TDMS Study 05184-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest GLUTARALDEHYDE DATE: 09/14/98
EXPERIMENT: 05184 TEST: 05 TIME: 08:28:49
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55425C
PATHOLOGIST: RENNE, ROGER CAS: 111-30-8
------------------------------------------------------------------------------------------------------------------------------------
2 YEAR CHRONIC
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest GLUTARALDEHYDE DATE: 09/14/98
EXPERIMENT: 05184 TEST: 05 TIME: 08:28:49
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55425C
PATHOLOGIST: RENNE, ROGER CAS: 111-30-8
Rats(FISCHER 344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Clitoral/Preputial Gland
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pancreas
Pituitary Gland
Testes
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest GLUTARALDEHYDE DATE: 09/14/98
EXPERIMENT: 05184 TEST: 05 TIME: 08:28:49
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55425C
PATHOLOGIST: RENNE, ROGER CAS: 111-30-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF GLUTARALDEHYDE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Fibroma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Testes Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Mammary Gland Carcinoma
Carcinoma or Adenoma
Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Mesentery Sarcoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
Thyroid Gland: Follicular Cell Adenoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 6/50 (12%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 11.4% 12.7% 16.5% 7.3% |0.0% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 2/12 (17%) 2/14 (14%) 1/9 (11%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | 702 632 617 673 |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.510 P=0.610 P=0.293 P=0.525N |P=0.386 (e) P=0.390 (e) |
|POLY 3 | P=0.514N P=0.571 P=0.386 P=0.456N |P=0.450 (e) P=0.469 (e) |
|POLY 1.5 | P=0.490N P=0.543 P=0.383 P=0.444N |P=0.457 (e) P=0.482 (e) |
|POLY 6 | P=0.535N P=0.609 P=0.390 P=0.463N |P=0.447 (e) P=0.452 (e) |
|LOGISTIC REGRESSION| P=0.503N P=0.612 P=0.352 P=0.487N |(e) (e) P=0.390 (e) |
|COCH-ARM / FISHERS | P=0.335N P=0.500 P=0.370 P=0.349N |P=0.497 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 1/49 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.8% 7.6% 5.5% 3.6% |0.0% 2.3% 0.0% 3.2% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 689 579 593 646 |--- 437 --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491 P=0.374 P=0.472 P=0.683 |P=0.283 P=0.496 (e) P=0.377 |
|POLY 3 | P=0.541 P=0.344 P=0.509 P=0.704 |P=0.341 P=0.506 (e) P=0.446 |
|POLY 1.5 | P=0.550 P=0.329 P=0.507 P=0.709 |P=0.353 P=0.502 (e) P=0.457 |
|POLY 6 | P=0.535 P=0.365 P=0.510 P=0.702 |P=0.326 P=0.512 (e) P=0.435 |
|LOGISTIC REGRESSION| P=0.559 P=0.340 P=0.504 P=0.708 |P=0.419 P=0.542 (e) P=0.377 |
|COCH-ARM / FISHERS | P=0.507N P=0.309 P=0.500 P=0.747 |P=0.371 P=0.500 (e) P=0.495 |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) 9/50 (18%) 3/49 (6%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 17.0% 17.5% 24.2% 10.8% |0.0% 2.3% 2.8% 3.2% |
|TERMINAL (d) | 3/12 (25%) 2/14 (14%) 1/9 (11%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 1/15 (7%) 1/14 (7%) |
|FIRST INCIDENCE | 689 579 593 646 |--- 437 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.493 P=0.595N P=0.220 P=0.475N |P=0.181 P=0.496 P=0.390 P=0.377 |
|POLY 3 | P=0.503N P=0.595 P=0.317 P=0.370N |P=0.241 P=0.506 P=0.469 P=0.446 |
|POLY 1.5 | P=0.477N P=0.557 P=0.307 P=0.359N |P=0.256 P=0.502 P=0.482 P=0.457 |
|POLY 6 | P=0.522N P=0.598N P=0.335 P=0.372N |P=0.226 P=0.512 P=0.452 P=0.435 |
|LOGISTIC REGRESSION| P=0.475N P=0.620N P=0.280 P=0.399N |P=0.298 P=0.542 P=0.390 P=0.377 |
|COCH-ARM / FISHERS | P=0.295N P=0.500 P=0.288 P=0.254N |P=0.297 P=0.500 P=0.500 P=0.495 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |3/49 (6%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.9% 5.1% 0.0% 0.0% |7.3% 7.1% 2.8% 0.0% |
|TERMINAL (d) | 1/12 (8%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |2/26 (8%) 2/31 (7%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | 729 (T) 495 --- --- |694 694 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.228N P=0.538 P=0.557N P=0.638N |P=0.131N P=0.592N P=0.503N P=0.231N |
|POLY 3 | P=0.189N P=0.541 P=0.497N P=0.548N |P=0.080N P=0.650N P=0.356N P=0.170N |
|POLY 1.5 | P=0.183N P=0.525 P=0.497N P=0.541N |P=0.066N P=0.655N P=0.330N P=0.155N |
|POLY 6 | P=0.196N P=0.561 P=0.499N P=0.553N |P=0.098N P=0.639N P=0.391N P=0.186N |
|LOGISTIC REGRESSION| P=0.165N P=0.506 (e) (e) |P=0.093N P=0.632N P=0.440N P=0.191N |
|COCH-ARM / FISHERS | P=0.149N P=0.500 P=0.500N P=0.500N |P=0.041N* P=0.651N P=0.301N P=0.117N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |3/49 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.1% 2.8% 7.1% |7.3% 4.8% 2.8% 3.1% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |2/26 (8%) 2/31 (7%) 0/15 (0%) 1/14 (7%) |
|FIRST INCIDENCE | --- 617 689 620 |660 730 (T) 634 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.137 P=0.300 P=0.460 P=0.206 |P=0.339N P=0.436N P=0.459N P=0.527N |
|POLY 3 | P=0.178 P=0.262 P=0.504 P=0.190 |P=0.220N P=0.490N P=0.354N P=0.401N |
|POLY 1.5 | P=0.181 P=0.252 P=0.503 P=0.195 |P=0.196N P=0.494N P=0.329N P=0.374N |
|POLY 6 | P=0.175 P=0.276 P=0.503 P=0.187 |P=0.249N P=0.481N P=0.386N P=0.429N |
|LOGISTIC REGRESSION| P=0.151 P=0.249 P=0.500 P=0.187 |P=0.239N P=0.471N P=0.348N P=0.432N |
|COCH-ARM / FISHERS | P=0.209 P=0.247 P=0.500 P=0.247 |P=0.146N P=0.490N P=0.301N P=0.301N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 1/50 (2%) 2/50 (4%) |6/49 (12%) 5/50 (10%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.9% 10.0% 2.8% 7.1% |14.5% 11.8% 5.5% 3.1% |
|TERMINAL (d) | 1/12 (8%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |4/26 (15%) 4/31 (13%) 1/15 (7%) 1/14 (7%) |
|FIRST INCIDENCE | 729 (T) 495 689 620 |660 694 634 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.398 P=0.238 P=0.705 P=0.386 |P=0.107N P=0.401N P=0.328N P=0.197N |
|POLY 3 | P=0.502 P=0.218 P=0.758N P=0.422 |P=0.042N* P=0.485N P=0.179N P=0.109N |
|POLY 1.5 | P=0.508 P=0.202 P=0.757N P=0.431 |P=0.032N* P=0.491N P=0.155N P=0.092N |
|POLY 6 | P=0.498 P=0.241 P=0.760N P=0.419 |P=0.057N P=0.471N P=0.214N P=0.128N |
|LOGISTIC REGRESSION| P=0.482 P=0.187 P=0.755 P=0.406 |P=0.054N P=0.454N P=0.212N P=0.129N |
|COCH-ARM / FISHERS | P=0.564 P=0.181 P=0.753N P=0.500 |P=0.016N* P=0.486N P=0.128N P=0.053N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/49 (6%) 1/50 (2%) 1/48 (2%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.8% 7.8% 2.8% 3.7% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 3/14 (21%) 0/9 (0%) 1/6 (17%) |0/26 (0%) 1/31 (3%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 708 729 (T) 726 729 (T) |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.502 P=0.376 P=0.725 P=0.669 |P=0.614N P=0.535 (e) (e) |
|POLY 3 | P=0.519N P=0.338 P=0.759N P=0.702 |P=0.588N P=0.506 (e) (e) |
|POLY 1.5 | P=0.508N P=0.324 P=0.758N P=0.708 |P=0.562N P=0.503 (e) (e) |
|POLY 6 | P=0.532N P=0.356 P=0.763 P=0.697 |P=0.618N P=0.511 (e) (e) |
|LOGISTIC REGRESSION| P=0.564 P=0.378 P=0.748 P=0.687 |(e) P=0.535 (e) (e) |
|COCH-ARM / FISHERS | P=0.437N P=0.301 P=0.753N P=0.742 |P=0.497N P=0.505 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/49 (2%) 1/50 (2%) 1/48 (2%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 11.2% 2.6% 2.8% 3.7% |0.0% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 612 708 702 689 |--- --- 617 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.153N P=0.133N P=0.228N P=0.324N |P=0.461 (e) P=0.473 (e) |
|POLY 3 | P=0.116N P=0.152N P=0.175N P=0.265N |P=0.450 (e) P=0.475 (e) |
|POLY 1.5 | P=0.111N P=0.163N P=0.174N P=0.255N |P=0.460 (e) P=0.488 (e) |
|POLY 6 | P=0.122N P=0.140N P=0.179N P=0.274N |P=0.444 (e) P=0.460 (e) |
|LOGISTIC REGRESSION| P=0.122N P=0.135N P=0.178N P=0.268N |P=0.518 (e) P=0.523 (e) |
|COCH-ARM / FISHERS | P=0.089N P=0.187N P=0.181N P=0.194N |P=0.503 (e) P=0.505 (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/49 (8%) 2/50 (4%) 2/48 (4%) |0/49 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 14.0% 10.3% 5.6% 7.3% |0.0% 2.4% 2.8% 0.0% |
|TERMINAL (d) | 1/12 (8%) 3/14 (21%) 0/9 (0%) 1/6 (17%) |0/26 (0%) 1/31 (3%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 612 708 702 689 |--- 730 (T) 617 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.260N P=0.382N P=0.285N P=0.408N |P=0.524 P=0.535 P=0.473 (e) |
|POLY 3 | P=0.158N P=0.449N P=0.212N P=0.333N |P=0.547 P=0.506 P=0.475 (e) |
|POLY 1.5 | P=0.150N P=0.471N P=0.211N P=0.319N |P=0.567 P=0.503 P=0.488 (e) |
|POLY 6 | P=0.169N P=0.426N P=0.218N P=0.347N |P=0.527 P=0.511 P=0.460 (e) |
|LOGISTIC REGRESSION| P=0.179N P=0.381N P=0.217N P=0.341N |P=0.596 P=0.535 P=0.523 (e) |
|COCH-ARM / FISHERS | P=0.107N P=0.513N P=0.218N P=0.235N |P=0.621N P=0.505 P=0.505 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.7% 0.0% 3.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 675 --- 720 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.454 P=0.156 (e) P=0.419 |(e) (e) (e) (e) |
|POLY 3 | P=0.559 P=0.137 (e) P=0.453 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.561 P=0.130 (e) P=0.459 |(e) (e) (e) (e) |
|POLY 6 | P=0.556 P=0.148 (e) P=0.448 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.493 P=0.152 (e) P=0.428 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.589 P=0.121 (e) P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.7% 0.0% 7.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 675 --- 652 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.212 P=0.156 (e) P=0.161 |(e) (e) (e) (e) |
|POLY 3 | P=0.322 P=0.137 (e) P=0.189 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.323 P=0.130 (e) P=0.195 |(e) (e) (e) (e) |
|POLY 6 | P=0.319 P=0.148 (e) P=0.185 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.247 P=0.152 (e) P=0.179 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.343 P=0.121 (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 2.8% 7.1% |0.0% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 1/6 (17%) |0/26 (0%) 0/31 (0%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | --- 729 (T) 533 589 |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060 P=0.531 P=0.495 P=0.150 |P=0.386 (e) P=0.390 (e) |
|POLY 3 | P=0.114 P=0.520 P=0.506 P=0.190 |P=0.450 (e) P=0.469 (e) |
|POLY 1.5 | P=0.116 P=0.512 P=0.505 P=0.195 |P=0.457 (e) P=0.482 (e) |
|POLY 6 | P=0.112 P=0.530 P=0.507 P=0.186 |P=0.447 (e) P=0.452 (e) |
|LOGISTIC REGRESSION| P=0.102 P=0.531 P=0.458 P=0.189 |(e) (e) P=0.390 (e) |
|COCH-ARM / FISHERS | P=0.129 P=0.500 P=0.500 P=0.247 |P=0.497 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 2.8% 7.1% |0.0% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 1/6 (17%) |0/26 (0%) 0/31 (0%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | --- 729 (T) 533 589 |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060 P=0.531 P=0.495 P=0.150 |P=0.386 (e) P=0.390 (e) |
|POLY 3 | P=0.114 P=0.520 P=0.506 P=0.190 |P=0.450 (e) P=0.469 (e) |
|POLY 1.5 | P=0.116 P=0.512 P=0.505 P=0.195 |P=0.457 (e) P=0.482 (e) |
|POLY 6 | P=0.112 P=0.530 P=0.507 P=0.186 |P=0.447 (e) P=0.452 (e) |
|LOGISTIC REGRESSION| P=0.102 P=0.531 P=0.458 P=0.189 |(e) (e) P=0.390 (e) |
|COCH-ARM / FISHERS | P=0.129 P=0.500 P=0.500 P=0.247 |P=0.497 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |5/50 (10%) 8/50 (16%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.8% 5.2% 0.0% 0.0% |11.8% 18.5% 8.2% 3.1% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |3/26 (12%) 5/31 (16%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 694 708 --- --- |589 593 654 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.216N P=0.580 P=0.545N P=0.571N |P=0.162N P=0.358 P=0.586N P=0.243N |
|POLY 3 | P=0.190N P=0.534 P=0.498N P=0.548N |P=0.097N P=0.289 P=0.441N P=0.173N |
|POLY 1.5 | P=0.183N P=0.521 P=0.497N P=0.541N |P=0.074N P=0.277 P=0.405N P=0.153N |
|POLY 6 | P=0.197N P=0.551 P=0.501N P=0.554N |P=0.128N P=0.312 P=0.486N P=0.193N |
|LOGISTIC REGRESSION| P=0.189N P=0.568 P=0.502N P=0.556N |P=0.053N P=0.275 P=0.421N P=0.122N |
|COCH-ARM / FISHERS | P=0.149N P=0.500 P=0.500N P=0.500N |P=0.035N* P=0.277 P=0.357N P=0.102N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |5/50 (10%) 8/50 (16%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.8% 5.2% 0.0% 3.6% |11.8% 18.5% 8.2% 3.1% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |3/26 (12%) 5/31 (16%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 694 708 --- 638 |589 593 654 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.530N P=0.580 P=0.545N P=0.693 |P=0.162N P=0.358 P=0.586N P=0.243N |
|POLY 3 | P=0.457N P=0.534 P=0.498N P=0.707 |P=0.097N P=0.289 P=0.441N P=0.173N |
|POLY 1.5 | P=0.451N P=0.521 P=0.497N P=0.714 |P=0.074N P=0.277 P=0.405N P=0.153N |
|POLY 6 | P=0.465N P=0.551 P=0.501N P=0.703 |P=0.128N P=0.312 P=0.486N P=0.193N |
|LOGISTIC REGRESSION| P=0.491N P=0.568 P=0.502N P=0.711 |P=0.053N P=0.275 P=0.421N P=0.122N |
|COCH-ARM / FISHERS | P=0.411N P=0.500 P=0.500N P=0.753N |P=0.035N* P=0.277 P=0.357N P=0.102N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |24/50 (48%) 23/50 (46%) 18/50 (36%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 2.8% 7.7% 5.6% 7.1% |54.6% 52.2% 45.4% 28.9% |
|TERMINAL (d) | 0/12 (0%) 2/14 (14%) 1/9 (11%) 1/6 (17%) |14/26 (54%) 16/31 (52%) 5/15 (33%) 2/14 (14%) |
|FIRST INCIDENCE | 657 712 721 508 |566 561 533 514 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225 P=0.383 P=0.462 P=0.360 |P=0.270N P=0.289N P=0.391 P=0.170N |
|POLY 3 | P=0.354 P=0.338 P=0.502 P=0.422 |P=0.014N* P=0.496N P=0.263N P=0.017N* |
|POLY 1.5 | P=0.365 P=0.326 P=0.504 P=0.431 |P=0.008N** P=0.512N P=0.212N P=0.011N* |
|POLY 6 | P=0.341 P=0.353 P=0.497 P=0.415 |P=0.024N* P=0.467N P=0.326N P=0.023N* |
|LOGISTIC REGRESSION| P=0.319 P=0.371 P=0.492 P=0.446 |P=0.017N* P=0.486N P=0.330N P=0.022N* |
|COCH-ARM / FISHERS | P=0.436 P=0.309 P=0.500 P=0.500 |P<0.001N** P=0.500N P=0.156N P=0.003N** |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |24/50 (48%) 23/50 (46%) 18/50 (36%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 2.8% 7.7% 5.6% 10.5% |54.6% 52.2% 45.4% 28.9% |
|TERMINAL (d) | 0/12 (0%) 2/14 (14%) 1/9 (11%) 1/6 (17%) |14/26 (54%) 16/31 (52%) 5/15 (33%) 2/14 (14%) |
|FIRST INCIDENCE | 657 712 721 508 |566 561 533 514 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.109 P=0.383 P=0.462 P=0.189 |P=0.270N P=0.289N P=0.391 P=0.170N |
|POLY 3 | P=0.212 P=0.338 P=0.502 P=0.231 |P=0.014N* P=0.496N P=0.263N P=0.017N* |
|POLY 1.5 | P=0.220 P=0.326 P=0.504 P=0.239 |P=0.008N** P=0.512N P=0.212N P=0.011N* |
|POLY 6 | P=0.203 P=0.353 P=0.497 P=0.227 |P=0.024N* P=0.467N P=0.326N P=0.023N* |
|LOGISTIC REGRESSION| P=0.173 P=0.371 P=0.492 P=0.248 |P=0.017N* P=0.486N P=0.330N P=0.022N* |
|COCH-ARM / FISHERS | P=0.271 P=0.309 P=0.500 P=0.309 |P<0.001N** P=0.500N P=0.156N P=0.003N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 2/50 (4%) 3/50 (6%) |26/50 (52%) 27/50 (54%) 21/50 (42%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 5.6% 12.9% 5.6% 10.5% |58.5% 60.1% 52.1% 31.1% |
|TERMINAL (d) | 0/12 (0%) 3/14 (21%) 1/9 (11%) 1/6 (17%) |15/26 (58%) 18/31 (58%) 5/15 (33%) 2/14 (14%) |
|FIRST INCIDENCE | 657 708 721 508 |566 561 533 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.302 P=0.316 P=0.642 P=0.341 |P=0.278N P=0.405N P=0.285 P=0.159N |
|POLY 3 | P=0.464 P=0.252 P=0.695N P=0.401 |P=0.010N* P=0.524 P=0.349N P=0.011N* |
|POLY 1.5 | P=0.476 P=0.239 P=0.691N P=0.412 |P=0.005N** P=0.497 P=0.287N P=0.007N** |
|POLY 6 | P=0.450 P=0.267 P=0.691 P=0.395 |P=0.017N* P=0.571 P=0.413N P=0.015N* |
|LOGISTIC REGRESSION| P=0.407 P=0.294 P=0.691 P=0.414 |P=0.009N** P=0.500 P=0.414N P=0.013N* |
|COCH-ARM / FISHERS | P=0.553 P=0.218 P=0.691N P=0.500 |P<0.001N** P=0.500 P=0.212N P=0.002N** |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- --- |518 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.086N P=0.222N P=0.313N P=0.353N |
|POLY 3 | (e) (e) (e) (e) |P=0.068N P=0.238N P=0.277N P=0.305N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.063N P=0.240N P=0.259N P=0.287N |
|POLY 6 | (e) (e) (e) (e) |P=0.075N P=0.234N P=0.300N P=0.323N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.045N* P=0.229N P=0.216N P=0.224N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.056N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 0.0% 7.3% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 1/6 (17%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 675 --- 720 |698 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075 P=0.532 (e) P=0.130 |P=0.228N P=0.482N P=0.578N P=0.568N |
|POLY 3 | P=0.156 P=0.521 (e) P=0.187 |P=0.215N P=0.499N P=0.531N P=0.553N |
|POLY 1.5 | P=0.154 P=0.513 (e) P=0.194 |P=0.205N P=0.501N P=0.518N P=0.540N |
|POLY 6 | P=0.154 P=0.532 (e) P=0.181 |P=0.227N P=0.494N P=0.549N P=0.565N |
|LOGISTIC REGRESSION| P=0.092 P=0.519 (e) P=0.145 |P=0.211N P=0.499N P=0.541N P=0.558N |
|COCH-ARM / FISHERS | P=0.149 P=0.500 (e) P=0.247 |P=0.185N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 2.8% 7.3% |4.8% 0.0% 0.0% 3.1% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 1/6 (17%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 675 688 720 |666 --- --- 512 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.059 P=0.532 P=0.481 P=0.130 |P=0.394N P=0.227N P=0.324N P=0.617N |
|POLY 3 | P=0.112 P=0.521 P=0.504 P=0.187 |P=0.335N P=0.237N P=0.275N P=0.587N |
|POLY 1.5 | P=0.114 P=0.513 P=0.503 P=0.194 |P=0.321N P=0.239N P=0.258N P=0.567N |
|POLY 6 | P=0.109 P=0.532 P=0.503 P=0.181 |P=0.353N P=0.232N P=0.298N P=0.607N |
|LOGISTIC REGRESSION| P=0.075 P=0.519 P=0.500 P=0.145 |P=0.281N P=0.238N P=0.259N P=0.502N |
|COCH-ARM / FISHERS | P=0.129 P=0.500 P=0.500 P=0.247 |P=0.301N P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 26/49 (53%) 26/50 (52%) 20/50 (40%) |37/50 (74%) 37/50 (74%) 27/50 (54%) 24/49 (49%) |
|POLY-3 ADJUSTED (b)| 71.0% 62.2% 58.8% 61.0% |81.1% 80.2% 64.5% 66.7% |
|TERMINAL (d) | 8/12 (67%) 10/14 (71%) 3/9 (33%) 4/6 (67%) |22/26 (85%) 26/31 (84%) 9/15 (60%) 9/14 (64%) |
|FIRST INCIDENCE | 392 550 393 502 |542 561 469 474 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.437N P=0.068N P=0.303N P=0.393N |P=0.304 P=0.256N P=0.377 P=0.457 |
|POLY 3 | P=0.136N P=0.246N P=0.149N P=0.237N |P=0.022N* P=0.562N P=0.050N P=0.092N |
|POLY 1.5 | P=0.101N P=0.205N P=0.142N P=0.152N |P=0.011N* P=0.599 P=0.037N* P=0.061N |
|POLY 6 | P=0.171N P=0.319N P=0.161N P=0.332N |P=0.042N* P=0.471N P=0.072N P=0.124N |
|LOGISTIC REGRESSION| P=0.065N P=0.126N P=0.162N P=0.083N |P=0.044N* P=0.573 P=0.107N P=0.155N |
|COCH-ARM / FISHERS | P=0.012N* P=0.184N P=0.156N P=0.014N* |P<0.001N** P=0.590N P=0.030N* P=0.009N** |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 4/50 (8%) 3/50 (6%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.8% 15.1% 11.1% 10.5% |7.1% 2.4% 2.8% 0.0% |
|TERMINAL (d) | 0/12 (0%) 2/14 (14%) 1/9 (11%) 1/6 (17%) |1/26 (4%) 1/31 (3%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | 652 638 617 502 |680 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.162 P=0.105 P=0.173 P=0.181 |P=0.130N P=0.272N P=0.497N P=0.221N |
|POLY 3 | P=0.240 P=0.074 P=0.183 P=0.231 |P=0.085N P=0.305N P=0.366N P=0.176N |
|POLY 1.5 | P=0.252 P=0.067 P=0.183 P=0.239 |P=0.074N P=0.308N P=0.339N P=0.160N |
|POLY 6 | P=0.230 P=0.086 P=0.180 P=0.226 |P=0.099N P=0.297N P=0.402N P=0.193N |
|LOGISTIC REGRESSION| P=0.239 P=0.075 P=0.181 P=0.248 |P=0.091N P=0.299N P=0.396N P=0.172N |
|COCH-ARM / FISHERS | P=0.355 P=0.056 P=0.181 P=0.309 |P=0.053N P=0.309N P=0.309N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 11.2% 7.6% 0.0% 3.6% |0.0% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 1/12 (8%) 1/14 (7%) 0/9 (0%) 1/6 (17%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 638 550 --- 729 (T) |--- --- 619 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.088N P=0.409N P=0.088N P=0.346N |P=0.460 (e) P=0.462 (e) |
|POLY 3 | P=0.051N P=0.444N P=0.059N P=0.264N |P=0.448 (e) P=0.471 (e) |
|POLY 1.5 | P=0.048N* P=0.465N P=0.058N P=0.250N |P=0.457 (e) P=0.484 (e) |
|POLY 6 | P=0.055N P=0.419N P=0.060N P=0.280N |P=0.442 (e) P=0.457 (e) |
|LOGISTIC REGRESSION| P=0.055N P=0.455N P=0.061N P=0.269N |P=0.514 (e) P=0.518 (e) |
|COCH-ARM / FISHERS | P=0.038N* P=0.500N P=0.059N P=0.181N |P=0.500 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 11.2% 12.5% 2.8% 3.6% |4.7% 2.4% 2.8% 0.0% |
|TERMINAL (d) | 1/12 (8%) 2/14 (14%) 0/9 (0%) 1/6 (17%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 638 533 666 729 (T) |533 674 619 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123N P=0.597 P=0.223N P=0.346N |P=0.198N P=0.499N P=0.570N P=0.332N |
|POLY 3 | P=0.079N P=0.574 P=0.174N P=0.264N |P=0.196N P=0.502N P=0.557N P=0.306N |
|POLY 1.5 | P=0.073N P=0.546 P=0.174N P=0.250N |P=0.176N P=0.504N P=0.533N P=0.288N |
|POLY 6 | P=0.088N P=0.609 P=0.178N P=0.280N |P=0.220N P=0.496N P=0.587N P=0.326N |
|LOGISTIC REGRESSION| P=0.072N P=0.533 P=0.176N P=0.269N |P=0.109N P=0.489N P=0.459N P=0.203N |
|COCH-ARM / FISHERS | P=0.048N* P=0.500 P=0.181N P=0.181N |P=0.129N P=0.500N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.1% 0.0% 0.0% |2.4% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 533 --- --- |533 674 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.470N P=0.267 (e) (e) |P=0.223N P=0.760N P=0.522N P=0.569N |
|POLY 3 | P=0.443N P=0.263 (e) (e) |P=0.229N P=0.761 P=0.534N P=0.555N |
|POLY 1.5 | P=0.434N P=0.253 (e) (e) |P=0.209N P=0.759 P=0.519N P=0.541N |
|POLY 6 | P=0.451N P=0.277 (e) (e) |P=0.252N P=0.756N P=0.552N P=0.568N |
|LOGISTIC REGRESSION| P=0.387N P=0.224 (e) (e) |P=0.140N P=0.754N P=0.472N P=0.433N |
|COCH-ARM / FISHERS | P=0.375N P=0.247 (e) (e) |P=0.170N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.1% 2.8% 0.0% |4.7% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 533 666 --- |533 674 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.607 P=0.267 P=0.500 (e) |P=0.095N P=0.499N P=0.286N P=0.332N |
|POLY 3 | P=0.610N P=0.263 P=0.504 (e) |P=0.087N P=0.502N P=0.278N P=0.306N |
|POLY 1.5 | P=0.595N P=0.253 P=0.504 (e) |P=0.077N P=0.504N P=0.260N P=0.288N |
|POLY 6 | P=0.622 P=0.277 P=0.504 (e) |P=0.100N P=0.496N P=0.303N P=0.326N |
|LOGISTIC REGRESSION| P=0.532N P=0.224 P=0.502 (e) |P=0.048N* P=0.489N P=0.209N P=0.203N |
|COCH-ARM / FISHERS | P=0.500N P=0.247 P=0.500 (e) |P=0.059N P=0.500N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 2/50 (4%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.8% 12.7% 5.6% 3.5% |4.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 2/14 (14%) 0/9 (0%) 0/6 (0%) |1/26 (4%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 652 638 666 502 |682 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.552N P=0.163 P=0.498 P=0.692 |P=0.094N P=0.214N P=0.355N P=0.357N |
|POLY 3 | P=0.502N P=0.126 P=0.505 P=0.709 |P=0.068N P=0.236N P=0.274N P=0.302N |
|POLY 1.5 | P=0.487N P=0.116 P=0.505 P=0.715 |P=0.063N P=0.238N P=0.258N P=0.285N |
|POLY 6 | P=0.517N P=0.139 P=0.501 P=0.705 |P=0.074N P=0.230N P=0.296N P=0.319N |
|LOGISTIC REGRESSION| P=0.470N P=0.131 P=0.502 P=0.771N |P=0.075N P=0.233N P=0.292N P=0.310N |
|COCH-ARM / FISHERS | P=0.380N P=0.102 P=0.500 P=0.753N |P=0.056N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 3/50 (6%) 3/50 (6%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.8% 12.7% 8.3% 10.5% |7.1% 2.4% 2.8% 0.0% |
|TERMINAL (d) | 0/12 (0%) 2/14 (14%) 0/9 (0%) 1/6 (17%) |1/26 (4%) 1/31 (3%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | 652 638 617 502 |680 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.173 P=0.163 P=0.315 P=0.181 |P=0.130N P=0.272N P=0.497N P=0.221N |
|POLY 3 | P=0.252 P=0.126 P=0.312 P=0.231 |P=0.085N P=0.305N P=0.366N P=0.176N |
|POLY 1.5 | P=0.262 P=0.116 P=0.312 P=0.239 |P=0.074N P=0.308N P=0.339N P=0.160N |
|POLY 6 | P=0.245 P=0.139 P=0.311 P=0.226 |P=0.099N P=0.297N P=0.402N P=0.193N |
|LOGISTIC REGRESSION| P=0.243 P=0.131 P=0.309 P=0.248 |P=0.091N P=0.299N P=0.396N P=0.172N |
|COCH-ARM / FISHERS | P=0.345 P=0.102 P=0.309 P=0.309 |P=0.053N P=0.309N P=0.309N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 3/50 (6%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.8% 12.7% 8.3% 7.1% |4.8% 2.4% 2.8% 0.0% |
|TERMINAL (d) | 0/12 (0%) 2/14 (14%) 0/9 (0%) 1/6 (17%) |1/26 (4%) 1/31 (3%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | 652 638 617 502 |682 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.303 P=0.163 P=0.315 P=0.354 |P=0.255N P=0.453N P=0.676N P=0.357N |
|POLY 3 | P=0.384 P=0.126 P=0.312 P=0.422 |P=0.192N P=0.498N P=0.555N P=0.302N |
|POLY 1.5 | P=0.397 P=0.116 P=0.312 P=0.431 |P=0.174N P=0.502N P=0.531N P=0.285N |
|POLY 6 | P=0.372 P=0.139 P=0.311 P=0.415 |P=0.214N P=0.490N P=0.586N P=0.319N |
|LOGISTIC REGRESSION| P=0.391 P=0.131 P=0.309 P=0.450 |P=0.206N P=0.486N P=0.610N P=0.310N |
|COCH-ARM / FISHERS | P=0.500 P=0.102 P=0.309 P=0.500 |P=0.129N P=0.500N P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 44/50 (88%) 40/50 (80%) 31/50 (62%) | |
|POLY-3 ADJUSTED (b)| 85.9% 92.2% 88.1% 87.4% | |
|TERMINAL (d) | 12/12 (100%) 13/14 (93%) 9/9 (100%) 6/6 (100%) | |
|FIRST INCIDENCE | 495 356 365 449 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.093 P=0.499 P=0.174 P=0.164 | |
|POLY 3 | P=0.553 P=0.219 P=0.507 P=0.571 | |
|POLY 1.5 | P=0.547 P=0.109 P=0.383 P=0.554 | |
|POLY 6 | P=0.534N P=0.548 P=0.695N P=0.735 | |
|LOGISTIC REGRESSION| P=0.304 P=0.119 P=0.269 P=0.288 | |
|COCH-ARM / FISHERS | P=0.093N P=0.039 * P=0.241 P=0.198N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 2/49 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.9% 10.2% 5.5% 7.1% |4.8% 2.4% 5.7% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |2/26 (8%) 1/31 (3%) 2/15 (13%) 0/14 (0%) |
|FIRST INCIDENCE | 729 (T) 615 638 564 |730 (T) 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.351 P=0.264 P=0.488 P=0.365 |P=0.415N P=0.438N P=0.484 P=0.382N |
|POLY 3 | P=0.419 P=0.214 P=0.511 P=0.426 |P=0.312N P=0.497N P=0.629 P=0.303N |
|POLY 1.5 | P=0.425 P=0.200 P=0.508 P=0.432 |P=0.287N P=0.501N P=0.654 P=0.288N |
|POLY 6 | P=0.418 P=0.236 P=0.514 P=0.425 |P=0.338N P=0.487N P=0.596 P=0.317N |
|LOGISTIC REGRESSION| P=0.406 P=0.222 P=0.503 P=0.426 |P=0.415N P=0.438N P=0.484 (e) |
|COCH-ARM / FISHERS | P=0.500 P=0.181 P=0.500 P=0.500 |P=0.215N P=0.500N P=0.684 P=0.253N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 0.0% 0.0% |0.0% 4.8% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 2/31 (7%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.608N P=0.531 (e) (e) |P=0.528N P=0.277 (e) (e) |
|POLY 3 | P=0.563N P=0.520 (e) (e) |P=0.487N P=0.239 (e) (e) |
|POLY 1.5 | P=0.555N P=0.512 (e) (e) |P=0.456N P=0.236 (e) (e) |
|POLY 6 | P=0.571N P=0.530 (e) (e) |P=0.522N P=0.245 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.531 (e) (e) |(e) P=0.277 (e) (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.500 (e) (e) |P=0.380N P=0.247 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 2/50 (4%) 2/50 (4%) |2/50 (4%) 3/50 (6%) 2/49 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.9% 12.7% 5.5% 7.1% |4.8% 7.1% 5.7% 0.0% |
|TERMINAL (d) | 1/12 (8%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |2/26 (8%) 3/31 (10%) 2/15 (13%) 0/14 (0%) |
|FIRST INCIDENCE | 729 (T) 615 638 564 |730 (T) 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.382 P=0.168 P=0.488 P=0.365 |P=0.370N P=0.581 P=0.484 P=0.382N |
|POLY 3 | P=0.471 P=0.128 P=0.511 P=0.426 |P=0.264N P=0.504 P=0.629 P=0.303N |
|POLY 1.5 | P=0.477 P=0.117 P=0.508 P=0.432 |P=0.234N P=0.498 P=0.654 P=0.288N |
|POLY 6 | P=0.472 P=0.145 P=0.514 P=0.425 |P=0.298N P=0.517 P=0.596 P=0.317N |
|LOGISTIC REGRESSION| P=0.451 P=0.140 P=0.503 P=0.426 |P=0.370N P=0.581 P=0.484 (e) |
|COCH-ARM / FISHERS | P=0.558 P=0.102 P=0.500 P=0.500 |P=0.157N P=0.500 P=0.684 P=0.253N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 2.8% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 6.2% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 638 --- --- --- |--- --- --- 654 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.194N P=0.461N P=0.480N P=0.548N |P=0.034 * (e) (e) P=0.165 |
|POLY 3 | P=0.212N P=0.482N P=0.499N P=0.549N |P=0.055 (e) (e) P=0.184 |
|POLY 1.5 | P=0.206N P=0.488N P=0.498N P=0.542N |P=0.056 (e) (e) P=0.194 |
|POLY 6 | P=0.217N P=0.474N P=0.503N P=0.556N |P=0.051 (e) (e) P=0.176 |
|LOGISTIC REGRESSION| P=0.188N P=0.505N P=0.500N P=0.534N |P=0.043 * (e) (e) P=0.196 |
|COCH-ARM / FISHERS | P=0.185N P=0.500N P=0.500N P=0.500N |P=0.055 (e) (e) P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 2.8% 2.6% 0.0% 0.0% |0.0% 0.0% 0.0% 6.2% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 638 675 --- --- |--- --- --- 654 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199N P=0.721N P=0.480N P=0.548N |P=0.034 * (e) (e) P=0.165 |
|POLY 3 | P=0.208N P=0.740N P=0.499N P=0.549N |P=0.055 (e) (e) P=0.184 |
|POLY 1.5 | P=0.201N P=0.747N P=0.498N P=0.542N |P=0.056 (e) (e) P=0.194 |
|POLY 6 | P=0.216N P=0.730N P=0.503N P=0.556N |P=0.051 (e) (e) P=0.176 |
|LOGISTIC REGRESSION| P=0.186N P=0.757N P=0.500N P=0.534N |P=0.043 * (e) (e) P=0.196 |
|COCH-ARM / FISHERS | P=0.170N P=0.753N P=0.500N P=0.500N |P=0.055 (e) (e) P=0.242 |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |8/50 (16%) 10/50 (20%) 8/50 (16%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| |18.6% 23.1% 21.1% 9.3% |
|TERMINAL (d) | |3/26 (12%) 6/31 (19%) 2/15 (13%) 1/14 (7%) |
|FIRST INCIDENCE | |566 612 455 641 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.397N P=0.504 P=0.310 P=0.315N |
|POLY 3 | |P=0.239N P=0.400 P=0.499 P=0.215N |
|POLY 1.5 | |P=0.181N P=0.391 P=0.547 P=0.180N |
|POLY 6 | |P=0.313N P=0.423 P=0.437 P=0.253N |
|LOGISTIC REGRESSION| |P=0.145N P=0.396 P=0.592 P=0.185N |
|COCH-ARM / FISHERS | |P=0.075N P=0.398 P=0.607N P=0.100N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |8/50 (16%) 10/50 (20%) 8/50 (16%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| |18.6% 23.1% 21.1% 9.3% |
|TERMINAL (d) | |3/26 (12%) 6/31 (19%) 2/15 (13%) 1/14 (7%) |
|FIRST INCIDENCE | |566 612 455 641 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.397N P=0.504 P=0.310 P=0.315N |
|POLY 3 | |P=0.239N P=0.400 P=0.499 P=0.215N |
|POLY 1.5 | |P=0.181N P=0.391 P=0.547 P=0.180N |
|POLY 6 | |P=0.313N P=0.423 P=0.437 P=0.253N |
|LOGISTIC REGRESSION| |P=0.145N P=0.396 P=0.592 P=0.185N |
|COCH-ARM / FISHERS | |P=0.075N P=0.398 P=0.607N P=0.100N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.8% 5.1% 2.8% 0.0% |0.0% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | 652 652 581 --- |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.335N P=0.557 P=0.747N P=0.570N |P=0.386 (e) P=0.390 (e) |
|POLY 3 | P=0.339N P=0.534 P=0.757N P=0.549N |P=0.449 (e) P=0.469 (e) |
|POLY 1.5 | P=0.324N P=0.522 P=0.757N P=0.542N |P=0.458 (e) P=0.482 (e) |
|POLY 6 | P=0.354N P=0.551 P=0.760N P=0.556N |P=0.445 (e) P=0.452 (e) |
|LOGISTIC REGRESSION| P=0.282N P=0.535 P=0.759 P=0.541N |(e) (e) P=0.390 (e) |
|COCH-ARM / FISHERS | P=0.249N P=0.500 P=0.753N P=0.500N |P=0.500 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.8% 7.7% 2.8% 0.0% |0.0% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | 652 652 581 --- |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.298N P=0.367 P=0.747N P=0.570N |P=0.386 (e) P=0.390 (e) |
|POLY 3 | P=0.296N P=0.342 P=0.757N P=0.549N |P=0.449 (e) P=0.469 (e) |
|POLY 1.5 | P=0.282N P=0.328 P=0.757N P=0.542N |P=0.458 (e) P=0.482 (e) |
|POLY 6 | P=0.310N P=0.362 P=0.760N P=0.556N |P=0.445 (e) P=0.452 (e) |
|LOGISTIC REGRESSION| P=0.246N P=0.340 P=0.759 P=0.541N |(e) (e) P=0.390 (e) |
|COCH-ARM / FISHERS | P=0.209N P=0.309 P=0.753N P=0.500N |P=0.500 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 24/50 (48%) 25/50 (50%) 16/50 (32%) |18/50 (36%) 20/50 (40%) 25/50 (50%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 51.4% 53.2% 58.6% 50.5% |39.7% 45.2% 57.5% 34.4% |
|TERMINAL (d) | 5/12 (42%) 4/14 (29%) 3/9 (33%) 1/6 (17%) |7/26 (27%) 11/31 (36%) 4/15 (27%) 3/14 (21%) |
|FIRST INCIDENCE | 495 449 481 449 |533 542 355 514 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312 P=0.507N P=0.263 P=0.501 |P=0.154 P=0.559N P=0.018 * P=0.537 |
|POLY 3 | P=0.439 P=0.522 P=0.324 P=0.566N |P=0.410 P=0.375 P=0.065 P=0.401N |
|POLY 1.5 | P=0.505 P=0.456 P=0.309 P=0.500N |P=0.521 P=0.381 P=0.083 P=0.326N |
|POLY 6 | P=0.389 P=0.586N P=0.347 P=0.587 |P=0.314 P=0.381 P=0.050 P=0.470N |
|LOGISTIC REGRESSION| P=0.428N P=0.353 P=0.285 P=0.474N |P=0.369N P=0.414 P=0.135 P=0.264N |
|COCH-ARM / FISHERS | P=0.203N P=0.344 P=0.274 P=0.204N |P=0.217N P=0.418 P=0.113 P=0.138N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.6% 2.6% 0.0% 3.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 638 729 (T) --- 666 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.340N P=0.446N P=0.233N P=0.597N |(e) (e) (e) (e) |
|POLY 3 | P=0.278N P=0.470N P=0.236N P=0.585N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.273N P=0.481N P=0.235N P=0.573N |(e) (e) (e) (e) |
|POLY 6 | P=0.286N P=0.459N P=0.241N P=0.597N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.300N P=0.461N P=0.235N P=0.578N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.249N P=0.500N P=0.247N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.6% 2.6% 0.0% 3.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 638 729 (T) --- 666 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.340N P=0.446N P=0.233N P=0.597N |(e) (e) (e) (e) |
|POLY 3 | P=0.278N P=0.470N P=0.236N P=0.585N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.273N P=0.481N P=0.235N P=0.573N |(e) (e) (e) (e) |
|POLY 6 | P=0.286N P=0.459N P=0.241N P=0.597N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.300N P=0.461N P=0.235N P=0.578N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.249N P=0.500N P=0.247N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 48/50 (96%) 50/50 (100%) 38/50 (76%) |42/50 (84%) 43/50 (86%) 40/50 (80%) 31/50 (62%) |
|POLY-3 ADJUSTED (b)| 98.6% 98.2% 100.0% 97.9% |90.8% 92.2% 88.8% 80.9% |
|TERMINAL (d) | 12/12 (100%) 14/14 (100%) 9/9 (100%) 6/6 (100%) |25/26 (96%) 29/31 (94%) 14/15 (93%) 10/14 (71%) |
|FIRST INCIDENCE | 392 356 365 106 |542 561 455 474 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140 P=0.197N P=0.307 P=0.314 |P=0.034 * P=0.270N P=0.022 * P=0.201 |
|POLY 3 | P=0.625 P=0.811N P=0.684 P=0.809N |P=0.079N P=0.552 P=0.517N P=0.132N |
|POLY 1.5 | P=0.363N P=0.678N P=0.553 P=0.347N |P=0.048N* P=0.478 P=0.460N P=0.094N |
|POLY 6 | P=0.515 P=0.961 P=0.890 P=0.960 |P=0.100N P=0.658N P=0.574N P=0.142N |
|LOGISTIC REGRESSION| P=0.332N P=0.489N P=0.376 P=0.345N |P=0.236N P=0.430 P=0.433 P=0.332N |
|COCH-ARM / FISHERS | P<0.001N** P=0.691N P=0.247 P=0.004N** |P=0.004N** P=0.500 P=0.398N P=0.012N* |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 33/50 (66%) 31/50 (62%) 19/50 (38%) |27/50 (54%) 26/50 (52%) 29/50 (58%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 66.5% 71.1% 69.5% 59.0% |57.8% 56.7% 63.2% 44.1% |
|TERMINAL (d) | 6/12 (50%) 7/14 (50%) 3/9 (33%) 2/6 (33%) |11/26 (42%) 14/31 (45%) 4/15 (27%) 5/14 (36%) |
|FIRST INCIDENCE | 495 449 481 449 |518 437 276 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.457 P=0.540N P=0.313 P=0.494N |P=0.301 P=0.329N P=0.071 P=0.478N |
|POLY 3 | P=0.338N P=0.401 P=0.471 P=0.328N |P=0.259N P=0.541N P=0.369 P=0.152N |
|POLY 1.5 | P=0.269N P=0.323 P=0.423 P=0.258N |P=0.175N P=0.538N P=0.405 P=0.102N |
|POLY 6 | P=0.395N P=0.496 P=0.535 P=0.400N |P=0.362N P=0.536N P=0.326 P=0.215N |
|LOGISTIC REGRESSION| P=0.197N P=0.272 P=0.365 P=0.260N |P=0.065N P=0.505N P=0.529 P=0.071N |
|COCH-ARM / FISHERS | P=0.037N* P=0.206 P=0.342 P=0.054N |P=0.033N* P=0.500N P=0.420 P=0.021N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 50/50 (100%) 38/50 (76%) |49/50 (98%) 46/50 (92%) 49/50 (98%) 36/50 (72%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 100.0% 97.9% |100.0% 95.8% 98.0% 89.8% |
|TERMINAL (d) | 12/12 (100%) 14/14 (100%) 9/9 (100%) 6/6 (100%) |26/26 (100%) 29/31 (94%) 14/15 (93%) 12/14 (86%) |
|FIRST INCIDENCE | 392 356 365 106 |518 437 276 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.185 P=0.231N P=0.350 P=0.354 |P=0.024 * P=0.115N P=0.013 * P=0.205 |
|POLY 3 | P=0.115N P=1.000 P=1.000 P=0.603N |P=0.026N* P=0.230N P=0.506N P=0.021N* |
|POLY 1.5 | P=0.008N** P=1.000 P=1.000 P=0.085N |P=0.006N** P=0.209N P=0.530N P=0.005N** |
|POLY 6 | P=0.986N P=1.000 P=1.000 P=1.000N |P=0.065N P=0.233N P=0.504N P=0.056N |
|LOGISTIC REGRESSION| P=0.038N* (e) (e) P=0.163N |P=0.010N* P=0.224N P=0.761 P=0.028N* |
|COCH-ARM / FISHERS | P<0.001N** P=0.500 P=0.500 P<0.001N** |P<0.001N** P=0.181N P=0.753N P<0.001N** |
|=================================================================================================================================|
(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).