TDMS Study 88036-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus ANTHRAQUINONE DATE: 02/25/99
EXPERIMENT: 88036 TEST: 03 TIME: 11:51:59
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-25337 ROUTE: DOSED FEED NTP C#: C88036
PATHOLOGIST: SINGER, A. CAS: 84-65-1
------------------------------------------------------------------------------------------------------------------------------------
2 YEAR CHRONIC RATS
REASONS FOR REMOVAL: 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: Battelle Columbus ANTHRAQUINONE DATE: 02/25/99
EXPERIMENT: 88036 TEST: 03 TIME: 11:51:59
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-25337 ROUTE: DOSED FEED NTP C#: C88036
PATHOLOGIST: SINGER, A. CAS: 84-65-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF ANTHRAQUINONE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Bone Fibrous Osteodystrophy
Osteomalacia
Bone Marrow Hyperplasia
Eye Mineralization
Heart: Atrium Thrombosis
Intestine Small, Duodenum Inflammation
Kidney Accumulation, Hyaline Droplet
Cyst
Mineralization Diffuse
Pigmentation
Kidney: Medulla Mineralization
Kidney: Renal Tubule Hyperplasia
Kidney: Transitional Epithelium Hyperplasia
Liver Angiectasis
Basophilic Focus
Degeneration Cystic
Eosinophilic Focus
Inflammation
Mixed Cell Focus
Vacuolization Cytoplasmic
Liver: Centrilobular Hypertrophy
Lung Mineralization
Lymph Node, Mandibular Ectasia
Mammary Gland Hyperplasia
Mesentery: Artery Mineralization
Mesentery: Fat Necrosis
Nose: Respiratory Epithelium Inflammation
Pancreas: Artery Inflammation
Mineralization
Parathyroid Gland Hyperplasia
Pituitary Gland: Pars Distalis Hyperplasia
Pituitary Gland: Pars Nervosa Hyperplasia
Preputial Gland Inflammation
Skin Inflammation
Spleen Congestion
Fibrosis
Hematopoietic Cell Proliferation
Pigmentation
Spleen: Lymphoid Follicle Atrophy
Stomach, Forestomach Hyperplasia
Mineralization
Stomach, Glandular Mineralization
Thymus Atrophy
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus ANTHRAQUINONE DATE: 02/25/99
EXPERIMENT: 88036 TEST: 03 TIME: 11:51:59
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-25337 ROUTE: DOSED FEED NTP C#: C88036
PATHOLOGIST: SINGER, A. CAS: 84-65-1
Adrenal Cortex Degeneration Cystic
Hyperplasia
Adrenal Medulla Hyperplasia
Bone Osteopetrosis
Bone Marrow Atrophy
Hyperplasia
Clitoral Gland Hyperplasia
Inflammation
Heart Inflammation
Intestine Large, Rectum Parasite Metazoan
Kidney Accumulation, Hyaline Droplet
Nephropathy
Pigmentation
Kidney: Medulla Mineralization
Kidney: Renal Tubule Hyperplasia
Kidney: Transitional Epithelium Hyperplasia
Liver Angiectasis
Basophilic Focus
Degeneration Cystic
Eosinophilic Focus
Hematopoietic Cell Proliferation
Inflammation
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Liver: Centrilobular Hypertrophy
Lung Inflammation
Pigmentation
Lung: Alveolar Epithelium Hyperplasia
Mammary Gland Cyst
Hyperplasia
Nose Foreign Body
Pancreas Atrophy
Pituitary Gland Angiectasis
Cyst
Pituitary Gland: Pars Distalis Hyperplasia
Spleen Congestion
Hematopoietic Cell Proliferation
Pigmentation
Stomach, Forestomach Ulcer
Thymus Atrophy
Thyroid Gland: C-Cell Hyperplasia
Urinary Bladder Inflammation
Urinary Bladder: Transitional Epithelium
Hyperplasia
===============================================================
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 4/50 (8%) 3/50 (6%) 7/50 (14%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 16.9% 9.1% 7.0% 15.8% 21.6% |
|TERMINAL (d) | 5/22 (23%) 2/23 (9%) 1/22 (5%) 1/26 (4%) 4/22 (18%) |
|FIRST INCIDENCE | 540 676 638 681 603 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.116 P=0.229N P=0.145N P=0.455N P=0.413 |
|POLY 3 | P=0.098 P=0.227N P=0.140N P=0.561N P=0.392 |
|POLY 1.5 | P=0.100 P=0.242N P=0.149N P=0.588N P=0.384 |
|POLY 6 | P=0.097 P=0.208N P=0.126N P=0.520N P=0.409 |
|LOGISTIC REGRESSION| P=0.098 P=0.212N P=0.143N P=0.552N P=0.393 |
|COCH-ARM / FISHERS | P=0.111 P=0.262N P=0.159N P=0.613N P=0.393 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 6/50 (12%) 9/50 (18%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 13.8% 4.3% 13.1% 19.1% 6.3% |
|TERMINAL (d) | 5/23 (22%) 1/40 (3%) 3/35 (9%) 7/37 (19%) 2/40 (5%) |
|FIRST INCIDENCE | 571 645 571 701 712 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.262N P=0.041N* P=0.392N P=0.589N P=0.071N |
|POLY 3 | P=0.398N P=0.110N P=0.585N P=0.346 P=0.203N |
|POLY 1.5 | P=0.425N P=0.122N P=0.609N P=0.319 P=0.226N |
|POLY 6 | P=0.358N P=0.092N P=0.540N P=0.396 P=0.166N |
|LOGISTIC REGRESSION| P=0.435N P=0.131N P=0.618N P=0.420 P=0.206N |
|COCH-ARM / FISHERS | P=0.459N P=0.134N P=0.620N P=0.288 P=0.254N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.3% 4.6% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 699 681 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.576 (e) P=0.548 P=0.285 (e) |
|POLY 3 | P=0.553 (e) P=0.510 P=0.254 (e) |
|POLY 1.5 | P=0.559 (e) P=0.505 P=0.246 (e) |
|POLY 6 | P=0.545 (e) P=0.518 P=0.267 (e) |
|LOGISTIC REGRESSION| P=0.574 (e) P=0.511 P=0.258 (e) |
|COCH-ARM / FISHERS | P=0.578 (e) P=0.500 P=0.247 (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 701 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.675 (e) (e) P=0.561 (e) |
|POLY 3 | P=0.671 (e) (e) P=0.518 (e) |
|POLY 1.5 | P=0.656 (e) (e) P=0.510 (e) |
|POLY 6 | P=0.695 (e) (e) P=0.532 (e) |
|LOGISTIC REGRESSION| P=0.638 (e) (e) P=0.498 (e) |
|COCH-ARM / FISHERS | P=0.639 (e) (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 10/50 (20%) 8/50 (16%) 13/50 (26%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 19.4% 22.1% 18.5% 28.8% 14.6% |
|TERMINAL (d) | 5/22 (23%) 3/23 (13%) 4/22 (18%) 8/26 (31%) 3/22 (14%) |
|FIRST INCIDENCE | 642 597 603 583 677 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.349N P=0.495 P=0.559N P=0.301 P=0.386N |
|POLY 3 | P=0.374N P=0.486 P=0.566N P=0.220 P=0.385N |
|POLY 1.5 | P=0.369N P=0.446 P=0.587N P=0.190 P=0.394N |
|POLY 6 | P=0.380N P=0.542 P=0.535N P=0.268 P=0.371N |
|LOGISTIC REGRESSION| P=0.360N P=0.449 P=0.531N P=0.228 P=0.374N |
|COCH-ARM / FISHERS | P=0.339N P=0.398 P=0.607N P=0.163 P=0.387N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/50 (26%) 12/50 (24%) 17/50 (34%) 17/50 (34%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 29.3% 25.3% 37.6% 36.0% 6.4% |
|TERMINAL (d) | 6/23 (26%) 9/40 (23%) 14/35 (40%) 15/37 (41%) 3/40 (8%) |
|FIRST INCIDENCE | 645 513 703 689 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=0.129N P=0.479N P=0.409N P<0.001N** |
|POLY 3 | P=0.004N** P=0.426N P=0.267 P=0.320 P=0.003N** |
|POLY 1.5 | P=0.006N** P=0.460N P=0.251 P=0.290 P=0.005N** |
|POLY 6 | P=0.002N** P=0.371N P=0.300 P=0.368 P=0.002N** |
|LOGISTIC REGRESSION| P=0.003N** P=0.466N P=0.380 P=0.442 P=0.005N** |
|COCH-ARM / FISHERS | P=0.010N* P=0.500N P=0.257 P=0.257 P=0.007N** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.6% 2.3% 4.7% 9.1% 2.5% |
|TERMINAL (d) | 1/22 (5%) 1/23 (4%) 1/22 (5%) 4/26 (15%) 0/22 (0%) |
|FIRST INCIDENCE | 537 729 (T) 687 729 (T) 690 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.291N P=0.160N P=0.307N P=0.551N P=0.175N |
|POLY 3 | P=0.323N P=0.164N P=0.325N P=0.618N P=0.185N |
|POLY 1.5 | P=0.317N P=0.171N P=0.332N P=0.631N P=0.185N |
|POLY 6 | P=0.331N P=0.157N P=0.314N P=0.601N P=0.184N |
|LOGISTIC REGRESSION| P=0.306N P=0.198N P=0.343N P=0.629N P=0.175N |
|COCH-ARM / FISHERS | P=0.299N P=0.181N P=0.339N P=0.643N P=0.181N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 7/50 (14%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| 6.9% 2.2% 2.2% 14.8% 10.6% |
|TERMINAL (d) | 2/23 (9%) 1/40 (3%) 1/35 (3%) 6/37 (16%) 5/40 (13%) |
|FIRST INCIDENCE | 617 730 (T) 730 (T) 689 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.128 P=0.173N P=0.202N P=0.373 P=0.637 |
|POLY 3 | P=0.066 P=0.281N P=0.292N P=0.193 P=0.404 |
|POLY 1.5 | P=0.059 P=0.293N P=0.302N P=0.176 P=0.376 |
|POLY 6 | P=0.078 P=0.261N P=0.274N P=0.223 P=0.452 |
|LOGISTIC REGRESSION| P=0.085 P=0.297N P=0.298N P=0.217 P=0.432 |
|COCH-ARM / FISHERS | P=0.053 P=0.309N P=0.309N P=0.159 P=0.346 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 7.2% 4.6% 0.0% 2.3% 9.7% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 565 710 --- 583 646 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.239 P=0.438N P=0.116N P=0.271N P=0.512 |
|POLY 3 | P=0.247 P=0.476N P=0.113N P=0.283N P=0.498 |
|POLY 1.5 | P=0.248 P=0.486N P=0.116N P=0.294N P=0.493 |
|POLY 6 | P=0.248 P=0.464N P=0.109N P=0.268N P=0.507 |
|LOGISTIC REGRESSION| P=0.271 P=0.521N P=0.123N P=0.313N P=0.505 |
|COCH-ARM / FISHERS | P=0.253 P=0.500N P=0.121N P=0.309N P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 4/50 (8%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 2.3% 4.3% 2.2% 8.5% 6.4% |
|TERMINAL (d) | 0/23 (0%) 2/40 (5%) 1/35 (3%) 4/37 (11%) 3/40 (8%) |
|FIRST INCIDENCE | 715 730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.274 P=0.673 P=0.673N P=0.341 P=0.510 |
|POLY 3 | P=0.195 P=0.526 P=0.751N P=0.206 P=0.339 |
|POLY 1.5 | P=0.178 P=0.514 P=0.758N P=0.193 P=0.319 |
|POLY 6 | P=0.223 P=0.549 P=0.738N P=0.229 P=0.373 |
|LOGISTIC REGRESSION| P=0.272 P=0.608 P=0.719N P=0.298 P=0.456 |
|COCH-ARM / FISHERS | P=0.159 P=0.500 P=0.753N P=0.181 P=0.301 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 17/50 (34%) 24/50 (48%) 22/50 (44%) 20/50 (40%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 40.1% 52.3% 49.8% 43.4% 34.9% |
|TERMINAL (d) | 8/22 (36%) 11/23 (48%) 10/22 (46%) 8/26 (31%) 6/22 (27%) |
|FIRST INCIDENCE | 562 597 648 620 537 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.178N P=0.248 P=0.306 P=0.541N P=0.403N |
|POLY 3 | P=0.125N P=0.168 P=0.239 P=0.460 P=0.389N |
|POLY 1.5 | P=0.140N P=0.139 P=0.219 P=0.398 P=0.414N |
|POLY 6 | P=0.107N P=0.218 P=0.275 P=0.555 P=0.355N |
|LOGISTIC REGRESSION| P=0.155N P=0.190 P=0.299 P=0.438 P=0.418N |
|COCH-ARM / FISHERS | P=0.138N P=0.111 P=0.206 P=0.339 P=0.415N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 3/50 (6%) 4/50 (8%) 4/50 (8%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 18.2% 6.5% 8.9% 8.4% 12.7% |
|TERMINAL (d) | 3/23 (13%) 3/40 (8%) 2/35 (6%) 2/37 (5%) 6/40 (15%) |
|FIRST INCIDENCE | 649 730 (T) 703 635 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.354N P=0.025N* P=0.072N P=0.070N P=0.110N |
|POLY 3 | P=0.535N P=0.081N P=0.162N P=0.141N P=0.331N |
|POLY 1.5 | P=0.550N P=0.090N P=0.174N P=0.157N P=0.365N |
|POLY 6 | P=0.513N P=0.068N P=0.142N P=0.117N P=0.279N |
|LOGISTIC REGRESSION| P=0.515N P=0.077N P=0.155N P=0.182N P=0.310N |
|COCH-ARM / FISHERS | P=0.548 P=0.100N P=0.178N P=0.178N P=0.403N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Blood Vessel |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 7/50 (14%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 7.2% 6.8% 9.3% 15.5% 16.7% |
|TERMINAL (d) | 0/22 (0%) 1/23 (4%) 0/22 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 555 676 699 620 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.056 P=0.609N P=0.557 P=0.255 P=0.188 |
|POLY 3 | P=0.051 P=0.637N P=0.516 P=0.192 P=0.158 |
|POLY 1.5 | P=0.051 P=0.648N P=0.507 P=0.175 P=0.154 |
|POLY 6 | P=0.054 P=0.624N P=0.529 P=0.220 P=0.167 |
|LOGISTIC REGRESSION| P=0.055 P=0.644 P=0.507 P=0.143 P=0.159 |
|COCH-ARM / FISHERS | P=0.056 P=0.661N P=0.500 P=0.159 P=0.159 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Blood Vessel |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 8/50 (16%) 11/50 (22%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 4.9% 9.1% 18.2% 24.4% 21.2% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 3/26 (12%) 0/22 (0%) |
|FIRST INCIDENCE | 681 676 565 620 607 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * P=0.407 P=0.078 P=0.030 * P=0.041 * |
|POLY 3 | P=0.017 * P=0.371 P=0.056 P=0.011 * P=0.028 * |
|POLY 1.5 | P=0.015 * P=0.356 P=0.051 P=0.009 ** P=0.025 * |
|POLY 6 | P=0.020 * P=0.392 P=0.066 P=0.016 * P=0.033 * |
|LOGISTIC REGRESSION| P=0.016 * P=0.380 P=0.051 P=0.011 * P=0.027 * |
|COCH-ARM / FISHERS | P=0.018 * P=0.339 P=0.046 * P=0.007 ** P=0.026 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 1/35 (3%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 730 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.607N (e) P=0.584 (e) (e) |
|POLY 3 | P=0.640N (e) P=0.509 (e) (e) |
|POLY 1.5 | P=0.645N (e) P=0.503 (e) (e) |
|POLY 6 | P=0.633N (e) P=0.520 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.584 (e) (e) |
|COCH-ARM / FISHERS | P=0.649N (e) P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Bone |
| Osteomalacia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 13/50 (26%) 12/50 (24%) 8/50 (16%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 28.7% 26.3% 17.9% 7.3% |
|TERMINAL (d) | 0/22 (0%) 4/23 (17%) 0/22 (0%) 2/26 (8%) 0/22 (0%) |
|FIRST INCIDENCE | --- 615 561 628 646 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.236N P<0.001 ** P=0.002 ** P=0.014 * P=0.137 |
|POLY 3 | P=0.192N P<0.001 ** P<0.001 ** P=0.005 ** P=0.121 |
|POLY 1.5 | P=0.206N P<0.001 ** P<0.001 ** P=0.004 ** P=0.118 |
|POLY 6 | P=0.172N P<0.001 ** P<0.001 ** P=0.007 ** P=0.125 |
|LOGISTIC REGRESSION| P=0.210N P<0.001 ** P<0.001 ** P=0.006 ** P=0.121 |
|COCH-ARM / FISHERS | P=0.212N P<0.001 ** P<0.001 ** P=0.003 ** P=0.121 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Bone |
| Osteomalacia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Bone |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 645 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.363N P=0.470N P=0.484N P=0.480N P=0.500N |
|POLY 3 | P=0.359N P=0.487N P=0.492N P=0.487N P=0.502N |
|POLY 1.5 | P=0.358N P=0.493N P=0.496N P=0.494N P=0.503N |
|POLY 6 | P=0.360N P=0.481N P=0.486N P=0.478N P=0.501N |
|LOGISTIC REGRESSION| P=0.342N P=0.531N P=0.503N P=0.506N P=0.492N |
|COCH-ARM / FISHERS | P=0.359N P=0.500N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Bone |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.0% 4.3% 6.7% 2.1% 0.0% |
|TERMINAL (d) | 3/23 (13%) 1/40 (3%) 2/35 (6%) 1/37 (3%) 0/40 (0%) |
|FIRST INCIDENCE | 730 (T) 589 703 730 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.034N* P=0.303N P=0.470N P=0.154N P=0.043N* |
|POLY 3 | P=0.052N P=0.460N P=0.641N P=0.274N P=0.100N |
|POLY 1.5 | P=0.056N P=0.479N P=0.656N P=0.289N P=0.109N |
|POLY 6 | P=0.047N* P=0.427N P=0.612N P=0.251N P=0.087N |
|LOGISTIC REGRESSION| P=0.053N P=0.493N P=0.537N P=0.154N (e) |
|COCH-ARM / FISHERS | P=0.061N P=0.500N P=0.661N P=0.309N P=0.121N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 13/50 (26%) 13/50 (26%) 11/50 (22%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| 9.2% 28.0% 28.5% 23.3% 27.0% |
|TERMINAL (d) | 3/23 (13%) 13/40 (33%) 12/35 (34%) 9/37 (24%) 13/40 (33%) |
|FIRST INCIDENCE | 571 730 (T) 506 675 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.337 P=0.146 P=0.084 P=0.209 P=0.146 |
|POLY 3 | P=0.161 P=0.020 * P=0.018 * P=0.062 P=0.025 * |
|POLY 1.5 | P=0.131 P=0.017 * P=0.015 * P=0.053 P=0.019 * |
|POLY 6 | P=0.221 P=0.027 * P=0.023 * P=0.079 P=0.038 * |
|LOGISTIC REGRESSION| P=0.224 P=0.041 * P=0.020 * P=0.080 P=0.048 * |
|COCH-ARM / FISHERS | P=0.103 P=0.016 * P=0.016 * P=0.045 * P=0.016 * |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.9% 4.6% 0.0% 2.3% 2.5% |
|TERMINAL (d) | 0/22 (0%) 2/23 (9%) 0/22 (0%) 1/26 (4%) 1/22 (5%) |
|FIRST INCIDENCE | 648 729 (T) --- 729 (T) 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.379N P=0.660N P=0.228N P=0.452N P=0.505N |
|POLY 3 | P=0.382N P=0.672N P=0.228N P=0.478N P=0.504N |
|POLY 1.5 | P=0.382N P=0.681N P=0.233N P=0.489N P=0.505N |
|POLY 6 | P=0.381N P=0.660N P=0.222N P=0.462N P=0.502N |
|LOGISTIC REGRESSION| P=0.385N P=0.656N P=0.233N P=0.473N P=0.498N |
|COCH-ARM / FISHERS | P=0.378N P=0.691N P=0.247N P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 25/50 (50%) 28/50 (56%) 37/50 (74%) 36/50 (72%) 33/50 (66%) |
|POLY-3 ADJUSTED (b)| 55.8% 61.2% 78.2% 74.6% 70.8% |
|TERMINAL (d) | 12/22 (55%) 15/23 (65%) 17/22 (77%) 17/26 (65%) 16/22 (73%) |
|FIRST INCIDENCE | 499 641 477 249 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.128 P=0.517 P=0.075 P=0.230 P=0.149 |
|POLY 3 | P=0.091 P=0.373 P=0.013 * P=0.038 * P=0.090 |
|POLY 1.5 | P=0.081 P=0.360 P=0.011 * P=0.027 * P=0.084 |
|POLY 6 | P=0.103 P=0.388 P=0.020 * P=0.062 P=0.098 |
|LOGISTIC REGRESSION| P=0.059 P=0.462 P=0.014 * P=0.023 * P=0.077 |
|COCH-ARM / FISHERS | P=0.071 P=0.344 P=0.011 * P=0.020 * P=0.078 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 19/50 (38%) 31/50 (62%) 28/50 (56%) 19/50 (38%) 23/50 (46%) |
|POLY-3 ADJUSTED (b)| 41.4% 62.2% 56.4% 39.2% 46.1% |
|TERMINAL (d) | 6/23 (26%) 22/40 (55%) 15/35 (43%) 12/37 (32%) 15/40 (38%) |
|FIRST INCIDENCE | 571 513 85 611 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.067N P=0.398 P=0.393 P=0.160N P=0.248N |
|POLY 3 | P=0.217N P=0.030 * P=0.099 P=0.500N P=0.398 |
|POLY 1.5 | P=0.258N P=0.020 * P=0.075 P=0.538N P=0.338 |
|POLY 6 | P=0.165N P=0.053 P=0.146 P=0.441N P=0.492 |
|LOGISTIC REGRESSION| P=0.536N P=0.006 ** P=0.035 * P=0.522 P=0.153 |
|COCH-ARM / FISHERS | P=0.317N P=0.014 * P=0.054 P=0.582N P=0.272 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 499 --- --- --- 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.591N P=0.229N P=0.242N P=0.227N P=0.509N |
|POLY 3 | P=0.581N P=0.225N P=0.230N P=0.225N P=0.504N |
|POLY 1.5 | P=0.579N P=0.231N P=0.234N P=0.231N P=0.506N |
|POLY 6 | P=0.584N P=0.218N P=0.224N P=0.215N P=0.500N |
|LOGISTIC REGRESSION| P=0.518N P=0.292N P=0.228N P=0.231N P=0.467N |
|COCH-ARM / FISHERS | P=0.577N P=0.247N P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 2.2% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 1/40 (3%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 665 730 (T) 638 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.177N P=0.682N P=0.744N P=0.465N P=0.448N |
|POLY 3 | P=0.201N P=0.745N P=0.750N P=0.483N P=0.480N |
|POLY 1.5 | P=0.205N P=0.752N P=0.757N P=0.491N P=0.491N |
|POLY 6 | P=0.195N P=0.730N P=0.737N P=0.471N P=0.463N |
|LOGISTIC REGRESSION| P=0.226N P=0.762 P=0.753N P=0.569N P=0.612N |
|COCH-ARM / FISHERS | P=0.210N P=0.753N P=0.753N P=0.500N P=0.505N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 5/46 (11%) 8/48 (17%) 4/49 (8%) 3/48 (6%) |
|POLY-3 ADJUSTED (b)| 4.7% 11.5% 18.6% 8.7% 6.5% |
|TERMINAL (d) | 2/23 (9%) 5/39 (13%) 7/34 (21%) 4/37 (11%) 3/38 (8%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 723 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.245N P=0.468 P=0.148 P=0.570 P=0.644N |
|POLY 3 | P=0.344N P=0.224 P=0.046 * P=0.374 P=0.537 |
|POLY 1.5 | P=0.375N P=0.208 P=0.042 * P=0.357 P=0.514 |
|POLY 6 | P=0.296N P=0.256 P=0.054 P=0.404 P=0.574 |
|LOGISTIC REGRESSION| P=0.237N P=0.468 P=0.125 P=0.570 P=0.644N |
|COCH-ARM / FISHERS | P=0.411N P=0.192 P=0.042 * P=0.339 P=0.490 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/49 (20%) 21/46 (46%) 13/48 (27%) 11/49 (22%) 12/48 (25%) |
|POLY-3 ADJUSTED (b)| 23.1% 46.3% 29.3% 23.6% 26.0% |
|TERMINAL (d) | 6/23 (26%) 16/39 (41%) 8/34 (24%) 8/37 (22%) 12/38 (32%) |
|FIRST INCIDENCE | 645 513 571 675 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.080N P=0.228 P=0.542N P=0.296N P=0.297N |
|POLY 3 | P=0.185N P=0.017 * P=0.339 P=0.577 P=0.472 |
|POLY 1.5 | P=0.216N P=0.011 * P=0.309 P=0.541 P=0.429 |
|POLY 6 | P=0.144N P=0.033 * P=0.399 P=0.563N P=0.546 |
|LOGISTIC REGRESSION| P=0.222N P=0.009 ** P=0.315 P=0.555N P=0.533N |
|COCH-ARM / FISHERS | P=0.260N P=0.008 ** P=0.297 P=0.500 P=0.383 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/49 (8%) 5/46 (11%) 2/48 (4%) 4/49 (8%) 3/48 (6%) |
|POLY-3 ADJUSTED (b)| 9.3% 11.5% 4.6% 8.7% 6.5% |
|TERMINAL (d) | 3/23 (13%) 5/39 (13%) 2/34 (6%) 4/37 (11%) 3/38 (8%) |
|FIRST INCIDENCE | 649 730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.245N P=0.485N P=0.196N P=0.398N P=0.264N |
|POLY 3 | P=0.344N P=0.509 P=0.335N P=0.603N P=0.460N |
|POLY 1.5 | P=0.363N P=0.486 P=0.346N P=0.622N P=0.485N |
|POLY 6 | P=0.316N P=0.552 P=0.313N P=0.571N P=0.418N |
|LOGISTIC REGRESSION| P=0.270N P=0.605 P=0.296N P=0.532N P=0.403N |
|COCH-ARM / FISHERS | P=0.387N P=0.459 P=0.349N P=0.643N P=0.512N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Epididymis |
| Granuloma Sperm |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.3% 0.0% 6.9% 2.5% |
|TERMINAL (d) | 0/22 (0%) 1/23 (4%) 0/22 (0%) 3/26 (12%) 0/22 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) 705 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.257 P=0.509 (e) P=0.150 P=0.484 |
|POLY 3 | P=0.249 P=0.514 (e) P=0.132 P=0.500 |
|POLY 1.5 | P=0.252 P=0.508 (e) P=0.125 P=0.498 |
|POLY 6 | P=0.246 P=0.522 (e) P=0.141 P=0.503 |
|LOGISTIC REGRESSION| P=0.245 P=0.509 (e) P=0.150 P=0.502 |
|COCH-ARM / FISHERS | P=0.266 P=0.500 (e) P=0.121 P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Epididymis |
| Granuloma Sperm |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/2 (100%) 0/0 (0%) 2/4 (50%) 4/5 (80%) 0/2 (0%) |
|POLY-3 ADJUSTED (b)| 100.0% 0.0% 50.0% 83.5% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/2 (0%) 3/3 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 485 --- 663 727 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.338N (e) P=0.663N P=0.445N P=0.236N |
|POLY 3 | (e) (e) P=0.386N P=0.754N P=0.128N |
|POLY 1.5 | (e) (e) P=0.386N P=0.712N P<0.001N** |
|POLY 6 | (e) (e) P=0.386N P=0.838N P=0.625N |
|LOGISTIC REGRESSION| P=0.128N (e) (e) P=0.780N P=0.159N |
|COCH-ARM / FISHERS | P=0.111N (e) P=0.400N P=0.714N P=0.167N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/2 (100%) 3/3 (100%) 1/2 (50%) 2/3 (67%) 3/5 (60%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 60.0% 69.3% 60.0% |
|TERMINAL (d) | 1/1 (100%) 3/3 (100%) 0/0 (0%) 2/2 (100%) 3/5 (60%) |
|FIRST INCIDENCE | 676 730 (T) 703 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.061N (e) P=0.684N P=0.446N P=0.267N |
|POLY 3 | P=0.185N (e) P=0.645N P=0.616N P=0.451N |
|POLY 1.5 | P=0.206N (e) P=0.567N P=0.596N P=0.451N |
|POLY 6 | P=0.156N (e) P=0.822N P=0.658N P=0.451N |
|LOGISTIC REGRESSION| P=0.054N (e) (e) P=0.474N P=0.267N |
|COCH-ARM / FISHERS | P=0.210N (e) P=0.500N P=0.600N P=0.476N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Eye |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 0/0 (0%) 0/4 (0%) 1/5 (20%) 0/2 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 20.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/2 (0%) 0/3 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 674 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.637 (e) (e) P=0.531 (e) |
|POLY 3 | (e) (e) (e) P=0.746 (e) |
|POLY 1.5 | (e) (e) (e) P=0.718 (e) |
|POLY 6 | (e) (e) (e) P=0.773 (e) |
|LOGISTIC REGRESSION| P=0.736 (e) (e) P=0.780 (e) |
|COCH-ARM / FISHERS | P=0.731 (e) (e) P=0.714 (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Eye |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 0/3 (0%) 1/2 (50%) 2/3 (67%) 2/5 (40%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 52.8% 66.7% 40.0% |
|TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/0 (0%) 1/2 (50%) 2/5 (40%) |
|FIRST INCIDENCE | --- --- 638 701 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.290 (e) P=0.536 P=0.357 P=0.638 |
|POLY 3 | P=0.252 (e) P=0.511 P=0.316 P=0.481 |
|POLY 1.5 | P=0.241 (e) P=0.506 P=0.299 P=0.467 |
|POLY 6 | P=0.272 (e) P=0.520 P=0.348 P=0.506 |
|LOGISTIC REGRESSION| P=0.093 (e) (e) P=0.297 P=0.638 |
|COCH-ARM / FISHERS | P=0.222 (e) P=0.500 P=0.300 P=0.476 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Eye |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 0/0 (0%) 0/4 (0%) 2/5 (40%) 0/2 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 41.8% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/2 (0%) 2/3 (67%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.662 (e) (e) P=1.000N (e) |
|POLY 3 | (e) (e) (e) P=0.593 (e) |
|POLY 1.5 | (e) (e) (e) P=0.535 (e) |
|POLY 6 | (e) (e) (e) P=0.661 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=1.000N (e) |
|COCH-ARM / FISHERS | P=0.605 (e) (e) P=0.476 (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Eye |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/3 (0%) 1/5 (20%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/2 (0%) 1/5 (20%) |
|FIRST INCIDENCE | --- --- --- --- 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.339 (e) (e) (e) P=0.814 |
|POLY 3 | P=0.289 (e) (e) (e) P=0.689 |
|POLY 1.5 | P=0.282 (e) (e) (e) P=0.681 |
|POLY 6 | P=0.301 (e) (e) (e) P=0.702 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.814 |
|COCH-ARM / FISHERS | P=0.248 (e) (e) (e) P=0.714 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Eye |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 0/0 (0%) 0/4 (0%) 4/5 (80%) 1/2 (50%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 83.5% 77.4% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/2 (0%) 3/3 (100%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 727 646 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.064 (e) (e) P=0.541 P=0.517 |
|POLY 3 | (e) (e) (e) P=0.307 P=0.556 |
|POLY 1.5 | (e) (e) (e) P=0.192 P=0.520 |
|POLY 6 | (e) (e) (e) P=0.498 P=0.665 |
|LOGISTIC REGRESSION| P=0.021 * (e) (e) (e) P=0.450 |
|COCH-ARM / FISHERS | P=0.120 (e) (e) P=0.143 P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Eye |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 0/3 (0%) 0/2 (0%) 0/3 (0%) 0/5 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/2 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Eye: Lens |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 0/0 (0%) 0/4 (0%) 0/5 (0%) 0/2 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/2 (0%) 0/3 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Eye: Lens |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 2/3 (67%) 1/2 (50%) 0/3 (0%) 0/5 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 66.7% 60.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 2/3 (67%) 0/0 (0%) 0/2 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 730 (T) 703 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.108N P=0.500 P=0.589 (e) (e) |
|POLY 3 | P=0.062N P=0.316 P=0.484 (e) (e) |
|POLY 1.5 | P=0.071N P=0.299 P=0.492 (e) (e) |
|POLY 6 | P=0.049N* P=0.348 P=0.471 (e) (e) |
|LOGISTIC REGRESSION| P=0.085N P=0.500 P=0.383 (e) (e) |
|COCH-ARM / FISHERS | P=0.118N P=0.300 P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/2 (100%) 0/0 (0%) 3/4 (75%) 4/5 (80%) 1/2 (50%) |
|POLY-3 ADJUSTED (b)| 100.0% 0.0% 75.0% 83.5% 77.4% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 1/2 (50%) 3/3 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 485 --- 663 727 646 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.570N (e) P=0.663N P=0.445N P=0.487N |
|POLY 3 | (e) (e) P=0.631N P=0.754N P=0.962N |
|POLY 1.5 | (e) (e) P=0.631N P=0.712N P=0.736N |
|POLY 6 | (e) (e) P=0.631N P=0.838N P=1.000N |
|LOGISTIC REGRESSION| P=0.364N (e) (e) P=0.780N (e) |
|COCH-ARM / FISHERS | P=0.305N (e) P=0.667N P=0.714N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/2 (50%) 3/3 (100%) 2/2 (100%) 1/3 (33%) 3/5 (60%) |
|POLY-3 ADJUSTED (b)| 55.7% 100.0% 100.0% 34.7% 60.0% |
|TERMINAL (d) | 1/1 (100%) 3/3 (100%) 0/0 (0%) 1/2 (50%) 3/5 (60%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 638 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.160N P=1.000N P=0.311 P=0.638N P=0.638N |
|POLY 3 | P=0.299N P=0.503 P=0.577 P=0.660N P=0.745 |
|POLY 1.5 | P=0.323N P=0.455 P=0.536 P=0.665N P=0.722 |
|POLY 6 | P=0.261N P=0.618 P=0.669 P=0.650N P=0.769N |
|LOGISTIC REGRESSION| P=0.289N P=1.000N P=0.419 P=0.638N P=0.638N |
|COCH-ARM / FISHERS | P=0.345N P=0.400 P=0.500 P=0.700N P=0.714 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 42/50 (84%) 44/50 (88%) 44/50 (88%) 43/50 (86%) 41/50 (82%) |
|POLY-3 ADJUSTED (b)| 85.4% 89.2% 91.6% 88.7% 85.2% |
|TERMINAL (d) | 20/22 (91%) 21/23 (91%) 22/22 (100%) 22/26 (85%) 18/22 (82%) |
|FIRST INCIDENCE | 485 477 477 537 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.405N P=0.466N P=0.559 P=0.242N P=0.470N |
|POLY 3 | P=0.412N P=0.388 P=0.250 P=0.423 P=0.610N |
|POLY 1.5 | P=0.410N P=0.388 P=0.291 P=0.429 P=0.599N |
|POLY 6 | P=0.406N P=0.388 P=0.213 P=0.445 P=0.621N |
|LOGISTIC REGRESSION| P=0.366N P=0.323 P=0.402 P=0.519 P=0.507N |
|COCH-ARM / FISHERS | P=0.307N P=0.387 P=0.387 P=0.500 P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 22/50 (44%) 25/50 (50%) 27/50 (54%) 28/50 (56%) 28/48 (58%) |
|POLY-3 ADJUSTED (b)| 48.3% 53.6% 57.8% 59.1% 58.8% |
|TERMINAL (d) | 13/23 (57%) 24/40 (60%) 19/35 (54%) 25/37 (68%) 24/40 (60%) |
|FIRST INCIDENCE | 550 694 571 635 536 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.334N P=0.079N P=0.352N P=0.257N P=0.173N |
|POLY 3 | P=0.201 P=0.380 P=0.237 P=0.198 P=0.208 |
|POLY 1.5 | P=0.150 P=0.360 P=0.209 P=0.178 P=0.158 |
|POLY 6 | P=0.296 P=0.431 P=0.303 P=0.240 P=0.307 |
|LOGISTIC REGRESSION| P=0.290 P=0.556 P=0.243 P=0.344 P=0.182 |
|COCH-ARM / FISHERS | P=0.099 P=0.344 P=0.212 P=0.159 P=0.112 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Heart |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.3% 2.3% 4.5% 2.5% |
|TERMINAL (d) | 0/22 (0%) 1/23 (4%) 0/22 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- 729 (T) 638 628 724 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.368 P=0.509 P=0.520 P=0.272 P=0.492 |
|POLY 3 | P=0.361 P=0.514 P=0.511 P=0.255 P=0.500 |
|POLY 1.5 | P=0.362 P=0.508 P=0.505 P=0.246 P=0.498 |
|POLY 6 | P=0.359 P=0.522 P=0.519 P=0.269 P=0.502 |
|LOGISTIC REGRESSION| P=0.369 P=0.509 P=0.498 P=0.235 P=0.499 |
|COCH-ARM / FISHERS | P=0.374 P=0.500 P=0.500 P=0.247 P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Heart |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 9/50 (18%) 4/50 (8%) 1/50 (2%) 3/48 (6%) |
|POLY-3 ADJUSTED (b)| 4.6% 19.2% 8.9% 2.1% 6.4% |
|TERMINAL (d) | 1/23 (4%) 8/40 (20%) 4/35 (11%) 1/37 (3%) 3/40 (8%) |
|FIRST INCIDENCE | 718 592 730 (T) 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.096N P=0.136 P=0.538 P=0.343N P=0.623N |
|POLY 3 | P=0.158N P=0.035 * P=0.357 P=0.469N P=0.539 |
|POLY 1.5 | P=0.181N P=0.030 * P=0.343 P=0.484N P=0.512 |
|POLY 6 | P=0.127N P=0.046 * P=0.384 P=0.446N P=0.581 |
|LOGISTIC REGRESSION| P=0.133N P=0.044 * P=0.498 P=0.382N P=0.665N |
|COCH-ARM / FISHERS | P=0.216N P=0.026 * P=0.339 P=0.500N P=0.480 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 4/50 (8%) 5/50 (10%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.4% 4.6% 9.3% 11.1% 12.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 681 676 704 628 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.059 P=0.549 P=0.227 P=0.164 P=0.122 |
|POLY 3 | P=0.062 P=0.525 P=0.192 P=0.123 P=0.105 |
|POLY 1.5 | P=0.061 P=0.514 P=0.185 P=0.112 P=0.101 |
|POLY 6 | P=0.066 P=0.540 P=0.203 P=0.142 P=0.112 |
|LOGISTIC REGRESSION| P=0.063 P=0.509 P=0.206 P=0.097 P=0.103 |
|COCH-ARM / FISHERS | P=0.064 P=0.500 P=0.181 P=0.102 P=0.102 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Heart: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.3% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- 710 --- --- 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.394 P=0.538 (e) (e) P=0.500 |
|POLY 3 | P=0.407 P=0.514 (e) (e) P=0.500 |
|POLY 1.5 | P=0.404 P=0.508 (e) (e) P=0.498 |
|POLY 6 | P=0.410 P=0.523 (e) (e) P=0.502 |
|LOGISTIC REGRESSION| P=0.394 P=0.524 (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.404 P=0.500 (e) (e) P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Heart: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 2/40 (5%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 730 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.255N P=0.367 (e) (e) (e) |
|POLY 3 | P=0.285N P=0.255 (e) (e) (e) |
|POLY 1.5 | P=0.295N P=0.246 (e) (e) (e) |
|POLY 6 | P=0.268N P=0.271 (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.367 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.310N P=0.247 (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 14.4% 0.0% 2.3% 2.3% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/23 (0%) 0/22 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 620 --- 699 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.021N* P=0.014N* P=0.050N P=0.042N* P=0.021N* |
|POLY 3 | P=0.020N* P=0.013N* P=0.051N P=0.048N* P=0.016N* |
|POLY 1.5 | P=0.019N* P=0.014N* P=0.054N P=0.052N P=0.016N* |
|POLY 6 | P=0.021N* P=0.011N* P=0.047N* P=0.043N* P=0.016N* |
|LOGISTIC REGRESSION| P=0.020N* P=0.017N* P=0.056N P=0.053N P=0.018N* |
|COCH-ARM / FISHERS | P=0.020N* P=0.013N* P=0.056N P=0.056N P=0.013N* |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| 4.6% 0.0% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 605 --- --- --- 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.534N P=0.232N P=0.234N P=0.223N P=0.412N |
|POLY 3 | P=0.600N P=0.224N P=0.231N P=0.221N P=0.476N |
|POLY 1.5 | P=0.593N P=0.230N P=0.236N P=0.229N P=0.493N |
|POLY 6 | P=0.613N P=0.212N P=0.221N P=0.210N P=0.447N |
|LOGISTIC REGRESSION| P=0.637N P=0.276N P=0.203N P=0.374N P=0.717N |
|COCH-ARM / FISHERS | P=0.587N P=0.247N P=0.247N P=0.247N P=0.515N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 674 --- --- --- 690 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.365 P=0.214N P=0.210N P=0.193N P=0.671N |
|POLY 3 | P=0.348 P=0.224N P=0.229N P=0.223N P=0.688 |
|POLY 1.5 | P=0.352 P=0.229N P=0.233N P=0.230N P=0.683 |
|POLY 6 | P=0.344 P=0.217N P=0.223N P=0.214N P=0.694 |
|LOGISTIC REGRESSION| P=0.357 P=0.240N P=0.237N P=0.239N P=0.687 |
|COCH-ARM / FISHERS | P=0.360 P=0.247N P=0.247N P=0.247N P=0.684 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 635 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.653 (e) (e) P=0.518 (e) |
|POLY 3 | P=0.672 (e) (e) P=0.519 (e) |
|POLY 1.5 | P=0.657 (e) (e) P=0.510 (e) |
|POLY 6 | P=0.695 (e) (e) P=0.534 (e) |
|LOGISTIC REGRESSION| P=0.621 (e) (e) P=0.385 (e) |
|COCH-ARM / FISHERS | P=0.640 (e) (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.3% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 1/23 (4%) 1/22 (5%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.200N P=0.753N P=0.763 P=0.467N P=0.500N |
|POLY 3 | P=0.206N P=0.745N P=0.750N P=0.486N P=0.500N |
|POLY 1.5 | P=0.208N P=0.752N P=0.756N P=0.493N P=0.502N |
|POLY 6 | P=0.202N P=0.736N P=0.743N P=0.475N P=0.498N |
|LOGISTIC REGRESSION| P=0.200N P=0.753N P=0.763 (e) (e) |
|COCH-ARM / FISHERS | P=0.207N P=0.753N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/49 (4%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.2% 4.5% 2.1% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 2/35 (6%) 1/37 (3%) 0/40 (0%) |
|FIRST INCIDENCE | --- 513 730 (T) 730 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.272N P=0.244 P=0.335 P=0.595 (e) |
|POLY 3 | P=0.285N P=0.260 P=0.242 P=0.518 (e) |
|POLY 1.5 | P=0.304N P=0.249 P=0.235 P=0.509 (e) |
|POLY 6 | P=0.257N P=0.279 P=0.255 P=0.531 (e) |
|LOGISTIC REGRESSION| P=0.366N P=0.214 P=0.335 P=0.595 (e) |
|COCH-ARM / FISHERS | P=0.325N P=0.247 P=0.242 P=0.500 (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 7/50 (14%) 7/50 (14%) 5/50 (10%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 12.0% 16.0% 16.3% 11.4% 7.4% |
|TERMINAL (d) | 2/22 (9%) 6/23 (26%) 4/22 (18%) 5/26 (19%) 3/22 (14%) |
|FIRST INCIDENCE | 620 724 705 729 (T) 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.152N P=0.427 P=0.420 P=0.529N P=0.348N |
|POLY 3 | P=0.172N P=0.412 P=0.399 P=0.600N P=0.369N |
|POLY 1.5 | P=0.171N P=0.399 P=0.388 P=0.615N P=0.368N |
|POLY 6 | P=0.175N P=0.427 P=0.413 P=0.580N P=0.372N |
|LOGISTIC REGRESSION| P=0.162N P=0.456 P=0.426 P=0.573N P=0.355N |
|COCH-ARM / FISHERS | P=0.159N P=0.380 P=0.380 P=0.630N P=0.357N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 11/50 (22%) 2/49 (4%) 8/50 (16%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 13.9% 23.4% 4.5% 17.0% 0.0% |
|TERMINAL (d) | 5/23 (22%) 10/40 (25%) 1/35 (3%) 6/37 (16%) 0/40 (0%) |
|FIRST INCIDENCE | 676 592 571 723 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002N** P=0.518 P=0.055N P=0.478N P=0.002N** |
|POLY 3 | P=0.004N** P=0.186 P=0.122N P=0.454 P=0.010N* |
|POLY 1.5 | P=0.006N** P=0.164 P=0.134N P=0.422 P=0.013N* |
|POLY 6 | P=0.003N** P=0.230 P=0.104N P=0.506 P=0.008N** |
|LOGISTIC REGRESSION| P=0.005N** P=0.247 P=0.132N P=0.601N P=0.005N** |
|COCH-ARM / FISHERS | P=0.010N* P=0.143 P=0.141N P=0.387 P=0.013N* |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 4.9% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- --- --- --- 690 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.021 * (e) (e) (e) P=0.251 |
|POLY 3 | P=0.021 * (e) (e) (e) P=0.237 |
|POLY 1.5 | P=0.021 * (e) (e) (e) P=0.235 |
|POLY 6 | P=0.021 * (e) (e) (e) P=0.240 |
|LOGISTIC REGRESSION| P=0.020 * (e) (e) (e) P=0.240 |
|COCH-ARM / FISHERS | P=0.023 * (e) (e) (e) P=0.247 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 2.3% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 708 718 719 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.107N P=0.456N P=0.469N P=0.199N P=0.249N |
|POLY 3 | P=0.107N P=0.476N P=0.484N P=0.222N P=0.238N |
|POLY 1.5 | P=0.108N P=0.486N P=0.492N P=0.229N P=0.240N |
|POLY 6 | P=0.107N P=0.462N P=0.472N P=0.211N P=0.235N |
|LOGISTIC REGRESSION| P=0.103N P=0.450N P=0.458N P=0.198N P=0.234N |
|COCH-ARM / FISHERS | P=0.106N P=0.500N P=0.500N P=0.247N P=0.247N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 14/50 (28%) 10/50 (20%) 16/50 (32%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 7.4% 30.3% 22.3% 34.5% 37.2% |
|TERMINAL (d) | 2/22 (9%) 6/23 (26%) 5/22 (23%) 8/26 (31%) 11/22 (50%) |
|FIRST INCIDENCE | 724 481 312 249 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.009 ** P=0.010 * P=0.045 * P=0.005 ** P<0.001 ** |
|POLY 3 | P=0.006 ** P=0.006 ** P=0.050 P=0.002 ** P<0.001 ** |
|POLY 1.5 | P=0.006 ** P=0.004 ** P=0.043 * P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.006 ** P=0.010 * P=0.061 P=0.003 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.009 ** P=0.004 ** P=0.034 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.007 ** P=0.003 ** P=0.036 * P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 33/50 (66%) 48/50 (96%) 45/50 (90%) 44/50 (88%) 44/49 (90%) |
|POLY-3 ADJUSTED (b)| 71.4% 97.1% 91.7% 90.8% 91.2% |
|TERMINAL (d) | 21/23 (91%) 40/40 (100%) 33/35 (94%) 37/37 (100%) 37/40 (93%) |
|FIRST INCIDENCE | 550 513 85 550 536 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.053N P=0.333N P=0.509N P=0.210N P=0.083N |
|POLY 3 | P=0.073 P<0.001 ** P=0.005 ** P=0.008 ** P=0.008 ** |
|POLY 1.5 | P=0.050 P<0.001 ** P=0.004 ** P=0.007 ** P=0.005 ** |
|POLY 6 | P=0.153 P<0.001 ** P=0.012 * P=0.009 ** P=0.022 * |
|LOGISTIC REGRESSION| P=0.089 P<0.001 ** P=0.004 ** P=0.056 P=0.028 * |
|COCH-ARM / FISHERS | P=0.043 * P<0.001 ** P=0.004 ** P=0.008 ** P=0.004 ** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 9/50 (18%) 7/50 (14%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| 7.3% 9.1% 20.7% 15.9% 30.7% |
|TERMINAL (d) | 2/22 (9%) 1/23 (4%) 4/22 (18%) 4/26 (15%) 4/22 (18%) |
|FIRST INCIDENCE | 565 676 596 681 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.551 P=0.083 P=0.243 P=0.013 * |
|POLY 3 | P=0.002 ** P=0.535 P=0.070 P=0.183 P=0.005 ** |
|POLY 1.5 | P=0.002 ** P=0.519 P=0.065 P=0.170 P=0.005 ** |
|POLY 6 | P=0.002 ** P=0.556 P=0.080 P=0.204 P=0.007 ** |
|LOGISTIC REGRESSION| P=0.002 ** P=0.529 P=0.070 P=0.202 P=0.007 ** |
|COCH-ARM / FISHERS | P=0.002 ** P=0.500 P=0.061 P=0.159 P=0.006 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 4.6% 0.0% 4.8% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 555 --- 643 --- 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.482 P=0.225N P=0.660N P=0.225N P=0.686 |
|POLY 3 | P=0.487 P=0.226N P=0.682N P=0.226N P=0.694N |
|POLY 1.5 | P=0.490 P=0.231N P=0.688N P=0.232N P=0.694 |
|POLY 6 | P=0.484 P=0.221N P=0.672N P=0.218N P=0.694N |
|LOGISTIC REGRESSION| P=0.525N P=0.304N P=0.695 P=0.215N P=0.521N |
|COCH-ARM / FISHERS | P=0.496 P=0.247N P=0.691N P=0.247N P=0.691N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.4% 0.0% 2.1% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 1/35 (3%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 718 --- 709 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.487 (e) P=0.331 (e) P=0.599 |
|POLY 3 | P=0.434 (e) P=0.247 (e) P=0.519 |
|POLY 1.5 | P=0.418 (e) P=0.240 (e) P=0.508 |
|POLY 6 | P=0.459 (e) P=0.261 (e) P=0.537 |
|LOGISTIC REGRESSION| P=0.436 (e) P=0.287 (e) P=0.507 |
|COCH-ARM / FISHERS | P=0.402 (e) P=0.247 (e) P=0.495 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 2/50 (4%) 5/50 (10%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 17.0% 11.4% 4.7% 11.4% 9.6% |
|TERMINAL (d) | 5/22 (23%) 4/23 (17%) 2/22 (9%) 5/26 (19%) 2/22 (9%) |
|FIRST INCIDENCE | 645 676 729 (T) 729 (T) 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.298N P=0.332N P=0.073N P=0.263N P=0.255N |
|POLY 3 | P=0.320N P=0.334N P=0.069N P=0.336N P=0.250N |
|POLY 1.5 | P=0.318N P=0.354N P=0.074N P=0.358N P=0.256N |
|POLY 6 | P=0.323N P=0.310N P=0.062N P=0.307N P=0.243N |
|LOGISTIC REGRESSION| P=0.323N P=0.287N P=0.056N P=0.259N P=0.247N |
|COCH-ARM / FISHERS | P=0.314N P=0.380N P=0.080N P=0.380N P=0.262N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 6.9% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 635 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.057N P=0.069N P=0.080N P=0.072N P=0.063N |
|POLY 3 | P=0.078N P=0.107N P=0.112N P=0.105N P=0.104N |
|POLY 1.5 | P=0.074N P=0.113N P=0.117N P=0.111N P=0.113N |
|POLY 6 | P=0.086N P=0.097N P=0.103N P=0.095N P=0.092N |
|LOGISTIC REGRESSION| P=0.075N P=0.124N P=0.120N P=0.126N P=0.135N |
|COCH-ARM / FISHERS | P=0.074N P=0.121N P=0.121N P=0.121N P=0.125N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 9/50 (18%) 8/50 (16%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 4.8% 4.6% 20.2% 17.6% 14.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 555 676 561 620 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.105 P=0.646N P=0.050 P=0.101 P=0.156 |
|POLY 3 | P=0.105 P=0.673N P=0.032 * P=0.061 P=0.142 |
|POLY 1.5 | P=0.103 P=0.682N P=0.029 * P=0.053 P=0.137 |
|POLY 6 | P=0.112 P=0.661N P=0.040 * P=0.076 P=0.150 |
|LOGISTIC REGRESSION| P=0.145 P=0.657 P=0.025 * P=0.041 * P=0.183 |
|COCH-ARM / FISHERS | P=0.105 P=0.691N P=0.026 * P=0.046 * P=0.134 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) 50/50 (100%) 50/50 (100%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 22/22 (100%) 23/23 (100%) 22/22 (100%) 26/26 (100%) 22/22 (100%) |
|FIRST INCIDENCE | 485 477 312 249 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 39/50 (78%) 49/50 (98%) 47/50 (94%) 49/50 (98%) 49/49 (100%) |
|POLY-3 ADJUSTED (b)| 81.7% 98.6% 96.6% 98.0% 100.0% |
|TERMINAL (d) | 22/23 (96%) 40/40 (100%) 34/35 (97%) 36/37 (97%) 40/40 (100%) |
|FIRST INCIDENCE | 550 513 506 550 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.097N P=0.064N P=0.196N P=0.154N P=0.031N* |
|POLY 3 | P<0.001 ** P=0.002 ** P=0.012 * P=0.004 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.002 ** P=0.010 * P=0.003 ** P<0.001 ** |
|POLY 6 | P=0.003 ** P=0.003 ** P=0.020 * P=0.010 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.005 ** P=0.015 * P=0.006 ** P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P=0.020 * P=0.002 ** P<0.001 ** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 25/50 (50%) 31/50 (62%) 36/50 (72%) 38/50 (76%) 33/50 (66%) |
|POLY-3 ADJUSTED (b)| 56.1% 66.6% 77.8% 81.8% 74.5% |
|TERMINAL (d) | 14/22 (64%) 15/23 (65%) 19/22 (86%) 24/26 (92%) 19/22 (86%) |
|FIRST INCIDENCE | 499 597 561 537 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.131 P=0.342 P=0.079 P=0.122 P=0.123 |
|POLY 3 | P=0.036 * P=0.199 P=0.017 * P=0.004 ** P=0.043 * |
|POLY 1.5 | P=0.046 * P=0.176 P=0.016 * P=0.004 ** P=0.049 * |
|POLY 6 | P=0.026 * P=0.246 P=0.023 * P=0.005 ** P=0.038 * |
|LOGISTIC REGRESSION| P=0.054 P=0.230 P=0.028 * P=0.014 * P=0.065 |
|COCH-ARM / FISHERS | P=0.091 P=0.157 P=0.020 * P=0.006 ** P=0.078 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 27/50 (54%) 50/50 (100%) 48/50 (96%) 50/50 (100%) 47/49 (96%) |
|POLY-3 ADJUSTED (b)| 57.6% 100.0% 99.0% 100.0% 95.9% |
|TERMINAL (d) | 12/23 (52%) 40/40 (100%) 35/35 (100%) 37/37 (100%) 38/40 (95%) |
|FIRST INCIDENCE | 571 513 506 550 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.464N P=0.150 P=0.088 P=0.105 P=0.372 |
|POLY 3 | 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 ** |
|POLY 6 | 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 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Medulla |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 30/50 (60%) 42/50 (84%) 46/50 (92%) 47/50 (94%) 49/50 (98%) |
|POLY-3 ADJUSTED (b)| 65.4% 87.7% 94.9% 94.5% 100.0% |
|TERMINAL (d) | 12/22 (55%) 21/23 (91%) 22/22 (100%) 24/26 (92%) 22/22 (100%) |
|FIRST INCIDENCE | 537 597 312 249 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010 * P=0.137 P=0.034 * P=0.088 P=0.008 ** |
|POLY 3 | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Medulla |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 17/50 (34%) 25/50 (50%) 27/50 (54%) 28/50 (56%) 20/49 (41%) |
|POLY-3 ADJUSTED (b)| 36.8% 51.4% 56.5% 58.6% 42.3% |
|TERMINAL (d) | 4/23 (17%) 20/40 (50%) 17/35 (49%) 23/37 (62%) 18/40 (45%) |
|FIRST INCIDENCE | 550 513 506 638 712 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.124N P=0.562 P=0.317 P=0.382 P=0.213N |
|POLY 3 | P=0.523N P=0.108 P=0.040 * P=0.025 * P=0.371 |
|POLY 1.5 | P=0.522 P=0.093 P=0.033 * P=0.022 * P=0.341 |
|POLY 6 | P=0.469N P=0.136 P=0.055 P=0.029 * P=0.426 |
|LOGISTIC REGRESSION| P=0.523 P=0.048 * P=0.035 * P=0.029 * P=0.319 |
|COCH-ARM / FISHERS | P=0.488 P=0.078 P=0.035 * P=0.022 * P=0.311 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) 3/50 (6%) 9/50 (18%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 7.3% 15.8% 7.0% 20.4% 21.8% |
|TERMINAL (d) | 2/22 (9%) 3/23 (13%) 1/22 (5%) 7/26 (27%) 6/22 (27%) |
|FIRST INCIDENCE | 690 669 719 620 646 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.039 * P=0.209 P=0.627N P=0.112 P=0.069 |
|POLY 3 | P=0.035 * P=0.189 P=0.642N P=0.077 P=0.058 |
|POLY 1.5 | P=0.035 * P=0.175 P=0.652N P=0.068 P=0.057 |
|POLY 6 | P=0.035 * P=0.210 P=0.627N P=0.091 P=0.061 |
|LOGISTIC REGRESSION| P=0.030 * P=0.209 P=0.607N P=0.100 P=0.061 |
|COCH-ARM / FISHERS | P=0.040 * P=0.159 P=0.661N P=0.061 P=0.061 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 12/50 (24%) 13/50 (26%) 15/50 (30%) 11/49 (22%) |
|POLY-3 ADJUSTED (b)| 0.0% 25.6% 28.8% 31.7% 23.2% |
|TERMINAL (d) | 0/23 (0%) 11/40 (28%) 11/35 (31%) 14/37 (38%) 9/40 (23%) |
|FIRST INCIDENCE | --- 592 703 638 689 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.183 P=0.005 ** P=0.002 ** P<0.001 ** P=0.010 * |
|POLY 3 | P=0.071 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.049 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.121 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.113 P<0.001 ** P<0.001 ** P<0.001 ** P=0.003 ** |
|COCH-ARM / FISHERS | P=0.036 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia Oncocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.3% 2.4% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) 667 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.160 (e) (e) P=0.533 P=0.517 |
|POLY 3 | P=0.151 (e) (e) P=0.514 P=0.501 |
|POLY 1.5 | P=0.153 (e) (e) P=0.507 P=0.498 |
|POLY 6 | P=0.149 (e) (e) P=0.525 P=0.504 |
|LOGISTIC REGRESSION| P=0.154 (e) (e) P=0.533 P=0.500 |
|COCH-ARM / FISHERS | P=0.159 (e) (e) P=0.500 P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia Oncocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.3% 0.0% 2.1% 2.1% |
|TERMINAL (d) | 0/23 (0%) 2/40 (5%) 0/35 (0%) 1/37 (3%) 1/40 (3%) |
|FIRST INCIDENCE | --- 730 (T) --- 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.590 P=0.367 (e) P=0.595 P=0.610 |
|POLY 3 | P=0.544 P=0.255 (e) P=0.518 P=0.519 |
|POLY 1.5 | P=0.524 P=0.246 (e) P=0.509 P=0.508 |
|POLY 6 | P=0.576 P=0.271 (e) P=0.531 P=0.537 |
|LOGISTIC REGRESSION| (e) P=0.367 (e) P=0.595 P=0.610 |
|COCH-ARM / FISHERS | P=0.500 P=0.247 (e) P=0.500 P=0.495 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 28/50 (56%) 45/50 (90%) 44/50 (88%) 48/50 (96%) 48/50 (96%) |
|POLY-3 ADJUSTED (b)| 64.5% 93.1% 93.5% 97.9% 99.5% |
|TERMINAL (d) | 16/22 (73%) 22/23 (96%) 22/22 (100%) 25/26 (96%) 22/22 (100%) |
|FIRST INCIDENCE | 593 481 561 537 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.009 ** P=0.024 * P=0.018 * P=0.026 * P=0.002 ** |
|POLY 3 | 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 ** |
|POLY 6 | 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 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) 12/50 (24%) 3/50 (6%) 10/49 (20%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.8% 26.3% 6.4% 21.2% |
|TERMINAL (d) | 0/23 (0%) 5/40 (13%) 9/35 (26%) 3/37 (8%) 10/40 (25%) |
|FIRST INCIDENCE | --- 730 (T) 571 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.076 P=0.102 P=0.003 ** P=0.216 P=0.013 * |
|POLY 3 | P=0.027 * P=0.037 * P<0.001 ** P=0.135 P<0.001 ** |
|POLY 1.5 | P=0.021 * P=0.034 * P<0.001 ** P=0.128 P<0.001 ** |
|POLY 6 | P=0.041 * P=0.044 * P<0.001 ** P=0.149 P=0.002 ** |
|LOGISTIC REGRESSION| P=0.048 * P=0.102 P<0.001 ** P=0.216 P=0.013 * |
|COCH-ARM / FISHERS | P=0.018 * P=0.028 * P<0.001 ** P=0.121 P<0.001 ** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 21/50 (42%) 13/50 (26%) 9/50 (18%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 14.7% 46.7% 29.9% 20.5% 21.0% |
|TERMINAL (d) | 5/22 (23%) 12/23 (52%) 8/22 (36%) 7/26 (27%) 2/22 (9%) |
|FIRST INCIDENCE | 724 663 643 681 466 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.191N P=0.002 ** P=0.076 P=0.419 P=0.309 |
|POLY 3 | P=0.138N P<0.001 ** P=0.076 P=0.342 P=0.320 |
|POLY 1.5 | P=0.163N P<0.001 ** P=0.068 P=0.314 P=0.298 |
|POLY 6 | P=0.106N P<0.001 ** P=0.093 P=0.385 P=0.357 |
|LOGISTIC REGRESSION| P=0.197N P=0.002 ** P=0.096 P=0.445 P=0.282 |
|COCH-ARM / FISHERS | P=0.185N P<0.001 ** P=0.062 P=0.288 P=0.288 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 15/50 (30%) 18/50 (36%) 15/50 (30%) 21/49 (43%) |
|POLY-3 ADJUSTED (b)| 6.9% 32.3% 39.1% 31.7% 44.2% |
|TERMINAL (d) | 2/23 (9%) 15/40 (38%) 14/35 (40%) 11/37 (30%) 18/40 (45%) |
|FIRST INCIDENCE | 681 730 (T) 571 689 689 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.026 * P=0.039 * P=0.005 ** P=0.033 * P=0.004 ** |
|POLY 3 | P=0.002 ** P=0.002 ** P<0.001 ** P=0.003 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.002 ** P<0.001 ** P=0.002 ** P<0.001 ** |
|POLY 6 | P=0.005 ** P=0.003 ** P<0.001 ** P=0.004 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.007 ** P=0.014 * P<0.001 ** P=0.009 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** P=0.002 ** P<0.001 ** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 47
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 25/50 (50%) 35/50 (70%) 35/50 (70%) 32/50 (64%) 23/50 (46%) |
|POLY-3 ADJUSTED (b)| 58.5% 76.0% 77.0% 70.4% 53.9% |
|TERMINAL (d) | 18/22 (82%) 21/23 (91%) 20/22 (91%) 21/26 (81%) 13/22 (59%) |
|FIRST INCIDENCE | 540 641 561 628 593 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.100N P=0.098 P=0.067 P=0.411 P=0.395N |
|POLY 3 | P=0.073N P=0.048 * P=0.037 * P=0.157 P=0.410N |
|POLY 1.5 | P=0.086N P=0.038 * P=0.031 * P=0.127 P=0.436N |
|POLY 6 | P=0.054N P=0.074 P=0.055 P=0.218 P=0.359N |
|LOGISTIC REGRESSION| P=0.076N P=0.108 P=0.063 P=0.309 P=0.379N |
|COCH-ARM / FISHERS | P=0.081N P=0.033 * P=0.033 * P=0.113 P=0.421N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 37/50 (74%) 50/50 (100%) 34/50 (68%) 33/50 (66%) 15/49 (31%) |
|POLY-3 ADJUSTED (b)| 79.4% 100.0% 71.9% 68.7% 31.6% |
|TERMINAL (d) | 23/23 (100%) 40/40 (100%) 27/35 (77%) 27/37 (73%) 13/40 (33%) |
|FIRST INCIDENCE | 550 513 506 611 689 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=0.155N P=0.004N** P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P<0.001 ** P=0.260N P=0.157N P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001 ** P=0.317N P=0.202N P<0.001N** |
|POLY 6 | P<0.001N** P<0.001 ** P=0.172N P=0.095N P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P<0.001 ** P=0.267N P=0.064N P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P<0.001 ** P=0.330N P=0.257N P<0.001N** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 48
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 5/50 (10%) 6/50 (12%) 8/50 (16%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 22.1% 11.5% 14.1% 18.3% 12.3% |
|TERMINAL (d) | 9/22 (41%) 5/23 (22%) 6/22 (27%) 8/26 (31%) 4/22 (18%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) 677 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.263N P=0.146N P=0.265N P=0.336N P=0.172N |
|POLY 3 | P=0.319N P=0.151N P=0.250N P=0.434N P=0.185N |
|POLY 1.5 | P=0.317N P=0.170N P=0.269N P=0.467N P=0.195N |
|POLY 6 | P=0.320N P=0.129N P=0.222N P=0.386N P=0.171N |
|LOGISTIC REGRESSION| P=0.321N P=0.146N P=0.265N P=0.336N P=0.183N |
|COCH-ARM / FISHERS | P=0.297N P=0.194N P=0.288N P=0.500N P=0.194N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 6/50 (12%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 2.3% 6.5% 4.4% 12.8% 6.4% |
|TERMINAL (d) | 1/23 (4%) 3/40 (8%) 2/35 (6%) 6/37 (16%) 3/40 (8%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.375 P=0.517 P=0.645 P=0.166 P=0.517 |
|POLY 3 | P=0.275 P=0.333 P=0.516 P=0.071 P=0.340 |
|POLY 1.5 | P=0.248 P=0.320 P=0.505 P=0.064 P=0.320 |
|POLY 6 | P=0.321 P=0.359 P=0.536 P=0.085 P=0.375 |
|LOGISTIC REGRESSION| P=0.375 P=0.517 P=0.645 P=0.166 P=0.517 |
|COCH-ARM / FISHERS | P=0.218 P=0.309 P=0.500 P=0.056 P=0.301 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 49
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 31/50 (62%) 36/50 (72%) 28/50 (56%) 29/50 (58%) |
|POLY-3 ADJUSTED (b)| 21.8% 66.8% 77.1% 59.0% 65.4% |
|TERMINAL (d) | 5/22 (23%) 15/23 (65%) 16/22 (73%) 12/26 (46%) 11/22 (50%) |
|FIRST INCIDENCE | 677 597 561 537 607 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.044 * P<0.001 ** P<0.001 ** P=0.004 ** P<0.001 ** |
|POLY 3 | P=0.018 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.011 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.040 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.010 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.018 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) 10/50 (20%) 10/50 (20%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.6% 22.0% 20.6% 12.7% |
|TERMINAL (d) | 0/23 (0%) 3/40 (8%) 8/35 (23%) 4/37 (11%) 5/40 (13%) |
|FIRST INCIDENCE | --- 647 625 550 689 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.253 P=0.082 P=0.007 ** P=0.008 ** P=0.067 |
|POLY 3 | P=0.152 P=0.039 * P<0.001 ** P=0.002 ** P=0.021 * |
|POLY 1.5 | P=0.122 P=0.035 * P<0.001 ** P<0.001 ** P=0.018 * |
|POLY 6 | P=0.210 P=0.047 * P=0.002 ** P=0.003 ** P=0.029 * |
|LOGISTIC REGRESSION| P=0.094 P=0.033 * P=0.002 ** P<0.001 ** P=0.034 * |
|COCH-ARM / FISHERS | P=0.097 P=0.028 * P<0.001 ** P<0.001 ** P=0.012 * |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 50
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 22/50 (44%) 30/50 (60%) 29/50 (58%) 20/50 (40%) |
|POLY-3 ADJUSTED (b)| 21.9% 49.8% 66.7% 63.9% 47.7% |
|TERMINAL (d) | 7/22 (32%) 18/23 (78%) 18/22 (82%) 22/26 (85%) 16/22 (73%) |
|FIRST INCIDENCE | 677 663 603 605 466 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.097 P=0.004 ** P<0.001 ** P<0.001 ** P=0.009 ** |
|POLY 3 | P=0.082 P=0.005 ** P<0.001 ** P<0.001 ** P=0.009 ** |
|POLY 1.5 | P=0.081 P=0.004 ** P<0.001 ** P<0.001 ** P=0.010 * |
|POLY 6 | P=0.081 P=0.005 ** P<0.001 ** P<0.001 ** P=0.009 ** |
|LOGISTIC REGRESSION| P=0.070 P=0.009 ** P<0.001 ** P<0.001 ** P=0.011 * |
|COCH-ARM / FISHERS | P=0.113 P=0.004 ** P<0.001 ** P<0.001 ** P=0.013 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 32/50 (64%) 34/50 (68%) 39/50 (78%) 34/49 (69%) |
|POLY-3 ADJUSTED (b)| 18.5% 68.1% 72.6% 81.2% 71.8% |
|TERMINAL (d) | 7/23 (30%) 29/40 (73%) 27/35 (77%) 32/37 (87%) 32/40 (80%) |
|FIRST INCIDENCE | 645 647 506 550 712 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.023 * 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 ** |
|POLY 1.5 | 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 ** |
|LOGISTIC REGRESSION| 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 ** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 51
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 2.3% 7.0% 6.8% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 648 645 705 593 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.252N P=0.447N P=0.548 P=0.581 P=0.238N |
|POLY 3 | P=0.259N P=0.478N P=0.517 P=0.533 P=0.240N |
|POLY 1.5 | P=0.255N P=0.488N P=0.508 P=0.517 P=0.241N |
|POLY 6 | P=0.265N P=0.467N P=0.529 P=0.555 P=0.240N |
|LOGISTIC REGRESSION| P=0.236N P=0.552N P=0.510 P=0.483 P=0.229N |
|COCH-ARM / FISHERS | P=0.239N P=0.500N P=0.500 P=0.500 P=0.247N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 6.9% 2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 645 679 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.039N* P=0.207N P=0.085N P=0.077N P=0.065N |
|POLY 3 | P=0.054N P=0.280N P=0.112N P=0.105N P=0.104N |
|POLY 1.5 | P=0.052N P=0.292N P=0.117N P=0.111N P=0.113N |
|POLY 6 | P=0.056N P=0.259N P=0.104N P=0.096N P=0.092N |
|LOGISTIC REGRESSION| P=0.056N P=0.326N P=0.120N P=0.129N P=0.137N |
|COCH-ARM / FISHERS | P=0.053N P=0.309N P=0.121N P=0.121N P=0.125N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 52
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 9/50 (18%) 2/50 (4%) 5/50 (10%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 12.1% 19.8% 4.7% 11.2% 9.6% |
|TERMINAL (d) | 3/22 (14%) 3/23 (13%) 1/22 (5%) 2/26 (8%) 2/22 (9%) |
|FIRST INCIDENCE | 540 481 638 583 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.275N P=0.253 P=0.205N P=0.529N P=0.495N |
|POLY 3 | P=0.264N P=0.244 P=0.200N P=0.583N P=0.495N |
|POLY 1.5 | P=0.270N P=0.222 P=0.209N P=0.607N P=0.502N |
|POLY 6 | P=0.259N P=0.277 P=0.188N P=0.548N P=0.486N |
|LOGISTIC REGRESSION| P=0.244N P=0.168 P=0.214N P=0.624 P=0.488N |
|COCH-ARM / FISHERS | P=0.268N P=0.194 P=0.218N P=0.630N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 10/50 (20%) 7/50 (14%) 6/50 (12%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| 11.4% 21.5% 15.4% 12.6% 10.6% |
|TERMINAL (d) | 3/23 (13%) 9/40 (23%) 6/35 (17%) 3/37 (8%) 4/40 (10%) |
|FIRST INCIDENCE | 550 718 571 638 722 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.122N P=0.441 P=0.602 P=0.514N P=0.339N |
|POLY 3 | P=0.226N P=0.156 P=0.404 P=0.555 P=0.583N |
|POLY 1.5 | P=0.255N P=0.143 P=0.385 P=0.529 P=0.612N |
|POLY 6 | P=0.183N P=0.183 P=0.441 P=0.598 P=0.532N |
|LOGISTIC REGRESSION| P=0.245N P=0.174 P=0.380 P=0.445 P=0.610 |
|COCH-ARM / FISHERS | P=0.290N P=0.131 P=0.380 P=0.500 P=0.617 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 53
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/50 (26%) 30/50 (60%) 28/50 (56%) 30/50 (60%) 27/50 (54%) |
|POLY-3 ADJUSTED (b)| 29.3% 64.6% 61.8% 63.4% 62.6% |
|TERMINAL (d) | 6/22 (27%) 19/23 (83%) 19/22 (86%) 18/26 (69%) 19/22 (86%) |
|FIRST INCIDENCE | 485 481 312 537 466 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.060 P=0.004 ** P=0.005 ** P=0.011 * P=0.005 ** |
|POLY 3 | P=0.019 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.014 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.039 * P<0.001 ** P=0.002 ** P<0.001 ** P=0.003 ** |
|COCH-ARM / FISHERS | P=0.052 P<0.001 ** P=0.002 ** P<0.001 ** P=0.004 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 25/50 (50%) 46/50 (92%) 44/50 (88%) 38/50 (76%) 46/49 (94%) |
|POLY-3 ADJUSTED (b)| 55.0% 93.0% 91.5% 78.4% 96.6% |
|TERMINAL (d) | 18/23 (78%) 38/40 (95%) 33/35 (94%) 30/37 (81%) 40/40 (100%) |
|FIRST INCIDENCE | 550 513 506 550 689 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.507 P=0.182 P=0.096 P=0.569 P=0.285 |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P=0.010 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P=0.007 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P=0.018 * P<0.001 ** |
|LOGISTIC REGRESSION| P=0.002 ** P<0.001 ** P<0.001 ** P=0.027 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P=0.006 ** P<0.001 ** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 54
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 12/50 (24%) 15/50 (30%) 13/50 (26%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 9.8% 27.5% 35.2% 29.7% 24.5% |
|TERMINAL (d) | 4/22 (18%) 12/23 (52%) 14/22 (64%) 13/26 (50%) 9/22 (41%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 723 729 (T) 677 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.267 P=0.020 * P=0.002 ** P=0.024 * P=0.062 |
|POLY 3 | P=0.260 P=0.033 * P=0.004 ** P=0.019 * P=0.068 |
|POLY 1.5 | P=0.258 P=0.030 * P=0.004 ** P=0.017 * P=0.068 |
|POLY 6 | P=0.266 P=0.038 * P=0.005 ** P=0.024 * P=0.069 |
|LOGISTIC REGRESSION| P=0.194 P=0.020 * (e) P=0.024 * P=0.058 |
|COCH-ARM / FISHERS | P=0.285 P=0.027 * P=0.005 ** P=0.016 * P=0.074 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 30/50 (60%) 20/50 (40%) 23/50 (46%) 13/49 (27%) |
|POLY-3 ADJUSTED (b)| 7.0% 64.1% 43.8% 48.7% 27.5% |
|TERMINAL (d) | 3/23 (13%) 29/40 (73%) 17/35 (49%) 21/37 (57%) 12/40 (30%) |
|FIRST INCIDENCE | 730 (T) 645 571 689 722 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.106N P<0.001 ** P=0.002 ** P<0.001 ** P=0.086 |
|POLY 3 | P=0.323N P<0.001 ** P<0.001 ** P<0.001 ** P=0.010 * |
|POLY 1.5 | P=0.431N P<0.001 ** P<0.001 ** P<0.001 ** P=0.007 ** |
|POLY 6 | P=0.175N P<0.001 ** P<0.001 ** P<0.001 ** P=0.017 * |
|LOGISTIC REGRESSION| P=0.159N P<0.001 ** P<0.001 ** P<0.001 ** P=0.079 |
|COCH-ARM / FISHERS | P=0.519 P<0.001 ** P<0.001 ** P<0.001 ** P=0.005 ** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 55
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 5/50 (10%) 7/50 (14%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 11.8% 11.3% 11.4% 15.7% 11.9% |
|TERMINAL (d) | 1/22 (5%) 2/23 (9%) 0/22 (0%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE | 485 645 603 620 537 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.485 P=0.569N P=0.567N P=0.508 P=0.623 |
|POLY 3 | P=0.484 P=0.604N P=0.607N P=0.417 P=0.630 |
|POLY 1.5 | P=0.483 P=0.615N P=0.619N P=0.397 P=0.624 |
|POLY 6 | P=0.487 P=0.591N P=0.586N P=0.448 P=0.626N |
|LOGISTIC REGRESSION| P=0.528 P=0.596 P=0.612 P=0.359 P=0.596N |
|COCH-ARM / FISHERS | P=0.501 P=0.630N P=0.630N P=0.380 P=0.630N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 5/50 (10%) 6/50 (12%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 9.1% 8.5% 11.0% 12.5% 6.3% |
|TERMINAL (d) | 0/23 (0%) 2/40 (5%) 3/35 (9%) 3/37 (8%) 2/40 (5%) |
|FIRST INCIDENCE | 645 575 570 611 712 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.292N P=0.492N P=0.622N P=0.540 P=0.303N |
|POLY 3 | P=0.398N P=0.603N P=0.523 P=0.426 P=0.459N |
|POLY 1.5 | P=0.422N P=0.622N P=0.507 P=0.400 P=0.484N |
|POLY 6 | P=0.361N P=0.570N P=0.553 P=0.466 P=0.419N |
|LOGISTIC REGRESSION| P=0.501N P=0.570 P=0.500 P=0.250 P=0.567N |
|COCH-ARM / FISHERS | P=0.452N P=0.643N P=0.500 P=0.370 P=0.511N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 56
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 18/50 (36%) 23/50 (46%) 17/50 (34%) 23/50 (46%) |
|POLY-3 ADJUSTED (b)| 11.8% 40.2% 52.3% 38.3% 55.1% |
|TERMINAL (d) | 1/22 (5%) 12/23 (52%) 16/22 (73%) 13/26 (50%) 17/22 (77%) |
|FIRST INCIDENCE | 485 615 561 628 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.006 ** P<0.001 ** P=0.015 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** P=0.003 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.002 ** P<0.001 ** P=0.003 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P=0.004 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.002 ** P=0.003 ** P<0.001 ** P=0.006 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.004 ** P=0.002 ** P<0.001 ** P=0.004 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 6/50 (12%) 4/50 (8%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 11.2% 8.6% 13.1% 8.4% 8.4% |
|TERMINAL (d) | 0/23 (0%) 3/40 (8%) 3/35 (9%) 2/37 (5%) 1/40 (3%) |
|FIRST INCIDENCE | 550 694 570 550 709 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.269N P=0.329N P=0.615N P=0.367N P=0.296N |
|POLY 3 | P=0.380N P=0.471N P=0.522 P=0.456N P=0.461N |
|POLY 1.5 | P=0.401N P=0.486N P=0.505 P=0.476N P=0.486N |
|POLY 6 | P=0.348N P=0.444N P=0.555 P=0.425N P=0.419N |
|LOGISTIC REGRESSION| P=0.490N P=0.579N P=0.517 P=0.527 P=0.629 |
|COCH-ARM / FISHERS | P=0.426N P=0.500N P=0.500 P=0.500N P=0.513N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 57
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 729 (T) --- 705 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.317N P=0.491N P=0.741N P=0.467N P=0.500N |
|POLY 3 | P=0.316N P=0.486N P=0.750N P=0.486N P=0.500N |
|POLY 1.5 | P=0.315N P=0.492N P=0.755N P=0.493N P=0.502N |
|POLY 6 | P=0.315N P=0.478N P=0.742N P=0.475N P=0.498N |
|LOGISTIC REGRESSION| P=0.313N (e) P=0.738N (e) (e) |
|COCH-ARM / FISHERS | P=0.313N P=0.500N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% 2.1% 4.2% |
|TERMINAL (d) | 0/23 (0%) 1/40 (3%) 0/35 (0%) 1/37 (3%) 2/40 (5%) |
|FIRST INCIDENCE | --- 730 (T) --- 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.155 P=0.610 (e) P=0.595 P=0.367 |
|POLY 3 | P=0.121 P=0.515 (e) P=0.518 P=0.259 |
|POLY 1.5 | P=0.114 P=0.508 (e) P=0.509 P=0.246 |
|POLY 6 | P=0.134 P=0.529 (e) P=0.531 P=0.281 |
|LOGISTIC REGRESSION| (e) P=0.610 (e) P=0.595 P=0.367 |
|COCH-ARM / FISHERS | P=0.105 P=0.500 (e) P=0.500 P=0.242 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 58
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 48/50 (96%) 50/50 (100%) 47/50 (94%) 49/50 (98%) 47/50 (94%) |
|POLY-3 ADJUSTED (b)| 96.9% 100.0% 96.7% 98.2% 97.2% |
|TERMINAL (d) | 22/22 (100%) 23/23 (100%) 22/22 (100%) 26/26 (100%) 22/22 (100%) |
|FIRST INCIDENCE | 485 477 477 249 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.448N P=0.429N P=0.362N P=0.203N P=0.469N |
|POLY 3 | P=0.528N P=0.312 P=0.716N P=0.601 P=0.717 |
|POLY 1.5 | P=0.487N P=0.272 P=0.655N P=0.552 P=0.713 |
|POLY 6 | P=0.608N P=0.402 P=0.752N P=0.683 P=0.735 |
|LOGISTIC REGRESSION| P=0.470N P=0.253 P=0.507N P=0.504 P=0.652N |
|COCH-ARM / FISHERS | P=0.269N P=0.247 P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 17/50 (34%) 22/50 (44%) 20/50 (40%) 20/50 (40%) 12/49 (24%) |
|POLY-3 ADJUSTED (b)| 36.9% 45.9% 43.2% 41.4% 25.4% |
|TERMINAL (d) | 6/23 (26%) 19/40 (48%) 16/35 (46%) 15/37 (41%) 11/40 (28%) |
|FIRST INCIDENCE | 571 513 85 611 718 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006N** P=0.378N P=0.383N P=0.334N P=0.018N* |
|POLY 3 | P=0.047N* P=0.246 P=0.341 P=0.406 P=0.164N |
|POLY 1.5 | P=0.058N P=0.227 P=0.338 P=0.375 P=0.184N |
|POLY 6 | P=0.033N* P=0.281 P=0.356 P=0.458 P=0.132N |
|LOGISTIC REGRESSION| P=0.077N P=0.175 P=0.337 P=0.258 P=0.250N |
|COCH-ARM / FISHERS | P=0.073N P=0.206 P=0.339 P=0.339 P=0.207N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 59
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 4.9% 4.5% 4.7% 2.3% 4.9% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 645 597 699 593 607 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.554N P=0.637N P=0.645N P=0.453N P=0.673N |
|POLY 3 | P=0.552N P=0.668N P=0.681N P=0.476N P=0.694 |
|POLY 1.5 | P=0.553N P=0.679N P=0.687N P=0.488N P=0.690 |
|POLY 6 | P=0.549N P=0.654N P=0.671N P=0.460N P=0.691N |
|LOGISTIC REGRESSION| P=0.515N P=0.645 P=0.691N P=0.511N P=0.688N |
|COCH-ARM / FISHERS | P=0.549N P=0.691N P=0.691N P=0.500N P=0.691N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.3% 2.1% 2.2% 0.0% 2.1% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 702 645 571 --- 724 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.521N P=0.722N P=0.737N P=0.444N P=0.649N |
|POLY 3 | P=0.565N P=0.742N P=0.749N P=0.483N P=0.740N |
|POLY 1.5 | P=0.571N P=0.751N P=0.756N P=0.491N P=0.752N |
|POLY 6 | P=0.558N P=0.726N P=0.735N P=0.470N P=0.718N |
|LOGISTIC REGRESSION| P=0.624N P=0.735 P=0.747N P=0.500N P=0.752N |
|COCH-ARM / FISHERS | P=0.578N P=0.753N P=0.753N P=0.500N P=0.747 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 60
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 21/50 (42%) 13/50 (26%) 29/50 (58%) |
|POLY-3 ADJUSTED (b)| 0.0% 9.2% 47.5% 29.3% 64.1% |
|TERMINAL (d) | 0/22 (0%) 4/23 (17%) 15/22 (68%) 12/26 (46%) 18/22 (82%) |
|FIRST INCIDENCE | --- 729 (T) 477 537 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.066 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.069 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.065 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.074 P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.066 P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.059 P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 18/50 (36%) 23/50 (46%) 19/50 (38%) 26/49 (53%) |
|POLY-3 ADJUSTED (b)| 0.0% 38.7% 49.9% 40.4% 55.0% |
|TERMINAL (d) | 0/23 (0%) 18/40 (45%) 21/35 (60%) 19/37 (51%) 25/40 (63%) |
|FIRST INCIDENCE | --- 730 (T) 85 730 (T) 722 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | 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 ** |
|POLY 1.5 | 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 ** |
|LOGISTIC REGRESSION| 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 ** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 61
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.3% 0.0% 4.5% 2.4% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- 724 --- 583 603 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.301 P=0.523 (e) P=0.290 P=0.514 |
|POLY 3 | P=0.292 P=0.514 (e) P=0.257 P=0.502 |
|POLY 1.5 | P=0.292 P=0.508 (e) P=0.247 P=0.499 |
|POLY 6 | P=0.292 P=0.522 (e) P=0.271 P=0.506 |
|LOGISTIC REGRESSION| P=0.328 P=0.529 (e) P=0.230 P=0.529 |
|COCH-ARM / FISHERS | P=0.301 P=0.500 (e) P=0.247 P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 722 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.686 (e) (e) P=0.610 (e) |
|POLY 3 | P=0.672 (e) (e) P=0.518 (e) |
|POLY 1.5 | P=0.657 (e) (e) P=0.510 (e) |
|POLY 6 | P=0.695 (e) (e) P=0.531 (e) |
|LOGISTIC REGRESSION| P=0.663 (e) (e) P=0.552 (e) |
|COCH-ARM / FISHERS | P=0.639 (e) (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 62
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.3% 4.6% 2.3% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- 718 603 628 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.437N P=0.531 P=0.270 P=0.524 (e) |
|POLY 3 | P=0.437N P=0.514 P=0.251 P=0.516 (e) |
|POLY 1.5 | P=0.441N P=0.508 P=0.244 P=0.508 (e) |
|POLY 6 | P=0.431N P=0.522 P=0.262 P=0.527 (e) |
|LOGISTIC REGRESSION| P=0.417N P=0.528 P=0.233 P=0.498 (e) |
|COCH-ARM / FISHERS | P=0.437N P=0.500 P=0.247 P=0.500 (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.173 (e) (e) (e) P=0.610 |
|POLY 3 | P=0.150 (e) (e) (e) P=0.517 |
|POLY 1.5 | P=0.145 (e) (e) (e) P=0.505 |
|POLY 6 | P=0.156 (e) (e) (e) P=0.536 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.610 |
|COCH-ARM / FISHERS | P=0.140 (e) (e) (e) P=0.490 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 63
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.3% 4.5% 4.8% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 699 628 638 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.068 (e) P=0.548 P=0.272 P=0.248 |
|POLY 3 | P=0.071 (e) P=0.510 P=0.255 P=0.240 |
|POLY 1.5 | P=0.071 (e) P=0.505 P=0.246 P=0.236 |
|POLY 6 | P=0.071 (e) P=0.518 P=0.269 P=0.245 |
|LOGISTIC REGRESSION| P=0.080 (e) P=0.511 P=0.235 P=0.246 |
|COCH-ARM / FISHERS | P=0.075 (e) P=0.500 P=0.247 P=0.247 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 64
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 13/50 (26%) 13/50 (26%) 8/50 (16%) 14/50 (28%) |
|POLY-3 ADJUSTED (b)| 25.8% 28.4% 29.7% 18.2% 31.6% |
|TERMINAL (d) | 5/22 (23%) 4/23 (17%) 6/22 (27%) 5/26 (19%) 5/22 (23%) |
|FIRST INCIDENCE | 537 477 603 705 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.408 P=0.516 P=0.459 P=0.200N P=0.338 |
|POLY 3 | P=0.426 P=0.489 P=0.438 P=0.275N P=0.361 |
|POLY 1.5 | P=0.414 P=0.454 P=0.421 P=0.291N P=0.337 |
|POLY 6 | P=0.433 P=0.536 P=0.464 P=0.256N P=0.388 |
|LOGISTIC REGRESSION| P=0.411 P=0.391 P=0.444 P=0.247N P=0.335 |
|COCH-ARM / FISHERS | P=0.414 P=0.408 P=0.408 P=0.306N P=0.322 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/50 (26%) 18/50 (36%) 19/50 (38%) 21/50 (42%) 24/48 (50%) |
|POLY-3 ADJUSTED (b)| 29.6% 37.7% 40.3% 44.6% 50.2% |
|TERMINAL (d) | 9/23 (39%) 14/40 (35%) 12/35 (34%) 18/37 (49%) 19/40 (48%) |
|FIRST INCIDENCE | 617 592 570 722 536 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.211 P=0.425N P=0.516 P=0.547 P=0.431 |
|POLY 3 | P=0.029 * P=0.274 P=0.197 P=0.100 P=0.033 * |
|POLY 1.5 | P=0.019 * P=0.233 P=0.161 P=0.084 P=0.020 * |
|POLY 6 | P=0.050 P=0.355 P=0.270 P=0.134 P=0.068 |
|LOGISTIC REGRESSION| P=0.025 * P=0.284 P=0.152 P=0.265 P=0.044 * |
|COCH-ARM / FISHERS | P=0.011 * P=0.194 P=0.142 P=0.069 P=0.012 * |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 65
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 7/50 (14%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 2.4% 4.6% 7.0% 15.5% 14.3% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 681 676 699 620 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.017 * P=0.549 P=0.358 P=0.067 P=0.075 |
|POLY 3 | P=0.016 * P=0.525 P=0.321 P=0.042 * P=0.059 |
|POLY 1.5 | P=0.015 * P=0.514 P=0.313 P=0.036 * P=0.056 |
|POLY 6 | P=0.017 * P=0.540 P=0.334 P=0.052 P=0.064 |
|LOGISTIC REGRESSION| P=0.017 * P=0.509 P=0.333 P=0.030 * P=0.058 |
|COCH-ARM / FISHERS | P=0.018 * P=0.500 P=0.309 P=0.030 * P=0.056 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 66
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 4/50 (8%) 5/50 (10%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 7.3% 13.7% 9.4% 11.3% 12.2% |
|TERMINAL (d) | 1/22 (5%) 5/23 (22%) 4/22 (18%) 2/26 (8%) 3/22 (14%) |
|FIRST INCIDENCE | 648 718 729 (T) 593 690 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.411 P=0.286 P=0.524 P=0.471 P=0.368 |
|POLY 3 | P=0.396 P=0.271 P=0.520 P=0.398 P=0.351 |
|POLY 1.5 | P=0.395 P=0.259 P=0.510 P=0.378 P=0.349 |
|POLY 6 | P=0.399 P=0.286 P=0.534 P=0.428 P=0.355 |
|LOGISTIC REGRESSION| P=0.387 P=0.310 P=0.554 P=0.373 P=0.361 |
|COCH-ARM / FISHERS | P=0.410 P=0.243 P=0.500 P=0.357 P=0.357 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 44/50 (88%) 50/50 (100%) 48/50 (96%) 47/50 (94%) 48/48 (100%) |
|POLY-3 ADJUSTED (b)| 92.2% 100.0% 98.0% 95.2% 100.0% |
|TERMINAL (d) | 23/23 (100%) 40/40 (100%) 34/35 (97%) 36/37 (97%) 40/40 (100%) |
|FIRST INCIDENCE | 571 513 506 550 536 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008N** P=0.010N* P=0.052N P=0.009N** P<0.001N** |
|POLY 3 | P=0.118 P=0.031 * P=0.162 P=0.412 P=0.035 * |
|POLY 1.5 | P=0.079 P=0.021 * P=0.102 P=0.321 P=0.024 * |
|POLY 6 | P=0.217 P=0.075 P=0.358 P=0.599 P=0.082 |
|LOGISTIC REGRESSION| P=0.143 P=0.023 * P=0.077 P=0.588 P=0.107 |
|COCH-ARM / FISHERS | P=0.054 P=0.013 * P=0.134 P=0.243 P=0.015 * |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 67
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 631 --- --- 583 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.577N P=0.471N P=0.485N P=0.543 P=0.495N |
|POLY 3 | P=0.597N P=0.488N P=0.492N P=0.526 P=0.502N |
|POLY 1.5 | P=0.591N P=0.493N P=0.496N P=0.513 P=0.503N |
|POLY 6 | P=0.605N P=0.481N P=0.487N P=0.544 P=0.501N |
|LOGISTIC REGRESSION| P=0.549N P=0.541N P=0.501N P=0.487 P=0.486N |
|COCH-ARM / FISHERS | P=0.577N P=0.500N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 713 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.323N P=0.424N P=0.439N P=0.429N P=0.410N |
|POLY 3 | P=0.384N P=0.485N P=0.491N P=0.483N P=0.483N |
|POLY 1.5 | P=0.374N P=0.492N P=0.497N P=0.491N P=0.495N |
|POLY 6 | P=0.403N P=0.472N P=0.480N P=0.469N P=0.464N |
|LOGISTIC REGRESSION| P=0.352N P=0.476N P=0.482N P=0.474N P=0.485N |
|COCH-ARM / FISHERS | P=0.363N P=0.500N P=0.500N P=0.500N P=0.510N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 68
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 9/50 (18%) 9/50 (18%) 7/50 (14%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 7.3% 20.3% 20.7% 15.9% 7.4% |
|TERMINAL (d) | 2/22 (9%) 4/23 (17%) 5/22 (23%) 6/26 (23%) 2/22 (9%) |
|FIRST INCIDENCE | 562 669 603 637 682 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.209N P=0.093 P=0.078 P=0.223 P=0.655N |
|POLY 3 | P=0.224N P=0.074 P=0.070 P=0.184 P=0.658 |
|POLY 1.5 | P=0.226N P=0.068 P=0.065 P=0.170 P=0.655 |
|POLY 6 | P=0.220N P=0.085 P=0.080 P=0.205 P=0.663 |
|LOGISTIC REGRESSION| P=0.222N P=0.082 P=0.070 P=0.195 P=0.663 |
|COCH-ARM / FISHERS | P=0.213N P=0.061 P=0.061 P=0.159 P=0.661N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) 2/50 (4%) 5/50 (10%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 7.0% 15.0% 4.4% 10.6% 0.0% |
|TERMINAL (d) | 2/23 (9%) 6/40 (15%) 1/35 (3%) 4/37 (11%) 0/40 (0%) |
|FIRST INCIDENCE | 718 718 625 635 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.022N* P=0.446 P=0.351N P=0.597 P=0.046N* |
|POLY 3 | P=0.036N* P=0.190 P=0.476N P=0.410 P=0.104N |
|POLY 1.5 | P=0.044N* P=0.174 P=0.492N P=0.385 P=0.114N |
|POLY 6 | P=0.026N* P=0.221 P=0.448N P=0.451 P=0.090N |
|LOGISTIC REGRESSION| P=0.039N* P=0.344 P=0.482N P=0.452 P=0.056N |
|COCH-ARM / FISHERS | P=0.058N P=0.159 P=0.500N P=0.357 P=0.129N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 69
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 2/50 (4%) 2/47 (4%) 1/50 (2%) 4/47 (9%) |
|POLY-3 ADJUSTED (b)| 18.9% 4.6% 4.9% 2.3% 10.1% |
|TERMINAL (d) | 4/22 (18%) 1/23 (4%) 0/22 (0%) 1/26 (4%) 2/22 (9%) |
|FIRST INCIDENCE | 499 708 620 729 (T) 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.272N P=0.041N* P=0.047N* P=0.012N* P=0.192N |
|POLY 3 | P=0.292N P=0.038N* P=0.047N* P=0.013N* P=0.208N |
|POLY 1.5 | P=0.291N P=0.042N* P=0.052N P=0.014N* P=0.214N |
|POLY 6 | P=0.293N P=0.034N* P=0.041N* P=0.011N* P=0.198N |
|LOGISTIC REGRESSION| P=0.262N P=0.051N P=0.064N P=0.019N* P=0.198N |
|COCH-ARM / FISHERS | P=0.286N P=0.046N* P=0.056N P=0.015N* P=0.210N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 0/49 (0%) 2/50 (4%) 1/48 (2%) 0/47 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 4.4% 2.2% 0.0% |
|TERMINAL (d) | 2/23 (9%) 0/39 (0%) 1/35 (3%) 0/36 (0%) 0/38 (0%) |
|FIRST INCIDENCE | 730 (T) --- 638 550 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.180N P=0.132N P=0.573N P=0.397N P=0.136N |
|POLY 3 | P=0.211N P=0.220N P=0.667N P=0.469N P=0.219N |
|POLY 1.5 | P=0.217N P=0.228N P=0.680N P=0.487N P=0.231N |
|POLY 6 | P=0.203N P=0.206N P=0.643N P=0.442N P=0.200N |
|LOGISTIC REGRESSION| P=0.253N (e) P=0.673N P=0.621N (e) |
|COCH-ARM / FISHERS | P=0.226N P=0.247N P=0.684N P=0.508N P=0.258N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 70
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 0/47 (0%) 1/50 (2%) 3/47 (6%) |
|POLY-3 ADJUSTED (b)| 7.4% 4.6% 0.0% 2.3% 7.5% |
|TERMINAL (d) | 3/22 (14%) 1/23 (4%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 729 (T) 705 --- 674 537 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.457 P=0.465N P=0.118N P=0.246N P=0.654N |
|POLY 3 | P=0.437 P=0.467N P=0.119N P=0.278N P=0.653 |
|POLY 1.5 | P=0.435 P=0.482N P=0.124N P=0.291N P=0.639 |
|POLY 6 | P=0.440 P=0.447N P=0.110N P=0.258N P=0.654N |
|LOGISTIC REGRESSION| P=0.449 P=0.433N (e) P=0.248N P=0.643 |
|COCH-ARM / FISHERS | P=0.439 P=0.500N P=0.133N P=0.309N P=0.631 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 1/50 (2%) 0/48 (0%) 1/47 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 2.2% 0.0% 2.2% |
|TERMINAL (d) | 0/23 (0%) 0/39 (0%) 0/35 (0%) 0/36 (0%) 1/38 (3%) |
|FIRST INCIDENCE | --- 589 638 --- 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.530 P=0.508 P=0.509 (e) P=0.600 |
|POLY 3 | P=0.522 P=0.518 P=0.515 (e) P=0.517 |
|POLY 1.5 | P=0.505 P=0.509 P=0.508 (e) P=0.505 |
|POLY 6 | P=0.548 P=0.532 P=0.528 (e) P=0.536 |
|LOGISTIC REGRESSION| P=0.430 P=0.487 P=0.523 (e) P=0.600 |
|COCH-ARM / FISHERS | P=0.485 P=0.500 P=0.505 (e) P=0.490 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 71
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 1/50 (2%) 1/50 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 2.3% 2.3% 4.8% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 1/22 (5%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 562 --- 729 (T) 729 (T) 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.380 P=0.213N P=0.482N P=0.449N P=0.690 |
|POLY 3 | P=0.375 P=0.229N P=0.489N P=0.480N P=0.694N |
|POLY 1.5 | P=0.377 P=0.234N P=0.495N P=0.490N P=0.691 |
|POLY 6 | P=0.372 P=0.222N P=0.480N P=0.466N P=0.688N |
|LOGISTIC REGRESSION| P=0.559 P=0.281N P=0.506N P=0.510N P=0.531N |
|COCH-ARM / FISHERS | P=0.382 P=0.253N P=0.500N P=0.500N P=0.684 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 0/49 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.3% 2.2% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/23 (0%) 1/40 (3%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 666 730 (T) --- --- 724 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.586N P=0.678N P=0.474N P=0.460N P=0.662N |
|POLY 3 | P=0.652N P=0.748N P=0.496N P=0.483N P=0.740N |
|POLY 1.5 | P=0.653N P=0.757N P=0.502N P=0.491N P=0.752N |
|POLY 6 | P=0.652N P=0.734N P=0.486N P=0.471N P=0.720N |
|LOGISTIC REGRESSION| P=0.656N P=0.758 P=0.498N P=0.567N P=0.744 |
|COCH-ARM / FISHERS | P=0.657N P=0.747 P=0.505N P=0.500N P=0.747 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 72
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 5/49 (10%) 7/50 (14%) 7/50 (14%) 7/49 (14%) |
|POLY-3 ADJUSTED (b)| 7.1% 11.4% 16.3% 16.0% 17.4% |
|TERMINAL (d) | 0/22 (0%) 2/23 (9%) 5/22 (23%) 6/26 (23%) 6/22 (27%) |
|FIRST INCIDENCE | 565 597 663 717 667 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.155 P=0.427 P=0.187 P=0.232 P=0.169 |
|POLY 3 | P=0.130 P=0.378 P=0.165 P=0.173 P=0.137 |
|POLY 1.5 | P=0.136 P=0.364 P=0.161 P=0.165 P=0.139 |
|POLY 6 | P=0.122 P=0.397 P=0.171 P=0.184 P=0.134 |
|LOGISTIC REGRESSION| P=0.141 P=0.268 P=0.160 P=0.167 P=0.148 |
|COCH-ARM / FISHERS | P=0.155 P=0.346 P=0.159 P=0.159 P=0.151 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 2.2% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 0/40 (0%) 1/35 (3%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 730 (T) 606 730 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.172N P=0.698N P=0.665N P=0.405N P=0.390N |
|POLY 3 | P=0.200N P=0.745N P=0.756N P=0.482N P=0.481N |
|POLY 1.5 | P=0.204N P=0.755N P=0.759 P=0.491N P=0.492N |
|POLY 6 | P=0.195N P=0.727N P=0.743N P=0.469N P=0.463N |
|LOGISTIC REGRESSION| P=0.217N P=0.725 P=0.665N (e) (e) |
|COCH-ARM / FISHERS | P=0.209N P=0.747 P=0.747 P=0.500N P=0.505N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 73
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 485 669 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.105N P=0.483N P=0.244N P=0.224N P=0.249N |
|POLY 3 | P=0.106N P=0.486N P=0.230N P=0.225N P=0.245N |
|POLY 1.5 | P=0.106N P=0.496N P=0.234N P=0.231N P=0.246N |
|POLY 6 | P=0.106N P=0.472N P=0.224N P=0.215N P=0.242N |
|LOGISTIC REGRESSION| P=0.085N P=0.583N P=0.225N P=0.229N P=0.207N |
|COCH-ARM / FISHERS | P=0.107N P=0.508N P=0.247N P=0.247N P=0.253N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 74
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/45 (0%) 1/47 (2%) 0/46 (0%) 0/50 (0%) 0/47 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/21 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- 724 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.507N P=0.523 (e) (e) (e) |
|POLY 3 | P=0.475N P=0.520 (e) (e) (e) |
|POLY 1.5 | P=0.482N P=0.515 (e) (e) (e) |
|POLY 6 | P=0.468N P=0.524 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.499N P=0.519 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.491N P=0.511 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 11.4% 6.4% 8.9% 4.2% 2.1% |
|TERMINAL (d) | 2/23 (9%) 2/40 (5%) 4/35 (11%) 1/37 (3%) 1/40 (3%) |
|FIRST INCIDENCE | 550 679 730 (T) 550 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.034N* P=0.181N P=0.306N P=0.123N P=0.038N* |
|POLY 3 | P=0.056N P=0.323N P=0.484N P=0.184N P=0.082N |
|POLY 1.5 | P=0.061N P=0.340N P=0.498N P=0.199N P=0.091N |
|POLY 6 | P=0.050N P=0.293N P=0.457N P=0.163N P=0.068N |
|LOGISTIC REGRESSION| P=0.071N P=0.383N P=0.490N P=0.352N P=0.134N |
|COCH-ARM / FISHERS | P=0.067N P=0.357N P=0.500N P=0.218N P=0.102N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 75
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/45 (22%) 21/47 (45%) 12/46 (26%) 12/50 (24%) 10/47 (21%) |
|POLY-3 ADJUSTED (b)| 26.5% 49.0% 29.4% 26.8% 25.6% |
|TERMINAL (d) | 7/22 (32%) 10/21 (48%) 4/21 (19%) 7/26 (27%) 6/22 (27%) |
|FIRST INCIDENCE | 537 615 638 537 638 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.150N P=0.029 * P=0.438 P=0.584 P=0.590 |
|POLY 3 | P=0.122N P=0.028 * P=0.487 P=0.588 P=0.569N |
|POLY 1.5 | P=0.125N P=0.023 * P=0.455 P=0.552 P=0.574N |
|POLY 6 | P=0.119N P=0.039 * P=0.537 P=0.566N P=0.562N |
|LOGISTIC REGRESSION| P=0.130N P=0.030 * P=0.478 P=0.591 P=0.562N |
|COCH-ARM / FISHERS | P=0.118N P=0.019 * P=0.427 P=0.516 P=0.556N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/50 (46%) 8/50 (16%) 11/50 (22%) 5/50 (10%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 49.7% 16.8% 23.6% 10.5% 10.3% |
|TERMINAL (d) | 8/23 (35%) 6/40 (15%) 6/35 (17%) 1/37 (3%) 2/40 (5%) |
|FIRST INCIDENCE | 571 513 571 635 536 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P<0.001N** P=0.002N** P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P<0.001N** P=0.006N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001N** P=0.008N** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P<0.001N** P=0.004N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.002N** P=0.010N* P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P<0.001N** P=0.010N* P<0.001N** P<0.001N** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 76
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/4 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) |
|POLY-3 ADJUSTED (b)| 23.8% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/1 (0%) 0/4 (0%) 0/1 (0%) |
|FIRST INCIDENCE | 562 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.155N P=0.214N P=0.224N P=0.219N P=0.238N |
|POLY 3 | P=0.177N P=0.422N P=0.348N P=0.297N P=0.352N |
|POLY 1.5 | P=0.177N P=0.438N P=0.350N P=0.305N P=0.351N |
|POLY 6 | P=0.174N P=0.392N P=0.344N P=0.277N P=0.353N |
|LOGISTIC REGRESSION| P=0.221N P=0.960N P=0.498N P=0.399N P=0.502N |
|COCH-ARM / FISHERS | P=0.177N P=0.495N P=0.375N P=0.331N P=0.375N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/4 (0%) 0/4 (0%) 1/6 (17%) 0/3 (0%) 0/2 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 16.8% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/4 (0%) 0/2 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- 703 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.607N (e) P=0.573 (e) (e) |
|POLY 3 | P=0.756N (e) P=0.621 (e) (e) |
|POLY 1.5 | P=0.759N (e) P=0.603 (e) (e) |
|POLY 6 | P=0.751N (e) P=0.649 (e) (e) |
|LOGISTIC REGRESSION| P=0.778N (e) P=0.616 (e) (e) |
|COCH-ARM / FISHERS | P=0.781N (e) P=0.600 (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 77
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Mesentery: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/4 (0%) 0/6 (0%) 0/7 (0%) 2/6 (33%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 37.8% |
|TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/1 (0%) 0/4 (0%) 0/1 (0%) |
|FIRST INCIDENCE | --- --- --- --- 671 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * (e) (e) (e) P=0.250 |
|POLY 3 | P=0.009 ** (e) (e) (e) P=0.124 |
|POLY 1.5 | P=0.009 ** (e) (e) (e) P=0.114 |
|POLY 6 | P=0.010 * (e) (e) (e) P=0.148 |
|LOGISTIC REGRESSION| P=0.015 * (e) (e) (e) P=0.144 |
|COCH-ARM / FISHERS | P=0.016 * (e) (e) (e) P=0.125 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Mesentery: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/4 (0%) 0/4 (0%) 0/6 (0%) 0/3 (0%) 0/2 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/4 (0%) 0/2 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 78
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 3/4 (75%) 2/6 (33%) 2/7 (29%) 4/6 (67%) |
|POLY-3 ADJUSTED (b)| 68.4% 80.0% 38.6% 32.6% 70.7% |
|TERMINAL (d) | 0/1 (0%) 3/3 (100%) 1/1 (100%) 2/4 (50%) 1/1 (100%) |
|FIRST INCIDENCE | 642 729 (T) 687 729 (T) 603 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.451N P=0.073N P=0.119N P=0.038N* P=0.373N |
|POLY 3 | P=0.546N P=0.611 P=0.291N P=0.189N P=0.693 |
|POLY 1.5 | P=0.558N P=0.574 P=0.297N P=0.202N P=0.650 |
|POLY 6 | P=0.530N P=0.668 P=0.295N P=0.173N P=0.752 |
|LOGISTIC REGRESSION| P=0.501N P=0.662N P=0.193N P=0.111N P=0.698 |
|COCH-ARM / FISHERS | P=0.573N P=0.545 P=0.304N P=0.218N P=0.608 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/4 (75%) 4/4 (100%) 4/6 (67%) 2/3 (67%) 2/2 (100%) |
|POLY-3 ADJUSTED (b)| 77.1% 100.0% 68.4% 77.3% 100.0% |
|TERMINAL (d) | 1/1 (100%) 3/3 (100%) 4/4 (100%) 2/2 (100%) 2/2 (100%) |
|FIRST INCIDENCE | 571 513 730 (T) 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.097N P=0.468N P=0.214N P=0.203N P=0.193N |
|POLY 3 | P=0.561 P=0.542 P=0.657N P=0.808 P=0.668 |
|POLY 1.5 | P=0.564 P=0.520 P=0.652N P=0.758N P=0.649 |
|POLY 6 | P=0.568 P=0.588 P=0.666N P=0.802 P=0.707 |
|LOGISTIC REGRESSION| P=0.633 P=0.470 P=0.769N P=0.700N P=0.601 |
|COCH-ARM / FISHERS | P=0.578 P=0.500 P=0.667N P=0.714N P=0.667 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 79
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 7/50 (14%) 5/50 (10%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 9.7% 6.7% 16.0% 11.3% 14.1% |
|TERMINAL (d) | 1/22 (5%) 0/23 (0%) 2/22 (9%) 3/26 (12%) 1/22 (5%) |
|FIRST INCIDENCE | 645 477 565 628 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.270 P=0.447N P=0.320 P=0.595 P=0.398 |
|POLY 3 | P=0.262 P=0.456N P=0.293 P=0.545 P=0.384 |
|POLY 1.5 | P=0.260 P=0.475N P=0.277 P=0.523 P=0.373 |
|POLY 6 | P=0.266 P=0.435N P=0.316 P=0.574 P=0.399 |
|LOGISTIC REGRESSION| P=0.307 P=0.585N P=0.263 P=0.507 P=0.385 |
|COCH-ARM / FISHERS | P=0.270 P=0.500N P=0.262 P=0.500 P=0.370 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.3% 2.2% 2.2% 0.0% 2.1% |
|TERMINAL (d) | 4/23 (17%) 1/40 (3%) 0/35 (0%) 0/37 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 570 --- 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.092N P=0.054N P=0.095N P=0.019N* P=0.054N |
|POLY 3 | P=0.137N P=0.156N P=0.162N P=0.050N P=0.147N |
|POLY 1.5 | P=0.136N P=0.167N P=0.173N P=0.055N P=0.162N |
|POLY 6 | P=0.141N P=0.138N P=0.143N P=0.043N* P=0.124N |
|LOGISTIC REGRESSION| P=0.132N P=0.054N P=0.177N (e) P=0.054N |
|COCH-ARM / FISHERS | P=0.137N P=0.181N P=0.181N P=0.059N P=0.181N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 80
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 8/50 (16%) 6/50 (12%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 9.7% 6.7% 18.2% 13.5% 14.3% |
|TERMINAL (d) | 1/22 (5%) 0/23 (0%) 2/22 (9%) 3/26 (12%) 1/22 (5%) |
|FIRST INCIDENCE | 645 477 565 628 603 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.279 P=0.447N P=0.238 P=0.482 P=0.403 |
|POLY 3 | P=0.260 P=0.456N P=0.206 P=0.417 P=0.379 |
|POLY 1.5 | P=0.259 P=0.475N P=0.192 P=0.393 P=0.368 |
|POLY 6 | P=0.266 P=0.435N P=0.229 P=0.449 P=0.395 |
|LOGISTIC REGRESSION| P=0.298 P=0.585N P=0.178 P=0.377 P=0.370 |
|COCH-ARM / FISHERS | P=0.276 P=0.500N P=0.178 P=0.370 P=0.370 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.2% 4.3% 2.2% 2.1% 2.1% |
|TERMINAL (d) | 3/23 (13%) 2/40 (5%) 0/35 (0%) 0/37 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 617 730 (T) 703 701 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.086N P=0.155N P=0.102N P=0.092N P=0.072N |
|POLY 3 | P=0.129N P=0.306N P=0.167N P=0.155N P=0.149N |
|POLY 1.5 | P=0.132N P=0.321N P=0.176N P=0.166N P=0.163N |
|POLY 6 | P=0.125N P=0.280N P=0.151N P=0.137N P=0.128N |
|LOGISTIC REGRESSION| P=0.125N P=0.290N P=0.173N P=0.173N P=0.158N |
|COCH-ARM / FISHERS | P=0.137N P=0.339N P=0.181N P=0.181N P=0.181N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 81
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 0.0% 7.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 565 --- --- --- 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.037 * P=0.483N P=0.487N P=0.483N P=0.301 |
|POLY 3 | P=0.036 * P=0.489N P=0.493N P=0.488N P=0.318 |
|POLY 1.5 | P=0.036 * P=0.494N P=0.497N P=0.494N P=0.310 |
|POLY 6 | P=0.036 * P=0.482N P=0.488N P=0.480N P=0.327 |
|LOGISTIC REGRESSION| P=0.112 P=0.566N P=0.464N P=0.469N P=0.462 |
|COCH-ARM / FISHERS | P=0.038 * P=0.500N P=0.500N P=0.500N P=0.309 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 570 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.651N (e) P=0.496 (e) (e) |
|POLY 3 | P=0.639N (e) P=0.511 (e) (e) |
|POLY 1.5 | P=0.644N (e) P=0.504 (e) (e) |
|POLY 6 | P=0.631N (e) P=0.524 (e) (e) |
|LOGISTIC REGRESSION| P=0.709N (e) P=0.563 (e) (e) |
|COCH-ARM / FISHERS | P=0.649N (e) P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 82
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 8/50 (16%) 9/50 (18%) 8/50 (16%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 11.5% 17.0% 19.8% 16.7% 12.7% |
|TERMINAL (d) | 3/23 (13%) 7/40 (18%) 6/35 (17%) 5/37 (14%) 5/40 (13%) |
|FIRST INCIDENCE | 652 575 652 550 718 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.271N P=0.601 P=0.431 P=0.550 P=0.417N |
|POLY 3 | P=0.437N P=0.326 P=0.215 P=0.338 P=0.557 |
|POLY 1.5 | P=0.476N P=0.302 P=0.199 P=0.310 P=0.523 |
|POLY 6 | P=0.377N P=0.370 P=0.247 P=0.386 P=0.613 |
|LOGISTIC REGRESSION| P=0.473N P=0.310 P=0.234 P=0.266 P=0.603 |
|COCH-ARM / FISHERS | P=0.523N P=0.277 P=0.194 P=0.277 P=0.486 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 83
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 26/50 (52%) 30/50 (60%) 25/50 (50%) 28/50 (56%) 24/50 (48%) |
|POLY-3 ADJUSTED (b)| 55.3% 63.3% 55.6% 59.5% 54.0% |
|TERMINAL (d) | 7/22 (32%) 13/23 (57%) 11/22 (50%) 15/26 (58%) 12/22 (55%) |
|FIRST INCIDENCE | 537 481 603 583 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.336N P=0.482 P=0.401N P=0.421N P=0.412N |
|POLY 3 | P=0.379N P=0.279 P=0.575 P=0.418 P=0.534N |
|POLY 1.5 | P=0.351N P=0.279 P=0.558N P=0.411 P=0.499N |
|POLY 6 | P=0.424N P=0.270 P=0.535 P=0.426 P=0.586 |
|LOGISTIC REGRESSION| P=0.301N P=0.218 P=0.494N P=0.395 P=0.420N |
|COCH-ARM / FISHERS | P=0.277N P=0.273 P=0.500N P=0.421 P=0.421N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/50 (42%) 27/50 (54%) 16/50 (32%) 22/50 (44%) 9/49 (18%) |
|POLY-3 ADJUSTED (b)| 45.7% 56.5% 34.8% 45.6% 19.1% |
|TERMINAL (d) | 11/23 (48%) 23/40 (58%) 12/35 (34%) 18/37 (49%) 9/40 (23%) |
|FIRST INCIDENCE | 550 589 571 550 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=0.283N P=0.034N* P=0.134N P<0.001N** |
|POLY 3 | P<0.001N** P=0.199 P=0.193N P=0.575N P=0.004N** |
|POLY 1.5 | P<0.001N** P=0.177 P=0.209N P=0.549 P=0.006N** |
|POLY 6 | P<0.001N** P=0.246 P=0.164N P=0.517N P=0.002N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.199 P=0.193N P=0.505 P=0.009N** |
|COCH-ARM / FISHERS | P=0.002N** P=0.158 P=0.204N P=0.500 P=0.009N** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 84
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.9% 9.2% 4.6% 4.5% 2.4% |
|TERMINAL (d) | 1/22 (5%) 3/23 (13%) 1/22 (5%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 665 724 565 628 646 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.220N P=0.372 P=0.679N P=0.639N P=0.490N |
|POLY 3 | P=0.222N P=0.367 P=0.675N P=0.667N P=0.500N |
|POLY 1.5 | P=0.226N P=0.354 P=0.684N P=0.680N P=0.504N |
|POLY 6 | P=0.217N P=0.383 P=0.662N P=0.648N P=0.495N |
|LOGISTIC REGRESSION| P=0.226N P=0.403 P=0.692 P=0.689N P=0.502N |
|COCH-ARM / FISHERS | P=0.222N P=0.339 P=0.691N P=0.691N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 4.6% 2.2% 0.0% 4.3% 2.1% |
|TERMINAL (d) | 0/23 (0%) 1/40 (3%) 0/35 (0%) 2/37 (5%) 1/40 (3%) |
|FIRST INCIDENCE | 704 730 (T) --- 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.444N P=0.347N P=0.172N P=0.531N P=0.326N |
|POLY 3 | P=0.539N P=0.474N P=0.228N P=0.663N P=0.469N |
|POLY 1.5 | P=0.547N P=0.487N P=0.235N P=0.677N P=0.487N |
|POLY 6 | P=0.529N P=0.452N P=0.216N P=0.639N P=0.439N |
|LOGISTIC REGRESSION| P=0.484N P=0.440N P=0.218N P=0.613N P=0.438N |
|COCH-ARM / FISHERS | P=0.559N P=0.500N P=0.247N P=0.691N P=0.508N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 85
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 13.7% 7.0% 4.6% 4.9% |
|TERMINAL (d) | 1/22 (5%) 6/23 (26%) 1/22 (5%) 2/26 (8%) 2/22 (9%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 620 729 (T) 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.340N P=0.059 P=0.314 P=0.559 P=0.500 |
|POLY 3 | P=0.342N P=0.067 P=0.325 P=0.525 P=0.499 |
|POLY 1.5 | P=0.350N P=0.062 P=0.315 P=0.513 P=0.496 |
|POLY 6 | P=0.332N P=0.073 P=0.341 P=0.543 P=0.504 |
|LOGISTIC REGRESSION| P=0.362N P=0.059 P=0.325 P=0.559 P=0.500 |
|COCH-ARM / FISHERS | P=0.349N P=0.056 P=0.309 P=0.500 P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.3% 4.3% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/23 (0%) 2/40 (5%) 0/35 (0%) 0/37 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 649 730 (T) --- --- 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.420N P=0.634 P=0.486N P=0.481N P=0.678N |
|POLY 3 | P=0.485N P=0.525 P=0.492N P=0.484N P=0.741N |
|POLY 1.5 | P=0.491N P=0.513 P=0.498N P=0.491N P=0.753N |
|POLY 6 | P=0.476N P=0.546 P=0.482N P=0.471N P=0.721N |
|LOGISTIC REGRESSION| P=0.490N P=0.508 P=0.487N P=0.594N P=0.733 |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.500N P=0.500N P=0.747 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 86
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.6% 4.7% 2.3% 0.0% |
|TERMINAL (d) | 0/22 (0%) 2/23 (9%) 2/22 (9%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.312N P=0.247 P=0.237 P=0.533 (e) |
|POLY 3 | P=0.317N P=0.253 P=0.247 P=0.514 (e) |
|POLY 1.5 | P=0.322N P=0.246 P=0.242 P=0.507 (e) |
|POLY 6 | P=0.310N P=0.262 P=0.255 P=0.525 (e) |
|LOGISTIC REGRESSION| (e) P=0.247 P=0.237 P=0.533 (e) |
|COCH-ARM / FISHERS | P=0.321N P=0.247 P=0.247 P=0.500 (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 87
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 1/50 (2%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.3% 7.0% 2.3% 11.9% |
|TERMINAL (d) | 1/22 (5%) 0/23 (0%) 2/22 (9%) 1/26 (4%) 2/22 (9%) |
|FIRST INCIDENCE | 729 (T) 676 620 729 (T) 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.040 * P=0.739N P=0.312 P=0.725N P=0.113 |
|POLY 3 | P=0.039 * P=0.744N P=0.325 P=0.745N P=0.107 |
|POLY 1.5 | P=0.038 * P=0.751N P=0.315 P=0.753N P=0.103 |
|POLY 6 | P=0.040 * P=0.734N P=0.340 P=0.733N P=0.113 |
|LOGISTIC REGRESSION| P=0.042 * P=0.744N P=0.327 P=0.725N P=0.108 |
|COCH-ARM / FISHERS | P=0.039 * P=0.753N P=0.309 P=0.753N P=0.102 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.173 (e) (e) (e) P=0.610 |
|POLY 3 | P=0.151 (e) (e) (e) P=0.519 |
|POLY 1.5 | P=0.147 (e) (e) (e) P=0.508 |
|POLY 6 | P=0.157 (e) (e) (e) P=0.537 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.610 |
|COCH-ARM / FISHERS | P=0.142 (e) (e) (e) P=0.495 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 88
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.3% 7.3% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- 727 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** (e) (e) P=0.541 P=0.137 |
|POLY 3 | P=0.006 ** (e) (e) P=0.514 P=0.120 |
|POLY 1.5 | P=0.006 ** (e) (e) P=0.507 P=0.118 |
|POLY 6 | P=0.006 ** (e) (e) P=0.525 P=0.125 |
|LOGISTIC REGRESSION| P=0.006 ** (e) (e) P=0.541 P=0.121 |
|COCH-ARM / FISHERS | P=0.006 ** (e) (e) P=0.500 P=0.121 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 89
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/49 (10%) 13/48 (27%) 19/48 (40%) 20/50 (40%) 12/45 (27%) |
|POLY-3 ADJUSTED (b)| 12.2% 29.3% 43.9% 43.5% 30.5% |
|TERMINAL (d) | 2/22 (9%) 5/23 (22%) 5/22 (23%) 8/26 (31%) 3/21 (14%) |
|FIRST INCIDENCE | 555 642 565 620 537 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.175 P=0.071 P=0.006 ** P=0.007 ** P=0.070 |
|POLY 3 | P=0.119 P=0.044 * P<0.001 ** P<0.001 ** P=0.038 * |
|POLY 1.5 | P=0.105 P=0.037 * P<0.001 ** P<0.001 ** P=0.034 * |
|POLY 6 | P=0.148 P=0.056 P<0.001 ** P=0.002 ** P=0.047 * |
|LOGISTIC REGRESSION| P=0.103 P=0.040 * P<0.001 ** P<0.001 ** P=0.035 * |
|COCH-ARM / FISHERS | P=0.117 P=0.029 * P<0.001 ** P<0.001 ** P=0.035 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/42 (0%) 1/44 (2%) 0/48 (0%) 0/48 (0%) 1/41 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.4% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/18 (0%) 0/34 (0%) 0/33 (0%) 0/36 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 589 --- --- 718 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.443 P=0.508 (e) (e) P=0.613 |
|POLY 3 | P=0.426 P=0.530 (e) (e) P=0.524 |
|POLY 1.5 | P=0.412 P=0.520 (e) (e) P=0.511 |
|POLY 6 | P=0.448 P=0.546 (e) (e) P=0.546 |
|LOGISTIC REGRESSION| P=0.347 P=0.486 (e) (e) P=0.556 |
|COCH-ARM / FISHERS | P=0.394 P=0.512 (e) (e) P=0.494 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 90
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.3% 0.0% 2.3% 2.5% |
|TERMINAL (d) | 0/22 (0%) 1/23 (4%) 0/22 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 565 729 (T) --- 583 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.580 P=0.746N P=0.487N P=0.736N P=0.758N |
|POLY 3 | P=0.563 P=0.748N P=0.497N P=0.745N P=0.758 |
|POLY 1.5 | P=0.566 P=0.753N P=0.501N P=0.753N P=0.757 |
|POLY 6 | P=0.558 P=0.741N P=0.490N P=0.734N P=0.759 |
|LOGISTIC REGRESSION| P=0.604 P=0.733 P=0.468N P=0.753N P=0.757N |
|COCH-ARM / FISHERS | P=0.577 P=0.753N P=0.505N P=0.753N P=0.753N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 12/50 (24%) 2/50 (4%) 10/49 (20%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 2.3% 25.8% 4.4% 21.7% 12.5% |
|TERMINAL (d) | 0/23 (0%) 11/40 (28%) 1/35 (3%) 10/36 (28%) 5/40 (13%) |
|FIRST INCIDENCE | 635 718 723 730 (T) 724 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.515 P=0.018 * P=0.605 P=0.028 * P=0.177 |
|POLY 3 | P=0.367 P<0.001 ** P=0.513 P=0.005 ** P=0.074 |
|POLY 1.5 | P=0.316 P<0.001 ** P=0.503 P=0.004 ** P=0.064 |
|POLY 6 | P=0.450 P=0.002 ** P=0.531 P=0.007 ** P=0.093 |
|LOGISTIC REGRESSION| P=0.478 P=0.004 ** P=0.501 P=0.012 * P=0.071 |
|COCH-ARM / FISHERS | P=0.262 P<0.001 ** P=0.500 P=0.003 ** P=0.053 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 91
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/49 (6%) 3/50 (6%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 4.9% 6.7% 7.1% 6.8% 14.5% |
|TERMINAL (d) | 0/22 (0%) 1/23 (4%) 1/22 (5%) 2/26 (8%) 4/22 (18%) |
|FIRST INCIDENCE | 648 477 666 653 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.075 P=0.550 P=0.540 P=0.579 P=0.138 |
|POLY 3 | P=0.074 P=0.540 P=0.512 P=0.531 P=0.134 |
|POLY 1.5 | P=0.075 P=0.523 P=0.501 P=0.516 P=0.131 |
|POLY 6 | P=0.073 P=0.560 P=0.529 P=0.553 P=0.137 |
|LOGISTIC REGRESSION| P=0.083 P=0.403 P=0.509 P=0.519 P=0.132 |
|COCH-ARM / FISHERS | P=0.079 P=0.500 P=0.490 P=0.500 P=0.134 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 7/50 (14%) 3/50 (6%) 0/49 (0%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 20.5% 14.9% 6.6% 0.0% 6.2% |
|TERMINAL (d) | 5/23 (22%) 5/40 (13%) 2/35 (6%) 0/36 (0%) 2/40 (5%) |
|FIRST INCIDENCE | 571 592 506 --- 536 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006N** P=0.116N P=0.020N* P<0.001N** P=0.011N* |
|POLY 3 | P=0.012N* P=0.335N P=0.050N P<0.001N** P=0.040N* |
|POLY 1.5 | P=0.014N* P=0.363N P=0.056N P=0.002N** P=0.050N |
|POLY 6 | P=0.011N* P=0.288N P=0.040N* P<0.001N** P=0.027N* |
|LOGISTIC REGRESSION| P=0.022N* P=0.356N P=0.062N P=0.002N** P=0.107N |
|COCH-ARM / FISHERS | P=0.017N* P=0.393N P=0.061N P<0.001N** P=0.065N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 92
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/50 (26%) 26/50 (52%) 24/49 (49%) 28/50 (56%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 31.6% 57.1% 55.6% 60.5% 44.8% |
|TERMINAL (d) | 10/22 (46%) 14/23 (61%) 17/22 (77%) 17/26 (65%) 11/22 (50%) |
|FIRST INCIDENCE | 648 597 643 593 537 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.391 P=0.021 * P=0.020 * P=0.019 * P=0.151 |
|POLY 3 | P=0.400 P=0.011 * P=0.018 * P=0.004 ** P=0.148 |
|POLY 1.5 | P=0.374 P=0.008 ** P=0.015 * P=0.002 ** P=0.136 |
|POLY 6 | P=0.445 P=0.018 * P=0.025 * P=0.010 * P=0.173 |
|LOGISTIC REGRESSION| P=0.340 P=0.018 * P=0.032 * P=0.006 ** P=0.139 |
|COCH-ARM / FISHERS | P=0.397 P=0.007 ** P=0.015 * P=0.002 ** P=0.142 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 24/50 (48%) 27/50 (54%) 21/50 (42%) 26/49 (53%) 32/49 (65%) |
|POLY-3 ADJUSTED (b)| 51.0% 56.7% 45.3% 56.3% 65.8% |
|TERMINAL (d) | 11/23 (48%) 23/40 (58%) 17/35 (49%) 24/36 (67%) 27/40 (68%) |
|FIRST INCIDENCE | 571 592 571 689 536 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.483 P=0.130N P=0.063N P=0.129N P=0.269N |
|POLY 3 | P=0.060 P=0.362 P=0.365N P=0.381 P=0.100 |
|POLY 1.5 | P=0.049 * P=0.350 P=0.373N P=0.380 P=0.080 |
|POLY 6 | P=0.081 P=0.396 P=0.339N P=0.387 P=0.140 |
|LOGISTIC REGRESSION| P=0.080 P=0.361 P=0.340N P=0.469 P=0.035 * |
|COCH-ARM / FISHERS | P=0.037 * P=0.345 P=0.344N P=0.381 P=0.062 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 93
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.3% 0.0% 4.6% 2.5% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE | --- 676 --- 729 (T) 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.303 P=0.530 (e) P=0.275 P=0.500 |
|POLY 3 | P=0.289 P=0.515 (e) P=0.253 P=0.500 |
|POLY 1.5 | P=0.291 P=0.508 (e) P=0.245 P=0.498 |
|POLY 6 | P=0.285 P=0.524 (e) P=0.265 P=0.502 |
|LOGISTIC REGRESSION| P=0.288 P=0.494 (e) P=0.275 P=0.500 |
|COCH-ARM / FISHERS | P=0.302 P=0.500 (e) P=0.247 P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/23 (0%) 1/40 (3%) 0/35 (0%) 0/36 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 730 (T) --- --- 709 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.468 P=0.610 (e) (e) P=0.599 |
|POLY 3 | P=0.429 P=0.515 (e) (e) P=0.521 |
|POLY 1.5 | P=0.416 P=0.508 (e) (e) P=0.510 |
|POLY 6 | P=0.450 P=0.529 (e) (e) P=0.540 |
|LOGISTIC REGRESSION| P=0.431 P=0.610 (e) (e) P=0.504 |
|COCH-ARM / FISHERS | P=0.399 P=0.500 (e) (e) P=0.495 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 94
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Nervosa |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 0/49 (0%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 12.3% 2.3% 0.0% 9.1% 2.5% |
|TERMINAL (d) | 5/22 (23%) 1/23 (4%) 0/22 (0%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 674 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.239N P=0.087N P=0.030N* P=0.388N P=0.096N |
|POLY 3 | P=0.269N P=0.085N P=0.027N* P=0.451N P=0.100N |
|POLY 1.5 | P=0.262N P=0.092N P=0.030N* P=0.476N P=0.103N |
|POLY 6 | P=0.280N P=0.076N P=0.024N* P=0.415N P=0.095N |
|LOGISTIC REGRESSION| P=0.254N P=0.087N (e) P=0.379N P=0.096N |
|COCH-ARM / FISHERS | P=0.247N P=0.102N P=0.030N* P=0.500N P=0.102N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Nervosa |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 1/36 (3%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 730 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.678 (e) (e) P=0.589 (e) |
|POLY 3 | P=0.677 (e) (e) P=0.513 (e) |
|POLY 1.5 | P=0.660 (e) (e) P=0.505 (e) |
|POLY 6 | P=0.702 (e) (e) P=0.527 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.589 (e) |
|COCH-ARM / FISHERS | P=0.638 (e) (e) P=0.495 (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 95
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/49 (8%) 3/50 (6%) 0/49 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 7.4% 9.3% 7.0% 0.0% 2.5% |
|TERMINAL (d) | 3/22 (14%) 4/23 (17%) 3/22 (14%) 0/25 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.070N P=0.525 P=0.668 P=0.097N P=0.302N |
|POLY 3 | P=0.076N P=0.530 P=0.641N P=0.110N P=0.305N |
|POLY 1.5 | P=0.078N P=0.512 P=0.652N P=0.116N P=0.309N |
|POLY 6 | P=0.073N P=0.554 P=0.625N P=0.101N P=0.300N |
|LOGISTIC REGRESSION| P=0.070N P=0.525 P=0.668 (e) P=0.302N |
|COCH-ARM / FISHERS | P=0.079N P=0.489 P=0.661N P=0.125N P=0.309N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 96
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 42/50 (84%) 34/49 (69%) 43/50 (86%) 37/49 (76%) 43/50 (86%) |
|POLY-3 ADJUSTED (b)| 87.4% 73.9% 88.7% 78.3% 89.9% |
|TERMINAL (d) | 19/22 (86%) 17/23 (74%) 19/22 (86%) 19/25 (76%) 19/22 (86%) |
|FIRST INCIDENCE | 485 597 312 249 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.304 P=0.064N P=0.479N P=0.079N P=0.533 |
|POLY 3 | P=0.222 P=0.067N P=0.551 P=0.169N P=0.474 |
|POLY 1.5 | P=0.200 P=0.066N P=0.527 P=0.183N P=0.442 |
|POLY 6 | P=0.261 P=0.076N P=0.583 P=0.170N P=0.522 |
|LOGISTIC REGRESSION| P=0.191 P=0.037N* P=0.523 P=0.199N P=0.438 |
|COCH-ARM / FISHERS | P=0.241 P=0.069N P=0.500 P=0.212N P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 97
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 4/49 (8%) 4/50 (8%) 4/49 (8%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 9.2% 9.3% 9.3% 0.0% |
|TERMINAL (d) | 1/22 (5%) 2/23 (9%) 2/22 (9%) 1/25 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 729 (T) 663 663 681 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.181N P=0.214 P=0.198 P=0.256 P=0.500N |
|POLY 3 | P=0.190N P=0.198 P=0.194 P=0.197 P=0.500N |
|POLY 1.5 | P=0.192N P=0.187 P=0.186 P=0.184 P=0.502N |
|POLY 6 | P=0.188N P=0.216 P=0.207 P=0.216 P=0.498N |
|LOGISTIC REGRESSION| P=0.190N P=0.201 P=0.210 P=0.199 (e) |
|COCH-ARM / FISHERS | P=0.185N P=0.175 P=0.181 P=0.175 P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 98
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 33/50 (66%) 37/50 (74%) 36/50 (72%) 31/50 (62%) 34/50 (68%) |
|POLY-3 ADJUSTED (b)| 69.9% 75.0% 75.2% 66.6% 71.2% |
|TERMINAL (d) | 15/22 (68%) 17/23 (74%) 16/22 (73%) 19/26 (73%) 15/22 (68%) |
|FIRST INCIDENCE | 485 477 312 537 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.431N P=0.501 P=0.484 P=0.173N P=0.523 |
|POLY 3 | P=0.417N P=0.366 P=0.359 P=0.450N P=0.538 |
|POLY 1.5 | P=0.404N P=0.317 P=0.345 P=0.445N P=0.524 |
|POLY 6 | P=0.448N P=0.438 P=0.387 P=0.460N P=0.550 |
|LOGISTIC REGRESSION| P=0.375N P=0.195 P=0.326 P=0.386N P=0.510 |
|COCH-ARM / FISHERS | P=0.389N P=0.257 P=0.333 P=0.418N P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 99
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/48 (0%) 0/50 (0%) 1/47 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 6.8% 0.0% 0.0% 2.6% |
|TERMINAL (d) | 1/22 (5%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 729 (T) 615 --- --- 603 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.373N P=0.359 P=0.500N P=0.467N P=0.752N |
|POLY 3 | P=0.367N P=0.337 P=0.499N P=0.486N P=0.750 |
|POLY 1.5 | P=0.375N P=0.323 P=0.504N P=0.493N P=0.746 |
|POLY 6 | P=0.356N P=0.357 P=0.491N P=0.475N P=0.757 |
|LOGISTIC REGRESSION| P=0.369N P=0.297 (e) (e) P=0.750 |
|COCH-ARM / FISHERS | P=0.384N P=0.309 P=0.510N P=0.500N P=0.737 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 1/39 (3%) |
|FIRST INCIDENCE | --- 513 --- --- 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.431 P=0.500 (e) (e) P=0.605 |
|POLY 3 | P=0.426 P=0.518 (e) (e) P=0.517 |
|POLY 1.5 | P=0.413 P=0.510 (e) (e) P=0.505 |
|POLY 6 | P=0.446 P=0.533 (e) (e) P=0.535 |
|LOGISTIC REGRESSION| P=0.331 (e) (e) (e) P=0.605 |
|COCH-ARM / FISHERS | P=0.396 P=0.500 (e) (e) P=0.490 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 100
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 643 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.521N (e) P=0.269 (e) (e) |
|POLY 3 | P=0.511N (e) P=0.250 (e) (e) |
|POLY 1.5 | P=0.516N (e) P=0.243 (e) (e) |
|POLY 6 | P=0.503N (e) P=0.260 (e) (e) |
|LOGISTIC REGRESSION| P=0.507N (e) P=0.234 (e) (e) |
|COCH-ARM / FISHERS | P=0.516N (e) P=0.247 (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 101
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/49 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 2.3% 4.6% 7.2% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 681 --- 723 628 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.066 P=0.481N P=0.734N P=0.568 P=0.327 |
|POLY 3 | P=0.064 P=0.487N P=0.751N P=0.523 P=0.309 |
|POLY 1.5 | P=0.064 P=0.493N P=0.756N P=0.508 P=0.304 |
|POLY 6 | P=0.064 P=0.480N P=0.745N P=0.544 P=0.318 |
|LOGISTIC REGRESSION| P=0.073 P=0.502N P=0.749N P=0.480 P=0.308 |
|COCH-ARM / FISHERS | P=0.068 P=0.500N P=0.753N P=0.492 P=0.309 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 102
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 4.9% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- --- --- --- 537 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.021 * (e) (e) (e) P=0.235 |
|POLY 3 | P=0.021 * (e) (e) (e) P=0.239 |
|POLY 1.5 | P=0.021 * (e) (e) (e) P=0.236 |
|POLY 6 | P=0.021 * (e) (e) (e) P=0.244 |
|LOGISTIC REGRESSION| P=0.028 * (e) (e) (e) P=0.249 |
|COCH-ARM / FISHERS | P=0.023 * (e) (e) (e) P=0.247 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 103
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 35/50 (70%) 37/50 (74%) 30/50 (60%) 31/50 (62%) |
|POLY-3 ADJUSTED (b)| 14.7% 74.6% 80.3% 64.7% 69.5% |
|TERMINAL (d) | 5/22 (23%) 21/23 (91%) 21/22 (96%) 20/26 (77%) 18/22 (82%) |
|FIRST INCIDENCE | 681 481 477 537 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.004 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.004 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 46/50 (92%) 42/50 (84%) 44/50 (88%) 45/49 (92%) |
|POLY-3 ADJUSTED (b)| 2.3% 92.9% 87.9% 89.5% 94.5% |
|TERMINAL (d) | 0/23 (0%) 38/40 (95%) 33/35 (94%) 35/37 (95%) 40/40 (100%) |
|FIRST INCIDENCE | 571 513 85 550 689 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | 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 ** |
|POLY 1.5 | 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 ** |
|LOGISTIC REGRESSION| 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 ** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 104
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 12.0% 0.0% 7.0% 4.6% 4.9% |
|TERMINAL (d) | 2/22 (9%) 0/23 (0%) 1/22 (5%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 565 --- 638 690 603 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.332N P=0.031N* P=0.314N P=0.153N P=0.205N |
|POLY 3 | P=0.356N P=0.026N* P=0.336N P=0.194N P=0.218N |
|POLY 1.5 | P=0.352N P=0.028N* P=0.347N P=0.205N P=0.222N |
|POLY 6 | P=0.359N P=0.024N* P=0.321N P=0.179N P=0.214N |
|LOGISTIC REGRESSION| P=0.338N P=0.034N* P=0.353N P=0.210N P=0.215N |
|COCH-ARM / FISHERS | P=0.340N P=0.028N* P=0.357N P=0.218N P=0.218N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 665 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.334N P=0.470N P=0.480N P=0.465N P=0.448N |
|POLY 3 | P=0.379N P=0.486N P=0.492N P=0.483N P=0.483N |
|POLY 1.5 | P=0.370N P=0.493N P=0.498N P=0.491N P=0.493N |
|POLY 6 | P=0.397N P=0.473N P=0.482N P=0.471N P=0.465N |
|LOGISTIC REGRESSION| P=0.375N P=0.532N P=0.494N P=0.569N P=0.553N |
|COCH-ARM / FISHERS | P=0.361N P=0.500N P=0.500N P=0.500N P=0.505N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 105
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 37/50 (74%) 45/50 (90%) 44/50 (88%) 43/50 (86%) 39/50 (78%) |
|POLY-3 ADJUSTED (b)| 77.1% 93.0% 92.4% 87.7% 82.8% |
|TERMINAL (d) | 16/22 (73%) 23/23 (100%) 22/22 (100%) 23/26 (89%) 19/22 (86%) |
|FIRST INCIDENCE | 485 481 477 249 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.459N P=0.308 P=0.278 P=0.538N P=0.460 |
|POLY 3 | P=0.466N P=0.019 * P=0.025 * P=0.122 P=0.320 |
|POLY 1.5 | P=0.464N P=0.024 * P=0.034 * P=0.114 P=0.333 |
|POLY 6 | P=0.485N P=0.014 * P=0.017 * P=0.139 P=0.294 |
|LOGISTIC REGRESSION| P=0.470N P=0.043 * P=0.071 P=0.098 P=0.388 |
|COCH-ARM / FISHERS | P=0.388N P=0.033 * P=0.062 P=0.105 P=0.408 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 39/50 (78%) 50/50 (100%) 47/50 (94%) 47/50 (94%) 46/49 (94%) |
|POLY-3 ADJUSTED (b)| 80.5% 100.0% 94.6% 94.7% 94.0% |
|TERMINAL (d) | 19/23 (83%) 40/40 (100%) 34/35 (97%) 35/37 (95%) 38/40 (95%) |
|FIRST INCIDENCE | 550 513 85 550 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.027N* P=0.134N P=0.247N P=0.122N P=0.023N* |
|POLY 3 | P=0.148 P<0.001 ** P=0.026 * P=0.026 * P=0.037 * |
|POLY 1.5 | P=0.117 P<0.001 ** P=0.023 * P=0.022 * P=0.029 * |
|POLY 6 | P=0.218 P<0.001 ** P=0.034 * P=0.036 * P=0.059 |
|LOGISTIC REGRESSION| P=0.103 P<0.001 ** P=0.022 * P=0.029 * P=0.027 * |
|COCH-ARM / FISHERS | P=0.096 P<0.001 ** P=0.020 * P=0.020 * P=0.022 * |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 106
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 499 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.156N P=0.232N P=0.235N P=0.230N P=0.244N |
|POLY 3 | P=0.153N P=0.228N P=0.233N P=0.227N P=0.244N |
|POLY 1.5 | P=0.153N P=0.232N P=0.236N P=0.233N P=0.243N |
|POLY 6 | P=0.154N P=0.222N P=0.228N P=0.220N P=0.244N |
|LOGISTIC REGRESSION| P=0.072N P=0.291N P=0.160N P=0.170N P=0.146N |
|COCH-ARM / FISHERS | P=0.155N P=0.247N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 107
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Infiltration Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.6% 0.0% 2.3% 2.5% |
|TERMINAL (d) | 0/22 (0%) 2/23 (9%) 0/22 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) 690 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.513 P=0.247 (e) P=0.533 P=0.521 |
|POLY 3 | P=0.505 P=0.253 (e) P=0.514 P=0.500 |
|POLY 1.5 | P=0.502 P=0.246 (e) P=0.507 P=0.498 |
|POLY 6 | P=0.510 P=0.262 (e) P=0.525 P=0.504 |
|LOGISTIC REGRESSION| P=0.496 P=0.247 (e) P=0.533 P=0.499 |
|COCH-ARM / FISHERS | P=0.505 P=0.247 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Infiltration Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 108
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 36/50 (72%) 38/50 (76%) 33/50 (66%) 28/50 (56%) |
|POLY-3 ADJUSTED (b)| 27.3% 73.8% 77.6% 69.6% 61.0% |
|TERMINAL (d) | 4/22 (18%) 14/23 (61%) 17/22 (77%) 18/26 (69%) 12/22 (55%) |
|FIRST INCIDENCE | 537 477 312 537 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.176 P<0.001 ** P<0.001 ** P=0.003 ** P=0.006 ** |
|POLY 3 | P=0.108 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.105 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.114 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.128 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.120 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 33/50 (66%) 45/50 (90%) 48/50 (96%) 48/50 (96%) 47/49 (96%) |
|POLY-3 ADJUSTED (b)| 71.8% 92.3% 97.0% 96.7% 98.6% |
|TERMINAL (d) | 21/23 (91%) 39/40 (98%) 34/35 (97%) 36/37 (97%) 40/40 (100%) |
|FIRST INCIDENCE | 550 513 85 550 689 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.264N P=0.147N P=0.454 P=0.496N P=0.141N |
|POLY 3 | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** P=0.004 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 109
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen: Capsule |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.354N P=0.491N P=0.500N P=0.467N P=0.500N |
|POLY 3 | P=0.361N P=0.486N P=0.491N P=0.486N P=0.500N |
|POLY 1.5 | P=0.359N P=0.492N P=0.495N P=0.493N P=0.502N |
|POLY 6 | P=0.363N P=0.478N P=0.483N P=0.475N P=0.498N |
|LOGISTIC REGRESSION| P=0.354N (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.359N P=0.500N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen: Capsule |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.6% 0.0% 2.2% 2.1% 0.0% |
|TERMINAL (d) | 1/23 (4%) 0/40 (0%) 1/35 (3%) 1/37 (3%) 0/40 (0%) |
|FIRST INCIDENCE | 571 --- 730 (T) 730 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.194N P=0.180N P=0.408N P=0.391N P=0.182N |
|POLY 3 | P=0.236N P=0.223N P=0.489N P=0.473N P=0.220N |
|POLY 1.5 | P=0.239N P=0.230N P=0.498N P=0.486N P=0.230N |
|POLY 6 | P=0.234N P=0.210N P=0.471N P=0.452N P=0.203N |
|LOGISTIC REGRESSION| P=0.254N P=0.277N P=0.497N P=0.584N P=0.302N |
|COCH-ARM / FISHERS | P=0.242N P=0.247N P=0.500N P=0.500N P=0.253N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 110
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 4.6% 4.6% 14.1% |
|TERMINAL (d) | 1/22 (5%) 0/23 (0%) 0/22 (0%) 2/26 (8%) 0/22 (0%) |
|FIRST INCIDENCE | 729 (T) --- 666 729 (T) 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.491N P=0.534 P=0.559 P=0.069 |
|POLY 3 | P=0.003 ** P=0.486N P=0.520 P=0.525 P=0.063 |
|POLY 1.5 | P=0.003 ** P=0.492N P=0.510 P=0.513 P=0.059 |
|POLY 6 | P=0.003 ** P=0.478N P=0.536 P=0.543 P=0.069 |
|LOGISTIC REGRESSION| P=0.006 ** (e) P=0.511 P=0.559 P=0.078 |
|COCH-ARM / FISHERS | P=0.003 ** P=0.500N P=0.500 P=0.500 P=0.056 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 3/50 (6%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 0.0% 4.4% 6.3% 0.0% |
|TERMINAL (d) | 1/23 (4%) 0/40 (0%) 1/35 (3%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 730 (T) --- 652 611 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.433N P=0.390N P=0.607 P=0.395 P=0.390N |
|POLY 3 | P=0.473N P=0.485N P=0.518 P=0.345 P=0.481N |
|POLY 1.5 | P=0.491N P=0.492N P=0.506 P=0.326 P=0.492N |
|POLY 6 | P=0.445N P=0.471N P=0.540 P=0.376 P=0.463N |
|LOGISTIC REGRESSION| P=0.552N (e) P=0.509 P=0.195 (e) |
|COCH-ARM / FISHERS | P=0.512N P=0.500N P=0.500 P=0.309 P=0.505N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 111
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen: Red Pulp |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 7.4% 6.9% 4.7% 9.1% 4.9% |
|TERMINAL (d) | 2/22 (9%) 3/23 (13%) 2/22 (9%) 4/26 (15%) 1/22 (5%) |
|FIRST INCIDENCE | 724 729 (T) 729 (T) 729 (T) 690 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.449N P=0.638N P=0.500N P=0.588 P=0.494N |
|POLY 3 | P=0.473N P=0.630N P=0.479N P=0.539 P=0.500N |
|POLY 1.5 | P=0.472N P=0.644N P=0.490N P=0.520 P=0.504N |
|POLY 6 | P=0.473N P=0.612N P=0.463N P=0.567 P=0.492N |
|LOGISTIC REGRESSION| P=0.484N P=0.614N P=0.460N P=0.608 P=0.497N |
|COCH-ARM / FISHERS | P=0.458N P=0.661N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen: Red Pulp |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 4.4% 4.3% 0.0% |
|TERMINAL (d) | 0/23 (0%) 1/40 (3%) 1/35 (3%) 2/37 (5%) 0/40 (0%) |
|FIRST INCIDENCE | --- 730 (T) 652 730 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.419N P=0.610 P=0.297 P=0.348 (e) |
|POLY 3 | P=0.466N P=0.515 P=0.249 P=0.258 (e) |
|POLY 1.5 | P=0.488N P=0.508 P=0.241 P=0.248 (e) |
|POLY 6 | P=0.431N P=0.529 P=0.263 P=0.274 (e) |
|LOGISTIC REGRESSION| P=0.487N P=0.610 P=0.237 P=0.348 (e) |
|COCH-ARM / FISHERS | P=0.513N P=0.500 P=0.247 P=0.247 (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 112
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 4.8% 9.1% 4.7% 4.5% 7.3% |
|TERMINAL (d) | 0/22 (0%) 1/23 (4%) 0/22 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 499 663 682 653 690 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.525 P=0.404 P=0.653N P=0.640N P=0.499 |
|POLY 3 | P=0.533 P=0.365 P=0.682N P=0.673N P=0.495 |
|POLY 1.5 | P=0.532 P=0.353 P=0.689N P=0.684N P=0.492 |
|POLY 6 | P=0.537 P=0.383 P=0.672N P=0.656N P=0.501 |
|LOGISTIC REGRESSION| P=0.540 P=0.307 P=0.687 P=0.682 P=0.506 |
|COCH-ARM / FISHERS | P=0.543 P=0.339 P=0.691N P=0.691N P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 1/35 (3%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 730 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.607N (e) P=0.584 (e) (e) |
|POLY 3 | P=0.643N (e) P=0.509 (e) (e) |
|POLY 1.5 | P=0.648N (e) P=0.503 (e) (e) |
|POLY 6 | P=0.636N (e) P=0.520 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.584 (e) (e) |
|COCH-ARM / FISHERS | P=0.652N (e) P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 113
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 11/50 (22%) 7/50 (14%) 4/50 (8%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 9.5% 24.2% 15.9% 9.0% 9.7% |
|TERMINAL (d) | 0/22 (0%) 3/23 (13%) 0/22 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 499 597 638 637 684 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.171N P=0.093 P=0.353 P=0.548N P=0.626N |
|POLY 3 | P=0.158N P=0.060 P=0.284 P=0.613N P=0.632 |
|POLY 1.5 | P=0.160N P=0.052 P=0.271 P=0.629N P=0.631 |
|POLY 6 | P=0.155N P=0.072 P=0.307 P=0.589N P=0.635 |
|LOGISTIC REGRESSION| P=0.145N P=0.031 * P=0.247 P=0.619 P=0.635N |
|COCH-ARM / FISHERS | P=0.152N P=0.045 * P=0.262 P=0.643N P=0.643N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 2/50 (4%) 2/50 (4%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 9.1% 2.1% 4.4% 4.2% 4.2% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 1/35 (3%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 550 694 652 550 689 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.318N P=0.118N P=0.252N P=0.252N P=0.198N |
|POLY 3 | P=0.400N P=0.161N P=0.323N P=0.300N P=0.303N |
|POLY 1.5 | P=0.409N P=0.170N P=0.335N P=0.317N P=0.324N |
|POLY 6 | P=0.388N P=0.146N P=0.302N P=0.274N P=0.269N |
|LOGISTIC REGRESSION| P=0.484N P=0.226N P=0.328N P=0.569N P=0.454N |
|COCH-ARM / FISHERS | P=0.422N P=0.181N P=0.339N P=0.339N P=0.349N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 114
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.5% 0.0% 4.6% 0.0% 2.4% |
|TERMINAL (d) | 1/22 (5%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 499 --- 565 --- 646 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.179N P=0.056N P=0.315N P=0.052N P=0.188N |
|POLY 3 | P=0.177N P=0.055N P=0.320N P=0.055N P=0.185N |
|POLY 1.5 | P=0.176N P=0.057N P=0.329N P=0.058N P=0.186N |
|POLY 6 | P=0.178N P=0.052N P=0.305N P=0.050N P=0.183N |
|LOGISTIC REGRESSION| P=0.127N P=0.086N P=0.342N P=0.065N P=0.159N |
|COCH-ARM / FISHERS | P=0.173N P=0.059N P=0.339N P=0.059N P=0.181N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 2.1% 4.4% 2.1% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 550 694 571 635 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.244N P=0.729N P=0.502 P=0.750N P=0.508N |
|POLY 3 | P=0.249N P=0.746N P=0.517 P=0.742N P=0.484N |
|POLY 1.5 | P=0.259N P=0.753N P=0.506 P=0.751N P=0.494N |
|POLY 6 | P=0.233N P=0.731N P=0.539 P=0.727N P=0.467N |
|LOGISTIC REGRESSION| P=0.324N P=0.726 P=0.580 P=0.577 P=0.426N |
|COCH-ARM / FISHERS | P=0.270N P=0.753N P=0.500 P=0.753N P=0.505N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 115
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.5% 9.7% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- 628 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** (e) (e) P=0.280 P=0.074 |
|POLY 3 | P<0.001 ** (e) (e) P=0.256 P=0.062 |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.247 P=0.060 |
|POLY 6 | P<0.001 ** (e) (e) P=0.271 P=0.065 |
|LOGISTIC REGRESSION| P=0.002 ** (e) (e) P=0.229 P=0.062 |
|COCH-ARM / FISHERS | P=0.002 ** (e) (e) P=0.247 P=0.059 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 116
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 8/50 (16%) 4/50 (8%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 7.2% 17.9% 9.1% 0.0% 7.3% |
|TERMINAL (d) | 0/22 (0%) 2/23 (9%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 499 642 561 --- 667 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.167N P=0.160 P=0.551 P=0.105N P=0.656N |
|POLY 3 | P=0.145N P=0.118 P=0.525 P=0.111N P=0.654 |
|POLY 1.5 | P=0.149N P=0.109 P=0.512 P=0.115N P=0.653 |
|POLY 6 | P=0.140N P=0.131 P=0.544 P=0.105N P=0.658 |
|LOGISTIC REGRESSION| P=0.135N P=0.080 P=0.487 P=0.110N P=0.646N |
|COCH-ARM / FISHERS | P=0.150N P=0.100 P=0.500 P=0.121N P=0.661N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 13.4% 0.0% 2.2% 6.2% 2.1% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 1/35 (3%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 550 --- 730 (T) 550 718 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.125N P=0.012N* P=0.041N* P=0.190N P=0.030N* |
|POLY 3 | P=0.150N P=0.013N* P=0.055N P=0.205N P=0.047N* |
|POLY 1.5 | P=0.154N P=0.014N* P=0.057N P=0.222N P=0.053N |
|POLY 6 | P=0.146N P=0.011N* P=0.049N* P=0.181N P=0.039N* |
|LOGISTIC REGRESSION| P=0.218N P=0.027N* P=0.051N P=0.627N P=0.118N |
|COCH-ARM / FISHERS | P=0.164N P=0.013N* P=0.056N P=0.243N P=0.059N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 117
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.8% 9.0% 2.3% 4.5% 2.4% |
|TERMINAL (d) | 1/22 (5%) 1/23 (4%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 499 615 648 628 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.253N P=0.382 P=0.490N P=0.644N P=0.510N |
|POLY 3 | P=0.242N P=0.371 P=0.487N P=0.670N P=0.500N |
|POLY 1.5 | P=0.245N P=0.356 P=0.494N P=0.682N P=0.503N |
|POLY 6 | P=0.239N P=0.394 P=0.475N P=0.652N P=0.496N |
|LOGISTIC REGRESSION| P=0.182N P=0.272 P=0.501N P=0.683 P=0.394N |
|COCH-ARM / FISHERS | P=0.243N P=0.339 P=0.500N P=0.691N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.6% 2.2% 2.2% 2.1% 0.0% |
|TERMINAL (d) | 0/23 (0%) 1/40 (3%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 617 730 (T) 571 635 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.150N P=0.429N P=0.502N P=0.474N P=0.218N |
|POLY 3 | P=0.162N P=0.479N P=0.486N P=0.472N P=0.220N |
|POLY 1.5 | P=0.167N P=0.489N P=0.496N P=0.485N P=0.231N |
|POLY 6 | P=0.156N P=0.460N P=0.468N P=0.451N P=0.204N |
|LOGISTIC REGRESSION| P=0.201N P=0.558N P=0.442N P=0.710N P=0.300N |
|COCH-ARM / FISHERS | P=0.171N P=0.500N P=0.500N P=0.500N P=0.253N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 118
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 7/50 (14%) 10/50 (20%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 4.9% 9.1% 16.1% 22.0% 23.5% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 1/26 (4%) 1/22 (5%) |
|FIRST INCIDENCE | 681 676 648 620 603 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008 ** P=0.408 P=0.125 P=0.049 * P=0.027 * |
|POLY 3 | P=0.006 ** P=0.370 P=0.091 P=0.021 * P=0.015 * |
|POLY 1.5 | P=0.006 ** P=0.356 P=0.085 P=0.017 * P=0.013 * |
|POLY 6 | P=0.008 ** P=0.389 P=0.102 P=0.029 * P=0.018 * |
|LOGISTIC REGRESSION| P=0.006 ** P=0.367 P=0.090 P=0.015 * P=0.015 * |
|COCH-ARM / FISHERS | P=0.007 ** P=0.339 P=0.080 P=0.014 * P=0.014 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.173 (e) (e) (e) P=0.610 |
|POLY 3 | P=0.151 (e) (e) (e) P=0.519 |
|POLY 1.5 | P=0.147 (e) (e) (e) P=0.508 |
|POLY 6 | P=0.157 (e) (e) (e) P=0.537 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.610 |
|COCH-ARM / FISHERS | P=0.142 (e) (e) (e) P=0.495 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 119
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 7.3% 4.6% 6.9% 2.3% 7.2% |
|TERMINAL (d) | 1/22 (5%) 1/23 (4%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 674 718 561 653 466 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.572 P=0.449N P=0.606N P=0.244N P=0.649N |
|POLY 3 | P=0.578 P=0.471N P=0.635N P=0.280N P=0.655N |
|POLY 1.5 | P=0.575 P=0.483N P=0.649N P=0.292N P=0.662N |
|POLY 6 | P=0.581N P=0.455N P=0.616N P=0.263N P=0.645N |
|LOGISTIC REGRESSION| P=0.562N P=0.443N P=0.661 P=0.292N P=0.655N |
|COCH-ARM / FISHERS | P=0.581 P=0.500N P=0.661N P=0.309N P=0.661N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.6% 2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 571 645 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.096N P=0.448N P=0.211N P=0.201N P=0.193N |
|POLY 3 | P=0.108N P=0.475N P=0.230N P=0.221N P=0.220N |
|POLY 1.5 | P=0.107N P=0.488N P=0.236N P=0.228N P=0.230N |
|POLY 6 | P=0.111N P=0.454N P=0.219N P=0.208N P=0.203N |
|LOGISTIC REGRESSION| P=0.117N P=0.572N P=0.214N P=0.349N P=0.303N |
|COCH-ARM / FISHERS | P=0.107N P=0.500N P=0.247N P=0.247N P=0.253N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 120
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 10/50 (20%) 7/50 (14%) 6/50 (12%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 14.2% 22.0% 15.5% 13.5% 12.1% |
|TERMINAL (d) | 1/22 (5%) 3/23 (13%) 1/22 (5%) 3/26 (12%) 2/22 (9%) |
|FIRST INCIDENCE | 537 481 477 620 646 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.235N P=0.290 P=0.549 P=0.512N P=0.499N |
|POLY 3 | P=0.242N P=0.255 P=0.552 P=0.586N P=0.516N |
|POLY 1.5 | P=0.238N P=0.233 P=0.527 P=0.604N P=0.515N |
|POLY 6 | P=0.248N P=0.283 P=0.587 P=0.561N P=0.516N |
|LOGISTIC REGRESSION| P=0.197N P=0.163 P=0.468 P=0.619 P=0.503N |
|COCH-ARM / FISHERS | P=0.217N P=0.207 P=0.500 P=0.620N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 121
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 27/50 (54%) 27/50 (54%) 26/50 (52%) 24/50 (48%) 26/50 (52%) |
|POLY-3 ADJUSTED (b)| 57.5% 57.2% 54.8% 49.5% 55.5% |
|TERMINAL (d) | 10/22 (46%) 12/23 (52%) 11/22 (50%) 11/26 (42%) 8/22 (36%) |
|FIRST INCIDENCE | 485 597 312 249 466 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.440N P=0.418N P=0.418N P=0.186N P=0.486N |
|POLY 3 | P=0.408N P=0.571N P=0.477N P=0.280N P=0.507N |
|POLY 1.5 | P=0.430N P=0.579N P=0.487N P=0.308N P=0.526N |
|POLY 6 | P=0.373N P=0.548N P=0.464N P=0.241N P=0.471N |
|LOGISTIC REGRESSION| P=0.363N P=0.505 P=0.580N P=0.523N P=0.484N |
|COCH-ARM / FISHERS | P=0.411N P=0.579N P=0.500N P=0.345N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 122
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 40/46 (87%) 43/44 (98%) 44/45 (98%) 46/46 (100%) 41/41 (100%) |
|POLY-3 ADJUSTED (b)| 88.7% 97.9% 99.8% 100.0% 100.0% |
|TERMINAL (d) | 18/20 (90%) 20/20 (100%) 22/22 (100%) 24/24 (100%) 17/17 (100%) |
|FIRST INCIDENCE | 485 477 477 249 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.312 P=0.541 P=0.553 P=0.489N P=0.369 |
|POLY 3 | P=0.008 ** P=0.079 P=0.025 * P=0.020 * P=0.028 * |
|POLY 1.5 | P=0.006 ** P=0.071 P=0.028 * P=0.017 * P=0.024 * |
|POLY 6 | P=0.012 * P=0.097 P=0.031 * P=0.027 * P=0.037 * |
|LOGISTIC REGRESSION| P=0.006 ** P=0.057 P=0.065 P=0.016 * P=0.024 * |
|COCH-ARM / FISHERS | P=0.008 ** P=0.062 P=0.059 P=0.013 * P=0.019 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 44/46 (96%) 48/48 (100%) 47/48 (98%) 49/49 (100%) 46/46 (100%) |
|POLY-3 ADJUSTED (b)| 96.3% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 21/21 (100%) 40/40 (100%) 33/33 (100%) 36/36 (100%) 39/39 (100%) |
|FIRST INCIDENCE | 550 513 506 550 536 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004N** P=0.002N** P=0.040N* P=0.016N* P<0.001N** |
|POLY 3 | P=0.175 P=0.267 P=0.272 P=0.262 P=0.277 |
|POLY 1.5 | P=0.160 P=0.246 P=0.261 P=0.242 P=0.256 |
|POLY 6 | P=0.206 P=0.314 P=0.319 P=0.309 P=0.324 |
|LOGISTIC REGRESSION| P=0.194 P=0.237 P=0.292 P=0.238 P=0.272 |
|COCH-ARM / FISHERS | P=0.153 P=0.237 P=0.484 P=0.232 P=0.247 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 123
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 14/50 (28%) 22/50 (44%) 14/48 (29%) 13/50 (26%) 12/47 (26%) |
|POLY-3 ADJUSTED (b)| 33.7% 48.8% 34.0% 29.2% 30.6% |
|TERMINAL (d) | 9/22 (41%) 13/23 (57%) 11/22 (50%) 10/26 (39%) 8/22 (36%) |
|FIRST INCIDENCE | 620 481 704 537 646 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.105N P=0.135 P=0.549N P=0.300N P=0.394N |
|POLY 3 | P=0.139N P=0.108 P=0.581 P=0.411N P=0.475N |
|POLY 1.5 | P=0.152N P=0.090 P=0.558 P=0.455N P=0.492N |
|POLY 6 | P=0.119N P=0.134 P=0.578N P=0.354N P=0.445N |
|LOGISTIC REGRESSION| P=0.138N P=0.146 P=0.467N P=0.332N P=0.438N |
|COCH-ARM / FISHERS | P=0.148N P=0.072 P=0.538 P=0.500N P=0.483N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/50 (42%) 29/50 (58%) 20/50 (40%) 18/50 (36%) 18/49 (37%) |
|POLY-3 ADJUSTED (b)| 48.0% 61.5% 43.9% 38.0% 37.6% |
|TERMINAL (d) | 17/23 (74%) 26/40 (65%) 17/35 (49%) 16/37 (43%) 16/40 (40%) |
|FIRST INCIDENCE | 575 589 652 638 718 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002N** P=0.208N P=0.044N* P=0.009N** P=0.004N** |
|POLY 3 | P=0.032N* P=0.130 P=0.428N P=0.222N P=0.210N |
|POLY 1.5 | P=0.052N P=0.101 P=0.481N P=0.276N P=0.281N |
|POLY 6 | P=0.014N* P=0.207 P=0.327N P=0.145N P=0.118N |
|LOGISTIC REGRESSION| P=0.006N** P=0.351 P=0.218N P=0.064N P=0.024N* |
|COCH-ARM / FISHERS | P=0.093N P=0.081 P=0.500N P=0.341N P=0.371N |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 124
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 3/48 (6%) 5/50 (10%) 4/47 (9%) |
|POLY-3 ADJUSTED (b)| 7.3% 4.6% 7.3% 11.3% 10.0% |
|TERMINAL (d) | 1/22 (5%) 2/23 (9%) 2/22 (9%) 3/26 (12%) 1/22 (5%) |
|FIRST INCIDENCE | 648 729 (T) 719 663 421 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.263 P=0.455N P=0.629N P=0.465 P=0.494 |
|POLY 3 | P=0.244 P=0.472N P=0.663 P=0.396 P=0.486 |
|POLY 1.5 | P=0.238 P=0.484N P=0.652 P=0.376 P=0.473 |
|POLY 6 | P=0.251 P=0.458N P=0.651N P=0.424 P=0.503 |
|LOGISTIC REGRESSION| P=0.241 P=0.449N P=0.639N P=0.405 P=0.509 |
|COCH-ARM / FISHERS | P=0.240 P=0.500N P=0.641 P=0.357 P=0.465 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 722 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.686 (e) (e) P=0.610 (e) |
|POLY 3 | P=0.678 (e) (e) P=0.518 (e) |
|POLY 1.5 | P=0.661 (e) (e) P=0.510 (e) |
|POLY 6 | P=0.702 (e) (e) P=0.531 (e) |
|LOGISTIC REGRESSION| P=0.665 (e) (e) P=0.552 (e) |
|COCH-ARM / FISHERS | P=0.639 (e) (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 125
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/48 (2%) 1/50 (2%) 3/47 (6%) |
|POLY-3 ADJUSTED (b)| 7.3% 6.8% 2.4% 2.3% 7.8% |
|TERMINAL (d) | 2/22 (9%) 2/23 (9%) 1/22 (5%) 0/26 (0%) 2/22 (9%) |
|FIRST INCIDENCE | 665 642 729 (T) 690 690 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.576N P=0.626N P=0.300N P=0.241N P=0.650N |
|POLY 3 | P=0.562 P=0.629N P=0.304N P=0.280N P=0.635 |
|POLY 1.5 | P=0.560 P=0.644N P=0.312N P=0.293N P=0.629 |
|POLY 6 | P=0.565 P=0.611N P=0.292N P=0.263N P=0.644 |
|LOGISTIC REGRESSION| P=0.562 P=0.620N P=0.280N P=0.271N P=0.652 |
|COCH-ARM / FISHERS | P=0.567 P=0.661N P=0.324N P=0.309N P=0.631 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 1/37 (3%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 730 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.679 (e) (e) P=0.595 (e) |
|POLY 3 | P=0.678 (e) (e) P=0.518 (e) |
|POLY 1.5 | P=0.661 (e) (e) P=0.509 (e) |
|POLY 6 | P=0.702 (e) (e) P=0.531 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.595 (e) |
|COCH-ARM / FISHERS | P=0.639 (e) (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 126
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.6% 0.0% 2.5% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 643 --- 699 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.391 (e) P=0.269 (e) P=0.492 |
|POLY 3 | P=0.397 (e) P=0.250 (e) P=0.496 |
|POLY 1.5 | P=0.395 (e) P=0.243 (e) P=0.494 |
|POLY 6 | P=0.400 (e) P=0.260 (e) P=0.499 |
|LOGISTIC REGRESSION| P=0.405 (e) P=0.234 (e) P=0.496 |
|COCH-ARM / FISHERS | P=0.402 (e) P=0.247 (e) P=0.495 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/40 (0%) 0/35 (0%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 127
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 8/50 (16%) 11/50 (22%) 8/50 (16%) 9/49 (18%) |
|POLY-3 ADJUSTED (b)| 18.7% 17.9% 25.1% 17.8% 22.6% |
|TERMINAL (d) | 4/22 (18%) 4/23 (17%) 4/22 (18%) 4/26 (15%) 8/22 (36%) |
|FIRST INCIDENCE | 485 597 643 593 690 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.489 P=0.542N P=0.359 P=0.490N P=0.498 |
|POLY 3 | P=0.409 P=0.569N P=0.323 P=0.568N P=0.435 |
|POLY 1.5 | P=0.427 P=0.586N P=0.311 P=0.589N P=0.446 |
|POLY 6 | P=0.388 P=0.544N P=0.349 P=0.534N P=0.421 |
|LOGISTIC REGRESSION| P=0.456 P=0.547 P=0.302 P=0.581 P=0.475 |
|COCH-ARM / FISHERS | P=0.474 P=0.607N P=0.306 P=0.607N P=0.482 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/49 (27%) 16/49 (33%) 9/49 (18%) 25/50 (50%) 17/49 (35%) |
|POLY-3 ADJUSTED (b)| 30.1% 35.0% 20.2% 51.7% 35.4% |
|TERMINAL (d) | 8/23 (35%) 16/40 (40%) 7/35 (20%) 18/37 (49%) 14/40 (35%) |
|FIRST INCIDENCE | 575 730 (T) 652 634 536 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.418 P=0.243N P=0.057N P=0.257 P=0.322N |
|POLY 3 | P=0.175 P=0.392 P=0.205N P=0.026 * P=0.377 |
|POLY 1.5 | P=0.134 P=0.360 P=0.227N P=0.018 * P=0.317 |
|POLY 6 | P=0.252 P=0.454 P=0.168N P=0.045 * P=0.481 |
|LOGISTIC REGRESSION| P=0.176 P=0.561 P=0.185N P=0.033 * P=0.336 |
|COCH-ARM / FISHERS | P=0.096 P=0.329 P=0.234N P=0.014 * P=0.256 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 128
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.3% 2.3% 2.3% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/22 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- 718 603 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.506N P=0.531 P=0.519 P=0.533 (e) |
|POLY 3 | P=0.508N P=0.514 P=0.511 P=0.514 (e) |
|POLY 1.5 | P=0.511N P=0.508 P=0.506 P=0.507 (e) |
|POLY 6 | P=0.504N P=0.522 P=0.520 P=0.525 (e) |
|LOGISTIC REGRESSION| P=0.510N P=0.528 P=0.511 P=0.533 (e) |
|COCH-ARM / FISHERS | P=0.508N P=0.500 P=0.500 P=0.500 (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 1/49 (2%) 4/50 (8%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 2.3% 8.5% 8.4% |
|TERMINAL (d) | 0/23 (0%) 1/40 (3%) 0/35 (0%) 3/37 (8%) 2/40 (5%) |
|FIRST INCIDENCE | --- 730 (T) 703 675 712 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.038 * P=0.610 P=0.557 P=0.129 P=0.153 |
|POLY 3 | P=0.021 * P=0.516 P=0.510 P=0.076 P=0.077 |
|POLY 1.5 | P=0.018 * P=0.508 P=0.503 P=0.070 P=0.069 |
|POLY 6 | P=0.027 * P=0.530 P=0.522 P=0.088 P=0.093 |
|LOGISTIC REGRESSION| P=0.022 * P=0.610 P=0.505 P=0.084 P=0.098 |
|COCH-ARM / FISHERS | P=0.015 * P=0.500 P=0.500 P=0.061 P=0.059 |
|=================================================================================================================================|
Date: 02/25/99 EXPERIMENT: 88036 TEST: 03 Page 129
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 ADJUSTED (b)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 469 PPM 938 PPM 1875 PPM 3750 PPM |
| | |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 3/50 (6%) 3/50 (6%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.5% 6.7% 6.4% 8.5% |
|TERMINAL (d) | 0/23 (0%) 3/40 (8%) 2/35 (6%) 3/37 (8%) 4/40 (10%) |
|FIRST INCIDENCE | --- 730 (T) 723 730 (T) 730 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.208 P=0.234 P=0.210 P=0.216 P=0.153 |
|POLY 3 | P=0.140 P=0.133 P=0.127 P=0.135 P=0.073 |
|POLY 1.5 | P=0.124 P=0.126 P=0.121 P=0.128 P=0.066 |
|POLY 6 | P=0.169 P=0.147 P=0.138 P=0.149 P=0.088 |
|LOGISTIC REGRESSION| P=0.212 P=0.234 P=0.179 P=0.216 P=0.153 |
|COCH-ARM / FISHERS | P=0.106 P=0.121 P=0.121 P=0.121 P=0.056 |
|=================================================================================================================================|
(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).