TDMS Study 88120-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus P,P'-DICHLORODIPHENYL SULFONE DATE: 10/27/99
EXPERIMENT: 88120 TEST: 03 TIME: 13:00:41
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55388 ROUTE: DOSED FEED NTP C#: 88120B
PATHOLOGIST: SINGER, ALLEN CAS: 80-07-9
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 CORE STUDY RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus P,P'-DICHLORODIPHENYL SULFONE DATE: 10/27/99
EXPERIMENT: 88120 TEST: 03 TIME: 13:00:41
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55388 ROUTE: DOSED FEED NTP C#: 88120B
PATHOLOGIST: SINGER, ALLEN CAS: 80-07-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF P,P'-DICHLORODIPHENYL SULFONE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Heart Cardiomyopathy
Kidney Nephropathy
Pigmentation
Liver Mixed Cell Focus
Vacuolization Cytoplasmic
Liver: Centrilobular Hypertrophy
Lung: Alveolar Epithelium Hyperplasia
Lymph Node, Mandibular Hyperplasia
Mammary Gland Galactocele
Hyperplasia
Pituitary Gland Cyst
Pituitary Gland: Pars Distalis Pseudocyst
Prostate Inflammation
Testes: Interstitial Cell Hyperplasia
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Hyperplasia
Heart Inflammation
Kidney Pigmentation
Liver Basophilic Focus
Inflammation
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Liver: Centrilobular Degeneration
Hypertrophy
Lung Inflammation
Necrosis
Lymph Node, Mandibular Ectasia
Hyperplasia
Skin Ulcer
Spleen Pigmentation
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |27/50 (54%) 21/50 (42%) 26/50 (52%) 26/50 (52%) |
|POLY-3 ADJUSTED (b)| 5.0% 2.3% 5.0% 2.4% |59.3% 46.2% 55.7% 60.5% |
|TERMINAL (d) | 2/24 (8%) 0/30 (0%) 1/20 (5%) 1/28 (4%) |24/36 (67%) 19/38 (50%) 23/35 (66%) 25/35 (71%) |
|FIRST INCIDENCE | 729 (T) 687 691 729 (T) |575 633 536 633 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.452N P=0.420N P=0.654 P=0.446N |P=0.286 P=0.098N P=0.543N P=0.576N |
|POLY 3 | P=0.475N P=0.468N P=0.690N P=0.478N |P=0.275 P=0.143N P=0.444N P=0.541 |
|POLY 1.5 | P=0.474N P=0.479N P=0.688N P=0.483N |P=0.321 P=0.149N P=0.462N P=0.582 |
|POLY 6 | P=0.481N P=0.455N P=0.695N P=0.475N |P=0.232 P=0.135N P=0.435N P=0.499 |
|LOGISTIC REGRESSION| P=0.469N P=0.453N P=0.687 P=0.446N |P=0.267 P=0.127N P=0.410N P=0.553 |
|COCH-ARM / FISHERS | P=0.479N P=0.500N P=0.691N P=0.500N |P=0.414 P=0.158N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |3/50 (6%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 2.3% |6.6% 2.2% 4.3% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |2/36 (6%) 1/38 (3%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 361 --- --- 677 |429 730 (T) 625 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.542 P=0.492N P=0.492N P=0.746N |P=0.143N P=0.292N P=0.491N P=0.129N |
|POLY 3 | P=0.533 P=0.487N P=0.503N P=0.751N |P=0.143N P=0.308N P=0.488N P=0.130N |
|POLY 1.5 | P=0.535 P=0.491N P=0.500N P=0.753N |P=0.140N P=0.308N P=0.493N P=0.126N |
|POLY 6 | P=0.530 P=0.481N P=0.507N P=0.749N |P=0.146N P=0.307N P=0.482N P=0.132N |
|LOGISTIC REGRESSION| P=0.374 P=0.836N P=0.882N P=0.609 |P=0.109N P=0.305N P=0.580N P=0.093N |
|COCH-ARM / FISHERS | P=0.536 P=0.500N P=0.500N P=0.753N |P=0.132N P=0.309N P=0.500N P=0.121N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 13/50 (26%) 8/50 (16%) 9/50 (18%) |14/50 (28%) 11/50 (22%) 19/50 (38%) 18/50 (36%) |
|POLY-3 ADJUSTED (b)| 26.8% 29.3% 19.4% 20.7% |30.8% 24.4% 40.8% 40.8% |
|TERMINAL (d) | 8/24 (33%) 10/30 (33%) 3/20 (15%) 6/28 (21%) |11/36 (31%) 10/38 (26%) 14/35 (40%) 15/35 (43%) |
|FIRST INCIDENCE | 361 512 537 490 |613 680 662 414 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.228N P=0.557N P=0.405N P=0.281N |P=0.093 P=0.276N P=0.205 P=0.227 |
|POLY 3 | P=0.246N P=0.493 P=0.296N P=0.343N |P=0.099 P=0.327N P=0.217 P=0.220 |
|POLY 1.5 | P=0.254N P=0.462 P=0.295N P=0.359N |P=0.108 P=0.325N P=0.210 P=0.232 |
|POLY 6 | P=0.243N P=0.527 P=0.302N P=0.332N |P=0.093 P=0.331N P=0.222 P=0.209 |
|LOGISTIC REGRESSION| P=0.256N P=0.493 P=0.296N P=0.358N |P=0.089 P=0.306N P=0.228 P=0.221 |
|COCH-ARM / FISHERS | P=0.280N P=0.408 P=0.306N P=0.402N |P=0.129 P=0.322N P=0.198 P=0.260 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) 3/50 (6%) 2/50 (4%) |4/50 (8%) 4/50 (8%) 5/50 (10%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 7.4% 15.9% 7.5% 4.7% |8.9% 8.9% 10.7% 7.0% |
|TERMINAL (d) | 0/24 (0%) 5/30 (17%) 2/20 (10%) 2/28 (7%) |3/36 (8%) 4/38 (11%) 3/35 (9%) 3/35 (9%) |
|FIRST INCIDENCE | 617 592 712 729 (T) |660 730 (T) 575 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.175N P=0.245 P=0.605 P=0.459N |P=0.448N P=0.615N P=0.504 P=0.521N |
|POLY 3 | P=0.167N P=0.193 P=0.661 P=0.478N |P=0.446N P=0.641N P=0.526 P=0.526N |
|POLY 1.5 | P=0.170N P=0.181 P=0.659N P=0.482N |P=0.436N P=0.642N P=0.516 P=0.518N |
|POLY 6 | P=0.169N P=0.205 P=0.650 P=0.480N |P=0.455N P=0.640N P=0.535 P=0.533N |
|LOGISTIC REGRESSION| P=0.175N P=0.186 P=0.662N P=0.475N |P=0.439N P=0.635N P=0.498 P=0.527N |
|COCH-ARM / FISHERS | P=0.186N P=0.159 P=0.661N P=0.500N |P=0.412N P=0.643N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 0.0% 0.0% |0.0% 0.0% 2.2% 4.6% |
|TERMINAL (d) | 1/24 (4%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 454 --- --- --- |--- --- 714 531 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.254N P=0.211N P=0.255N P=0.214N |P=0.074 (e) P=0.505 P=0.227 |
|POLY 3 | P=0.270N P=0.222N P=0.239N P=0.227N |P=0.080 (e) P=0.507 P=0.232 |
|POLY 1.5 | P=0.267N P=0.227N P=0.236N P=0.229N |P=0.081 (e) P=0.504 P=0.233 |
|POLY 6 | P=0.274N P=0.216N P=0.244N P=0.226N |P=0.080 (e) P=0.509 P=0.233 |
|LOGISTIC REGRESSION| P=0.300N P=0.290N P=0.262N P=0.297N |P=0.112 (e) P=0.506 P=0.283 |
|COCH-ARM / FISHERS | P=0.262N P=0.247N P=0.247N P=0.247N |P=0.084 (e) P=0.500 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 6/50 (12%) 4/50 (8%) 3/50 (6%) |3/50 (6%) 6/50 (12%) 5/50 (10%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 19.4% 13.7% 9.6% 7.1% |6.7% 13.0% 10.8% 2.3% |
|TERMINAL (d) | 3/24 (13%) 4/30 (13%) 1/20 (5%) 2/28 (7%) |2/36 (6%) 2/38 (5%) 2/35 (6%) 1/35 (3%) |
|FIRST INCIDENCE | 361 659 557 701 |723 616 575 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.093N P=0.258N P=0.231N P=0.078N |P=0.134N P=0.277 P=0.354 P=0.319N |
|POLY 3 | P=0.094N P=0.336N P=0.170N P=0.086N |P=0.128N P=0.259 P=0.380 P=0.321N |
|POLY 1.5 | P=0.093N P=0.354N P=0.170N P=0.089N |P=0.122N P=0.251 P=0.371 P=0.316N |
|POLY 6 | P=0.097N P=0.317N P=0.172N P=0.086N |P=0.133N P=0.273 P=0.389 P=0.323N |
|LOGISTIC REGRESSION| P=0.094N P=0.360N P=0.182N P=0.092N |P=0.112N P=0.242 P=0.366 P=0.321N |
|COCH-ARM / FISHERS | P=0.097N P=0.387N P=0.178N P=0.100N |P=0.111N P=0.243 P=0.357 P=0.309N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.4% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 2/35 (6%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.708N (e) P=0.232 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.712N (e) P=0.244 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.707N (e) P=0.242 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.716N (e) P=0.246 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.232 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.695N (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 10/50 (20%) 15/50 (30%) 12/50 (24%) |4/50 (8%) 8/49 (16%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 34.5% 22.9% 36.2% 27.3% |9.0% 17.9% 6.4% 2.3% |
|TERMINAL (d) | 8/24 (33%) 8/30 (27%) 5/20 (25%) 7/28 (25%) |3/36 (8%) 6/38 (16%) 1/35 (3%) 1/35 (3%) |
|FIRST INCIDENCE | 614 708 557 569 |694 652 575 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432N P=0.108N P=0.362 P=0.291N |P=0.051N P=0.204 P=0.500N P=0.191N |
|POLY 3 | P=0.437N P=0.172N P=0.528 P=0.314N |P=0.045N* P=0.177 P=0.474N P=0.192N |
|POLY 1.5 | P=0.454N P=0.194N P=0.527 P=0.342N |P=0.043N* P=0.172 P=0.484N P=0.188N |
|POLY 6 | P=0.424N P=0.154N P=0.521 P=0.292N |P=0.046N* P=0.184 P=0.464N P=0.195N |
|LOGISTIC REGRESSION| P=0.467N P=0.122N P=0.492 P=0.334N |P=0.042N* P=0.176 P=0.516N P=0.194N |
|COCH-ARM / FISHERS | P=0.500N P=0.241N P=0.500 P=0.410N |P=0.040N* P=0.168 P=0.500N P=0.181N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 6/50 (12%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.3% 0.0% 2.4% |4.4% 4.4% 13.1% 9.4% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |1/36 (3%) 1/38 (3%) 4/35 (11%) 4/35 (11%) |
|FIRST INCIDENCE | 512 659 --- 722 |575 666 723 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.683 P=0.729N P=0.496N P=0.735N |P=0.246 P=0.676N P=0.135 P=0.324 |
|POLY 3 | P=0.676 P=0.743N P=0.501N P=0.750N |P=0.236 P=0.693N P=0.139 P=0.312 |
|POLY 1.5 | P=0.676 P=0.749N P=0.499N P=0.752N |P=0.248 P=0.693N P=0.138 P=0.320 |
|POLY 6 | P=0.674 P=0.736N P=0.506N P=0.750N |P=0.226 P=0.691N P=0.140 P=0.306 |
|LOGISTIC REGRESSION| P=0.648 P=0.705 P=0.588N P=0.727 |P=0.246 P=0.694 P=0.140 P=0.322 |
|COCH-ARM / FISHERS | P=0.673 P=0.753N P=0.500N P=0.753N |P=0.273 P=0.691N P=0.134 P=0.339 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 18/50 (36%) 16/50 (32%) 20/50 (40%) |9/50 (18%) 12/50 (24%) 8/50 (16%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 41.4% 39.5% 37.6% 44.3% |19.4% 25.1% 17.3% 27.1% |
|TERMINAL (d) | 8/24 (33%) 11/30 (37%) 8/20 (40%) 13/28 (46%) |4/36 (11%) 7/38 (18%) 6/35 (17%) 7/35 (20%) |
|FIRST INCIDENCE | 361 585 523 537 |429 403 662 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.435 P=0.350N P=0.540N P=0.569N |P=0.307 P=0.351 P=0.495N P=0.292 |
|POLY 3 | P=0.373 P=0.514N P=0.445N P=0.474 |P=0.294 P=0.337 P=0.504N P=0.267 |
|POLY 1.5 | P=0.371 P=0.538N P=0.425N P=0.462 |P=0.309 P=0.329 P=0.501N P=0.279 |
|POLY 6 | P=0.362 P=0.486N P=0.475N P=0.476 |P=0.288 P=0.343 P=0.508N P=0.264 |
|LOGISTIC REGRESSION| P=0.362 P=0.571N P=0.409N P=0.425 |P=0.407 P=0.292 P=0.528N P=0.327 |
|COCH-ARM / FISHERS | P=0.346 P=0.582N P=0.417N P=0.418 |P=0.353 P=0.312 P=0.500N P=0.312 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 0.0% |0.0% 0.0% 4.4% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 1/20 (5%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 2/35 (6%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.761N (e) P=0.464 (e) |P=0.708N (e) P=0.232 (e) |
|POLY 3 | P=0.776N (e) P=0.502 (e) |P=0.713N (e) P=0.244 (e) |
|POLY 1.5 | P=0.776N (e) P=0.503 (e) |P=0.709N (e) P=0.242 (e) |
|POLY 6 | P=0.777N (e) P=0.499 (e) |P=0.717N (e) P=0.246 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.464 (e) |(e) (e) P=0.232 (e) |
|COCH-ARM / FISHERS | P=0.779N (e) P=0.500 (e) |P=0.697N (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.7% 4.6% 2.5% 4.6% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |1/36 (3%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 512 687 708 529 |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.385N P=0.284N P=0.199N P=0.312N |P=0.482N P=0.489N P=0.506N P=0.506N |
|POLY 3 | P=0.391N P=0.311N P=0.185N P=0.316N |P=0.475N P=0.498N P=0.494N P=0.508N |
|POLY 1.5 | P=0.391N P=0.318N P=0.180N P=0.320N |P=0.475N P=0.499N P=0.496N P=0.506N |
|POLY 6 | P=0.393N P=0.304N P=0.196N P=0.316N |P=0.476N P=0.497N P=0.492N P=0.510N |
|LOGISTIC REGRESSION| P=0.431N P=0.375N P=0.189N P=0.438N |P=0.482N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.397N P=0.339N P=0.181N P=0.339N |P=0.474N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 3/50 (6%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 2.3% 9.7% 6.9% |4.4% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |1/36 (3%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 368 617 562 633 |543 --- 725 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.361 P=0.470N P=0.329 P=0.527 |P=0.283N P=0.236N P=0.503N P=0.250N |
|POLY 3 | P=0.365 P=0.476N P=0.339 P=0.524 |P=0.280N P=0.238N P=0.494N P=0.250N |
|POLY 1.5 | P=0.364 P=0.484N P=0.341 P=0.518 |P=0.277N P=0.238N P=0.496N P=0.246N |
|POLY 6 | P=0.363 P=0.467N P=0.335 P=0.530 |P=0.283N P=0.237N P=0.492N P=0.253N |
|LOGISTIC REGRESSION| P=0.276 P=0.663N P=0.287 P=0.356 |P=0.254N P=0.236N P=0.531N P=0.208N |
|COCH-ARM / FISHERS | P=0.354 P=0.500N P=0.339 P=0.500 |P=0.271N P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 9.9% 0.0% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 1/20 (5%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 648 --- 712 --- |--- --- --- 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.398N P=0.463N P=0.153 P=0.483N |P=0.195 (e) (e) P=0.481 |
|POLY 3 | P=0.402N P=0.484N P=0.179 P=0.489N |P=0.208 (e) (e) P=0.493 |
|POLY 1.5 | P=0.400N P=0.489N P=0.182 P=0.491N |P=0.210 (e) (e) P=0.495 |
|POLY 6 | P=0.410N P=0.478N P=0.172 P=0.488N |P=0.207 (e) (e) P=0.493 |
|LOGISTIC REGRESSION| P=0.400N P=0.516N P=0.177 P=0.515N |P=0.241 (e) (e) P=0.522 |
|COCH-ARM / FISHERS | P=0.408N P=0.500N P=0.181 P=0.500N |P=0.214 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |6/47 (13%) 6/50 (12%) 6/50 (12%) 3/48 (6%) |
|POLY-3 ADJUSTED (b)| |14.0% 13.3% 13.0% 7.3% |
|TERMINAL (d) | |6/36 (17%) 5/38 (13%) 5/35 (14%) 3/34 (9%) |
|FIRST INCIDENCE | |730 (T) 659 687 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.211N P=0.583N P=0.608 P=0.268N |
|POLY 3 | |P=0.207N P=0.585N P=0.571N P=0.265N |
|POLY 1.5 | |P=0.197N P=0.583N P=0.572N P=0.254N |
|POLY 6 | |P=0.216N P=0.586N P=0.572N P=0.273N |
|LOGISTIC REGRESSION| |P=0.211N P=0.596N P=0.586N P=0.268N |
|COCH-ARM / FISHERS | |P=0.174N P=0.576N P=0.576N P=0.232N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |16/47 (34%) 17/50 (34%) 21/50 (42%) 18/48 (38%) |
|POLY-3 ADJUSTED (b)| |36.5% 36.5% 45.3% 42.3% |
|TERMINAL (d) | |13/36 (36%) 12/38 (32%) 18/35 (51%) 16/34 (47%) |
|FIRST INCIDENCE | |543 540 662 347 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.295 P=0.562 P=0.193 P=0.341 |
|POLY 3 | |P=0.310 P=0.585 P=0.261 P=0.367 |
|POLY 1.5 | |P=0.344 P=0.582 P=0.269 P=0.395 |
|POLY 6 | |P=0.271 P=0.580N P=0.249 P=0.336 |
|LOGISTIC REGRESSION| |P=0.327 P=0.575 P=0.276 P=0.386 |
|COCH-ARM / FISHERS | |P=0.402 P=0.583N P=0.275 P=0.445 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/47 (6%) 5/50 (10%) 2/50 (4%) 3/48 (6%) |
|POLY-3 ADJUSTED (b)| |7.0% 10.9% 4.4% 7.3% |
|TERMINAL (d) | |3/36 (8%) 2/38 (5%) 2/35 (6%) 2/34 (6%) |
|FIRST INCIDENCE | |730 (T) 451 730 (T) 614 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.496N P=0.381 P=0.513N P=0.638 |
|POLY 3 | |P=0.488N P=0.396 P=0.470N P=0.645 |
|POLY 1.5 | |P=0.479N P=0.393 P=0.470N P=0.653 |
|POLY 6 | |P=0.494N P=0.400 P=0.471N P=0.641 |
|LOGISTIC REGRESSION| |P=0.447N P=0.403 P=0.513N P=0.646 |
|COCH-ARM / FISHERS | |P=0.457N P=0.393 P=0.470N P=0.651N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/0 (0%) 1/1 (100%) 1/1 (100%) |1/3 (33%) 2/2 (100%) 0/0 (0%) 3/4 (75%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 100.0% 100.0% |37.2% 100.0% 0.0% 75.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |1/2 (50%) 2/2 (100%) 0/0 (0%) 3/4 (75%) |
|FIRST INCIDENCE | --- --- 729 (T) 585 |730 (T) 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.237 (e) P=1.000N P=0.520 |P=0.675 P=0.500 P=1.000N P=0.610 |
|POLY 3 | (e) (e) P=1.000N P=1.000N |(e) P=0.321 (e) P=0.436 |
|POLY 1.5 | (e) (e) P=1.000N P=1.000N |(e) P=0.300 (e) P=0.409 |
|POLY 6 | (e) (e) P=1.000N P=1.000N |(e) P=0.363 (e) P=0.482 |
|LOGISTIC REGRESSION| P=0.887 (e) P=1.000N (e) |P=0.675 P=0.500 (e) P=0.610 |
|COCH-ARM / FISHERS | P=0.404 (e) P=0.500 P=0.500 |P=0.461 P=0.300 P=1.000 P=0.371 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/0 (0%) 1/1 (100%) 1/1 (100%) |1/3 (33%) 2/2 (100%) 0/0 (0%) 3/4 (75%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 100.0% 100.0% |37.2% 100.0% 0.0% 75.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |1/2 (50%) 2/2 (100%) 0/0 (0%) 3/4 (75%) |
|FIRST INCIDENCE | --- --- 729 (T) 585 |730 (T) 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.237 (e) P=1.000 P=0.520 |P=0.675 P=0.500 P=1.000N P=0.610 |
|POLY 3 | (e) (e) P=1.000 P=1.000 |(e) P=0.321 (e) P=0.436 |
|POLY 1.5 | (e) (e) P=1.000 P=1.000 |(e) P=0.300 (e) P=0.409 |
|POLY 6 | (e) (e) P=1.000 P=1.000 |(e) P=0.363 (e) P=0.482 |
|LOGISTIC REGRESSION| P=0.887 (e) P=1.000 (e) |P=0.675 P=0.500 (e) P=0.610 |
|COCH-ARM / FISHERS | P=0.404 (e) P=0.500 P=0.500 |P=0.461 P=0.300 P=1.000 P=0.371 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 46/50 (92%) 43/50 (86%) 43/50 (86%) |30/50 (60%) 23/50 (46%) 23/50 (46%) 27/50 (54%) |
|POLY-3 ADJUSTED (b)| 87.6% 94.4% 91.4% 90.4% |65.5% 50.8% 48.8% 60.1% |
|TERMINAL (d) | 23/24 (96%) 29/30 (97%) 20/20 (100%) 27/28 (96%) |26/36 (72%) 21/38 (55%) 20/35 (57%) 20/35 (57%) |
|FIRST INCIDENCE | 312 386 482 490 |575 666 536 531 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.442N P=0.506N P=0.123 P=0.506N |P=0.420 P=0.064N P=0.130N P=0.417N |
|POLY 3 | P=0.570N P=0.181 P=0.383 P=0.451 |P=0.507 P=0.106N P=0.073N P=0.372N |
|POLY 1.5 | P=0.591 P=0.104 P=0.316 P=0.368 |P=0.506 P=0.108N P=0.086N P=0.373N |
|POLY 6 | P=0.618 P=0.304 P=0.450 P=0.496 |P=0.530 P=0.102N P=0.063N P=0.349N |
|LOGISTIC REGRESSION| P=0.519N P=0.123 P=0.271 P=0.444 |P=0.419 P=0.082N P=0.077N P=0.433N |
|COCH-ARM / FISHERS | P=0.439 P=0.045 * P=0.218 P=0.218 |P=0.540 P=0.115N P=0.115N P=0.343N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |5/50 (10%) 4/50 (8%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 0.0% |11.2% 8.7% 0.0% 2.3% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |5/36 (14%) 2/38 (5%) 0/35 (0%) 1/35 (3%) |
|FIRST INCIDENCE | 682 --- --- --- |730 (T) 540 --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500N P=0.471N P=0.500N P=0.488N |P=0.070N P=0.471N P=0.035N* P=0.108N |
|POLY 3 | P=0.511N P=0.483N P=0.499N P=0.488N |P=0.065N P=0.481N P=0.028N* P=0.111N |
|POLY 1.5 | P=0.508N P=0.489N P=0.498N P=0.491N |P=0.064N P=0.490N P=0.029N* P=0.108N |
|POLY 6 | P=0.514N P=0.477N P=0.503N P=0.488N |P=0.067N P=0.469N P=0.027N* P=0.112N |
|LOGISTIC REGRESSION| P=0.498N P=0.495N P=0.498N P=0.494N |P=0.063N P=0.499N (e) P=0.108N |
|COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.500N P=0.500N |P=0.062N P=0.500N P=0.028N* P=0.102N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 5/50 (10%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 11.4% 12.4% 4.7% |0.0% 2.2% 2.2% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/30 (3%) 1/20 (5%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 674 663 708 701 |--- 659 662 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.421N P=0.153 P=0.090 P=0.538 |P=0.560N P=0.510 P=0.523 (e) |
|POLY 3 | P=0.410N P=0.124 P=0.102 P=0.521 |P=0.547N P=0.503 P=0.507 (e) |
|POLY 1.5 | P=0.416N P=0.116 P=0.104 P=0.516 |P=0.544N P=0.502 P=0.505 (e) |
|POLY 6 | P=0.411N P=0.135 P=0.097 P=0.524 |P=0.549N P=0.506 P=0.510 (e) |
|LOGISTIC REGRESSION| P=0.427N P=0.117 P=0.098 P=0.521 |P=0.512N P=0.499 P=0.479 (e) |
|COCH-ARM / FISHERS | P=0.442N P=0.102 P=0.102 P=0.500 |P=0.536N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 9.2% 2.5% 4.7% |2.2% 2.2% 4.4% 2.3% |
|TERMINAL (d) | 1/24 (4%) 4/30 (13%) 0/20 (0%) 2/28 (7%) |1/36 (3%) 1/38 (3%) 2/35 (6%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 676 729 (T) |730 (T) 730 (T) 730 (T) 614 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.554N P=0.250 P=0.744 P=0.554 |P=0.646 P=0.750N P=0.490 P=0.755 |
|POLY 3 | P=0.566N P=0.206 P=0.758N P=0.522 |P=0.644 P=0.759N P=0.511 P=0.753 |
|POLY 1.5 | P=0.573N P=0.197 P=0.757N P=0.517 |P=0.648 P=0.760N P=0.507 P=0.755 |
|POLY 6 | P=0.563N P=0.217 P=0.761N P=0.525 |P=0.643 P=0.757N P=0.514 P=0.753 |
|LOGISTIC REGRESSION| P=0.579N P=0.250 P=0.763 P=0.554 |P=0.652 P=0.750N P=0.490 P=0.757N |
|COCH-ARM / FISHERS | P=0.591N P=0.181 P=0.753N P=0.500 |P=0.640N P=0.753N P=0.500 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 1/20 (5%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 715 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.659N (e) P=0.204 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.670N (e) P=0.239 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.670N (e) P=0.240 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.673N (e) P=0.235 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.668N (e) P=0.227 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.675N (e) P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 8/50 (16%) 7/50 (14%) |8/50 (16%) 4/50 (8%) 3/50 (6%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 7.5% 13.7% 19.4% 16.3% |17.4% 8.8% 6.5% 9.4% |
|TERMINAL (d) | 2/24 (8%) 5/30 (17%) 5/20 (25%) 6/28 (21%) |5/36 (14%) 2/38 (5%) 2/35 (6%) 4/35 (11%) |
|FIRST INCIDENCE | 597 663 523 569 |429 540 687 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.293 P=0.348 P=0.072 P=0.213 |P=0.288N P=0.173N P=0.108N P=0.202N |
|POLY 3 | P=0.268 P=0.284 P=0.103 P=0.182 |P=0.287N P=0.181N P=0.099N P=0.216N |
|POLY 1.5 | P=0.265 P=0.270 P=0.104 P=0.177 |P=0.275N P=0.181N P=0.099N P=0.203N |
|POLY 6 | P=0.264 P=0.299 P=0.099 P=0.184 |P=0.298N P=0.180N P=0.099N P=0.228N |
|LOGISTIC REGRESSION| P=0.260 P=0.294 P=0.103 P=0.183 |P=0.241N P=0.178N P=0.117N P=0.174N |
|COCH-ARM / FISHERS | P=0.243 P=0.243 P=0.100 P=0.159 |P=0.253N P=0.178N P=0.100N P=0.178N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.3% 7.4% 2.4% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 633 663 708 690 |--- --- 676 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.593N P=0.728N P=0.282 P=0.736N |P=0.799N (e) P=0.519 (e) |
|POLY 3 | P=0.595N P=0.741N P=0.306 P=0.748N |P=0.793N (e) P=0.507 (e) |
|POLY 1.5 | P=0.595N P=0.748N P=0.309 P=0.751N |P=0.791N (e) P=0.505 (e) |
|POLY 6 | P=0.600N P=0.734N P=0.299 P=0.747N |P=0.794N (e) P=0.510 (e) |
|LOGISTIC REGRESSION| P=0.597N P=0.749 P=0.307 P=0.759 |P=0.779N (e) P=0.488 (e) |
|COCH-ARM / FISHERS | P=0.605N P=0.753N P=0.309 P=0.753N |P=0.786N (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.5% 0.0% 0.0% |2.2% 2.2% 2.2% 4.7% |
|TERMINAL (d) | 0/24 (0%) 1/30 (3%) 0/20 (0%) 0/28 (0%) |1/36 (3%) 1/38 (3%) 0/35 (0%) 2/35 (6%) |
|FIRST INCIDENCE | --- 386 --- --- |730 (T) 730 (T) 662 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.381N P=0.274 (e) (e) |P=0.338 P=0.750N P=0.751N P=0.490 |
|POLY 3 | P=0.365N P=0.262 (e) (e) |P=0.344 P=0.759N P=0.752N P=0.485 |
|POLY 1.5 | P=0.374N P=0.253 (e) (e) |P=0.349 P=0.760N P=0.755N P=0.489 |
|POLY 6 | P=0.357N P=0.271 (e) (e) |P=0.340 P=0.757N P=0.749N P=0.483 |
|LOGISTIC REGRESSION| P=0.485N P=0.143 (e) (e) |P=0.340 P=0.750N P=0.761 P=0.490 |
|COCH-ARM / FISHERS | P=0.392N P=0.247 (e) (e) |P=0.360 P=0.753N P=0.753N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 676 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.656N (e) P=0.230 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.670N (e) P=0.240 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.670N (e) P=0.241 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.673N (e) P=0.237 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.670N (e) P=0.238 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.675N (e) P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 48/50 (96%) 41/50 (82%) 44/50 (88%) |39/50 (78%) 43/50 (86%) 42/50 (84%) 42/50 (84%) |
|POLY-3 ADJUSTED (b)| 93.0% 97.6% 89.9% 92.8% |80.4% 91.3% 86.5% 91.7% |
|TERMINAL (d) | 24/24 (100%) 30/30 (100%) 20/20 (100%) 28/28 (100%)|29/36 (81%) 36/38 (95%) 32/35 (91%) 34/35 (97%) |
|FIRST INCIDENCE | 312 386 508 537 |414 540 526 309 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347N P=0.410N P=0.349 P=0.360N |P=0.238 P=0.416 P=0.321 P=0.252 |
|POLY 3 | P=0.417N P=0.237 P=0.433N P=0.677N |P=0.150 P=0.097 P=0.290 P=0.084 |
|POLY 1.5 | P=0.436N P=0.130 P=0.429N P=0.599 |P=0.231 P=0.130 P=0.299 P=0.145 |
|POLY 6 | P=0.489N P=0.367 P=0.511N P=0.737N |P=0.095 P=0.078 P=0.272 P=0.050 |
|LOGISTIC REGRESSION| P=0.286N P=0.136 P=0.383N P=0.524N |P=0.228 P=0.214 P=0.343 P=0.193 |
|COCH-ARM / FISHERS | P=0.544N P=0.046 * P=0.500N P=0.387 |P=0.408 P=0.218 P=0.306 P=0.306 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 4/50 (8%) 15/50 (30%) 19/50 (38%) |5/50 (10%) 2/50 (4%) 9/50 (18%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 29.8% 9.0% 34.1% 41.2% |11.1% 4.4% 19.2% 20.4% |
|TERMINAL (d) | 4/24 (17%) 0/30 (0%) 2/20 (10%) 7/28 (25%) |2/36 (6%) 1/38 (3%) 5/35 (14%) 4/35 (11%) |
|FIRST INCIDENCE | 361 585 537 569 |645 659 575 631 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.025 * P=0.012N* P=0.375 P=0.263 |P=0.047 * P=0.209N P=0.220 P=0.182 |
|POLY 3 | P=0.010 * P=0.012N* P=0.421 P=0.179 |P=0.046 * P=0.216N P=0.215 P=0.178 |
|POLY 1.5 | P=0.009 ** P=0.013N* P=0.419 P=0.166 |P=0.048 * P=0.216N P=0.207 P=0.181 |
|POLY 6 | P=0.012 * P=0.011N* P=0.431 P=0.201 |P=0.047 * P=0.216N P=0.223 P=0.180 |
|LOGISTIC REGRESSION| P=0.006 ** P=0.027N* P=0.384 P=0.103 |P=0.056 P=0.217N P=0.186 P=0.191 |
|COCH-ARM / FISHERS | P=0.009 ** P=0.016N* P=0.412 P=0.142 |P=0.055 P=0.218N P=0.194 P=0.194 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 0.0% |4.5% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |2/36 (6%) 1/38 (3%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 602 --- |730 (T) 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.780N (e) P=0.490 (e) |P=0.177N P=0.481N P=0.244N P=0.244N |
|POLY 3 | P=0.776N (e) P=0.504 (e) |P=0.173N P=0.497N P=0.230N P=0.247N |
|POLY 1.5 | P=0.776N (e) P=0.504 (e) |P=0.172N P=0.498N P=0.233N P=0.244N |
|POLY 6 | P=0.777N (e) P=0.503 (e) |P=0.174N P=0.494N P=0.228N P=0.248N |
|LOGISTIC REGRESSION| P=0.820N (e) P=0.478 (e) |P=0.177N P=0.481N (e) (e) |
|COCH-ARM / FISHERS | P=0.779N (e) P=0.500 (e) |P=0.169N P=0.500N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 0.0% |0.0% 2.2% 2.2% 4.7% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 1/20 (5%) 0/28 (0%) |0/36 (0%) 1/38 (3%) 1/35 (3%) 2/35 (6%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.761N (e) P=0.464 (e) |P=0.181 P=0.511 P=0.494 P=0.232 |
|POLY 3 | P=0.776N (e) P=0.502 (e) |P=0.183 P=0.502 P=0.506 P=0.228 |
|POLY 1.5 | P=0.776N (e) P=0.503 (e) |P=0.186 P=0.501 P=0.504 P=0.230 |
|POLY 6 | P=0.777N (e) P=0.499 (e) |P=0.180 P=0.503 P=0.508 P=0.226 |
|LOGISTIC REGRESSION| (e) (e) P=0.464 (e) |(e) P=0.511 P=0.494 P=0.232 |
|COCH-ARM / FISHERS | P=0.779N (e) P=0.500 (e) |P=0.194 P=0.500 P=0.500 P=0.247 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 29/50 (58%) 26/50 (52%) 27/50 (54%) |47/50 (94%) 48/50 (96%) 43/50 (86%) 36/50 (72%) |
|POLY-3 ADJUSTED (b)| 70.7% 64.9% 59.4% 59.9% |96.7% 98.0% 89.1% 79.3% |
|TERMINAL (d) | 22/24 (92%) 24/30 (80%) 16/20 (80%) 21/28 (75%) |36/36 (100%) 38/38 (100%) 34/35 (97%) 30/35 (86%) |
|FIRST INCIDENCE | 312 410 482 490 |414 403 468 414 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.188N P=0.087N P=0.536N P=0.107N |P=0.014N* P=0.479N P=0.298N P=0.032N* |
|POLY 3 | P=0.221N P=0.353N P=0.175N P=0.186N |P<0.001N** P=0.614 P=0.111N P=0.004N** |
|POLY 1.5 | P=0.256N P=0.400N P=0.203N P=0.232N |P<0.001N** P=0.550 P=0.125N P=0.004N** |
|POLY 6 | P=0.197N P=0.317N P=0.156N P=0.155N |P<0.001N** P=0.728 P=0.117N P=0.006N** |
|LOGISTIC REGRESSION| P=0.264N P=0.257N P=0.238N P=0.210N |P<0.001N** P=0.490 P=0.088N P=0.006N** |
|COCH-ARM / FISHERS | P=0.337N P=0.500N P=0.273N P=0.343N |P<0.001N** P=0.500 P=0.159N P=0.003N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 11/50 (22%) 2/50 (4%) 4/50 (8%) |2/50 (4%) 5/50 (10%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 15.1% 25.3% 5.0% 9.4% |4.5% 11.1% 2.2% 4.7% |
|TERMINAL (d) | 6/24 (25%) 11/30 (37%) 2/20 (10%) 4/28 (14%) |2/36 (6%) 5/38 (13%) 1/35 (3%) 2/35 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.269 P=0.189N P=0.268N |P=0.388N P=0.237 P=0.510N P=0.685 |
|POLY 3 | P=0.103N P=0.187 P=0.127N P=0.329N |P=0.382N P=0.220 P=0.489N P=0.679 |
|POLY 1.5 | P=0.109N P=0.171 P=0.127N P=0.339N |P=0.377N P=0.218 P=0.493N P=0.683 |
|POLY 6 | P=0.099N P=0.205 P=0.130N P=0.322N |P=0.385N P=0.222 P=0.486N P=0.676 |
|LOGISTIC REGRESSION| P=0.091N P=0.269 P=0.189N P=0.268N |P=0.388N P=0.237 P=0.510N P=0.685 |
|COCH-ARM / FISHERS | P=0.128N P=0.143 P=0.134N P=0.370N |P=0.364N P=0.218 P=0.500N P=0.691N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 4/50 (8%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.9% 9.0% 9.9% 13.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/24 (8%) 1/30 (3%) 2/20 (10%) 2/28 (7%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 648 410 646 529 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.314 P=0.540N P=0.608 P=0.444 |(e) (e) (e) (e) |
|POLY 3 | P=0.294 P=0.586N P=0.640N P=0.419 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.291 P=0.605N P=0.636N P=0.405 |(e) (e) (e) (e) |
|POLY 6 | P=0.294 P=0.566N P=0.642 P=0.430 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.272 P=0.626 P=0.642N P=0.385 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.274 P=0.643N P=0.643N P=0.370 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 8/50 (16%) 6/50 (12%) 8/50 (16%) |9/50 (18%) 10/50 (20%) 14/50 (28%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 15.1% 18.3% 14.9% 18.8% |20.2% 22.1% 30.4% 16.3% |
|TERMINAL (d) | 6/24 (25%) 7/30 (23%) 5/20 (25%) 7/28 (25%) |8/36 (22%) 9/38 (24%) 13/35 (37%) 6/35 (17%) |
|FIRST INCIDENCE | 729 (T) 663 691 659 |723 633 701 633 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.475 P=0.565 P=0.507 P=0.507 |P=0.319N P=0.550 P=0.151 P=0.419N |
|POLY 3 | P=0.439 P=0.461 P=0.614N P=0.440 |P=0.315N P=0.516 P=0.190 P=0.421N |
|POLY 1.5 | P=0.433 P=0.434 P=0.610N P=0.425 |P=0.303N P=0.508 P=0.183 P=0.414N |
|POLY 6 | P=0.438 P=0.492 P=0.623N P=0.451 |P=0.322N P=0.529 P=0.196 P=0.422N |
|LOGISTIC REGRESSION| P=0.430 P=0.524 P=0.574 P=0.459 |P=0.328N P=0.522 P=0.184 P=0.435N |
|COCH-ARM / FISHERS | P=0.407 P=0.387 P=0.620N P=0.387 |P=0.273N P=0.500 P=0.171 P=0.393N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 10/50 (20%) 4/50 (8%) |9/50 (18%) 11/50 (22%) 12/50 (24%) 14/50 (28%) |
|POLY-3 ADJUSTED (b)| 17.2% 11.5% 24.5% 9.3% |19.9% 23.5% 25.8% 29.8% |
|TERMINAL (d) | 4/24 (17%) 4/30 (13%) 5/20 (25%) 2/28 (7%) |7/36 (19%) 6/38 (16%) 9/35 (26%) 6/35 (17%) |
|FIRST INCIDENCE | 633 709 602 529 |575 451 575 309 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.226N P=0.257N P=0.221 P=0.207N |P=0.141 P=0.449 P=0.306 P=0.169 |
|POLY 3 | P=0.225N P=0.329N P=0.295 P=0.225N |P=0.178 P=0.431 P=0.335 P=0.193 |
|POLY 1.5 | P=0.229N P=0.345N P=0.304 P=0.234N |P=0.173 P=0.418 P=0.327 P=0.184 |
|POLY 6 | P=0.228N P=0.317N P=0.276 P=0.223N |P=0.184 P=0.449 P=0.340 P=0.204 |
|LOGISTIC REGRESSION| P=0.232N P=0.304N P=0.292 P=0.238N |P=0.209 P=0.399 P=0.328 P=0.221 |
|COCH-ARM / FISHERS | P=0.250N P=0.380N P=0.298 P=0.262N |P=0.162 P=0.402 P=0.312 P=0.171 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 27/50 (54%) 19/50 (38%) 21/50 (42%) |43/50 (86%) 44/50 (88%) 39/50 (78%) 30/50 (60%) |
|POLY-3 ADJUSTED (b)| 43.3% 58.7% 44.2% 47.5% |92.3% 89.2% 81.1% 68.8% |
|TERMINAL (d) | 14/24 (58%) 20/30 (67%) 13/20 (65%) 17/28 (61%) |35/36 (97%) 35/38 (92%) 33/35 (94%) 27/35 (77%) |
|FIRST INCIDENCE | 312 386 482 490 |575 403 468 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364N P=0.230 P=0.297 P=0.551 |P=0.002N** P=0.492N P=0.280N P=0.007N** |
|POLY 3 | P=0.440N P=0.103 P=0.558 P=0.432 |P<0.001N** P=0.423N P=0.075N P=0.002N** |
|POLY 1.5 | P=0.452N P=0.081 P=0.543 P=0.405 |P<0.001N** P=0.546N P=0.114N P=0.002N** |
|POLY 6 | P=0.444N P=0.134 P=0.566 P=0.451 |P<0.001N** P=0.316N P=0.057N P=0.002N** |
|LOGISTIC REGRESSION| P=0.451N P=0.090 P=0.518 P=0.428 |P<0.001N** P=0.508 P=0.105N P=0.002N** |
|COCH-ARM / FISHERS | P=0.500N P=0.054 P=0.500 P=0.341 |P<0.001N** P=0.500 P=0.218N P=0.003N** |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 17/50 (34%) 8/50 (16%) 11/50 (22%) |8/50 (16%) 19/50 (38%) 7/50 (14%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 17.6% 38.9% 19.9% 26.0% |17.8% 42.3% 15.2% 21.1% |
|TERMINAL (d) | 7/24 (29%) 16/30 (53%) 7/20 (35%) 11/28 (39%) |7/36 (19%) 19/38 (50%) 6/35 (17%) 9/35 (26%) |
|FIRST INCIDENCE | 729 (T) 663 708 729 (T) |613 730 (T) 708 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.477N P=0.046 * P=0.349 P=0.320 |P=0.245N P=0.014 * P=0.516N P=0.473 |
|POLY 3 | P=0.518N P=0.025 * P=0.510 P=0.256 |P=0.242N P=0.009 ** P=0.480N P=0.453 |
|POLY 1.5 | P=0.529N P=0.021 * P=0.513 P=0.248 |P=0.230N P=0.009 ** P=0.486N P=0.468 |
|POLY 6 | P=0.518N P=0.030 * P=0.498 P=0.259 |P=0.253N P=0.008 ** P=0.475N P=0.440 |
|LOGISTIC REGRESSION| P=0.527N P=0.039 * P=0.392 P=0.320 |P=0.254N P=0.012 * P=0.466N P=0.453 |
|COCH-ARM / FISHERS | P=0.553 P=0.017 * P=0.500 P=0.218 |P=0.208N P=0.012 * P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 4/50 (8%) |3/50 (6%) 0/50 (0%) 1/50 (2%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 9.8% 2.3% 7.4% 9.4% |6.7% 0.0% 2.2% 9.1% |
|TERMINAL (d) | 1/24 (4%) 1/30 (3%) 0/20 (0%) 1/28 (4%) |1/36 (3%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 368 729 (T) 676 701 |645 --- 703 511 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.397 P=0.140N P=0.533N P=0.582N |P=0.131 P=0.121N P=0.296N P=0.470 |
|POLY 3 | P=0.365 P=0.160N P=0.507N P=0.624N |P=0.140 P=0.119N P=0.297N P=0.489 |
|POLY 1.5 | P=0.369 P=0.167N P=0.500N P=0.627N |P=0.141 P=0.119N P=0.300N P=0.490 |
|POLY 6 | P=0.357 P=0.154N P=0.518N P=0.624N |P=0.141 P=0.119N P=0.295N P=0.490 |
|LOGISTIC REGRESSION| P=0.372 P=0.208N P=0.506N P=0.640 |P=0.178 P=0.121N P=0.310N P=0.538 |
|COCH-ARM / FISHERS | P=0.366 P=0.181N P=0.500N P=0.643N |P=0.147 P=0.121N P=0.309N P=0.500 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 0.0% 0.0% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 512 --- --- --- |--- --- 625 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.255N P=0.209N P=0.257N P=0.214N |P=0.796N (e) P=0.509 (e) |
|POLY 3 | P=0.271N P=0.221N P=0.238N P=0.226N |P=0.793N (e) P=0.508 (e) |
|POLY 1.5 | P=0.268N P=0.226N P=0.236N P=0.229N |P=0.791N (e) P=0.505 (e) |
|POLY 6 | P=0.274N P=0.215N P=0.243N P=0.226N |P=0.794N (e) P=0.511 (e) |
|LOGISTIC REGRESSION| P=0.282N P=0.269N P=0.249N P=0.270N |P=0.750N (e) P=0.454 (e) |
|COCH-ARM / FISHERS | P=0.262N P=0.247N P=0.247N P=0.247N |P=0.786N (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.3% 4.9% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- 410 602 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491N P=0.513 P=0.216 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.485N P=0.521 P=0.241 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.487N P=0.514 P=0.241 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.485N P=0.529 P=0.239 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.597N P=0.260 P=0.237 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 4/50 (8%) 2/50 (4%) 5/50 (10%) |7/50 (14%) 11/50 (22%) 9/50 (18%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 22.2% 9.2% 5.0% 11.8% |15.5% 24.1% 19.3% 20.3% |
|TERMINAL (d) | 7/24 (29%) 2/30 (7%) 1/20 (5%) 5/28 (18%) |5/36 (14%) 8/38 (21%) 4/35 (11%) 5/35 (14%) |
|FIRST INCIDENCE | 617 687 725 729 (T) |613 652 575 511 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.308N P=0.060N P=0.048N* P=0.121N |P=0.467 P=0.262 P=0.400 P=0.370 |
|POLY 3 | P=0.346N P=0.085N P=0.024N* P=0.164N |P=0.502 P=0.222 P=0.421 P=0.378 |
|POLY 1.5 | P=0.343N P=0.095N P=0.023N* P=0.170N |P=0.506 P=0.219 P=0.411 P=0.380 |
|POLY 6 | P=0.356N P=0.076N P=0.026N* P=0.164N |P=0.505 P=0.228 P=0.430 P=0.382 |
|LOGISTIC REGRESSION| P=0.330N P=0.077N P=0.027N* P=0.149N |P=0.512 P=0.221 P=0.401 P=0.394 |
|COCH-ARM / FISHERS | P=0.347N P=0.117N P=0.026N* P=0.194N |P=0.525 P=0.218 P=0.393 P=0.393 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 47/50 (94%) 44/50 (88%) 48/50 (96%) |5/50 (10%) 12/50 (24%) 21/50 (42%) 32/50 (64%) |
|POLY-3 ADJUSTED (b)| 97.0% 94.8% 94.3% 96.5% |10.9% 26.1% 44.8% 71.3% |
|TERMINAL (d) | 24/24 (100%) 28/30 (93%) 19/20 (95%) 27/28 (96%) |2/36 (6%) 8/38 (21%) 16/35 (46%) 25/35 (71%) |
|FIRST INCIDENCE | 313 386 508 490 |501 616 625 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.498N P=0.165N P=0.425 P=0.368N |P<0.001 ** P=0.076 P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.561 P=0.491N P=0.442N P=0.684N |P<0.001 ** P=0.052 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.462 P=0.589N P=0.362N P=0.647 |P<0.001 ** P=0.052 P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.617 P=0.461N P=0.609N P=0.653N |P<0.001 ** P=0.054 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.486 P=0.624N P=0.170N P=0.618 |P<0.001 ** P=0.054 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.291 P=0.500 P=0.370N P=0.339 |P<0.001 ** P=0.054 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 15/50 (30%) 20/50 (40%) 23/50 (46%) |1/50 (2%) 5/50 (10%) 10/50 (20%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 41.1% 32.2% 44.1% 48.1% |2.2% 11.0% 21.1% 15.3% |
|TERMINAL (d) | 4/24 (17%) 3/30 (10%) 1/20 (5%) 6/28 (21%) |0/36 (0%) 2/38 (5%) 3/35 (9%) 1/35 (3%) |
|FIRST INCIDENCE | 512 585 444 529 |701 659 575 309 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.171 P=0.215N P=0.380 P=0.363 |P=0.089 P=0.119 P=0.009 ** P=0.034 * |
|POLY 3 | P=0.138 P=0.254N P=0.468 P=0.321 |P=0.104 P=0.106 P=0.006 ** P=0.032 * |
|POLY 1.5 | P=0.123 P=0.277N P=0.461 P=0.286 |P=0.099 P=0.104 P=0.005 ** P=0.031 * |
|POLY 6 | P=0.150 P=0.238N P=0.464 P=0.350 |P=0.112 P=0.110 P=0.007 ** P=0.035 * |
|LOGISTIC REGRESSION| P=0.074 P=0.360N P=0.411 P=0.173 |P=0.145 P=0.103 P=0.004 ** P=0.051 |
|COCH-ARM / FISHERS | P=0.093 P=0.335N P=0.418 P=0.208 |P=0.099 P=0.102 P=0.004 ** P=0.030 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 16/50 (32%) |0/50 (0%) 2/50 (4%) 24/50 (48%) 38/50 (76%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.3% 7.5% 37.3% |0.0% 4.4% 52.2% 83.6% |
|TERMINAL (d) | 0/24 (0%) 1/30 (3%) 3/20 (15%) 15/28 (54%) |0/36 (0%) 1/38 (3%) 22/35 (63%) 33/35 (94%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 569 |--- 666 708 347 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.545 P=0.089 P<0.001 ** |P<0.001 ** P=0.254 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.518 P=0.119 P<0.001 ** |P<0.001 ** P=0.240 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.512 P=0.121 P<0.001 ** |P<0.001 ** P=0.239 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.524 P=0.116 P<0.001 ** |P<0.001 ** P=0.243 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.545 P=0.089 P<0.001 ** |P<0.001 ** P=0.238 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.121 P<0.001 ** |P<0.001 ** P=0.247 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) 4/50 (8%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.0% 0.0% 7.3% 9.2% |0.0% 2.2% 2.2% 2.3% |
|TERMINAL (d) | 1/24 (4%) 0/30 (0%) 0/20 (0%) 1/28 (4%) |0/36 (0%) 0/38 (0%) 1/35 (3%) 0/35 (0%) |
|FIRST INCIDENCE | 640 --- 549 569 |--- 690 730 (T) 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.121 P=0.205N P=0.482 P=0.378 |P=0.467 P=0.500 P=0.494 P=0.486 |
|POLY 3 | P=0.116 P=0.219N P=0.512 P=0.373 |P=0.471 P=0.503 P=0.506 P=0.493 |
|POLY 1.5 | P=0.115 P=0.225N P=0.511 P=0.363 |P=0.475 P=0.501 P=0.504 P=0.495 |
|POLY 6 | P=0.116 P=0.214N P=0.511 P=0.382 |P=0.469 P=0.505 P=0.508 P=0.493 |
|LOGISTIC REGRESSION| P=0.097 P=0.228N P=0.493 P=0.330 |P=0.491 P=0.500 P=0.494 P=0.523 |
|COCH-ARM / FISHERS | P=0.111 P=0.247N P=0.500 P=0.339 |P=0.485 P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 16/50 (32%) 14/50 (28%) 18/50 (36%) |23/50 (46%) 21/50 (42%) 23/50 (46%) 31/50 (62%) |
|POLY-3 ADJUSTED (b)| 26.3% 36.0% 33.0% 40.8% |49.5% 45.7% 48.4% 68.4% |
|TERMINAL (d) | 6/24 (25%) 12/30 (40%) 8/20 (40%) 13/28 (46%) |17/36 (47%) 19/38 (50%) 18/35 (51%) 23/35 (66%) |
|FIRST INCIDENCE | 368 603 523 537 |575 403 468 511 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199 P=0.372 P=0.236 P=0.183 |P=0.018 * P=0.348N P=0.555 P=0.079 |
|POLY 3 | P=0.150 P=0.229 P=0.332 P=0.113 |P=0.015 * P=0.439N P=0.538N P=0.047 * |
|POLY 1.5 | P=0.149 P=0.213 P=0.334 P=0.109 |P=0.017 * P=0.426N P=0.547N P=0.054 |
|POLY 6 | P=0.143 P=0.249 P=0.324 P=0.111 |P=0.015 * P=0.466N P=0.547N P=0.045 * |
|LOGISTIC REGRESSION| P=0.151 P=0.234 P=0.330 P=0.114 |P=0.015 * P=0.409N P=0.555N P=0.052 |
|COCH-ARM / FISHERS | P=0.133 P=0.184 P=0.322 P=0.093 |P=0.027 * P=0.420N P=0.579N P=0.080 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.3% 0.0% 0.0% |0.0% 0.0% 0.0% 4.7% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 1/35 (3%) |
|FIRST INCIDENCE | 723 617 --- --- |--- --- --- 707 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.324N P=0.730N P=0.533N P=0.478N |P=0.039 * (e) (e) P=0.234 |
|POLY 3 | P=0.321N P=0.739N P=0.498N P=0.488N |P=0.038 * (e) (e) P=0.228 |
|POLY 1.5 | P=0.322N P=0.747N P=0.497N P=0.491N |P=0.039 * (e) (e) P=0.231 |
|POLY 6 | P=0.321N P=0.730N P=0.502N P=0.486N |P=0.038 * (e) (e) P=0.227 |
|LOGISTIC REGRESSION| P=0.326N P=0.763 P=0.509N P=0.482N |P=0.036 * (e) (e) P=0.227 |
|COCH-ARM / FISHERS | P=0.325N P=0.753N P=0.500N P=0.500N |P=0.042 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |40/50 (80%) 40/50 (80%) 42/50 (84%) 35/50 (70%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 0.0% |85.1% 84.6% 88.0% 81.5% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |31/36 (86%) 34/38 (90%) 33/35 (94%) 34/35 (97%) |
|FIRST INCIDENCE | 633 --- --- --- |575 429 526 633 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.502N P=0.480N P=0.505N P=0.495N |P=0.242N P=0.423N P=0.383 P=0.244N |
|POLY 3 | P=0.510N P=0.484N P=0.500N P=0.489N |P=0.357N P=0.594N P=0.455 P=0.422N |
|POLY 1.5 | P=0.507N P=0.489N P=0.498N P=0.491N |P=0.222N P=0.590N P=0.446 P=0.297N |
|POLY 6 | P=0.513N P=0.479N P=0.504N P=0.489N |P=0.575N P=0.623N P=0.418 P=0.624N |
|LOGISTIC REGRESSION| P=0.518N P=0.526N P=0.508N P=0.527N |P=0.200N P=0.586N P=0.536 P=0.269N |
|COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.500N P=0.500N |P=0.098N P=0.598N P=0.398 P=0.178N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.3% 5.0% 0.0% |0.0% 2.2% 2.2% 2.3% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 633 723 712 --- |--- 690 662 701 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.319N P=0.729N P=0.470 P=0.495N |P=0.467 P=0.500 P=0.523 P=0.495 |
|POLY 3 | P=0.319N P=0.743N P=0.501 P=0.489N |P=0.469 P=0.503 P=0.507 P=0.492 |
|POLY 1.5 | P=0.319N P=0.748N P=0.504 P=0.491N |P=0.474 P=0.501 P=0.505 P=0.494 |
|POLY 6 | P=0.322N P=0.737N P=0.494 P=0.489N |P=0.466 P=0.505 P=0.510 P=0.491 |
|LOGISTIC REGRESSION| P=0.319N P=0.761N P=0.503 P=0.527N |P=0.492 P=0.500 P=0.479 P=0.495 |
|COCH-ARM / FISHERS | P=0.325N P=0.753N P=0.500 P=0.500N |P=0.485 P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 7/50 (14%) 2/50 (4%) 5/50 (10%) |8/50 (16%) 7/50 (14%) 9/50 (18%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 22.3% 16.1% 5.0% 11.8% |17.9% 15.6% 19.6% 20.9% |
|TERMINAL (d) | 7/24 (29%) 7/30 (23%) 2/20 (10%) 3/28 (11%) |7/36 (19%) 7/38 (18%) 8/35 (23%) 8/35 (23%) |
|FIRST INCIDENCE | 613 729 (T) 729 (T) 699 |645 730 (T) 708 614 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.176N P=0.222N P=0.044N* P=0.128N |P=0.342 P=0.456N P=0.483 P=0.470 |
|POLY 3 | P=0.199N P=0.328N P=0.023N* P=0.160N |P=0.353 P=0.498N P=0.524 P=0.464 |
|POLY 1.5 | P=0.201N P=0.349N P=0.023N* P=0.168N |P=0.365 P=0.499N P=0.516 P=0.474 |
|POLY 6 | P=0.199N P=0.309N P=0.025N* P=0.157N |P=0.345 P=0.496N P=0.529 P=0.458 |
|LOGISTIC REGRESSION| P=0.195N P=0.268N P=0.027N* P=0.148N |P=0.332 P=0.482N P=0.540 P=0.456 |
|COCH-ARM / FISHERS | P=0.213N P=0.393N P=0.026N* P=0.194N |P=0.396 P=0.500N P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 3/49 (6%) 2/50 (4%) |1/49 (2%) 8/50 (16%) 5/48 (10%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 7.5% 11.5% 7.6% 4.7% |2.3% 17.7% 11.2% 11.7% |
|TERMINAL (d) | 3/24 (13%) 5/30 (17%) 2/20 (10%) 1/28 (4%) |1/35 (3%) 7/38 (18%) 5/35 (14%) 5/35 (14%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 691 701 |730 (T) 680 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.247N P=0.483 P=0.600 P=0.435N |P=0.393 P=0.024 * P=0.102 P=0.102 |
|POLY 3 | P=0.256N P=0.406 P=0.661 P=0.470N |P=0.394 P=0.018 * P=0.107 P=0.096 |
|POLY 1.5 | P=0.261N P=0.389 P=0.661 P=0.478N |P=0.404 P=0.018 * P=0.103 P=0.099 |
|POLY 6 | P=0.254N P=0.424 P=0.658 P=0.465N |P=0.387 P=0.019 * P=0.111 P=0.094 |
|LOGISTIC REGRESSION| P=0.262N P=0.483 P=0.645 P=0.457N |P=0.384 P=0.021 * P=0.102 P=0.102 |
|COCH-ARM / FISHERS | P=0.278N P=0.357 P=0.651 P=0.500N |P=0.430 P=0.017 * P=0.097 P=0.107 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |0/49 (0%) 4/50 (8%) 1/48 (2%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 10.1% 2.3% 0.0% 0.0% |0.0% 8.8% 2.2% 11.5% |
|TERMINAL (d) | 3/24 (13%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/35 (0%) 2/38 (5%) 0/35 (0%) 2/35 (6%) |
|FIRST INCIDENCE | 723 603 --- --- |--- 652 723 614 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066N P=0.133N P=0.088N P=0.047N* |P=0.057 P=0.074 P=0.500 P=0.034 * |
|POLY 3 | P=0.067N P=0.150N P=0.060N P=0.052N |P=0.062 P=0.066 P=0.505 P=0.030 * |
|POLY 1.5 | P=0.066N P=0.160N P=0.060N P=0.054N |P=0.063 P=0.064 P=0.502 P=0.030 * |
|POLY 6 | P=0.070N P=0.138N P=0.061N P=0.050N |P=0.062 P=0.068 P=0.509 P=0.030 * |
|LOGISTIC REGRESSION| P=0.064N P=0.152N P=0.074N P=0.048N* |P=0.067 P=0.066 P=0.510 P=0.034 * |
|COCH-ARM / FISHERS | P=0.066N P=0.181N P=0.061N P=0.059N |P=0.068 P=0.061 P=0.495 P=0.030 * |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 4/50 (8%) 3/50 (6%) |26/50 (52%) 19/50 (38%) 26/50 (52%) 24/50 (48%) |
|POLY-3 ADJUSTED (b)| 9.9% 2.3% 9.6% 6.9% |54.7% 41.8% 56.0% 55.5% |
|TERMINAL (d) | 2/24 (8%) 0/30 (0%) 1/20 (5%) 0/28 (0%) |18/36 (50%) 17/38 (45%) 22/35 (63%) 22/35 (63%) |
|FIRST INCIDENCE | 613 585 537 529 |414 652 667 633 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.591 P=0.141N P=0.603 P=0.453N |P=0.359 P=0.094N P=0.554 P=0.492N |
|POLY 3 | P=0.589 P=0.154N P=0.628N P=0.459N |P=0.306 P=0.148N P=0.531 P=0.554 |
|POLY 1.5 | P=0.588 P=0.162N P=0.629N P=0.470N |P=0.363 P=0.133N P=0.555 P=0.544N |
|POLY 6 | P=0.586 P=0.146N P=0.632N P=0.452N |P=0.252 P=0.169N P=0.490 P=0.479 |
|LOGISTIC REGRESSION| P=0.511 P=0.188N P=0.634 P=0.546N |P=0.360 P=0.109N P=0.537N P=0.494N |
|COCH-ARM / FISHERS | P=0.576 P=0.181N P=0.643N P=0.500N |P=0.472 P=0.114N P=0.579N P=0.421N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Reticulum Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.5% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- 386 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.392N P=0.254 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.367N P=0.264 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.376N P=0.255 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.357N P=0.275 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.601N P=0.089 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.397N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |2/36 (6%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.250N P=0.226N P=0.244N P=0.244N |
|POLY 3 | (e) (e) (e) (e) |P=0.244N P=0.235N P=0.230N P=0.247N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.243N P=0.236N P=0.233N P=0.244N |
|POLY 6 | (e) (e) (e) (e) |P=0.245N P=0.233N P=0.228N P=0.248N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.250N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.242N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/50 (0%) 0/48 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 6/50 (12%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.7% |2.2% 0.0% 12.9% 2.3% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 2/28 (7%) |1/36 (3%) 0/38 (0%) 3/35 (9%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |730 (T) --- 575 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.052 (e) (e) P=0.272 |P=0.545 P=0.489N P=0.063 P=0.746 |
|POLY 3 | P=0.044 * (e) (e) P=0.258 |P=0.545 P=0.498N P=0.063 P=0.753 |
|POLY 1.5 | P=0.044 * (e) (e) P=0.257 |P=0.553 P=0.499N P=0.061 P=0.755 |
|POLY 6 | P=0.043 * (e) (e) P=0.258 |P=0.541 P=0.497N P=0.066 P=0.753 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.272 |P=0.573 (e) P=0.059 P=0.763N |
|COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.263 |P=0.573 P=0.500N P=0.056 P=0.753N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/47 (4%) 8/50 (16%) 9/48 (19%) 6/50 (12%) |14/50 (28%) 19/50 (38%) 20/50 (40%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 5.1% 18.0% 22.2% 14.0% |30.3% 40.4% 42.7% 23.3% |
|TERMINAL (d) | 1/24 (4%) 2/30 (7%) 3/20 (15%) 3/28 (11%) |10/36 (28%) 14/38 (37%) 17/35 (49%) 9/35 (26%) |
|FIRST INCIDENCE | 617 617 562 676 |501 451 575 633 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.453 P=0.098 P=0.025 * P=0.182 |P=0.114N P=0.255 P=0.144 P=0.279N |
|POLY 3 | P=0.458 P=0.070 P=0.027 * P=0.163 |P=0.126N P=0.212 P=0.151 P=0.305N |
|POLY 1.5 | P=0.460 P=0.064 P=0.028 * P=0.162 |P=0.106N P=0.205 P=0.149 P=0.283N |
|POLY 6 | P=0.450 P=0.078 P=0.027 * P=0.164 |P=0.148N P=0.221 P=0.151 P=0.325N |
|LOGISTIC REGRESSION| P=0.452 P=0.062 P=0.029 * P=0.164 |P=0.089N P=0.196 P=0.157 P=0.267N |
|COCH-ARM / FISHERS | P=0.445 P=0.056 P=0.027 * P=0.155 |P=0.076N P=0.198 P=0.146 P=0.241N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/7 (0%) 1/12 (8%) 1/12 (8%) 0/14 (0%) |0/7 (0%) 2/8 (25%) 0/4 (0%) 0/4 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 9.7% 12.2% 0.0% |0.0% 26.3% 0.0% 0.0% |
|TERMINAL (d) | 0/2 (0%) 1/7 (14%) 1/5 (20%) 0/6 (0%) |0/5 (0%) 0/5 (0%) 0/4 (0%) 0/4 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |--- 451 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.449N P=0.748 P=0.682 (e) |P=0.380N P=0.242 (e) (e) |
|POLY 3 | P=0.402N P=0.643 P=0.604 (e) |P=0.478N P=0.265 (e) (e) |
|POLY 1.5 | P=0.414N P=0.630 P=0.606 (e) |P=0.488N P=0.260 (e) (e) |
|POLY 6 | P=0.391N P=0.659 P=0.610 (e) |P=0.466N P=0.271 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.748 P=0.682 (e) |P=0.916N P=0.413 (e) (e) |
|COCH-ARM / FISHERS | P=0.439N P=0.632 P=0.632 (e) |P=0.500N P=0.267 (e) (e) |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/7 (14%) 1/12 (8%) 0/12 (0%) 2/14 (14%) |0/7 (0%) 0/8 (0%) 0/4 (0%) 0/4 (0%) |
|POLY-3 ADJUSTED (b)| 20.5% 9.7% 0.0% 16.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/2 (50%) 1/7 (14%) 0/5 (0%) 0/6 (0%) |0/5 (0%) 0/5 (0%) 0/4 (0%) 0/4 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 633 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.390 P=0.460N P=0.318N P=0.643 |(e) (e) (e) (e) |
|POLY 3 | P=0.493 P=0.586N P=0.393N P=0.679N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.480 P=0.604N P=0.391N P=0.700N |(e) (e) (e) (e) |
|POLY 6 | P=0.506 P=0.562N P=0.386N P=0.649N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.488 P=0.460N (e) P=0.722N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.459 P=0.614N P=0.368N P=0.726N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/7 (43%) 7/12 (58%) 8/12 (67%) 7/14 (50%) |6/7 (86%) 6/8 (75%) 4/4 (100%) 3/4 (75%) |
|POLY-3 ADJUSTED (b)| 50.7% 66.2% 73.3% 57.2% |87.5% 86.4% 100.0% 75.0% |
|TERMINAL (d) | 0/2 (0%) 5/7 (71%) 3/5 (60%) 5/6 (83%) |5/5 (100%) 5/5 (100%) 4/4 (100%) 3/4 (75%) |
|FIRST INCIDENCE | 611 663 400 537 |575 616 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.463 P=0.525 P=0.192 P=0.451 |P=0.079N P=0.750N P=0.496N P=0.222N |
|POLY 3 | P=0.497N P=0.463 P=0.347 P=0.595 |P=0.510N P=0.785N P=0.666 P=0.615N |
|POLY 1.5 | P=0.478N P=0.473 P=0.347 P=0.603 |P=0.557N P=0.688N P=0.637 P=0.623N |
|POLY 6 | P=0.565N P=0.423 P=0.331 P=0.546 |P=0.440N P=0.814 P=0.727 P=0.597N |
|LOGISTIC REGRESSION| P=0.461N P=0.599 P=0.298 P=0.661 |P=0.399N P=0.742N P=0.681 P=0.648N |
|COCH-ARM / FISHERS | P=0.502N P=0.430 P=0.297 P=0.562 |P=0.622N P=0.554N P=0.636 P=0.618N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) 3/50 (6%) 5/50 (10%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 12.4% 13.8% 7.4% 11.6% |4.5% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 4/24 (17%) 4/30 (13%) 0/20 (0%) 3/28 (11%) |1/36 (3%) 0/38 (0%) 1/35 (3%) 0/35 (0%) |
|FIRST INCIDENCE | 611 708 676 585 |645 --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.513N P=0.615N P=0.405N P=0.556N |P=0.287N P=0.231N P=0.501N P=0.257N |
|POLY 3 | P=0.521N P=0.558 P=0.350N P=0.586N |P=0.280N P=0.236N P=0.492N P=0.248N |
|POLY 1.5 | P=0.528N P=0.539 P=0.348N P=0.598N |P=0.277N P=0.237N P=0.494N P=0.245N |
|POLY 6 | P=0.518N P=0.579 P=0.355N P=0.578N |P=0.283N P=0.236N P=0.490N P=0.251N |
|LOGISTIC REGRESSION| P=0.530N P=0.592 P=0.354N P=0.596N |P=0.274N P=0.238N P=0.498N P=0.237N |
|COCH-ARM / FISHERS | P=0.549N P=0.500 P=0.357N P=0.630N |P=0.271N P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 9/50 (18%) 6/50 (12%) 8/50 (16%) |3/50 (6%) 2/50 (4%) 4/50 (8%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 29.1% 20.5% 14.8% 18.6% |6.7% 4.4% 8.6% 9.4% |
|TERMINAL (d) | 6/24 (25%) 6/30 (20%) 3/20 (15%) 6/28 (21%) |1/36 (3%) 1/38 (3%) 3/35 (9%) 4/35 (11%) |
|FIRST INCIDENCE | 569 639 676 585 |645 652 468 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252N P=0.179N P=0.159N P=0.160N |P=0.310 P=0.480N P=0.505 P=0.474 |
|POLY 3 | P=0.265N P=0.250N P=0.094N P=0.187N |P=0.311 P=0.498N P=0.519 P=0.470 |
|POLY 1.5 | P=0.267N P=0.268N P=0.090N P=0.195N |P=0.323 P=0.499N P=0.513 P=0.480 |
|POLY 6 | P=0.271N P=0.235N P=0.105N P=0.188N |P=0.300 P=0.497N P=0.521 P=0.461 |
|LOGISTIC REGRESSION| P=0.260N P=0.232N P=0.092N P=0.183N |P=0.347 P=0.501N P=0.460 P=0.480 |
|COCH-ARM / FISHERS | P=0.284N P=0.312N P=0.096N P=0.227N |P=0.345 P=0.500N P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |4.5% 4.5% 2.2% 0.0% |
|TERMINAL (d) | |1/36 (3%) 2/38 (5%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | |645 730 (T) 625 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.154N P=0.677N P=0.493N P=0.257N |
|POLY 3 | |P=0.150N P=0.693N P=0.489N P=0.248N |
|POLY 1.5 | |P=0.148N P=0.693N P=0.493N P=0.245N |
|POLY 6 | |P=0.153N P=0.692N P=0.485N P=0.251N |
|LOGISTIC REGRESSION| |P=0.140N P=0.693N P=0.531N P=0.237N |
|COCH-ARM / FISHERS | |P=0.141N P=0.691N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 7/50 (14%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |6.7% 15.5% 6.4% 4.7% |
|TERMINAL (d) | |3/36 (8%) 6/38 (16%) 1/35 (3%) 1/35 (3%) |
|FIRST INCIDENCE | |730 (T) 666 575 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.204N P=0.182 P=0.659N P=0.519N |
|POLY 3 | |P=0.192N P=0.163 P=0.640N P=0.516N |
|POLY 1.5 | |P=0.188N P=0.160 P=0.648N P=0.512N |
|POLY 6 | |P=0.193N P=0.167 P=0.631N P=0.516N |
|LOGISTIC REGRESSION| |P=0.187N P=0.165 P=0.656 P=0.519N |
|COCH-ARM / FISHERS | |P=0.178N P=0.159 P=0.661N P=0.500N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| |0.0% 4.5% 6.5% 2.3% |
|TERMINAL (d) | |0/36 (0%) 2/38 (5%) 2/35 (6%) 1/35 (3%) |
|FIRST INCIDENCE | |--- 730 (T) 536 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.599 P=0.250 P=0.121 P=0.494 |
|POLY 3 | |P=0.593 P=0.239 P=0.127 P=0.492 |
|POLY 1.5 | |P=0.601 P=0.238 P=0.124 P=0.494 |
|POLY 6 | |P=0.588 P=0.241 P=0.130 P=0.490 |
|LOGISTIC REGRESSION| |P=0.615 P=0.250 P=0.102 P=0.494 |
|COCH-ARM / FISHERS | |P=0.618 P=0.247 P=0.121 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 14/50 (28%) 13/50 (26%) 12/50 (24%) |10/50 (20%) 8/50 (16%) 8/50 (16%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 32.9% 31.5% 31.8% 27.3% |22.3% 17.7% 17.2% 18.6% |
|TERMINAL (d) | 7/24 (29%) 9/30 (30%) 8/20 (40%) 8/28 (29%) |8/36 (22%) 7/38 (18%) 5/35 (14%) 7/35 (20%) |
|FIRST INCIDENCE | 512 603 602 529 |665 633 662 633 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.301N P=0.381N P=0.543 P=0.299N |P=0.481N P=0.354N P=0.396N P=0.427N |
|POLY 3 | P=0.325N P=0.533N P=0.549N P=0.367N |P=0.472N P=0.388N P=0.365N P=0.435N |
|POLY 1.5 | P=0.327N P=0.546N P=0.515N P=0.370N |P=0.459N P=0.393N P=0.377N P=0.424N |
|POLY 6 | P=0.341N P=0.528N P=0.583 P=0.382N |P=0.483N P=0.382N P=0.352N P=0.443N |
|LOGISTIC REGRESSION| P=0.324N P=0.526N P=0.489N P=0.385N |P=0.480N P=0.382N P=0.366N P=0.441N |
|COCH-ARM / FISHERS | P=0.356N P=0.588N P=0.500N P=0.410N |P=0.427N P=0.398N P=0.398N P=0.398N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.0% 4.6% 0.0% 2.4% |0.0% 0.0% 2.2% 2.3% |
|TERMINAL (d) | 1/24 (4%) 1/30 (3%) 0/20 (0%) 1/28 (4%) |0/36 (0%) 0/38 (0%) 1/35 (3%) 1/35 (3%) |
|FIRST INCIDENCE | 648 639 --- 729 (T) |--- --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.397N P=0.623N P=0.253N P=0.455N |P=0.292 (e) P=0.494 P=0.494 |
|POLY 3 | P=0.402N P=0.662N P=0.236N P=0.481N |P=0.289 (e) P=0.506 P=0.492 |
|POLY 1.5 | P=0.403N P=0.673N P=0.235N P=0.485N |P=0.293 (e) P=0.504 P=0.494 |
|POLY 6 | P=0.403N P=0.650N P=0.241N P=0.480N |P=0.285 (e) P=0.508 P=0.490 |
|LOGISTIC REGRESSION| P=0.400N P=0.682N P=0.236N P=0.478N |(e) (e) P=0.494 P=0.494 |
|COCH-ARM / FISHERS | P=0.408N P=0.691N P=0.247N P=0.500N |P=0.303 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 7.5% 4.6% 0.0% 4.7% |0.0% 2.2% 0.0% 2.3% |
|TERMINAL (d) | 1/24 (4%) 2/30 (7%) 0/20 (0%) 2/28 (7%) |0/36 (0%) 1/38 (3%) 0/35 (0%) 1/35 (3%) |
|FIRST INCIDENCE | 674 729 (T) --- 729 (T) |--- 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.509N P=0.418N P=0.145N P=0.444N |P=0.452 P=0.511 (e) P=0.494 |
|POLY 3 | P=0.536N P=0.462N P=0.117N P=0.474N |P=0.453 P=0.502 (e) P=0.492 |
|POLY 1.5 | P=0.536N P=0.475N P=0.116N P=0.480N |P=0.456 P=0.501 (e) P=0.494 |
|POLY 6 | P=0.538N P=0.450N P=0.121N P=0.473N |P=0.451 P=0.503 (e) P=0.490 |
|LOGISTIC REGRESSION| P=0.528N P=0.438N P=0.121N P=0.464N |(e) P=0.511 (e) P=0.494 |
|COCH-ARM / FISHERS | P=0.539N P=0.500N P=0.121N P=0.500N |P=0.464 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 4/50 (8%) 2/50 (4%) |5/50 (10%) 2/50 (4%) 7/50 (14%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.5% 9.2% 9.9% 4.7% |11.2% 4.5% 15.3% 7.0% |
|TERMINAL (d) | 1/24 (4%) 4/30 (13%) 3/20 (15%) 2/28 (7%) |5/36 (14%) 2/38 (5%) 7/35 (20%) 3/35 (9%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 691 729 (T) |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.489N P=0.250 P=0.143 P=0.554 |P=0.476N P=0.194N P=0.357 P=0.370N |
|POLY 3 | P=0.503N P=0.206 P=0.181 P=0.522 |P=0.479N P=0.212N P=0.401 P=0.379N |
|POLY 1.5 | P=0.509N P=0.197 P=0.183 P=0.517 |P=0.467N P=0.214N P=0.394 P=0.373N |
|POLY 6 | P=0.503N P=0.217 P=0.176 P=0.525 |P=0.488N P=0.208N P=0.407 P=0.383N |
|LOGISTIC REGRESSION| P=0.513N P=0.250 P=0.165 P=0.554 |P=0.476N P=0.194N P=0.357 P=0.370N |
|COCH-ARM / FISHERS | P=0.532N P=0.181 P=0.181 P=0.500 |P=0.442N P=0.218N P=0.380 P=0.357N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 0.0% |0.0% 2.2% 0.0% 2.3% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 1/20 (5%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 549 --- |--- 451 --- 614 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.659N (e) P=0.220 (e) |P=0.456 P=0.500 (e) P=0.495 |
|POLY 3 | P=0.669N (e) P=0.242 (e) |P=0.455 P=0.505 (e) P=0.493 |
|POLY 1.5 | P=0.670N (e) P=0.242 (e) |P=0.457 P=0.503 (e) P=0.495 |
|POLY 6 | P=0.672N (e) P=0.240 (e) |P=0.455 P=0.508 (e) P=0.493 |
|LOGISTIC REGRESSION| P=0.697N (e) P=0.230 (e) |P=0.619 P=0.538 (e) P=0.537 |
|COCH-ARM / FISHERS | P=0.675N (e) P=0.247 (e) |P=0.464 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 6/50 (12%) 3/50 (6%) |19/50 (38%) 17/49 (35%) 23/50 (46%) 21/50 (42%) |
|POLY-3 ADJUSTED (b)| 17.5% 13.6% 14.8% 7.0% |42.1% 38.4% 50.0% 47.7% |
|TERMINAL (d) | 5/24 (21%) 4/30 (13%) 3/20 (15%) 2/28 (7%) |17/36 (47%) 15/37 (41%) 21/35 (60%) 19/35 (54%) |
|FIRST INCIDENCE | 682 617 691 633 |625 666 703 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.117N P=0.355N P=0.590N P=0.116N |P=0.232 P=0.374N P=0.231 P=0.366 |
|POLY 3 | P=0.117N P=0.424N P=0.491N P=0.129N |P=0.265 P=0.441N P=0.291 P=0.374 |
|POLY 1.5 | P=0.119N P=0.451N P=0.488N P=0.137N |P=0.282 P=0.445N P=0.286 P=0.387 |
|POLY 6 | P=0.119N P=0.394N P=0.501N P=0.124N |P=0.247 P=0.434N P=0.289 P=0.361 |
|LOGISTIC REGRESSION| P=0.118N P=0.408N P=0.518N P=0.127N |P=0.219 P=0.422N P=0.333 P=0.346 |
|COCH-ARM / FISHERS | P=0.130N P=0.500N P=0.500N P=0.159N |P=0.320 P=0.447N P=0.272 P=0.419 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 8/50 (16%) 10/50 (20%) 6/50 (12%) |4/50 (8%) 4/49 (8%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 5.0% 17.7% 23.9% 13.8% |8.9% 9.1% 0.0% 7.0% |
|TERMINAL (d) | 1/24 (4%) 3/30 (10%) 5/20 (25%) 3/28 (11%) |3/36 (8%) 4/37 (11%) 0/35 (0%) 1/35 (3%) |
|FIRST INCIDENCE | 640 512 549 569 |543 730 (T) --- 633 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.467 P=0.088 P=0.012 * P=0.175 |P=0.458N P=0.632N P=0.067N P=0.519N |
|POLY 3 | P=0.475 P=0.068 P=0.015 * P=0.159 |P=0.445N P=0.629 P=0.058N P=0.525N |
|POLY 1.5 | P=0.464 P=0.059 P=0.015 * P=0.152 |P=0.441N P=0.630 P=0.059N P=0.518N |
|POLY 6 | P=0.478 P=0.080 P=0.015 * P=0.165 |P=0.447N P=0.629 P=0.057N P=0.528N |
|LOGISTIC REGRESSION| P=0.424 P=0.042 * P=0.016 * P=0.139 |P=0.441N P=0.635 P=0.067N P=0.500N |
|COCH-ARM / FISHERS | P=0.425 P=0.046 * P=0.014 * P=0.134 |P=0.430N P=0.631 P=0.059N P=0.500N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 4.9% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 1/20 (5%) 0/28 (0%) |0/36 (0%) 0/37 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 613 --- 508 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.433N P=0.490N P=0.478 P=0.505N |(e) (e) (e) (e) |
|POLY 3 | P=0.441N P=0.484N P=0.505 P=0.489N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.439N P=0.489N P=0.506 P=0.492N |(e) (e) (e) (e) |
|POLY 6 | P=0.447N P=0.479N P=0.500 P=0.489N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.485N P=0.540N P=0.475 P=0.545N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.441N P=0.500N P=0.500 P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 17/50 (34%) 21/50 (42%) 15/50 (30%) |23/50 (46%) 28/49 (57%) 23/50 (46%) 24/50 (48%) |
|POLY-3 ADJUSTED (b)| 36.7% 37.1% 48.1% 34.0% |48.4% 60.9% 49.0% 54.0% |
|TERMINAL (d) | 10/24 (42%) 10/30 (33%) 10/20 (50%) 10/28 (36%) |17/36 (47%) 22/37 (60%) 19/35 (54%) 19/35 (54%) |
|FIRST INCIDENCE | 611 386 444 569 |414 403 575 511 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.358N P=0.510N P=0.089 P=0.433N |P=0.542 P=0.271 P=0.557 P=0.442 |
|POLY 3 | P=0.381N P=0.572 P=0.194 P=0.489N |P=0.523 P=0.154 P=0.557 P=0.371 |
|POLY 1.5 | P=0.389N P=0.518 P=0.181 P=0.516N |P=0.535N P=0.161 P=0.564 P=0.407 |
|POLY 6 | P=0.387N P=0.551N P=0.204 P=0.468N |P=0.499 P=0.157 P=0.555 P=0.352 |
|LOGISTIC REGRESSION| P=0.397N P=0.507 P=0.153 P=0.504N |P=0.494N P=0.182 P=0.576N P=0.467 |
|COCH-ARM / FISHERS | P=0.432N P=0.415 P=0.149 P=0.586N |P=0.436N P=0.182 P=0.579N P=0.500 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Pseudocyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 14.5% 0.0% 0.0% 2.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/24 (8%) 0/30 (0%) 0/20 (0%) 1/28 (4%) |0/36 (0%) 0/37 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 597 --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.142N P=0.014N* P=0.026N* P=0.054N |(e) (e) (e) (e) |
|POLY 3 | P=0.138N P=0.012N* P=0.016N* P=0.051N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.137N P=0.013N* P=0.015N* P=0.051N |(e) (e) (e) (e) |
|POLY 6 | P=0.140N P=0.012N* P=0.018N* P=0.053N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.141N P=0.019N* P=0.018N* P=0.058N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.139N P=0.013N* P=0.013N* P=0.056N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Pseudocyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/37 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 313 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152N P=0.112N P=0.126N P=0.121N |(e) (e) (e) (e) |
|POLY 3 | P=0.150N P=0.109N P=0.123N P=0.113N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.149N P=0.112N P=0.120N P=0.114N |(e) (e) (e) (e) |
|POLY 6 | P=0.153N P=0.106N P=0.128N P=0.114N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.213N P=0.197N P=0.164N P=0.218N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.149N P=0.121N P=0.121N P=0.121N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 4/50 (8%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 9.8% 4.7% | |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 2/20 (10%) 2/28 (7%) | |
|FIRST INCIDENCE | --- --- 523 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.244 (e) P=0.051 P=0.272 | |
|POLY 3 | P=0.220 (e) P=0.063 P=0.251 | |
|POLY 1.5 | P=0.220 (e) P=0.063 P=0.248 | |
|POLY 6 | P=0.215 (e) P=0.061 P=0.253 | |
|LOGISTIC REGRESSION| P=0.221 (e) P=0.064 P=0.272 | |
|COCH-ARM / FISHERS | P=0.213 (e) P=0.059 P=0.247 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 45/50 (90%) 48/50 (96%) 48/50 (96%) | |
|POLY-3 ADJUSTED (b)| 96.2% 91.7% 99.2% 98.2% | |
|TERMINAL (d) | 23/24 (96%) 28/30 (93%) 20/20 (100%) 28/28 (100%)| |
|FIRST INCIDENCE | 313 386 482 490 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.526N P=0.105N P=0.227 P=0.363N | |
|POLY 3 | P=0.188 P=0.287N P=0.364 P=0.510 | |
|POLY 1.5 | P=0.209 P=0.334N P=0.357 P=0.467 | |
|POLY 6 | P=0.155 P=0.293N P=0.388 P=0.494 | |
|LOGISTIC REGRESSION| P=0.365 P=0.354N P=0.571 P=0.681 | |
|COCH-ARM / FISHERS | P=0.210 P=0.500N P=0.339 P=0.339 | |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 0.0% 6.9% 5.0% 4.7% | |
|TERMINAL (d) | 0/24 (0%) 3/30 (10%) 0/20 (0%) 1/28 (4%) | |
|FIRST INCIDENCE | --- 729 (T) 715 569 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.488 P=0.162 P=0.204 P=0.262 | |
|POLY 3 | P=0.496 P=0.135 P=0.239 P=0.254 | |
|POLY 1.5 | P=0.487 P=0.129 P=0.240 P=0.249 | |
|POLY 6 | P=0.503 P=0.141 P=0.236 P=0.258 | |
|LOGISTIC REGRESSION| P=0.472 P=0.162 P=0.229 P=0.217 | |
|COCH-ARM / FISHERS | P=0.461 P=0.121 P=0.247 P=0.247 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 38/50 (76%) 31/50 (62%) 29/50 (58%) | |
|POLY-3 ADJUSTED (b)| 61.2% 77.7% 67.8% 60.3% | |
|TERMINAL (d) | 15/24 (63%) 21/30 (70%) 12/20 (60%) 13/28 (46%) | |
|FIRST INCIDENCE | 361 386 482 490 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.272N P=0.259 P=0.191 P=0.503N | |
|POLY 3 | P=0.172N P=0.060 P=0.329 P=0.550N | |
|POLY 1.5 | P=0.209N P=0.040 * P=0.316 P=0.558 | |
|POLY 6 | P=0.147N P=0.084 P=0.333 P=0.503N | |
|LOGISTIC REGRESSION| P=0.301N P=0.025 * P=0.291 P=0.440 | |
|COCH-ARM / FISHERS | P=0.313N P=0.018 * P=0.272 P=0.420 | |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 2.5% 0.0% |2.2% 2.2% 4.4% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 1/38 (3%) 1/35 (3%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) --- 523 --- |501 730 (T) 703 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.447N P=0.455N P=0.745 P=0.469N |P=0.346N P=0.757N P=0.508 P=0.508N |
|POLY 3 | P=0.468N P=0.482N P=0.756N P=0.487N |P=0.353N P=0.759 P=0.506 P=0.511N |
|POLY 1.5 | P=0.465N P=0.488N P=0.756N P=0.491N |P=0.347N P=0.759 P=0.504 P=0.508N |
|POLY 6 | P=0.473N P=0.476N P=0.758N P=0.486N |P=0.357N P=0.760 P=0.508 P=0.514N |
|LOGISTIC REGRESSION| P=0.493N (e) P=0.753 (e) |P=0.310N P=0.764N P=0.445 P=0.377N |
|COCH-ARM / FISHERS | P=0.464N P=0.500N P=0.753N P=0.500N |P=0.333N P=0.753N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 4.7% |2.2% 2.2% 2.2% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 2/28 (7%) |1/36 (3%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 611 --- --- 729 (T) |730 (T) 540 687 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199 P=0.495N P=0.515N P=0.530 |P=0.336N P=0.754N P=0.755N P=0.506N |
|POLY 3 | P=0.184 P=0.484N P=0.500N P=0.518 |P=0.336N P=0.756N P=0.753N P=0.508N |
|POLY 1.5 | P=0.186 P=0.489N P=0.498N P=0.515 |P=0.332N P=0.758N P=0.756N P=0.506N |
|POLY 6 | P=0.181 P=0.479N P=0.505N P=0.519 |P=0.338N P=0.753N P=0.750N P=0.510N |
|LOGISTIC REGRESSION| P=0.190 P=0.541N P=0.517N P=0.516 |P=0.292N P=0.764N P=0.759N (e) |
|COCH-ARM / FISHERS | P=0.186 P=0.500N P=0.500N P=0.500 |P=0.323N P=0.753N P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.3% 0.0% 0.0% |0.0% 0.0% 0.0% 4.8% |
|TERMINAL (d) | 0/24 (0%) 1/30 (3%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 2/34 (6%) |
|FIRST INCIDENCE | 682 729 (T) --- --- |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.320N P=0.719N P=0.500N P=0.488N |P=0.036 * (e) (e) P=0.226 |
|POLY 3 | P=0.321N P=0.742N P=0.499N P=0.488N |P=0.036 * (e) (e) P=0.223 |
|POLY 1.5 | P=0.322N P=0.748N P=0.498N P=0.491N |P=0.037 * (e) (e) P=0.226 |
|POLY 6 | P=0.321N P=0.735N P=0.503N P=0.488N |P=0.036 * (e) (e) P=0.220 |
|LOGISTIC REGRESSION| P=0.320N P=0.741N P=0.498N P=0.494N |(e) (e) (e) P=0.226 |
|COCH-ARM / FISHERS | P=0.325N P=0.753N P=0.500N P=0.500N |P=0.040 * (e) (e) P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.3% 0.0% 4.7% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/24 (4%) 1/30 (3%) 0/20 (0%) 1/28 (4%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 691 |--- --- 708 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.352 P=0.712N P=0.536N P=0.555 |P=0.798N (e) P=0.511 (e) |
|POLY 3 | P=0.334 P=0.741N P=0.498N P=0.523 |P=0.793N (e) P=0.507 (e) |
|POLY 1.5 | P=0.332 P=0.748N P=0.497N P=0.517 |P=0.791N (e) P=0.504 (e) |
|POLY 6 | P=0.333 P=0.733N P=0.501N P=0.528 |P=0.794N (e) P=0.509 (e) |
|LOGISTIC REGRESSION| P=0.334 P=0.712N (e) P=0.528 |P=0.793N (e) P=0.504 (e) |
|COCH-ARM / FISHERS | P=0.325 P=0.753N P=0.500N P=0.500 |P=0.786N (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 4/50 (8%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.0% 9.2% 9.9% 11.7% |0.0% 0.0% 4.4% 2.3% |
|TERMINAL (d) | 1/24 (4%) 4/30 (13%) 2/20 (10%) 3/28 (11%) |0/36 (0%) 0/38 (0%) 2/35 (6%) 1/35 (3%) |
|FIRST INCIDENCE | 718 729 (T) 682 632 |--- --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.288 P=0.436 P=0.276 P=0.272 |P=0.336 (e) P=0.232 P=0.494 |
|POLY 3 | P=0.270 P=0.378 P=0.342 P=0.244 |P=0.329 (e) P=0.244 P=0.492 |
|POLY 1.5 | P=0.265 P=0.364 P=0.344 P=0.237 |P=0.336 (e) P=0.242 P=0.494 |
|POLY 6 | P=0.271 P=0.393 P=0.336 P=0.250 |P=0.324 (e) P=0.246 P=0.490 |
|LOGISTIC REGRESSION| P=0.257 P=0.421 P=0.323 P=0.245 |(e) (e) P=0.232 P=0.494 |
|COCH-ARM / FISHERS | P=0.246 P=0.339 P=0.339 P=0.218 |P=0.350 (e) P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 3/50 (6%) 5/50 (10%) |3/50 (6%) 4/50 (8%) 7/50 (14%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 9.7% 10.9% 7.2% 11.3% |6.6% 8.4% 15.2% 4.6% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 4/35 (11%) 1/35 (3%) |
|FIRST INCIDENCE | 597 410 523 537 |429 403 703 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.480 P=0.547 P=0.504N P=0.523 |P=0.365N P=0.505 P=0.175 P=0.524N |
|POLY 3 | P=0.497 P=0.564 P=0.491N P=0.545 |P=0.383N P=0.521 P=0.160 P=0.527N |
|POLY 1.5 | P=0.493 P=0.543 P=0.489N P=0.533 |P=0.365N P=0.514 P=0.160 P=0.519N |
|POLY 6 | P=0.496 P=0.584 P=0.502N P=0.551 |P=0.397N P=0.528 P=0.160 P=0.533N |
|LOGISTIC REGRESSION| P=0.310 P=0.349 P=0.574N P=0.377 |P=0.215N P=0.512 P=0.140 P=0.422N |
|COCH-ARM / FISHERS | P=0.474 P=0.500 P=0.500N P=0.500 |P=0.328N P=0.500 P=0.159 P=0.500N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |25/50 (50%) 26/50 (52%) 28/50 (56%) 32/50 (64%) |
|POLY-3 ADJUSTED (b)| 2.5% 4.6% 4.8% 2.4% |53.6% 56.9% 58.7% 69.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 1/28 (4%) |19/36 (53%) 24/38 (63%) 22/35 (63%) 26/35 (74%) |
|FIRST INCIDENCE | 361 687 482 729 (T) |414 540 468 347 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500N P=0.561 P=0.517 P=0.739N |P=0.048 * P=0.559N P=0.337 P=0.098 |
|POLY 3 | P=0.513N P=0.526 P=0.507 P=0.752N |P=0.070 P=0.457 P=0.387 P=0.090 |
|POLY 1.5 | P=0.513N P=0.516 P=0.507 P=0.753N |P=0.073 P=0.472 P=0.374 P=0.097 |
|POLY 6 | P=0.516N P=0.538 P=0.506 P=0.751N |P=0.064 P=0.437 P=0.393 P=0.080 |
|LOGISTIC REGRESSION| P=0.657N P=0.390 P=0.242 P=0.648 |P=0.056 P=0.516 P=0.371 P=0.096 |
|COCH-ARM / FISHERS | P=0.521N P=0.500 P=0.500 P=0.753N |P=0.081 P=0.500 P=0.344 P=0.113 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 7.2% 4.6% |0.0% 2.2% 2.1% 6.8% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 454 --- 482 490 |--- 652 468 414 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.488 P=0.215N P=0.474 P=0.655N |P=0.056 P=0.509 P=0.508 P=0.116 |
|POLY 3 | P=0.469 P=0.222N P=0.510 P=0.672N |P=0.063 P=0.503 P=0.509 P=0.118 |
|POLY 1.5 | P=0.469 P=0.227N P=0.509 P=0.677N |P=0.063 P=0.502 P=0.506 P=0.118 |
|POLY 6 | P=0.464 P=0.216N P=0.507 P=0.669N |P=0.063 P=0.506 P=0.512 P=0.119 |
|LOGISTIC REGRESSION| P=0.347 P=0.291N P=0.437 P=0.598 |P=0.165 P=0.500 P=0.255 P=0.189 |
|COCH-ARM / FISHERS | P=0.461 P=0.247N P=0.500 P=0.691N |P=0.064 P=0.500 P=0.500 P=0.121 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.0% 4.5% 2.5% 0.0% |2.2% 2.2% 2.2% 2.3% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |1/36 (3%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 648 512 585 --- |730 (T) 666 526 309 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.150N P=0.645N P=0.522N P=0.223N |P=0.654 P=0.746N P=0.759N P=0.757 |
|POLY 3 | P=0.145N P=0.659N P=0.496N P=0.225N |P=0.656 P=0.757N P=0.751N P=0.756 |
|POLY 1.5 | P=0.145N P=0.671N P=0.494N P=0.228N |P=0.660 P=0.759N P=0.754N P=0.757 |
|POLY 6 | P=0.147N P=0.647N P=0.501N P=0.224N |P=0.653 P=0.755N P=0.747N P=0.755 |
|LOGISTIC REGRESSION| P=0.163N P=0.671 P=0.505N P=0.230N |P=0.497N P=0.762N P=0.721 P=0.662N |
|COCH-ARM / FISHERS | P=0.148N P=0.691N P=0.500N P=0.247N |P=0.667 P=0.753N P=0.753N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.0% 0.0% 7.4% 4.7% |0.0% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 648 --- 653 676 |--- --- 526 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.470 P=0.205N P=0.482 P=0.658N |P=0.711N (e) P=0.250 (e) |
|POLY 3 | P=0.465 P=0.219N P=0.505 P=0.672N |P=0.713N (e) P=0.248 (e) |
|POLY 1.5 | P=0.467 P=0.225N P=0.507 P=0.677N |P=0.709N (e) P=0.244 (e) |
|POLY 6 | P=0.460 P=0.214N P=0.499 P=0.669N |P=0.717N (e) P=0.252 (e) |
|LOGISTIC REGRESSION| P=0.469 P=0.229N P=0.504 P=0.683N |P=0.636N (e) P=0.176 (e) |
|COCH-ARM / FISHERS | P=0.461 P=0.247N P=0.500 P=0.691N |P=0.697N (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 47
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 3/50 (6%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 5.0% 2.3% 9.7% 6.9% |4.5% 2.2% 0.0% 7.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 2/35 (6%) |
|FIRST INCIDENCE | 674 663 585 529 |656 680 --- 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.365 P=0.449N P=0.323 P=0.543 |P=0.232 P=0.497N P=0.227N P=0.473 |
|POLY 3 | P=0.373 P=0.469N P=0.350 P=0.536 |P=0.244 P=0.498N P=0.232N P=0.480 |
|POLY 1.5 | P=0.370 P=0.480N P=0.348 P=0.526 |P=0.248 P=0.499N P=0.234N P=0.486 |
|POLY 6 | P=0.372 P=0.458N P=0.348 P=0.544 |P=0.241 P=0.497N P=0.232N P=0.476 |
|LOGISTIC REGRESSION| P=0.336 P=0.487N P=0.338 P=0.484 |P=0.261 P=0.501N P=0.249N P=0.497 |
|COCH-ARM / FISHERS | P=0.354 P=0.500N P=0.339 P=0.500 |P=0.256 P=0.500N P=0.247N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |3/50 (6%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 4.6% 9.6% 4.7% |6.5% 2.2% 6.4% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/30 (3%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 368 709 508 569 |501 666 526 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.559N P=0.638N P=0.326 P=0.664N |P=0.157N P=0.306N P=0.633N P=0.132N |
|POLY 3 | P=0.570N P=0.671N P=0.343 P=0.676N |P=0.161N P=0.311N P=0.652N P=0.132N |
|POLY 1.5 | P=0.571N P=0.679N P=0.344 P=0.680N |P=0.155N P=0.309N P=0.655N P=0.128N |
|POLY 6 | P=0.572N P=0.662N P=0.340 P=0.674N |P=0.167N P=0.312N P=0.649N P=0.136N |
|LOGISTIC REGRESSION| P=0.590 P=0.640 P=0.276 P=0.573 |P=0.090N P=0.295N P=0.543 P=0.069N |
|COCH-ARM / FISHERS | P=0.582N P=0.691N P=0.339 P=0.691N |P=0.144N P=0.309N P=0.661N P=0.121N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 48
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 7/50 (14%) 3/50 (6%) 6/50 (12%) | |
|POLY-3 ADJUSTED (b)| 12.1% 15.8% 7.3% 13.9% | |
|TERMINAL (d) | 2/24 (8%) 4/30 (13%) 0/20 (0%) 3/28 (11%) | |
|FIRST INCIDENCE | 361 585 562 562 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.560 P=0.499 P=0.397N P=0.574 | |
|POLY 3 | P=0.542 P=0.428 P=0.356N P=0.531 | |
|POLY 1.5 | P=0.539 P=0.411 P=0.353N P=0.524 | |
|POLY 6 | P=0.539 P=0.448 P=0.364N P=0.534 | |
|LOGISTIC REGRESSION| P=0.514 P=0.364 P=0.386N P=0.476 | |
|COCH-ARM / FISHERS | P=0.524 P=0.380 P=0.357N P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 37/50 (74%) 28/50 (56%) 24/50 (48%) | |
|POLY-3 ADJUSTED (b)| 57.6% 76.8% 58.1% 49.6% | |
|TERMINAL (d) | 6/24 (25%) 23/30 (77%) 10/20 (50%) 9/28 (32%) | |
|FIRST INCIDENCE | 312 386 400 490 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.083N P=0.350 P=0.466 P=0.226N | |
|POLY 3 | P=0.042N* P=0.032 * P=0.560 P=0.281N | |
|POLY 1.5 | P=0.043N* P=0.039 * P=0.578 P=0.271N | |
|POLY 6 | P=0.045N* P=0.023 * P=0.520 P=0.305N | |
|LOGISTIC REGRESSION| P=0.055N P=0.022 * P=0.584N P=0.379N | |
|COCH-ARM / FISHERS | P=0.049N* P=0.046 * P=0.580N P=0.274N | |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 49
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 44/46 (96%) 45/47 (96%) 40/46 (87%) 43/47 (91%) |46/46 (100%) 46/48 (96%) 47/50 (94%) 48/48 (100%) |
|POLY-3 ADJUSTED (b)| 95.7% 96.5% 91.2% 94.1% |100.0% 96.1% 95.1% 100.0% |
|TERMINAL (d) | 22/23 (96%) 28/28 (100%) 16/17 (94%) 26/27 (96%) |34/34 (100%) 35/36 (97%) 34/35 (97%) 35/35 (100%) |
|FIRST INCIDENCE | 312 386 482 490 |414 403 468 309 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.268N P=0.199N P=0.447 P=0.214N |P=0.320 P=0.402N P=0.536N (e) |
|POLY 3 | P=0.449N P=0.644 P=0.316N P=0.547N |P=0.384 P=0.267N P=0.170N (e) |
|POLY 1.5 | P=0.378N P=0.664 P=0.224N P=0.455N |P=0.378 P=0.256N P=0.151N (e) |
|POLY 6 | P=0.549N P=0.610 P=0.436N P=0.664N |P=0.398 P=0.288N P=0.218N (e) |
|LOGISTIC REGRESSION| P=0.263N P=0.663 P=0.123N P=0.328N |P=0.369 P=0.245N P=0.127N (e) |
|COCH-ARM / FISHERS | P=0.305N P=0.683 P=0.133N P=0.349N |P=0.374 P=0.258N P=0.137N (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 30/50 (60%) 26/50 (52%) 20/50 (40%) |35/50 (70%) 38/50 (76%) 34/50 (68%) 23/50 (46%) |
|POLY-3 ADJUSTED (b)| 46.0% 67.5% 60.0% 44.3% |76.8% 82.7% 71.0% 53.5% |
|TERMINAL (d) | 12/24 (50%) 23/30 (77%) 14/20 (70%) 12/28 (43%) |32/36 (89%) 35/38 (92%) 27/35 (77%) 22/35 (63%) |
|FIRST INCIDENCE | 640 663 508 529 |575 540 526 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.162N P=0.168 P=0.057 P=0.470N |P<0.001N** P=0.485 P=0.544N P=0.008N** |
|POLY 3 | P=0.101N P=0.029 * P=0.132 P=0.523N |P<0.001N** P=0.317 P=0.336N P=0.013N* |
|POLY 1.5 | P=0.133N P=0.027 * P=0.131 P=0.564N |P<0.001N** P=0.317 P=0.401N P=0.012N* |
|POLY 6 | P=0.081N P=0.031 * P=0.123 P=0.498N |P<0.001N** P=0.321 P=0.264N P=0.013N* |
|LOGISTIC REGRESSION| P=0.171N P=0.062 P=0.106 P=0.572N |P<0.001N** P=0.365 P=0.385N P=0.013N* |
|COCH-ARM / FISHERS | P=0.223N P=0.022 * P=0.114 P=0.500 |P<0.001N** P=0.326 P=0.500N P=0.013N* |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 50
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 7.5% 0.0% |2.2% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 3/20 (15%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |665 652 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.592N (e) P=0.089 (e) |P=0.320N P=0.750N P=0.481N P=0.516N |
|POLY 3 | P=0.609N (e) P=0.119 (e) |P=0.307N P=0.758N P=0.495N P=0.509N |
|POLY 1.5 | P=0.609N (e) P=0.121 (e) |P=0.306N P=0.759N P=0.497N P=0.507N |
|POLY 6 | P=0.614N (e) P=0.116 (e) |P=0.308N P=0.757N P=0.494N P=0.512N |
|LOGISTIC REGRESSION| (e) (e) P=0.089 (e) |P=0.283N P=0.762 P=0.519N P=0.491N |
|COCH-ARM / FISHERS | P=0.617N (e) P=0.121 (e) |P=0.303N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 3/4 (75%) |
|POLY-3 ADJUSTED (b)| 100.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 80.3% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 3/3 (100%) |
|FIRST INCIDENCE | 723 --- --- --- |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000 (e) P=1.000N (e) |P=1.000N (e) (e) P=1.000N |
|POLY 3 | (e) (e) P=1.000N (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) P=1.000N (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) P=1.000N (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=1.000N |
|COCH-ARM / FISHERS | P=0.970N (e) P=0.500N (e) |P=1.000N (e) (e) P=1.000 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 51
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 1/20 (5%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 721 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.652N (e) P=0.207 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.670N (e) P=0.239 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.670N (e) P=0.240 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.673N (e) P=0.235 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.667N (e) P=0.221 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.675N (e) P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 0.0% |2.2% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 1/20 (5%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 537 --- |656 --- --- 414 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.656N (e) P=0.222 (e) |P=0.520 P=0.495N P=0.486N P=0.745 |
|POLY 3 | P=0.669N (e) P=0.242 (e) |P=0.529 P=0.499N P=0.495N P=0.754 |
|POLY 1.5 | P=0.669N (e) P=0.242 (e) |P=0.532 P=0.500N P=0.497N P=0.756 |
|POLY 6 | P=0.672N (e) P=0.240 (e) |P=0.527 P=0.499N P=0.494N P=0.753 |
|LOGISTIC REGRESSION| P=0.702N (e) P=0.227 (e) |P=0.681 P=0.501N P=0.524N P=0.675N |
|COCH-ARM / FISHERS | P=0.675N (e) P=0.247 (e) |P=0.536 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 52
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |4.5% 0.0% 8.7% 0.0% |
|TERMINAL (d) | |1/36 (3%) 0/38 (0%) 4/35 (11%) 0/35 (0%) |
|FIRST INCIDENCE | |694 --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.320N P=0.237N P=0.331 P=0.249N |
|POLY 3 | |P=0.325N P=0.236N P=0.350 P=0.247N |
|POLY 1.5 | |P=0.318N P=0.237N P=0.346 P=0.244N |
|POLY 6 | |P=0.332N P=0.234N P=0.353 P=0.250N |
|LOGISTIC REGRESSION| |P=0.322N P=0.235N P=0.356 P=0.246N |
|COCH-ARM / FISHERS | |P=0.304N P=0.247N P=0.339 P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus: Cervix |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |2.2% 0.0% 2.2% 4.7% |
|TERMINAL (d) | |1/36 (3%) 0/38 (0%) 1/35 (3%) 2/35 (6%) |
|FIRST INCIDENCE | |730 (T) --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.217 P=0.489N P=0.756 P=0.490 |
|POLY 3 | |P=0.219 P=0.498N P=0.754N P=0.485 |
|POLY 1.5 | |P=0.223 P=0.499N P=0.756N P=0.489 |
|POLY 6 | |P=0.215 P=0.497N P=0.752N P=0.483 |
|LOGISTIC REGRESSION| |P=0.217 (e) P=0.756 P=0.490 |
|COCH-ARM / FISHERS | |P=0.231 P=0.500N P=0.753N P=0.500 |
|=================================================================================================================================|
Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 53
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 7/50 (14%) 7/50 (14%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| |6.7% 15.5% 15.0% 14.1% |
|TERMINAL (d) | |2/36 (6%) 6/38 (16%) 4/35 (11%) 6/35 (17%) |
|FIRST INCIDENCE | |660 690 625 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.356 P=0.181 P=0.172 P=0.225 |
|POLY 3 | |P=0.352 P=0.160 P=0.174 P=0.218 |
|POLY 1.5 | |P=0.366 P=0.159 P=0.168 P=0.226 |
|POLY 6 | |P=0.339 P=0.161 P=0.181 P=0.211 |
|LOGISTIC REGRESSION| |P=0.353 P=0.163 P=0.162 P=0.216 |
|COCH-ARM / FISHERS | |P=0.397 P=0.159 P=0.159 P=0.243 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM |
| | | |
|=================================================================================================================================|
| |
|Vagina |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/0 (0%) 2/2 (100%) 0/0 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| |0.0% 100.0% 0.0% 0.0% |
|TERMINAL (d) | |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | |--- 403 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |(e) (e) (e) (e) |
|POLY 3 | |(e) (e) (e) (e) |
|POLY 1.5 | |(e) (e) (e) (e) |
|POLY 6 | |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | |(e) (e) (e) (e) |
|=================================================================================================================================|
(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).
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