TDMS Study 93026-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest DECALIN DATE: 08/28/01
EXPERIMENT: 93026 TEST: 07 TIME: 09:20:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C93026
PATHOLOGIST: RENNE, ROGER CAS: 91-17-8
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1/RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 CONTROL
INCLUDE 003 25 PPM
INCLUDE 005 50 PPM
INCLUDE 006 100 PPM
INCLUDE 008 400 PPM
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest DECALIN DATE: 08/28/01
EXPERIMENT: 93026 TEST: 07 TIME: 09:20:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C93026
PATHOLOGIST: RENNE, ROGER CAS: 91-17-8
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 Medulla
Clitoral/Preputial Gland
Islets, Pancreatic
Kidney
Lung
Pancreas
Pituitary Gland
Prostate, NOS
Salivary Glands
Testes
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest DECALIN DATE: 08/28/01
EXPERIMENT: 93026 TEST: 07 TIME: 09:20:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C93026
PATHOLOGIST: RENNE, ROGER CAS: 91-17-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DECALIN
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Malignant
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Carcinoma
Kidney: Renal Tubule Adenoma
Carcinoma
Carcinoma or Adenoma
Testes Adenoma
All Organs Malignant Tumors
===============================================================
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/49 (14%) 9/49 (18%) 11/49 (22%) 10/49 (20%) 6/20 (30%) |
|POLY-3 RATE (b) | 7/41.92 9/40.83 11/43.99 10/40.30 6/18.88 |
|POLY-3 PERCENT (g) | 16.7% 22.0% 25.0% 24.8% 31.8% |
|TERMINAL (d) | 4/28 (14%) 8/23 (35%) 6/23 (26%) 6/20 (30%) 4/14 (29%) |
|FIRST INCIDENCE | 561 589 602 600 708 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.321 P=0.258 P=0.156 P=0.139 P=0.245 |
|POLY 3 | P=0.173 P=0.368 P=0.247 P=0.261 P=0.155 |
|POLY 1.5 | P=0.151 P=0.379 P=0.238 P=0.278 P=0.137 |
|POLY 6 | P=0.215 P=0.351 P=0.250 P=0.237 P=0.185 |
|LOGISTIC REGRESSION| P=0.206 P=0.363 P=0.234 P=0.245 P=0.173 |
|COCH-ARM / FISHERS | P=0.129 P=0.393 P=0.217 P=0.297 P=0.121 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 0/49 (0%) 2/49 (4%) 7/49 (14%) 3/20 (15%) |
|POLY-3 RATE (b) | 2/41.35 0/40.35 2/43.10 7/40.53 3/18.75 |
|POLY-3 PERCENT (g) | 4.8% 0.0% 4.6% 17.3% 16.0% |
|TERMINAL (d) | 1/28 (4%) 0/23 (0%) 0/23 (0%) 3/20 (15%) 2/14 (14%) |
|FIRST INCIDENCE | 706 --- 638 506 716 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.076 P=0.265N P=0.673 P=0.044 * P=0.227 |
|POLY 3 | P=0.034 * P=0.242N P=0.679N P=0.072 P=0.166 |
|POLY 1.5 | P=0.028 * P=0.240N P=0.683N P=0.075 P=0.154 |
|POLY 6 | P=0.045 * P=0.246N P=0.680N P=0.066 P=0.185 |
|LOGISTIC REGRESSION| P=0.030 * P=0.248N P=0.692N P=0.074 P=0.208 |
|COCH-ARM / FISHERS | P=0.025 * P=0.247N P=0.691N P=0.080 P=0.142 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/49 (16%) 9/49 (18%) 13/49 (27%) 16/49 (33%) 8/20 (40%) |
|POLY-3 RATE (b) | 8/41.92 9/40.83 13/44.46 16/41.43 8/18.95 |
|POLY-3 PERCENT (g) | 19.1% 22.0% 29.2% 38.6% 42.2% |
|TERMINAL (d) | 5/28 (18%) 8/23 (35%) 6/23 (26%) 8/20 (40%) 5/14 (36%) |
|FIRST INCIDENCE | 561 589 602 506 708 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.134 P=0.347 P=0.117 P=0.014 * P=0.115 |
|POLY 3 | P=0.038 * P=0.476 P=0.196 P=0.038 * P=0.049 * |
|POLY 1.5 | P=0.029 * P=0.487 P=0.184 P=0.042 * P=0.041 * |
|POLY 6 | P=0.056 P=0.458 P=0.205 P=0.032 * P=0.065 |
|LOGISTIC REGRESSION| P=0.044 * P=0.468 P=0.176 P=0.036 * P=0.067 |
|COCH-ARM / FISHERS | P=0.023 * P=0.500 P=0.162 P=0.049 * P=0.039 * |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/42.09 0/40.74 0/42.63 2/40.40 0/18.68 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/23 (0%) 0/23 (0%) 1/20 (5%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- 688 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.758 (e) (e) P=0.184 (e) |
|POLY 3 | P=0.795 (e) (e) P=0.228 (e) |
|POLY 1.5 | P=0.776 (e) (e) P=0.232 (e) |
|POLY 6 | P=0.819 (e) (e) P=0.220 (e) |
|LOGISTIC REGRESSION| P=0.756 (e) (e) P=0.218 (e) |
|COCH-ARM / FISHERS | P=0.749 (e) (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 1/49 (2%) 3/50 (6%) 2/20 (10%) |
|POLY-3 RATE (b) | 0/42.09 1/40.12 1/42.97 3/41.09 2/18.68 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 2.3% 7.3% 10.7% |
|TERMINAL (d) | 0/28 (0%) 0/23 (0%) 0/23 (0%) 2/20 (10%) 2/14 (14%) |
|FIRST INCIDENCE | --- 638 638 379 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.082 P=0.495 P=0.510 P=0.085 P=0.103 |
|POLY 3 | P=0.053 P=0.490 P=0.504 P=0.114 P=0.075 |
|POLY 1.5 | P=0.047 * P=0.493 P=0.502 P=0.117 P=0.070 |
|POLY 6 | P=0.062 P=0.488 P=0.504 P=0.108 P=0.082 |
|LOGISTIC REGRESSION| P=0.029 * P=0.507 P=0.441 P=0.131 P=0.103 |
|COCH-ARM / FISHERS | P=0.042 * P=0.495 P=0.495 P=0.121 P=0.079 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 2/49 (4%) 3/50 (6%) 2/20 (10%) |
|POLY-3 RATE (b) | 0/42.09 2/40.12 2/42.97 3/41.09 2/18.68 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 4.7% 7.3% 10.7% |
|TERMINAL (d) | 0/28 (0%) 1/23 (4%) 1/23 (4%) 2/20 (10%) 2/14 (14%) |
|FIRST INCIDENCE | --- 638 638 379 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.170 P=0.216 P=0.223 P=0.085 P=0.103 |
|POLY 3 | P=0.122 P=0.226 P=0.241 P=0.114 P=0.075 |
|POLY 1.5 | P=0.111 P=0.229 P=0.239 P=0.117 P=0.070 |
|POLY 6 | P=0.140 P=0.223 P=0.241 P=0.108 P=0.082 |
|LOGISTIC REGRESSION| P=0.087 P=0.230 P=0.228 P=0.131 P=0.103 |
|COCH-ARM / FISHERS | P=0.099 P=0.242 P=0.242 P=0.121 P=0.079 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/49 (6%) 2/50 (4%) 1/20 (5%) |
|POLY-3 RATE (b) | 3/42.52 3/40.88 3/42.90 2/40.71 1/18.68 |
|POLY-3 PERCENT (g) | 7.1% 7.3% 7.0% 4.9% 5.4% |
|TERMINAL (d) | 1/28 (4%) 1/23 (4%) 1/23 (4%) 0/20 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 658 708 680 649 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.445N P=0.609 P=0.628 P=0.574N P=0.557N |
|POLY 3 | P=0.535N P=0.645 P=0.659N P=0.520N P=0.624N |
|POLY 1.5 | P=0.549N P=0.652 P=0.661N P=0.510N P=0.638N |
|POLY 6 | P=0.512N P=0.634 P=0.663N P=0.536N P=0.603N |
|LOGISTIC REGRESSION| P=0.521N P=0.644 P=0.661N P=0.505N P=0.634N |
|COCH-ARM / FISHERS | P=0.565N P=0.661N P=0.651 P=0.500N P=0.749 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 0/49 (0%) 4/50 (8%) 0/20 (0%) |
|POLY-3 RATE (b) | 4/43.31 1/40.74 0/42.63 4/40.40 0/18.68 |
|POLY-3 PERCENT (g) | 9.2% 2.5% 0.0% 9.9% 0.0% |
|TERMINAL (d) | 2/28 (7%) 1/23 (4%) 0/23 (0%) 3/20 (15%) 0/14 (0%) |
|FIRST INCIDENCE | 421 733 (T) --- 688 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.301N P=0.224N P=0.077N P=0.509 P=0.203N |
|POLY 3 | P=0.326N P=0.197N P=0.062N P=0.605 P=0.209N |
|POLY 1.5 | P=0.343N P=0.190N P=0.062N P=0.622 P=0.220N |
|POLY 6 | P=0.298N P=0.207N P=0.063N P=0.580 P=0.194N |
|LOGISTIC REGRESSION| P=0.368N P=0.166N P=0.099N P=0.640N P=0.280N |
|COCH-ARM / FISHERS | P=0.364N P=0.181N P=0.061N P=0.643N P=0.251N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 4/50 (8%) 3/49 (6%) 6/50 (12%) 1/20 (5%) |
|POLY-3 RATE (b) | 7/43.74 4/40.88 3/42.90 6/40.88 1/18.68 |
|POLY-3 PERCENT (g) | 16.0% 9.8% 7.0% 14.7% 5.4% |
|TERMINAL (d) | 3/28 (11%) 2/23 (9%) 1/23 (4%) 3/20 (15%) 1/14 (7%) |
|FIRST INCIDENCE | 421 708 680 649 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.236N P=0.339N P=0.200N P=0.573 P=0.192N |
|POLY 3 | P=0.292N P=0.299N P=0.163N P=0.553N P=0.227N |
|POLY 1.5 | P=0.313N P=0.284N P=0.163N P=0.530N P=0.241N |
|POLY 6 | P=0.260N P=0.321N P=0.170N P=0.586N P=0.207N |
|LOGISTIC REGRESSION| P=0.315N P=0.262N P=0.193N P=0.499N P=0.298N |
|COCH-ARM / FISHERS | P=0.335N P=0.262N P=0.167N P=0.500N P=0.268N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 6/49 (12%) 9/50 (18%) 5/20 (25%) |
|POLY-3 RATE (b) | 1/42.09 2/41.09 6/42.90 9/41.34 5/18.75 |
|POLY-3 PERCENT (g) | 2.4% 4.9% 14.0% 21.8% 26.7% |
|TERMINAL (d) | 1/28 (4%) 0/23 (0%) 4/23 (17%) 5/20 (25%) 4/14 (29%) |
|FIRST INCIDENCE | 733 (T) 644 680 617 716 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.024 * P=0.453 P=0.038 * P=0.004 ** P=0.012 * |
|POLY 3 | P=0.005 ** P=0.492 P=0.058 P=0.007 ** P=0.004 ** |
|POLY 1.5 | P=0.004 ** P=0.495 P=0.057 P=0.007 ** P=0.003 ** |
|POLY 6 | P=0.007 ** P=0.488 P=0.057 P=0.006 ** P=0.005 ** |
|LOGISTIC REGRESSION| P=0.009 ** P=0.489 P=0.051 P=0.007 ** P=0.012 * |
|COCH-ARM / FISHERS | P=0.003 ** P=0.500 P=0.053 P=0.008 ** P=0.006 ** |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/49 (2%) 4/50 (8%) 1/20 (5%) |
|POLY-3 RATE (b) | 0/42.09 1/40.74 1/42.78 4/40.81 1/18.78 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 2.3% 9.8% 5.3% |
|TERMINAL (d) | 0/28 (0%) 1/23 (4%) 0/23 (0%) 2/20 (10%) 0/14 (0%) |
|FIRST INCIDENCE | --- 733 (T) 694 617 708 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.358 P=0.461 P=0.494 P=0.044 * P=0.393 |
|POLY 3 | P=0.303 P=0.493 P=0.503 P=0.056 P=0.334 |
|POLY 1.5 | P=0.278 P=0.496 P=0.501 P=0.058 P=0.326 |
|POLY 6 | P=0.343 P=0.490 P=0.503 P=0.052 P=0.347 |
|LOGISTIC REGRESSION| P=0.277 P=0.461 P=0.498 P=0.059 P=0.332 |
|COCH-ARM / FISHERS | P=0.249 P=0.500 P=0.495 P=0.059 P=0.286 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 7/49 (14%) 12/50 (24%) 6/20 (30%) |
|POLY-3 RATE (b) | 1/42.09 3/41.09 7/43.05 12/41.51 6/18.85 |
|POLY-3 PERCENT (g) | 2.4% 7.3% 16.3% 28.9% 31.8% |
|TERMINAL (d) | 1/28 (4%) 1/23 (4%) 4/23 (17%) 7/20 (35%) 4/14 (29%) |
|FIRST INCIDENCE | 733 (T) 644 680 617 708 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.015 * P=0.255 P=0.022 * P<0.001 ** P=0.005 ** |
|POLY 3 | P=0.002 ** P=0.296 P=0.031 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.300 P=0.031 * P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.003 ** P=0.291 P=0.031 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.004 ** P=0.289 P=0.029 * P<0.001 ** P=0.004 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.309 P=0.028 * P<0.001 ** P=0.002 ** |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/49 (4%) 1/50 (2%) 0/20 (0%) |
|POLY-3 RATE (b) | 1/42.29 1/40.74 2/42.78 1/40.22 0/18.68 |
|POLY-3 PERCENT (g) | 2.4% 2.5% 4.7% 2.5% 0.0% |
|TERMINAL (d) | 0/28 (0%) 1/23 (4%) 1/23 (4%) 1/20 (5%) 0/14 (0%) |
|FIRST INCIDENCE | 680 733 (T) 694 733 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.416N P=0.729 P=0.474 P=0.706 P=0.627N |
|POLY 3 | P=0.466N P=0.753 P=0.504 P=0.750 P=0.665N |
|POLY 1.5 | P=0.477N P=0.756 P=0.501 P=0.755 P=0.673N |
|POLY 6 | P=0.448N P=0.748 P=0.502 P=0.741 P=0.654N |
|LOGISTIC REGRESSION| P=0.444N P=0.754 P=0.502 P=0.748 P=0.696N |
|COCH-ARM / FISHERS | P=0.490N P=0.753N P=0.492 P=0.753N P=0.714N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/49 (6%) 1/50 (2%) 1/20 (5%) |
|POLY-3 RATE (b) | 2/42.29 1/40.74 3/42.93 1/40.22 1/18.68 |
|POLY-3 PERCENT (g) | 4.7% 2.5% 7.0% 2.5% 5.4% |
|TERMINAL (d) | 1/28 (4%) 1/23 (4%) 1/23 (4%) 1/20 (5%) 1/14 (7%) |
|FIRST INCIDENCE | 680 733 (T) 694 733 (T) 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.643N P=0.556N P=0.459 P=0.595N P=0.726N |
|POLY 3 | P=0.646 P=0.513N P=0.507 P=0.517N P=0.706 |
|POLY 1.5 | P=0.630 P=0.507N P=0.503 P=0.509N P=0.693 |
|POLY 6 | P=0.671 P=0.522N P=0.506 P=0.532N P=0.724 |
|LOGISTIC REGRESSION| P=0.664 P=0.520N P=0.504 P=0.537N P=0.719 |
|COCH-ARM / FISHERS | P=0.611 P=0.500N P=0.490 P=0.500N P=0.642 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/20 (0%) |
|POLY-3 RATE (b) | 2/42.09 1/40.74 0/42.63 1/40.40 0/18.68 |
|POLY-3 PERCENT (g) | 4.8% 2.5% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 2/28 (7%) 1/23 (4%) 0/23 (0%) 0/20 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) --- 687 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.386N P=0.569N P=0.282N P=0.588N P=0.400N |
|POLY 3 | P=0.434N P=0.511N P=0.234N P=0.514N P=0.428N |
|POLY 1.5 | P=0.440N P=0.507N P=0.236N P=0.508N P=0.440N |
|POLY 6 | P=0.423N P=0.518N P=0.235N P=0.526N P=0.410N |
|LOGISTIC REGRESSION| P=0.397N P=0.569N (e) P=0.542N (e) |
|COCH-ARM / FISHERS | P=0.445N P=0.500N P=0.247N P=0.500N P=0.507N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 1/50 (2%) 0/20 (0%) |
|POLY-3 RATE (b) | 2/42.11 1/40.74 3/42.88 1/40.30 0/18.68 |
|POLY-3 PERCENT (g) | 4.8% 2.5% 7.0% 2.5% 0.0% |
|TERMINAL (d) | 1/28 (4%) 1/23 (4%) 2/23 (9%) 0/20 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 728 733 (T) 666 715 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.295N P=0.572N P=0.429 P=0.602N P=0.406N |
|POLY 3 | P=0.325N P=0.512N P=0.508 P=0.515N P=0.428N |
|POLY 1.5 | P=0.337N P=0.507N P=0.503 P=0.508N P=0.440N |
|POLY 6 | P=0.306N P=0.519N P=0.508 P=0.528N P=0.411N |
|LOGISTIC REGRESSION| P=0.300N P=0.543N P=0.495 P=0.562N P=0.390N |
|COCH-ARM / FISHERS | P=0.351N P=0.500N P=0.500 P=0.500N P=0.507N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 3/50 (6%) 1/50 (2%) 0/20 (0%) |
|POLY-3 RATE (b) | 3/42.11 1/40.74 3/42.88 1/40.30 0/18.68 |
|POLY-3 PERCENT (g) | 7.1% 2.5% 7.0% 2.5% 0.0% |
|TERMINAL (d) | 2/28 (7%) 1/23 (4%) 2/23 (9%) 0/20 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 728 733 (T) 666 715 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.226N P=0.382N P=0.584 P=0.422N P=0.271N |
|POLY 3 | P=0.248N P=0.317N P=0.655N P=0.321N P=0.291N |
|POLY 1.5 | P=0.259N P=0.312N P=0.659N P=0.313N P=0.304N |
|POLY 6 | P=0.231N P=0.323N P=0.656N P=0.333N P=0.272N |
|LOGISTIC REGRESSION| P=0.225N P=0.350N P=0.655 P=0.375N P=0.256N |
|COCH-ARM / FISHERS | P=0.270N P=0.309N P=0.661N P=0.309N P=0.358N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 2/50 (4%) 0/20 (0%) |
|POLY-3 RATE (b) | 4/42.11 2/40.74 3/42.88 2/40.47 0/18.68 |
|POLY-3 PERCENT (g) | 9.5% 4.9% 7.0% 4.9% 0.0% |
|TERMINAL (d) | 3/28 (11%) 2/23 (9%) 2/23 (9%) 0/20 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 728 733 (T) 666 687 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.163N P=0.433N P=0.592N P=0.471N P=0.186N |
|POLY 3 | P=0.181N P=0.352N P=0.490N P=0.355N P=0.201N |
|POLY 1.5 | P=0.193N P=0.346N P=0.496N P=0.347N P=0.215N |
|POLY 6 | P=0.163N P=0.360N P=0.490N P=0.369N P=0.183N |
|LOGISTIC REGRESSION| P=0.164N P=0.401N P=0.517N P=0.403N P=0.172N |
|COCH-ARM / FISHERS | P=0.206N P=0.339N P=0.500N P=0.339N P=0.251N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/42.09 2/40.91 3/42.63 0/40.22 0/18.68 |
|POLY-3 PERCENT (g) | 0.0% 4.9% 7.0% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 1/23 (4%) 3/23 (13%) 0/20 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 688 733 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.382N P=0.212 P=0.087 (e) (e) |
|POLY 3 | P=0.430N P=0.230 P=0.120 (e) (e) |
|POLY 1.5 | P=0.439N P=0.233 P=0.119 (e) (e) |
|POLY 6 | P=0.416N P=0.227 P=0.119 (e) (e) |
|LOGISTIC REGRESSION| P=0.389N P=0.227 P=0.087 (e) (e) |
|COCH-ARM / FISHERS | P=0.449N P=0.247 P=0.121 (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 1/50 (2%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/42.09 2/40.91 3/42.63 1/40.43 0/18.68 |
|POLY-3 PERCENT (g) | 0.0% 4.9% 7.0% 2.5% 0.0% |
|TERMINAL (d) | 0/28 (0%) 1/23 (4%) 3/23 (13%) 0/20 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 688 733 (T) 679 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.409N P=0.212 P=0.087 P=0.477 (e) |
|POLY 3 | P=0.459N P=0.230 P=0.120 P=0.492 (e) |
|POLY 1.5 | P=0.473N P=0.233 P=0.119 P=0.496 (e) |
|POLY 6 | P=0.437N P=0.227 P=0.119 P=0.486 (e) |
|LOGISTIC REGRESSION| P=0.434N P=0.227 P=0.087 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.490N P=0.247 P=0.121 P=0.500 (e) |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/42.09 1/40.91 2/42.63 0/40.22 0/18.68 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 4.7% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/23 (0%) 2/23 (9%) 0/20 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 688 733 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.526N P=0.488 P=0.195 (e) (e) |
|POLY 3 | P=0.587N P=0.494 P=0.240 (e) (e) |
|POLY 1.5 | P=0.593N P=0.497 P=0.238 (e) (e) |
|POLY 6 | P=0.577N P=0.491 P=0.238 (e) (e) |
|LOGISTIC REGRESSION| P=0.549N P=0.498 P=0.195 (e) (e) |
|COCH-ARM / FISHERS | P=0.599N P=0.500 P=0.247 (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 27/50 (54%) 33/50 (66%) 25/49 (51%) 25/49 (51%) 9/20 (45%) |
|POLY-3 RATE (b) | 27/46.10 33/45.82 25/45.02 25/44.21 9/19.11 |
|POLY-3 PERCENT (g) | 58.6% 72.0% 55.5% 56.5% 47.1% |
|TERMINAL (d) | 14/28 (50%) 14/23 (61%) 14/23 (61%) 8/19 (42%) 5/14 (36%) |
|FIRST INCIDENCE | 561 509 574 506 694 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.061N P=0.097 P=0.513 P=0.340 P=0.152N |
|POLY 3 | P=0.121N P=0.120 P=0.467N P=0.508N P=0.280N |
|POLY 1.5 | P=0.146N P=0.131 P=0.452N P=0.488N P=0.306N |
|POLY 6 | P=0.087N P=0.109 P=0.521N P=0.536N P=0.243N |
|LOGISTIC REGRESSION| P=0.137N P=0.135 P=0.415N P=0.482N P=0.297N |
|COCH-ARM / FISHERS | P=0.179N P=0.154 P=0.462N P=0.462N P=0.339N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 27/50 (54%) 33/50 (66%) 26/49 (53%) 26/49 (53%) 9/20 (45%) |
|POLY-3 RATE (b) | 27/46.10 33/45.82 26/45.42 26/44.21 9/19.11 |
|POLY-3 PERCENT (g) | 58.6% 72.0% 57.2% 58.8% 47.1% |
|TERMINAL (d) | 14/28 (50%) 14/23 (61%) 14/23 (61%) 9/19 (47%) 5/14 (36%) |
|FIRST INCIDENCE | 561 509 574 506 694 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.060N P=0.097 P=0.450 P=0.275 P=0.152N |
|POLY 3 | P=0.121N P=0.120 P=0.534N P=0.577 P=0.280N |
|POLY 1.5 | P=0.146N P=0.131 P=0.525N P=0.573N P=0.306N |
|POLY 6 | P=0.087N P=0.109 P=0.576N P=0.552 P=0.243N |
|LOGISTIC REGRESSION| P=0.137N P=0.135 P=0.505N P=0.568N P=0.297N |
|COCH-ARM / FISHERS | P=0.177N P=0.154 P=0.543N P=0.543N P=0.339N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/20 (5%) |
|POLY-3 RATE (b) | 1/42.50 2/40.97 0/42.63 0/40.22 1/18.68 |
|POLY-3 PERCENT (g) | 2.4% 4.9% 0.0% 0.0% 5.4% |
|TERMINAL (d) | 0/28 (0%) 1/23 (4%) 0/23 (0%) 0/20 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 614 670 --- --- 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.563 P=0.466 P=0.491N P=0.500N P=0.587 |
|POLY 3 | P=0.519 P=0.487 P=0.499N P=0.511N P=0.569 |
|POLY 1.5 | P=0.514 P=0.493 P=0.500N P=0.506N P=0.558 |
|POLY 6 | P=0.529 P=0.480 P=0.502N P=0.520N P=0.585 |
|LOGISTIC REGRESSION| P=0.514 P=0.503 P=0.482N P=0.485N P=0.527 |
|COCH-ARM / FISHERS | P=0.508 P=0.500 P=0.500N P=0.500N P=0.493 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or |
| Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/20 (5%) |
|POLY-3 RATE (b) | 1/42.50 2/40.97 0/42.63 1/40.22 1/18.68 |
|POLY-3 PERCENT (g) | 2.4% 4.9% 0.0% 2.5% 5.4% |
|TERMINAL (d) | 0/28 (0%) 1/23 (4%) 0/23 (0%) 1/20 (5%) 1/14 (7%) |
|FIRST INCIDENCE | 614 670 --- 733 (T) 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.536 P=0.466 P=0.491N P=0.724 P=0.587 |
|POLY 3 | P=0.492 P=0.487 P=0.499N P=0.749 P=0.569 |
|POLY 1.5 | P=0.481 P=0.493 P=0.500N P=0.754 P=0.558 |
|POLY 6 | P=0.510 P=0.480 P=0.502N P=0.739 P=0.585 |
|LOGISTIC REGRESSION| P=0.486 P=0.503 P=0.482N P=0.761N P=0.527 |
|COCH-ARM / FISHERS | P=0.468 P=0.500 P=0.500N P=0.753N P=0.493 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/20 (5%) |
|POLY-3 RATE (b) | 1/42.50 2/40.97 0/42.63 1/40.22 1/18.68 |
|POLY-3 PERCENT (g) | 2.4% 4.9% 0.0% 2.5% 5.4% |
|TERMINAL (d) | 0/28 (0%) 1/23 (4%) 0/23 (0%) 1/20 (5%) 1/14 (7%) |
|FIRST INCIDENCE | 614 670 --- 733 (T) 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.536 P=0.466 P=0.491N P=0.724 P=0.587 |
|POLY 3 | P=0.492 P=0.487 P=0.499N P=0.749 P=0.569 |
|POLY 1.5 | P=0.481 P=0.493 P=0.500N P=0.754 P=0.558 |
|POLY 6 | P=0.510 P=0.480 P=0.502N P=0.739 P=0.585 |
|LOGISTIC REGRESSION| P=0.486 P=0.503 P=0.482N P=0.761N P=0.527 |
|COCH-ARM / FISHERS | P=0.468 P=0.500 P=0.500N P=0.753N P=0.493 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|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) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 2/50 (4%) 1/20 (5%) |
|POLY-3 RATE (b) | 3/42.70 3/41.61 1/42.63 2/40.22 1/18.68 |
|POLY-3 PERCENT (g) | 7.0% 7.2% 2.4% 5.0% 5.4% |
|TERMINAL (d) | 1/28 (4%) 1/23 (4%) 1/23 (4%) 2/20 (10%) 1/14 (7%) |
|FIRST INCIDENCE | 614 525 733 (T) 733 (T) 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.531N P=0.615 P=0.338N P=0.604N P=0.575N |
|POLY 3 | P=0.612N P=0.651 P=0.305N P=0.527N P=0.625N |
|POLY 1.5 | P=0.621N P=0.656 P=0.306N P=0.514N P=0.639N |
|POLY 6 | P=0.594N P=0.643 P=0.311N P=0.550N P=0.605N |
|LOGISTIC REGRESSION| P=0.622N P=0.652N P=0.305N P=0.520N P=0.663N |
|COCH-ARM / FISHERS | P=0.633N P=0.661N P=0.309N P=0.500N P=0.749 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) 2/50 (4%) 1/20 (5%) |
|POLY-3 RATE (b) | 2/42.09 5/41.68 3/42.63 2/40.90 1/18.68 |
|POLY-3 PERCENT (g) | 4.8% 12.0% 7.0% 4.9% 5.4% |
|TERMINAL (d) | 2/28 (7%) 2/23 (9%) 3/23 (13%) 1/20 (5%) 1/14 (7%) |
|FIRST INCIDENCE | 733 (T) 532 733 (T) 506 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.428N P=0.174 P=0.409 P=0.601 P=0.735 |
|POLY 3 | P=0.503N P=0.211 P=0.506 P=0.684 P=0.707 |
|POLY 1.5 | P=0.519N P=0.213 P=0.502 P=0.689 P=0.694 |
|POLY 6 | P=0.477N P=0.208 P=0.503 P=0.674 P=0.726 |
|LOGISTIC REGRESSION| P=0.515N P=0.209 P=0.409 P=0.694N P=0.735 |
|COCH-ARM / FISHERS | P=0.537N P=0.218 P=0.500 P=0.691N P=0.642 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 3/50 (6%) 3/50 (6%) 1/20 (5%) |
|POLY-3 RATE (b) | 4/42.94 5/41.68 3/42.63 3/40.90 1/18.68 |
|POLY-3 PERCENT (g) | 9.3% 12.0% 7.0% 7.3% 5.4% |
|TERMINAL (d) | 3/28 (11%) 2/23 (9%) 3/23 (13%) 2/20 (10%) 1/14 (7%) |
|FIRST INCIDENCE | 387 532 733 (T) 506 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.315N P=0.427 P=0.594N P=0.630N P=0.453N |
|POLY 3 | P=0.379N P=0.481 P=0.504N P=0.527N P=0.494N |
|POLY 1.5 | P=0.395N P=0.487 P=0.505N P=0.515N P=0.511N |
|POLY 6 | P=0.352N P=0.476 P=0.510N P=0.546N P=0.467N |
|LOGISTIC REGRESSION| P=0.415N P=0.513 P=0.500N P=0.479N P=0.577N |
|COCH-ARM / FISHERS | P=0.412N P=0.500 P=0.500N P=0.500N P=0.556N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/20 (0%) |
|POLY-3 RATE (b) | 2/42.94 0/40.74 0/42.63 1/40.22 0/18.68 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 1/28 (4%) 0/23 (0%) 0/23 (0%) 1/20 (5%) 0/14 (0%) |
|FIRST INCIDENCE | 387 --- --- 733 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.502N P=0.264N P=0.264N P=0.580N P=0.428N |
|POLY 3 | P=0.533N P=0.249N P=0.238N P=0.523N P=0.433N |
|POLY 1.5 | P=0.539N P=0.244N P=0.239N P=0.513N P=0.444N |
|POLY 6 | P=0.522N P=0.254N P=0.240N P=0.538N P=0.417N |
|LOGISTIC REGRESSION| P=0.580N P=0.198N P=0.186N P=0.475N P=0.536N |
|COCH-ARM / FISHERS | P=0.546N P=0.247N P=0.247N P=0.500N P=0.507N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/20 (0%) |
|POLY-3 RATE (b) | 1/42.29 2/41.61 0/42.63 1/40.22 0/18.68 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/23 (0%) 0/23 (0%) 1/20 (5%) 0/14 (0%) |
|FIRST INCIDENCE | 680 525 --- 733 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.445N P=0.487 P=0.500N P=0.706 P=0.627N |
|POLY 3 | P=0.480N P=0.494 P=0.498N P=0.750 P=0.665N |
|POLY 1.5 | P=0.486N P=0.497 P=0.500N P=0.755 P=0.673N |
|POLY 6 | P=0.469N P=0.491 P=0.500N P=0.741 P=0.654N |
|LOGISTIC REGRESSION| P=0.511N P=0.524 P=0.500N P=0.748 P=0.696N |
|COCH-ARM / FISHERS | P=0.492N P=0.500 P=0.500N P=0.753N P=0.714N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/20 (0%) |
|POLY-3 RATE (b) | 2/42.29 2/41.61 1/42.63 1/40.22 0/18.68 |
|POLY-3 PERCENT (g) | 4.7% 4.8% 2.4% 2.5% 0.0% |
|TERMINAL (d) | 1/28 (4%) 0/23 (0%) 1/23 (4%) 1/20 (5%) 0/14 (0%) |
|FIRST INCIDENCE | 680 525 733 (T) 733 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.299N P=0.664 P=0.546N P=0.595N P=0.395N |
|POLY 3 | P=0.328N P=0.689 P=0.497N P=0.517N P=0.429N |
|POLY 1.5 | P=0.335N P=0.691 P=0.499N P=0.509N P=0.441N |
|POLY 6 | P=0.315N P=0.685 P=0.501N P=0.532N P=0.413N |
|LOGISTIC REGRESSION| P=0.343N P=0.684N P=0.500N P=0.537N P=0.434N |
|COCH-ARM / FISHERS | P=0.342N P=0.691N P=0.500N P=0.500N P=0.507N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/20 (0%) |
|POLY-3 RATE (b) | 2/42.29 2/41.61 1/42.63 1/40.22 0/18.68 |
|POLY-3 PERCENT (g) | 4.7% 4.8% 2.4% 2.5% 0.0% |
|TERMINAL (d) | 1/28 (4%) 0/23 (0%) 1/23 (4%) 1/20 (5%) 0/14 (0%) |
|FIRST INCIDENCE | 680 525 733 (T) 733 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.299N P=0.664 P=0.546N P=0.595N P=0.395N |
|POLY 3 | P=0.328N P=0.689 P=0.497N P=0.517N P=0.429N |
|POLY 1.5 | P=0.335N P=0.691 P=0.499N P=0.509N P=0.441N |
|POLY 6 | P=0.315N P=0.685 P=0.501N P=0.532N P=0.413N |
|LOGISTIC REGRESSION| P=0.343N P=0.684N P=0.500N P=0.537N P=0.434N |
|COCH-ARM / FISHERS | P=0.342N P=0.691N P=0.500N P=0.500N P=0.507N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 40/50 (80%) 41/50 (82%) 47/49 (96%) 44/50 (88%) 20/20 (100%) |
|POLY-3 RATE (b) | 40/45.00 41/46.57 47/48.20 44/48.10 20/20.00 |
|POLY-3 PERCENT (g) | 88.9% 88.0% 97.5% 91.5% 100.0% |
|TERMINAL (d) | 27/28 (96%) 21/23 (91%) 23/23 (100%) 19/20 (95%) 14/14 (100%) |
|FIRST INCIDENCE | 581 532 596 419 433 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.347N P=0.175 P=0.037 * P=0.022 * P=0.550N |
|POLY 3 | P=0.089 P=0.591N P=0.056 P=0.467 P=0.087 |
|POLY 1.5 | P=0.053 P=0.598 P=0.030 * P=0.325 P=0.052 |
|POLY 6 | P=0.177 P=0.470N P=0.145 P=0.688 P=0.210 |
|LOGISTIC REGRESSION| P=0.029 * P=0.341 P=0.060 P=0.111 P=0.049 * |
|COCH-ARM / FISHERS | P=0.031 * P=0.500 P=0.015 * P=0.207 P=0.026 * |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 4/50 (8%) 4/49 (8%) 3/49 (6%) 2/20 (10%) |
|POLY-3 RATE (b) | 7/42.70 4/40.97 4/43.27 3/39.85 2/18.78 |
|POLY-3 PERCENT (g) | 16.4% 9.8% 9.2% 7.5% 10.7% |
|TERMINAL (d) | 5/28 (18%) 1/23 (4%) 2/23 (9%) 1/20 (5%) 1/14 (7%) |
|FIRST INCIDENCE | 581 694 602 617 708 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.381N P=0.352N P=0.330N P=0.270N P=0.344N |
|POLY 3 | P=0.487N P=0.283N P=0.251N P=0.184N P=0.422N |
|POLY 1.5 | P=0.505N P=0.274N P=0.258N P=0.176N P=0.447N |
|POLY 6 | P=0.455N P=0.295N P=0.251N P=0.199N P=0.384N |
|LOGISTIC REGRESSION| P=0.471N P=0.288N P=0.259N P=0.186N P=0.415N |
|COCH-ARM / FISHERS | P=0.523N P=0.262N P=0.274N P=0.167N P=0.495N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/49 (2%) 0/49 (0%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/42.09 2/40.74 1/42.63 0/39.27 0/18.68 |
|POLY-3 PERCENT (g) | 0.0% 4.9% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 2/23 (9%) 1/23 (4%) 0/20 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 733 (T) 733 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.483N P=0.195 P=0.461 (e) (e) |
|POLY 3 | P=0.543N P=0.230 P=0.503 (e) (e) |
|POLY 1.5 | P=0.545N P=0.233 P=0.501 (e) (e) |
|POLY 6 | P=0.537N P=0.225 P=0.501 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.195 P=0.461 (e) (e) |
|COCH-ARM / FISHERS | P=0.546N P=0.247 P=0.495 (e) (e) |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 5/49 (10%) 3/49 (6%) 2/20 (10%) |
|POLY-3 RATE (b) | 7/42.70 6/40.97 5/43.27 3/39.85 2/18.78 |
|POLY-3 PERCENT (g) | 16.4% 14.7% 11.6% 7.5% 10.7% |
|TERMINAL (d) | 5/28 (18%) 3/23 (13%) 3/23 (13%) 1/20 (5%) 1/14 (7%) |
|FIRST INCIDENCE | 581 694 602 617 708 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.287N P=0.612N P=0.464N P=0.270N P=0.344N |
|POLY 3 | P=0.381N P=0.532N P=0.368N P=0.184N P=0.422N |
|POLY 1.5 | P=0.400N P=0.518N P=0.375N P=0.176N P=0.447N |
|POLY 6 | P=0.348N P=0.551N P=0.370N P=0.199N P=0.384N |
|LOGISTIC REGRESSION| P=0.353N P=0.543N P=0.374N P=0.186N P=0.415N |
|COCH-ARM / FISHERS | P=0.419N P=0.500N P=0.394N P=0.167N P=0.495N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/42.09 0/40.74 2/42.76 2/40.40 0/18.68 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 5.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/23 (0%) 1/23 (4%) 1/20 (5%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- 699 688 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.655N (e) P=0.215 P=0.184 (e) |
|POLY 3 | P=0.716N (e) P=0.240 P=0.228 (e) |
|POLY 1.5 | P=0.732N (e) P=0.238 P=0.232 (e) |
|POLY 6 | P=0.692N (e) P=0.240 P=0.220 (e) |
|LOGISTIC REGRESSION| P=0.703N (e) P=0.236 P=0.218 (e) |
|COCH-ARM / FISHERS | P=0.751N (e) P=0.247 P=0.247 (e) |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/42.09 2/41.72 0/42.63 0/40.22 0/18.68 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/23 (0%) 0/23 (0%) 0/20 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 509 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.603N P=0.239 (e) (e) (e) |
|POLY 3 | P=0.628N P=0.235 (e) (e) (e) |
|POLY 1.5 | P=0.626N P=0.236 (e) (e) (e) |
|POLY 6 | P=0.627N P=0.233 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.672N P=0.261 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.623N P=0.247 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 19/50 (38%) 23/50 (46%) 27/50 (54%) 25/50 (50%) 10/20 (50%) |
|POLY-3 RATE (b) | 19/44.35 23/45.99 27/47.39 25/44.76 10/19.93 |
|POLY-3 PERCENT (g) | 42.8% 50.0% 57.0% 55.9% 50.2% |
|TERMINAL (d) | 8/28 (29%) 8/23 (35%) 8/23 (35%) 9/20 (45%) 5/14 (36%) |
|FIRST INCIDENCE | 614 315 596 529 433 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.414N P=0.192 P=0.092 P=0.062 P=0.566 |
|POLY 3 | P=0.482 P=0.316 P=0.122 P=0.149 P=0.389 |
|POLY 1.5 | P=0.418 P=0.300 P=0.097 P=0.152 P=0.333 |
|POLY 6 | P=0.563 P=0.329 P=0.153 P=0.141 P=0.458 |
|LOGISTIC REGRESSION| P=0.328 P=0.273 P=0.080 P=0.134 P=0.285 |
|COCH-ARM / FISHERS | P=0.328 P=0.272 P=0.080 P=0.157 P=0.256 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 5/50 (10%) 0/20 (0%) |
|POLY-3 RATE (b) | 1/42.09 2/41.01 2/42.63 5/41.28 0/18.68 |
|POLY-3 PERCENT (g) | 2.4% 4.9% 4.7% 12.1% 0.0% |
|TERMINAL (d) | 1/28 (4%) 0/23 (0%) 2/23 (9%) 2/20 (10%) 0/14 (0%) |
|FIRST INCIDENCE | 733 (T) 688 733 (T) 419 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.439N P=0.470 P=0.431 P=0.064 P=0.638N |
|POLY 3 | P=0.485N P=0.491 P=0.504 P=0.095 P=0.665N |
|POLY 1.5 | P=0.512N P=0.495 P=0.502 P=0.099 P=0.672N |
|POLY 6 | P=0.445N P=0.487 P=0.503 P=0.089 P=0.653N |
|LOGISTIC REGRESSION| P=0.536N P=0.484 P=0.431 P=0.106 (e) |
|COCH-ARM / FISHERS | P=0.546N P=0.500 P=0.500 P=0.102 P=0.714N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 5/50 (10%) 0/20 (0%) |
|POLY-3 RATE (b) | 1/42.09 2/41.01 2/42.63 5/41.28 0/18.68 |
|POLY-3 PERCENT (g) | 2.4% 4.9% 4.7% 12.1% 0.0% |
|TERMINAL (d) | 1/28 (4%) 0/23 (0%) 2/23 (9%) 2/20 (10%) 0/14 (0%) |
|FIRST INCIDENCE | 733 (T) 688 733 (T) 419 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.439N P=0.470 P=0.431 P=0.064 P=0.638N |
|POLY 3 | P=0.485N P=0.491 P=0.504 P=0.095 P=0.665N |
|POLY 1.5 | P=0.512N P=0.495 P=0.502 P=0.099 P=0.672N |
|POLY 6 | P=0.445N P=0.487 P=0.503 P=0.089 P=0.653N |
|LOGISTIC REGRESSION| P=0.536N P=0.484 P=0.431 P=0.106 (e) |
|COCH-ARM / FISHERS | P=0.546N P=0.500 P=0.500 P=0.102 P=0.714N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/42.09 0/40.74 0/42.63 2/40.40 0/18.68 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/23 (0%) 0/23 (0%) 1/20 (5%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- 688 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.758 (e) (e) P=0.184 (e) |
|POLY 3 | P=0.795 (e) (e) P=0.228 (e) |
|POLY 1.5 | P=0.776 (e) (e) P=0.232 (e) |
|POLY 6 | P=0.819 (e) (e) P=0.220 (e) |
|LOGISTIC REGRESSION| P=0.756 (e) (e) P=0.218 (e) |
|COCH-ARM / FISHERS | P=0.749 (e) (e) P=0.247 (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 47/50 (94%) 49/50 (98%) 49/50 (98%) 48/50 (96%) 20/20 (100%) |
|POLY-3 RATE (b) | 47/47.82 49/49.08 49/49.00 48/49.09 20/20.00 |
|POLY-3 PERCENT (g) | 98.3% 99.8% 100.0% 97.8% 100.0% |
|TERMINAL (d) | 28/28 (100%) 23/23 (100%) 23/23 (100%) 20/20 (100%) 14/14 (100%) |
|FIRST INCIDENCE | 561 509 574 419 433 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.114N P=0.140 P=0.192 P=0.067 P=0.212N |
|POLY 3 | P=0.816 P=0.670 P=0.620 P=0.751N P=0.849 |
|POLY 1.5 | P=0.631 P=0.397 P=0.283 P=0.720 P=0.555 |
|POLY 6 | P=0.926 P=0.998 P=0.998 P=0.657N P=1.000 |
|LOGISTIC REGRESSION| P=0.379 P=0.220 P=0.761 P=0.420 P=0.311 |
|COCH-ARM / FISHERS | P=0.351 P=0.309 P=0.309 P=0.500 P=0.358 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 27/50 (54%) 29/50 (58%) 32/50 (64%) 42/50 (84%) 13/20 (65%) |
|POLY-3 RATE (b) | 27/46.01 29/47.85 32/47.61 42/48.40 13/20.00 |
|POLY-3 PERCENT (g) | 58.7% 60.6% 67.2% 86.8% 65.0% |
|TERMINAL (d) | 14/28 (50%) 9/23 (39%) 11/23 (48%) 16/20 (80%) 7/14 (50%) |
|FIRST INCIDENCE | 387 315 596 379 433 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.425N P=0.275 P=0.173 P<0.001 ** P=0.503N |
|POLY 3 | P=0.309 P=0.508 P=0.256 P<0.001 ** P=0.415 |
|POLY 1.5 | P=0.250 P=0.468 P=0.218 P<0.001 ** P=0.354 |
|POLY 6 | P=0.398 P=0.566 P=0.313 P<0.001 ** P=0.503 |
|LOGISTIC REGRESSION| P=0.163 P=0.447 P=0.207 P<0.001 ** P=0.273 |
|COCH-ARM / FISHERS | P=0.185 P=0.420 P=0.208 P<0.001 ** P=0.285 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 25 PPM 50 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 49/50 (98%) 50/50 (100%) 20/20 (100%) |
|POLY-3 RATE (b) | 49/49.49 50/50.00 49/49.00 50/50.00 20/20.00 |
|POLY-3 PERCENT (g) | 99.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 28/28 (100%) 23/23 (100%) 23/23 (100%) 20/20 (100%) 14/14 (100%) |
|FIRST INCIDENCE | 387 315 574 379 433 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.094N P=0.184 P=0.288 P=0.072 P=0.156N |
|POLY 3 | P=0.984 P=0.851 P=0.853 P=0.851 P=0.947 |
|POLY 1.5 | P=0.899 P=0.665 P=0.672 P=0.665 P=0.827 |
|POLY 6 | P=1.000 P=0.999 P=0.999 P=0.999 P=1.000 |
|LOGISTIC REGRESSION| P=0.790 P=0.473 P=0.685 P=0.480 P=0.746 |
|COCH-ARM / FISHERS | P=0.623 P=0.500 P=0.753N P=0.500 P=0.714 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(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.
(g) Poly-3 adjusted lifetime tumor incidence.
(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).