TDMS Study 88124-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 10/28/99
EXPERIMENT: 88124 TEST: 03 TIME: 14:11:42
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124
PATHOLOGIST: GRUMBEIN, S. CAS: 22398-80-7
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1 CORE STUDY RATS
REASONS FOR REMOVAL: 25022 Accidently Killed
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 CONTROL
INCLUDE 002 CONTROL
INCLUDE 005 0.1MG/M3 STOP
INCLUDE 006 0.1MG/M3 STOP
INCLUDE 007 0.3MG/M3 STOP
INCLUDE 008 0.3MG/M3 STOP
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 10/28/99
EXPERIMENT: 88124 TEST: 03 TIME: 14:11:42
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124
PATHOLOGIST: GRUMBEIN, S. CAS: 22398-80-7
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
Brain
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Prostate
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 10/28/99
EXPERIMENT: 88124 TEST: 03 TIME: 14:11:42
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124
PATHOLOGIST: GRUMBEIN, S. CAS: 22398-80-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF INDIUM PHOSPHIDE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Squamous Cell Carcinoma
Pituitary Gland: Pars Distalis or Unspecified Site
Carcinoma or Adenoma
Skin Fibroma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Malignant Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
===============================================================
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 16/49 (33%) 23/50 (46%) | 2/50 (4%) 2/50 (4%) 9/49 (18%) |
|POLY-3 ADJUSTED (b)| 23.8% 38.0% 51.1% | 4.6% 4.5% 20.6% |
|TERMINAL (d) | 6/27 (22%) 11/28 (39%) 15/26 (58%) | 1/34 (3%) 2/36 (6%) 6/34 (18%) |
|FIRST INCIDENCE | 537 537 525 | 615 735 (T) 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.163 P=0.008 ** | P=0.006 ** P=0.674N P=0.031 * |
|POLY 3 | P=0.006 ** P=0.117 P=0.006 ** | P=0.005 ** P=0.682N P=0.026 * |
|POLY 1.5 | P=0.006 ** P=0.118 P=0.006 ** | P=0.005 ** P=0.686N P=0.025 * |
|POLY 6 | P=0.006 ** P=0.119 P=0.006 ** | P=0.005 ** P=0.678N P=0.025 * |
|LOGISTIC REGRESSION| P=0.007 ** P=0.123 P=0.007 ** | P=0.006 ** P=0.687N P=0.027 * |
|COCH-ARM / FISHERS | P=0.005 ** P=0.115 P=0.005 ** | P=0.006 ** P=0.691N P=0.023 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/49 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.4% 2.3% | 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/27 (0%) 2/28 (7%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 1/34 (3%) |
|FIRST INCIDENCE | --- 698 684 | --- --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.545 P=0.129 P=0.506 | P=0.293 (e) P=0.500 |
|POLY 3 | P=0.586 P=0.119 P=0.511 | P=0.297 (e) P=0.501 |
|POLY 1.5 | P=0.578 P=0.118 P=0.508 | P=0.297 (e) P=0.501 |
|POLY 6 | P=0.592 P=0.120 P=0.513 | P=0.296 (e) P=0.500 |
|LOGISTIC REGRESSION| P=0.572 P=0.121 P=0.503 | (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.555 P=0.117 P=0.500 | P=0.292 (e) P=0.495 |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 18/49 (37%) 24/50 (48%) | 2/50 (4%) 2/50 (4%) 9/49 (18%) |
|POLY-3 ADJUSTED (b)| 23.8% 42.6% 53.1% | 4.6% 4.5% 20.6% |
|TERMINAL (d) | 6/27 (22%) 12/28 (43%) 15/26 (58%) | 1/34 (3%) 2/36 (6%) 6/34 (18%) |
|FIRST INCIDENCE | 537 537 525 | 615 735 (T) 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** P=0.086 P=0.005 ** | P=0.006 ** P=0.674N P=0.031 * |
|POLY 3 | P=0.005 ** P=0.051 P=0.003 ** | P=0.005 ** P=0.682N P=0.026 * |
|POLY 1.5 | P=0.004 ** P=0.052 P=0.003 ** | P=0.005 ** P=0.686N P=0.025 * |
|POLY 6 | P=0.005 ** P=0.052 P=0.003 ** | P=0.005 ** P=0.678N P=0.025 * |
|LOGISTIC REGRESSION| P=0.005 ** P=0.056 P=0.004 ** | P=0.006 ** P=0.687N P=0.027 * |
|COCH-ARM / FISHERS | P=0.004 ** P=0.052 P=0.003 ** | P=0.006 ** P=0.691N P=0.023 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 2.4% 2.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 408 435 671 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256N P=0.296N P=0.284N | (e) (e) (e) |
|POLY 3 | P=0.268N P=0.302N P=0.298N | (e) (e) (e) |
|POLY 1.5 | P=0.268N P=0.301N P=0.298N | (e) (e) (e) |
|POLY 6 | P=0.269N P=0.303N P=0.301N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.415N P=0.398N P=0.407N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.272N P=0.309N P=0.309N | (e) (e) (e) |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 4.7% 2.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 408 435 671 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.234N P=0.487N P=0.284N | (e) (e) (e) |
|POLY 3 | P=0.248N P=0.494N P=0.298N | (e) (e) (e) |
|POLY 1.5 | P=0.248N P=0.494N P=0.298N | (e) (e) (e) |
|POLY 6 | P=0.250N P=0.494N P=0.301N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.374N P=0.596N P=0.407N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.252N P=0.500N P=0.309N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 5/49 (10%) 4/47 (9%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% | 12.0% 9.5% 14.0% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/26 (0%) | 5/33 (15%) 4/35 (11%) 6/34 (18%) |
|FIRST INCIDENCE | 733 (T) --- --- | 735 (T) 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.402N P=0.486N P=0.508N | P=0.424 P=0.463N P=0.521 |
|POLY 3 | P=0.397N P=0.495N P=0.490N | P=0.431 P=0.492N P=0.520 |
|POLY 1.5 | P=0.396N P=0.496N P=0.492N | P=0.432 P=0.505N P=0.518 |
|POLY 6 | P=0.398N P=0.493N P=0.489N | P=0.426 P=0.477N P=0.520 |
|LOGISTIC REGRESSION| P=0.402N (e) (e) | P=0.424 P=0.463N P=0.521 |
|COCH-ARM / FISHERS | P=0.394N P=0.500N P=0.500N | P=0.420 P=0.527N P=0.500 |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/49 (0%) 3/47 (6%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 2.4% 0.0% | 0.0% 7.1% 0.0% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/26 (0%) | 0/33 (0%) 3/35 (9%) 0/34 (0%) |
|FIRST INCIDENCE | 537 733 (T) --- | --- 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.173N P=0.483N P=0.227N | P=0.494N P=0.131 (e) |
|POLY 3 | P=0.171N P=0.499N P=0.231N | P=0.482N P=0.120 (e) |
|POLY 1.5 | P=0.172N P=0.497N P=0.231N | P=0.484N P=0.117 (e) |
|POLY 6 | P=0.172N P=0.501N P=0.233N | P=0.481N P=0.125 (e) |
|LOGISTIC REGRESSION| P=0.193N P=0.519N P=0.292N | (e) P=0.131 (e) |
|COCH-ARM / FISHERS | P=0.175N P=0.500N P=0.247N | P=0.497N P=0.113 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) | 5/49 (10%) 7/47 (15%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 7.3% 2.4% 0.0% | 12.0% 16.6% 14.0% |
|TERMINAL (d) | 1/27 (4%) 1/29 (3%) 0/26 (0%) | 5/33 (15%) 7/35 (20%) 6/34 (18%) |
|FIRST INCIDENCE | 537 733 (T) --- | 735 (T) 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.088N P=0.289N P=0.119N | P=0.515 P=0.419 P=0.521 |
|POLY 3 | P=0.084N P=0.304N P=0.113N | P=0.525 P=0.387 P=0.520 |
|POLY 1.5 | P=0.084N P=0.302N P=0.114N | P=0.525 P=0.373 P=0.518 |
|POLY 6 | P=0.084N P=0.305N P=0.115N | P=0.521 P=0.404 P=0.520 |
|LOGISTIC REGRESSION| P=0.091N P=0.310N P=0.136N | P=0.515 P=0.419 P=0.521 |
|COCH-ARM / FISHERS | P=0.088N P=0.309N P=0.121N | P=0.507 P=0.350 P=0.500 |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 2.4% | 0.0% 0.0% 4.7% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 1/26 (4%) | 0/34 (0%) 0/36 (0%) 2/34 (6%) |
|FIRST INCIDENCE | 672 --- 733 (T) | --- --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.652 P=0.506N P=0.755N | P=0.089 (e) P=0.238 |
|POLY 3 | P=0.655 P=0.496N P=0.751N | P=0.090 (e) P=0.238 |
|POLY 1.5 | P=0.654 P=0.497N P=0.753N | P=0.090 (e) P=0.238 |
|POLY 6 | P=0.655 P=0.495N P=0.752N | P=0.089 (e) P=0.237 |
|LOGISTIC REGRESSION| P=0.657 P=0.500N P=0.753N | (e) (e) P=0.238 |
|COCH-ARM / FISHERS | P=0.648 P=0.500N P=0.753N | P=0.091 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 4.8% 7.0% | 2.3% 0.0% 2.3% |
|TERMINAL (d) | 1/27 (4%) 2/29 (7%) 2/26 (8%) | 1/34 (3%) 0/36 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 658 | 735 (T) --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.243 P=0.525 P=0.310 | P=0.646 P=0.489N P=0.762 |
|POLY 3 | P=0.273 P=0.509 P=0.325 | P=0.646 P=0.491N P=0.760N |
|POLY 1.5 | P=0.268 P=0.507 P=0.320 | P=0.646 P=0.494N P=0.760N |
|POLY 6 | P=0.277 P=0.512 P=0.328 | P=0.644 P=0.488N P=0.760N |
|LOGISTIC REGRESSION| P=0.267 P=0.525 P=0.323 | P=0.646 (e) P=0.762 |
|COCH-ARM / FISHERS | P=0.252 P=0.500 P=0.309 | P=0.644 P=0.500N P=0.747 |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 9.5% 7.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 2/29 (7%) 1/26 (4%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 617 649 684 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.508 P=0.366 P=0.501 | (e) (e) (e) |
|POLY 3 | P=0.526 P=0.349 P=0.519 | (e) (e) (e) |
|POLY 1.5 | P=0.521 P=0.346 P=0.516 | (e) (e) (e) |
|POLY 6 | P=0.526 P=0.353 P=0.520 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.513 P=0.341 P=0.510 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500 P=0.339 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 6/50 (12%) | 1/50 (2%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 7.3% 14.3% 14.0% | 2.3% 0.0% 2.3% |
|TERMINAL (d) | 1/27 (4%) 4/29 (14%) 3/26 (12%) | 1/34 (3%) 0/36 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 617 649 658 | 735 (T) --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.262 P=0.278 P=0.253 | P=0.646 P=0.489N P=0.762 |
|POLY 3 | P=0.285 P=0.253 P=0.265 | P=0.646 P=0.491N P=0.760N |
|POLY 1.5 | P=0.279 P=0.251 P=0.260 | P=0.646 P=0.494N P=0.760N |
|POLY 6 | P=0.288 P=0.257 P=0.267 | P=0.644 P=0.488N P=0.760N |
|LOGISTIC REGRESSION| P=0.280 P=0.253 P=0.263 | P=0.646 (e) P=0.762 |
|COCH-ARM / FISHERS | P=0.256 P=0.243 P=0.243 | P=0.644 P=0.500N P=0.747 |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 27/50 (54%) 30/50 (60%) | 0/50 (0%) 5/50 (10%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 14.8% 62.9% 67.0% | 0.0% 11.2% 43.6% |
|TERMINAL (d) | 4/27 (15%) 21/29 (72%) 20/26 (77%) | 0/34 (0%) 5/36 (14%) 17/34 (50%) |
|FIRST INCIDENCE | 697 644 525 | --- 735 (T) 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.038 * P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.034 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.033 * P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.036 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.038 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.028 * P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 8/50 (16%) 16/50 (32%) | 1/50 (2%) 1/50 (2%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 2.5% 19.3% 36.5% | 2.3% 2.2% 25.3% |
|TERMINAL (d) | 0/27 (0%) 7/29 (24%) 9/26 (35%) | 1/34 (3%) 1/36 (3%) 10/34 (29%) |
|FIRST INCIDENCE | 639 710 621 | 735 (T) 735 (T) 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.024 * P<0.001 ** | P<0.001 ** P=0.749N P=0.003 ** |
|POLY 3 | P<0.001 ** P=0.016 * P<0.001 ** | P<0.001 ** P=0.751N P=0.002 ** |
|POLY 1.5 | P<0.001 ** P=0.016 * P<0.001 ** | P<0.001 ** P=0.754N P=0.002 ** |
|POLY 6 | P<0.001 ** P=0.016 * P<0.001 ** | P<0.001 ** P=0.747N P=0.002 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.019 * P<0.001 ** | P<0.001 ** P=0.749N P=0.003 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.015 * P<0.001 ** | P<0.001 ** P=0.753N P=0.002 ** |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 30/50 (60%) 35/50 (70%) | 1/50 (2%) 6/50 (12%) 26/50 (52%) |
|POLY-3 ADJUSTED (b)| 17.1% 69.8% 76.1% | 2.3% 13.5% 58.8% |
|TERMINAL (d) | 4/27 (15%) 24/29 (83%) 21/26 (81%) | 1/34 (3%) 6/36 (17%) 23/34 (68%) |
|FIRST INCIDENCE | 639 644 525 | 735 (T) 735 (T) 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.066 P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.063 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.060 P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.065 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.066 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.056 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Lung |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 9.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 545 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014 * (e) P=0.075 | (e) (e) (e) |
|POLY 3 | P=0.011 * (e) P=0.071 | (e) (e) (e) |
|POLY 1.5 | P=0.011 * (e) P=0.068 | (e) (e) (e) |
|POLY 6 | P=0.012 * (e) P=0.075 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.005 ** (e) P=0.035 * | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.011 * (e) P=0.059 | (e) (e) (e) |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.4% 2.4% | 0.0% 6.7% 4.7% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 1/26 (4%) | 0/34 (0%) 1/36 (3%) 2/34 (6%) |
|FIRST INCIDENCE | --- 733 (T) 733 (T) | --- 714 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.410 P=0.514 P=0.492 | P=0.313 P=0.136 P=0.238 |
|POLY 3 | P=0.443 P=0.505 P=0.510 | P=0.316 P=0.127 P=0.238 |
|POLY 1.5 | P=0.439 P=0.504 P=0.508 | P=0.316 P=0.124 P=0.238 |
|POLY 6 | P=0.445 P=0.507 P=0.511 | P=0.314 P=0.131 P=0.237 |
|LOGISTIC REGRESSION| (e) P=0.514 P=0.492 | P=0.307 P=0.130 P=0.238 |
|COCH-ARM / FISHERS | P=0.425 P=0.500 P=0.500 | P=0.313 P=0.121 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 20/50 (40%) 18/50 (36%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 5.0% 0.0% 2.4% | 46.1% 38.8% 27.7% |
|TERMINAL (d) | 2/27 (7%) 0/29 (0%) 1/26 (4%) | 18/34 (53%) 12/36 (33%) 11/34 (32%) |
|FIRST INCIDENCE | 733 (T) --- 733 (T) | 590 566 593 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.516N P=0.222N P=0.513N | P=0.059N P=0.328N P=0.059N |
|POLY 3 | P=0.496N P=0.231N P=0.483N | P=0.051N P=0.312N P=0.056N |
|POLY 1.5 | P=0.497N P=0.233N P=0.487N | P=0.049N* P=0.354N P=0.058N |
|POLY 6 | P=0.497N P=0.229N P=0.481N | P=0.055N P=0.262N P=0.055N |
|LOGISTIC REGRESSION| P=0.516N (e) P=0.513N | P=0.050N P=0.353N P=0.058N |
|COCH-ARM / FISHERS | P=0.500N P=0.247N P=0.500N | P=0.053N P=0.418N P=0.066N |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) | 20/50 (40%) 21/50 (42%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| 5.0% 2.4% 4.7% | 46.1% 45.1% 30.0% |
|TERMINAL (d) | 2/27 (7%) 1/29 (3%) 2/26 (8%) | 18/34 (53%) 13/36 (36%) 12/34 (35%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) | 590 566 593 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.578 P=0.475N P=0.683 | P=0.078N P=0.550N P=0.091N |
|POLY 3 | P=0.612 P=0.491N P=0.677N | P=0.064N P=0.547N P=0.088N |
|POLY 1.5 | P=0.608 P=0.493N P=0.680N | P=0.063N P=0.572 P=0.090N |
|POLY 6 | P=0.613 P=0.488N P=0.675N | P=0.070N P=0.482N P=0.088N |
|LOGISTIC REGRESSION| P=0.578 P=0.475N P=0.683 | P=0.063N P=0.572 P=0.090N |
|COCH-ARM / FISHERS | P=0.596 P=0.500N P=0.691N | P=0.067N P=0.500 P=0.101N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 7.2% 2.4% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 2/29 (7%) 1/26 (4%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 733 (T) 698 733 (T) | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.569N P=0.328 P=0.754 | (e) (e) (e) |
|POLY 3 | P=0.526N P=0.315 P=0.750N | (e) (e) (e) |
|POLY 1.5 | P=0.531N P=0.313 P=0.752N | (e) (e) (e) |
|POLY 6 | P=0.525N P=0.319 P=0.749N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.534N P=0.318 P=0.754 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.548N P=0.309 P=0.753N | (e) (e) (e) |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 2.2% 4.7% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 1/36 (3%) 2/34 (6%) |
|FIRST INCIDENCE | --- --- --- | --- 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.170 P=0.511 P=0.238 |
|POLY 3 | (e) (e) (e) | P=0.176 P=0.509 P=0.238 |
|POLY 1.5 | (e) (e) (e) | P=0.176 P=0.506 P=0.238 |
|POLY 6 | (e) (e) (e) | P=0.174 P=0.512 P=0.237 |
|LOGISTIC REGRESSION| (e) (e) (e) | (e) P=0.511 P=0.238 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.175 P=0.500 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 7.2% 2.4% | 0.0% 2.2% 4.7% |
|TERMINAL (d) | 1/27 (4%) 2/29 (7%) 1/26 (4%) | 0/34 (0%) 1/36 (3%) 2/34 (6%) |
|FIRST INCIDENCE | 733 (T) 698 733 (T) | --- 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.569N P=0.328 P=0.754 | P=0.170 P=0.511 P=0.238 |
|POLY 3 | P=0.526N P=0.315 P=0.750N | P=0.176 P=0.509 P=0.238 |
|POLY 1.5 | P=0.531N P=0.313 P=0.752N | P=0.176 P=0.506 P=0.238 |
|POLY 6 | P=0.525N P=0.319 P=0.749N | P=0.174 P=0.512 P=0.237 |
|LOGISTIC REGRESSION| P=0.534N P=0.318 P=0.754 | (e) P=0.511 P=0.238 |
|COCH-ARM / FISHERS | P=0.548N P=0.309 P=0.753N | P=0.175 P=0.500 P=0.247 |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 0.0% 4.7% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 2/34 (6%) |
|FIRST INCIDENCE | --- --- --- | --- --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.089 (e) P=0.238 |
|POLY 3 | (e) (e) (e) | P=0.090 (e) P=0.238 |
|POLY 1.5 | (e) (e) (e) | P=0.090 (e) P=0.238 |
|POLY 6 | (e) (e) (e) | P=0.089 (e) P=0.237 |
|LOGISTIC REGRESSION| (e) (e) (e) | (e) (e) P=0.238 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.091 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 7.2% 2.4% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 2/29 (7%) 1/26 (4%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 733 (T) 698 733 (T) | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.569N P=0.328 P=0.754 | (e) (e) (e) |
|POLY 3 | P=0.526N P=0.315 P=0.750N | (e) (e) (e) |
|POLY 1.5 | P=0.531N P=0.313 P=0.752N | (e) (e) (e) |
|POLY 6 | P=0.525N P=0.319 P=0.749N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.534N P=0.318 P=0.754 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.548N P=0.309 P=0.753N | (e) (e) (e) |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 1/50 (2%) 2/50 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| | 2.3% 4.4% 0.0% |
|TERMINAL (d) | | 1/34 (3%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | | 735 (T) 225 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.326N P=0.521 P=0.500N |
|POLY 3 | | P=0.320N P=0.524 P=0.499N |
|POLY 1.5 | | P=0.320N P=0.517 P=0.499N |
|POLY 6 | | P=0.322N P=0.532 P=0.500N |
|LOGISTIC REGRESSION| | P=0.418N P=0.440 (e) |
|COCH-ARM / FISHERS | | P=0.325N P=0.500 P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 36/49 (73%) 31/50 (62%) 30/50 (60%) | 30/50 (60%) 29/48 (60%) 25/49 (51%) |
|POLY-3 ADJUSTED (b)| 79.6% 67.6% 64.0% | 64.2% 65.7% 56.8% |
|TERMINAL (d) | 21/27 (78%) 19/29 (66%) 16/26 (62%) | 20/34 (59%) 23/34 (68%) 21/34 (62%) |
|FIRST INCIDENCE | 495 435 525 | 397 448 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.226N P=0.173N P=0.204N | P=0.204N P=0.466N P=0.237N |
|POLY 3 | P=0.078N P=0.135N P=0.067N | P=0.247N P=0.529 P=0.302N |
|POLY 1.5 | P=0.085N P=0.128N P=0.072N | P=0.211N P=0.548 P=0.262N |
|POLY 6 | P=0.080N P=0.155N P=0.073N | P=0.304N P=0.507 P=0.362N |
|LOGISTIC REGRESSION| P=0.096N P=0.132N P=0.083N | P=0.161N P=0.556N P=0.204N |
|COCH-ARM / FISHERS | P=0.129N P=0.157N P=0.113N | P=0.196N P=0.565 P=0.243N |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 37/49 (76%) 31/50 (62%) 30/50 (60%) | 30/50 (60%) 30/48 (63%) 25/49 (51%) |
|POLY-3 ADJUSTED (b)| 81.8% 67.6% 64.0% | 64.2% 67.3% 56.8% |
|TERMINAL (d) | 22/27 (82%) 19/29 (66%) 16/26 (62%) | 20/34 (59%) 23/34 (68%) 21/34 (62%) |
|FIRST INCIDENCE | 495 435 525 | 397 448 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.186N P=0.132N P=0.162N | P=0.196N P=0.533N P=0.237N |
|POLY 3 | P=0.049N* P=0.083N P=0.038N* | P=0.238N P=0.465 P=0.302N |
|POLY 1.5 | P=0.056N P=0.081N P=0.042N* | P=0.200N P=0.475 P=0.262N |
|POLY 6 | P=0.050N P=0.096N P=0.040N* | P=0.296N P=0.457 P=0.362N |
|LOGISTIC REGRESSION| P=0.066N P=0.087N P=0.051N | P=0.151N P=0.522 P=0.204N |
|COCH-ARM / FISHERS | P=0.093N P=0.109N P=0.075N | P=0.184N P=0.482 P=0.243N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Prostate |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 2.5% 4.8% 4.7% | |
|TERMINAL (d) | 1/27 (4%) 2/29 (7%) 2/26 (8%) | |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.429 P=0.525 P=0.487 | |
|POLY 3 | P=0.474 P=0.509 P=0.517 | |
|POLY 1.5 | P=0.469 P=0.507 P=0.513 | |
|POLY 6 | P=0.476 P=0.512 P=0.519 | |
|LOGISTIC REGRESSION| P=0.429 P=0.525 P=0.487 | |
|COCH-ARM / FISHERS | P=0.452 P=0.500 P=0.500 | |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|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) | 2/50 (4%) 6/50 (12%) 3/50 (6%) | 1/50 (2%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.0% 14.5% 7.0% | 2.3% 6.7% 0.0% |
|TERMINAL (d) | 2/27 (7%) 6/29 (21%) 2/26 (8%) | 0/34 (0%) 3/36 (8%) 0/34 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 560 | 566 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.543 P=0.152 P=0.493 | P=0.294N P=0.328 P=0.491N |
|POLY 3 | P=0.591N P=0.139 P=0.528 | P=0.297N P=0.316 P=0.501N |
|POLY 1.5 | P=0.601 P=0.138 P=0.521 | P=0.294N P=0.313 P=0.500N |
|POLY 6 | P=0.582N P=0.140 P=0.534 | P=0.300N P=0.320 P=0.503N |
|LOGISTIC REGRESSION| P=0.594 P=0.152 P=0.519 | P=0.294N P=0.306 P=0.514N |
|COCH-ARM / FISHERS | P=0.566 P=0.134 P=0.500 | P=0.294N P=0.309 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 7/50 (14%) 3/50 (6%) | 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 16.8% 7.0% | 7.0% 2.2% 0.0% |
|TERMINAL (d) | 0/27 (0%) 6/29 (21%) 1/26 (4%) | 3/34 (9%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 672 665 672 | 735 (T) 716 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.466 P=0.040 * P=0.326 | P=0.088N P=0.287N P=0.121N |
|POLY 3 | P=0.508 P=0.032 * P=0.323 | P=0.089N P=0.289N P=0.117N |
|POLY 1.5 | P=0.498 P=0.032 * P=0.319 | P=0.088N P=0.295N P=0.118N |
|POLY 6 | P=0.512 P=0.032 * P=0.324 | P=0.090N P=0.282N P=0.117N |
|LOGISTIC REGRESSION| P=0.495 P=0.035 * P=0.320 | P=0.087N P=0.279N (e) |
|COCH-ARM / FISHERS | P=0.467 P=0.030 * P=0.309 | P=0.088N P=0.309N P=0.121N |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 8/50 (16%) 4/50 (8%) | 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.9% 19.2% 9.3% | 7.0% 2.2% 2.3% |
|TERMINAL (d) | 1/27 (4%) 7/29 (24%) 1/26 (4%) | 3/34 (9%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 672 665 671 | 735 (T) 716 726 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.471 P=0.058 P=0.362 | P=0.272N P=0.287N P=0.304N |
|POLY 3 | P=0.519 P=0.047 * P=0.362 | P=0.276N P=0.289N P=0.303N |
|POLY 1.5 | P=0.506 P=0.048 * P=0.356 | P=0.274N P=0.295N P=0.303N |
|POLY 6 | P=0.528 P=0.047 * P=0.366 | P=0.278N P=0.282N P=0.303N |
|LOGISTIC REGRESSION| P=0.502 P=0.051 P=0.357 | P=0.273N P=0.279N P=0.302N |
|COCH-ARM / FISHERS | P=0.470 P=0.046 * P=0.339 | P=0.272N P=0.309N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 2/50 (4%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.0% 12.1% 4.7% | 0.0% 4.5% 0.0% |
|TERMINAL (d) | 2/27 (7%) 5/29 (17%) 2/26 (8%) | 0/34 (0%) 2/36 (6%) 0/34 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) | --- 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.529N P=0.242 P=0.683 | P=0.579N P=0.251 (e) |
|POLY 3 | P=0.470N P=0.225 P=0.677N | P=0.573N P=0.247 (e) |
|POLY 1.5 | P=0.477N P=0.224 P=0.680N | P=0.573N P=0.243 (e) |
|POLY 6 | P=0.467N P=0.227 P=0.675N | P=0.574N P=0.251 (e) |
|LOGISTIC REGRESSION| P=0.529N P=0.242 P=0.683 | (e) P=0.251 (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.218 P=0.691N | P=0.575N P=0.247 (e) |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Skin |
| Lipoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 4.8% 2.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 1/29 (3%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 733 (T) 698 547 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.615N P=0.520 P=0.760N | (e) (e) (e) |
|POLY 3 | P=0.585N P=0.510 P=0.747N | (e) (e) (e) |
|POLY 1.5 | P=0.591N P=0.508 P=0.750N | (e) (e) (e) |
|POLY 6 | P=0.581N P=0.514 P=0.744N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.607N P=0.514 P=0.744 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.607N P=0.500 P=0.753N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.0% 12.1% 7.0% | 2.3% 4.5% 0.0% |
|TERMINAL (d) | 2/27 (7%) 5/29 (17%) 2/26 (8%) | 0/34 (0%) 2/36 (6%) 0/34 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 560 | 566 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.512 P=0.242 P=0.493 | P=0.319N P=0.521 P=0.491N |
|POLY 3 | P=0.578 P=0.225 P=0.528 | P=0.324N P=0.511 P=0.501N |
|POLY 1.5 | P=0.566 P=0.224 P=0.521 | P=0.321N P=0.507 P=0.500N |
|POLY 6 | P=0.587 P=0.227 P=0.534 | P=0.327N P=0.515 P=0.503N |
|LOGISTIC REGRESSION| P=0.562 P=0.242 P=0.519 | P=0.321N P=0.495 P=0.514N |
|COCH-ARM / FISHERS | P=0.535 P=0.218 P=0.500 | P=0.320N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.0% 12.1% 7.0% | 0.0% 4.5% 0.0% |
|TERMINAL (d) | 2/27 (7%) 5/29 (17%) 2/26 (8%) | 0/34 (0%) 2/36 (6%) 0/34 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 560 | --- 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.512 P=0.242 P=0.493 | P=0.579N P=0.251 (e) |
|POLY 3 | P=0.578 P=0.225 P=0.528 | P=0.573N P=0.247 (e) |
|POLY 1.5 | P=0.566 P=0.224 P=0.521 | P=0.573N P=0.243 (e) |
|POLY 6 | P=0.587 P=0.227 P=0.534 | P=0.574N P=0.251 (e) |
|LOGISTIC REGRESSION| P=0.562 P=0.242 P=0.519 | (e) P=0.251 (e) |
|COCH-ARM / FISHERS | P=0.535 P=0.218 P=0.500 | P=0.575N P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 40/50 (80%) 41/50 (82%) 33/50 (66%) | |
|POLY-3 ADJUSTED (b)| 86.1% 91.3% 73.9% | |
|TERMINAL (d) | 24/27 (89%) 29/29 (100%) 23/26 (89%) | |
|FIRST INCIDENCE | 408 552 532 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113N P=0.474N P=0.154N | |
|POLY 3 | P=0.029N* P=0.301 P=0.092N | |
|POLY 1.5 | P=0.027N* P=0.405 P=0.075N | |
|POLY 6 | P=0.050N P=0.206 P=0.146N | |
|LOGISTIC REGRESSION| P=0.007N** P=0.591 P=0.030N* | |
|COCH-ARM / FISHERS | P=0.046N* P=0.500 P=0.088N | |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 4/48 (8%) 9/48 (19%) | 6/47 (13%) 6/50 (12%) 2/47 (4%) |
|POLY-3 ADJUSTED (b)| 12.6% 9.9% 21.5% | 14.6% 13.3% 4.9% |
|TERMINAL (d) | 4/27 (15%) 4/29 (14%) 6/26 (23%) | 6/34 (18%) 3/36 (8%) 2/33 (6%) |
|FIRST INCIDENCE | 697 733 (T) 525 | 735 (T) 672 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.101 P=0.460N P=0.192 | P=0.111N P=0.564N P=0.141N |
|POLY 3 | P=0.126 P=0.489N P=0.218 | P=0.103N P=0.556N P=0.132N |
|POLY 1.5 | P=0.120 P=0.496N P=0.208 | P=0.100N P=0.564N P=0.130N |
|POLY 6 | P=0.130 P=0.483N P=0.227 | P=0.107N P=0.541N P=0.134N |
|LOGISTIC REGRESSION| P=0.120 P=0.472N P=0.206 | P=0.104N P=0.563N P=0.141N |
|COCH-ARM / FISHERS | P=0.107 P=0.513N P=0.182 | P=0.102N P=0.576N P=0.134N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 3/48 (6%) 1/48 (2%) | 3/47 (6%) 2/50 (4%) 1/47 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 7.4% 2.5% | 7.3% 4.5% 2.4% |
|TERMINAL (d) | 0/27 (0%) 3/29 (10%) 1/26 (4%) | 3/34 (9%) 2/36 (6%) 1/33 (3%) |
|FIRST INCIDENCE | 672 733 (T) 733 (T) | 735 (T) 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.558N P=0.323 P=0.755N | P=0.263N P=0.474N P=0.315N |
|POLY 3 | P=0.536N P=0.310 P=0.756N | P=0.257N P=0.465N P=0.305N |
|POLY 1.5 | P=0.539N P=0.307 P=0.757N | P=0.254N P=0.467N P=0.303N |
|POLY 6 | P=0.538N P=0.312 P=0.757N | P=0.260N P=0.461N P=0.309N |
|LOGISTIC REGRESSION| P=0.541N P=0.317 P=0.758N | P=0.263N P=0.474N P=0.315N |
|COCH-ARM / FISHERS | P=0.555N P=0.301 P=0.747 | P=0.254N P=0.470N P=0.308N |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 7/48 (15%) 10/48 (21%) | 8/47 (17%) 8/50 (16%) 3/47 (6%) |
|POLY-3 ADJUSTED (b)| 15.0% 17.3% 23.9% | 19.4% 17.7% 7.3% |
|TERMINAL (d) | 4/27 (15%) 7/29 (24%) 7/26 (27%) | 8/34 (24%) 5/36 (14%) 3/33 (9%) |
|FIRST INCIDENCE | 672 733 (T) 525 | 735 (T) 672 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.148 P=0.545 P=0.208 | P=0.083N P=0.545N P=0.105N |
|POLY 3 | P=0.188 P=0.509 P=0.230 | P=0.075N P=0.530N P=0.096N |
|POLY 1.5 | P=0.180 P=0.503 P=0.221 | P=0.073N P=0.540N P=0.095N |
|POLY 6 | P=0.193 P=0.512 P=0.236 | P=0.078N P=0.513N P=0.098N |
|LOGISTIC REGRESSION| P=0.176 P=0.534 P=0.221 | P=0.077N P=0.535N P=0.105N |
|COCH-ARM / FISHERS | P=0.156 P=0.484 P=0.194 | P=0.076N P=0.554N P=0.099N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | | 10/50 (20%) 10/50 (20%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| | 23.5% 22.5% 22.6% |
|TERMINAL (d) | | 10/34 (29%) 10/36 (28%) 7/34 (21%) |
|FIRST INCIDENCE | | 735 (T) 735 (T) 535 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.555 P=0.545N P=0.597N |
|POLY 3 | | P=0.536N P=0.557N P=0.563N |
|POLY 1.5 | | P=0.547N P=0.572N P=0.576N |
|POLY 6 | | P=0.524N P=0.539N P=0.547N |
|LOGISTIC REGRESSION| | P=0.558 P=0.545N P=0.595N |
|COCH-ARM / FISHERS | | P=0.565N P=0.598N P=0.598N |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 29/50 (58%) 25/50 (50%) | 14/50 (28%) 14/50 (28%) 24/50 (48%) |
|POLY-3 ADJUSTED (b)| 37.0% 61.6% 55.8% | 31.6% 30.7% 51.0% |
|TERMINAL (d) | 9/27 (33%) 14/29 (48%) 14/26 (54%) | 10/34 (29%) 9/36 (25%) 14/34 (41%) |
|FIRST INCIDENCE | 135 403 532 | 504 595 411 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.146 P=0.035 * P=0.080 | P=0.023 * P=0.513N P=0.051 |
|POLY 3 | P=0.104 P=0.013 * P=0.053 | P=0.021 * P=0.555N P=0.044 * |
|POLY 1.5 | P=0.103 P=0.009 ** P=0.052 | P=0.018 * P=0.567N P=0.038 * |
|POLY 6 | P=0.104 P=0.024 * P=0.054 | P=0.025 * P=0.536N P=0.054 |
|LOGISTIC REGRESSION| P=0.108 P=0.007 ** P=0.061 | P=0.016 * P=0.561N P=0.032 * |
|COCH-ARM / FISHERS | P=0.102 P=0.008 ** P=0.052 | P=0.016 * P=0.588N P=0.032 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 2.4% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 714 656 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.168N P=0.481N P=0.240N | (e) (e) (e) |
|POLY 3 | P=0.170N P=0.489N P=0.226N | (e) (e) (e) |
|POLY 1.5 | P=0.171N P=0.492N P=0.229N | (e) (e) (e) |
|POLY 6 | P=0.170N P=0.485N P=0.225N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.167N P=0.491N P=0.226N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.175N P=0.500N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 2.4% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 714 656 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.168N P=0.481N P=0.240N | (e) (e) (e) |
|POLY 3 | P=0.170N P=0.489N P=0.226N | (e) (e) (e) |
|POLY 1.5 | P=0.171N P=0.492N P=0.229N | (e) (e) (e) |
|POLY 6 | P=0.170N P=0.485N P=0.225N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.167N P=0.491N P=0.226N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.175N P=0.500N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 2.4% 2.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 408 435 671 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256N P=0.296N P=0.284N | (e) (e) (e) |
|POLY 3 | P=0.268N P=0.302N P=0.298N | (e) (e) (e) |
|POLY 1.5 | P=0.268N P=0.301N P=0.298N | (e) (e) (e) |
|POLY 6 | P=0.269N P=0.303N P=0.301N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.415N P=0.398N P=0.407N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.272N P=0.309N P=0.309N | (e) (e) (e) |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 4.7% 2.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 408 435 671 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.234N P=0.487N P=0.284N | (e) (e) (e) |
|POLY 3 | P=0.248N P=0.494N P=0.298N | (e) (e) (e) |
|POLY 1.5 | P=0.248N P=0.494N P=0.298N | (e) (e) (e) |
|POLY 6 | P=0.250N P=0.494N P=0.301N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.374N P=0.596N P=0.407N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.252N P=0.500N P=0.309N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 48/50 (96%) 48/50 (96%) | 44/50 (88%) 44/50 (88%) 40/50 (80%) |
|POLY-3 ADJUSTED (b)| 97.0% 99.1% 98.0% | 92.4% 90.6% 86.5% |
|TERMINAL (d) | 26/27 (96%) 29/29 (100%) 26/26 (100%) | 32/34 (94%) 32/36 (89%) 31/34 (91%) |
|FIRST INCIDENCE | 408 435 525 | 397 436 535 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.478 P=0.462N P=0.521 | P=0.275N P=0.381N P=0.280N |
|POLY 3 | P=0.632 P=0.494 P=0.657 | P=0.217N P=0.521N P=0.261N |
|POLY 1.5 | P=0.628 P=0.550 P=0.659 | P=0.175N P=0.556N P=0.225N |
|POLY 6 | P=0.556 P=0.465 P=0.607 | P=0.272N P=0.468N P=0.306N |
|LOGISTIC REGRESSION| P=0.470N P=0.652 P=0.628N | P=0.122N P=0.548N P=0.157N |
|COCH-ARM / FISHERS | P=0.459 P=0.500 P=0.500 | P=0.147N P=0.620N P=0.207N |
|=================================================================================================================================|
Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 24
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 42/50 (84%) 37/50 (74%) | 25/50 (50%) 24/50 (48%) 32/50 (64%) |
|POLY-3 ADJUSTED (b)| 56.0% 85.6% 78.5% | 54.0% 51.1% 68.0% |
|TERMINAL (d) | 11/27 (41%) 23/29 (79%) 19/26 (73%) | 17/34 (50%) 17/36 (47%) 21/34 (62%) |
|FIRST INCIDENCE | 135 403 532 | 476 225 411 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.128 P=0.028 * P=0.079 | P=0.099 P=0.403N P=0.160 |
|POLY 3 | P=0.030 * P<0.001 ** P=0.014 * | P=0.073 P=0.467N P=0.117 |
|POLY 1.5 | P=0.032 * P<0.001 ** P=0.015 * | P=0.073 P=0.468N P=0.115 |
|POLY 6 | P=0.029 * P<0.001 ** P=0.013 * | P=0.076 P=0.465N P=0.121 |
|LOGISTIC REGRESSION| P=0.040 * P<0.001 ** P=0.018 * | P=0.074 P=0.492N P=0.115 |
|COCH-ARM / FISHERS | P=0.043 * P<0.001 ** P=0.019 * | P=0.074 P=0.500N P=0.113 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 |
| | STOP STOP | STOP STOP |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 50/50 (100%) | 49/50 (98%) 48/50 (96%) 46/50 (92%) |
|POLY-3 ADJUSTED (b)| 99.1% 100.0% 100.0% | 100.0% 96.0% 94.8% |
|TERMINAL (d) | 27/27 (100%) 29/29 (100%) 26/26 (100%) | 34/34 (100%) 34/36 (94%) 32/34 (94%) |
|FIRST INCIDENCE | 135 403 525 | 397 225 411 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482 P=0.460N P=0.523 | P=0.377N P=0.303N P=0.364N |
|POLY 3 | P=0.795 P=0.910 P=0.910 | P=0.156N P=0.243N P=0.150N |
|POLY 1.5 | P=0.565 P=0.702 P=0.702 | P=0.126N P=0.258N P=0.127N |
|POLY 6 | P=1.000 P=1.000 P=1.000 | P=0.193N P=0.242N P=0.184N |
|LOGISTIC REGRESSION| P=0.471 P=0.553 P=0.594 | P=0.106N P=0.433N P=0.119N |
|COCH-ARM / FISHERS | P=0.394 P=0.500 P=0.500 | P=0.128N P=0.500N P=0.181N |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).
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