TDMS Study 56348-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus CITRAL DATE: 07/06/01
EXPERIMENT: 56348 TEST: 04 TIME: 08:03:53
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: C56348
PATHOLOGIST: DR. M. RYAN CAS: 5392-40-5
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 UNTREAT CONTROL
INCLUDE 002 UNTREAT CONTROL
INCLUDE 005 500 PPM
INCLUDE 006 500 PPM
INCLUDE 007 1000 PPM
INCLUDE 008 1000 PPM
INCLUDE 009 2000 PPM
INCLUDE 010 2000 PPM
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus CITRAL DATE: 07/06/01
EXPERIMENT: 56348 TEST: 04 TIME: 08:03:53
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: C56348
PATHOLOGIST: DR. M. RYAN CAS: 5392-40-5
Mice(B6C3F1)
-----------------------------
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
Bone Marrow
Brain
Clitoral/Preputial Gland
Heart
Liver
Lung
Ovary
Pancreas
Pituitary Gland
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus CITRAL DATE: 07/06/01
EXPERIMENT: 56348 TEST: 04 TIME: 08:03:53
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: C56348
PATHOLOGIST: DR. M. RYAN CAS: 5392-40-5
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF CITRAL
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
All Organs Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Lung Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type
===============================================================
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/48.80 0/45.14 2/47.99 1/45.81 |0/43.96 0/47.89 0/47.49 0/45.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.2% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/48 (0%) 0/40 (0%) 2/42 (5%) 1/40 (3%) |0/40 (0%) 0/45 (0%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 727 (T) 727 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.219 (e) P=0.210 P=0.464 |(e) (e) (e) (e) |
|POLY 3 | P=0.231 (e) P=0.234 P=0.487 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.238 (e) P=0.236 P=0.493 |(e) (e) (e) (e) |
|POLY 6 | P=0.221 (e) P=0.230 P=0.480 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.210 P=0.464 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.246 (e) P=0.247 P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/48.80 1/45.14 2/47.99 0/45.81 |1/43.96 1/47.89 2/47.49 1/45.29 |
|POLY-3 PERCENT (g) | 4.1% 2.2% 4.2% 0.0% |2.3% 2.1% 4.2% 2.2% |
|TERMINAL (d) | 2/48 (4%) 1/40 (3%) 2/42 (5%) 0/40 (0%) |1/40 (3%) 1/45 (2%) 2/43 (5%) 1/40 (3%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) --- |733 (T) 733 (T) 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236N P=0.564N P=0.646 P=0.280N |P=0.582 P=0.735N P=0.525 P=0.762 |
|POLY 3 | P=0.209N P=0.527N P=0.687 P=0.252N |P=0.592 P=0.741N P=0.527 P=0.754N |
|POLY 1.5 | P=0.205N P=0.516N P=0.690 P=0.246N |P=0.597 P=0.744N P=0.524 P=0.752N |
|POLY 6 | P=0.215N P=0.539N P=0.682 P=0.260N |P=0.584 P=0.740N P=0.527 P=0.758N |
|LOGISTIC REGRESSION| P=0.236N P=0.564N P=0.646 (e) |P=0.582 P=0.735N P=0.525 P=0.762 |
|COCH-ARM / FISHERS | P=0.200N P=0.500N P=0.691N P=0.247N |P=0.591 P=0.753N P=0.500 P=0.753N |
|=================================================================================================================================|
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/48.80 1/45.14 3/47.99 0/45.81 |2/43.96 1/47.89 3/47.49 1/45.29 |
|POLY-3 PERCENT (g) | 4.1% 2.2% 6.3% 0.0% |4.6% 2.1% 6.3% 2.2% |
|TERMINAL (d) | 2/48 (4%) 1/40 (3%) 3/42 (7%) 0/40 (0%) |2/40 (5%) 1/45 (2%) 3/43 (7%) 1/40 (3%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) --- |733 (T) 733 (T) 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.286N P=0.564N P=0.439 P=0.280N |P=0.487N P=0.459N P=0.533 P=0.500N |
|POLY 3 | P=0.255N P=0.527N P=0.492 P=0.252N |P=0.477N P=0.470N P=0.535 P=0.490N |
|POLY 1.5 | P=0.249N P=0.516N P=0.496 P=0.246N |P=0.471N P=0.475N P=0.531 P=0.487N |
|POLY 6 | P=0.264N P=0.539N P=0.486 P=0.260N |P=0.485N P=0.468N P=0.535 P=0.495N |
|LOGISTIC REGRESSION| P=0.286N P=0.564N P=0.439 (e) |P=0.487N P=0.459N P=0.533 P=0.500N |
|COCH-ARM / FISHERS | P=0.242N P=0.500N P=0.500 P=0.247N |P=0.474N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/48.80 0/45.14 0/47.99 0/45.81 |0/43.96 0/47.89 1/47.49 0/45.29 |
|POLY-3 PERCENT (g) | 4.1% 0.0% 0.0% 0.0% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 2/48 (4%) 0/40 (0%) 0/42 (0%) 0/40 (0%) |0/40 (0%) 0/45 (0%) 1/43 (2%) 0/40 (0%) |
|FIRST INCIDENCE | 727 (T) --- --- --- |--- --- 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.132N P=0.280N P=0.268N P=0.280N |P=0.694 (e) P=0.514 (e) |
|POLY 3 | P=0.107N P=0.255N P=0.241N P=0.252N |P=0.694 (e) P=0.515 (e) |
|POLY 1.5 | P=0.109N P=0.248N P=0.239N P=0.246N |P=0.699 (e) P=0.514 (e) |
|POLY 6 | P=0.104N P=0.264N P=0.245N P=0.260N |P=0.686 (e) P=0.515 (e) |
|LOGISTIC REGRESSION| P=0.132N (e) (e) (e) |(e) (e) P=0.514 (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.695 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 11/50 (22%) 11/50 (22%) 13/50 (26%) |5/50 (10%) 2/50 (4%) 8/50 (16%) 8/50 (16%) |
|POLY-3 RATE (b) | 10/48.80 11/46.67 11/48.78 13/46.16 |5/43.96 2/47.89 8/47.49 8/45.57 |
|POLY-3 PERCENT (g) | 20.5% 23.6% 22.6% 28.2% |11.4% 4.2% 16.9% 17.6% |
|TERMINAL (d) | 10/48 (21%) 8/40 (20%) 10/42 (24%) 11/40 (28%) |5/40 (13%) 2/45 (4%) 8/43 (19%) 7/40 (18%) |
|FIRST INCIDENCE | 727 (T) 419 427 681 |733 (T) 733 (T) 733 (T) 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170 P=0.338 P=0.373 P=0.170 |P=0.080 P=0.172N P=0.323 P=0.276 |
|POLY 3 | P=0.235 P=0.454 P=0.500 P=0.264 |P=0.092 P=0.183N P=0.328 P=0.299 |
|POLY 1.5 | P=0.252 P=0.474 P=0.503 P=0.286 |P=0.096 P=0.188N P=0.322 P=0.302 |
|POLY 6 | P=0.214 P=0.429 P=0.488 P=0.238 |P=0.087 P=0.181N P=0.327 P=0.291 |
|LOGISTIC REGRESSION| P=0.275 P=0.530 P=0.506 P=0.222 |P=0.085 P=0.172N P=0.323 P=0.284 |
|COCH-ARM / FISHERS | P=0.274 P=0.500 P=0.500 P=0.318 |P=0.095 P=0.218N P=0.277 P=0.277 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 13/50 (26%) 5/50 (10%) 9/50 (18%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/48.80 13/47.34 5/48.20 9/47.04 |1/43.96 1/47.89 1/47.89 1/45.29 |
|POLY-3 PERCENT (g) | 8.2% 27.5% 10.4% 19.1% |2.3% 2.1% 2.1% 2.2% |
|TERMINAL (d) | 4/48 (8%) 7/40 (18%) 3/42 (7%) 5/40 (13%) |1/40 (3%) 1/45 (2%) 0/43 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 727 (T) 418 689 626 |733 (T) 733 (T) 618 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.238 P=0.009 ** P=0.428 P=0.076 |P=0.629 P=0.735N P=0.740N P=0.762 |
|POLY 3 | P=0.278 P=0.012 * P=0.492 P=0.102 |P=0.630N P=0.741N P=0.741N P=0.754N |
|POLY 1.5 | P=0.290 P=0.013 * P=0.496 P=0.108 |P=0.628N P=0.744N P=0.744N P=0.752N |
|POLY 6 | P=0.264 P=0.011 * P=0.486 P=0.096 |P=0.629 P=0.740N P=0.740N P=0.758N |
|LOGISTIC REGRESSION| P=0.338 P=0.025 * P=0.493 P=0.130 |P=0.634N P=0.735N P=0.754 P=0.762 |
|COCH-ARM / FISHERS | P=0.310 P=0.016 * P=0.500 P=0.117 |P=0.634 P=0.753N P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 22/50 (44%) 15/50 (30%) 21/50 (42%) |6/50 (12%) 3/50 (6%) 9/50 (18%) 9/50 (18%) |
|POLY-3 RATE (b) | 13/48.80 22/48.81 15/49.00 21/47.39 |6/43.96 3/47.89 9/47.89 9/45.57 |
|POLY-3 PERCENT (g) | 26.6% 45.1% 30.6% 44.3% |13.7% 6.3% 18.8% 19.8% |
|TERMINAL (d) | 13/48 (27%) 14/40 (35%) 12/42 (29%) 15/40 (38%) |6/40 (15%) 3/45 (7%) 8/43 (19%) 8/40 (20%) |
|FIRST INCIDENCE | 727 (T) 418 427 626 |733 (T) 733 (T) 618 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.077 P=0.019 * P=0.277 P=0.025 * |P=0.095 P=0.187N P=0.344 P=0.287 |
|POLY 3 | P=0.114 P=0.044 * P=0.417 P=0.053 |P=0.108 P=0.202N P=0.352 P=0.313 |
|POLY 1.5 | P=0.123 P=0.045 * P=0.419 P=0.058 |P=0.113 P=0.208N P=0.342 P=0.316 |
|POLY 6 | P=0.105 P=0.043 * P=0.408 P=0.049 * |P=0.102 P=0.199N P=0.355 P=0.304 |
|LOGISTIC REGRESSION| P=0.161 P=0.076 P=0.416 P=0.055 |P=0.106 P=0.187N P=0.342 P=0.294 |
|COCH-ARM / FISHERS | P=0.141 P=0.046 * P=0.412 P=0.069 |P=0.111 P=0.243N P=0.288 P=0.288 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 22/50 (44%) 15/50 (30%) 21/50 (42%) |6/50 (12%) 3/50 (6%) 9/50 (18%) 9/50 (18%) |
|POLY-3 RATE (b) | 13/48.80 22/48.81 15/49.00 21/47.39 |6/43.96 3/47.89 9/47.89 9/45.57 |
|POLY-3 PERCENT (g) | 26.6% 45.1% 30.6% 44.3% |13.7% 6.3% 18.8% 19.8% |
|TERMINAL (d) | 13/48 (27%) 14/40 (35%) 12/42 (29%) 15/40 (38%) |6/40 (15%) 3/45 (7%) 8/43 (19%) 8/40 (20%) |
|FIRST INCIDENCE | 727 (T) 418 427 626 |733 (T) 733 (T) 618 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.077 P=0.019 * P=0.277 P=0.025 * |P=0.095 P=0.187N P=0.344 P=0.287 |
|POLY 3 | P=0.114 P=0.044 * P=0.417 P=0.053 |P=0.108 P=0.202N P=0.352 P=0.313 |
|POLY 1.5 | P=0.123 P=0.045 * P=0.419 P=0.058 |P=0.113 P=0.208N P=0.342 P=0.316 |
|POLY 6 | P=0.105 P=0.043 * P=0.408 P=0.049 * |P=0.102 P=0.199N P=0.355 P=0.304 |
|LOGISTIC REGRESSION| P=0.161 P=0.076 P=0.416 P=0.055 |P=0.106 P=0.187N P=0.342 P=0.294 |
|COCH-ARM / FISHERS | P=0.141 P=0.046 * P=0.412 P=0.069 |P=0.111 P=0.243N P=0.288 P=0.288 |
|=================================================================================================================================|
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 6/50 (12%) 2/50 (4%) |3/50 (6%) 7/50 (14%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/48.80 5/45.14 6/48.16 2/45.81 |3/43.96 7/47.89 3/47.49 1/45.57 |
|POLY-3 PERCENT (g) | 8.2% 11.1% 12.5% 4.4% |6.8% 14.6% 6.3% 2.2% |
|TERMINAL (d) | 4/48 (8%) 5/40 (13%) 5/42 (12%) 2/40 (5%) |3/40 (8%) 7/45 (16%) 3/43 (7%) 0/40 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 682 727 (T) |733 (T) 733 (T) 733 (T) 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.339N P=0.387 P=0.297 P=0.424N |P=0.116N P=0.209 P=0.629N P=0.307N |
|POLY 3 | P=0.290N P=0.451 P=0.362 P=0.367N |P=0.098N P=0.195 P=0.626N P=0.292N |
|POLY 1.5 | P=0.276N P=0.471 P=0.366 P=0.354N |P=0.097N P=0.189 P=0.630N P=0.291N |
|POLY 6 | P=0.309N P=0.429 P=0.354 P=0.384N |P=0.101N P=0.198 P=0.626N P=0.296N |
|LOGISTIC REGRESSION| P=0.308N P=0.387 P=0.357 P=0.424N |P=0.109N P=0.209 P=0.629N P=0.295N |
|COCH-ARM / FISHERS | P=0.260N P=0.500 P=0.370 P=0.339N |P=0.112N P=0.159 P=0.661N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 1/50 (2%) 3/50 (6%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/48.80 4/45.14 1/47.99 3/45.81 |3/43.96 1/47.89 0/47.49 0/45.29 |
|POLY-3 PERCENT (g) | 8.2% 8.9% 2.1% 6.6% |6.8% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 4/48 (8%) 4/40 (10%) 1/42 (2%) 3/40 (8%) |3/40 (8%) 1/45 (2%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 727 (T) |733 (T) 733 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.417N P=0.540 P=0.222N P=0.599N |P=0.043N* P=0.264N P=0.109N P=0.121N |
|POLY 3 | P=0.358N P=0.599 P=0.184N P=0.534N |P=0.044N* P=0.276N P=0.106N P=0.113N |
|POLY 1.5 | P=0.352N P=0.617 P=0.182N P=0.520N |P=0.044N* P=0.280N P=0.107N P=0.112N |
|POLY 6 | P=0.368N P=0.579 P=0.189N P=0.554N |P=0.045N* P=0.273N P=0.106N P=0.116N |
|LOGISTIC REGRESSION| P=0.417N P=0.540 P=0.222N P=0.599N |P=0.043N* P=0.264N (e) (e) |
|COCH-ARM / FISHERS | P=0.344N P=0.643N P=0.181N P=0.500N |P=0.044N* P=0.309N P=0.121N P=0.121N |
|=================================================================================================================================|
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 9/50 (18%) 7/50 (14%) 4/50 (8%) |6/50 (12%) 8/50 (16%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 8/48.80 9/45.14 7/48.16 4/45.81 |6/43.96 8/47.89 3/47.49 1/45.57 |
|POLY-3 PERCENT (g) | 16.4% 19.9% 14.5% 8.7% |13.7% 16.7% 6.3% 2.2% |
|TERMINAL (d) | 8/48 (17%) 9/40 (23%) 6/42 (14%) 4/40 (10%) |6/40 (15%) 8/45 (18%) 3/43 (7%) 0/40 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 682 727 (T) |733 (T) 733 (T) 733 (T) 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.174N P=0.338 P=0.604N P=0.277N |P=0.019N* P=0.480 P=0.207N P=0.060N |
|POLY 3 | P=0.127N P=0.430 P=0.511N P=0.210N |P=0.015N* P=0.454 P=0.206N P=0.050N |
|POLY 1.5 | P=0.118N P=0.458 P=0.505N P=0.196N |P=0.015N* P=0.444 P=0.210N P=0.050N |
|POLY 6 | P=0.140N P=0.398 P=0.521N P=0.229N |P=0.016N* P=0.459 P=0.205N P=0.051N |
|LOGISTIC REGRESSION| P=0.152N P=0.338 P=0.524N P=0.277N |P=0.017N* P=0.480 P=0.207N P=0.054N |
|COCH-ARM / FISHERS | P=0.107N P=0.500 P=0.500N P=0.178N |P=0.018N* P=0.387 P=0.243N P=0.056N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/47 (0%) 0/50 (0%) |4/49 (8%) 5/50 (10%) 2/49 (4%) 3/49 (6%) |
|POLY-3 RATE (b) | 0/48.80 0/44.95 0/45.31 0/45.81 |4/42.96 5/47.89 2/46.49 3/44.92 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |9.3% 10.4% 4.3% 6.7% |
|TERMINAL (d) | 0/48 (0%) 0/40 (0%) 0/41 (0%) 0/40 (0%) |4/39 (10%) 5/45 (11%) 2/42 (5%) 3/40 (8%) |
|FIRST INCIDENCE | --- --- --- --- |733 (T) 733 (T) 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.325N P=0.589 P=0.303N P=0.486N |
|POLY 3 | (e) (e) (e) (e) |P=0.309N P=0.567 P=0.302N P=0.476N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.308N P=0.559 P=0.306N P=0.475N |
|POLY 6 | (e) (e) (e) (e) |P=0.314N P=0.572 P=0.302N P=0.481N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.325N P=0.589 P=0.303N P=0.486N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.323N P=0.513 P=0.339N P=0.500N |
|=================================================================================================================================|
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/48.80 1/45.83 1/47.99 0/45.81 |0/43.96 2/47.89 2/47.49 2/45.95 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 2.1% 0.0% |0.0% 4.2% 4.2% 4.4% |
|TERMINAL (d) | 0/48 (0%) 0/40 (0%) 1/42 (2%) 0/40 (0%) |0/40 (0%) 2/45 (4%) 2/43 (5%) 0/40 (0%) |
|FIRST INCIDENCE | --- 491 727 (T) --- |--- 733 (T) 733 (T) 557 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.610N P=0.496 P=0.473 (e) |P=0.234 P=0.265 P=0.254 P=0.244 |
|POLY 3 | P=0.612N P=0.487 P=0.497 (e) |P=0.258 P=0.257 P=0.255 P=0.247 |
|POLY 1.5 | P=0.604N P=0.493 P=0.498 (e) |P=0.259 P=0.254 P=0.253 P=0.247 |
|POLY 6 | P=0.621N P=0.481 P=0.494 (e) |P=0.254 P=0.258 P=0.255 P=0.245 |
|LOGISTIC REGRESSION| P=0.581N P=0.631 P=0.473 (e) |P=0.240 P=0.265 P=0.254 P=0.207 |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.242 P=0.247 P=0.247 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/48.80 1/45.83 1/47.99 0/45.81 |0/43.96 2/47.89 2/47.49 2/45.95 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 2.1% 0.0% |0.0% 4.2% 4.2% 4.4% |
|TERMINAL (d) | 0/48 (0%) 0/40 (0%) 1/42 (2%) 0/40 (0%) |0/40 (0%) 2/45 (4%) 2/43 (5%) 0/40 (0%) |
|FIRST INCIDENCE | --- 491 727 (T) --- |--- 733 (T) 733 (T) 557 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.610N P=0.496 P=0.473 (e) |P=0.234 P=0.265 P=0.254 P=0.244 |
|POLY 3 | P=0.612N P=0.487 P=0.497 (e) |P=0.258 P=0.257 P=0.255 P=0.247 |
|POLY 1.5 | P=0.604N P=0.493 P=0.498 (e) |P=0.259 P=0.254 P=0.253 P=0.247 |
|POLY 6 | P=0.621N P=0.481 P=0.494 (e) |P=0.254 P=0.258 P=0.255 P=0.245 |
|LOGISTIC REGRESSION| P=0.581N P=0.631 P=0.473 (e) |P=0.240 P=0.265 P=0.254 P=0.207 |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.242 P=0.247 P=0.247 P=0.247 |
|=================================================================================================================================|
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/48.80 1/45.83 0/47.99 0/45.81 |0/43.96 2/47.89 1/47.49 2/45.95 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |0.0% 4.2% 2.1% 4.4% |
|TERMINAL (d) | 0/48 (0%) 0/40 (0%) 0/42 (0%) 0/40 (0%) |0/40 (0%) 2/45 (4%) 1/43 (2%) 0/40 (0%) |
|FIRST INCIDENCE | --- 491 --- --- |--- 733 (T) 733 (T) 557 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.570N P=0.496 (e) (e) |P=0.238 P=0.265 P=0.514 P=0.244 |
|POLY 3 | P=0.577N P=0.487 (e) (e) |P=0.261 P=0.257 P=0.515 P=0.247 |
|POLY 1.5 | P=0.573N P=0.493 (e) (e) |P=0.262 P=0.254 P=0.514 P=0.247 |
|POLY 6 | P=0.582N P=0.481 (e) (e) |P=0.258 P=0.258 P=0.515 P=0.245 |
|LOGISTIC REGRESSION| P=0.591N P=0.631 (e) (e) |P=0.240 P=0.265 P=0.514 P=0.207 |
|COCH-ARM / FISHERS | P=0.568N P=0.500 (e) (e) |P=0.246 P=0.247 P=0.500 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/48.80 0/44.79 3/47.99 2/45.81 |0/43.96 0/47.89 0/46.81 0/45.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.3% 4.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/48 (0%) 0/40 (0%) 3/42 (7%) 2/40 (5%) |0/40 (0%) 0/45 (0%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 727 (T) 727 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.078 (e) P=0.099 P=0.199 |(e) (e) (e) (e) |
|POLY 3 | P=0.087 (e) P=0.116 P=0.224 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.092 (e) P=0.118 P=0.229 |(e) (e) (e) (e) |
|POLY 6 | P=0.081 (e) P=0.113 P=0.216 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.099 P=0.199 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.098 (e) P=0.121 P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/48.80 0/45.14 1/47.99 0/45.81 |1/43.96 0/47.89 1/47.55 2/45.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 0.0% |2.3% 0.0% 2.1% 4.4% |
|TERMINAL (d) | 0/48 (0%) 0/40 (0%) 1/42 (2%) 0/40 (0%) |1/40 (3%) 0/45 (0%) 0/43 (0%) 2/40 (5%) |
|FIRST INCIDENCE | --- --- 727 (T) --- |733 (T) --- 717 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.675 (e) P=0.473 (e) |P=0.235 P=0.477N P=0.744N P=0.500 |
|POLY 3 | P=0.675 (e) P=0.497 (e) |P=0.243 P=0.483N P=0.743N P=0.510 |
|POLY 1.5 | P=0.684 (e) P=0.498 (e) |P=0.247 P=0.486N P=0.745N P=0.513 |
|POLY 6 | P=0.663 (e) P=0.494 (e) |P=0.239 P=0.482N P=0.743N P=0.505 |
|LOGISTIC REGRESSION| (e) (e) P=0.473 (e) |P=0.240 (e) P=0.746N P=0.500 |
|COCH-ARM / FISHERS | P=0.695 (e) P=0.500 (e) |P=0.247 P=0.500N P=0.753N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/48.80 0/45.14 1/47.99 0/45.81 |1/43.96 0/47.89 0/47.49 2/45.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 0.0% |2.3% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/48 (0%) 0/40 (0%) 1/42 (2%) 0/40 (0%) |1/40 (3%) 0/45 (0%) 0/43 (0%) 2/40 (5%) |
|FIRST INCIDENCE | --- --- 727 (T) --- |733 (T) --- --- 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.675 (e) P=0.473 (e) |P=0.235 P=0.477N P=0.486N P=0.500 |
|POLY 3 | P=0.675 (e) P=0.497 (e) |P=0.240 P=0.483N P=0.485N P=0.510 |
|POLY 1.5 | P=0.684 (e) P=0.498 (e) |P=0.242 P=0.486N P=0.486N P=0.513 |
|POLY 6 | P=0.663 (e) P=0.494 (e) |P=0.238 P=0.482N P=0.485N P=0.505 |
|LOGISTIC REGRESSION| (e) (e) P=0.473 (e) |P=0.235 (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.695 (e) P=0.500 (e) |P=0.245 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/48.80 0/45.14 1/47.99 0/45.81 |1/43.96 0/47.89 0/47.49 0/45.29 |
|POLY-3 PERCENT (g) | 4.1% 0.0% 2.1% 0.0% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/48 (4%) 0/40 (0%) 1/42 (2%) 0/40 (0%) |1/40 (3%) 0/45 (0%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 727 (T) --- 727 (T) --- |733 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.215N P=0.280N P=0.547N P=0.280N |P=0.307N P=0.477N P=0.486N P=0.500N |
|POLY 3 | P=0.185N P=0.255N P=0.506N P=0.252N |P=0.314N P=0.483N P=0.485N P=0.494N |
|POLY 1.5 | P=0.186N P=0.248N P=0.503N P=0.246N |P=0.314N P=0.486N P=0.486N P=0.493N |
|POLY 6 | P=0.185N P=0.264N P=0.511N P=0.260N |P=0.313N P=0.482N P=0.485N P=0.497N |
|LOGISTIC REGRESSION| P=0.215N (e) P=0.547N (e) |P=0.307N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.188N P=0.247N P=0.500N P=0.247N |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/48.80 0/45.14 3/47.99 3/45.81 |0/43.96 0/47.89 1/47.49 0/45.29 |
|POLY-3 PERCENT (g) | 4.1% 0.0% 6.3% 6.6% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 2/48 (4%) 0/40 (0%) 3/42 (7%) 3/40 (8%) |0/40 (0%) 0/45 (0%) 1/43 (2%) 0/40 (0%) |
|FIRST INCIDENCE | 727 (T) --- 727 (T) 727 (T) |--- --- 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.188 P=0.280N P=0.439 P=0.417 |P=0.694 (e) P=0.514 (e) |
|POLY 3 | P=0.224 P=0.255N P=0.492 P=0.471 |P=0.694 (e) P=0.515 (e) |
|POLY 1.5 | P=0.228 P=0.248N P=0.496 P=0.484 |P=0.699 (e) P=0.514 (e) |
|POLY 6 | P=0.216 P=0.264N P=0.486 P=0.455 |P=0.686 (e) P=0.515 (e) |
|LOGISTIC REGRESSION| P=0.188 (e) P=0.439 P=0.417 |(e) (e) P=0.514 (e) |
|COCH-ARM / FISHERS | P=0.232 P=0.247N P=0.500 P=0.500 |P=0.695 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 4/50 (8%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/48.80 0/45.14 4/47.99 3/45.81 |1/43.96 0/47.89 1/47.49 0/45.29 |
|POLY-3 PERCENT (g) | 8.2% 0.0% 8.3% 6.6% |2.3% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 4/48 (8%) 0/40 (0%) 4/42 (10%) 3/40 (8%) |1/40 (3%) 0/45 (0%) 1/43 (2%) 0/40 (0%) |
|FIRST INCIDENCE | 727 (T) --- 727 (T) 727 (T) |733 (T) --- 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.448 P=0.089N P=0.568 P=0.599N |P=0.410N P=0.477N P=0.746N P=0.500N |
|POLY 3 | P=0.511 P=0.071N P=0.633 P=0.534N |P=0.412N P=0.483N P=0.743N P=0.494N |
|POLY 1.5 | P=0.517 P=0.067N P=0.638 P=0.520N |P=0.410N P=0.486N P=0.745N P=0.493N |
|POLY 6 | P=0.501 P=0.077N P=0.625 P=0.554N |P=0.416N P=0.482N P=0.743N P=0.497N |
|LOGISTIC REGRESSION| P=0.448 (e) P=0.568 P=0.599N |P=0.410N (e) P=0.746N (e) |
|COCH-ARM / FISHERS | P=0.521 P=0.059N P=0.643N P=0.500N |P=0.405N P=0.500N P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |4/50 (8%) 5/50 (10%) 9/50 (18%) 12/50 (24%) |
|POLY-3 RATE (b) | 4/50.00 2/45.64 3/48.02 1/46.48 |4/43.96 5/47.89 9/48.32 12/46.62 |
|POLY-3 PERCENT (g) | 8.0% 4.4% 6.3% 2.2% |9.1% 10.4% 18.6% 25.7% |
|TERMINAL (d) | 2/48 (4%) 1/40 (3%) 2/42 (5%) 0/40 (0%) |4/40 (10%) 5/45 (11%) 7/43 (16%) 10/40 (25%) |
|FIRST INCIDENCE | 397 576 720 500 |733 (T) 733 (T) 469 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.196N P=0.396N P=0.550N P=0.213N |P=0.008 ** P=0.574 P=0.151 P=0.030 * |
|POLY 3 | P=0.174N P=0.381N P=0.522N P=0.202N |P=0.011 * P=0.553 P=0.156 P=0.034 * |
|POLY 1.5 | P=0.169N P=0.364N P=0.513N P=0.193N |P=0.011 * P=0.545 P=0.149 P=0.034 * |
|POLY 6 | P=0.182N P=0.398N P=0.534N P=0.215N |P=0.010 * P=0.557 P=0.158 P=0.033 * |
|LOGISTIC REGRESSION| P=0.130N P=0.181N P=0.486N P=0.056N |P=0.010 * P=0.574 P=0.132 P=0.031 * |
|COCH-ARM / FISHERS | P=0.162N P=0.339N P=0.500N P=0.181N |P=0.010 * P=0.500 P=0.117 P=0.027 * |
|=================================================================================================================================|
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 18/50 (36%) 21/50 (42%) 14/50 (28%) |16/50 (32%) 19/50 (38%) 13/50 (26%) 14/50 (28%) |
|POLY-3 RATE (b) | 20/48.80 18/46.67 21/48.96 14/46.16 |16/43.96 19/47.89 13/47.49 14/45.57 |
|POLY-3 PERCENT (g) | 41.0% 38.6% 42.9% 30.3% |36.4% 39.7% 27.4% 30.7% |
|TERMINAL (d) | 20/48 (42%) 15/40 (38%) 19/42 (45%) 12/40 (30%) |16/40 (40%) 19/45 (42%) 13/43 (30%) 13/40 (33%) |
|FIRST INCIDENCE | 727 (T) 419 427 681 |733 (T) 733 (T) 733 (T) 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.303N P=0.477 P=0.299 P=0.341N |P=0.278N P=0.505 P=0.243N P=0.411N |
|POLY 3 | P=0.181N P=0.488N P=0.505 P=0.192N |P=0.225N P=0.457 P=0.242N P=0.365N |
|POLY 1.5 | P=0.164N P=0.458N P=0.508 P=0.171N |P=0.220N P=0.438 P=0.252N P=0.362N |
|POLY 6 | P=0.207N P=0.526N P=0.492 P=0.222N |P=0.237N P=0.467 P=0.241N P=0.378N |
|LOGISTIC REGRESSION| P=0.160N P=0.472N P=0.493 P=0.257N |P=0.276N P=0.505 P=0.243N P=0.408N |
|COCH-ARM / FISHERS | P=0.143N P=0.418N P=0.500 P=0.146N |P=0.251N P=0.338 P=0.330N P=0.414N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 20/50 (40%) 17/50 (34%) 18/50 (36%) |12/50 (24%) 13/50 (26%) 13/50 (26%) 18/50 (36%) |
|POLY-3 RATE (b) | 14/50.00 20/48.54 17/48.52 18/47.89 |12/44.55 13/48.30 13/48.78 18/47.42 |
|POLY-3 PERCENT (g) | 28.0% 41.2% 35.0% 37.6% |26.9% 26.9% 26.7% 38.0% |
|TERMINAL (d) | 12/48 (25%) 12/40 (30%) 13/42 (31%) 12/40 (30%) |11/40 (28%) 12/45 (27%) 9/43 (21%) 13/40 (33%) |
|FIRST INCIDENCE | 397 418 650 500 |545 615 469 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.213 P=0.074 P=0.220 P=0.140 |P=0.092 P=0.550N P=0.582 P=0.153 |
|POLY 3 | P=0.278 P=0.122 P=0.297 P=0.214 |P=0.125 P=0.591N P=0.579N P=0.183 |
|POLY 1.5 | P=0.299 P=0.129 P=0.311 P=0.231 |P=0.123 P=0.579 P=0.588 P=0.178 |
|POLY 6 | P=0.257 P=0.116 P=0.282 P=0.198 |P=0.123 P=0.585N P=0.573N P=0.182 |
|LOGISTIC REGRESSION| P=0.384 P=0.280 P=0.347 P=0.350 |P=0.104 P=0.582 P=0.542 P=0.153 |
|COCH-ARM / FISHERS | P=0.335 P=0.146 P=0.333 P=0.260 |P=0.101 P=0.500 P=0.500 P=0.138 |
|=================================================================================================================================|
Date: 07/06/01 EXPERIMENT: 56348 TEST: 04 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 500 PPM 1000 PPM 2000 PPM |UNTREAT 500 PPM 1000 PPM 2000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 35/50 (70%) 33/50 (66%) 26/50 (52%) |23/50 (46%) 27/50 (54%) 23/50 (46%) 30/50 (60%) |
|POLY-3 RATE (b) | 27/50.00 35/50.00 33/49.49 26/48.06 |23/44.55 27/48.30 23/48.78 30/47.70 |
|POLY-3 PERCENT (g) | 54.0% 70.0% 66.7% 54.1% |51.6% 55.9% 47.2% 62.9% |
|TERMINAL (d) | 25/48 (52%) 25/40 (63%) 27/42 (64%) 19/40 (48%) |22/40 (55%) 26/45 (58%) 19/43 (44%) 24/40 (60%) |
|FIRST INCIDENCE | 397 418 427 500 |545 615 469 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.481 P=0.020 * P=0.059 P=0.337 |P=0.105 P=0.493 P=0.446N P=0.127 |
|POLY 3 | P=0.390N P=0.074 P=0.138 P=0.576 |P=0.189 P=0.419 P=0.411N P=0.187 |
|POLY 1.5 | P=0.351N P=0.074 P=0.145 P=0.554N |P=0.182 P=0.397 P=0.437N P=0.176 |
|POLY 6 | P=0.427N P=0.074 P=0.128 P=0.550 |P=0.191 P=0.430 P=0.399N P=0.191 |
|LOGISTIC REGRESSION| P=0.239N (e) P=0.173 P=0.466N |P=0.146 P=0.434 P=0.455N P=0.146 |
|COCH-ARM / FISHERS | P=0.286N P=0.074 P=0.154 P=0.500N |P=0.130 P=0.274 P=0.579N P=0.115 |
|=================================================================================================================================|
(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).