TDMS Study 05197-11 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest 2-BUTOXYETHANOL DATE: 02/23/98
EXPERIMENT: 05197 TEST: 11 TIME: 09:02:49
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: NO1-ES-15318 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62077D
PATHOLOGIST: GRUMBEIN, S. CAS: 111-76-0002
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest 2-BUTOXYETHANOL DATE: 02/23/98
EXPERIMENT: 05197 TEST: 11 TIME: 09:02:49
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: NO1-ES-15318 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62077D
PATHOLOGIST: GRUMBEIN, S. CAS: 111-76-0002
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF 2-BUTOXYETHANOL
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia
Heart Cardiomyopathy
Heart: Atrium Thrombosis
Kidney Infarct
Liver Degeneration Cystic
Liver: Kupffer Cell Pigmentation
Lung: Alveolar Epithelium Hyperplasia
Nose: Olfactory Epithelium Degeneration Hyaline
Spleen Fibrosis
Stomach, Forestomach Ulcer
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Degeneration Cystic
Hypertrophy
Vacuolization Cytoplasmic
Adrenal Medulla Hyperplasia
Clitoral Gland Hyperplasia
Kidney: Renal Tubule Necrosis
Liver Eosinophilic Focus
Hematopoietic Cell Proliferation
Hepatodiaphragmatic Nodule
Liver: Kupffer Cell Pigmentation
Lung: Alveolar Epithelium Hyperplasia
Nose: Olfactory Epithelium Degeneration Hyaline
Pituitary Gland: Pars Distalis Hyperplasia
Spleen Hematopoietic Cell Proliferation
Pigmentation Hemosiderin
Stomach, Glandular Mineralization
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/49 (6%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 7.8% 5.0% |0.0% 2.3% 2.5% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 2/21 (10%) 1/24 (4%) |0/29 (0%) 0/27 (0%) 1/23 (4%) 0/21 (0%) |
|FIRST INCIDENCE | 642 --- 701 694 |--- 701 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.358 P=0.519N P=0.345 P=0.562 |P=0.665N P=0.488 P=0.454 (e) |
|POLY 3 | P=0.267 P=0.512N P=0.300 P=0.513 |P=0.609N P=0.500 P=0.482 (e) |
|POLY 1.5 | P=0.254 P=0.506N P=0.297 P=0.506 |P=0.601N P=0.500 P=0.489 (e) |
|POLY 6 | P=0.296 P=0.524N P=0.311 P=0.526 |P=0.622N P=0.498 P=0.474 (e) |
|LOGISTIC REGRESSION| P=0.290 P=0.497N P=0.314 P=0.515 |P=0.625N P=0.500 P=0.454 (e) |
|COCH-ARM / FISHERS | P=0.241 P=0.500N P=0.301 P=0.500 |P=0.595N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 2.3% 0.0% 7.3% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 2/21 (10%) |
|FIRST INCIDENCE | --- --- --- --- |--- 722 --- 701 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.023 * P=0.500 (e) P=0.071 |
|POLY 3 | (e) (e) (e) (e) |P=0.039 * P=0.500 (e) P=0.111 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.041 * P=0.500 (e) P=0.115 |
|POLY 6 | (e) (e) (e) (e) |P=0.036 * P=0.497 (e) P=0.103 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.030 * P=0.493 (e) P=0.087 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.044 * P=0.500 (e) P=0.121 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 27/50 (54%) 25/49 (51%) 30/50 (60%) |28/50 (56%) 24/50 (48%) 19/50 (38%) 20/50 (40%) |
|POLY-3 ADJUSTED (b)| 54.1% 62.6% 60.9% 67.8% |61.6% 54.7% 44.8% 46.0% |
|TERMINAL (d) | 11/19 (58%) 10/11 (91%) 16/21 (76%) 20/24 (83%) |20/29 (69%) 21/27 (78%) 10/23 (44%) 12/21 (57%) |
|FIRST INCIDENCE | 529 465 549 481 |558 617 496 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.400N P=0.041 * P=0.570N P=0.399 |P=0.382N P=0.380N P=0.267N P=0.423N |
|POLY 3 | P=0.123 P=0.268 P=0.334 P=0.124 |P=0.065N P=0.322N P=0.079N P=0.095N |
|POLY 1.5 | P=0.118 P=0.279 P=0.342 P=0.119 |P=0.061N P=0.293N P=0.069N P=0.085N |
|POLY 6 | P=0.141 P=0.229 P=0.353 P=0.134 |P=0.078N P=0.386N P=0.092N P=0.123N |
|LOGISTIC REGRESSION| P=0.158 P=0.235 P=0.405 P=0.136 |P=0.095N P=0.277N P=0.097N P=0.111N |
|COCH-ARM / FISHERS | P=0.118 P=0.274 P=0.383 P=0.115 |P=0.059N P=0.274N P=0.054N P=0.080N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) 8/49 (16%) 4/50 (8%) |18/50 (36%) 11/50 (22%) 9/50 (18%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 17.6% 18.3% 19.9% 9.8% |40.8% 24.9% 22.1% 16.8% |
|TERMINAL (d) | 1/19 (5%) 2/11 (18%) 4/21 (19%) 3/24 (13%) |14/29 (48%) 7/27 (26%) 3/23 (13%) 5/21 (24%) |
|FIRST INCIDENCE | 631 561 561 534 |575 638 390 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.111N P=0.422 P=0.565 P=0.187N |P=0.057N P=0.130N P=0.131N P=0.063N |
|POLY 3 | P=0.187N P=0.582 P=0.506 P=0.243N |P=0.010N* P=0.082N P=0.048N* P=0.011N* |
|POLY 1.5 | P=0.203N P=0.599 P=0.490 P=0.252N |P=0.009N** P=0.085N P=0.042N* P=0.009N** |
|POLY 6 | P=0.163N P=0.547 P=0.539 P=0.230N |P=0.013N* P=0.081N P=0.056N P=0.014N* |
|LOGISTIC REGRESSION| P=0.203N P=0.579 P=0.485 P=0.245N |P=0.013N* P=0.093N P=0.059N P=0.018N* |
|COCH-ARM / FISHERS | P=0.219N P=0.613N P=0.483 P=0.262N |P=0.009N** P=0.093N P=0.035N* P=0.010N* |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 1/50 (2%) |0/50 (0%) 3/50 (6%) 4/50 (8%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 2.5% 2.5% |0.0% 6.8% 9.8% 7.2% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 638 --- 370 617 |--- 495 529 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.553 P=0.524N P=0.760 P=0.748N |P=0.143 P=0.128 P=0.055 P=0.107 |
|POLY 3 | P=0.563 P=0.512N P=0.759N P=0.752N |P=0.146 P=0.123 P=0.053 P=0.113 |
|POLY 1.5 | P=0.550 P=0.506N P=0.759 P=0.756N |P=0.154 P=0.122 P=0.055 P=0.116 |
|POLY 6 | P=0.587 P=0.524N P=0.752N P=0.743N |P=0.133 P=0.123 P=0.052 P=0.107 |
|LOGISTIC REGRESSION| P=0.527 P=0.496N P=0.701N P=0.754 |P=0.177 P=0.076 P=0.082 P=0.124 |
|COCH-ARM / FISHERS | P=0.538 P=0.500N P=0.747 P=0.753N |P=0.162 P=0.121 P=0.059 P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 4/49 (8%) 4/50 (8%) |7/50 (14%) 9/50 (18%) 1/50 (2%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 5.1% 5.4% 10.4% 9.7% |16.0% 20.4% 2.5% 12.0% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 2/21 (10%) 2/24 (8%) |4/29 (14%) 5/27 (19%) 1/23 (4%) 2/21 (10%) |
|FIRST INCIDENCE | 683 652 694 576 |652 564 730 (T) 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.362 P=0.606 P=0.391 P=0.419 |P=0.315N P=0.355 P=0.066N P=0.573N |
|POLY 3 | P=0.243 P=0.678 P=0.332 P=0.361 |P=0.182N P=0.399 P=0.041N* P=0.410N |
|POLY 1.5 | P=0.226 P=0.686 P=0.327 P=0.349 |P=0.170N P=0.399 P=0.037N* P=0.394N |
|POLY 6 | P=0.277 P=0.661 P=0.347 P=0.384 |P=0.205N P=0.393 P=0.048N* P=0.444N |
|LOGISTIC REGRESSION| P=0.247 P=0.666 P=0.364 P=0.347 |P=0.192N P=0.391 P=0.047N* P=0.431N |
|COCH-ARM / FISHERS | P=0.210 P=0.691N P=0.329 P=0.339 |P=0.160N P=0.393 P=0.030N* P=0.380N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 22/50 (44%) 31/49 (63%) 27/50 (54%) |11/50 (22%) 11/50 (22%) 8/49 (16%) 17/49 (35%) |
|POLY-3 ADJUSTED (b)| 56.2% 53.4% 71.8% 60.5% |25.0% 24.9% 19.8% 39.6% |
|TERMINAL (d) | 11/19 (58%) 6/11 (55%) 16/21 (76%) 16/24 (67%) |7/29 (24%) 7/27 (26%) 2/22 (9%) 7/21 (33%) |
|FIRST INCIDENCE | 529 533 484 444 |554 495 583 533 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.333N P=0.274 P=0.255 P=0.481N |P=0.030 * P=0.537 P=0.493N P=0.046 * |
|POLY 3 | P=0.270 P=0.487N P=0.084 P=0.418 |P=0.067 P=0.594N P=0.375N P=0.106 |
|POLY 1.5 | P=0.227 P=0.451N P=0.078 P=0.384 |P=0.072 P=0.591N P=0.359N P=0.112 |
|POLY 6 | P=0.358 P=0.550N P=0.114 P=0.478 |P=0.061 P=0.593 P=0.388N P=0.095 |
|LOGISTIC REGRESSION| P=0.243 P=0.495N P=0.085 P=0.381 |P=0.069 P=0.593 P=0.363N P=0.099 |
|COCH-ARM / FISHERS | P=0.191 P=0.421N P=0.092 P=0.345 |P=0.081 P=0.595N P=0.323N P=0.119 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 2/2 (100%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 100.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 722 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 8.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/19 (5%) 1/11 (9%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 729 (T) 722 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.102N P=0.166 P=0.480N P=0.453N |(e) (e) (e) (e) |
|POLY 3 | P=0.147N P=0.286 P=0.500N P=0.492N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.149N P=0.296 P=0.502N P=0.496N |(e) (e) (e) (e) |
|POLY 6 | P=0.143N P=0.267 P=0.493N P=0.484N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.104N P=0.183 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.153N P=0.309 P=0.500N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Hyperostosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |9/50 (18%) 10/50 (20%) 8/50 (16%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.1% 4.9% |20.5% 22.4% 20.0% 21.2% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |5/29 (17%) 6/27 (22%) 4/23 (17%) 4/21 (19%) |
|FIRST INCIDENCE | --- --- 561 628 |652 495 691 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.111 (e) P=0.235 P=0.275 |P=0.352 P=0.451 P=0.515 P=0.395 |
|POLY 3 | P=0.099 (e) P=0.242 P=0.248 |P=0.549N P=0.517 P=0.584N P=0.575 |
|POLY 1.5 | P=0.092 (e) P=0.238 P=0.243 |P=0.526N P=0.513 P=0.553N P=0.590 |
|POLY 6 | P=0.114 (e) P=0.253 P=0.259 |P=0.514 P=0.513 P=0.596 P=0.545 |
|LOGISTIC REGRESSION| P=0.080 (e) P=0.258 P=0.240 |P=0.547 P=0.500 P=0.599 P=0.556 |
|COCH-ARM / FISHERS | P=0.086 (e) P=0.247 P=0.247 |P=0.500N P=0.500 P=0.500N P=0.602N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 4/50 (8%) 6/49 (12%) |5/50 (10%) 4/50 (8%) 3/50 (6%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 12.8% 10.5% 10.0% 14.9% |11.4% 9.3% 7.4% 16.8% |
|TERMINAL (d) | 3/19 (16%) 0/11 (0%) 1/21 (5%) 3/24 (13%) |2/29 (7%) 3/27 (11%) 0/23 (0%) 4/21 (19%) |
|FIRST INCIDENCE | 673 465 461 576 |558 691 583 663 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.559N P=0.588 P=0.452N P=0.620N |P=0.153 P=0.529N P=0.450N P=0.221 |
|POLY 3 | P=0.416 P=0.514N P=0.482N P=0.526 |P=0.239 P=0.513N P=0.405N P=0.340 |
|POLY 1.5 | P=0.394 P=0.505N P=0.495N P=0.506 |P=0.254 P=0.505N P=0.387N P=0.360 |
|POLY 6 | P=0.459 P=0.534N P=0.455N P=0.562 |P=0.216 P=0.527N P=0.425N P=0.305 |
|LOGISTIC REGRESSION| P=0.378 P=0.521N P=0.503N P=0.526 |P=0.249 P=0.500N P=0.336N P=0.350 |
|COCH-ARM / FISHERS | P=0.374 P=0.500N P=0.500N P=0.486 |P=0.270 P=0.500N P=0.357N P=0.380 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |7/46 (15%) 4/45 (9%) 2/44 (5%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| |17.2% 10.2% 5.9% 5.0% |
|TERMINAL (d) | |4/27 (15%) 2/23 (9%) 1/20 (5%) 1/20 (5%) |
|FIRST INCIDENCE | |554 564 688 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.092N P=0.327N P=0.162N P=0.162N |
|POLY 3 | |P=0.048N* P=0.281N P=0.127N P=0.080N |
|POLY 1.5 | |P=0.045N* P=0.276N P=0.111N P=0.074N |
|POLY 6 | |P=0.055N P=0.292N P=0.147N P=0.093N |
|LOGISTIC REGRESSION| |P=0.045N* P=0.273N P=0.125N P=0.073N |
|COCH-ARM / FISHERS | |P=0.042N* P=0.274N P=0.090N P=0.070N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 0/0 (0%) 2/2 (100%) 1/1 (100%) |0/0 (0%) 5/7 (71%) 2/3 (67%) 1/1 (100%) |
|POLY-3 ADJUSTED (b)| 100.0% 0.0% 100.0% 100.0% |0.0% 71.8% 79.5% 100.0% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 1/1 (100%) 1/1 (100%) |0/0 (0%) 4/5 (80%) 1/1 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 617 --- 718 729 (T) |--- 708 496 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.339 P=0.507 P=0.491 (e) |
|POLY 3 | (e) (e) (e) (e) |P=1.000 P=1.000 P=1.000 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=1.000 P=1.000 P=1.000 (e) |
|POLY 6 | (e) (e) (e) (e) |P=1.000 P=1.000 P=1.000 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.657 (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.609 P=1.000 P=1.000 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 0/0 (0%) 2/2 (100%) 1/1 (100%) |0/0 (0%) 5/7 (71%) 1/3 (33%) 1/1 (100%) |
|POLY-3 ADJUSTED (b)| 100.0% 0.0% 100.0% 100.0% |0.0% 71.8% 54.6% 100.0% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 1/1 (100%) 1/1 (100%) |0/0 (0%) 4/5 (80%) 1/1 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 617 --- 718 729 (T) |--- 708 730 (T) 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.346 P=0.507 P=1.000N (e) |
|POLY 3 | (e) (e) (e) (e) |P=1.000N P=1.000N P=1.000 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=1.000N P=1.000N P=1.000 (e) |
|POLY 6 | (e) (e) (e) (e) |P=1.000N P=1.000N P=1.000 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.276 (e) P=1.000N (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.718 P=1.000 P=1.000 (e) |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 44/50 (88%) 39/50 (78%) 41/50 (82%) |34/50 (68%) 31/50 (62%) 34/50 (68%) 30/50 (60%) |
|POLY-3 ADJUSTED (b)| 89.5% 93.1% 87.8% 89.4% |74.0% 67.2% 78.9% 67.8% |
|TERMINAL (d) | 18/19 (95%) 11/11 (100%) 20/21 (95%) 24/24 (100%)|25/29 (86%) 21/27 (78%) 21/23 (91%) 20/21 (95%) |
|FIRST INCIDENCE | 354 465 370 495 |508 495 496 472 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.023N* P=0.054 P=0.223N P=0.146N |P=0.144 P=0.489N P=0.128 P=0.244 |
|POLY 3 | P=0.461N P=0.377 P=0.537N P=0.655N |P=0.387N P=0.305N P=0.371 P=0.327N |
|POLY 1.5 | P=0.402N P=0.381 P=0.450N P=0.585N |P=0.333N P=0.315N P=0.448 P=0.292N |
|POLY 6 | P=0.540N P=0.373 P=0.598N P=0.650 |P=0.495N P=0.299N P=0.298 P=0.409N |
|LOGISTIC REGRESSION| P=0.264N P=0.343 P=0.388N P=0.456N |P=0.396N P=0.327N P=0.314 P=0.346N |
|COCH-ARM / FISHERS | P=0.328N P=0.387 P=0.306N P=0.500N |P=0.283N P=0.338N P=0.585N P=0.266N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 722 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.330N P=0.168 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.405N P=0.225 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.405N P=0.232 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.405N P=0.213 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.346N P=0.170 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 4/50 (8%) 3/50 (6%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 15.9% 10.0% 7.3% |2.3% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 718 627 461 628 |688 495 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.543N P=0.034 * P=0.199 P=0.372 |P=0.220N P=0.489 P=0.523N P=0.530N |
|POLY 3 | P=0.511 P=0.049 * P=0.188 P=0.326 |P=0.198N P=0.504 P=0.519N P=0.510N |
|POLY 1.5 | P=0.486 P=0.053 P=0.182 P=0.315 |P=0.193N P=0.504 P=0.512N P=0.505N |
|POLY 6 | P=0.559 P=0.044 * P=0.205 P=0.346 |P=0.207N P=0.502 P=0.527N P=0.520N |
|LOGISTIC REGRESSION| P=0.465 P=0.044 * P=0.186 P=0.311 |P=0.169N P=0.466 P=0.510N P=0.502N |
|COCH-ARM / FISHERS | P=0.463 P=0.056 P=0.181 P=0.309 |P=0.188N P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/46 (13%) 7/47 (15%) 4/47 (9%) 5/46 (11%) |8/47 (17%) 6/49 (12%) 4/48 (8%) 5/48 (10%) |
|POLY-3 ADJUSTED (b)| 16.1% 19.1% 10.7% 12.9% |18.8% 13.8% 10.2% 12.5% |
|TERMINAL (d) | 5/19 (26%) 2/11 (18%) 4/21 (19%) 2/24 (8%) |5/29 (17%) 1/27 (4%) 4/23 (17%) 4/21 (19%) |
|FIRST INCIDENCE | 617 529 729 (T) 508 |533 652 730 (T) 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.183N P=0.282 P=0.304N P=0.381N |P=0.369N P=0.419N P=0.288N P=0.433N |
|POLY 3 | P=0.322N P=0.483 P=0.367N P=0.475N |P=0.251N P=0.369N P=0.217N P=0.313N |
|POLY 1.5 | P=0.339N P=0.500 P=0.365N P=0.488N |P=0.231N P=0.362N P=0.194N P=0.288N |
|POLY 6 | P=0.289N P=0.458 P=0.360N P=0.447N |P=0.288N P=0.380N P=0.252N P=0.358N |
|LOGISTIC REGRESSION| P=0.336N P=0.459 P=0.321N P=0.497N |P=0.225N P=0.356N P=0.181N P=0.263N |
|COCH-ARM / FISHERS | P=0.353N P=0.517 P=0.356N P=0.500N |P=0.209N P=0.354N P=0.167N P=0.262N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/47 (9%) 4/47 (9%) 4/47 (9%) 4/48 (8%) |4/49 (8%) 5/50 (10%) 2/50 (4%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 10.5% 11.3% 10.7% 10.3% |9.2% 11.6% 5.0% 7.4% |
|TERMINAL (d) | 3/19 (16%) 1/11 (9%) 3/21 (14%) 3/23 (13%) |2/29 (7%) 5/27 (19%) 0/23 (0%) 2/21 (10%) |
|FIRST INCIDENCE | 558 617 701 534 |558 730 (T) 544 695 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.396N P=0.457 P=0.598N P=0.572N |P=0.460N P=0.467 P=0.411N P=0.622N |
|POLY 3 | P=0.542N P=0.607 P=0.638 P=0.631N |P=0.357N P=0.493 P=0.374N P=0.537N |
|POLY 1.5 | P=0.551N P=0.625 P=0.637 P=0.632N |P=0.341N P=0.504 P=0.357N P=0.519N |
|POLY 6 | P=0.520N P=0.578 P=0.646N P=0.621N |P=0.386N P=0.474 P=0.395N P=0.569N |
|LOGISTIC REGRESSION| P=0.529N P=0.600 P=0.632N P=0.632N |P=0.340N P=0.509 P=0.282N P=0.504N |
|COCH-ARM / FISHERS | P=0.557N P=0.643N P=0.643N P=0.631N |P=0.321N P=0.513 P=0.329N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/46 (2%) 2/47 (4%) 6/48 (13%) 3/47 (6%) |1/44 (2%) 4/47 (9%) 3/48 (6%) 4/47 (9%) |
|POLY-3 ADJUSTED (b)| 2.8% 5.7% 15.4% 7.9% |2.6% 9.6% 7.8% 10.0% |
|TERMINAL (d) | 1/18 (6%) 1/11 (9%) 4/21 (19%) 3/23 (13%) |1/26 (4%) 3/27 (11%) 1/22 (5%) 1/21 (5%) |
|FIRST INCIDENCE | 729 (T) 617 565 729 (T) |730 (T) 638 589 462 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.373 P=0.387 P=0.082 P=0.394 |P=0.147 P=0.189 P=0.261 P=0.126 |
|POLY 3 | P=0.240 P=0.493 P=0.067 P=0.324 |P=0.209 P=0.201 P=0.302 P=0.187 |
|POLY 1.5 | P=0.226 P=0.501 P=0.064 P=0.318 |P=0.219 P=0.200 P=0.314 P=0.193 |
|POLY 6 | P=0.273 P=0.479 P=0.075 P=0.338 |P=0.192 P=0.202 P=0.291 P=0.177 |
|LOGISTIC REGRESSION| P=0.275 P=0.473 P=0.074 P=0.394 |P=0.229 P=0.199 P=0.326 P=0.212 |
|COCH-ARM / FISHERS | P=0.216 P=0.508 P=0.062 P=0.317 |P=0.230 P=0.202 P=0.342 P=0.202 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.3% 10.1% 2.5% |4.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 1/21 (5%) 1/24 (4%) |2/29 (7%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 529 617 729 (T) |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.511 P=0.215 P=0.077 P=0.547 |P=0.146N P=0.254N P=0.290N P=0.311N |
|POLY 3 | P=0.455 P=0.229 P=0.062 P=0.508 |P=0.116N P=0.238N P=0.262N P=0.247N |
|POLY 1.5 | P=0.439 P=0.234 P=0.060 P=0.504 |P=0.116N P=0.237N P=0.254N P=0.242N |
|POLY 6 | P=0.490 P=0.220 P=0.069 P=0.516 |P=0.115N P=0.240N P=0.270N P=0.258N |
|LOGISTIC REGRESSION| P=0.424 P=0.242 P=0.062 P=0.547 |P=0.146N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.423 P=0.247 P=0.059 P=0.500 |P=0.116N P=0.247N P=0.253N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 6/50 (12%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.6% 5.4% 2.5% 14.3% |0.0% 2.3% 4.9% 7.1% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 1/24 (4%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 718 610 387 575 |--- 729 390 533 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * P=0.441 P=0.752N P=0.094 |P=0.056 P=0.493 P=0.228 P=0.113 |
|POLY 3 | P=0.022 * P=0.488 P=0.756N P=0.069 |P=0.058 P=0.499 P=0.223 P=0.115 |
|POLY 1.5 | P=0.020 * P=0.494 P=0.760N P=0.062 |P=0.060 P=0.500 P=0.228 P=0.117 |
|POLY 6 | P=0.027 * P=0.475 P=0.748N P=0.083 |P=0.054 P=0.497 P=0.217 P=0.110 |
|LOGISTIC REGRESSION| P=0.015 * P=0.494 P=0.720N P=0.056 |P=0.063 P=0.489 P=0.359 P=0.119 |
|COCH-ARM / FISHERS | P=0.019 * P=0.500 P=0.753N P=0.056 |P=0.062 P=0.500 P=0.247 P=0.121 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 722 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.330N P=0.168 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.405N P=0.225 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.405N P=0.232 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.405N P=0.213 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.346N P=0.170 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 50/50 (100%) 49/50 (98%) 50/50 (100%)|47/50 (94%) 48/50 (96%) 43/50 (86%) 46/50 (92%) |
|POLY-3 ADJUSTED (b)| 97.8% 100.0% 99.5% 100.0% |96.9% 98.1% 93.3% 95.2% |
|TERMINAL (d) | 19/19 (100%) 11/11 (100%) 21/21 (100%) 24/24 (100%)|29/29 (100%) 27/27 (100%) 22/23 (96%) 21/21 (100%) |
|FIRST INCIDENCE | 354 465 340 444 |400 495 390 462 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.081N P=0.060 P=0.434N P=0.275N |P=0.077 P=0.348 P=0.279 P=0.088 |
|POLY 3 | P=0.258 P=0.462 P=0.589 P=0.462 |P=0.295N P=0.654 P=0.330N P=0.543N |
|POLY 1.5 | P=0.205 P=0.330 P=0.520 P=0.330 |P=0.293N P=0.571 P=0.256N P=0.514N |
|POLY 6 | P=0.479 P=0.780 P=0.817 P=0.780 |P=0.326N P=0.833 P=0.422N P=0.637N |
|LOGISTIC REGRESSION| P=0.178 P=0.236 P=0.411 P=0.253 |P=0.357N P=0.614 P=0.387N P=0.520N |
|COCH-ARM / FISHERS | P=0.188 P=0.247 P=0.500 P=0.247 |P=0.298N P=0.500 P=0.159N P=0.500N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.8% 2.7% 0.0% 2.5% |2.3% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 3/19 (16%) 0/11 (0%) 0/21 (0%) 1/24 (4%) |0/29 (0%) 1/27 (4%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 729 (T) 722 --- 729 (T) |533 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.126N P=0.490N P=0.101N P=0.222N |P=0.264N P=0.755 P=0.517N P=0.500N |
|POLY 3 | P=0.190N P=0.322N P=0.117N P=0.290N |P=0.245N P=0.757 P=0.521N P=0.512N |
|POLY 1.5 | P=0.196N P=0.313N P=0.120N P=0.298N |P=0.241N P=0.759 P=0.513N P=0.506N |
|POLY 6 | P=0.180N P=0.341N P=0.110N P=0.274N |P=0.251N P=0.753 P=0.530N P=0.522N |
|LOGISTIC REGRESSION| P=0.127N P=0.445N (e) P=0.222N |P=0.219N P=0.746 P=0.385N P=0.532N |
|COCH-ARM / FISHERS | P=0.200N P=0.309N P=0.121N P=0.309N |P=0.235N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.4% 0.0% 0.0% |0.0% 0.0% 0.0% 4.8% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- 633 --- --- |--- --- --- 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.368N P=0.202 (e) (e) |P=0.039 * (e) (e) P=0.207 |
|POLY 3 | P=0.403N P=0.227 (e) (e) |P=0.043 * (e) (e) P=0.230 |
|POLY 1.5 | P=0.404N P=0.233 (e) (e) |P=0.044 * (e) (e) P=0.234 |
|POLY 6 | P=0.401N P=0.218 (e) (e) |P=0.042 * (e) (e) P=0.221 |
|LOGISTIC REGRESSION| P=0.401N P=0.230 (e) (e) |P=0.046 * (e) (e) P=0.244 |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Larynx: Epiglottis |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) |1/50 (2%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 9.3% 5.1% 2.4% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |1/29 (3%) 4/27 (15%) 1/23 (4%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 730 (T) 688 662 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.516N P=0.156 P=0.433 P=0.725 |
|POLY 3 | (e) (e) (e) (e) |P=0.427N P=0.177 P=0.470 P=0.752 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.415N P=0.179 P=0.481 P=0.757 |
|POLY 6 | (e) (e) (e) (e) |P=0.450N P=0.172 P=0.458 P=0.743 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.466N P=0.156 P=0.449 P=0.756 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.403N P=0.181 P=0.500 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.6% 2.7% 5.2% 2.5% |4.6% 4.6% 0.0% 2.4% |
|TERMINAL (d) | 1/19 (5%) 0/11 (0%) 2/21 (10%) 1/24 (4%) |2/29 (7%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 729 (T) 652 729 (T) 729 (T) |730 (T) 606 --- 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.519N P=0.701 P=0.535 P=0.710N |P=0.378N P=0.676 P=0.290N P=0.617N |
|POLY 3 | P=0.616 P=0.752 P=0.500 P=0.752N |P=0.310N P=0.691N P=0.257N P=0.515N |
|POLY 1.5 | P=0.603 P=0.756 P=0.497 P=0.756N |P=0.304N P=0.691N P=0.250N P=0.507N |
|POLY 6 | P=0.609N P=0.742 P=0.512 P=0.743N |P=0.320N P=0.692N P=0.267N P=0.530N |
|LOGISTIC REGRESSION| P=0.576N P=0.742 P=0.535 P=0.710N |P=0.308N P=0.695N (e) P=0.571N |
|COCH-ARM / FISHERS | P=0.591 P=0.753N P=0.500 P=0.753N |P=0.296N P=0.691N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 21/50 (42%) 25/50 (50%) 27/50 (54%) |39/50 (78%) 41/50 (82%) 41/50 (82%) 38/50 (76%) |
|POLY-3 ADJUSTED (b)| 62.6% 53.5% 61.5% 62.3% |82.4% 86.5% 88.9% 82.4% |
|TERMINAL (d) | 14/19 (74%) 9/11 (82%) 18/21 (86%) 19/24 (79%) |25/29 (86%) 27/27 (100%) 23/23 (100%) 20/21 (95%) |
|FIRST INCIDENCE | 558 610 340 481 |508 495 247 472 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.135N P=0.343 P=0.314N P=0.282N |P=0.072 P=0.285 P=0.070 P=0.109 |
|POLY 3 | P=0.438 P=0.255N P=0.553N P=0.583N |P=0.521N P=0.389 P=0.255 P=0.612N |
|POLY 1.5 | P=0.379 P=0.227N P=0.535N P=0.558 |P=0.454N P=0.402 P=0.320 P=0.553N |
|POLY 6 | P=0.544 P=0.330N P=0.567N P=0.532N |P=0.492 P=0.360 P=0.169 P=0.541 |
|LOGISTIC REGRESSION| P=0.520 P=0.357N P=0.446N P=0.559N |P=0.477N P=0.419 P=0.244 P=0.567N |
|COCH-ARM / FISHERS | P=0.325 P=0.212N P=0.500N P=0.500 |P=0.395N P=0.402 P=0.402 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 7/50 (14%) 13/50 (26%) 9/50 (18%) |12/50 (24%) 8/50 (16%) 5/50 (10%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 25.9% 19.0% 33.6% 22.4% |27.8% 18.6% 12.4% 21.8% |
|TERMINAL (d) | 10/19 (53%) 6/11 (55%) 13/21 (62%) 9/24 (38%) |11/29 (38%) 8/27 (30%) 4/23 (17%) 9/21 (43%) |
|FIRST INCIDENCE | 729 (T) 677 729 (T) 729 (T) |710 730 (T) 462 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.145N P=0.445 P=0.394 P=0.250N |P=0.529 P=0.271N P=0.125N P=0.565 |
|POLY 3 | P=0.518N P=0.326N P=0.307 P=0.459N |P=0.317N P=0.224N P=0.068N P=0.351N |
|POLY 1.5 | P=0.547 P=0.310N P=0.303 P=0.480N |P=0.301N P=0.223N P=0.063N P=0.330N |
|POLY 6 | P=0.441N P=0.361N P=0.334 P=0.415N |P=0.350N P=0.231N P=0.077N P=0.398N |
|LOGISTIC REGRESSION| P=0.177N P=0.607N P=0.394 P=0.250N |P=0.459N P=0.255N P=0.091N P=0.567 |
|COCH-ARM / FISHERS | P=0.512 P=0.298N P=0.318 P=0.500N |P=0.283N P=0.227N P=0.054N P=0.312N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 15/50 (30%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 17.9% 16.0% 38.0% 14.8% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 5/19 (26%) 1/11 (9%) 10/21 (48%) 4/24 (17%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 617 579 644 654 |--- --- --- 663 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256N P=0.459 P=0.075 P=0.341N |P=0.197 (e) (e) P=0.495 |
|POLY 3 | P=0.512N P=0.536N P=0.036 * P=0.471N |P=0.194 (e) (e) P=0.492 |
|POLY 1.5 | P=0.547N P=0.516N P=0.037 * P=0.486N |P=0.196 (e) (e) P=0.496 |
|POLY 6 | P=0.440N P=0.573N P=0.041 * P=0.440N |P=0.189 (e) (e) P=0.484 |
|LOGISTIC REGRESSION| P=0.399N P=0.613N P=0.054 P=0.410N |P=0.200 (e) (e) P=0.505 |
|COCH-ARM / FISHERS | P=0.525 P=0.500N P=0.045 * P=0.500N |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 3/50 (6%) 4/50 (8%) |13/50 (26%) 10/50 (20%) 6/50 (12%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 15.2% 10.8% 7.7% 9.9% |29.9% 23.1% 15.2% 12.0% |
|TERMINAL (d) | 3/19 (16%) 2/11 (18%) 0/21 (0%) 4/24 (17%) |9/29 (31%) 9/27 (33%) 5/23 (22%) 4/21 (19%) |
|FIRST INCIDENCE | 617 674 673 729 (T) |687 655 708 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.166N P=0.601N P=0.208N P=0.251N |P=0.079N P=0.388N P=0.168N P=0.135N |
|POLY 3 | P=0.294N P=0.407N P=0.242N P=0.354N |P=0.020N* P=0.317N P=0.088N P=0.036N* |
|POLY 1.5 | P=0.308N P=0.387N P=0.247N P=0.362N |P=0.019N* P=0.314N P=0.077N P=0.034N* |
|POLY 6 | P=0.269N P=0.445N P=0.226N P=0.338N |P=0.025N* P=0.329N P=0.105N P=0.044N* |
|LOGISTIC REGRESSION| P=0.237N P=0.451N P=0.233N P=0.302N |P=0.042N* P=0.347N P=0.126N P=0.064N |
|COCH-ARM / FISHERS | P=0.319N P=0.370N P=0.243N P=0.370N |P=0.018N* P=0.318N P=0.062N P=0.033N* |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 10/50 (20%) 6/50 (12%) 3/50 (6%) |11/50 (22%) 12/50 (24%) 12/50 (24%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 16.8% 25.2% 14.6% 7.2% |23.7% 25.8% 27.6% 13.9% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |3/29 (10%) 3/27 (11%) 1/23 (4%) 0/21 (0%) |
|FIRST INCIDENCE | 521 533 387 444 |400 495 390 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054N P=0.245 P=0.490N P=0.156N |P=0.199N P=0.479 P=0.370 P=0.221N |
|POLY 3 | P=0.058N P=0.256 P=0.509N P=0.151N |P=0.145N P=0.503 P=0.429 P=0.180N |
|POLY 1.5 | P=0.062N P=0.276 P=0.510N P=0.154N |P=0.125N P=0.503 P=0.452 P=0.163N |
|POLY 6 | P=0.050N P=0.227 P=0.497N P=0.144N |P=0.179N P=0.497 P=0.407 P=0.209N |
|LOGISTIC REGRESSION| P=0.072N P=0.325 P=0.433N P=0.162N |P=0.062N P=0.483 P=0.529N P=0.107N |
|COCH-ARM / FISHERS | P=0.068N P=0.298 P=0.500N P=0.159N |P=0.101N P=0.500 P=0.500 P=0.143N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |4/50 (8%) 5/50 (10%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 8.0% 0.0% 2.5% |9.2% 11.6% 2.5% 0.0% |
|TERMINAL (d) | 1/19 (5%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |2/29 (7%) 4/27 (15%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 708 617 --- 723 |708 667 583 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.175N P=0.396 P=0.215N P=0.418N |P=0.040N* P=0.454 P=0.256N P=0.125N |
|POLY 3 | P=0.233N P=0.485 P=0.237N P=0.486N |P=0.020N* P=0.500 P=0.203N P=0.066N |
|POLY 1.5 | P=0.238N P=0.493 P=0.239N P=0.493N |P=0.019N* P=0.501 P=0.194N P=0.063N |
|POLY 6 | P=0.223N P=0.469 P=0.229N P=0.472N |P=0.023N* P=0.493 P=0.214N P=0.073N |
|LOGISTIC REGRESSION| P=0.221N P=0.470 P=0.215N P=0.439N |P=0.023N* P=0.483 P=0.198N P=0.087N |
|COCH-ARM / FISHERS | P=0.242N P=0.500 P=0.247N P=0.500N |P=0.019N* P=0.500 P=0.181N P=0.059N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |9/50 (18%) 6/50 (12%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.6% 5.4% 0.0% 2.5% |19.6% 13.6% 7.4% 2.4% |
|TERMINAL (d) | 1/19 (5%) 1/11 (9%) 0/21 (0%) 1/24 (4%) |4/29 (14%) 2/27 (7%) 1/23 (4%) 1/21 (5%) |
|FIRST INCIDENCE | 729 (T) 723 --- 729 (T) |400 544 583 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.379N P=0.332 P=0.480N P=0.710N |P=0.011N* P=0.324N P=0.114N P=0.022N* |
|POLY 3 | P=0.493N P=0.482 P=0.500N P=0.752N |P=0.006N** P=0.312N P=0.092N P=0.013N* |
|POLY 1.5 | P=0.497N P=0.492 P=0.502N P=0.756N |P=0.005N** P=0.301N P=0.079N P=0.010N* |
|POLY 6 | P=0.486N P=0.464 P=0.493N P=0.743N |P=0.008N** P=0.328N P=0.108N P=0.017N* |
|LOGISTIC REGRESSION| P=0.388N P=0.367 (e) P=0.710N |P=0.003N** P=0.304N P=0.031N* P=0.007N** |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.500N P=0.753N |P=0.004N** P=0.288N P=0.061N P=0.008N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |6/50 (12%) 2/50 (4%) 4/50 (8%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 2.6% 2.5% |13.8% 4.6% 10.0% 9.7% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 1/24 (4%) |5/29 (17%) 1/27 (4%) 3/23 (13%) 4/21 (19%) |
|FIRST INCIDENCE | --- 617 627 729 (T) |617 722 544 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.434 P=0.500 P=0.500 P=0.547 |P=0.532 P=0.155N P=0.502N P=0.562N |
|POLY 3 | P=0.403 P=0.492 P=0.502 P=0.508 |P=0.461N P=0.135N P=0.423N P=0.403N |
|POLY 1.5 | P=0.394 P=0.496 P=0.499 P=0.504 |P=0.447N P=0.134N P=0.403N P=0.386N |
|POLY 6 | P=0.422 P=0.483 P=0.510 P=0.516 |P=0.486N P=0.140N P=0.447N P=0.438N |
|LOGISTIC REGRESSION| P=0.384 P=0.505 P=0.507 P=0.547 |P=0.498N P=0.138N P=0.425N P=0.474N |
|COCH-ARM / FISHERS | P=0.384 P=0.500 P=0.500 P=0.500 |P=0.430N P=0.134N P=0.370N P=0.370N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 9/50 (18%) 4/50 (8%) 11/50 (22%) |3/50 (6%) 4/50 (8%) 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 17.1% 23.0% 10.1% 25.8% |6.9% 9.1% 7.4% 7.2% |
|TERMINAL (d) | 1/19 (5%) 1/11 (9%) 0/21 (0%) 2/24 (8%) |1/29 (3%) 0/27 (0%) 0/23 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 354 579 627 575 |648 495 586 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.400 P=0.273 P=0.239N P=0.334 |P=0.538 P=0.484 P=0.598 P=0.579 |
|POLY 3 | P=0.245 P=0.347 P=0.279N P=0.237 |P=0.550N P=0.503 P=0.625 P=0.643 |
|POLY 1.5 | P=0.230 P=0.367 P=0.278N P=0.224 |P=0.535N P=0.504 P=0.638 P=0.653 |
|POLY 6 | P=0.283 P=0.318 P=0.268N P=0.271 |P=0.574 P=0.497 P=0.611 P=0.621 |
|LOGISTIC REGRESSION| P=0.218 P=0.412 P=0.248N P=0.203 |P=0.501N P=0.489 P=0.642N P=0.656N |
|COCH-ARM / FISHERS | P=0.224 P=0.393 P=0.262N P=0.218 |P=0.519N P=0.500 P=0.661N P=0.661N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 10.0% 0.0% |2.3% 0.0% 0.0% 7.2% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |1/29 (3%) 0/27 (0%) 0/23 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 648 --- 561 --- |730 (T) --- --- 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482N P=0.513N P=0.208 P=0.476N |P=0.061 P=0.514N P=0.546N P=0.234 |
|POLY 3 | P=0.499N P=0.512N P=0.185 P=0.493N |P=0.080 P=0.501N P=0.518N P=0.292 |
|POLY 1.5 | P=0.515N P=0.506N P=0.179 P=0.497N |P=0.082 P=0.500N P=0.511N P=0.299 |
|POLY 6 | P=0.466N P=0.524N P=0.200 P=0.487N |P=0.077 P=0.503N P=0.526N P=0.278 |
|LOGISTIC REGRESSION| P=0.539N P=0.498N P=0.183 P=0.504N |P=0.079 (e) (e) P=0.288 |
|COCH-ARM / FISHERS | P=0.531N P=0.500N P=0.181 P=0.500N |P=0.086 P=0.500N P=0.500N P=0.309 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 29/50 (58%) 30/50 (60%) 36/50 (72%) |8/50 (16%) 8/50 (16%) 8/50 (16%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 62.6% 63.2% 68.6% 77.2% |18.2% 17.8% 19.0% 11.8% |
|TERMINAL (d) | 10/19 (53%) 4/11 (36%) 12/21 (57%) 17/24 (71%) |5/29 (17%) 4/27 (15%) 1/23 (4%) 1/21 (5%) |
|FIRST INCIDENCE | 529 465 484 481 |554 495 390 533 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.506 P=0.201 P=0.554N P=0.381 |P=0.371N P=0.570 P=0.463 P=0.430N |
|POLY 3 | P=0.050 P=0.564 P=0.351 P=0.087 |P=0.246N P=0.593N P=0.573 P=0.296N |
|POLY 1.5 | P=0.046 * P=0.544 P=0.362 P=0.077 |P=0.232N P=0.596N P=0.584 P=0.285N |
|POLY 6 | P=0.066 P=0.576 P=0.376 P=0.113 |P=0.272N P=0.597N P=0.561 P=0.320N |
|LOGISTIC REGRESSION| P=0.056 P=0.522 P=0.396 P=0.079 |P=0.189N P=0.603 P=0.558N P=0.272N |
|COCH-ARM / FISHERS | P=0.050 P=0.500 P=0.420 P=0.072 |P=0.217N P=0.607N P=0.607N P=0.277N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 9/50 (18%) 5/50 (10%) 4/50 (8%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 10.1% 23.0% 12.4% 9.5% |4.5% 2.3% 2.5% 11.6% |
|TERMINAL (d) | 1/19 (5%) 0/11 (0%) 2/21 (10%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 558 544 461 481 |508 561 666 541 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.253N P=0.075 P=0.528 P=0.585N |P=0.071 P=0.495N P=0.536N P=0.206 |
|POLY 3 | P=0.302N P=0.103 P=0.510 P=0.613N |P=0.068 P=0.506N P=0.539N P=0.202 |
|POLY 1.5 | P=0.326N P=0.110 P=0.501 P=0.627N |P=0.070 P=0.503N P=0.524N P=0.210 |
|POLY 6 | P=0.263N P=0.094 P=0.533 P=0.587N |P=0.064 P=0.513N P=0.555N P=0.190 |
|LOGISTIC REGRESSION| P=0.369N P=0.118 P=0.513 P=0.623 |P=0.080 P=0.654N P=0.371N P=0.217 |
|COCH-ARM / FISHERS | P=0.351N P=0.117 P=0.500 P=0.643N |P=0.075 P=0.500N P=0.500N P=0.218 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 30/50 (60%) 34/50 (68%) 42/50 (84%) |15/50 (30%) 19/50 (38%) 36/50 (72%) 47/50 (94%) |
|POLY-3 ADJUSTED (b)| 51.6% 67.8% 75.0% 90.1% |32.8% 39.4% 77.7% 94.7% |
|TERMINAL (d) | 5/19 (26%) 5/11 (46%) 15/21 (71%) 23/24 (96%) |6/29 (21%) 4/27 (15%) 17/23 (74%) 20/21 (95%) |
|FIRST INCIDENCE | 558 479 340 481 |508 495 390 462 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.086 P=0.054 P=0.122 P=0.031 * |P<0.001 ** P=0.266 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.080 P=0.013 * P<0.001 ** |P<0.001 ** P=0.327 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.097 P=0.015 * P<0.001 ** |P<0.001 ** P=0.303 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.057 P=0.014 * P<0.001 ** |P<0.001 ** P=0.352 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.113 P=0.021 * P<0.001 ** |P<0.001 ** P=0.250 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.115 P=0.021 * P<0.001 ** |P<0.001 ** P=0.263 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 2.7% 5.2% 0.0% |0.0% 4.6% 2.5% 0.0% |
|TERMINAL (d) | 1/19 (5%) 1/11 (9%) 1/21 (5%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/20 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 708 --- |--- 652 666 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.268N P=0.636 P=0.538 P=0.453N |P=0.504N P=0.236 P=0.477 (e) |
|POLY 3 | P=0.346N P=0.750 P=0.501 P=0.492N |P=0.486N P=0.238 P=0.483 (e) |
|POLY 1.5 | P=0.357N P=0.756 P=0.498 P=0.496N |P=0.476N P=0.238 P=0.489 (e) |
|POLY 6 | P=0.326N P=0.738 P=0.514 P=0.484N |P=0.504N P=0.237 P=0.477 (e) |
|LOGISTIC REGRESSION| P=0.283N P=0.636 P=0.539 (e) |P=0.463N P=0.236 P=0.505 (e) |
|COCH-ARM / FISHERS | P=0.366N P=0.753N P=0.500 P=0.500N |P=0.466N P=0.247 P=0.500 (e) |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 3/50 (6%) |11/50 (22%) 11/50 (22%) 9/50 (18%) 13/49 (27%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 7.5% 7.5% |24.6% 25.0% 22.3% 31.5% |
|TERMINAL (d) | 0/19 (0%) 1/11 (9%) 1/21 (5%) 3/24 (13%) |6/29 (21%) 6/27 (22%) 6/23 (26%) 7/20 (35%) |
|FIRST INCIDENCE | --- 729 (T) 340 729 (T) |533 610 583 663 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.128 P=0.391 P=0.132 P=0.163 |P=0.130 P=0.541 P=0.595 P=0.163 |
|POLY 3 | P=0.077 P=0.490 P=0.124 P=0.125 |P=0.270 P=0.582 P=0.500N P=0.317 |
|POLY 1.5 | P=0.072 P=0.495 P=0.121 P=0.122 |P=0.303 P=0.589 P=0.463N P=0.350 |
|POLY 6 | P=0.088 P=0.479 P=0.132 P=0.132 |P=0.223 P=0.568 P=0.543N P=0.266 |
|LOGISTIC REGRESSION| P=0.067 P=0.391 P=0.147 P=0.163 |P=0.277 P=0.595N P=0.460N P=0.332 |
|COCH-ARM / FISHERS | P=0.067 P=0.500 P=0.121 P=0.121 |P=0.343 P=0.595N P=0.402N P=0.385 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/20 (0%) |
|FIRST INCIDENCE | --- 722 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.330N P=0.168 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.405N P=0.225 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.405N P=0.232 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.405N P=0.213 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.346N P=0.170 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 13/50 (26%) 6/50 (12%) 14/50 (28%) |17/50 (34%) 7/50 (14%) 8/50 (16%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| 12.9% 32.9% 15.4% 32.5% |38.5% 16.1% 19.5% 12.2% |
|TERMINAL (d) | 3/19 (16%) 6/11 (55%) 4/21 (19%) 8/24 (33%) |11/29 (38%) 6/27 (22%) 4/23 (17%) 2/20 (10%) |
|FIRST INCIDENCE | 687 479 666 444 |638 584 496 662 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.206 P=0.005 ** P=0.580 P=0.059 |P=0.034N* P=0.029N* P=0.113N P=0.033N* |
|POLY 3 | P=0.070 P=0.028 * P=0.502 P=0.029 * |P=0.006N** P=0.015N* P=0.042N* P=0.004N** |
|POLY 1.5 | P=0.058 P=0.031 * P=0.495 P=0.024 * |P=0.006N** P=0.015N* P=0.037N* P=0.004N** |
|POLY 6 | P=0.100 P=0.023 * P=0.527 P=0.041 * |P=0.007N** P=0.016N* P=0.049N* P=0.006N** |
|LOGISTIC REGRESSION| P=0.062 P=0.025 * P=0.559 P=0.023 * |P=0.009N** P=0.017N* P=0.050N P=0.008N** |
|COCH-ARM / FISHERS | P=0.050 P=0.033 * P=0.500 P=0.020 * |P=0.006N** P=0.017N* P=0.032N* P=0.004N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Artery |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 5.1% 0.0% 0.0% 0.0% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/20 (0%) |
|FIRST INCIDENCE | 597 --- --- --- |--- 553 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.114N P=0.259N P=0.243N P=0.234N |P=0.572N P=0.504 (e) (e) |
|POLY 3 | P=0.108N P=0.253N P=0.241N P=0.232N |P=0.578N P=0.502 (e) (e) |
|POLY 1.5 | P=0.111N P=0.245N P=0.241N P=0.235N |P=0.574N P=0.502 (e) (e) |
|POLY 6 | P=0.103N P=0.269N P=0.237N P=0.226N |P=0.585N P=0.501 (e) (e) |
|LOGISTIC REGRESSION| P=0.114N P=0.231N P=0.224N P=0.247N |P=0.555N P=0.408 (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.570N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Artery, Mediastinum |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/20 (0%) |
|FIRST INCIDENCE | --- 722 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.330N P=0.168 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.405N P=0.225 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.405N P=0.232 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.405N P=0.213 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.346N P=0.170 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/44 (0%) 0/40 (0%) 1/44 (2%) 1/45 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.9% 2.8% |0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/9 (0%) 0/18 (0%) 1/21 (5%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- 716 729 (T) |--- 655 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326 (e) P=0.528 P=0.567 |P=0.440N P=0.243 (e) (e) |
|POLY 3 | P=0.270 (e) P=0.508 P=0.515 |P=0.420N P=0.238 (e) (e) |
|POLY 1.5 | P=0.259 (e) P=0.503 P=0.510 |P=0.414N P=0.238 (e) (e) |
|POLY 6 | P=0.294 (e) P=0.518 P=0.526 |P=0.432N P=0.236 (e) (e) |
|LOGISTIC REGRESSION| P=0.320 (e) P=0.533 P=0.567 |P=0.412N P=0.238 (e) (e) |
|COCH-ARM / FISHERS | P=0.247 (e) P=0.500 P=0.506 |P=0.409N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/8 (100%) 6/6 (100%) 11/15 (73%) 8/8 (100%) |12/12 (100%) 9/9 (100%) 6/8 (75%) 3/3 (100%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 78.2% 100.0% |100.0% 100.0% 77.7% 100.0% |
|TERMINAL (d) | 2/2 (100%) 1/1 (100%) 4/4 (100%) 5/5 (100%) |9/9 (100%) 3/3 (100%) 3/3 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 521 533 644 628 |617 495 544 612 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.147N (e) P=0.578 (e) |P=0.348N (e) P=0.583 (e) |
|POLY 3 | P=0.596N (e) P=0.200N (e) |P=0.380N (e) P=0.160N (e) |
|POLY 1.5 | P=0.581N (e) P=0.175N (e) |P=0.355N (e) P=0.146N (e) |
|POLY 6 | P=0.614N (e) P=0.234N (e) |P=0.437N (e) P=0.194N (e) |
|LOGISTIC REGRESSION| P=0.447N (e) P=0.120N (e) |P=0.328N (e) P=0.151N (e) |
|COCH-ARM / FISHERS | P=0.554N (e) P=0.154N (e) |P=0.338N (e) P=0.147N (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/48 (15%) 7/49 (14%) 10/49 (20%) 5/50 (10%) |9/50 (18%) 8/48 (17%) 5/50 (10%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 17.6% 18.6% 25.0% 12.2% |20.6% 19.0% 12.5% 9.8% |
|TERMINAL (d) | 1/19 (5%) 1/11 (9%) 4/21 (19%) 3/24 (13%) |6/29 (21%) 5/27 (19%) 2/23 (9%) 3/21 (14%) |
|FIRST INCIDENCE | 529 575 370 495 |617 606 619 689 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.197N P=0.431 P=0.355 P=0.299N |P=0.181N P=0.553N P=0.336N P=0.256N |
|POLY 3 | P=0.308N P=0.570 P=0.294 P=0.355N |P=0.085N P=0.534N P=0.242N P=0.142N |
|POLY 1.5 | P=0.318N P=0.599 P=0.297 P=0.354N |P=0.077N P=0.533N P=0.224N P=0.132N |
|POLY 6 | P=0.285N P=0.521 P=0.305 P=0.349N |P=0.100N P=0.540N P=0.265N P=0.164N |
|LOGISTIC REGRESSION| P=0.325N P=0.595N P=0.324 P=0.355N |P=0.097N P=0.535N P=0.256N P=0.168N |
|COCH-ARM / FISHERS | P=0.325N P=0.597N P=0.314 P=0.351N |P=0.069N P=0.537N P=0.194N P=0.125N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |3/50 (6%) 0/48 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.9% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |2/29 (7%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- --- --- |533 --- 583 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.107N P=0.130N P=0.364N P=0.162N |
|POLY 3 | (e) (e) (e) (e) |P=0.090N P=0.127N P=0.338N P=0.133N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.088N P=0.127N P=0.326N P=0.128N |
|POLY 6 | (e) (e) (e) (e) |P=0.092N P=0.129N P=0.352N P=0.142N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.077N P=0.132N P=0.265N P=0.119N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.087N P=0.129N P=0.309N P=0.125N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/48 (15%) 13/49 (27%) 11/49 (22%) 10/50 (20%) |2/50 (4%) 4/48 (8%) 6/50 (12%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| 17.2% 32.5% 26.2% 23.2% |4.5% 9.2% 14.6% 11.9% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 1/21 (5%) 1/24 (4%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 354 533 387 481 |508 495 586 571 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.521N P=0.084 P=0.266 P=0.405 |P=0.153 P=0.341 P=0.104 P=0.208 |
|POLY 3 | P=0.463 P=0.088 P=0.234 P=0.340 |P=0.158 P=0.329 P=0.108 P=0.194 |
|POLY 1.5 | P=0.443 P=0.098 P=0.227 P=0.332 |P=0.168 P=0.326 P=0.116 P=0.201 |
|POLY 6 | P=0.511 P=0.076 P=0.259 P=0.366 |P=0.142 P=0.331 P=0.101 P=0.183 |
|LOGISTIC REGRESSION| P=0.408 P=0.141 P=0.307 P=0.316 |P=0.209 P=0.201 P=0.177 P=0.215 |
|COCH-ARM / FISHERS | P=0.434 P=0.114 P=0.232 P=0.330 |P=0.181 P=0.319 P=0.134 P=0.210 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/48 (27%) 21/49 (43%) 23/49 (47%) 40/50 (80%) |13/50 (26%) 18/48 (38%) 28/50 (56%) 40/49 (82%) |
|POLY-3 ADJUSTED (b)| 31.0% 50.9% 52.3% 81.1% |28.3% 40.9% 60.4% 83.6% |
|TERMINAL (d) | 2/19 (11%) 5/11 (46%) 8/21 (38%) 17/24 (71%) |5/29 (17%) 9/27 (33%) 11/23 (48%) 17/21 (81%) |
|FIRST INCIDENCE | 529 536 370 444 |533 564 390 462 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.035 * P=0.079 P<0.001 ** |P<0.001 ** P=0.192 P=0.002 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.045 * P=0.032 * P<0.001 ** |P<0.001 ** P=0.149 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.058 P=0.031 * P<0.001 ** |P<0.001 ** P=0.153 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.032 * P=0.038 * P<0.001 ** |P<0.001 ** P=0.141 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.088 P=0.042 * P<0.001 ** |P<0.001 ** P=0.153 P=0.004 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.078 P=0.034 * P<0.001 ** |P<0.001 ** P=0.157 P=0.002 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 5/49 (10%) 2/49 (4%) 3/50 (6%) |3/50 (6%) 2/48 (4%) 0/50 (0%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 10.4% 13.5% 5.3% 7.3% |6.9% 4.8% 0.0% 7.4% |
|TERMINAL (d) | 1/19 (5%) 1/11 (9%) 0/21 (0%) 1/24 (4%) |2/29 (7%) 2/27 (7%) 0/23 (0%) 2/21 (10%) |
|FIRST INCIDENCE | 563 617 687 517 |617 730 (T) --- 689 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.210N P=0.349 P=0.305N P=0.421N |P=0.483 P=0.528N P=0.159N P=0.548 |
|POLY 3 | P=0.286N P=0.478 P=0.341N P=0.465N |P=0.572 P=0.521N P=0.137N P=0.631 |
|POLY 1.5 | P=0.295N P=0.495 P=0.340N P=0.472N |P=0.582 P=0.519N P=0.130N P=0.642 |
|POLY 6 | P=0.267N P=0.449 P=0.334N P=0.450N |P=0.556 P=0.526N P=0.146N P=0.609 |
|LOGISTIC REGRESSION| P=0.292N P=0.480 P=0.335N P=0.477N |P=0.548 P=0.517N P=0.130N P=0.627 |
|COCH-ARM / FISHERS | P=0.301N P=0.513 P=0.329N P=0.477N |P=0.593 P=0.520N P=0.121N P=0.651 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 4/49 (8%) 6/49 (12%) 1/50 (2%) |2/50 (4%) 0/48 (0%) 2/50 (4%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 10.5% 10.8% 15.5% 2.5% |4.6% 0.0% 5.0% 2.5% |
|TERMINAL (d) | 2/19 (11%) 0/11 (0%) 3/21 (14%) 1/24 (4%) |1/29 (3%) 0/27 (0%) 1/23 (4%) 1/21 (5%) |
|FIRST INCIDENCE | 708 575 584 729 (T) |718 --- 619 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.466 P=0.428 P=0.119N |P=0.619 P=0.258N P=0.618 P=0.621N |
|POLY 3 | P=0.139N P=0.635 P=0.382 P=0.159N |P=0.549N P=0.245N P=0.665 P=0.522N |
|POLY 1.5 | P=0.148N P=0.643N P=0.376 P=0.163N |P=0.542N P=0.245N P=0.675 P=0.514N |
|POLY 6 | P=0.121N P=0.615 P=0.405 P=0.150N |P=0.562N P=0.246N P=0.653 P=0.538N |
|LOGISTIC REGRESSION| P=0.142N P=0.608 P=0.374 P=0.122N |P=0.560N P=0.248N P=0.665 P=0.596N |
|COCH-ARM / FISHERS | P=0.157N P=0.631N P=0.383 P=0.168N |P=0.533N P=0.258N P=0.691N P=0.508N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) |1/50 (2%) 3/48 (6%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 0.0% |2.3% 7.2% 0.0% 2.5% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 2/27 (7%) 0/23 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- --- 703 --- |687 729 --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.732 (e) P=0.533 (e) |P=0.506N P=0.287 P=0.529N P=0.704 |
|POLY 3 | P=0.715 (e) P=0.500 (e) |P=0.431N P=0.291 P=0.519N P=0.746 |
|POLY 1.5 | P=0.707 (e) P=0.500 (e) |P=0.421N P=0.292 P=0.512N P=0.751 |
|POLY 6 | P=0.732 (e) P=0.505 (e) |P=0.447N P=0.287 P=0.527N P=0.735 |
|LOGISTIC REGRESSION| P=0.711 (e) P=0.505 (e) |P=0.475N P=0.288 P=0.509N P=0.742 |
|COCH-ARM / FISHERS | P=0.699 (e) P=0.505 (e) |P=0.411N P=0.293 P=0.500N P=0.747 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |9/50 (18%) 7/50 (14%) 3/50 (6%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| |20.7% 15.7% 7.6% 9.4% |
|TERMINAL (d) | |6/29 (21%) 2/27 (7%) 2/23 (9%) 0/21 (0%) |
|FIRST INCIDENCE | |648 495 649 533 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.139N P=0.443N P=0.131N P=0.234N |
|POLY 3 | |P=0.069N P=0.370N P=0.080N P=0.120N |
|POLY 1.5 | |P=0.065N P=0.378N P=0.072N P=0.117N |
|POLY 6 | |P=0.076N P=0.364N P=0.091N P=0.130N |
|LOGISTIC REGRESSION| |P=0.063N P=0.392N P=0.094N P=0.121N |
|COCH-ARM / FISHERS | |P=0.062N P=0.393N P=0.061N P=0.117N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 25/50 (50%) 26/50 (52%) 22/50 (44%) |17/50 (34%) 15/50 (30%) 13/50 (26%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| 56.6% 59.4% 59.0% 49.4% |37.4% 32.8% 30.9% 30.5% |
|TERMINAL (d) | 10/19 (53%) 6/11 (55%) 9/21 (43%) 11/24 (46%) |11/29 (38%) 7/27 (26%) 7/23 (30%) 7/21 (33%) |
|FIRST INCIDENCE | 520 544 472 495 |508 495 462 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.080N P=0.216 P=0.514N P=0.188N |P=0.501N P=0.484N P=0.480N P=0.553N |
|POLY 3 | P=0.235N P=0.479 P=0.494 P=0.317N |P=0.285N P=0.404N P=0.337N P=0.319N |
|POLY 1.5 | P=0.264N P=0.528 P=0.481 P=0.328N |P=0.252N P=0.406N P=0.307N P=0.288N |
|POLY 6 | P=0.193N P=0.407 P=0.544 P=0.298N |P=0.341N P=0.407N P=0.374N P=0.375N |
|LOGISTIC REGRESSION| P=0.273N P=0.540 P=0.490 P=0.339N |P=0.223N P=0.417N P=0.272N P=0.280N |
|COCH-ARM / FISHERS | P=0.299N P=0.579N P=0.500 P=0.344N |P=0.215N P=0.415N P=0.257N P=0.257N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 5/50 (10%) 2/50 (4%) |2/50 (4%) 5/50 (10%) 4/50 (8%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.8% 5.5% 12.5% 5.0% |4.6% 11.6% 10.1% 0.0% |
|TERMINAL (d) | 3/19 (16%) 2/11 (18%) 3/21 (14%) 1/24 (4%) |2/29 (7%) 5/27 (19%) 3/23 (13%) 0/21 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 370 723 |730 (T) 730 (T) 722 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.316N P=0.630 P=0.404 P=0.390N |P=0.238N P=0.184 P=0.239 P=0.311N |
|POLY 3 | P=0.460N P=0.524N P=0.372 P=0.481N |P=0.152N P=0.214 P=0.296 P=0.247N |
|POLY 1.5 | P=0.481N P=0.511N P=0.361 P=0.491N |P=0.142N P=0.216 P=0.311 P=0.242N |
|POLY 6 | P=0.419N P=0.549N P=0.397 P=0.461N |P=0.171N P=0.208 P=0.279 P=0.258N |
|LOGISTIC REGRESSION| P=0.453N P=0.630 P=0.354 P=0.389N |P=0.237N P=0.184 P=0.233 (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.357 P=0.500N |P=0.135N P=0.218 P=0.339 P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.8% 13.5% 5.2% 5.0% |2.3% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 3/19 (16%) 3/11 (27%) 2/21 (10%) 1/24 (4%) |0/29 (0%) 1/27 (4%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 729 (T) 677 729 (T) 723 |400 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.136N P=0.133 P=0.453N P=0.390N |P=0.262N P=0.752 P=0.508N P=0.500N |
|POLY 3 | P=0.251N P=0.330 P=0.499N P=0.481N |P=0.245N P=0.756 P=0.522N P=0.513N |
|POLY 1.5 | P=0.263N P=0.344 P=0.504N P=0.491N |P=0.242N P=0.758 P=0.514N P=0.507N |
|POLY 6 | P=0.228N P=0.304 P=0.484N P=0.461N |P=0.251N P=0.752 P=0.530N P=0.523N |
|LOGISTIC REGRESSION| P=0.156N P=0.212 P=0.453N P=0.389N |P=0.197N P=0.700 P=0.230N (e) |
|COCH-ARM / FISHERS | P=0.273N P=0.357 P=0.500N P=0.500N |P=0.235N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/47 (9%) 7/46 (15%) 2/47 (4%) 3/44 (7%) |0/46 (0%) 0/48 (0%) 1/42 (2%) 0/43 (0%) |
|POLY-3 ADJUSTED (b)| 11.0% 19.7% 5.6% 8.1% |0.0% 0.0% 3.0% 0.0% |
|TERMINAL (d) | 1/16 (6%) 2/10 (20%) 2/19 (11%) 1/22 (5%) |0/26 (0%) 0/26 (0%) 0/19 (0%) 0/17 (0%) |
|FIRST INCIDENCE | 564 536 729 (T) 519 |--- --- 666 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.135N P=0.140 P=0.286N P=0.424N |P=0.681 (e) P=0.477 (e) |
|POLY 3 | P=0.225N P=0.240 P=0.341N P=0.489N |P=0.676 (e) P=0.466 (e) |
|POLY 1.5 | P=0.246N P=0.247 P=0.344N P=0.511N |P=0.681 (e) P=0.471 (e) |
|POLY 6 | P=0.192N P=0.225 P=0.328N P=0.453N |P=0.662 (e) P=0.461 (e) |
|LOGISTIC REGRESSION| P=0.247N P=0.238 P=0.320N P=0.551N |P=0.686 (e) P=0.484 (e) |
|COCH-ARM / FISHERS | P=0.267N P=0.249 P=0.339N P=0.537N |P=0.683 (e) P=0.477 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/49 (33%) 12/49 (24%) 16/48 (33%) 14/47 (30%) |15/50 (30%) 14/50 (28%) 11/49 (22%) 23/49 (47%) |
|POLY-3 ADJUSTED (b)| 39.9% 31.7% 39.5% 35.9% |31.7% 31.3% 25.9% 52.2% |
|TERMINAL (d) | 9/18 (50%) 3/11 (27%) 8/20 (40%) 9/23 (39%) |6/29 (21%) 8/27 (30%) 4/23 (17%) 11/21 (52%) |
|FIRST INCIDENCE | 529 617 387 575 |400 495 462 533 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.168N P=0.564 P=0.489N P=0.214N |P=0.012 * P=0.553N P=0.420N P=0.029 * |
|POLY 3 | P=0.486N P=0.297N P=0.578N P=0.445N |P=0.020 * P=0.573N P=0.354N P=0.035 * |
|POLY 1.5 | P=0.516N P=0.273N P=0.576 P=0.459N |P=0.025 * P=0.540N P=0.318N P=0.045 * |
|POLY 6 | P=0.422N P=0.338N P=0.525N P=0.409N |P=0.014 * P=0.561 P=0.400N P=0.023 * |
|LOGISTIC REGRESSION| P=0.474N P=0.310N P=0.561 P=0.411N |P=0.039 * P=0.510N P=0.163N P=0.070 |
|COCH-ARM / FISHERS | P=0.540N P=0.251N P=0.557 P=0.467N |P=0.035 * P=0.500N P=0.266N P=0.063 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 3/47 (6%) 0/50 (0%) 4/43 (9%) | |
|POLY-3 ADJUSTED (b)| 0.0% 8.6% 0.0% 11.8% | |
|TERMINAL (d) | 0/16 (0%) 1/11 (9%) 0/21 (0%) 2/19 (11%) | |
|FIRST INCIDENCE | --- 702 --- 647 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.130 P=0.075 (e) P=0.092 | |
|POLY 3 | P=0.055 P=0.116 (e) P=0.054 | |
|POLY 1.5 | P=0.053 P=0.120 (e) P=0.053 | |
|POLY 6 | P=0.059 P=0.109 (e) P=0.059 | |
|LOGISTIC REGRESSION| P=0.077 P=0.090 (e) P=0.063 | |
|COCH-ARM / FISHERS | P=0.055 P=0.125 (e) P=0.051 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/46 (2%) 5/47 (11%) 2/50 (4%) 1/43 (2%) | |
|POLY-3 ADJUSTED (b)| 2.9% 14.2% 5.1% 3.0% | |
|TERMINAL (d) | 1/16 (6%) 1/11 (9%) 1/21 (5%) 0/19 (0%) | |
|FIRST INCIDENCE | 729 (T) 664 542 718 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.239N P=0.052 P=0.558 P=0.711N | |
|POLY 3 | P=0.348N P=0.098 P=0.541 P=0.754 | |
|POLY 1.5 | P=0.358N P=0.103 P=0.532 P=0.749 | |
|POLY 6 | P=0.326N P=0.090 P=0.560 P=0.762N | |
|LOGISTIC REGRESSION| P=0.329N P=0.071 P=0.530 P=0.736N | |
|COCH-ARM / FISHERS | P=0.367N P=0.107 P=0.532 P=0.736 | |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 9/49 (18%) 4/50 (8%) 8/50 (16%) | |
|POLY-3 ADJUSTED (b)| 15.6% 24.4% 10.2% 19.8% | |
|TERMINAL (d) | 3/18 (17%) 6/11 (55%) 1/21 (5%) 7/24 (29%) | |
|FIRST INCIDENCE | 609 610 622 708 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.348N P=0.093 P=0.310N P=0.578 | |
|POLY 3 | P=0.505 P=0.248 P=0.354N P=0.420 | |
|POLY 1.5 | P=0.490 P=0.269 P=0.361N P=0.411 | |
|POLY 6 | P=0.537 P=0.212 P=0.333N P=0.440 | |
|LOGISTIC REGRESSION| P=0.499N P=0.209 P=0.347N P=0.504 | |
|COCH-ARM / FISHERS | P=0.477 P=0.288 P=0.357N P=0.403 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 3/49 (6%) 2/50 (4%) 1/50 (2%) | |
|POLY-3 ADJUSTED (b)| 10.3% 8.1% 5.1% 2.5% | |
|TERMINAL (d) | 0/18 (0%) 0/11 (0%) 1/21 (5%) 0/24 (0%) | |
|FIRST INCIDENCE | 558 576 666 694 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.082N P=0.558N P=0.307N P=0.155N | |
|POLY 3 | P=0.101N P=0.529N P=0.336N P=0.166N | |
|POLY 1.5 | P=0.106N P=0.514N P=0.336N P=0.170N | |
|POLY 6 | P=0.092N P=0.557N P=0.329N P=0.159N | |
|LOGISTIC REGRESSION| P=0.109N P=0.492N P=0.327N P=0.181N | |
|COCH-ARM / FISHERS | P=0.109N P=0.500N P=0.329N P=0.175N | |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 2/44 (5%) 0/46 (0%) 0/48 (0%) | |
|POLY-3 ADJUSTED (b)| 0.0% 6.1% 0.0% 0.0% | |
|TERMINAL (d) | 0/18 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) | |
|FIRST INCIDENCE | --- 722 --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.330N P=0.168 (e) (e) | |
|POLY 3 | P=0.394N P=0.214 (e) (e) | |
|POLY 1.5 | P=0.395N P=0.218 (e) (e) | |
|POLY 6 | P=0.392N P=0.205 (e) (e) | |
|LOGISTIC REGRESSION| P=0.341N P=0.175 (e) (e) | |
|COCH-ARM / FISHERS | P=0.397N P=0.231 (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |1/49 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 2.7% 7.7% 0.0% |2.4% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 1/11 (9%) 2/21 (10%) 0/24 (0%) |1/28 (4%) 1/27 (4%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 718 729 (T) 687 --- |730 (T) 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.296N P=0.657 P=0.344 P=0.448N |P=0.282N P=0.754 P=0.539N P=0.557N |
|POLY 3 | P=0.382N P=0.750 P=0.306 P=0.492N |P=0.240N P=0.756N P=0.513N P=0.504N |
|POLY 1.5 | P=0.396N P=0.755 P=0.302 P=0.496N |P=0.237N P=0.756N P=0.507N P=0.500N |
|POLY 6 | P=0.356N P=0.738 P=0.318 P=0.484N |P=0.245N P=0.759N P=0.521N P=0.513N |
|LOGISTIC REGRESSION| P=0.328N P=0.695 P=0.334 P=0.468N |P=0.282N P=0.754 (e) (e) |
|COCH-ARM / FISHERS | P=0.409N P=0.753N P=0.309 P=0.500N |P=0.233N P=0.747N P=0.495N P=0.495N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.1% 2.7% 10.1% 0.0% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 1/21 (5%) 0/24 (0%) |1/28 (4%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 597 617 370 --- |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223N P=0.536N P=0.374 P=0.220N |P=0.342N P=0.507N P=0.539N P=0.557N |
|POLY 3 | P=0.255N P=0.520N P=0.342 P=0.231N |P=0.305N P=0.496N P=0.513N P=0.504N |
|POLY 1.5 | P=0.267N P=0.509N P=0.337 P=0.234N |P=0.305N P=0.495N P=0.507N P=0.500N |
|POLY 6 | P=0.233N P=0.540N P=0.355 P=0.225N |P=0.302N P=0.498N P=0.521N P=0.513N |
|LOGISTIC REGRESSION| P=0.287N P=0.491N P=0.349 P=0.243N |P=0.342N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.279N P=0.500N P=0.339 P=0.247N |P=0.303N P=0.495N P=0.495N P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 14/50 (28%) 19/50 (38%) 20/50 (40%) |2/50 (4%) 6/50 (12%) 7/50 (14%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 27.2% 35.7% 46.7% 46.9% |4.6% 13.5% 17.0% 16.3% |
|TERMINAL (d) | 4/19 (21%) 4/11 (36%) 11/21 (52%) 12/24 (50%) |1/29 (3%) 1/27 (4%) 2/23 (9%) 1/21 (5%) |
|FIRST INCIDENCE | 558 575 584 508 |688 561 390 533 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.234 P=0.121 P=0.125 P=0.148 |P=0.058 P=0.133 P=0.056 P=0.056 |
|POLY 3 | P=0.032 * P=0.276 P=0.049 * P=0.045 * |P=0.088 P=0.140 P=0.066 P=0.075 |
|POLY 1.5 | P=0.027 * P=0.299 P=0.050 P=0.042 * |P=0.092 P=0.138 P=0.071 P=0.078 |
|POLY 6 | P=0.047 * P=0.240 P=0.056 P=0.057 |P=0.079 P=0.141 P=0.062 P=0.070 |
|LOGISTIC REGRESSION| P=0.042 * P=0.258 P=0.061 P=0.051 |P=0.106 P=0.132 P=0.092 P=0.085 |
|COCH-ARM / FISHERS | P=0.026 * P=0.322 P=0.063 P=0.041 * |P=0.097 P=0.134 P=0.080 P=0.080 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 8/50 (16%) 6/50 (12%) 5/50 (10%) |11/50 (22%) 17/50 (34%) 6/50 (12%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 20.0% 20.9% 14.7% 12.2% |24.6% 38.7% 15.0% 9.6% |
|TERMINAL (d) | 2/19 (11%) 1/11 (9%) 2/21 (10%) 2/24 (8%) |5/29 (17%) 13/27 (48%) 3/23 (13%) 2/21 (10%) |
|FIRST INCIDENCE | 609 617 387 589 |558 617 583 663 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.100N P=0.398 P=0.346N P=0.200N |P=0.037N* P=0.110 P=0.275N P=0.130N |
|POLY 3 | P=0.162N P=0.572 P=0.369N P=0.254N |P=0.008N** P=0.111 P=0.201N P=0.058N |
|POLY 1.5 | P=0.176N P=0.591 P=0.381N P=0.265N |P=0.006N** P=0.122 P=0.177N P=0.050N |
|POLY 6 | P=0.139N P=0.534 P=0.349N P=0.236N |P=0.013N* P=0.095 P=0.234N P=0.074N |
|LOGISTIC REGRESSION| P=0.186N P=0.559 P=0.382N P=0.256N |P=0.010N* P=0.127 P=0.175N P=0.051N |
|COCH-ARM / FISHERS | P=0.191N P=0.607N P=0.387N P=0.277N |P=0.006N** P=0.133 P=0.143N P=0.045N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.1% 7.9% 7.6% 7.3% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 1/21 (5%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 648 533 387 628 |--- 701 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.536 P=0.459 P=0.540 P=0.558 |P=0.620N P=0.488 (e) (e) |
|POLY 3 | P=0.472 P=0.485 P=0.506 P=0.522 |P=0.576N P=0.500 (e) (e) |
|POLY 1.5 | P=0.454 P=0.493 P=0.501 P=0.511 |P=0.572N P=0.500 (e) (e) |
|POLY 6 | P=0.507 P=0.467 P=0.520 P=0.544 |P=0.582N P=0.498 (e) (e) |
|LOGISTIC REGRESSION| P=0.422 P=0.510 P=0.514 P=0.498 |P=0.576N P=0.500 (e) (e) |
|COCH-ARM / FISHERS | P=0.438 P=0.500 P=0.500 P=0.500 |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 45/50 (90%) 40/50 (80%) 44/50 (88%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 88.1% 93.1% 87.1% 92.6% |5.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 16/19 (84%) 11/11 (100%) 21/21 (100%) 23/24 (96%) |1/19 (5%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 354 465 340 444 |568 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.073N P=0.053 P=0.285N P=0.300N |P=0.101N P=0.296N P=0.231N P=0.209N |
|POLY 3 | P=0.361 P=0.290 P=0.578N P=0.329 |P=0.109N P=0.251N P=0.239N P=0.230N |
|POLY 1.5 | P=0.401 P=0.284 P=0.503N P=0.351 |P=0.112N P=0.244N P=0.240N P=0.234N |
|POLY 6 | P=0.322 P=0.298 P=0.651 P=0.314 |P=0.104N P=0.265N P=0.233N P=0.223N |
|LOGISTIC REGRESSION| P=0.496 P=0.261 P=0.438N P=0.415 |P=0.115N P=0.235N P=0.236N P=0.241N |
|COCH-ARM / FISHERS | P=0.460 P=0.277 P=0.398N P=0.387 |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.4% 0.0% 0.0% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 722 --- --- |--- --- --- 612 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.330N P=0.168 (e) (e) |P=0.202 (e) (e) P=0.500 |
|POLY 3 | P=0.405N P=0.225 (e) (e) |P=0.194 (e) (e) P=0.493 |
|POLY 1.5 | P=0.405N P=0.232 (e) (e) |P=0.197 (e) (e) P=0.497 |
|POLY 6 | P=0.405N P=0.213 (e) (e) |P=0.190 (e) (e) P=0.485 |
|LOGISTIC REGRESSION| P=0.346N P=0.170 (e) (e) |P=0.198 (e) (e) P=0.502 |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 9/50 (18%) 3/50 (6%) 3/50 (6%) |2/50 (4%) 4/50 (8%) 7/50 (14%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 17.0% 22.3% 7.4% 7.2% |4.5% 9.0% 16.5% 7.2% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 1/21 (5%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 1/23 (4%) 0/21 (0%) |
|FIRST INCIDENCE | 521 479 340 519 |575 553 462 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046N* P=0.337 P=0.165N P=0.146N |P=0.391 P=0.347 P=0.069 P=0.475 |
|POLY 3 | P=0.049N* P=0.369 P=0.164N P=0.153N |P=0.385 P=0.340 P=0.069 P=0.478 |
|POLY 1.5 | P=0.051N P=0.384 P=0.163N P=0.156N |P=0.407 P=0.340 P=0.072 P=0.489 |
|POLY 6 | P=0.044N* P=0.341 P=0.163N P=0.147N |P=0.348 P=0.338 P=0.066 P=0.459 |
|LOGISTIC REGRESSION| P=0.055N P=0.432 P=0.107N P=0.172N |P=0.479 P=0.289 P=0.142 P=0.516 |
|COCH-ARM / FISHERS | P=0.054N P=0.393 P=0.159N P=0.159N |P=0.430 P=0.339 P=0.080 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 8/50 (16%) 4/50 (8%) 4/50 (8%) |3/50 (6%) 5/50 (10%) 6/50 (12%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 12.6% 20.0% 10.0% 9.6% |6.8% 11.1% 14.5% 4.8% |
|TERMINAL (d) | 2/19 (11%) 0/11 (0%) 1/21 (5%) 0/24 (0%) |1/29 (3%) 0/27 (0%) 1/23 (4%) 0/21 (0%) |
|FIRST INCIDENCE | 609 533 472 444 |575 495 544 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.208N P=0.209 P=0.469N P=0.415N |P=0.425N P=0.363 P=0.193 P=0.544N |
|POLY 3 | P=0.243N P=0.279 P=0.493N P=0.465N |P=0.408N P=0.370 P=0.212 P=0.524N |
|POLY 1.5 | P=0.261N P=0.280 P=0.500N P=0.481N |P=0.386N P=0.366 P=0.222 P=0.512N |
|POLY 6 | P=0.212N P=0.273 P=0.473N P=0.436N |P=0.446N P=0.371 P=0.203 P=0.546N |
|LOGISTIC REGRESSION| P=0.299N P=0.295 P=0.496N P=0.516N |P=0.318N P=0.302 P=0.298 P=0.487N |
|COCH-ARM / FISHERS | P=0.279N P=0.277 P=0.500N P=0.500N |P=0.362N P=0.357 P=0.243 P=0.500N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 3/49 (6%) 2/50 (4%) 4/50 (8%) |3/50 (6%) 3/50 (6%) 2/49 (4%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 2.7% 8.3% 5.1% 9.8% |7.0% 7.0% 5.1% 18.8% |
|TERMINAL (d) | 1/18 (6%) 1/11 (9%) 1/21 (5%) 2/24 (8%) |3/29 (10%) 3/27 (11%) 2/23 (9%) 3/21 (14%) |
|FIRST INCIDENCE | 729 (T) 722 622 659 |730 (T) 730 (T) 730 (T) 612 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312 P=0.174 P=0.539 P=0.266 |P=0.015 * P=0.632 P=0.607N P=0.055 |
|POLY 3 | P=0.190 P=0.290 P=0.513 P=0.201 |P=0.034 * P=0.661 P=0.541N P=0.092 |
|POLY 1.5 | P=0.179 P=0.298 P=0.507 P=0.193 |P=0.036 * P=0.662N P=0.528N P=0.096 |
|POLY 6 | P=0.214 P=0.274 P=0.529 P=0.219 |P=0.031 * P=0.657 P=0.559N P=0.085 |
|LOGISTIC REGRESSION| P=0.228 P=0.197 P=0.517 P=0.220 |P=0.027 * P=0.632 P=0.607N P=0.088 |
|COCH-ARM / FISHERS | P=0.169 P=0.309 P=0.508 P=0.187 |P=0.039 * P=0.661N P=0.510N P=0.100 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 8/49 (16%) 4/50 (8%) 10/50 (20%) |2/50 (4%) 3/50 (6%) 4/49 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 10.2% 20.7% 10.0% 23.0% |4.5% 6.7% 9.9% 4.8% |
|TERMINAL (d) | 0/18 (0%) 0/11 (0%) 0/21 (0%) 1/24 (4%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 558 536 484 508 |508 495 586 638 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.174 P=0.145 P=0.624N P=0.129 |P=0.563 P=0.508 P=0.287 P=0.673 |
|POLY 3 | P=0.124 P=0.165 P=0.632N P=0.104 |P=0.559 P=0.502 P=0.294 P=0.672 |
|POLY 1.5 | P=0.108 P=0.172 P=0.636N P=0.091 |P=0.579 P=0.502 P=0.308 P=0.682 |
|POLY 6 | P=0.157 P=0.156 P=0.615N P=0.131 |P=0.526 P=0.499 P=0.281 P=0.654 |
|LOGISTIC REGRESSION| P=0.082 P=0.185 P=0.615N P=0.066 |P=0.521N P=0.364 P=0.407 P=0.698N |
|COCH-ARM / FISHERS | P=0.096 P=0.178 P=0.631N P=0.080 |P=0.563N P=0.500 P=0.329 P=0.691N |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 5.1% 5.3% 2.6% 5.0% | |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 1/21 (5%) 2/24 (8%) | |
|FIRST INCIDENCE | 642 533 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.475N P=0.658 P=0.473N P=0.630N | |
|POLY 3 | P=0.566N P=0.681 P=0.504N P=0.685N | |
|POLY 1.5 | P=0.572N P=0.688 P=0.505N P=0.689N | |
|POLY 6 | P=0.552N P=0.665 P=0.497N P=0.675N | |
|LOGISTIC REGRESSION| P=0.568N P=0.686N P=0.498N P=0.674N | |
|COCH-ARM / FISHERS | P=0.577N P=0.691N P=0.500N P=0.691N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 5/50 (10%) 8/50 (16%) | |
|POLY-3 ADJUSTED (b)| 12.2% 5.3% 12.2% 18.3% | |
|TERMINAL (d) | 1/19 (5%) 0/11 (0%) 0/21 (0%) 2/24 (8%) | |
|FIRST INCIDENCE | 520 533 472 444 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.148 P=0.258N P=0.622 P=0.325 | |
|POLY 3 | P=0.131 P=0.246N P=0.632N P=0.317 | |
|POLY 1.5 | P=0.116 P=0.231N P=0.626 P=0.299 | |
|POLY 6 | P=0.161 P=0.274N P=0.614N P=0.346 | |
|LOGISTIC REGRESSION| P=0.074 P=0.194N P=0.564N P=0.232 | |
|COCH-ARM / FISHERS | P=0.101 P=0.218N P=0.630N P=0.277 | |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 31/46 (67%) 32/48 (67%) 17/48 (35%) |37/50 (74%) 41/48 (85%) 36/49 (73%) 29/50 (58%) |
|POLY-3 ADJUSTED (b)| 53.1% 74.2% 75.1% 39.5% |77.6% 87.5% 78.9% 63.6% |
|TERMINAL (d) | 10/19 (53%) 9/11 (82%) 16/21 (76%) 7/24 (29%) |24/29 (83%) 25/27 (93%) 20/23 (87%) 15/21 (71%) |
|FIRST INCIDENCE | 354 479 472 444 |400 495 390 462 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011N* P=0.016 * P=0.172 P=0.085N |P=0.454N P=0.199 P=0.205 P=0.542N |
|POLY 3 | P=0.026N* P=0.026 * P=0.020 * P=0.138N |P=0.018N* P=0.149 P=0.542 P=0.090N |
|POLY 1.5 | P=0.040N* P=0.025 * P=0.021 * P=0.163N |P=0.014N* P=0.136 P=0.568 P=0.079N |
|POLY 6 | P=0.013N* P=0.031 * P=0.026 * P=0.105N |P=0.029N* P=0.177 P=0.522 P=0.115N |
|LOGISTIC REGRESSION| P=0.063N P=0.026 * P=0.029 * P=0.204N |P=0.014N* P=0.128 P=0.562 P=0.078N |
|COCH-ARM / FISHERS | P=0.070N P=0.028 * P=0.031 * P=0.195N |P=0.012N* P=0.125 P=0.567N P=0.069N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/46 (0%) 1/48 (2%) 1/48 (2%) |0/50 (0%) 1/48 (2%) 1/49 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.7% 2.6% |0.0% 2.4% 2.5% 4.8% |
|TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 1/24 (4%) |0/29 (0%) 1/27 (4%) 1/23 (4%) 1/21 (5%) |
|FIRST INCIDENCE | --- --- 701 729 (T) |--- 730 (T) 730 (T) 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.307 (e) P=0.532 P=0.547 |P=0.101 P=0.486 P=0.454 P=0.182 |
|POLY 3 | P=0.251 (e) P=0.495 P=0.501 |P=0.146 P=0.493 P=0.482 P=0.228 |
|POLY 1.5 | P=0.243 (e) P=0.492 P=0.496 |P=0.152 P=0.493 P=0.488 P=0.233 |
|POLY 6 | P=0.269 (e) P=0.503 P=0.510 |P=0.136 P=0.492 P=0.474 P=0.218 |
|LOGISTIC REGRESSION| P=0.277 (e) P=0.502 P=0.547 |P=0.118 P=0.486 P=0.454 P=0.212 |
|COCH-ARM / FISHERS | P=0.234 (e) P=0.490 P=0.490 |P=0.156 P=0.490 P=0.495 P=0.247 |
|=================================================================================================================================|
Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/3 (100%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 558 638 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
(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).