TDMS Study 56348-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus CITRAL DATE: 07/05/01
EXPERIMENT: 56348 TEST: 03 TIME: 13:17:14
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: C56348
PATHOLOGIST: SINGER, ALLEN CAS: 5392-40-5
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 UNTREAT CONTROL
INCLUDE 002 UNTREAT CONTROL
INCLUDE 005 1000 PPM
INCLUDE 006 1000 PPM
INCLUDE 007 2000 PPM
INCLUDE 008 2000 PPM
INCLUDE 009 4000 PPM
INCLUDE 010 4000 PPM
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus CITRAL DATE: 07/05/01
EXPERIMENT: 56348 TEST: 03 TIME: 13:17:14
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: C56348
PATHOLOGIST: SINGER, ALLEN CAS: 5392-40-5
Rats(FISCHER 344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Kidney
Lung
Nose
Pancreas
Parathyroid Gland
Pituitary Gland
Testes
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus CITRAL DATE: 07/05/01
EXPERIMENT: 56348 TEST: 03 TIME: 13:17:14
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: C56348
PATHOLOGIST: SINGER, ALLEN CAS: 5392-40-5
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF CITRAL
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Mammary Gland Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Testes Adenoma
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Skin Keratoacanthoma
Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
Squamous Cell Papilloma, Papilloma, or Keratoacanthoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Malignant Tumors
===============================================================
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 3/50 (6%) 8/50 (16%) |2/49 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/44.21 3/45.97 3/47.40 8/45.40 |2/44.20 1/45.60 2/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 13.6% 6.5% 6.3% 17.6% |4.5% 2.2% 4.4% 2.3% |
|TERMINAL (d) | 3/30 (10%) 2/32 (6%) 3/35 (9%) 8/34 (24%) |2/34 (6%) 1/36 (3%) 2/36 (6%) 1/36 (3%) |
|FIRST INCIDENCE | 639 695 726 (T) 726 (T) |732 (T) 732 (T) 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.274 P=0.201N P=0.177N P=0.478 |P=0.428N P=0.480N P=0.675N P=0.480N |
|POLY 3 | P=0.217 P=0.222N P=0.209N P=0.407 |P=0.448N P=0.489N P=0.686N P=0.500N |
|POLY 1.5 | P=0.215 P=0.232N P=0.223N P=0.397 |P=0.446N P=0.491N P=0.687N P=0.499N |
|POLY 6 | P=0.220 P=0.210N P=0.191N P=0.422 |P=0.446N P=0.486N P=0.682N P=0.498N |
|LOGISTIC REGRESSION| P=0.240 P=0.230N P=0.221N P=0.442 |P=0.428N P=0.480N P=0.675N P=0.480N |
|COCH-ARM / FISHERS | P=0.213 P=0.243N P=0.243N P=0.387 |P=0.438N P=0.492N P=0.684N P=0.492N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) 3/50 (6%) 9/50 (18%) |2/49 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 7/44.21 3/45.97 3/47.40 9/45.67 |2/44.20 1/45.60 2/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 15.8% 6.5% 6.3% 19.7% |4.5% 2.2% 4.4% 2.3% |
|TERMINAL (d) | 4/30 (13%) 2/32 (6%) 3/35 (9%) 8/34 (24%) |2/34 (6%) 1/36 (3%) 2/36 (6%) 1/36 (3%) |
|FIRST INCIDENCE | 639 695 726 (T) 655 |732 (T) 732 (T) 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.262 P=0.128N P=0.108N P=0.492 |P=0.428N P=0.480N P=0.675N P=0.480N |
|POLY 3 | P=0.205 P=0.141N P=0.130N P=0.419 |P=0.448N P=0.489N P=0.686N P=0.500N |
|POLY 1.5 | P=0.202 P=0.149N P=0.142N P=0.406 |P=0.446N P=0.491N P=0.687N P=0.499N |
|POLY 6 | P=0.209 P=0.131N P=0.116N P=0.440 |P=0.446N P=0.486N P=0.682N P=0.498N |
|LOGISTIC REGRESSION| P=0.222 P=0.143N P=0.132N P=0.441 |P=0.428N P=0.480N P=0.675N P=0.480N |
|COCH-ARM / FISHERS | P=0.200 P=0.159N P=0.159N P=0.393 |P=0.438N P=0.492N P=0.684N P=0.492N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/49 (10%) 4/50 (8%) 3/50 (6%) |9/49 (18%) 3/49 (6%) 4/50 (8%) 1/49 (2%) |
|POLY-3 RATE (b) | 4/43.69 5/46.39 4/47.47 3/45.98 |9/44.60 3/44.60 4/45.34 1/43.18 |
|POLY-3 PERCENT (g) | 9.2% 10.8% 8.4% 6.5% |20.2% 6.7% 8.8% 2.3% |
|TERMINAL (d) | 3/30 (10%) 0/32 (0%) 3/35 (9%) 2/34 (6%) |8/35 (23%) 3/35 (9%) 3/36 (8%) 1/35 (3%) |
|FIRST INCIDENCE | 660 505 709 544 |719 732 (T) 690 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309N P=0.564 P=0.544N P=0.446N |P=0.009N** P=0.062N P=0.108N P=0.010N* |
|POLY 3 | P=0.337N P=0.538 P=0.597N P=0.472N |P=0.009N** P=0.058N P=0.108N P=0.009N** |
|POLY 1.5 | P=0.347N P=0.515 P=0.617N P=0.485N |P=0.009N** P=0.059N P=0.109N P=0.009N** |
|POLY 6 | P=0.323N P=0.571 P=0.569N P=0.452N |P=0.009N** P=0.057N P=0.104N P=0.009N** |
|LOGISTIC REGRESSION| P=0.379N P=0.440 P=0.558N P=0.503N |P=0.009N** P=0.062N P=0.104N P=0.010N* |
|COCH-ARM / FISHERS | P=0.358N P=0.487 P=0.643N P=0.500N |P=0.009N** P=0.060N P=0.109N P=0.008N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/49 (10%) 5/50 (10%) 4/50 (8%) |9/49 (18%) 3/49 (6%) 4/50 (8%) 1/49 (2%) |
|POLY-3 RATE (b) | 5/44.08 5/46.39 5/47.67 4/46.05 |9/44.60 3/44.60 4/45.34 1/43.18 |
|POLY-3 PERCENT (g) | 11.3% 10.8% 10.5% 8.7% |20.2% 6.7% 8.8% 2.3% |
|TERMINAL (d) | 3/30 (10%) 0/32 (0%) 3/35 (9%) 2/34 (6%) |8/35 (23%) 3/35 (9%) 3/36 (8%) 1/35 (3%) |
|FIRST INCIDENCE | 617 505 674 544 |719 732 (T) 690 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.357N P=0.560N P=0.520N P=0.435N |P=0.009N** P=0.062N P=0.108N P=0.010N* |
|POLY 3 | P=0.397N P=0.598N P=0.580N P=0.473N |P=0.009N** P=0.058N P=0.108N P=0.009N** |
|POLY 1.5 | P=0.405N P=0.618N P=0.601N P=0.485N |P=0.009N** P=0.059N P=0.109N P=0.009N** |
|POLY 6 | P=0.385N P=0.568N P=0.551N P=0.453N |P=0.009N** P=0.057N P=0.104N P=0.009N** |
|LOGISTIC REGRESSION| P=0.441N P=0.560 P=0.622N P=0.512N |P=0.009N** P=0.062N P=0.104N P=0.010N* |
|COCH-ARM / FISHERS | P=0.415N P=0.617 P=0.630N P=0.500N |P=0.009N** P=0.060N P=0.109N P=0.008N** |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.44 2/46.51 1/47.40 0/45.40 |1/45.25 1/45.60 2/45.40 1/44.35 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 2.1% 0.0% |2.2% 2.2% 4.4% 2.3% |
|TERMINAL (d) | 0/30 (0%) 1/32 (3%) 1/35 (3%) 0/34 (0%) |0/35 (0%) 1/36 (3%) 1/36 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- 505 726 (T) --- |719 732 (T) 673 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.440N P=0.247 P=0.531 (e) |P=0.597 P=0.755 P=0.509 P=0.758N |
|POLY 3 | P=0.439N P=0.253 P=0.517 (e) |P=0.579 P=0.759N P=0.501 P=0.756 |
|POLY 1.5 | P=0.449N P=0.246 P=0.510 (e) |P=0.581 P=0.760N P=0.499 P=0.757 |
|POLY 6 | P=0.424N P=0.263 P=0.528 (e) |P=0.583 P=0.757N P=0.506 P=0.758 |
|LOGISTIC REGRESSION| P=0.471N P=0.191 P=0.531 (e) |P=0.586 P=0.758N P=0.499 P=0.761 |
|COCH-ARM / FISHERS | P=0.461N P=0.247 P=0.500 (e) |P=0.591 P=0.753N P=0.500 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/42.89 2/45.85 1/47.47 0/45.40 |0/45.20 0/45.60 2/45.17 1/43.98 |
|POLY-3 PERCENT (g) | 2.3% 4.4% 2.1% 0.0% |0.0% 0.0% 4.4% 2.3% |
|TERMINAL (d) | 0/30 (0%) 2/32 (6%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 2/36 (6%) 1/36 (3%) |
|FIRST INCIDENCE | 674 726 (T) 709 --- |--- --- 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.217N P=0.532 P=0.704N P=0.475N |P=0.250 (e) P=0.244 P=0.506 |
|POLY 3 | P=0.233N P=0.523 P=0.738N P=0.489N |P=0.237 (e) P=0.237 P=0.495 |
|POLY 1.5 | P=0.238N P=0.516 P=0.745N P=0.492N |P=0.237 (e) P=0.236 P=0.494 |
|POLY 6 | P=0.226N P=0.534 P=0.727N P=0.483N |P=0.239 (e) P=0.239 P=0.496 |
|LOGISTIC REGRESSION| P=0.234N P=0.529 P=0.759 P=0.502N |(e) (e) P=0.244 P=0.506 |
|COCH-ARM / FISHERS | P=0.243N P=0.508 P=0.747N P=0.495N |P=0.241 (e) P=0.247 P=0.495 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.56 2/45.85 0/47.40 0/45.40 |1/45.20 2/46.07 2/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 4.6% 4.4% 0.0% 0.0% |2.2% 4.3% 4.4% 2.3% |
|TERMINAL (d) | 1/30 (3%) 2/32 (6%) 0/35 (0%) 0/34 (0%) |1/35 (3%) 1/36 (3%) 2/36 (6%) 1/36 (3%) |
|FIRST INCIDENCE | 695 726 (T) --- --- |732 (T) 594 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.070N P=0.658N P=0.192N P=0.205N |P=0.553N P=0.507 P=0.510 P=0.756N |
|POLY 3 | P=0.081N P=0.676N P=0.219N P=0.228N |P=0.566N P=0.507 P=0.500 P=0.756 |
|POLY 1.5 | P=0.083N P=0.684N P=0.227N P=0.232N |P=0.564N P=0.503 P=0.499 P=0.756 |
|POLY 6 | P=0.079N P=0.663N P=0.209N P=0.221N |P=0.564N P=0.512 P=0.504 P=0.757 |
|LOGISTIC REGRESSION| P=0.072N P=0.649N P=0.211N P=0.221N |P=0.562N P=0.501 P=0.510 P=0.756N |
|COCH-ARM / FISHERS | P=0.086N P=0.691N P=0.247N P=0.247N |P=0.556N P=0.500 P=0.500 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.56 3/45.91 1/47.40 0/45.40 |1/45.20 2/46.07 2/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 4.6% 6.5% 2.1% 0.0% |2.2% 4.3% 4.4% 2.3% |
|TERMINAL (d) | 1/30 (3%) 2/32 (6%) 1/35 (3%) 0/34 (0%) |1/35 (3%) 1/36 (3%) 2/36 (6%) 1/36 (3%) |
|FIRST INCIDENCE | 695 709 726 (T) --- |732 (T) 594 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.082N P=0.551 P=0.430N P=0.205N |P=0.553N P=0.507 P=0.510 P=0.756N |
|POLY 3 | P=0.096N P=0.524 P=0.471N P=0.228N |P=0.566N P=0.507 P=0.500 P=0.756 |
|POLY 1.5 | P=0.099N P=0.513 P=0.483N P=0.232N |P=0.564N P=0.503 P=0.499 P=0.756 |
|POLY 6 | P=0.091N P=0.540 P=0.453N P=0.221N |P=0.564N P=0.512 P=0.504 P=0.757 |
|LOGISTIC REGRESSION| P=0.086N P=0.553 P=0.445N P=0.221N |P=0.562N P=0.501 P=0.510 P=0.756N |
|COCH-ARM / FISHERS | P=0.104N P=0.500 P=0.500N P=0.247N |P=0.556N P=0.500 P=0.500 P=0.753N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 0/47.40 0/45.40 |0/45.20 1/45.92 3/45.94 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 6.5% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 2/36 (6%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 645 453 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.633N P=0.519 P=0.125 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.617 P=0.503 P=0.122 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.621 P=0.501 P=0.120 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.619 P=0.506 P=0.124 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.570N P=0.516 P=0.139 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.634 P=0.500 P=0.121 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.59 0/45.85 0/47.40 0/45.40 |0/45.20 1/45.92 3/45.94 0/44.18 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |0.0% 2.2% 6.5% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 2/36 (6%) 0/36 (0%) |
|FIRST INCIDENCE | 688 --- --- --- |--- 645 453 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.289N P=0.458N P=0.449N P=0.473N |P=0.633N P=0.519 P=0.125 (e) |
|POLY 3 | P=0.311N P=0.490N P=0.483N P=0.492N |P=0.617 P=0.503 P=0.122 (e) |
|POLY 1.5 | P=0.308N P=0.494N P=0.490N P=0.496N |P=0.621 P=0.501 P=0.120 (e) |
|POLY 6 | P=0.316N P=0.483N P=0.474N P=0.486N |P=0.619 P=0.506 P=0.124 (e) |
|LOGISTIC REGRESSION| P=0.310N P=0.505N P=0.521N P=0.502N |P=0.570N P=0.516 P=0.139 (e) |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.634 P=0.500 P=0.121 (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |26/50 (52%) 22/50 (44%) 18/50 (36%) 16/50 (32%) |
|POLY-3 RATE (b) | 3/43.44 0/45.85 3/47.55 2/45.40 |26/45.82 22/46.19 18/45.59 16/45.45 |
|POLY-3 PERCENT (g) | 6.9% 0.0% 6.3% 4.4% |56.7% 47.6% 39.5% 35.2% |
|TERMINAL (d) | 3/30 (10%) 0/32 (0%) 2/35 (6%) 2/34 (6%) |21/35 (60%) 20/36 (56%) 15/36 (42%) 13/36 (36%) |
|FIRST INCIDENCE | 726 (T) --- 688 726 (T) |609 582 673 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.548N P=0.109N P=0.581N P=0.442N |P=0.020N* P=0.242N P=0.069N P=0.033N* |
|POLY 3 | P=0.593N P=0.109N P=0.620N P=0.480N |P=0.020N* P=0.248N P=0.070N P=0.028N* |
|POLY 1.5 | P=0.595N P=0.114N P=0.638N P=0.490N |P=0.022N* P=0.262N P=0.075N P=0.031N* |
|POLY 6 | P=0.590N P=0.103N P=0.593N P=0.464N |P=0.016N* P=0.232N P=0.060N P=0.022N* |
|LOGISTIC REGRESSION| P=0.552N (e) P=0.570N P=0.442N |P=0.025N* P=0.221N P=0.055N P=0.037N* |
|COCH-ARM / FISHERS | P=0.596 P=0.121N P=0.661N P=0.500N |P=0.023N* P=0.274N P=0.079N P=0.034N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |26/50 (52%) 22/50 (44%) 18/50 (36%) 16/50 (32%) |
|POLY-3 RATE (b) | 4/43.59 0/45.85 3/47.55 2/45.40 |26/45.82 22/46.19 18/45.59 16/45.45 |
|POLY-3 PERCENT (g) | 9.2% 0.0% 6.3% 4.4% |56.7% 47.6% 39.5% 35.2% |
|TERMINAL (d) | 3/30 (10%) 0/32 (0%) 2/35 (6%) 2/34 (6%) |21/35 (60%) 20/36 (56%) 15/36 (42%) 13/36 (36%) |
|FIRST INCIDENCE | 688 --- 688 726 (T) |609 582 673 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.380N P=0.052N P=0.401N P=0.281N |P=0.020N* P=0.242N P=0.069N P=0.033N* |
|POLY 3 | P=0.429N P=0.054N P=0.453N P=0.318N |P=0.020N* P=0.248N P=0.070N P=0.028N* |
|POLY 1.5 | P=0.430N P=0.057N P=0.473N P=0.328N |P=0.022N* P=0.262N P=0.075N P=0.031N* |
|POLY 6 | P=0.427N P=0.050N P=0.425N P=0.304N |P=0.016N* P=0.232N P=0.060N P=0.022N* |
|LOGISTIC REGRESSION| P=0.394N P=0.048N* P=0.418N P=0.278N |P=0.025N* P=0.221N P=0.055N P=0.037N* |
|COCH-ARM / FISHERS | P=0.432N P=0.059N P=0.500N P=0.339N |P=0.023N* P=0.274N P=0.079N P=0.034N* |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |26/50 (52%) 23/50 (46%) 20/50 (40%) 16/50 (32%) |
|POLY-3 RATE (b) | 4/43.59 0/45.85 3/47.55 2/45.40 |26/45.82 23/46.51 20/46.35 16/45.45 |
|POLY-3 PERCENT (g) | 9.2% 0.0% 6.3% 4.4% |56.7% 49.5% 43.2% 35.2% |
|TERMINAL (d) | 3/30 (10%) 0/32 (0%) 2/35 (6%) 2/34 (6%) |21/35 (60%) 20/36 (56%) 16/36 (44%) 13/36 (36%) |
|FIRST INCIDENCE | 688 --- 688 726 (T) |609 582 453 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.380N P=0.052N P=0.401N P=0.281N |P=0.021N* P=0.309N P=0.143N P=0.033N* |
|POLY 3 | P=0.429N P=0.054N P=0.453N P=0.318N |P=0.020N* P=0.308N P=0.131N P=0.028N* |
|POLY 1.5 | P=0.430N P=0.057N P=0.473N P=0.328N |P=0.022N* P=0.327N P=0.144N P=0.031N* |
|POLY 6 | P=0.427N P=0.050N P=0.425N P=0.304N |P=0.016N* P=0.282N P=0.113N P=0.022N* |
|LOGISTIC REGRESSION| P=0.394N P=0.048N* P=0.418N P=0.278N |P=0.026N* P=0.295N P=0.144N P=0.037N* |
|COCH-ARM / FISHERS | P=0.432N P=0.059N P=0.500N P=0.339N |P=0.022N* P=0.345N P=0.158N P=0.034N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.69 2/45.85 1/47.40 0/45.40 |0/45.20 1/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 2.3% 4.4% 2.1% 0.0% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 2/32 (6%) 1/35 (3%) 0/34 (0%) |0/35 (0%) 1/36 (3%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 660 726 (T) 726 (T) --- |--- 732 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223N P=0.531 P=0.725N P=0.485N |P=0.564N P=0.506 (e) (e) |
|POLY 3 | P=0.237N P=0.517 P=0.742N P=0.492N |P=0.567N P=0.502 (e) (e) |
|POLY 1.5 | P=0.242N P=0.509 P=0.750N P=0.496N |P=0.567N P=0.501 (e) (e) |
|POLY 6 | P=0.229N P=0.528 P=0.731N P=0.486N |P=0.565N P=0.503 (e) (e) |
|LOGISTIC REGRESSION| P=0.236N P=0.515 P=0.757 P=0.509N |(e) P=0.506 (e) (e) |
|COCH-ARM / FISHERS | P=0.247N P=0.500 P=0.753N P=0.500N |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|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%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.69 3/45.85 1/47.40 0/45.40 |0/45.20 1/45.60 0/45.17 1/44.33 |
|POLY-3 PERCENT (g) | 2.3% 6.5% 2.1% 0.0% |0.0% 2.2% 0.0% 2.3% |
|TERMINAL (d) | 0/30 (0%) 2/32 (6%) 1/35 (3%) 0/34 (0%) |0/35 (0%) 1/36 (3%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 660 725 726 (T) --- |--- 732 (T) --- 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.176N P=0.341 P=0.725N P=0.485N |P=0.406 P=0.506 (e) P=0.500 |
|POLY 3 | P=0.186N P=0.323 P=0.742N P=0.492N |P=0.401 P=0.502 (e) P=0.496 |
|POLY 1.5 | P=0.192N P=0.315 P=0.750N P=0.496N |P=0.401 P=0.501 (e) P=0.497 |
|POLY 6 | P=0.177N P=0.334 P=0.731N P=0.486N |P=0.403 P=0.503 (e) P=0.498 |
|LOGISTIC REGRESSION| P=0.185N P=0.329 P=0.757 P=0.509N |P=0.401 P=0.506 (e) P=0.502 |
|COCH-ARM / FISHERS | P=0.200N P=0.309 P=0.753N P=0.500N |P=0.405 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/45 (0%) 0/45 (0%) |2/43 (5%) 0/40 (0%) 0/43 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/42.01 0/43.06 0/42.40 0/41.20 |2/38.24 0/35.97 0/39.01 0/41.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |5.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/31 (0%) 0/30 (0%) 0/31 (0%) |2/29 (7%) 0/28 (0%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |732 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.103N P=0.246N P=0.223N P=0.210N |
|POLY 3 | (e) (e) (e) (e) |P=0.106N P=0.250N P=0.232N P=0.220N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.106N P=0.252N P=0.235N P=0.220N |
|POLY 6 | (e) (e) (e) (e) |P=0.107N P=0.247N P=0.228N P=0.217N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.103N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.108N P=0.265N P=0.247N P=0.225N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 7/50 (14%) 9/50 (18%) 6/49 (12%) |12/50 (24%) 11/50 (22%) 17/50 (34%) 13/49 (27%) |
|POLY-3 RATE (b) | 8/43.59 7/45.98 9/48.21 6/45.36 |12/45.77 11/46.43 17/46.88 13/43.58 |
|POLY-3 PERCENT (g) | 18.4% 15.2% 18.7% 13.2% |26.2% 23.7% 36.3% 29.8% |
|TERMINAL (d) | 7/30 (23%) 6/32 (19%) 5/35 (14%) 5/34 (15%) |8/35 (23%) 8/36 (22%) 11/36 (31%) 12/35 (34%) |
|FIRST INCIDENCE | 688 692 573 636 |609 612 445 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.278N P=0.429N P=0.556N P=0.295N |P=0.356 P=0.481N P=0.224 P=0.492 |
|POLY 3 | P=0.342N P=0.455N P=0.590 P=0.355N |P=0.294 P=0.484N P=0.206 P=0.443 |
|POLY 1.5 | P=0.362N P=0.476N P=0.551 P=0.377N |P=0.306 P=0.493N P=0.196 P=0.451 |
|POLY 6 | P=0.314N P=0.424N P=0.568N P=0.323N |P=0.291 P=0.471N P=0.224 P=0.444 |
|LOGISTIC REGRESSION| P=0.329N P=0.376N P=0.592 P=0.306N |P=0.310 P=0.491N P=0.187 P=0.451 |
|COCH-ARM / FISHERS | P=0.386N P=0.500N P=0.500 P=0.403N |P=0.338 P=0.500N P=0.189 P=0.477 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 7/50 (14%) 9/50 (18%) 6/49 (12%) |12/50 (24%) 11/50 (22%) 18/50 (36%) 13/49 (27%) |
|POLY-3 RATE (b) | 8/43.59 7/45.98 9/48.21 6/45.36 |12/45.77 11/46.43 18/47.03 13/43.58 |
|POLY-3 PERCENT (g) | 18.4% 15.2% 18.7% 13.2% |26.2% 23.7% 38.3% 29.8% |
|TERMINAL (d) | 7/30 (23%) 6/32 (19%) 5/35 (14%) 5/34 (15%) |8/35 (23%) 8/36 (22%) 11/36 (31%) 12/35 (34%) |
|FIRST INCIDENCE | 688 692 573 636 |609 612 445 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.278N P=0.429N P=0.556N P=0.295N |P=0.347 P=0.481N P=0.174 P=0.492 |
|POLY 3 | P=0.342N P=0.455N P=0.590 P=0.355N |P=0.283 P=0.484N P=0.152 P=0.443 |
|POLY 1.5 | P=0.362N P=0.476N P=0.551 P=0.377N |P=0.295 P=0.493N P=0.144 P=0.451 |
|POLY 6 | P=0.314N P=0.424N P=0.568N P=0.323N |P=0.281 P=0.471N P=0.170 P=0.444 |
|LOGISTIC REGRESSION| P=0.329N P=0.376N P=0.592 P=0.306N |P=0.301 P=0.491N P=0.136 P=0.451 |
|COCH-ARM / FISHERS | P=0.386N P=0.500N P=0.500 P=0.403N |P=0.328 P=0.500N P=0.138 P=0.477 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/49 (4%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/43.76 1/45.85 0/47.40 2/45.05 |1/45.20 1/45.77 1/45.17 0/43.18 |
|POLY-3 PERCENT (g) | 2.3% 2.2% 0.0% 4.4% |2.2% 2.2% 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 1/32 (3%) 0/35 (0%) 1/34 (3%) |1/35 (3%) 0/36 (0%) 1/36 (3%) 0/35 (0%) |
|FIRST INCIDENCE | 639 726 (T) --- 723 |732 (T) 687 732 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.395 P=0.741N P=0.478N P=0.537 |P=0.308N P=0.749N P=0.756N P=0.500N |
|POLY 3 | P=0.371 P=0.750N P=0.484N P=0.510 |P=0.323N P=0.758N P=0.760 P=0.509N |
|POLY 1.5 | P=0.366 P=0.755N P=0.491N P=0.502 |P=0.322N P=0.759N P=0.760 P=0.508N |
|POLY 6 | P=0.377 P=0.743N P=0.475N P=0.522 |P=0.322N P=0.755N P=0.759N P=0.508N |
|LOGISTIC REGRESSION| P=0.363 P=0.755 P=0.617N P=0.495 |P=0.321N P=0.762N P=0.756N (e) |
|COCH-ARM / FISHERS | P=0.360 P=0.753N P=0.500N P=0.492 |P=0.316N P=0.753N P=0.753N P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 2/45.85 1/47.40 0/45.40 |0/45.20 0/45.60 1/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 2.1% 0.0% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 2/32 (6%) 1/35 (3%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 1/36 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- 726 (T) 726 (T) --- |--- --- 732 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.429N P=0.252 P=0.531 (e) |P=0.697 (e) P=0.506 (e) |
|POLY 3 | P=0.440N P=0.249 P=0.517 (e) |P=0.683 (e) P=0.500 (e) |
|POLY 1.5 | P=0.450N P=0.244 P=0.510 (e) |P=0.686 (e) P=0.499 (e) |
|POLY 6 | P=0.425N P=0.258 P=0.528 (e) |P=0.684 (e) P=0.502 (e) |
|LOGISTIC REGRESSION| (e) P=0.252 P=0.531 (e) |(e) (e) P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.247 P=0.500 (e) |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or |
| Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.44 3/45.85 1/47.40 0/45.40 |0/45.20 0/45.60 1/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 2.3% 6.5% 2.1% 0.0% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/30 (3%) 3/32 (9%) 1/35 (3%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 1/36 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 726 (T) --- |--- --- 732 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170N P=0.327 P=0.727N P=0.475N |P=0.697 (e) P=0.506 (e) |
|POLY 3 | P=0.184N P=0.325 P=0.741N P=0.491N |P=0.683 (e) P=0.500 (e) |
|POLY 1.5 | P=0.191N P=0.316 P=0.749N P=0.495N |P=0.686 (e) P=0.499 (e) |
|POLY 6 | P=0.174N P=0.338 P=0.729N P=0.484N |P=0.684 (e) P=0.502 (e) |
|LOGISTIC REGRESSION| P=0.170N P=0.327 P=0.727N (e) |(e) (e) P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.200N P=0.309 P=0.753N P=0.500N |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.44 4/45.89 1/47.40 0/45.40 |0/45.20 0/45.60 1/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 2.3% 8.7% 2.1% 0.0% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/30 (3%) 3/32 (9%) 1/35 (3%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 1/36 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 726 (T) 716 726 (T) --- |--- --- 732 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.135N P=0.206 P=0.727N P=0.475N |P=0.697 (e) P=0.506 (e) |
|POLY 3 | P=0.145N P=0.195 P=0.741N P=0.491N |P=0.683 (e) P=0.500 (e) |
|POLY 1.5 | P=0.153N P=0.188 P=0.749N P=0.495N |P=0.686 (e) P=0.499 (e) |
|POLY 6 | P=0.135N P=0.207 P=0.729N P=0.484N |P=0.684 (e) P=0.502 (e) |
|LOGISTIC REGRESSION| P=0.128N P=0.224 P=0.727N (e) |(e) (e) P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.163N P=0.181 P=0.753N P=0.500N |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|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) | 7/50 (14%) 7/50 (14%) 7/50 (14%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 7/44.42 7/45.89 7/47.62 4/45.53 |0/45.20 0/45.60 1/45.17 2/44.35 |
|POLY-3 PERCENT (g) | 15.8% 15.3% 14.7% 8.8% |0.0% 0.0% 2.2% 4.5% |
|TERMINAL (d) | 5/30 (17%) 6/32 (19%) 5/35 (14%) 3/34 (9%) |0/35 (0%) 0/36 (0%) 1/36 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 505 716 688 695 |--- --- 732 (T) 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.145N P=0.558N P=0.487N P=0.204N |P=0.074 (e) P=0.506 P=0.251 |
|POLY 3 | P=0.190N P=0.589N P=0.559N P=0.246N |P=0.067 (e) P=0.500 P=0.233 |
|POLY 1.5 | P=0.197N P=0.600N P=0.583N P=0.255N |P=0.068 (e) P=0.499 P=0.233 |
|POLY 6 | P=0.177N P=0.569N P=0.524N P=0.231N |P=0.068 (e) P=0.502 P=0.235 |
|LOGISTIC REGRESSION| P=0.180N P=0.584N P=0.613N P=0.257N |P=0.067 (e) P=0.506 P=0.234 |
|COCH-ARM / FISHERS | P=0.203N P=0.613N P=0.613N P=0.262N |P=0.070 (e) P=0.500 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.85 3/45.87 2/47.40 2/45.53 |0/45.20 1/45.60 1/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 2.3% 6.5% 4.2% 4.4% |0.0% 2.2% 2.2% 2.3% |
|TERMINAL (d) | 0/30 (0%) 2/32 (6%) 2/35 (6%) 1/34 (3%) |0/35 (0%) 1/36 (3%) 1/36 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 610 720 726 (T) 695 |--- 732 (T) 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.551 P=0.334 P=0.543 P=0.540 |P=0.389 P=0.506 P=0.506 P=0.506 |
|POLY 3 | P=0.520 P=0.321 P=0.527 P=0.513 |P=0.375 P=0.502 P=0.500 P=0.495 |
|POLY 1.5 | P=0.510 P=0.314 P=0.516 P=0.507 |P=0.377 P=0.501 P=0.499 P=0.496 |
|POLY 6 | P=0.535 P=0.333 P=0.543 P=0.524 |P=0.377 P=0.503 P=0.502 P=0.497 |
|LOGISTIC REGRESSION| P=0.511 P=0.305 P=0.460 P=0.489 |(e) P=0.506 P=0.506 P=0.506 |
|COCH-ARM / FISHERS | P=0.500 P=0.309 P=0.500 P=0.500 |P=0.384 P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 3/50 (6%) 4/50 (8%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/44.05 6/46.09 3/47.43 4/46.16 |0/45.20 1/45.60 1/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 9.1% 13.0% 6.3% 8.7% |0.0% 2.2% 2.2% 2.3% |
|TERMINAL (d) | 2/30 (7%) 3/32 (9%) 2/35 (6%) 2/34 (6%) |0/35 (0%) 1/36 (3%) 1/36 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 610 688 720 520 |--- 732 (T) 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.378N P=0.438 P=0.414N P=0.581N |P=0.389 P=0.506 P=0.506 P=0.506 |
|POLY 3 | P=0.421N P=0.398 P=0.460N P=0.617N |P=0.375 P=0.502 P=0.500 P=0.495 |
|POLY 1.5 | P=0.434N P=0.385 P=0.477N P=0.629N |P=0.377 P=0.501 P=0.499 P=0.496 |
|POLY 6 | P=0.404N P=0.418 P=0.437N P=0.599N |P=0.377 P=0.503 P=0.502 P=0.497 |
|LOGISTIC REGRESSION| P=0.451N P=0.393 P=0.492N P=0.626 |(e) P=0.506 P=0.506 P=0.506 |
|COCH-ARM / FISHERS | P=0.449N P=0.370 P=0.500N P=0.643N |P=0.384 P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.44 1/45.91 1/47.43 1/45.40 |0/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 4.6% 2.2% 2.1% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 0/32 (0%) 0/35 (0%) 1/34 (3%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 726 (T) 709 720 726 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364N P=0.465N P=0.434N P=0.456N |(e) (e) (e) (e) |
|POLY 3 | P=0.404N P=0.481N P=0.469N P=0.485N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.406N P=0.490N P=0.483N P=0.492N |(e) (e) (e) (e) |
|POLY 6 | P=0.400N P=0.467N P=0.451N P=0.472N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.371N P=0.451N P=0.415N P=0.456N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.409N P=0.500N P=0.500N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/43.64 3/46.06 1/47.43 2/46.04 |0/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 6.9% 6.5% 2.1% 4.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 1/32 (3%) 0/35 (0%) 1/34 (3%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 674 688 720 520 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.297N P=0.603N P=0.243N P=0.453N |(e) (e) (e) (e) |
|POLY 3 | P=0.328N P=0.637N P=0.276N P=0.476N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.335N P=0.649N P=0.289N P=0.487N |(e) (e) (e) (e) |
|POLY 6 | P=0.319N P=0.620N P=0.260N P=0.459N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.353N P=0.634N P=0.262N P=0.516N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.343N P=0.661N P=0.309N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 5/50 (10%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 5/44.42 3/45.85 5/47.62 4/45.53 |0/45.20 0/45.60 0/45.17 2/44.35 |
|POLY-3 PERCENT (g) | 11.3% 6.5% 10.5% 8.8% |0.0% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 3/30 (10%) 3/32 (9%) 3/35 (9%) 3/34 (9%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 505 726 (T) 688 695 |--- --- --- 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.446N P=0.324N P=0.525N P=0.432N |P=0.049 * (e) (e) P=0.251 |
|POLY 3 | P=0.506N P=0.339N P=0.586N P=0.485N |P=0.044 * (e) (e) P=0.233 |
|POLY 1.5 | P=0.512N P=0.348N P=0.605N P=0.493N |P=0.045 * (e) (e) P=0.233 |
|POLY 6 | P=0.496N P=0.325N P=0.558N P=0.469N |P=0.045 * (e) (e) P=0.235 |
|LOGISTIC REGRESSION| P=0.511N P=0.369N P=0.577 P=0.507N |P=0.045 * (e) (e) P=0.234 |
|COCH-ARM / FISHERS | P=0.517N P=0.357N P=0.630N P=0.500N |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Lipoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 1/45.85 0/47.40 0/45.40 |2/45.68 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |4.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 1/32 (3%) 0/35 (0%) 0/34 (0%) |1/35 (3%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 726 (T) --- --- |588 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.549N P=0.513 (e) (e) |P=0.118N P=0.239N P=0.241N P=0.244N |
|POLY 3 | P=0.554N P=0.511 (e) (e) |P=0.113N P=0.238N P=0.240N P=0.245N |
|POLY 1.5 | P=0.560N P=0.506 (e) (e) |P=0.113N P=0.238N P=0.239N P=0.243N |
|POLY 6 | P=0.546N P=0.518 (e) (e) |P=0.113N P=0.237N P=0.239N P=0.245N |
|LOGISTIC REGRESSION| (e) P=0.513 (e) (e) |P=0.101N P=0.226N P=0.217N P=0.207N |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 6/50 (12%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 6/44.42 3/45.85 6/47.62 4/45.53 |0/45.20 0/45.60 0/45.17 2/44.35 |
|POLY-3 PERCENT (g) | 13.5% 6.5% 12.6% 8.8% |0.0% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 4/30 (13%) 3/32 (9%) 4/35 (11%) 3/34 (9%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 505 726 (T) 688 695 |--- --- --- 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347N P=0.214N P=0.505N P=0.305N |P=0.049 * (e) (e) P=0.251 |
|POLY 3 | P=0.409N P=0.226N P=0.571N P=0.354N |P=0.044 * (e) (e) P=0.233 |
|POLY 1.5 | P=0.415N P=0.234N P=0.593N P=0.363N |P=0.045 * (e) (e) P=0.233 |
|POLY 6 | P=0.398N P=0.213N P=0.539N P=0.338N |P=0.045 * (e) (e) P=0.235 |
|LOGISTIC REGRESSION| P=0.407N P=0.246N P=0.600 P=0.370N |P=0.045 * (e) (e) P=0.234 |
|COCH-ARM / FISHERS | P=0.419N P=0.243N P=0.620N P=0.370N |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 6/50 (12%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 6/44.42 3/45.85 6/47.62 4/45.53 |0/45.20 0/45.60 0/45.17 2/44.35 |
|POLY-3 PERCENT (g) | 13.5% 6.5% 12.6% 8.8% |0.0% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 4/30 (13%) 3/32 (9%) 4/35 (11%) 3/34 (9%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 505 726 (T) 688 695 |--- --- --- 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347N P=0.214N P=0.505N P=0.305N |P=0.049 * (e) (e) P=0.251 |
|POLY 3 | P=0.409N P=0.226N P=0.571N P=0.354N |P=0.044 * (e) (e) P=0.233 |
|POLY 1.5 | P=0.415N P=0.234N P=0.593N P=0.363N |P=0.045 * (e) (e) P=0.233 |
|POLY 6 | P=0.398N P=0.213N P=0.539N P=0.338N |P=0.045 * (e) (e) P=0.235 |
|LOGISTIC REGRESSION| P=0.407N P=0.246N P=0.600 P=0.370N |P=0.045 * (e) (e) P=0.234 |
|COCH-ARM / FISHERS | P=0.419N P=0.243N P=0.620N P=0.370N |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 49/50 (98%) 45/50 (90%) 47/50 (94%) | |
|POLY-3 RATE (b) | 49/49.24 49/49.68 45/49.09 47/48.99 | |
|POLY-3 PERCENT (g) | 99.5% 98.6% 91.7% 95.9% | |
|TERMINAL (d) | 30/30 (100%) 32/32 (100%) 34/35 (97%) 34/34 (100%)| |
|FIRST INCIDENCE | 505 478 600 520 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.078N P=0.297N P=0.028N* P=0.126N | |
|POLY 3 | P=0.149N P=0.779N P=0.060N P=0.283N | |
|POLY 1.5 | P=0.154N P=0.755N P=0.069N P=0.287N | |
|POLY 6 | P=0.144N P=0.896N P=0.068N P=0.293N | |
|LOGISTIC REGRESSION| P=0.135N P=0.723N P=0.013N* P=0.260N | |
|COCH-ARM / FISHERS | P=0.162N P=0.753N P=0.102N P=0.309N | |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 9/50 (18%) 10/50 (20%) 10/50 (20%) |8/50 (16%) 9/50 (18%) 9/50 (18%) 11/50 (22%) |
|POLY-3 RATE (b) | 7/43.44 9/45.91 10/48.40 10/45.95 |8/45.25 9/46.05 9/45.51 11/44.77 |
|POLY-3 PERCENT (g) | 16.1% 19.6% 20.7% 21.8% |17.7% 19.6% 19.8% 24.6% |
|TERMINAL (d) | 7/30 (23%) 8/32 (25%) 4/35 (11%) 6/34 (18%) |7/35 (20%) 6/36 (17%) 8/36 (22%) 7/36 (19%) |
|FIRST INCIDENCE | 726 (T) 709 573 636 |719 659 638 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.377 P=0.452 P=0.444 P=0.410 |P=0.277 P=0.518 P=0.526 P=0.331 |
|POLY 3 | P=0.310 P=0.439 P=0.386 P=0.341 |P=0.244 P=0.516 P=0.505 P=0.294 |
|POLY 1.5 | P=0.290 P=0.418 P=0.347 P=0.319 |P=0.246 P=0.507 P=0.500 P=0.293 |
|POLY 6 | P=0.345 P=0.473 P=0.445 P=0.379 |P=0.254 P=0.531 P=0.519 P=0.307 |
|LOGISTIC REGRESSION| P=0.310 P=0.515 P=0.369 P=0.386 |P=0.238 P=0.519 P=0.517 P=0.291 |
|COCH-ARM / FISHERS | P=0.267 P=0.393 P=0.298 P=0.298 |P=0.259 P=0.500 P=0.500 P=0.306 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.44 0/45.85 2/47.40 1/45.40 |0/45.20 2/45.70 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 4.2% 2.2% |0.0% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 0/32 (0%) 2/35 (6%) 1/34 (3%) |0/35 (0%) 1/36 (3%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 726 (T) --- 726 (T) 726 (T) |--- 708 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.490N P=0.224N P=0.639N P=0.456N |P=0.406N P=0.246 (e) (e) |
|POLY 3 | P=0.528N P=0.225N P=0.662N P=0.485N |P=0.406N P=0.240 (e) (e) |
|POLY 1.5 | P=0.529N P=0.231N P=0.676N P=0.492N |P=0.407N P=0.238 (e) (e) |
|POLY 6 | P=0.526N P=0.217N P=0.643N P=0.472N |P=0.403N P=0.242 (e) (e) |
|LOGISTIC REGRESSION| P=0.490N (e) P=0.639N P=0.456N |P=0.409N P=0.241 (e) (e) |
|COCH-ARM / FISHERS | P=0.531N P=0.247N P=0.691N P=0.500N |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 9/50 (18%) 12/50 (24%) 11/50 (22%) |8/50 (16%) 11/50 (22%) 9/50 (18%) 11/50 (22%) |
|POLY-3 RATE (b) | 9/43.44 9/45.91 12/48.40 11/45.95 |8/45.25 11/46.14 9/45.51 11/44.77 |
|POLY-3 PERCENT (g) | 20.7% 19.6% 24.8% 23.9% |17.7% 23.8% 19.8% 24.6% |
|TERMINAL (d) | 9/30 (30%) 8/32 (25%) 6/35 (17%) 7/34 (21%) |7/35 (20%) 7/36 (19%) 8/36 (22%) 7/36 (19%) |
|FIRST INCIDENCE | 726 (T) 709 573 636 |719 659 638 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.431 P=0.539N P=0.478 P=0.532 |P=0.344 P=0.329 P=0.526 P=0.331 |
|POLY 3 | P=0.354 P=0.553N P=0.415 P=0.456 |P=0.309 P=0.320 P=0.505 P=0.294 |
|POLY 1.5 | P=0.331 P=0.576N P=0.369 P=0.429 |P=0.310 P=0.312 P=0.500 P=0.293 |
|POLY 6 | P=0.391 P=0.516N P=0.483 P=0.501 |P=0.321 P=0.335 P=0.519 P=0.307 |
|LOGISTIC REGRESSION| P=0.366 P=0.472N P=0.428 P=0.521 |P=0.302 P=0.320 P=0.517 P=0.291 |
|COCH-ARM / FISHERS | P=0.307 P=0.602N P=0.312 P=0.402 |P=0.326 P=0.306 P=0.500 P=0.306 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.26 0/45.85 2/47.40 0/45.40 |0/45.20 1/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 6.8% 0.0% 4.2% 0.0% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/32 (0%) 2/35 (6%) 0/34 (0%) |0/35 (0%) 1/36 (3%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 450 --- 726 (T) --- |--- 732 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.110N P=0.113N P=0.436N P=0.109N |P=0.564N P=0.506 (e) (e) |
|POLY 3 | P=0.124N P=0.112N P=0.469N P=0.114N |P=0.567N P=0.502 (e) (e) |
|POLY 1.5 | P=0.125N P=0.116N P=0.483N P=0.117N |P=0.567N P=0.501 (e) (e) |
|POLY 6 | P=0.124N P=0.107N P=0.448N P=0.109N |P=0.565N P=0.503 (e) (e) |
|LOGISTIC REGRESSION| P=0.138N P=0.146N P=0.633N P=0.125N |(e) P=0.506 (e) (e) |
|COCH-ARM / FISHERS | P=0.126N P=0.121N P=0.500N P=0.121N |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.83 0/45.85 0/47.40 2/45.40 |0/45.20 0/45.60 1/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 4.4% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 2/34 (6%) |0/35 (0%) 0/36 (0%) 1/36 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 617 --- --- 726 (T) |--- --- 732 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.265 P=0.482N P=0.478N P=0.537 |P=0.697 (e) P=0.506 (e) |
|POLY 3 | P=0.246 P=0.491N P=0.484N P=0.512 |P=0.683 (e) P=0.500 (e) |
|POLY 1.5 | P=0.246 P=0.495N P=0.491N P=0.506 |P=0.686 (e) P=0.499 (e) |
|POLY 6 | P=0.247 P=0.485N P=0.475N P=0.522 |P=0.684 (e) P=0.502 (e) |
|LOGISTIC REGRESSION| P=0.243 P=0.538N P=0.664N P=0.497 |(e) (e) P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/44.65 0/45.85 2/47.40 2/45.40 |0/45.20 1/45.60 1/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 9.0% 0.0% 4.2% 4.4% |0.0% 2.2% 2.2% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/32 (0%) 2/35 (6%) 2/34 (6%) |0/35 (0%) 1/36 (3%) 1/36 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 450 --- 726 (T) 726 (T) |--- 732 (T) 732 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.365N P=0.058N P=0.280N P=0.298N |P=0.590N P=0.506 P=0.506 (e) |
|POLY 3 | P=0.404N P=0.057N P=0.310N P=0.329N |P=0.600N P=0.502 P=0.500 (e) |
|POLY 1.5 | P=0.404N P=0.059N P=0.322N P=0.334N |P=0.599N P=0.501 P=0.499 (e) |
|POLY 6 | P=0.403N P=0.054N P=0.293N P=0.319N |P=0.598N P=0.503 P=0.502 (e) |
|LOGISTIC REGRESSION| P=0.421N P=0.080N P=0.508N P=0.359N |(e) P=0.506 P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.404N P=0.059N P=0.339N P=0.339N |P=0.595N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |14/50 (28%) 8/50 (16%) 8/50 (16%) 10/50 (20%) |
|POLY-3 RATE (b) | |14/45.92 8/46.10 8/45.48 10/44.89 |
|POLY-3 PERCENT (g) | |30.5% 17.4% 17.6% 22.3% |
|TERMINAL (d) | |12/35 (34%) 6/36 (17%) 7/36 (19%) 7/36 (19%) |
|FIRST INCIDENCE | |508 612 649 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.267N P=0.108N P=0.102N P=0.233N |
|POLY 3 | |P=0.292N P=0.107N P=0.114N P=0.258N |
|POLY 1.5 | |P=0.289N P=0.111N P=0.116N P=0.257N |
|POLY 6 | |P=0.285N P=0.100N P=0.107N P=0.246N |
|LOGISTIC REGRESSION| |P=0.294N P=0.109N P=0.111N P=0.258N |
|COCH-ARM / FISHERS | |P=0.275N P=0.114N P=0.114N P=0.241N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 39/50 (78%) 32/50 (64%) 29/50 (58%) |14/50 (28%) 22/50 (44%) 14/50 (28%) 15/50 (30%) |
|POLY-3 RATE (b) | 33/48.54 39/49.03 32/48.86 29/47.51 |14/48.56 22/48.95 14/47.07 15/47.23 |
|POLY-3 PERCENT (g) | 68.0% 79.5% 65.5% 61.0% |28.8% 45.0% 29.7% 31.8% |
|TERMINAL (d) | 16/30 (53%) 26/32 (81%) 21/35 (60%) 18/34 (53%) |5/35 (14%) 13/36 (36%) 8/36 (22%) 7/36 (19%) |
|FIRST INCIDENCE | 450 478 600 596 |508 400 504 386 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060N P=0.390 P=0.210N P=0.162N |P=0.399N P=0.122 P=0.556N P=0.506 |
|POLY 3 | P=0.121N P=0.139 P=0.482N P=0.308N |P=0.438N P=0.073 P=0.550 P=0.464 |
|POLY 1.5 | P=0.113N P=0.136 P=0.487N P=0.295N |P=0.419N P=0.073 P=0.562 P=0.478 |
|POLY 6 | P=0.128N P=0.140 P=0.482N P=0.318N |P=0.454N P=0.074 P=0.542 P=0.452 |
|LOGISTIC REGRESSION| P=0.095N P=0.116 P=0.561N P=0.266N |P=0.305N P=0.043 * P=0.569N P=0.591N |
|COCH-ARM / FISHERS | P=0.098N P=0.133 P=0.500N P=0.268N |P=0.389N P=0.072 P=0.588N P=0.500 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 4/50 (8%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.91 4/46.05 4/47.53 2/45.57 |0/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 4.6% 8.7% 8.4% 4.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 3/32 (9%) 2/35 (6%) 1/34 (3%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 610 674 709 684 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.439N P=0.379 P=0.433 P=0.650N |(e) (e) (e) (e) |
|POLY 3 | P=0.479N P=0.359 P=0.375 P=0.681N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.489N P=0.349 P=0.359 P=0.687N |(e) (e) (e) (e) |
|POLY 6 | P=0.462N P=0.375 P=0.397 P=0.670N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.491N P=0.338 P=0.331 P=0.688 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.339 P=0.339 P=0.691N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 4/50 (8%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.91 4/46.05 4/47.53 2/45.57 |0/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 4.6% 8.7% 8.4% 4.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 3/32 (9%) 2/35 (6%) 1/34 (3%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 610 674 709 684 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.439N P=0.379 P=0.433 P=0.650N |(e) (e) (e) (e) |
|POLY 3 | P=0.479N P=0.359 P=0.375 P=0.681N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.489N P=0.349 P=0.359 P=0.687N |(e) (e) (e) (e) |
|POLY 6 | P=0.462N P=0.375 P=0.397 P=0.670N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.491N P=0.338 P=0.331 P=0.688 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.339 P=0.339 P=0.691N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 48/50 (96%) 48/50 (96%) |37/50 (74%) 39/50 (78%) 37/50 (74%) 38/50 (76%) |
|POLY-3 RATE (b) | 50/50.00 50/50.00 48/49.98 48/49.00 |37/46.97 39/48.01 37/47.68 38/46.98 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 96.0% 98.0% |78.8% 81.2% 77.6% 80.9% |
|TERMINAL (d) | 30/30 (100%) 32/32 (100%) 34/35 (97%) 34/34 (100%)|30/35 (86%) 30/36 (83%) 28/36 (78%) 28/36 (78%) |
|FIRST INCIDENCE | 450 478 573 520 |508 582 445 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.092N (e) P=0.068N P=0.131N |P=0.525N P=0.488 P=0.509N P=0.548 |
|POLY 3 | P=0.226N (e) P=0.239N P=0.495N |P=0.490 P=0.482 P=0.546N P=0.501 |
|POLY 1.5 | P=0.161N (e) P=0.238N P=0.371N |P=0.475 P=0.436 P=0.578N P=0.475 |
|POLY 6 | P=0.299N (e) P=0.241N P=0.647N |P=0.538N P=0.576 P=0.464N P=0.597 |
|LOGISTIC REGRESSION| P=0.089N (e) P=0.292N P=0.229N |P=0.392 P=0.432 P=0.571 P=0.389 |
|COCH-ARM / FISHERS | P=0.086N (e) P=0.247N P=0.247N |P=0.511 P=0.408 P=0.590N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 41/50 (82%) 37/50 (74%) 33/50 (66%) |15/50 (30%) 26/50 (52%) 22/50 (44%) 17/50 (34%) |
|POLY-3 RATE (b) | 35/48.93 41/49.10 37/49.42 33/48.98 |15/48.95 26/49.41 22/49.81 17/47.37 |
|POLY-3 PERCENT (g) | 71.5% 83.5% 74.9% 67.4% |30.6% 52.6% 44.2% 35.9% |
|TERMINAL (d) | 17/30 (57%) 27/32 (84%) 24/35 (69%) 20/34 (59%) |5/35 (14%) 15/36 (42%) 10/36 (28%) 8/36 (22%) |
|FIRST INCIDENCE | 450 478 600 397 |508 400 445 386 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.118N P=0.403 P=0.337N P=0.242N |P=0.467N P=0.057 P=0.166 P=0.431 |
|POLY 3 | P=0.198N P=0.115 P=0.442 P=0.410N |P=0.524N P=0.020 * P=0.118 P=0.371 |
|POLY 1.5 | P=0.201N P=0.118 P=0.431 P=0.410N |P=0.500N P=0.020 * P=0.113 P=0.388 |
|POLY 6 | P=0.199N P=0.111 P=0.452 P=0.415N |P=0.530 P=0.021 * P=0.125 P=0.355 |
|LOGISTIC REGRESSION| P=0.227N P=0.105 P=0.318 P=0.475N |P=0.383N P=0.008 ** P=0.048 * P=0.496 |
|COCH-ARM / FISHERS | P=0.209N P=0.121 P=0.412 P=0.415N |P=0.461N P=0.021 * P=0.107 P=0.415 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 49/50 (98%) 50/50 (100%)|47/50 (94%) 47/50 (94%) 46/50 (92%) 43/50 (86%) |
|POLY-3 RATE (b) | 50/50.00 50/50.00 49/50.00 50/50.00 |47/50.00 47/50.00 46/50.00 43/49.36 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 98.0% 100.0% |94.0% 94.0% 92.0% 87.1% |
|TERMINAL (d) | 30/30 (100%) 32/32 (100%) 34/35 (97%) 34/34 (100%)|32/35 (91%) 33/36 (92%) 32/36 (89%) 30/36 (83%) |
|FIRST INCIDENCE | 450 478 573 397 |508 400 445 386 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.180N (e) P=0.093N (e) |P=0.230N P=0.493N P=0.432N P=0.276N |
|POLY 3 | P=0.694N (e) P=0.500N (e) |P=0.113N P=0.662 P=0.500N P=0.201N |
|POLY 1.5 | P=0.694N (e) P=0.500N (e) |P=0.099N P=0.662 P=0.500N P=0.183N |
|POLY 6 | P=0.694N (e) P=0.500N (e) |P=0.129N P=0.662 P=0.500N P=0.221N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.072N (e) (e) P=0.151N |
|COCH-ARM / FISHERS | P=0.694N (e) P=0.500N (e) |P=0.079N P=0.661N P=0.500N P=0.159N |
|=================================================================================================================================|
(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).