TDMS Study 88036-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus ANTHRAQUINONE DATE: 05/27/99
EXPERIMENT: 88036 TEST: 04 TIME: 11:24:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-25337 ROUTE: DOSED FEED NTP C#: C88036
PATHOLOGIST: RYAN, M. CAS: 84-65-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL #2 CORE STUDY MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus ANTHRAQUINONE DATE: 05/27/99
EXPERIMENT: 88036 TEST: 04 TIME: 11:24:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25337 ROUTE: DOSED FEED NTP C#: C88036
PATHOLOGIST: RYAN, M. CAS: 84-65-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF ANTHRAQUINONE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Epididymis Granuloma Sperm
Heart: Myocardium Degeneration
Islets, Pancreatic Hyperplasia
Kidney Nephropathy
Pigmentation
Liver Clear Cell Focus
Degeneration Fatty Focal
Eosinophilic Focus
Hematopoietic Cell Proliferation
Mineralization
Necrosis Focal
Liver: Centrilobular Hypertrophy
Liver: Hepatocyte Erythrophagocytosis
Mesentery: Fat Necrosis
Preputial Gland Cyst
Seminal Vesicle Inflammation Chronic
Spleen Hematopoietic Cell Proliferation
Stomach, Forestomach: Epithelium Hyperplasia Focal
Testes: Germinal Epithelium Degeneration
Thyroid Gland: Follicular Cell Hyperplasia
Urinary Bladder: Transitional Epithelium
Inclusion Body Intracytoplasmic
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Heart: Myocardium Mineralization
Islets, Pancreatic Hyperplasia
Liver Degeneration Fatty Focal
Eosinophilic Focus
Infiltration Cellular Lymphocyte
Liver: Centrilobular Hypertrophy
Ovary Angiectasis
Spleen Hematopoietic Cell Proliferation
Urinary Bladder: Transitional Epithelium
Inclusion Body Intracytoplasmic
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 8/50 (16%) 8/50 (16%) 5/50 (10%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 14.6% 16.9% 16.9% 12.4% |0.0% 2.1% 2.2% 4.4% |
|TERMINAL (d) | 7/45 (16%) 6/41 (15%) 8/43 (19%) 4/23 (17%) |0/35 (0%) 1/42 (2%) 0/35 (0%) 2/42 (5%) |
|FIRST INCIDENCE | 729 (T) 657 729 (T) 570 |--- 730 (T) 700 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407 P=0.430 P=0.462 P=0.421 |P=0.221 P=0.536 P=0.490 P=0.279 |
|POLY 3 | P=0.400N P=0.488 P=0.488 P=0.505N |P=0.193 P=0.508 P=0.500 P=0.239 |
|POLY 1.5 | P=0.332N P=0.499 P=0.498 P=0.443N |P=0.188 P=0.505 P=0.501 P=0.234 |
|POLY 6 | P=0.499N P=0.476 P=0.481 P=0.594N |P=0.200 P=0.512 P=0.499 P=0.246 |
|LOGISTIC REGRESSION| P=0.456N P=0.488 P=0.462 P=0.608N |P=0.198 P=0.536 P=0.500 P=0.279 |
|COCH-ARM / FISHERS | P=0.260N P=0.500 P=0.500 P=0.380N |P=0.187 P=0.500 P=0.500 P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 2/44 (5%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 1/42 (2%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.318N P=0.254N P=0.244N P=0.390N |P=0.234 (e) (e) P=0.536 |
|POLY 3 | P=0.235N P=0.238N P=0.236N P=0.278N |P=0.214 (e) (e) P=0.501 |
|POLY 1.5 | P=0.238N P=0.234N P=0.233N P=0.257N |P=0.212 (e) (e) P=0.497 |
|POLY 6 | P=0.228N P=0.243N P=0.238N P=0.310N |P=0.218 (e) (e) P=0.508 |
|LOGISTIC REGRESSION| P=0.318N (e) (e) (e) |(e) (e) (e) P=0.536 |
|COCH-ARM / FISHERS | P=0.239N P=0.242N P=0.242N P=0.247N |P=0.212 (e) (e) P=0.495 |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/49 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.3% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/42 (0%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/34 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- --- |242 --- 589 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.272N P=0.240N P=0.497N P=0.249N |
|POLY 3 | (e) (e) (e) (e) |P=0.272N P=0.236N P=0.516N P=0.244N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.274N P=0.237N P=0.513N P=0.246N |
|POLY 6 | (e) (e) (e) (e) |P=0.270N P=0.234N P=0.522N P=0.238N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.076N P=0.319N P=0.700N P=0.096N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.270N P=0.247N P=0.508N P=0.253N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 1/50 (2%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 4.3% 2.2% 6.7% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |2/35 (6%) 2/42 (5%) 1/35 (3%) 3/42 (7%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.431 P=0.628N P=0.500N P=0.583 |
|POLY 3 | (e) (e) (e) (e) |P=0.374 P=0.679N P=0.500N P=0.503 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.367 P=0.684N P=0.498N P=0.494 |
|POLY 6 | (e) (e) (e) (e) |P=0.385 P=0.673N P=0.504N P=0.518 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.431 P=0.628N P=0.500N P=0.583 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.369 P=0.691N P=0.500N P=0.490 |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Granuloma Sperm |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 7.3% | |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 1/23 (4%) | |
|FIRST INCIDENCE | --- --- --- 554 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** (e) (e) P=0.080 | |
|POLY 3 | P=0.006 ** (e) (e) P=0.093 | |
|POLY 1.5 | P=0.007 ** (e) (e) P=0.105 | |
|POLY 6 | P=0.005 ** (e) (e) P=0.078 | |
|LOGISTIC REGRESSION| P=0.012 * (e) (e) P=0.127 | |
|COCH-ARM / FISHERS | P=0.009 ** (e) (e) P=0.121 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/45 (2%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 702 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.316N P=0.263N P=0.250N P=0.386N |(e) (e) (e) (e) |
|POLY 3 | P=0.234N P=0.244N P=0.241N P=0.282N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.237N P=0.239N P=0.238N P=0.259N |(e) (e) (e) (e) |
|POLY 6 | P=0.226N P=0.249N P=0.243N P=0.316N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.254N P=0.238N P=0.238N P=0.295N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.238N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 3/50 (6%) 5/50 (10%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 8.3% 0.0% 6.3% 12.2% |4.5% 0.0% 2.2% 2.2% |
|TERMINAL (d) | 4/45 (9%) 0/41 (0%) 3/43 (7%) 2/23 (9%) |1/35 (3%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 570 |717 --- 491 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * P=0.076N P=0.525N P=0.200 |P=0.604N P=0.209N P=0.507N P=0.470N |
|POLY 3 | P=0.111 P=0.064N P=0.508N P=0.401 |P=0.621N P=0.229N P=0.495N P=0.494N |
|POLY 1.5 | P=0.128 P=0.062N P=0.501N P=0.450 |P=0.624N P=0.232N P=0.495N P=0.503N |
|POLY 6 | P=0.090 P=0.067N P=0.512N P=0.336 |P=0.616N P=0.225N P=0.498N P=0.481N |
|LOGISTIC REGRESSION| P=0.138 (e) P=0.525N P=0.483 |P=0.548N P=0.223N P=0.537N P=0.501N |
|COCH-ARM / FISHERS | P=0.153 P=0.059N P=0.500N P=0.500 |P=0.621N P=0.247N P=0.500N P=0.508N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% 2.5% |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- 685 569 |242 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.247 (e) P=0.496 P=0.483 |P=0.245N P=0.240N P=0.242N P=0.249N |
|POLY 3 | P=0.255 (e) P=0.498 P=0.465 |P=0.240N P=0.236N P=0.245N P=0.244N |
|POLY 1.5 | P=0.279 (e) P=0.500 P=0.482 |P=0.240N P=0.237N P=0.242N P=0.246N |
|POLY 6 | P=0.222 (e) P=0.497 P=0.442 |P=0.240N P=0.234N P=0.250N P=0.238N |
|LOGISTIC REGRESSION| P=0.325 (e) P=0.494 P=0.492 |P=0.048N* P=0.319N P=0.321N P=0.096N |
|COCH-ARM / FISHERS | P=0.305 (e) P=0.500 P=0.500 |P=0.241N P=0.247N P=0.247N P=0.253N |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 40/50 (80%) 40/50 (80%) 29/50 (58%) 17/42 (40%) |6/50 (12%) 13/50 (26%) 10/50 (20%) 14/49 (29%) |
|POLY-3 ADJUSTED (b)| 80.0% 82.4% 60.9% 44.2% |13.4% 27.8% 22.3% 30.8% |
|TERMINAL (d) | 35/45 (78%) 35/41 (85%) 27/43 (63%) 10/23 (44%) |6/35 (17%) 12/42 (29%) 10/35 (29%) 13/42 (31%) |
|FIRST INCIDENCE | 15 456 662 497 |730 (T) 703 730 (T) 625 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.050N P=0.302 P=0.046N* P=0.133N |P=0.168 P=0.131 P=0.198 P=0.091 |
|POLY 3 | P<0.001N** P=0.482 P=0.029N* P<0.001N** |P=0.094 P=0.073 P=0.203 P=0.039 * |
|POLY 1.5 | P<0.001N** P=0.530 P=0.022N* P<0.001N** |P=0.085 P=0.069 P=0.208 P=0.034 * |
|POLY 6 | P<0.001N** P=0.418 P=0.038N* P<0.001N** |P=0.113 P=0.079 P=0.194 P=0.048 * |
|LOGISTIC REGRESSION| P<0.001N** P=0.598N P=0.015N* P<0.001N** |P=0.121 P=0.094 P=0.198 P=0.048 * |
|COCH-ARM / FISHERS | P<0.001N** P=0.598N P=0.015N* P<0.001N** |P=0.087 P=0.062 P=0.207 P=0.035 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/47 (0%) |0/49 (0%) 2/50 (4%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.1% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/40 (0%) 0/42 (0%) 0/23 (0%) |0/35 (0%) 2/42 (5%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 550 --- --- --- |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.480N P=0.504N P=0.508N P=0.513N |P=0.359N P=0.279 (e) (e) |
|POLY 3 | P=0.465N P=0.512N P=0.509N P=0.549N |P=0.373N P=0.249 (e) (e) |
|POLY 1.5 | P=0.474N P=0.507N P=0.506N P=0.532N |P=0.377N P=0.247 (e) (e) |
|POLY 6 | P=0.449N P=0.518N P=0.512N P=0.574N |P=0.366N P=0.252 (e) (e) |
|LOGISTIC REGRESSION| P=0.497N P=0.574N P=0.574N P=0.531N |(e) P=0.279 (e) (e) |
|COCH-ARM / FISHERS | P=0.480N P=0.505N P=0.505N P=0.515N |P=0.382N P=0.253 (e) (e) |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 25/49 (51%) 27/49 (55%) 18/47 (38%) |4/49 (8%) 3/50 (6%) 3/49 (6%) 7/49 (14%) |
|POLY-3 ADJUSTED (b)| 60.3% 54.1% 58.2% 46.4% |8.9% 6.4% 6.8% 15.4% |
|TERMINAL (d) | 28/45 (62%) 23/40 (58%) 25/42 (60%) 14/23 (61%) |3/35 (9%) 2/42 (5%) 2/35 (6%) 6/42 (14%) |
|FIRST INCIDENCE | 702 657 711 590 |554 703 700 625 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.195 P=0.509N P=0.570N P=0.264 |P=0.154 P=0.424N P=0.506N P=0.356 |
|POLY 3 | P=0.148N P=0.343N P=0.500N P=0.136N |P=0.110 P=0.476N P=0.504N P=0.270 |
|POLY 1.5 | P=0.078N P=0.315N P=0.472N P=0.073N |P=0.106 P=0.480N P=0.499N P=0.261 |
|POLY 6 | P=0.301N P=0.378N P=0.523N P=0.281N |P=0.117 P=0.471N P=0.513N P=0.286 |
|LOGISTIC REGRESSION| P=0.544 P=0.442N P=0.533N P=0.564N |P=0.107 P=0.492N P=0.499N P=0.261 |
|COCH-ARM / FISHERS | P=0.037N* P=0.310N P=0.465N P=0.041N* |P=0.109 P=0.489N P=0.500N P=0.262 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 2/49 (4%) 18/47 (38%) |1/49 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.3% 4.2% 43.3% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 1/40 (3%) 0/42 (0%) 6/23 (26%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- 658 481 554 |690 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.222 P=0.237 P<0.001 ** |P=0.468N P=0.486N P=0.515N P=0.490N |
|POLY 3 | P<0.001 ** P=0.228 P=0.234 P<0.001 ** |P=0.477N P=0.490N P=0.500N P=0.497N |
|POLY 1.5 | P<0.001 ** P=0.232 P=0.235 P<0.001 ** |P=0.476N P=0.492N P=0.499N P=0.500N |
|POLY 6 | P<0.001 ** P=0.224 P=0.233 P<0.001 ** |P=0.478N P=0.488N P=0.503N P=0.492N |
|LOGISTIC REGRESSION| P<0.001 ** P=0.230 P=0.170 P<0.001 ** |P=0.470N P=0.503N P=0.502N P=0.500N |
|COCH-ARM / FISHERS | P<0.001 ** P=0.242 P=0.242 P<0.001 ** |P=0.473N P=0.495N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/49 (0%) 0/47 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 4.2% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 2/45 (4%) 0/40 (0%) 0/42 (0%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 1/42 (2%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.321N P=0.265N P=0.254N P=0.395N |P=0.234 (e) (e) P=0.536 |
|POLY 3 | P=0.241N P=0.248N P=0.245N P=0.294N |P=0.215 (e) (e) P=0.504 |
|POLY 1.5 | P=0.244N P=0.244N P=0.243N P=0.272N |P=0.213 (e) (e) P=0.501 |
|POLY 6 | P=0.234N P=0.253N P=0.247N P=0.325N |P=0.218 (e) (e) P=0.510 |
|LOGISTIC REGRESSION| P=0.321N (e) (e) (e) |(e) (e) (e) P=0.536 |
|COCH-ARM / FISHERS | P=0.246N P=0.253N P=0.253N P=0.263N |P=0.214 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/49 (0%) |1/49 (2%) 1/50 (2%) 0/50 (0%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.4% 2.1% 0.0% |2.3% 2.1% 0.0% 6.6% |
|TERMINAL (d) | 0/45 (0%) 2/41 (5%) 1/43 (2%) 0/23 (0%) |1/35 (3%) 1/42 (2%) 0/35 (0%) 2/42 (5%) |
|FIRST INCIDENCE | --- 658 729 (T) --- |730 (T) 730 (T) --- 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424N P=0.110 P=0.491 (e) |P=0.155 P=0.721N P=0.500N P=0.363 |
|POLY 3 | P=0.338N P=0.115 P=0.497 (e) |P=0.127 P=0.749N P=0.497N P=0.314 |
|POLY 1.5 | P=0.312N P=0.118 P=0.500 (e) |P=0.124 P=0.751N P=0.496N P=0.307 |
|POLY 6 | P=0.376N P=0.112 P=0.495 (e) |P=0.131 P=0.745N P=0.501N P=0.326 |
|LOGISTIC REGRESSION| P=0.306N P=0.120 P=0.491 (e) |P=0.130 P=0.721N (e) P=0.311 |
|COCH-ARM / FISHERS | P=0.286N P=0.121 P=0.500 (e) |P=0.125 P=0.747N P=0.495N P=0.309 |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 12/50 (24%) 9/50 (18%) 2/49 (4%) |4/49 (8%) 1/50 (2%) 1/50 (2%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 29.2% 25.5% 19.0% 5.1% |8.9% 2.1% 2.2% 6.5% |
|TERMINAL (d) | 14/45 (31%) 11/41 (27%) 9/43 (21%) 1/23 (4%) |3/35 (9%) 1/42 (2%) 0/35 (0%) 2/42 (5%) |
|FIRST INCIDENCE | 729 (T) 666 729 (T) 690 |554 730 (T) 589 477 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.023N* P=0.518N P=0.201N P=0.042N* |P=0.580 P=0.142N P=0.181N P=0.435N |
|POLY 3 | P=0.003N** P=0.434N P=0.179N P=0.003N** |P=0.548 P=0.166N P=0.175N P=0.487N |
|POLY 1.5 | P=0.002N** P=0.416N P=0.172N P=0.002N** |P=0.542 P=0.168N P=0.173N P=0.497N |
|POLY 6 | P=0.006N** P=0.455N P=0.185N P=0.008N** |P=0.557 P=0.164N P=0.180N P=0.473N |
|LOGISTIC REGRESSION| P=0.011N* P=0.489N P=0.201N P=0.024N* |P=0.580 P=0.178N P=0.184N P=0.491N |
|COCH-ARM / FISHERS | P<0.001N** P=0.410N P=0.171N P<0.001N** |P=0.544 P=0.175N P=0.175N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Fatty Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 7/50 (14%) 6/50 (12%) 0/49 (0%) |2/49 (4%) 3/50 (6%) 1/50 (2%) 9/49 (18%) |
|POLY-3 ADJUSTED (b)| 0.0% 14.7% 12.7% 0.0% |4.5% 6.4% 2.2% 19.6% |
|TERMINAL (d) | 0/45 (0%) 5/41 (12%) 6/43 (14%) 0/23 (0%) |1/35 (3%) 3/42 (7%) 0/35 (0%) 7/42 (17%) |
|FIRST INCIDENCE | --- 456 729 (T) --- |554 730 (T) 676 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312N P=0.008 ** P=0.015 * (e) |P=0.006 ** P=0.564 P=0.506N P=0.049 * |
|POLY 3 | P=0.210N P=0.007 ** P=0.015 * (e) |P=0.003 ** P=0.519 P=0.498N P=0.027 * |
|POLY 1.5 | P=0.161N P=0.008 ** P=0.015 * (e) |P=0.003 ** P=0.516 P=0.494N P=0.025 * |
|POLY 6 | P=0.292N P=0.007 ** P=0.014 * (e) |P=0.003 ** P=0.522 P=0.505N P=0.031 * |
|LOGISTIC REGRESSION| P=0.126N P=0.008 ** P=0.015 * (e) |P=0.003 ** P=0.500 P=0.521N P=0.027 * |
|COCH-ARM / FISHERS | P=0.126N P=0.006 ** P=0.013 * (e) |P=0.003 ** P=0.510 P=0.492N P=0.025 * |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 17/50 (34%) 24/50 (48%) 20/49 (41%) |6/49 (12%) 15/50 (30%) 11/50 (22%) 22/49 (45%) |
|POLY-3 ADJUSTED (b)| 29.2% 35.6% 49.6% 48.6% |13.6% 32.2% 24.5% 48.0% |
|TERMINAL (d) | 14/45 (31%) 13/41 (32%) 22/43 (51%) 12/23 (52%) |5/35 (14%) 15/42 (36%) 10/35 (29%) 20/42 (48%) |
|FIRST INCIDENCE | 729 (T) 657 453 590 |717 730 (T) 676 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.239 P=0.021 * P<0.001 ** |P=0.004 ** P=0.062 P=0.138 P=0.002 ** |
|POLY 3 | P=0.042 * P=0.325 P=0.030 * P=0.045 * |P<0.001 ** P=0.029 * P=0.148 P<0.001 ** |
|POLY 1.5 | P=0.081 P=0.336 P=0.032 * P=0.078 |P<0.001 ** P=0.028 * P=0.153 P<0.001 ** |
|POLY 6 | P=0.016 * P=0.317 P=0.029 * P=0.019 * |P<0.001 ** P=0.031 * P=0.139 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.033 * P=0.308 P=0.030 * P=0.011 * |P<0.001 ** P=0.044 * P=0.123 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.152 P=0.333 P=0.032 * P=0.129 |P<0.001 ** P=0.027 * P=0.154 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |5/49 (10%) 2/50 (4%) 1/50 (2%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 2.1% 0.0% 0.0% 2.5% |11.3% 4.3% 2.2% 6.7% |
|TERMINAL (d) | 1/45 (2%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |5/35 (14%) 2/42 (5%) 0/35 (0%) 3/42 (7%) |
|FIRST INCIDENCE | 729 (T) --- --- 702 |730 (T) 730 (T) 676 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.412 P=0.519N P=0.509N P=0.614 |P=0.417N P=0.149N P=0.107N P=0.260N |
|POLY 3 | P=0.507 P=0.505N P=0.503N P=0.715 |P=0.480N P=0.195N P=0.097N P=0.345N |
|POLY 1.5 | P=0.520 P=0.502N P=0.500N P=0.736 |P=0.484N P=0.199N P=0.096N P=0.355N |
|POLY 6 | P=0.491 P=0.510N P=0.505N P=0.684 |P=0.472N P=0.189N P=0.099N P=0.330N |
|LOGISTIC REGRESSION| P=0.496 (e) (e) P=0.705 |P=0.454N P=0.149N P=0.104N P=0.260N |
|COCH-ARM / FISHERS | P=0.536 P=0.500N P=0.500N P=0.747 |P=0.478N P=0.210N P=0.098N P=0.357N |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 4/49 (8%) |1/49 (2%) 1/50 (2%) 3/50 (6%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.3% 0.0% 10.0% |2.3% 2.1% 6.5% 2.2% |
|TERMINAL (d) | 0/45 (0%) 2/41 (5%) 0/43 (0%) 1/23 (4%) |0/35 (0%) 0/42 (0%) 1/35 (3%) 1/42 (2%) |
|FIRST INCIDENCE | --- 729 (T) --- 569 |717 648 491 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** P=0.218 (e) P=0.021 * |P=0.593N P=0.741N P=0.307 P=0.729N |
|POLY 3 | P=0.022 * P=0.232 (e) P=0.041 * |P=0.619N P=0.747N P=0.318 P=0.756N |
|POLY 1.5 | P=0.025 * P=0.236 (e) P=0.049 * |P=0.624N P=0.750N P=0.318 P=0.760N |
|POLY 6 | P=0.018 * P=0.227 (e) P=0.032 * |P=0.610N P=0.743N P=0.315 P=0.750N |
|LOGISTIC REGRESSION| P=0.033 * P=0.218 (e) P=0.065 |P=0.580N P=0.757 P=0.268 P=0.753N |
|COCH-ARM / FISHERS | P=0.031 * P=0.247 (e) P=0.056 |P=0.621N P=0.747N P=0.316 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 6.7% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 3/42 (7%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.013 * (e) (e) P=0.155 |
|POLY 3 | (e) (e) (e) (e) |P=0.008 ** (e) (e) P=0.122 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.008 ** (e) (e) P=0.119 |
|POLY 6 | (e) (e) (e) (e) |P=0.008 ** (e) (e) P=0.127 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.155 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.008 ** (e) (e) P=0.121 |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- 554 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * (e) (e) P=0.223 |(e) (e) (e) (e) |
|POLY 3 | P=0.033 * (e) (e) P=0.201 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.036 * (e) (e) P=0.216 |(e) (e) (e) (e) |
|POLY 6 | P=0.030 * (e) (e) P=0.181 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.037 * (e) (e) P=0.212 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.040 * (e) (e) P=0.242 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) 1/49 (2%) |4/49 (8%) 2/50 (4%) 2/50 (4%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 6.3% 4.3% 8.5% 2.5% |8.9% 4.3% 4.5% 4.4% |
|TERMINAL (d) | 3/45 (7%) 2/41 (5%) 4/43 (9%) 0/23 (0%) |3/35 (9%) 2/42 (5%) 2/35 (6%) 2/42 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 621 |554 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.530N P=0.542N P=0.475 P=0.516N |P=0.329N P=0.273N P=0.338N P=0.274N |
|POLY 3 | P=0.360N P=0.512N P=0.492 P=0.376N |P=0.378N P=0.318N P=0.337N P=0.334N |
|POLY 1.5 | P=0.322N P=0.503N P=0.499 P=0.344N |P=0.383N P=0.321N P=0.331N P=0.340N |
|POLY 6 | P=0.415N P=0.522N P=0.488 P=0.422N |P=0.370N P=0.315N P=0.347N P=0.323N |
|LOGISTIC REGRESSION| P=0.374N P=0.542N P=0.475 P=0.336N |P=0.376N P=0.329N P=0.327N P=0.337N |
|COCH-ARM / FISHERS | P=0.281N P=0.500N P=0.500 P=0.316N |P=0.376N P=0.329N P=0.329N P=0.339N |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 8/49 (16%) |5/49 (10%) 3/50 (6%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 4.2% 6.3% 6.2% 19.4% |11.3% 6.4% 2.2% 2.2% |
|TERMINAL (d) | 1/45 (2%) 2/41 (5%) 1/43 (2%) 2/23 (9%) |3/35 (9%) 2/42 (5%) 0/35 (0%) 1/42 (2%) |
|FIRST INCIDENCE | 710 464 481 497 |690 611 700 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.467 P=0.490 P=0.008 ** |P=0.080N P=0.288N P=0.117N P=0.077N |
|POLY 3 | P=0.007 ** P=0.495 P=0.500 P=0.025 * |P=0.090N P=0.325N P=0.098N P=0.098N |
|POLY 1.5 | P=0.010 * P=0.501 P=0.503 P=0.032 * |P=0.091N P=0.332N P=0.097N P=0.101N |
|POLY 6 | P=0.005 ** P=0.486 P=0.498 P=0.016 * |P=0.087N P=0.317N P=0.102N P=0.092N |
|LOGISTIC REGRESSION| P=0.025 * P=0.481 P=0.479 P=0.053 |P=0.090N P=0.338N P=0.101N P=0.094N |
|COCH-ARM / FISHERS | P=0.014 * P=0.500 P=0.500 P=0.043 * |P=0.090N P=0.346N P=0.098N P=0.102N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/49 (2%) |3/49 (6%) 2/50 (4%) 2/50 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.1% 4.3% 0.0% 2.5% |6.8% 4.3% 4.5% 0.0% |
|TERMINAL (d) | 0/45 (0%) 2/41 (5%) 0/43 (0%) 1/23 (4%) |3/35 (9%) 2/42 (5%) 2/35 (6%) 0/42 (0%) |
|FIRST INCIDENCE | 550 729 (T) --- 729 (T) |730 (T) 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.663 P=0.476 P=0.508N P=0.680 |P=0.083N P=0.417N P=0.500N P=0.091N |
|POLY 3 | P=0.595N P=0.487 P=0.505N P=0.711 |P=0.098N P=0.476N P=0.494N P=0.115N |
|POLY 1.5 | P=0.582N P=0.495 P=0.502N P=0.734 |P=0.100N P=0.480N P=0.490N P=0.118N |
|POLY 6 | P=0.610N P=0.477 P=0.508N P=0.678 |P=0.094N P=0.469N P=0.502N P=0.110N |
|LOGISTIC REGRESSION| P=0.543N P=0.483 P=0.571N P=0.755N |P=0.083N P=0.417N P=0.500N (e) |
|COCH-ARM / FISHERS | P=0.564N P=0.500 P=0.500N P=0.747 |P=0.098N P=0.490N P=0.490N P=0.121N |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 34/50 (68%) 41/50 (82%) 33/49 (67%) |1/49 (2%) 27/50 (54%) 22/50 (44%) 39/49 (80%) |
|POLY-3 ADJUSTED (b)| 49.3% 70.4% 86.0% 76.6% |2.3% 57.9% 48.7% 82.6% |
|TERMINAL (d) | 22/45 (49%) 30/41 (73%) 38/43 (88%) 22/23 (96%) |1/35 (3%) 27/42 (64%) 21/35 (60%) 35/42 (83%) |
|FIRST INCIDENCE | 550 464 662 497 |730 (T) 730 (T) 626 172 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.012 * P=0.025 * P<0.001 ** P=0.004 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.044 * P=0.031 * P<0.001 ** P=0.014 * |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.020 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.007 ** P=0.031 * P<0.001 ** P=0.003 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.133 P=0.034 * P<0.001 ** P=0.040 * |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Erythrophagocytosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 9/50 (18%) 13/50 (26%) 6/49 (12%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.1% 19.2% 27.5% 15.0% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/45 (2%) 9/41 (22%) 13/43 (30%) 5/23 (22%) |1/35 (3%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 497 |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * P=0.006 ** P<0.001 ** P=0.007 ** |P=0.454N P=0.464N P=0.500N P=0.464N |
|POLY 3 | P=0.202 P=0.007 ** P<0.001 ** P=0.032 * |P=0.477N P=0.489N P=0.497N P=0.496N |
|POLY 1.5 | P=0.279 P=0.008 ** P<0.001 ** P=0.041 * |P=0.476N P=0.491N P=0.496N P=0.499N |
|POLY 6 | P=0.116 P=0.006 ** P<0.001 ** P=0.022 * |P=0.479N P=0.486N P=0.501N P=0.490N |
|LOGISTIC REGRESSION| P=0.139 P=0.006 ** P<0.001 ** P=0.044 * |P=0.454N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.373 P=0.008 ** P<0.001 ** P=0.053 |P=0.473N P=0.495N P=0.495N P=0.500N |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.4% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 675 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.680N (e) P=0.234 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.698N (e) P=0.239 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.702N (e) P=0.239 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.690N (e) P=0.238 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.690N (e) P=0.229 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.700N (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.2% 2.2% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 1/42 (2%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 519 505 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.384N P=0.260 P=0.500 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.380N P=0.249 P=0.503 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.387N P=0.245 P=0.503 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.369N P=0.255 P=0.502 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.289N P=0.173 P=0.354 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.390N P=0.247 P=0.500 (e) |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.1% 2.1% 2.1% 0.0% |0.0% 0.0% 4.4% 0.0% |
|TERMINAL (d) | 0/45 (0%) 1/41 (2%) 1/43 (2%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 710 729 (T) 729 (T) --- |--- --- 626 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.467N P=0.740 P=0.753 P=0.638N |P=0.685N (e) P=0.237 (e) |
|POLY 3 | P=0.364N P=0.754 P=0.757 P=0.537N |P=0.698N (e) P=0.240 (e) |
|POLY 1.5 | P=0.346N P=0.758 P=0.760 P=0.519N |P=0.702N (e) P=0.240 (e) |
|POLY 6 | P=0.389N P=0.749 P=0.755 P=0.563N |P=0.690N (e) P=0.239 (e) |
|LOGISTIC REGRESSION| P=0.401N P=0.760 P=0.762 P=0.545N |P=0.674N (e) P=0.213 (e) |
|COCH-ARM / FISHERS | P=0.323N P=0.753N P=0.753N P=0.500N |P=0.700N (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 2/2 (100%) 0/1 (0%) 5/5 (100%) |4/6 (67%) 3/4 (75%) 2/6 (33%) 7/7 (100%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 0.0% 100.0% |66.7% 86.0% 40.3% 100.0% |
|TERMINAL (d) | 2/2 (100%) 1/1 (100%) 0/1 (0%) 1/1 (100%) |1/3 (33%) 3/3 (100%) 2/2 (100%) 4/4 (100%) |
|FIRST INCIDENCE | 729 (T) 666 --- 586 |617 730 (T) 730 (T) 477 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** (e) P=0.362N (e) |P=0.127 P=0.477N P=0.437N P=0.352 |
|POLY 3 | P=1.000N (e) P=1.000N (e) |P=0.097 P=0.542 P=0.399N P=0.178 |
|POLY 1.5 | P=1.000N (e) P=1.000N (e) |P=0.094 P=0.591 P=0.344N P=0.178 |
|POLY 6 | P=1.000N (e) P=1.000N (e) |P=0.104 P=0.472 P=0.496N P=0.178 |
|LOGISTIC REGRESSION| P=0.005 ** (e) (e) (e) |P=0.073 P=0.620 P=0.355N (e) |
|COCH-ARM / FISHERS | P=0.602 (e) P=0.333N (e) |P=0.112 P=0.667 P=0.284N P=0.192 |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 6.4% 2.1% 4.9% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/45 (4%) 3/41 (7%) 1/43 (2%) 0/23 (0%) |1/35 (3%) 0/42 (0%) 0/34 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 554 |701 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.494 P=0.458 P=0.516N P=0.533 |P=0.230N P=0.212N P=0.255N P=0.212N |
|POLY 3 | P=0.595N P=0.488 P=0.505N P=0.633 |P=0.245N P=0.229N P=0.243N P=0.236N |
|POLY 1.5 | P=0.570N P=0.497 P=0.501N P=0.663 |P=0.244N P=0.232N P=0.241N P=0.241N |
|POLY 6 | P=0.594 P=0.478 P=0.508N P=0.588 |P=0.246N P=0.225N P=0.246N P=0.229N |
|LOGISTIC REGRESSION| P=0.533N P=0.458 P=0.516N P=0.673N |P=0.240N P=0.229N P=0.244N P=0.236N |
|COCH-ARM / FISHERS | P=0.541N P=0.500 P=0.500N P=0.691N |P=0.241N P=0.247N P=0.253N P=0.253N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/45 (0%) 0/50 (0%) 0/49 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | |0/33 (0%) 0/42 (0%) 0/34 (0%) 1/42 (2%) |
|FIRST INCIDENCE | |--- --- --- 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.048 * (e) (e) P=0.264 |
|POLY 3 | |P=0.044 * (e) (e) P=0.266 |
|POLY 1.5 | |P=0.043 * (e) (e) P=0.260 |
|POLY 6 | |P=0.046 * (e) (e) P=0.274 |
|LOGISTIC REGRESSION| |P=0.054 (e) (e) P=0.263 |
|COCH-ARM / FISHERS | |P=0.044 * (e) (e) P=0.269 |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/45 (7%) 4/50 (8%) 7/49 (14%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| |7.4% 8.6% 15.7% 10.9% |
|TERMINAL (d) | |2/33 (6%) 4/42 (10%) 4/34 (12%) 4/42 (10%) |
|FIRST INCIDENCE | |627 730 (T) 627 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.443 P=0.614 P=0.171 P=0.461 |
|POLY 3 | |P=0.401 P=0.574 P=0.196 P=0.422 |
|POLY 1.5 | |P=0.386 P=0.569 P=0.198 P=0.410 |
|POLY 6 | |P=0.423 P=0.579 P=0.191 P=0.439 |
|LOGISTIC REGRESSION| |P=0.384 P=0.577 P=0.195 P=0.404 |
|COCH-ARM / FISHERS | |P=0.386 P=0.559 P=0.195 P=0.406 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 1/42 (2%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 648 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.366N P=0.268 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.372N P=0.248 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.378N P=0.244 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.363N P=0.253 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.381N P=0.227 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.384N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 4.1% 2.1% 0.0% 2.5% |4.5% 2.1% 4.4% 2.2% |
|TERMINAL (d) | 1/45 (2%) 1/41 (2%) 0/43 (0%) 0/23 (0%) |2/35 (6%) 0/42 (0%) 1/35 (3%) 1/42 (2%) |
|FIRST INCIDENCE | 662 729 (T) --- 690 |730 (T) 549 631 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.671N P=0.529N P=0.247N P=0.686N |P=0.446N P=0.458N P=0.693 P=0.436N |
|POLY 3 | P=0.520N P=0.511N P=0.242N P=0.565N |P=0.486N P=0.482N P=0.691N P=0.498N |
|POLY 1.5 | P=0.513N P=0.504N P=0.239N P=0.533N |P=0.490N P=0.488N P=0.690N P=0.505N |
|POLY 6 | P=0.526N P=0.520N P=0.245N P=0.608N |P=0.478N P=0.473N P=0.694N P=0.486N |
|LOGISTIC REGRESSION| P=0.509N P=0.500N P=0.240N P=0.511N |P=0.474N P=0.534N P=0.694N P=0.436N |
|COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.247N P=0.500N |P=0.484N P=0.500N P=0.691N P=0.508N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Peripheral Nerve: Axon |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |2/2 (100%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 100.0% 0.0% |100.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 727 --- |554 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.321N (e) P=0.242N (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) P=1.000 (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) P=1.000 (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) P=1.000N (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.807N (e) P=0.333N (e) |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/47 (0%) 0/46 (0%) |2/47 (4%) 0/50 (0%) 1/48 (2%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.7% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/39 (0%) 0/41 (0%) 0/22 (0%) |2/33 (6%) 0/42 (0%) 0/35 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) --- 675 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.255N P=0.187N P=0.486N P=0.202N |
|POLY 3 | (e) (e) (e) (e) |P=0.279N P=0.216N P=0.494N P=0.239N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.280N P=0.219N P=0.492N P=0.243N |
|POLY 6 | (e) (e) (e) (e) |P=0.278N P=0.213N P=0.496N P=0.232N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.276N (e) P=0.495N (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.275N P=0.232N P=0.492N P=0.253N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/48 (0%) 2/47 (4%) 0/46 (0%) |8/47 (17%) 4/50 (8%) 12/48 (25%) 6/46 (13%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 4.5% 0.0% |18.7% 8.6% 27.9% 14.2% |
|TERMINAL (d) | 1/43 (2%) 0/39 (0%) 2/41 (5%) 0/22 (0%) |7/33 (21%) 4/42 (10%) 12/35 (34%) 5/39 (13%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |627 730 (T) 730 (T) 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.619N P=0.519N P=0.483 P=0.634N |P=0.428N P=0.089N P=0.263 P=0.277N |
|POLY 3 | P=0.516N P=0.505N P=0.488 P=0.543N |P=0.539N P=0.137N P=0.225 P=0.395N |
|POLY 1.5 | P=0.491N P=0.502N P=0.492 P=0.526N |P=0.551N P=0.141N P=0.236 P=0.407N |
|POLY 6 | P=0.551N P=0.510N P=0.486 P=0.566N |P=0.515N P=0.132N P=0.208 P=0.374N |
|LOGISTIC REGRESSION| P=0.619N (e) P=0.483 (e) |P=0.499N P=0.129N P=0.213 P=0.387N |
|COCH-ARM / FISHERS | P=0.462N P=0.500N P=0.492 P=0.511N |P=0.535N P=0.149N P=0.242 P=0.403N |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 25/50 (50%) 32/49 (65%) 22/49 (45%) | |
|POLY-3 ADJUSTED (b)| 45.8% 51.3% 69.1% 51.7% | |
|TERMINAL (d) | 21/45 (47%) 20/41 (49%) 32/42 (76%) 13/23 (57%) | |
|FIRST INCIDENCE | 710 464 729 (T) 497 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.222 P=0.010 * P=0.010 * | |
|POLY 3 | P=0.378 P=0.366 P=0.016 * P=0.359 | |
|POLY 1.5 | P=0.514 P=0.370 P=0.021 * P=0.456 | |
|POLY 6 | P=0.213 P=0.363 P=0.013 * P=0.236 | |
|LOGISTIC REGRESSION| P=0.355 P=0.339 P=0.013 * P=0.320 | |
|COCH-ARM / FISHERS | P=0.444N P=0.344 P=0.027 * P=0.545 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 4/50 (8%) 4/49 (8%) 4/49 (8%) | |
|POLY-3 ADJUSTED (b)| 14.3% 8.5% 8.6% 10.2% | |
|TERMINAL (d) | 5/45 (11%) 3/41 (7%) 3/42 (7%) 4/23 (17%) | |
|FIRST INCIDENCE | 550 662 711 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.474 P=0.314N P=0.299N P=0.608 | |
|POLY 3 | P=0.439N P=0.284N P=0.292N P=0.401N | |
|POLY 1.5 | P=0.391N P=0.270N P=0.281N P=0.337N | |
|POLY 6 | P=0.504N P=0.300N P=0.302N P=0.495N | |
|LOGISTIC REGRESSION| P=0.412N P=0.263N P=0.274N P=0.356N | |
|COCH-ARM / FISHERS | P=0.333N P=0.262N P=0.274N P=0.274N | |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 0/49 (0%) 1/49 (2%) | |
|POLY-3 ADJUSTED (b)| 0.0% 8.6% 0.0% 2.6% | |
|TERMINAL (d) | 0/45 (0%) 4/41 (10%) 0/42 (0%) 1/23 (4%) | |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.641 P=0.052 (e) P=0.366 | |
|POLY 3 | P=0.546N P=0.057 (e) P=0.460 | |
|POLY 1.5 | P=0.521N P=0.060 (e) P=0.477 | |
|POLY 6 | P=0.576N P=0.054 (e) P=0.435 | |
|LOGISTIC REGRESSION| (e) P=0.052 (e) P=0.366 | |
|COCH-ARM / FISHERS | P=0.494N P=0.059 (e) P=0.495 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) 4/50 (8%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 14.6% 6.4% 8.5% 0.0% | |
|TERMINAL (d) | 7/45 (16%) 3/41 (7%) 4/43 (9%) 0/23 (0%) | |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.059N P=0.198N P=0.287N P=0.059N | |
|POLY 3 | P=0.025N* P=0.169N P=0.270N P=0.016N* | |
|POLY 1.5 | P=0.019N* P=0.161N P=0.263N P=0.011N* | |
|POLY 6 | P=0.035N* P=0.178N P=0.275N P=0.026N* | |
|LOGISTIC REGRESSION| P=0.059N P=0.198N P=0.287N (e) | |
|COCH-ARM / FISHERS | P=0.015N* P=0.159N P=0.262N P=0.006N** | |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 14/50 (28%) 12/49 (24%) 30/42 (71%) |9/45 (20%) 17/49 (35%) 17/48 (35%) 26/48 (54%) |
|POLY-3 ADJUSTED (b)| 24.7% 29.0% 24.6% 74.3% |21.0% 36.0% 36.8% 56.2% |
|TERMINAL (d) | 10/45 (22%) 9/41 (22%) 8/43 (19%) 15/23 (65%) |4/35 (11%) 14/42 (33%) 9/35 (26%) 22/42 (52%) |
|FIRST INCIDENCE | 550 464 453 456 |554 519 491 186 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.327 P=0.547 P<0.001 ** |P=0.005 ** P=0.133 P=0.072 P=0.004 ** |
|POLY 3 | P<0.001 ** P=0.401 P=0.591N P<0.001 ** |P<0.001 ** P=0.091 P=0.079 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.413 P=0.591N P<0.001 ** |P<0.001 ** P=0.091 P=0.080 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.388 P=0.589N P<0.001 ** |P<0.001 ** P=0.090 P=0.076 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.408 P=0.551 P<0.001 ** |P<0.001 ** P=0.078 P=0.071 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.410 P=0.570 P<0.001 ** |P<0.001 ** P=0.086 P=0.077 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 1/49 (2%) 0/42 (0%) |8/45 (18%) 4/49 (8%) 5/48 (10%) 6/48 (13%) |
|POLY-3 ADJUSTED (b)| 8.3% 0.0% 2.1% 0.0% |19.3% 8.7% 11.4% 13.6% |
|TERMINAL (d) | 4/45 (9%) 0/41 (0%) 1/43 (2%) 0/23 (0%) |8/35 (23%) 4/42 (10%) 4/35 (11%) 6/42 (14%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |730 (T) 730 (T) 675 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.166N P=0.076N P=0.194N P=0.178N |P=0.442N P=0.100N P=0.274N P=0.251N |
|POLY 3 | P=0.117N P=0.064N P=0.185N P=0.108N |P=0.515N P=0.130N P=0.235N P=0.335N |
|POLY 1.5 | P=0.114N P=0.062N P=0.183N P=0.096N |P=0.521N P=0.132N P=0.232N P=0.343N |
|POLY 6 | P=0.121N P=0.067N P=0.187N P=0.128N |P=0.503N P=0.127N P=0.242N P=0.321N |
|LOGISTIC REGRESSION| P=0.166N (e) P=0.194N (e) |P=0.480N P=0.100N P=0.262N P=0.251N |
|COCH-ARM / FISHERS | P=0.111N P=0.059N P=0.187N P=0.082N |P=0.509N P=0.139N P=0.235N P=0.337N |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 2/50 (4%) |4/50 (8%) 1/50 (2%) 1/50 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% 4.9% |8.7% 2.1% 2.2% 4.3% |
|TERMINAL (d) | 0/45 (0%) 0/40 (0%) 0/43 (0%) 0/23 (0%) |2/35 (6%) 0/42 (0%) 0/35 (0%) 1/42 (2%) |
|FIRST INCIDENCE | --- 666 --- 570 |554 549 631 186 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.094 P=0.487 (e) P=0.191 |P=0.443N P=0.164N P=0.184N P=0.305N |
|POLY 3 | P=0.127 P=0.492 (e) P=0.202 |P=0.468N P=0.170N P=0.184N P=0.335N |
|POLY 1.5 | P=0.137 P=0.495 (e) P=0.219 |P=0.470N P=0.173N P=0.180N P=0.342N |
|POLY 6 | P=0.114 P=0.488 (e) P=0.181 |P=0.463N P=0.167N P=0.189N P=0.325N |
|LOGISTIC REGRESSION| P=0.171 P=0.485 (e) P=0.241 |P=0.308N P=0.244N P=0.206N P=0.285N |
|COCH-ARM / FISHERS | P=0.150 P=0.495 (e) P=0.247 |P=0.468N P=0.181N P=0.181N P=0.349N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.0% |0.0% 2.1% 2.2% 2.2% |
|TERMINAL (d) | 0/45 (0%) 0/40 (0%) 0/43 (0%) 2/23 (9%) |0/35 (0%) 1/42 (2%) 1/35 (3%) 1/42 (2%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** (e) (e) P=0.107 |P=0.515 P=0.536 P=0.500 P=0.536 |
|POLY 3 | P=0.034 * (e) (e) P=0.198 |P=0.485 P=0.508 P=0.500 P=0.501 |
|POLY 1.5 | P=0.037 * (e) (e) P=0.217 |P=0.478 P=0.505 P=0.501 P=0.497 |
|POLY 6 | P=0.030 * (e) (e) P=0.175 |P=0.497 P=0.512 P=0.497 P=0.508 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.107 |(e) P=0.536 P=0.500 P=0.536 |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |P=0.478 P=0.500 P=0.500 P=0.495 |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 0.0% 0.0% 2.5% |2.2% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/45 (2%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 710 --- --- 569 |554 --- 676 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.649 P=0.260N P=0.247N P=0.663N |P=0.459N P=0.504N P=0.755 P=0.508N |
|POLY 3 | P=0.652N P=0.244N P=0.241N P=0.561N |P=0.466N P=0.494N P=0.759 P=0.501N |
|POLY 1.5 | P=0.651N P=0.239N P=0.238N P=0.531N |P=0.468N P=0.496N P=0.760N P=0.504N |
|POLY 6 | P=0.648N P=0.249N P=0.243N P=0.602N |P=0.463N P=0.492N P=0.756 P=0.496N |
|LOGISTIC REGRESSION| P=0.619N P=0.240N P=0.238N P=0.481N |P=0.404N P=0.616N P=0.726 P=0.464N |
|COCH-ARM / FISHERS | P=0.646N P=0.247N P=0.247N P=0.500N |P=0.464N P=0.500N P=0.753N P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 2/42 (5%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.359N P=0.279 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.373N P=0.246 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.378N P=0.243 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.364N P=0.251 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.279 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.384N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.2% 7.4% | |
|TERMINAL (d) | 0/45 (0%) 0/40 (0%) 1/43 (2%) 1/23 (4%) | |
|FIRST INCIDENCE | --- --- 727 569 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.007 ** (e) P=0.232 P=0.054 | |
|POLY 3 | P=0.024 * (e) P=0.234 P=0.091 | |
|POLY 1.5 | P=0.030 * (e) P=0.237 P=0.104 | |
|POLY 6 | P=0.018 * (e) P=0.232 P=0.076 | |
|LOGISTIC REGRESSION| P=0.040 * (e) P=0.232 P=0.129 | |
|COCH-ARM / FISHERS | P=0.038 * (e) P=0.247 P=0.121 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | |
|POLY-3 ADJUSTED (b)| 4.2% 0.0% 2.1% 2.5% | |
|TERMINAL (d) | 2/45 (4%) 0/40 (0%) 1/43 (2%) 0/23 (0%) | |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 664 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.577 P=0.265N P=0.516N P=0.701N | |
|POLY 3 | P=0.642N P=0.248N P=0.505N P=0.562N | |
|POLY 1.5 | P=0.629N P=0.244N P=0.501N P=0.532N | |
|POLY 6 | P=0.644 P=0.253N P=0.508N P=0.604N | |
|LOGISTIC REGRESSION| P=0.668N (e) P=0.516N P=0.564N | |
|COCH-ARM / FISHERS | P=0.611N P=0.253N P=0.500N P=0.500N | |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/46 (0%) |2/45 (4%) 1/48 (2%) 0/48 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.8% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |1/35 (3%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- --- |627 549 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.166N P=0.474N P=0.240N P=0.215N |
|POLY 3 | (e) (e) (e) (e) |P=0.165N P=0.468N P=0.227N P=0.225N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.165N P=0.470N P=0.224N P=0.226N |
|POLY 6 | (e) (e) (e) (e) |P=0.164N P=0.465N P=0.232N P=0.222N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.127N P=0.552N P=0.229N P=0.218N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.163N P=0.476N P=0.231N P=0.231N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 10/50 (20%) 15/49 (31%) 21/46 (46%) |10/45 (22%) 14/48 (29%) 16/48 (33%) 15/48 (31%) |
|POLY-3 ADJUSTED (b)| 14.6% 21.3% 32.3% 55.1% |23.8% 30.9% 36.2% 34.0% |
|TERMINAL (d) | 7/45 (16%) 9/41 (22%) 15/43 (35%) 20/23 (87%) |9/35 (26%) 14/42 (33%) 15/35 (43%) 15/42 (36%) |
|FIRST INCIDENCE | 729 (T) 657 729 (T) 638 |554 730 (T) 626 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.232 P=0.033 * P<0.001 ** |P=0.377 P=0.412 P=0.119 P=0.331 |
|POLY 3 | P<0.001 ** P=0.281 P=0.035 * P<0.001 ** |P=0.259 P=0.308 P=0.152 P=0.212 |
|POLY 1.5 | P<0.001 ** P=0.294 P=0.038 * P<0.001 ** |P=0.256 P=0.308 P=0.163 P=0.211 |
|POLY 6 | P<0.001 ** P=0.267 P=0.033 * P<0.001 ** |P=0.271 P=0.310 P=0.136 P=0.220 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.258 P=0.033 * P<0.001 ** |P=0.291 P=0.326 P=0.152 P=0.230 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.298 P=0.040 * P<0.001 ** |P=0.285 P=0.299 P=0.168 P=0.228 |
|=================================================================================================================================|
Date: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/14 (100%) 19/19 (100%) 14/14 (100%) 5/5 (100%) |0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 100.0% 100.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 14/14 (100%) 17/17 (100%) 13/13 (100%) 4/4 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 658 711 638 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|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) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Inclusion Body Intracytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 46/49 (94%) 46/49 (94%) 42/45 (93%) |0/44 (0%) 40/48 (83%) 43/46 (93%) 46/48 (96%) |
|POLY-3 ADJUSTED (b)| 0.0% 94.9% 93.9% 96.3% |0.0% 84.5% 93.7% 97.8% |
|TERMINAL (d) | 0/45 (0%) 40/41 (98%) 41/43 (95%) 23/23 (100%)|0/35 (0%) 35/42 (83%) 33/35 (94%) 41/42 (98%) |
|FIRST INCIDENCE | --- 456 453 490 |--- 519 491 186 |
|-------------------| | |
|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: 05/27/99 EXPERIMENT: 88036 TEST: 04 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/50 (0%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| |4.5% 0.0% 2.2% 2.2% |
|TERMINAL (d) | |2/35 (6%) 0/42 (0%) 1/35 (3%) 1/42 (2%) |
|FIRST INCIDENCE | |730 (T) --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.576N P=0.199N P=0.500N P=0.436N |
|POLY 3 | |P=0.624N P=0.228N P=0.500N P=0.498N |
|POLY 1.5 | |P=0.625N P=0.231N P=0.498N P=0.505N |
|POLY 6 | |P=0.620N P=0.224N P=0.504N P=0.486N |
|LOGISTIC REGRESSION| |P=0.576N (e) P=0.500N P=0.436N |
|COCH-ARM / FISHERS | |P=0.621N P=0.247N P=0.500N P=0.508N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |35/50 (70%) 38/50 (76%) 23/50 (46%) 39/49 (80%) |
|POLY-3 ADJUSTED (b)| |76.1% 79.4% 50.9% 85.4% |
|TERMINAL (d) | |32/35 (91%) 35/42 (83%) 21/35 (60%) 37/42 (88%) |
|FIRST INCIDENCE | |554 549 675 625 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.539N P=0.284N P=0.005N** P=0.350N |
|POLY 3 | |P=0.146 P=0.445 P=0.007N** P=0.181 |
|POLY 1.5 | |P=0.136 P=0.399 P=0.008N** P=0.156 |
|POLY 6 | |P=0.186 P=0.519 P=0.007N** P=0.255 |
|LOGISTIC REGRESSION| |P=0.246 P=0.452 P=0.009N** P=0.280 |
|COCH-ARM / FISHERS | |P=0.190 P=0.326 P=0.013N* P=0.193 |
|=================================================================================================================================|
(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).