.249 |(e) (e) P=0.256 (e) |
|COCH-ARM / FISHERS | P=0.346 P=0.121 (e) P=0.247 |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.2% 2.2% 8.6% 0.0% |4.4% 2.2% 0.0% 2.2% |
|TERMINAL (d) | 1/41 (2%) 0/37 (0%) 4/40 (10%) 0/43 (0%) |2/37 (5%) 1/39 (3%) 0/40 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 639 695 729 (T) --- |731 (T) 731 (T) --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.261N P=0.525N P=0.326 P=0.237N |P=0.374N P=0.482N P=0.221N P=0.510N |
|POLY 3 | P=0.270N P=0.515N P=0.325 P=0.238N |P=0.364N P=0.497N P=0.228N P=0.497N |
|POLY 1.5 | P=0.274N P=0.510N P=0.330 P=0.239N |P=0.365N P=0.500N P=0.234N P=0.498N |
|POLY 6 | P=0.262N P=0.522N P=0.321 P=0.236N |P=0.362N P=0.490N P=0.220N P=0.495N |
|LOGISTIC REGRESSION| P=0.277N P=0.458N P=0.333 P=0.215N |P=0.374N P=0.482N (e) P=0.510N |
|COCH-ARM / FISHERS | P=0.277N P=0.500N P=0.339 P=0.247N |P=0.366N P=0.500N P=0.247N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) |1/48 (2%) 2/46 (4%) 1/47 (2%) 2/47 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 4.8% 2.2% 4.6% |
|TERMINAL (d) | 0/40 (0%) 0/36 (0%) 0/40 (0%) 0/41 (0%) |1/35 (3%) 2/36 (6%) 1/39 (3%) 2/35 (6%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.445 P=0.510 P=0.738N P=0.500 |
|POLY 3 | (e) (e) (e) (e) |P=0.456 P=0.487 P=0.751N P=0.503 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.450 P=0.485 P=0.759N P=0.499 |
|POLY 6 | (e) (e) (e) (e) |P=0.462 P=0.494 P=0.741N P=0.508 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.445 P=0.510 P=0.738N P=0.500 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.441 P=0.484 P=0.747 P=0.492 |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/46 (0%) 0/50 (0%) 1/49 (2%) |0/49 (0%) 1/48 (2%) 0/50 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.1% |0.0% 2.3% 0.0% 4.4% |
|TERMINAL (d) | 0/41 (0%) 0/34 (0%) 0/40 (0%) 0/43 (0%) |0/37 (0%) 1/38 (3%) 0/40 (0%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- 723 |--- 731 (T) --- 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.217 (e) (e) P=0.514 |P=0.133 P=0.505 (e) P=0.237 |
|POLY 3 | P=0.207 (e) (e) P=0.502 |P=0.145 P=0.497 (e) P=0.243 |
|POLY 1.5 | P=0.205 (e) (e) P=0.500 |P=0.143 P=0.495 (e) P=0.241 |
|POLY 6 | P=0.210 (e) (e) P=0.505 |P=0.147 P=0.500 (e) P=0.245 |
|LOGISTIC REGRESSION| P=0.210 (e) (e) P=0.503 |P=0.143 P=0.505 (e) P=0.243 |
|COCH-ARM / FISHERS | P=0.202 (e) (e) P=0.500 |P=0.141 P=0.495 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 4/46 (9%) 3/50 (6%) 5/49 (10%) |0/49 (0%) 0/48 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 14.9% 9.6% 6.4% 10.6% |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 6/41 (15%) 4/34 (12%) 2/40 (5%) 4/43 (9%) |0/37 (0%) 0/38 (0%) 0/40 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 636 729 (T) 688 684 |--- --- --- 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.302N P=0.371N P=0.173N P=0.354N |P=0.045 * (e) (e) P=0.242 |
|POLY 3 | P=0.329N P=0.333N P=0.160N P=0.376N |P=0.047 * (e) (e) P=0.243 |
|POLY 1.5 | P=0.337N P=0.319N P=0.157N P=0.381N |P=0.047 * (e) (e) P=0.241 |
|POLY 6 | P=0.317N P=0.349N P=0.163N P=0.365N |P=0.047 * (e) (e) P=0.246 |
|LOGISTIC REGRESSION| P=0.326N P=0.337N P=0.155N P=0.379N |P=0.047 * (e) (e) P=0.237 |
|COCH-ARM / FISHERS | P=0.342N P=0.300N P=0.151N P=0.380N |P=0.047 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/46 (0%) 1/50 (2%) 3/49 (6%) |0/49 (0%) 0/48 (0%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 4.3% 0.0% 2.1% 6.4% |0.0% 0.0% 2.1% 2.2% |
|TERMINAL (d) | 2/41 (5%) 0/34 (0%) 1/40 (3%) 3/43 (7%) |0/37 (0%) 0/38 (0%) 1/40 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |--- --- 731 (T) 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.282 P=0.280N P=0.509N P=0.522 |P=0.232 (e) P=0.516 P=0.505 |
|POLY 3 | P=0.262 P=0.263N P=0.501N P=0.504 |P=0.245 (e) P=0.512 P=0.505 |
|POLY 1.5 | P=0.257 P=0.258N P=0.498N P=0.500 |P=0.242 (e) P=0.507 P=0.503 |
|POLY 6 | P=0.269 P=0.267N P=0.503N P=0.512 |P=0.245 (e) P=0.519 P=0.507 |
|LOGISTIC REGRESSION| P=0.282 (e) P=0.509N P=0.522 |P=0.239 (e) P=0.516 P=0.494 |
|COCH-ARM / FISHERS | P=0.252 P=0.263N P=0.492N P=0.500 |P=0.237 (e) P=0.505 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/46 (2%) 1/50 (2%) 2/49 (4%) |1/49 (2%) 1/48 (2%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.4% 2.1% 4.2% |2.3% 2.3% 2.1% 2.2% |
|TERMINAL (d) | 0/41 (0%) 1/34 (3%) 1/40 (3%) 1/43 (2%) |1/37 (3%) 0/38 (0%) 1/40 (3%) 1/36 (3%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 723 |731 (T) 707 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.180 P=0.463 P=0.495 P=0.253 |P=0.628 P=0.746N P=0.744N P=0.756 |
|POLY 3 | P=0.162 P=0.478 P=0.500 P=0.239 |P=0.624N P=0.757 P=0.747N P=0.756N |
|POLY 1.5 | P=0.159 P=0.481 P=0.501 P=0.237 |P=0.626N P=0.756 P=0.752N P=0.757N |
|POLY 6 | P=0.167 P=0.474 P=0.499 P=0.243 |P=0.622N P=0.760N P=0.739N P=0.754N |
|LOGISTIC REGRESSION| P=0.178 P=0.463 P=0.495 P=0.245 |P=0.624N P=0.761 P=0.744N P=0.756 |
|COCH-ARM / FISHERS | P=0.157 P=0.484 P=0.505 P=0.247 |P=0.631N P=0.747 P=0.747N P=0.753N |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/1 (0%) |0/8 (0%) 0/7 (0%) 0/9 (0%) 2/7 (29%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 33.3% |
|TERMINAL (d) | 0/3 (0%) 0/2 (0%) 0/3 (0%) 0/1 (0%) |0/3 (0%) 0/4 (0%) 0/5 (0%) 1/2 (50%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.026 * (e) (e) P=0.196 |
|POLY 3 | (e) (e) (e) (e) |P=0.024 * (e) (e) P=0.185 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.025 * (e) (e) P=0.186 |
|POLY 6 | (e) (e) (e) (e) |P=0.023 * (e) (e) P=0.182 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.022 * (e) (e) P=0.165 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.035 * (e) (e) P=0.200 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/1 (0%) 0/1 (0%) 0/1 (0%) |2/49 (4%) 0/50 (0%) 1/49 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 2.2% 2.2% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/1 (0%) |0/36 (0%) 0/39 (0%) 1/39 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |484 --- 731 (T) 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.506N P=0.236N P=0.482N P=0.505N |
|POLY 3 | (e) (e) (e) (e) |P=0.494N P=0.234N P=0.491N P=0.495N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.495N P=0.235N P=0.498N P=0.495N |
|POLY 6 | (e) (e) (e) (e) |P=0.495N P=0.231N P=0.481N P=0.495N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.498N P=0.160N P=0.469N P=0.487N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.496N P=0.242N P=0.500N P=0.492N |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 2/4 (50%) 1/6 (17%) 1/5 (20%) |7/14 (50%) 10/16 (63%) 12/15 (80%) 6/11 (55%) |
|POLY-3 ADJUSTED (b)| 100.0% 54.2% 20.1% 21.5% |55.9% 68.3% 82.8% 61.8% |
|TERMINAL (d) | 2/2 (100%) 2/3 (67%) 1/4 (25%) 1/4 (25%) |6/8 (75%) 8/10 (80%) 10/10 (100%) 4/5 (80%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |587 707 658 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.100N P=0.581N P=0.215N P=0.215N |P=0.309 P=0.442 P=0.175 P=0.449 |
|POLY 3 | P=0.061N P=0.428N P=0.070N P=0.099N |P=0.416 P=0.392 P=0.118 P=0.562 |
|POLY 1.5 | P=0.065N P=0.407N P=0.058N P=0.094N |P=0.417 P=0.379 P=0.104 P=0.557 |
|POLY 6 | P=0.058N P=0.468N P=0.096N P=0.111N |P=0.437 P=0.431 P=0.151 P=0.587 |
|LOGISTIC REGRESSION| P=0.100N P=0.581N P=0.215N P=0.215N |P=0.504 P=0.560 P=0.229 P=0.624 |
|COCH-ARM / FISHERS | P=0.085N P=0.400N P=0.107N P=0.143N |P=0.441 P=0.374 P=0.095 P=0.570 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/45 (7%) 0/44 (0%) 4/48 (8%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| |7.3% 0.0% 8.7% 4.5% |
|TERMINAL (d) | |3/35 (9%) 0/34 (0%) 3/39 (8%) 2/35 (6%) |
|FIRST INCIDENCE | |731 (T) --- 720 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.576 P=0.126N P=0.560 P=0.500N |
|POLY 3 | |P=0.567N P=0.125N P=0.561 P=0.465N |
|POLY 1.5 | |P=0.570N P=0.125N P=0.546 P=0.467N |
|POLY 6 | |P=0.568N P=0.124N P=0.578 P=0.466N |
|LOGISTIC REGRESSION| |P=0.589N (e) P=0.590 P=0.500N |
|COCH-ARM / FISHERS | |P=0.578N P=0.125N P=0.536 P=0.469N |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |16/45 (36%) 11/44 (25%) 12/48 (25%) 11/48 (23%) |
|POLY-3 ADJUSTED (b)| |38.3% 27.8% 25.8% 23.7% |
|TERMINAL (d) | |14/35 (40%) 10/34 (29%) 10/39 (26%) 6/35 (17%) |
|FIRST INCIDENCE | |608 720 625 515 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.186N P=0.196N P=0.158N P=0.186N |
|POLY 3 | |P=0.102N P=0.220N P=0.151N P=0.103N |
|POLY 1.5 | |P=0.115N P=0.213N P=0.172N P=0.114N |
|POLY 6 | |P=0.092N P=0.225N P=0.130N P=0.095N |
|LOGISTIC REGRESSION| |P=0.135N P=0.202N P=0.169N P=0.140N |
|COCH-ARM / FISHERS | |P=0.139N P=0.197N P=0.189N P=0.133N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pancreas |
| Lipomatosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/48 (2%) 2/49 (4%) 2/49 (4%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.1% |2.3% 4.5% 4.2% 4.4% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/40 (0%) 1/43 (2%) |0/37 (0%) 1/39 (3%) 1/40 (3%) 2/36 (6%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |699 659 625 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.213 (e) (e) P=0.510 |P=0.418 P=0.523 P=0.536 P=0.491 |
|POLY 3 | P=0.204 (e) (e) P=0.504 |P=0.432 P=0.505 P=0.524 P=0.506 |
|POLY 1.5 | P=0.202 (e) (e) P=0.503 |P=0.428 P=0.505 P=0.514 P=0.504 |
|POLY 6 | P=0.207 (e) (e) P=0.507 |P=0.433 P=0.510 P=0.535 P=0.507 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.510 |P=0.416 P=0.511 P=0.511 P=0.508 |
|COCH-ARM / FISHERS | P=0.201 (e) (e) P=0.505 |P=0.420 P=0.508 P=0.508 P=0.500 |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/48 (2%) 1/49 (2%) 2/49 (4%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% 0.0% |2.3% 2.2% 4.3% 2.2% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/40 (0%) 0/43 (0%) |1/37 (3%) 1/39 (3%) 2/40 (5%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- 572 --- |731 (T) 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.697 (e) P=0.496 (e) |P=0.581 P=0.750N P=0.527 P=0.756 |
|POLY 3 | P=0.705 (e) P=0.502 (e) |P=0.600 P=0.758N P=0.522 P=0.756N |
|POLY 1.5 | P=0.701 (e) P=0.502 (e) |P=0.597 P=0.758N P=0.513 P=0.757N |
|POLY 6 | P=0.712 (e) P=0.502 (e) |P=0.601 P=0.756N P=0.533 P=0.755N |
|LOGISTIC REGRESSION| P=0.738N (e) P=0.748 (e) |P=0.581 P=0.750N P=0.527 P=0.756 |
|COCH-ARM / FISHERS | P=0.699 (e) P=0.505 (e) |P=0.590 P=0.747N P=0.508 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/48 (6%) 1/49 (2%) 1/49 (2%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.8% 2.2% 2.1% 4.4% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/40 (0%) 0/43 (0%) |3/37 (8%) 0/39 (0%) 0/40 (0%) 2/36 (6%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) 659 625 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.478N P=0.287N P=0.277N P=0.513N |
|POLY 3 | (e) (e) (e) (e) |P=0.467N P=0.299N P=0.280N P=0.490N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.470N P=0.300N P=0.290N P=0.494N |
|POLY 6 | (e) (e) (e) (e) |P=0.467N P=0.293N P=0.268N P=0.488N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.478N P=0.300N P=0.298N P=0.513N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.476N P=0.301N P=0.301N P=0.500N |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/44 (2%) 4/47 (9%) 1/46 (2%) 0/45 (0%) |0/44 (0%) 3/47 (6%) 0/45 (0%) 0/47 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 9.3% 2.3% 0.0% |0.0% 6.9% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 2/35 (6%) 1/37 (3%) 0/39 (0%) |0/31 (0%) 1/36 (3%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 636 645 729 (T) --- |--- 391 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.158N P=0.174 P=0.757 P=0.513N |P=0.304N P=0.136 (e) (e) |
|POLY 3 | P=0.162N P=0.187 P=0.754N P=0.494N |P=0.283N P=0.139 (e) (e) |
|POLY 1.5 | P=0.164N P=0.192 P=0.753N P=0.496N |P=0.291N P=0.135 (e) (e) |
|POLY 6 | P=0.158N P=0.184 P=0.754N P=0.491N |P=0.273N P=0.146 (e) (e) |
|LOGISTIC REGRESSION| P=0.160N P=0.227 P=0.735N P=0.444N |P=0.291N P=0.165 (e) (e) |
|COCH-ARM / FISHERS | P=0.164N P=0.202 P=0.742N P=0.494N |P=0.300N P=0.133 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/40 (3%) 2/38 (5%) 1/42 (2%) 1/46 (2%) |0/46 (0%) 1/45 (2%) 1/46 (2%) 0/44 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 5.7% 2.6% 2.3% |0.0% 2.4% 2.3% 0.0% |
|TERMINAL (d) | 1/34 (3%) 2/28 (7%) 1/34 (3%) 1/41 (2%) |0/34 (0%) 1/37 (3%) 1/39 (3%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.446N P=0.432 P=0.762 P=0.720N |P=0.613N P=0.517 P=0.527 (e) |
|POLY 3 | P=0.475N P=0.471 P=0.755N P=0.728N |P=0.599N P=0.501 P=0.510 (e) |
|POLY 1.5 | P=0.477N P=0.476 P=0.753N P=0.730N |P=0.601N P=0.498 P=0.504 (e) |
|POLY 6 | P=0.469N P=0.466 P=0.756N P=0.724N |P=0.597N P=0.507 P=0.519 (e) |
|LOGISTIC REGRESSION| P=0.446N P=0.432 P=0.762 P=0.720N |(e) P=0.517 P=0.527 (e) |
|COCH-ARM / FISHERS | P=0.477N P=0.481 P=0.741N P=0.717N |P=0.603N P=0.495 P=0.500 (e) |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/40 (0%) 0/38 (0%) 0/42 (0%) 0/46 (0%) |2/46 (4%) 2/45 (4%) 3/46 (7%) 3/44 (7%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.8% 4.8% 6.9% 7.5% |
|TERMINAL (d) | 0/34 (0%) 0/28 (0%) 0/34 (0%) 0/41 (0%) |2/34 (6%) 2/37 (5%) 2/39 (5%) 3/32 (9%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) 731 (T) 730 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.336 P=0.665N P=0.561 P=0.472 |
|POLY 3 | (e) (e) (e) (e) |P=0.354 P=0.692N P=0.523 P=0.483 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.354 P=0.691 P=0.509 P=0.481 |
|POLY 6 | (e) (e) (e) (e) |P=0.353 P=0.682N P=0.542 P=0.485 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.329 P=0.665N P=0.577 P=0.472 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.353 P=0.683 P=0.500 P=0.479 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/40 (0%) 0/38 (0%) 0/42 (0%) 0/46 (0%) |3/46 (7%) 1/45 (2%) 3/46 (7%) 3/44 (7%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |7.2% 2.4% 6.9% 7.5% |
|TERMINAL (d) | 0/34 (0%) 0/28 (0%) 0/34 (0%) 0/41 (0%) |2/34 (6%) 1/37 (3%) 3/39 (8%) 3/32 (9%) |
|FIRST INCIDENCE | --- --- --- --- |699 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.422 P=0.278N P=0.599N P=0.637 |
|POLY 3 | (e) (e) (e) (e) |P=0.435 P=0.304N P=0.640N P=0.644 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.437 P=0.309N P=0.654N P=0.643 |
|POLY 6 | (e) (e) (e) (e) |P=0.431 P=0.294N P=0.622N P=0.645 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.434 P=0.292N P=0.616N P=0.648 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.438 P=0.317N P=0.662N P=0.640 |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Preputial Gland |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/47 (32%) 21/50 (42%) 24/50 (48%) 24/50 (48%) | |
|POLY-3 ADJUSTED (b)| 32.8% 44.6% 49.8% 48.7% | |
|TERMINAL (d) | 10/38 (26%) 15/37 (41%) 18/40 (45%) 20/43 (47%) | |
|FIRST INCIDENCE | 636 631 541 281 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.156 P=0.139 P=0.085 P=0.126 | |
|POLY 3 | P=0.088 P=0.170 P=0.070 P=0.086 | |
|POLY 1.5 | P=0.082 P=0.183 P=0.073 P=0.083 | |
|POLY 6 | P=0.096 P=0.159 P=0.069 P=0.090 | |
|LOGISTIC REGRESSION| P=0.074 P=0.196 P=0.083 P=0.079 | |
|COCH-ARM / FISHERS | P=0.074 P=0.207 P=0.079 P=0.079 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/47 (17%) 6/50 (12%) 2/50 (4%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 17.7% 13.1% 4.3% 4.2% | |
|TERMINAL (d) | 6/38 (16%) 6/37 (16%) 1/40 (3%) 2/43 (5%) | |
|FIRST INCIDENCE | 639 729 (T) 639 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.013N* P=0.413N P=0.048N* P=0.036N* | |
|POLY 3 | P=0.013N* P=0.377N P=0.039N* P=0.036N* | |
|POLY 1.5 | P=0.014N* P=0.363N P=0.038N* P=0.037N* | |
|POLY 6 | P=0.013N* P=0.396N P=0.040N* P=0.035N* | |
|LOGISTIC REGRESSION| P=0.014N* P=0.368N P=0.034N* P=0.038N* | |
|COCH-ARM / FISHERS | P=0.015N* P=0.339N P=0.036N* P=0.036N* | |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 25/50 (50%) 18/50 (36%) 19/50 (38%) | |
|POLY-3 ADJUSTED (b)| 57.8% 53.1% 38.5% 39.8% | |
|TERMINAL (d) | 24/41 (59%) 22/37 (60%) 17/40 (43%) 18/43 (42%) | |
|FIRST INCIDENCE | 639 446 688 725 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014N* P=0.543N P=0.047N* P=0.038N* | |
|POLY 3 | P=0.029N* P=0.397N P=0.044N* P=0.056N | |
|POLY 1.5 | P=0.031N* P=0.374N P=0.039N* P=0.057N | |
|POLY 6 | P=0.026N* P=0.434N P=0.049N* P=0.055N | |
|LOGISTIC REGRESSION| P=0.023N* P=0.407N P=0.042N* P=0.043N* | |
|COCH-ARM / FISHERS | P=0.031N* P=0.344N P=0.035N* P=0.054N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 14/50 (28%) 14/50 (28%) 10/49 (20%) |9/48 (19%) 14/49 (29%) 17/49 (35%) 16/49 (33%) |
|POLY-3 ADJUSTED (b)| 26.4% 29.3% 28.7% 20.8% |20.1% 30.1% 36.0% 34.2% |
|TERMINAL (d) | 8/41 (20%) 7/37 (19%) 7/40 (18%) 7/43 (16%) |5/37 (14%) 9/39 (23%) 15/40 (38%) 10/36 (28%) |
|FIRST INCIDENCE | 556 446 497 604 |541 490 658 525 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222N P=0.407 P=0.471 P=0.303N |P=0.082 P=0.220 P=0.098 P=0.092 |
|POLY 3 | P=0.264N P=0.461 P=0.487 P=0.343N |P=0.099 P=0.195 P=0.069 P=0.098 |
|POLY 1.5 | P=0.271N P=0.476 P=0.492 P=0.346N |P=0.096 P=0.188 P=0.062 P=0.095 |
|POLY 6 | P=0.250N P=0.445 P=0.485 P=0.334N |P=0.101 P=0.208 P=0.078 P=0.100 |
|LOGISTIC REGRESSION| P=0.284N P=0.555N P=0.582N P=0.328N |P=0.090 P=0.192 P=0.068 P=0.089 |
|COCH-ARM / FISHERS | P=0.267N P=0.500 P=0.500 P=0.337N |P=0.090 P=0.185 P=0.061 P=0.091 |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 3/50 (6%) 2/49 (4%) |9/48 (19%) 10/49 (20%) 10/49 (20%) 12/49 (24%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.8% 6.4% 4.2% |20.4% 22.4% 21.3% 26.5% |
|TERMINAL (d) | 0/41 (0%) 4/37 (11%) 3/40 (8%) 2/43 (5%) |8/37 (22%) 9/39 (23%) 10/40 (25%) 12/36 (33%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |681 707 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.420 P=0.051 P=0.117 P=0.249 |P=0.229 P=0.553 P=0.577 P=0.284 |
|POLY 3 | P=0.380 P=0.055 P=0.115 P=0.235 |P=0.293 P=0.513 P=0.560 P=0.336 |
|POLY 1.5 | P=0.374 P=0.057 P=0.117 P=0.233 |P=0.290 P=0.512 P=0.537 P=0.335 |
|POLY 6 | P=0.393 P=0.053 P=0.114 P=0.239 |P=0.289 P=0.522 P=0.587 P=0.331 |
|LOGISTIC REGRESSION| (e) P=0.051 P=0.117 P=0.249 |P=0.265 P=0.537 P=0.586N P=0.316 |
|COCH-ARM / FISHERS | P=0.374 P=0.059 P=0.121 P=0.242 |P=0.281 P=0.520 P=0.520 P=0.331 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |1/50 (2%) 0/49 (0%) 2/48 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 2.1% 6.2% |2.2% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/40 (0%) 2/43 (5%) |0/37 (0%) 0/39 (0%) 1/40 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- 631 688 281 |587 --- 658 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.062 P=0.492 P=0.505 P=0.129 |P=0.457N P=0.509N P=0.527 P=0.500N |
|POLY 3 | P=0.057 P=0.493 P=0.496 P=0.123 |P=0.462N P=0.505N P=0.505 P=0.502N |
|POLY 1.5 | P=0.056 P=0.496 P=0.498 P=0.121 |P=0.463N P=0.505N P=0.494 P=0.503N |
|POLY 6 | P=0.059 P=0.491 P=0.496 P=0.126 |P=0.463N P=0.502N P=0.518 P=0.501N |
|LOGISTIC REGRESSION| P=0.071 P=0.608 P=0.523 P=0.183 |P=0.472N P=0.433N P=0.497 P=0.498N |
|COCH-ARM / FISHERS | P=0.054 P=0.500 P=0.500 P=0.121 |P=0.466N P=0.505N P=0.485 P=0.505N |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Glandular: Glands |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 5/50 (10%) 1/50 (2%) |1/50 (2%) 3/49 (6%) 1/48 (2%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| 2.1% 6.5% 10.7% 2.1% |2.2% 6.7% 2.2% 2.2% |
|TERMINAL (d) | 1/41 (2%) 2/37 (5%) 3/40 (8%) 1/43 (2%) |0/37 (0%) 3/39 (8%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) 639 688 729 (T) |721 731 (T) 658 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.511N P=0.274 P=0.105 P=0.751N |P=0.449N P=0.325 P=0.734N P=0.757 |
|POLY 3 | P=0.538N P=0.294 P=0.098 P=0.760N |P=0.441N P=0.300 P=0.755N P=0.760 |
|POLY 1.5 | P=0.544N P=0.298 P=0.099 P=0.760 |P=0.449N P=0.298 P=0.758 P=0.757 |
|POLY 6 | P=0.526N P=0.289 P=0.099 P=0.757N |P=0.433N P=0.307 P=0.745N P=0.758N |
|LOGISTIC REGRESSION| P=0.544N P=0.307 P=0.100 P=0.751N |P=0.451N P=0.318 P=0.753 P=0.761 |
|COCH-ARM / FISHERS | P=0.544N P=0.309 P=0.102 P=0.753N |P=0.459N P=0.301 P=0.742 P=0.742 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/42 (5%) 4/45 (9%) 3/46 (7%) 0/39 (0%) |0/49 (0%) 0/49 (0%) 0/46 (0%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| 5.0% 9.8% 6.9% 0.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 2/36 (6%) 3/34 (9%) 2/38 (5%) 0/34 (0%) |0/37 (0%) 0/39 (0%) 0/38 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) 699 688 --- |--- --- --- 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.141N P=0.309 P=0.520 P=0.251N |P=0.200 (e) (e) P=0.510 |
|POLY 3 | P=0.151N P=0.344 P=0.532 P=0.254N |P=0.199 (e) (e) P=0.501 |
|POLY 1.5 | P=0.154N P=0.354 P=0.535 P=0.255N |P=0.198 (e) (e) P=0.499 |
|POLY 6 | P=0.146N P=0.333 P=0.531 P=0.251N |P=0.200 (e) (e) P=0.503 |
|LOGISTIC REGRESSION| P=0.149N P=0.323 P=0.532 (e) |P=0.194 (e) (e) P=0.490 |
|COCH-ARM / FISHERS | P=0.152N P=0.372 P=0.544 P=0.266N |P=0.196 (e) (e) P=0.495 |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/42 (0%) 0/45 (0%) 0/46 (0%) 0/39 (0%) |2/49 (4%) 1/49 (2%) 0/46 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/34 (0%) 0/38 (0%) 0/34 (0%) |2/37 (5%) 1/39 (3%) 0/38 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.103N P=0.482N P=0.232N P=0.244N |
|POLY 3 | (e) (e) (e) (e) |P=0.103N P=0.493N P=0.239N P=0.237N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.104N P=0.497N P=0.246N P=0.239N |
|POLY 6 | (e) (e) (e) (e) |P=0.103N P=0.485N P=0.231N P=0.235N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.103N P=0.482N (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.105N P=0.500N P=0.263N P=0.253N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 8/50 (16%) 4/50 (8%) |14/50 (28%) 1/50 (2%) 5/50 (10%) 9/48 (19%) |
|POLY-3 ADJUSTED (b)| 6.3% 13.1% 17.1% 8.4% |30.5% 2.2% 10.5% 19.6% |
|TERMINAL (d) | 2/41 (5%) 6/37 (16%) 6/40 (15%) 3/43 (7%) |10/37 (27%) 1/39 (3%) 3/40 (8%) 4/36 (11%) |
|FIRST INCIDENCE | 680 729 (T) 688 723 |645 731 (T) 658 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.540 P=0.197 P=0.101 P=0.527 |P=0.370N P<0.001N** P=0.016N* P=0.194N |
|POLY 3 | P=0.492 P=0.221 P=0.092 P=0.500 |P=0.355N P<0.001N** P=0.014N* P=0.168N |
|POLY 1.5 | P=0.484 P=0.229 P=0.095 P=0.498 |P=0.367N P<0.001N** P=0.017N* P=0.181N |
|POLY 6 | P=0.507 P=0.211 P=0.090 P=0.506 |P=0.345N P<0.001N** P=0.012N* P=0.153N |
|LOGISTIC REGRESSION| P=0.517 P=0.210 P=0.093 P=0.503 |P=0.381N P<0.001N** P=0.016N* P=0.197N |
|COCH-ARM / FISHERS | P=0.484 P=0.243 P=0.100 P=0.500 |P=0.388N P<0.001N** P=0.020N* P=0.200N |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% 0.0% |4.4% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 1/40 (3%) 0/43 (0%) |2/37 (5%) 0/39 (0%) 1/40 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |731 (T) --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.704 (e) P=0.495 (e) |P=0.190N P=0.227N P=0.473N P=0.244N |
|POLY 3 | P=0.703 (e) P=0.496 (e) |P=0.191N P=0.235N P=0.485N P=0.240N |
|POLY 1.5 | P=0.699 (e) P=0.497 (e) |P=0.192N P=0.237N P=0.494N P=0.243N |
|POLY 6 | P=0.711 (e) P=0.495 (e) |P=0.192N P=0.231N P=0.472N P=0.237N |
|LOGISTIC REGRESSION| (e) (e) P=0.495 (e) |P=0.190N (e) P=0.473N (e) |
|COCH-ARM / FISHERS | P=0.697 (e) P=0.500 (e) |P=0.194N P=0.247N P=0.500N P=0.258N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 2.2% 0.0% 2.1% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 2/41 (5%) 1/37 (3%) 0/40 (0%) 1/43 (2%) |0/37 (0%) 0/39 (0%) 1/40 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347N P=0.536N P=0.244N P=0.483N |P=0.693 (e) P=0.516 (e) |
|POLY 3 | P=0.364N P=0.514N P=0.242N P=0.499N |P=0.698 (e) P=0.509 (e) |
|POLY 1.5 | P=0.366N P=0.509N P=0.240N P=0.501N |P=0.695 (e) P=0.503 (e) |
|POLY 6 | P=0.362N P=0.520N P=0.243N P=0.494N |P=0.699 (e) P=0.516 (e) |
|LOGISTIC REGRESSION| P=0.347N P=0.536N (e) P=0.483N |(e) (e) P=0.516 (e) |
|COCH-ARM / FISHERS | P=0.367N P=0.500N P=0.247N P=0.500N |P=0.690 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 6/50 (12%) 16/50 (32%) 18/50 (36%) |9/50 (18%) 11/50 (22%) 20/50 (40%) 8/48 (17%) |
|POLY-3 ADJUSTED (b)| 22.8% 13.1% 34.4% 37.4% |19.9% 24.0% 42.4% 18.0% |
|TERMINAL (d) | 8/41 (20%) 5/37 (14%) 16/40 (40%) 17/43 (40%) |9/37 (24%) 10/39 (26%) 19/40 (48%) 8/36 (22%) |
|FIRST INCIDENCE | 636 639 729 (T) 632 |731 (T) 659 720 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030 * P=0.207N P=0.165 P=0.122 |P=0.542N P=0.453 P=0.021 * P=0.526N |
|POLY 3 | P=0.015 * P=0.167N P=0.154 P=0.089 |P=0.512N P=0.415 P=0.016 * P=0.512N |
|POLY 1.5 | P=0.014 * P=0.157N P=0.166 P=0.088 |P=0.526N P=0.405 P=0.013 * P=0.522N |
|POLY 6 | P=0.017 * P=0.178N P=0.143 P=0.093 |P=0.501N P=0.439 P=0.021 * P=0.501N |
|LOGISTIC REGRESSION| P=0.020 * P=0.155N P=0.162 P=0.093 |P=0.510N P=0.451 P=0.030 * P=0.526N |
|COCH-ARM / FISHERS | P=0.016 * P=0.143N P=0.184 P=0.093 |P=0.541 P=0.402 P=0.013 * P=0.537N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Tooth |
| Developmental Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/12 (100%) 16/17 (94%) 18/18 (100%) 10/10 (100%)|0/0 (0%) 0/0 (0%) 1/2 (50%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 100.0% 94.1% 100.0% 100.0% |0.0% 0.0% 50.0% 0.0% |
|TERMINAL (d) | 11/11 (100%) 15/16 (94%) 16/16 (100%) 10/10 (100%)|0/0 (0%) 0/0 (0%) 1/2 (50%) 0/0 (0%) |
|FIRST INCIDENCE | 680 699 688 729 (T) |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.439N P=0.562N (e) (e) |P=1.000N (e) P=1.000N (e) |
|POLY 3 | P=0.616 P=0.569N (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.616 P=0.569N (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.616 P=0.569N (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=1.000N (e) |
|COCH-ARM / FISHERS | P=0.618 P=0.586N (e) (e) |P=1.000N (e) P=1.000 (e) |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Tooth |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/12 (0%) 0/17 (0%) 2/18 (11%) 0/10 (0%) |0/0 (0%) 0/0 (0%) 0/2 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 11.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/11 (0%) 0/16 (0%) 2/16 (13%) 0/10 (0%) |0/0 (0%) 0/0 (0%) 0/2 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.573 (e) P=0.322 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.570 (e) P=0.330 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.566 (e) P=0.329 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.576 (e) P=0.331 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.322 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.562 (e) P=0.352 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 2.1% 0.0% 4.3% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/41 (2%) 0/37 (0%) 0/40 (0%) 0/43 (0%) |0/37 (0%) 0/39 (0%) 0/40 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- 688 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.441N P=0.520N P=0.502 P=0.490N |(e) (e) (e) (e) |
|POLY 3 | P=0.445N P=0.504N P=0.502 P=0.496N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.450N P=0.501N P=0.503 P=0.497N |(e) (e) (e) (e) |
|POLY 6 | P=0.438N P=0.508N P=0.502 P=0.493N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.452N (e) P=0.522 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.453N P=0.495N P=0.508 P=0.495N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | |0/37 (0%) 0/39 (0%) 0/40 (0%) 2/36 (6%) |
|FIRST INCIDENCE | |--- --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.042 * (e) (e) P=0.232 |
|POLY 3 | |P=0.046 * (e) (e) P=0.239 |
|POLY 1.5 | |P=0.046 * (e) (e) P=0.238 |
|POLY 6 | |P=0.046 * (e) (e) P=0.240 |
|LOGISTIC REGRESSION| |(e) (e) (e) P=0.232 |
|COCH-ARM / FISHERS | |P=0.047 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |17/50 (34%) 16/50 (32%) 13/49 (27%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| |36.4% 34.7% 27.5% 28.1% |
|TERMINAL (d) | |12/37 (32%) 15/39 (39%) 10/40 (25%) 11/36 (31%) |
|FIRST INCIDENCE | |592 527 673 515 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.224N P=0.439N P=0.192N P=0.285N |
|POLY 3 | |P=0.193N P=0.516N P=0.240N P=0.262N |
|POLY 1.5 | |P=0.194N P=0.513N P=0.263N P=0.259N |
|POLY 6 | |P=0.199N P=0.513N P=0.216N P=0.273N |
|LOGISTIC REGRESSION| |P=0.187N P=0.496N P=0.258N P=0.251N |
|COCH-ARM / FISHERS | |P=0.196N P=0.500N P=0.278N P=0.257N |
|=================================================================================================================================|
Date: 04/07/99 EXPERIMENT: 05211 TEST: 06 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 160 312 625 |0 312 625 1250 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |47/50 (94%) 45/50 (90%) 48/49 (98%) 45/50 (90%) |
|POLY-3 ADJUSTED (b)| |96.8% 94.8% 98.2% 94.1% |
|TERMINAL (d) | |37/37 (100%) 39/39 (100%) 40/40 (100%) 36/36 (100%) |
|FIRST INCIDENCE | |484 391 90 525 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.543 P=0.213N P=0.339N P=0.487N |
|POLY 3 | |P=0.388N P=0.510N P=0.593 P=0.436N |
|POLY 1.5 | |P=0.393N P=0.440N P=0.443 P=0.403N |
|POLY 6 | |P=0.371N P=0.598N P=0.840 P=0.479N |
|LOGISTIC REGRESSION| |P=0.335N P=0.472N P=0.268 P=0.300N |
|COCH-ARM / FISHERS | |P=0.388N P=0.357N P=0.316 P=0.357N |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).