TDMS Study 56348-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus CITRAL DATE: 07/05/01
EXPERIMENT: 56348 TEST: 03 TIME: 13:13:17
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 NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus CITRAL DATE: 07/05/01
EXPERIMENT: 56348 TEST: 03 TIME: 13:13:17
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
----- ----------
Adrenal Medulla Hyperplasia
Heart Cardiomyopathy
Intestine Large, Cecum Inflammation
Intestine Large, Colon Parasite Metazoan
Kidney Accumulation, Hyaline Droplet
Mineralization
Pigmentation
Liver Basophilic Focus
Lung Hemorrhage
Inflammation
Pancreas Atrophy
Prostate Inflammation Chronic
Stomach, Forestomach: Epithelium Hyperplasia
Testes: Interstitial Cell Hyperplasia
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Angiectasis
Hypertrophy
Bone Osteopetrosis
Brain Hemorrhage
Clitoral Gland Hyperplasia
Inflammation
Intestine Large, Rectum Parasite Metazoan
Kidney Necrosis
Nephropathy
Liver Fatty Change
Liver: Bile Duct Hyperplasia
Lymph Node, Mandibular Ectasia
Hyperplasia
Mammary Gland Hyperplasia
Pancreas Atrophy
Stomach, Forestomach: Epithelium Hyperplasia
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 3/50 (6%) 10/50 (20%) |
|POLY-3 RATE (b) | 0/43.44 1/45.85 0/47.40 1/45.40 |0/45.20 1/45.60 3/45.17 10/44.18 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 2.2% |0.0% 2.2% 6.6% 22.6% |
|TERMINAL (d) | 0/30 (0%) 1/32 (3%) 0/35 (0%) 1/34 (3%) |0/35 (0%) 1/36 (3%) 3/36 (8%) 10/36 (28%) |
|FIRST INCIDENCE | --- 726 (T) --- 726 (T) |--- 732 (T) 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.430 P=0.513 (e) P=0.525 |P<0.001 ** P=0.506 P=0.126 P<0.001 ** |
|POLY 3 | P=0.419 P=0.511 (e) P=0.509 |P<0.001 ** P=0.502 P=0.118 P<0.001 ** |
|POLY 1.5 | P=0.413 P=0.506 (e) P=0.505 |P<0.001 ** P=0.501 P=0.118 P<0.001 ** |
|POLY 6 | P=0.430 P=0.518 (e) P=0.516 |P<0.001 ** P=0.503 P=0.120 P<0.001 ** |
|LOGISTIC REGRESSION| (e) P=0.513 (e) P=0.525 |(e) P=0.506 P=0.126 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.405 P=0.500 (e) P=0.500 |P<0.001 ** P=0.500 P=0.121 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 20/50 (40%) 11/50 (22%) 14/50 (28%) |14/50 (28%) 13/50 (26%) 12/50 (24%) 8/50 (16%) |
|POLY-3 RATE (b) | 12/44.54 20/46.64 11/47.82 14/45.81 |14/45.75 13/45.86 12/45.34 8/44.18 |
|POLY-3 PERCENT (g) | 26.9% 42.9% 23.0% 30.6% |30.6% 28.4% 26.5% 18.1% |
|TERMINAL (d) | 8/30 (27%) 15/32 (47%) 8/35 (23%) 11/34 (32%) |12/35 (34%) 12/36 (33%) 11/36 (31%) 8/36 (22%) |
|FIRST INCIDENCE | 600 639 639 636 |627 662 690 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326N P=0.124 P=0.333N P=0.549 |P=0.070N P=0.463N P=0.374N P=0.097N |
|POLY 3 | P=0.430N P=0.081 P=0.422N P=0.441 |P=0.097N P=0.497N P=0.419N P=0.127N |
|POLY 1.5 | P=0.448N P=0.073 P=0.455N P=0.426 |P=0.094N P=0.500N P=0.419N P=0.123N |
|POLY 6 | P=0.403N P=0.095 P=0.380N P=0.467 |P=0.097N P=0.492N P=0.413N P=0.127N |
|LOGISTIC REGRESSION| P=0.398N P=0.100 P=0.413N P=0.484 |P=0.082N P=0.474N P=0.389N P=0.113N |
|COCH-ARM / FISHERS | P=0.468N P=0.066 P=0.500N P=0.410 |P=0.084N P=0.500N P=0.410N P=0.114N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |10/50 (20%) 3/50 (6%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 1/47.40 0/45.40 |10/45.57 3/45.92 3/45.17 4/44.35 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 0.0% |21.9% 6.5% 6.6% 9.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 1/35 (3%) 0/34 (0%) |9/35 (26%) 2/36 (6%) 3/36 (8%) 3/36 (8%) |
|FIRST INCIDENCE | --- --- 726 (T) --- |627 645 732 (T) 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.710 (e) P=0.531 (e) |P=0.071N P=0.033N* P=0.032N* P=0.068N |
|POLY 3 | P=0.702 (e) P=0.517 (e) |P=0.078N P=0.033N* P=0.035N* P=0.079N |
|POLY 1.5 | P=0.698 (e) P=0.510 (e) |P=0.077N P=0.034N* P=0.036N* P=0.078N |
|POLY 6 | P=0.711 (e) P=0.528 (e) |P=0.077N P=0.031N* P=0.034N* P=0.077N |
|LOGISTIC REGRESSION| (e) (e) P=0.531 (e) |P=0.080N P=0.035N* P=0.034N* P=0.078N |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.076N P=0.036N* P=0.036N* P=0.074N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.20 1/46.16 0/47.40 2/46.43 |0/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 6.8% 2.2% 0.0% 4.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 549 639 --- 544 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.426N P=0.273N P=0.093N P=0.472N |(e) (e) (e) (e) |
|POLY 3 | P=0.441N P=0.290N P=0.107N P=0.478N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.442N P=0.297N P=0.112N P=0.488N |(e) (e) (e) (e) |
|POLY 6 | P=0.441N P=0.279N P=0.100N P=0.461N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.459N P=0.351N P=0.185N P=0.531N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.444N P=0.309N P=0.121N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |1/50 (2%) 6/50 (12%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/44.01 1/45.91 2/47.63 3/45.47 |1/45.59 6/45.75 2/45.23 0/44.18 |
|POLY-3 PERCENT (g) | 9.1% 2.2% 4.2% 6.6% |2.2% 13.1% 4.4% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/32 (0%) 0/35 (0%) 2/34 (6%) |0/35 (0%) 5/36 (14%) 1/36 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 660 709 674 709 |622 694 719 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.483N P=0.144N P=0.251N P=0.426N |P=0.138N P=0.066 P=0.500 P=0.514N |
|POLY 3 | P=0.539N P=0.166N P=0.302N P=0.482N |P=0.142N P=0.056 P=0.497 P=0.506N |
|POLY 1.5 | P=0.541N P=0.172N P=0.317N P=0.491N |P=0.140N P=0.056 P=0.497 P=0.505N |
|POLY 6 | P=0.536N P=0.158N P=0.282N P=0.469N |P=0.141N P=0.057 P=0.499 P=0.506N |
|LOGISTIC REGRESSION| P=0.541N P=0.180N P=0.366N P=0.483N |P=0.141N P=0.059 P=0.504 P=0.440N |
|COCH-ARM / FISHERS | P=0.544N P=0.181N P=0.339N P=0.500N |P=0.136N P=0.056 P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 23/50 (46%) 14/50 (28%) 15/50 (30%) |8/49 (16%) 4/50 (8%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 12/43.97 23/47.17 14/47.58 15/46.31 |8/44.80 4/45.84 3/45.23 3/44.18 |
|POLY-3 PERCENT (g) | 27.3% 48.8% 29.4% 32.4% |17.9% 8.7% 6.6% 6.8% |
|TERMINAL (d) | 9/30 (30%) 13/32 (41%) 12/35 (34%) 11/34 (32%) |5/34 (15%) 2/36 (6%) 2/36 (6%) 3/36 (8%) |
|FIRST INCIDENCE | 674 639 688 520 |627 694 719 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.337N P=0.057 P=0.572N P=0.479 |P=0.076N P=0.169N P=0.095N P=0.094N |
|POLY 3 | P=0.426N P=0.026 * P=0.502 P=0.382 |P=0.079N P=0.165N P=0.095N P=0.102N |
|POLY 1.5 | P=0.459N P=0.021 * P=0.463 P=0.356 |P=0.077N P=0.167N P=0.095N P=0.100N |
|POLY 6 | P=0.383N P=0.038 * P=0.555 P=0.423 |P=0.079N P=0.162N P=0.093N P=0.102N |
|LOGISTIC REGRESSION| P=0.421N P=0.033 * P=0.551N P=0.401 |P=0.077N P=0.164N P=0.092N P=0.098N |
|COCH-ARM / FISHERS | P=0.500N P=0.018 * P=0.410 P=0.326 |P=0.074N P=0.168N P=0.094N P=0.094N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Blood Vessel |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 2/47.40 0/45.40 |0/45.20 0/45.60 0/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.2% 0.0% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 2/35 (6%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- 726 (T) --- |--- --- --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.620 (e) P=0.273 (e) |P=0.201 (e) (e) P=0.506 |
|POLY 3 | P=0.607 (e) P=0.257 (e) |P=0.195 (e) (e) P=0.495 |
|POLY 1.5 | P=0.601 (e) P=0.249 (e) |P=0.196 (e) (e) P=0.496 |
|POLY 6 | P=0.618 (e) P=0.270 (e) |P=0.196 (e) (e) P=0.497 |
|LOGISTIC REGRESSION| (e) (e) P=0.273 (e) |(e) (e) (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Bone |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |3/50 (6%) 12/50 (24%) 5/50 (10%) 8/50 (16%) |
|POLY-3 RATE (b) | 0/43.44 1/45.85 1/47.42 0/45.40 |3/45.20 12/45.70 5/45.32 8/44.91 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 2.1% 0.0% |6.6% 26.3% 11.0% 17.8% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |3/35 (9%) 11/36 (31%) 4/36 (11%) 7/36 (19%) |
|FIRST INCIDENCE | --- 725 722 --- |732 (T) 708 694 473 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.569N P=0.519 P=0.542 (e) |P=0.302 P=0.013 * P=0.374 P=0.107 |
|POLY 3 | P=0.581N P=0.511 P=0.517 (e) |P=0.281 P=0.011 * P=0.358 P=0.096 |
|POLY 1.5 | P=0.587N P=0.506 P=0.510 (e) |P=0.280 P=0.011 * P=0.355 P=0.096 |
|POLY 6 | P=0.570N P=0.518 P=0.528 (e) |P=0.290 P=0.011 * P=0.365 P=0.098 |
|LOGISTIC REGRESSION| P=0.569N P=0.528 P=0.545 (e) |P=0.272 P=0.012 * P=0.367 P=0.095 |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.291 P=0.011 * P=0.357 P=0.100 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Bone Marrow |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.44 3/45.89 1/47.40 2/45.41 |1/45.25 0/45.60 2/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 0.0% 6.5% 2.1% 4.4% |2.2% 0.0% 4.4% 2.3% |
|TERMINAL (d) | 0/30 (0%) 2/32 (6%) 1/35 (3%) 1/34 (3%) |0/35 (0%) 0/36 (0%) 2/36 (6%) 1/36 (3%) |
|FIRST INCIDENCE | --- 716 726 (T) 723 |719 --- 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.383 P=0.140 P=0.531 P=0.271 |P=0.503 P=0.516N P=0.504 P=0.758 |
|POLY 3 | P=0.360 P=0.129 P=0.517 P=0.247 |P=0.487 P=0.498N P=0.499 P=0.755 |
|POLY 1.5 | P=0.350 P=0.124 P=0.510 P=0.242 |P=0.490 P=0.499N P=0.499 P=0.756 |
|POLY 6 | P=0.378 P=0.136 P=0.528 P=0.255 |P=0.488 P=0.497N P=0.503 P=0.757 |
|LOGISTIC REGRESSION| P=0.381 P=0.147 P=0.531 P=0.274 |P=0.498 P=0.497N P=0.508 P=0.761 |
|COCH-ARM / FISHERS | P=0.337 P=0.121 P=0.500 P=0.247 |P=0.500 P=0.500N 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 |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 20/50 (40%) 14/50 (28%) 13/50 (26%) |11/50 (22%) 12/50 (24%) 10/50 (20%) 10/50 (20%) |
|POLY-3 RATE (b) | 14/44.96 20/46.68 14/47.99 13/46.16 |11/46.72 12/45.87 10/47.84 10/46.03 |
|POLY-3 PERCENT (g) | 31.1% 42.8% 29.2% 28.2% |23.5% 26.2% 20.9% 21.7% |
|TERMINAL (d) | 10/30 (33%) 16/32 (50%) 11/35 (31%) 11/34 (32%) |5/35 (14%) 10/36 (28%) 4/36 (11%) 5/36 (14%) |
|FIRST INCIDENCE | 610 639 624 544 |588 687 445 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.165N P=0.222 P=0.407N P=0.371N |P=0.404N P=0.511 P=0.496N P=0.507N |
|POLY 3 | P=0.241N P=0.170 P=0.508N P=0.467N |P=0.402N P=0.480 P=0.476N P=0.515N |
|POLY 1.5 | P=0.256N P=0.158 P=0.542N P=0.483N |P=0.405N P=0.487 P=0.486N P=0.514N |
|POLY 6 | P=0.219N P=0.192 P=0.462N P=0.443N |P=0.390N P=0.471 P=0.464N P=0.508N |
|LOGISTIC REGRESSION| P=0.236N P=0.191 P=0.528N P=0.466N |P=0.355N P=0.503 P=0.466N P=0.466N |
|COCH-ARM / FISHERS | P=0.275N P=0.146 P=0.588N P=0.500N |P=0.397N P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/44.18 1/45.85 1/47.42 0/45.40 |1/45.54 1/45.60 0/45.17 1/44.35 |
|POLY-3 PERCENT (g) | 4.5% 2.2% 2.1% 0.0% |2.2% 2.2% 0.0% 2.3% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 1/36 (3%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 589 725 722 --- |636 732 (T) --- 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140N P=0.475N P=0.455N P=0.232N |P=0.611N P=0.750N P=0.486N P=0.752N |
|POLY 3 | P=0.151N P=0.487N P=0.475N P=0.231N |P=0.618N P=0.760N P=0.502N P=0.755 |
|POLY 1.5 | P=0.152N P=0.493N P=0.486N P=0.234N |P=0.617N P=0.760 P=0.502N P=0.756 |
|POLY 6 | P=0.149N P=0.478N P=0.461N P=0.226N |P=0.617N P=0.760N P=0.501N P=0.756 |
|LOGISTIC REGRESSION| P=0.165N P=0.541N P=0.647N P=0.243N |P=0.605N P=0.762N P=0.467N P=0.742N |
|COCH-ARM / FISHERS | P=0.153N P=0.500N P=0.500N P=0.247N |P=0.616N P=0.753N P=0.500N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |3/50 (6%) 4/50 (8%) 4/50 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/44.17 1/46.06 2/47.94 2/46.08 |3/46.51 4/47.81 4/46.76 0/44.18 |
|POLY-3 PERCENT (g) | 11.3% 2.2% 4.2% 4.3% |6.5% 8.4% 8.6% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 674 671 600 628 |508 400 504 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.191N P=0.075N P=0.144N P=0.176N |P=0.107N P=0.513 P=0.507 P=0.129N |
|POLY 3 | P=0.216N P=0.092N P=0.184N P=0.199N |P=0.110N P=0.515 P=0.503 P=0.128N |
|POLY 1.5 | P=0.218N P=0.096N P=0.198N P=0.207N |P=0.105N P=0.509 P=0.500 P=0.125N |
|POLY 6 | P=0.212N P=0.086N P=0.168N P=0.187N |P=0.114N P=0.522 P=0.510 P=0.130N |
|LOGISTIC REGRESSION| P=0.241N P=0.109N P=0.291N P=0.231N |P=0.017N* P=0.473 P=0.627 P=0.047N* |
|COCH-ARM / FISHERS | P=0.221N P=0.102N P=0.218N P=0.218N |P=0.095N P=0.500 P=0.500 P=0.121N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Brain |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 1/47.42 1/45.43 |0/45.20 0/45.60 4/45.91 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 2.2% |0.0% 0.0% 8.7% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 723 720 |--- --- 649 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.260 (e) P=0.536 P=0.536 |P=0.503 (e) P=0.075 (e) |
|POLY 3 | P=0.243 (e) P=0.517 P=0.509 |P=0.479 (e) P=0.062 (e) |
|POLY 1.5 | P=0.240 (e) P=0.510 P=0.505 |P=0.484 (e) P=0.061 (e) |
|POLY 6 | P=0.249 (e) P=0.528 P=0.516 |P=0.479 (e) P=0.065 (e) |
|LOGISTIC REGRESSION| P=0.250 (e) P=0.547 P=0.526 |P=0.515 (e) P=0.065 (e) |
|COCH-ARM / FISHERS | P=0.235 (e) P=0.500 P=0.500 |P=0.500 (e) P=0.059 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |7/49 (14%) 8/49 (16%) 15/50 (30%) 4/49 (8%) |
|POLY-3 RATE (b) | |7/44.55 8/44.60 15/45.17 4/43.58 |
|POLY-3 PERCENT (g) | |15.7% 17.9% 33.2% 9.2% |
|TERMINAL (d) | |7/35 (20%) 8/35 (23%) 15/36 (42%) 3/35 (9%) |
|FIRST INCIDENCE | |732 (T) 732 (T) 732 (T) 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.274N P=0.500 P=0.044 * P=0.262N |
|POLY 3 | |P=0.300N P=0.501 P=0.044 * P=0.273N |
|POLY 1.5 | |P=0.297N P=0.499 P=0.045 * P=0.271N |
|POLY 6 | |P=0.292N P=0.504 P=0.044 * P=0.268N |
|LOGISTIC REGRESSION| |P=0.295N P=0.500 P=0.044 * P=0.277N |
|COCH-ARM / FISHERS | |P=0.281N P=0.500 P=0.050 P=0.262N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions 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 Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |13/49 (27%) 20/49 (41%) 19/50 (38%) 24/49 (49%) |
|POLY-3 RATE (b) | |13/45.53 20/45.87 19/47.38 24/45.91 |
|POLY-3 PERCENT (g) | |28.6% 43.6% 40.1% 52.3% |
|TERMINAL (d) | |9/35 (26%) 16/35 (46%) 13/36 (36%) 16/35 (46%) |
|FIRST INCIDENCE | |595 582 445 473 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.033 * P=0.112 P=0.178 P=0.028 * |
|POLY 3 | |P=0.022 * P=0.098 P=0.169 P=0.015 * |
|POLY 1.5 | |P=0.022 * P=0.097 P=0.163 P=0.015 * |
|POLY 6 | |P=0.026 * P=0.100 P=0.181 P=0.018 * |
|LOGISTIC REGRESSION| |P=0.023 * P=0.099 P=0.159 P=0.017 * |
|COCH-ARM / FISHERS | |P=0.024 * P=0.100 P=0.157 P=0.018 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |5/49 (10%) 3/49 (6%) 6/50 (12%) 4/49 (8%) |
|POLY-3 RATE (b) | |5/44.60 3/44.60 6/45.84 4/43.28 |
|POLY-3 PERCENT (g) | |11.2% 6.7% 13.1% 9.2% |
|TERMINAL (d) | |4/35 (11%) 3/35 (9%) 5/36 (14%) 3/35 (9%) |
|FIRST INCIDENCE | |719 732 (T) 510 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.537N P=0.362N P=0.512 P=0.505N |
|POLY 3 | |P=0.552N P=0.356N P=0.519 P=0.519N |
|POLY 1.5 | |P=0.547N P=0.357N P=0.515 P=0.514N |
|POLY 6 | |P=0.551N P=0.355N P=0.527 P=0.518N |
|LOGISTIC REGRESSION| |P=0.553N P=0.362N P=0.511 P=0.516N |
|COCH-ARM / FISHERS | |P=0.532N P=0.357N P=0.514 P=0.500N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Epididymis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 RATE (b) | 1/43.44 3/46.09 1/47.43 2/45.74 | |
|POLY-3 PERCENT (g) | 2.3% 6.5% 2.1% 4.4% | |
|TERMINAL (d) | 1/30 (3%) 2/32 (6%) 0/35 (0%) 0/34 (0%) | |
|FIRST INCIDENCE | 726 (T) 660 720 655 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.572 P=0.337 P=0.714N P=0.549 | |
|POLY 3 | P=0.551 P=0.327 P=0.741N P=0.518 | |
|POLY 1.5 | P=0.539 P=0.317 P=0.749N P=0.509 | |
|POLY 6 | P=0.569 P=0.342 P=0.728N P=0.532 | |
|LOGISTIC REGRESSION| P=0.531 P=0.330 P=0.710N P=0.504 | |
|COCH-ARM / FISHERS | P=0.526 P=0.309 P=0.753N P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 2/3 (67%) 1/2 (50%) 3/3 (100%) |2/2 (100%) 1/1 (100%) 0/0 (0%) 1/2 (50%) |
|POLY-3 RATE (b) | 1/1.00 2/3.00 1/1.98 3/3.00 |2/2.00 1/1.00 0/0.00 1/2.00 |
|POLY-3 PERCENT (g) | 100.0% 66.7% 50.6% 100.0% |100.0% 100.0% 0.0% 50.0% |
|TERMINAL (d) | 0/0 (0%) 2/3 (67%) 1/1 (100%) 2/2 (100%) |2/2 (100%) 0/0 (0%) 0/0 (0%) 1/2 (50%) |
|FIRST INCIDENCE | 505 726 (T) 726 (T) 723 |732 (T) 582 --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.419 P=0.482N P=0.454N (e) |P=0.240N (e) (e) P=0.500N |
|POLY 3 | P=0.458 P=0.691N P=0.619N (e) |(e) (e) (e) P=0.500N |
|POLY 1.5 | P=0.458 P=0.691N P=0.616N (e) |(e) (e) (e) P=0.500N |
|POLY 6 | P=0.458 P=0.691N P=0.625N (e) |(e) (e) (e) P=0.500N |
|LOGISTIC REGRESSION| P=0.332 P=0.482N P=0.454N (e) |P=0.240N (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.451 P=0.750N P=0.667N (e) |P=0.232N (e) (e) P=0.500N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 2/3 (67%) 1/2 (50%) 3/3 (100%) |2/2 (100%) 1/1 (100%) 0/0 (0%) 1/2 (50%) |
|POLY-3 RATE (b) | 1/1.00 2/3.00 1/1.98 3/3.00 |2/2.00 1/1.00 0/0.00 1/2.00 |
|POLY-3 PERCENT (g) | 100.0% 66.7% 50.6% 100.0% |100.0% 100.0% 0.0% 50.0% |
|TERMINAL (d) | 0/0 (0%) 2/3 (67%) 1/1 (100%) 2/2 (100%) |2/2 (100%) 0/0 (0%) 0/0 (0%) 1/2 (50%) |
|FIRST INCIDENCE | 505 726 (T) 726 (T) 723 |732 (T) 582 --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.419 P=0.482N P=0.454N (e) |P=0.240N (e) (e) P=0.500N |
|POLY 3 | P=0.458 P=0.691N P=0.619N (e) |(e) (e) (e) P=0.500N |
|POLY 1.5 | P=0.458 P=0.691N P=0.616N (e) |(e) (e) (e) P=0.500N |
|POLY 6 | P=0.458 P=0.691N P=0.625N (e) |(e) (e) (e) P=0.500N |
|LOGISTIC REGRESSION| P=0.332 P=0.482N P=0.454N (e) |P=0.240N (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.451 P=0.750N P=0.667N (e) |P=0.232N (e) (e) P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 45/50 (90%) 50/50 (100%) 47/50 (94%) |41/50 (82%) 40/50 (80%) 42/50 (84%) 39/50 (78%) |
|POLY-3 RATE (b) | 39/48.10 45/48.27 50/50.00 47/49.24 |41/47.38 40/47.33 42/47.02 39/46.18 |
|POLY-3 PERCENT (g) | 81.1% 93.2% 100.0% 95.5% |86.5% 84.5% 89.3% 84.5% |
|TERMINAL (d) | 26/30 (87%) 31/32 (97%) 35/35 (100%) 33/34 (97%) |32/35 (91%) 33/36 (92%) 35/36 (97%) 35/36 (97%) |
|FIRST INCIDENCE | 450 478 573 397 |508 594 445 473 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.358 P=0.393 P=0.296 P=0.354 |P=0.329N P=0.420N P=0.582N P=0.333N |
|POLY 3 | P=0.005 ** P=0.054 P<0.001 ** P=0.019 * |P=0.493N P=0.506N P=0.455 P=0.503N |
|POLY 1.5 | P=0.005 ** P=0.064 P<0.001 ** P=0.019 * |P=0.453N P=0.513N P=0.465 P=0.470N |
|POLY 6 | P=0.006 ** P=0.051 P<0.001 ** P=0.022 * |P=0.527N P=0.478N P=0.473 P=0.529N |
|LOGISTIC REGRESSION| P=0.008 ** P=0.124 P<0.001 ** P=0.025 * |P=0.551N P=0.436N P=0.457 P=0.540N |
|COCH-ARM / FISHERS | P=0.006 ** P=0.086 P<0.001 ** P=0.020 * |P=0.380N P=0.500N P=0.500 P=0.402N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions 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 |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.44 2/46.17 2/47.57 2/45.59 |0/45.20 1/46.07 0/45.17 1/44.35 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 4.2% 4.4% |0.0% 2.2% 0.0% 2.3% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 674 688 684 |--- 594 --- 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.279 P=0.279 P=0.292 P=0.278 |P=0.404 P=0.500 (e) P=0.515 |
|POLY 3 | P=0.261 P=0.251 P=0.258 P=0.248 |P=0.401 P=0.504 (e) P=0.496 |
|POLY 1.5 | P=0.252 P=0.245 P=0.249 P=0.243 |P=0.401 P=0.502 (e) P=0.497 |
|POLY 6 | P=0.276 P=0.261 P=0.271 P=0.257 |P=0.404 P=0.507 (e) P=0.498 |
|LOGISTIC REGRESSION| P=0.240 P=0.228 P=0.244 P=0.243 |P=0.452 P=0.552 (e) P=0.505 |
|COCH-ARM / FISHERS | P=0.242 P=0.247 P=0.247 P=0.247 |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 |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 0/46.40 2/45.98 |0/45.20 1/45.60 0/45.17 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.4% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/34 (0%) 1/34 (3%) |0/35 (0%) 1/36 (3%) 0/36 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- --- 544 |--- 732 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.050 (e) (e) P=0.253 |P=0.568N P=0.506 (e) (e) |
|POLY 3 | P=0.047 * (e) (e) P=0.250 |P=0.570N P=0.502 (e) (e) |
|POLY 1.5 | P=0.047 * (e) (e) P=0.244 |P=0.571N P=0.501 (e) (e) |
|POLY 6 | P=0.048 * (e) (e) P=0.260 |P=0.568N P=0.503 (e) (e) |
|LOGISTIC REGRESSION| P=0.053 (e) (e) P=0.225 |(e) P=0.506 (e) (e) |
|COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.247 |P=0.570N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 2/50 (4%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/43.69 4/46.07 2/47.40 0/45.40 |2/45.20 0/45.60 0/45.17 2/44.18 |
|POLY-3 PERCENT (g) | 9.2% 8.7% 4.2% 0.0% |4.4% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 3/30 (10%) 2/32 (6%) 2/35 (6%) 0/34 (0%) |2/35 (6%) 0/36 (0%) 0/36 (0%) 2/36 (6%) |
|FIRST INCIDENCE | 660 674 726 (T) --- |732 (T) --- --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.023N* P=0.590N P=0.269N P=0.051N |P=0.506 P=0.232N P=0.232N P=0.685N |
|POLY 3 | P=0.028N* P=0.614N P=0.300N P=0.055N |P=0.495 P=0.235N P=0.237N P=0.686 |
|POLY 1.5 | P=0.029N* P=0.627N P=0.316N P=0.058N |P=0.496 P=0.236N P=0.238N P=0.687 |
|POLY 6 | P=0.026N* P=0.594N P=0.280N P=0.051N |P=0.494 P=0.233N P=0.235N P=0.688 |
|LOGISTIC REGRESSION| P=0.025N* P=0.601N P=0.269N P=0.054N |P=0.506 (e) (e) P=0.685N |
|COCH-ARM / FISHERS | P=0.031N* P=0.643N P=0.339N P=0.059N |P=0.500 P=0.247N P=0.247N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) 8/50 (16%) 8/50 (16%) |7/50 (14%) 1/50 (2%) 6/50 (12%) 3/50 (6%) |
|POLY-3 RATE (b) | 7/43.69 7/45.97 8/47.43 8/46.60 |7/45.68 1/45.60 6/45.17 3/44.18 |
|POLY-3 PERCENT (g) | 16.0% 15.2% 16.9% 17.2% |15.3% 2.2% 13.3% 6.8% |
|TERMINAL (d) | 6/30 (20%) 6/32 (19%) 7/35 (20%) 3/34 (9%) |6/35 (17%) 1/36 (3%) 6/36 (17%) 3/36 (8%) |
|FIRST INCIDENCE | 660 695 720 520 |588 732 (T) 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523 P=0.551N P=0.588N P=0.595 |P=0.250N P=0.031N* P=0.482N P=0.151N |
|POLY 3 | P=0.470 P=0.574N P=0.569 P=0.554 |P=0.275N P=0.030N* P=0.509N P=0.171N |
|POLY 1.5 | P=0.448 P=0.592N P=0.539 P=0.529 |P=0.271N P=0.030N* P=0.507N P=0.168N |
|POLY 6 | P=0.505 P=0.547N P=0.608 P=0.593 |P=0.275N P=0.029N* P=0.505N P=0.170N |
|LOGISTIC REGRESSION| P=0.455 P=0.507N P=0.546N P=0.513 |P=0.268N P=0.032N* P=0.494N P=0.166N |
|COCH-ARM / FISHERS | P=0.420 P=0.613N P=0.500 P=0.500 |P=0.260N P=0.030N* P=0.500N P=0.159N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Intestine Small, Ileum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 1/44.85 1/47.40 2/45.40 |0/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 2.1% 4.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 1/31 (3%) 1/35 (3%) 2/34 (6%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 726 (T) 726 (T) 726 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.177 P=0.507 P=0.531 P=0.266 |(e) (e) (e) (e) |
|POLY 3 | P=0.164 P=0.506 P=0.517 P=0.247 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.160 P=0.502 P=0.510 P=0.242 |(e) (e) (e) (e) |
|POLY 6 | P=0.172 P=0.514 P=0.528 P=0.255 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.507 P=0.531 P=0.266 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.154 P=0.495 P=0.500 P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.44 2/45.85 1/47.40 1/45.72 |0/45.20 1/45.60 0/44.17 0/44.18 |
|POLY-3 PERCENT (g) | 2.3% 4.4% 2.1% 2.2% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 2/32 (6%) 1/35 (3%) 0/34 (0%) |0/35 (0%) 1/36 (3%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 726 (T) 639 |--- 732 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.496N P=0.523 P=0.727N P=0.741N |P=0.564N P=0.506 (e) (e) |
|POLY 3 | P=0.513N P=0.519 P=0.741N P=0.749N |P=0.567N P=0.502 (e) (e) |
|POLY 1.5 | P=0.521N P=0.510 P=0.749N P=0.755N |P=0.568N P=0.501 (e) (e) |
|POLY 6 | P=0.501N P=0.532 P=0.729N P=0.740N |P=0.565N P=0.503 (e) (e) |
|LOGISTIC REGRESSION| P=0.520N P=0.523 P=0.727N P=0.758 |(e) P=0.506 (e) (e) |
|COCH-ARM / FISHERS | P=0.530N P=0.500 P=0.753N P=0.753N |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Kidney |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 2/47.67 3/45.63 |0/45.20 0/45.60 1/45.23 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.2% 6.6% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 1/34 (3%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 674 684 |--- --- 719 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035 * (e) P=0.296 P=0.155 |P=0.690 (e) P=0.495 (e) |
|POLY 3 | P=0.029 * (e) P=0.259 P=0.128 |P=0.683 (e) P=0.500 (e) |
|POLY 1.5 | P=0.028 * (e) P=0.249 P=0.123 |P=0.686 (e) P=0.499 (e) |
|POLY 6 | P=0.031 * (e) P=0.272 P=0.135 |P=0.684 (e) P=0.502 (e) |
|LOGISTIC REGRESSION| P=0.028 * (e) P=0.213 P=0.128 |P=0.692 (e) P=0.501 (e) |
|COCH-ARM / FISHERS | P=0.028 * (e) P=0.247 P=0.121 |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 |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 4/47.45 0/45.40 |0/45.20 0/45.60 0/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 8.4% 0.0% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 2/35 (6%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- 720 --- |--- --- --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.541 (e) P=0.094 (e) |P=0.201 (e) (e) P=0.506 |
|POLY 3 | P=0.516 (e) P=0.072 (e) |P=0.195 (e) (e) P=0.495 |
|POLY 1.5 | P=0.507 (e) P=0.067 (e) |P=0.196 (e) (e) P=0.496 |
|POLY 6 | P=0.531 (e) P=0.080 (e) |P=0.196 (e) (e) P=0.497 |
|LOGISTIC REGRESSION| P=0.540 (e) P=0.095 (e) |(e) (e) (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.500 (e) P=0.059 (e) |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 0/47.40 0/45.40 |0/45.20 0/45.60 2/45.56 1/44.83 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.4% 2.2% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 638 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.240 (e) P=0.247 P=0.487 |
|POLY 3 | (e) (e) (e) (e) |P=0.241 (e) P=0.239 P=0.498 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.241 (e) P=0.237 P=0.498 |
|POLY 6 | (e) (e) (e) (e) |P=0.244 (e) P=0.243 P=0.501 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.308 (e) P=0.244 P=0.718 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.246 (e) P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 45/50 (90%) 48/50 (96%) 50/50 (100%)|41/50 (82%) 43/50 (86%) 38/50 (76%) 41/50 (82%) |
|POLY-3 RATE (b) | 45/48.64 45/49.73 48/50.00 50/50.00 |41/48.52 43/49.34 38/48.59 41/49.16 |
|POLY-3 PERCENT (g) | 92.5% 90.5% 96.0% 100.0% |84.5% 87.2% 78.2% 83.4% |
|TERMINAL (d) | 29/30 (97%) 29/32 (91%) 33/35 (94%) 34/34 (100%)|29/35 (83%) 32/36 (89%) 29/36 (81%) 31/36 (86%) |
|FIRST INCIDENCE | 450 478 573 397 |519 400 445 386 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.510 P=0.314N P=0.273N P=0.539N |P=0.424N P=0.499 P=0.299N P=0.533N |
|POLY 3 | P=0.026 * P=0.500N P=0.371 P=0.051 |P=0.398N P=0.465 P=0.292N P=0.553N |
|POLY 1.5 | P=0.018 * P=0.561N P=0.292 P=0.038 * |P=0.412N P=0.436 P=0.299N P=0.570N |
|POLY 6 | P=0.044 * P=0.412N P=0.510 P=0.089 |P=0.394N P=0.490 P=0.287N P=0.546N |
|LOGISTIC REGRESSION| P=0.015 * P=0.598N P=0.323 P=0.036 * |P=0.448N P=0.393 P=0.321N P=0.595 |
|COCH-ARM / FISHERS | P=0.013 * P=0.630N P=0.218 P=0.028 * |P=0.439N P=0.393 P=0.312N P=0.602N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Kidney |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 0/47.40 0/45.40 |0/45.20 0/45.60 0/45.17 2/45.21 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 386 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.048 * (e) (e) P=0.248 |
|POLY 3 | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.237 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.236 |
|POLY 6 | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.240 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.091 (e) (e) P=0.413 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |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 |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 49/50 (98%) 50/50 (100%)|41/50 (82%) 45/50 (90%) 48/50 (96%) 44/50 (88%) |
|POLY-3 RATE (b) | 49/49.43 50/50.00 49/49.56 50/50.00 |41/46.97 45/49.41 48/49.24 44/47.83 |
|POLY-3 PERCENT (g) | 99.1% 100.0% 98.9% 100.0% |87.3% 91.1% 97.5% 92.0% |
|TERMINAL (d) | 30/30 (100%) 32/32 (100%) 35/35 (100%) 34/34 (100%)|34/35 (97%) 33/36 (92%) 35/36 (97%) 33/36 (92%) |
|FIRST INCIDENCE | 450 478 573 397 |588 400 445 386 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.213N P=0.355N P=0.113N P=0.270N |P=0.376 P=0.344 P=0.147 P=0.397 |
|POLY 3 | P=0.643 P=0.903 P=0.887N P=0.903 |P=0.225 P=0.385 P=0.041 * P=0.323 |
|POLY 1.5 | P=0.510 P=0.697 P=0.817N P=0.697 |P=0.211 P=0.286 P=0.028 * P=0.286 |
|POLY 6 | P=0.915 P=1.000 P=0.990N P=1.000 |P=0.311 P=0.554 P=0.094 P=0.448 |
|LOGISTIC REGRESSION| P=0.385 P=0.557 P=0.479N P=0.479 |P=0.124 P=0.183 P=0.009 ** P=0.134 |
|COCH-ARM / FISHERS | P=0.405 P=0.500 P=0.753N P=0.500 |P=0.246 P=0.194 P=0.026 * P=0.288 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 6/50 (12%) |2/50 (4%) 4/50 (8%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/44.58 0/45.85 2/47.72 6/45.51 |2/45.55 4/45.85 0/45.17 1/44.28 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 4.2% 13.2% |4.4% 8.7% 0.0% 2.3% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 3/34 (9%) |0/35 (0%) 2/36 (6%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 450 --- 660 709 |650 687 --- 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.071 P=0.105N P=0.417N P=0.317 |P=0.202N P=0.346 P=0.237N P=0.506N |
|POLY 3 | P=0.051 P=0.114N P=0.469N P=0.252 |P=0.203N P=0.340 P=0.239N P=0.510N |
|POLY 1.5 | P=0.050 P=0.116N P=0.483N P=0.246 |P=0.202N P=0.338 P=0.239N P=0.508N |
|POLY 6 | P=0.051 P=0.109N P=0.449N P=0.263 |P=0.202N P=0.343 P=0.238N P=0.509N |
|LOGISTIC REGRESSION| P=0.049 * P=0.148N P=0.627 P=0.230 |P=0.201N P=0.337 P=0.232N P=0.495N |
|COCH-ARM / FISHERS | P=0.052 P=0.121N P=0.500N P=0.243 |P=0.199N P=0.339 P=0.247N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.44 2/46.16 1/47.47 2/45.40 |0/45.20 0/45.60 0/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 2.1% 4.4% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/30 (0%) 1/32 (3%) 0/35 (0%) 2/34 (6%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (3%) |
|FIRST INCIDENCE | --- 639 709 726 (T) |--- --- --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.275 P=0.259 P=0.561 P=0.266 |P=0.201 (e) (e) P=0.506 |
|POLY 3 | P=0.262 P=0.251 P=0.518 P=0.247 |P=0.195 (e) (e) P=0.495 |
|POLY 1.5 | P=0.255 P=0.245 P=0.510 P=0.242 |P=0.196 (e) (e) P=0.496 |
|POLY 6 | P=0.274 P=0.261 P=0.528 P=0.255 |P=0.196 (e) (e) P=0.497 |
|LOGISTIC REGRESSION| P=0.249 P=0.227 P=0.518 P=0.266 |(e) (e) (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.246 P=0.247 P=0.500 P=0.247 |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/50 (8%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.44 1/45.85 4/47.40 1/45.40 |0/45.20 1/45.92 1/45.84 1/44.18 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 8.4% 2.2% |0.0% 2.2% 2.2% 2.3% |
|TERMINAL (d) | 0/30 (0%) 1/32 (3%) 4/35 (11%) 1/34 (3%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (3%) |
|FIRST INCIDENCE | --- 726 (T) 726 (T) 726 (T) |--- 645 510 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.378 P=0.513 P=0.083 P=0.525 |P=0.380 P=0.519 P=0.492 P=0.506 |
|POLY 3 | P=0.355 P=0.511 P=0.072 P=0.509 |P=0.375 P=0.503 P=0.503 P=0.495 |
|POLY 1.5 | P=0.345 P=0.506 P=0.067 P=0.505 |P=0.377 P=0.501 P=0.501 P=0.496 |
|POLY 6 | P=0.371 P=0.518 P=0.080 P=0.516 |P=0.377 P=0.506 P=0.506 P=0.497 |
|LOGISTIC REGRESSION| (e) P=0.513 P=0.083 P=0.525 |P=0.454 P=0.516 P=0.722 P=0.506 |
|COCH-ARM / FISHERS | P=0.337 P=0.500 P=0.059 P=0.500 |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 |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 33/50 (66%) 33/50 (66%) 29/50 (58%) |42/50 (84%) 44/50 (88%) 45/50 (90%) 42/50 (84%) |
|POLY-3 RATE (b) | 33/45.74 33/46.87 33/48.06 29/45.90 |42/46.87 44/47.31 45/48.59 42/46.90 |
|POLY-3 PERCENT (g) | 72.2% 70.4% 68.7% 63.2% |89.6% 93.0% 92.6% 89.6% |
|TERMINAL (d) | 27/30 (90%) 28/32 (88%) 29/35 (83%) 26/34 (77%) |34/35 (97%) 36/36 (100%) 36/36 (100%) 36/36 (100%) |
|FIRST INCIDENCE | 505 505 624 674 |588 594 445 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.031N* P=0.370N P=0.168N P=0.058N |P=0.456N P=0.497 P=0.405 P=0.530N |
|POLY 3 | P=0.185N P=0.518N P=0.441N P=0.233N |P=0.506N P=0.398 P=0.430 P=0.645N |
|POLY 1.5 | P=0.202N P=0.549N P=0.504N P=0.253N |P=0.534N P=0.379 P=0.349 P=0.611 |
|POLY 6 | P=0.153N P=0.467N P=0.347N P=0.194N |P=0.415N P=0.464 P=0.577 P=0.593N |
|LOGISTIC REGRESSION| P=0.086N P=0.361N P=0.236N P=0.109N |P=0.359 P=0.512 P=0.190 P=0.426 |
|COCH-ARM / FISHERS | P=0.213N P=0.583N P=0.583N P=0.268N |P=0.514N P=0.387 P=0.277 P=0.607N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 11/50 (22%) 16/50 (32%) 9/50 (18%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 14/43.44 11/45.87 16/47.43 9/45.40 |0/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 32.2% 24.0% 33.7% 19.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 14/30 (47%) 10/32 (31%) 15/35 (43%) 9/34 (27%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 726 (T) 720 720 726 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.097N P=0.239N P=0.561N P=0.080N |(e) (e) (e) (e) |
|POLY 3 | P=0.171N P=0.262N P=0.528 P=0.135N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.186N P=0.290N P=0.478 P=0.152N |(e) (e) (e) (e) |
|POLY 6 | P=0.148N P=0.223N P=0.581N P=0.110N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.083N P=0.187N P=0.482N P=0.080N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.204N P=0.322N P=0.414 P=0.171N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 5/50 (10%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/43.76 1/46.06 1/47.40 5/45.47 |1/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 6.9% 2.2% 2.1% 11.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 0/32 (0%) 1/35 (3%) 4/34 (12%) |1/35 (3%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 639 671 726 (T) 709 |732 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.197 P=0.272N P=0.257N P=0.427 |P=0.303N P=0.494N P=0.494N P=0.494N |
|POLY 3 | P=0.164 P=0.287N P=0.277N P=0.377 |P=0.305N P=0.498N P=0.500N P=0.505N |
|POLY 1.5 | P=0.163 P=0.295N P=0.289N P=0.367 |P=0.305N P=0.499N P=0.501N P=0.504N |
|POLY 6 | P=0.166 P=0.275N P=0.261N P=0.394 |P=0.305N P=0.497N P=0.498N P=0.503N |
|LOGISTIC REGRESSION| P=0.170 P=0.309N P=0.285N P=0.401 |P=0.303N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.162 P=0.309N P=0.309N P=0.357 |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 3/50 (6%) 6/50 (12%) |8/50 (16%) 7/50 (14%) 3/50 (6%) 9/50 (18%) |
|POLY-3 RATE (b) | 6/43.44 5/45.99 3/47.40 6/45.54 |8/45.25 7/45.60 3/45.17 9/44.18 |
|POLY-3 PERCENT (g) | 13.8% 10.9% 6.3% 13.2% |17.7% 15.4% 6.6% 20.4% |
|TERMINAL (d) | 6/30 (20%) 4/32 (13%) 3/35 (9%) 4/34 (12%) |7/35 (20%) 7/36 (19%) 3/36 (8%) 9/36 (25%) |
|FIRST INCIDENCE | 726 (T) 688 726 (T) 695 |719 732 (T) 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.478N P=0.445N P=0.168N P=0.525N |P=0.474 P=0.482N P=0.093N P=0.522 |
|POLY 3 | P=0.543N P=0.460N P=0.201N P=0.588N |P=0.440 P=0.494N P=0.098N P=0.478 |
|POLY 1.5 | P=0.552N P=0.478N P=0.218N P=0.604N |P=0.444 P=0.498N P=0.100N P=0.482 |
|POLY 6 | P=0.529N P=0.432N P=0.177N P=0.560N |P=0.442 P=0.487N P=0.094N P=0.482 |
|LOGISTIC REGRESSION| P=0.479N P=0.394N P=0.168N P=0.509N |P=0.458 P=0.496N P=0.091N P=0.498 |
|COCH-ARM / FISHERS | P=0.563 P=0.500N P=0.243N P=0.620N |P=0.458 P=0.500N P=0.100N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/44.38 0/45.85 1/47.91 0/45.40 |0/45.20 0/45.60 1/45.22 4/45.37 |
|POLY-3 PERCENT (g) | 4.5% 0.0% 2.1% 0.0% |0.0% 0.0% 2.2% 8.8% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 505 --- 573 --- |--- --- 721 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.185N P=0.227N P=0.474N P=0.232N |P=0.006 ** (e) P=0.505 P=0.069 |
|POLY 3 | P=0.188N P=0.230N P=0.473N P=0.232N |P=0.005 ** (e) P=0.500 P=0.061 |
|POLY 1.5 | P=0.188N P=0.233N P=0.485N P=0.235N |P=0.005 ** (e) P=0.499 P=0.060 |
|POLY 6 | P=0.189N P=0.224N P=0.457N P=0.227N |P=0.005 ** (e) P=0.502 P=0.063 |
|LOGISTIC REGRESSION| P=0.180N P=0.281N P=0.639 P=0.225N |P=0.008 ** (e) P=0.502 P=0.085 |
|COCH-ARM / FISHERS | P=0.188N P=0.247N P=0.500N P=0.247N |P=0.006 ** (e) P=0.500 P=0.059 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) 4/50 (8%) 7/50 (14%) |10/50 (20%) 8/50 (16%) 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 6/43.64 7/46.32 4/47.92 7/45.71 |10/46.04 8/45.97 4/45.48 5/44.18 |
|POLY-3 PERCENT (g) | 13.8% 15.1% 8.4% 15.3% |21.7% 17.4% 8.8% 11.3% |
|TERMINAL (d) | 5/30 (17%) 3/32 (9%) 2/35 (6%) 4/34 (12%) |8/35 (23%) 6/36 (17%) 3/36 (8%) 5/36 (14%) |
|FIRST INCIDENCE | 674 671 624 655 |508 659 649 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523N P=0.579 P=0.274N P=0.597 |P=0.072N P=0.373N P=0.071N P=0.122N |
|POLY 3 | P=0.529 P=0.546 P=0.312N P=0.536 |P=0.084N P=0.398N P=0.075N P=0.147N |
|POLY 1.5 | P=0.516 P=0.525 P=0.337N P=0.518 |P=0.082N P=0.400N P=0.075N P=0.143N |
|POLY 6 | P=0.550 P=0.579 P=0.279N P=0.564 |P=0.084N P=0.392N P=0.072N P=0.148N |
|LOGISTIC REGRESSION| P=0.528 P=0.571 P=0.325N P=0.577 |P=0.081N P=0.393N P=0.075N P=0.139N |
|COCH-ARM / FISHERS | P=0.500 P=0.500 P=0.370N P=0.500 |P=0.076N P=0.398N P=0.074N P=0.131N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 28/50 (56%) 27/50 (54%) 28/50 (56%) |40/50 (80%) 44/50 (88%) 41/50 (82%) 43/50 (86%) |
|POLY-3 RATE (b) | 21/44.90 28/46.34 27/48.01 28/48.03 |40/46.48 44/47.28 41/48.05 43/47.13 |
|POLY-3 PERCENT (g) | 46.8% 60.4% 56.2% 58.3% |86.1% 93.1% 85.3% 91.2% |
|TERMINAL (d) | 18/30 (60%) 23/32 (72%) 24/35 (69%) 23/34 (68%) |33/35 (94%) 35/36 (97%) 34/36 (94%) 36/36 (100%) |
|FIRST INCIDENCE | 505 688 573 397 |588 612 445 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326 P=0.189 P=0.383 P=0.245 |P=0.425 P=0.324 P=0.592 P=0.380 |
|POLY 3 | P=0.238 P=0.129 P=0.236 P=0.178 |P=0.373 P=0.184 P=0.583N P=0.300 |
|POLY 1.5 | P=0.195 P=0.120 P=0.200 P=0.147 |P=0.338 P=0.182 P=0.590 P=0.274 |
|POLY 6 | P=0.304 P=0.152 P=0.297 P=0.229 |P=0.478 P=0.228 P=0.495N P=0.403 |
|LOGISTIC REGRESSION| P=0.190 P=0.226 P=0.337 P=0.130 |P=0.157 P=0.245 P=0.458 P=0.130 |
|COCH-ARM / FISHERS | P=0.146 P=0.115 P=0.158 P=0.115 |P=0.348 P=0.207 P=0.500 P=0.298 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 8/50 (16%) 5/50 (10%) 7/50 (14%) |16/50 (32%) 11/50 (22%) 16/50 (32%) 15/50 (30%) |
|POLY-3 RATE (b) | 5/43.44 8/45.85 5/47.43 7/45.40 |16/45.25 11/45.60 16/45.32 15/44.18 |
|POLY-3 PERCENT (g) | 11.5% 17.5% 10.5% 15.4% |35.4% 24.1% 35.3% 34.0% |
|TERMINAL (d) | 5/30 (17%) 8/32 (25%) 4/35 (11%) 7/34 (21%) |15/35 (43%) 11/36 (31%) 15/36 (42%) 15/36 (42%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 720 726 (T) |719 732 (T) 694 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.527 P=0.312 P=0.524N P=0.468 |P=0.507 P=0.152N P=0.551N P=0.463N |
|POLY 3 | P=0.462 P=0.311 P=0.574N P=0.410 |P=0.440 P=0.171N P=0.585N P=0.533N |
|POLY 1.5 | P=0.446 P=0.295 P=0.598N P=0.395 |P=0.450 P=0.178N P=0.583 P=0.526N |
|POLY 6 | P=0.486 P=0.335 P=0.540N P=0.435 |P=0.444 P=0.162N P=0.569N P=0.527N |
|LOGISTIC REGRESSION| P=0.542 P=0.312 P=0.475N P=0.468 |P=0.472 P=0.167N P=0.560N P=0.501N |
|COCH-ARM / FISHERS | P=0.428 P=0.277 P=0.630N P=0.380 |P=0.479 P=0.184N P=0.585N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.01 0/45.85 0/47.40 1/45.40 |0/45.20 2/46.07 0/45.17 1/44.88 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 2.2% |0.0% 4.3% 0.0% 2.2% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 1/34 (3%) |0/35 (0%) 1/36 (3%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 549 --- --- 726 (T) |--- 594 --- 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.606 P=0.504N P=0.492N P=0.749N |P=0.530 P=0.243 (e) P=0.488 |
|POLY 3 | P=0.595 P=0.492N P=0.485N P=0.754N |P=0.538 P=0.241 (e) P=0.499 |
|POLY 1.5 | P=0.594 P=0.496N P=0.492N P=0.757N |P=0.537 P=0.239 (e) P=0.498 |
|POLY 6 | P=0.595 P=0.486N P=0.476N P=0.748N |P=0.543 P=0.245 (e) P=0.501 |
|LOGISTIC REGRESSION| P=0.587 P=0.557N P=0.833N P=0.754 |P=0.643 P=0.243 (e) P=0.783 |
|COCH-ARM / FISHERS | P=0.595 P=0.500N P=0.500N P=0.753N |P=0.539 P=0.247 (e) P=0.500 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) 8/50 (16%) 3/50 (6%) |5/50 (10%) 7/50 (14%) 4/50 (8%) 6/50 (12%) |
|POLY-3 RATE (b) | 7/43.44 7/45.98 8/47.50 3/45.53 |5/45.63 7/46.01 4/45.40 6/44.18 |
|POLY-3 PERCENT (g) | 16.1% 15.2% 16.8% 6.6% |11.0% 15.2% 8.8% 13.6% |
|TERMINAL (d) | 7/30 (23%) 5/32 (16%) 6/35 (17%) 2/34 (6%) |3/35 (9%) 5/36 (14%) 3/36 (8%) 6/36 (17%) |
|FIRST INCIDENCE | 726 (T) 692 709 695 |622 645 673 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.084N P=0.553N P=0.581N P=0.109N |P=0.541 P=0.402 P=0.484N P=0.512 |
|POLY 3 | P=0.113N P=0.569N P=0.575 P=0.138N |P=0.505 P=0.385 P=0.503N P=0.477 |
|POLY 1.5 | P=0.122N P=0.589N P=0.542 P=0.148N |P=0.512 P=0.382 P=0.504N P=0.483 |
|POLY 6 | P=0.100N P=0.537N P=0.603N P=0.123N |P=0.504 P=0.391 P=0.498N P=0.477 |
|LOGISTIC REGRESSION| P=0.079N P=0.494N P=0.518N P=0.100N |P=0.514 P=0.383 P=0.501N P=0.488 |
|COCH-ARM / FISHERS | P=0.131N P=0.613N P=0.500 P=0.159N |P=0.531 P=0.380 P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 50/50 (100%) 45/50 (90%) 47/50 (94%) |25/50 (50%) 17/50 (34%) 13/50 (26%) 13/50 (26%) |
|POLY-3 RATE (b) | 48/50.00 50/50.00 45/49.31 47/48.85 |25/48.04 17/47.83 13/46.23 13/44.80 |
|POLY-3 PERCENT (g) | 96.0% 100.0% 91.3% 96.2% |52.0% 35.5% 28.1% 29.0% |
|TERMINAL (d) | 28/30 (93%) 32/32 (100%) 33/35 (94%) 33/34 (97%) |15/35 (43%) 10/36 (28%) 9/36 (25%) 9/36 (25%) |
|FIRST INCIDENCE | 450 478 573 520 |519 515 595 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.107N P=0.426N P=0.057N P=0.187N |P=0.017N* P=0.100N P=0.019N* P=0.020N* |
|POLY 3 | P=0.411N P=0.237 P=0.283N P=0.684 |P=0.016N* P=0.075N P=0.013N* P=0.018N* |
|POLY 1.5 | P=0.333N P=0.237 P=0.250N P=0.648N |P=0.013N* P=0.076N P=0.012N* P=0.015N* |
|POLY 6 | P=0.500N P=0.237 P=0.342N P=0.620 |P=0.018N* P=0.075N P=0.014N* P=0.022N* |
|LOGISTIC REGRESSION| P=0.207N (e) P=0.206N P=0.473N |P=0.011N* P=0.079N P=0.012N* P=0.013N* |
|COCH-ARM / FISHERS | P=0.221N P=0.247 P=0.218N P=0.500N |P=0.010N* P=0.078N P=0.011N* P=0.011N* |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 14/50 (28%) 15/50 (30%) 16/50 (32%) |5/50 (10%) 9/50 (18%) 7/50 (14%) 7/50 (14%) |
|POLY-3 RATE (b) | 22/48.34 14/49.00 15/48.94 16/47.84 |5/46.85 9/48.21 7/47.00 7/45.53 |
|POLY-3 PERCENT (g) | 45.5% 28.6% 30.7% 33.4% |10.7% 18.7% 14.9% 15.4% |
|TERMINAL (d) | 6/30 (20%) 1/32 (3%) 5/35 (14%) 6/34 (18%) |0/35 (0%) 3/36 (8%) 2/36 (6%) 2/36 (6%) |
|FIRST INCIDENCE | 450 478 624 544 |595 400 504 386 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.160N P=0.065N P=0.061N P=0.124N |P=0.445 P=0.229 P=0.407 P=0.391 |
|POLY 3 | P=0.214N P=0.062N P=0.095N P=0.157N |P=0.413 P=0.209 P=0.381 P=0.359 |
|POLY 1.5 | P=0.210N P=0.066N P=0.100N P=0.156N |P=0.424 P=0.204 P=0.379 P=0.366 |
|POLY 6 | P=0.216N P=0.058N P=0.091N P=0.157N |P=0.407 P=0.214 P=0.387 P=0.355 |
|LOGISTIC REGRESSION| P=0.291N P=0.178N P=0.322N P=0.211N |P=0.530N P=0.145 P=0.433 P=0.468 |
|COCH-ARM / FISHERS | P=0.202N P=0.072N P=0.107N P=0.151N |P=0.445 P=0.194 P=0.380 P=0.380 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/43.89 1/46.51 0/47.40 2/45.63 |2/46.33 1/46.25 1/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 13.7% 2.2% 0.0% 4.4% |4.3% 2.2% 2.2% 2.3% |
|TERMINAL (d) | 4/30 (13%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 1/36 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 660 505 --- 674 |508 515 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.077N P=0.050N P=0.011N* P=0.104N |P=0.421N P=0.505N P=0.506N P=0.514N |
|POLY 3 | P=0.090N P=0.047N* P=0.012N* P=0.120N |P=0.421N P=0.501N P=0.509N P=0.517N |
|POLY 1.5 | P=0.090N P=0.051N P=0.013N* P=0.127N |P=0.418N P=0.501N P=0.506N P=0.512N |
|POLY 6 | P=0.091N P=0.042N* P=0.010N* P=0.110N |P=0.423N P=0.500N P=0.509N P=0.519N |
|LOGISTIC REGRESSION| P=0.101N P=0.066N P=0.013N* P=0.121N |P=0.299N P=0.382N P=0.411N P=0.379N |
|COCH-ARM / FISHERS | P=0.093N P=0.056N P=0.013N* P=0.134N |P=0.409N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions 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 |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 6/50 (12%) 8/50 (16%) 5/50 (10%) |9/50 (18%) 17/50 (34%) 9/50 (18%) 9/50 (18%) |
|POLY-3 RATE (b) | 12/44.55 6/47.24 8/48.06 5/45.40 |9/45.29 17/45.79 9/46.03 9/44.88 |
|POLY-3 PERCENT (g) | 26.9% 12.7% 16.6% 11.0% |19.9% 37.1% 19.6% 20.1% |
|TERMINAL (d) | 8/30 (27%) 2/32 (6%) 4/35 (11%) 5/34 (15%) |7/35 (20%) 15/36 (42%) 6/36 (17%) 8/36 (22%) |
|FIRST INCIDENCE | 617 505 639 726 (T) |719 708 510 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.048N* P=0.076N P=0.135N P=0.033N* |P=0.272N P=0.064 P=0.581N P=0.586N |
|POLY 3 | P=0.066N P=0.071N P=0.170N P=0.046N* |P=0.285N P=0.053 P=0.589N P=0.595 |
|POLY 1.5 | P=0.067N P=0.081N P=0.193N P=0.049N* |P=0.288N P=0.052 P=0.597N P=0.594 |
|POLY 6 | P=0.065N P=0.059N P=0.143N P=0.041N* |P=0.273N P=0.054 P=0.572N P=0.604N |
|LOGISTIC REGRESSION| P=0.071N P=0.107N P=0.203N P=0.040N* |P=0.302N P=0.054 P=0.603N P=0.585 |
|COCH-ARM / FISHERS | P=0.069N P=0.096N P=0.227N P=0.054N |P=0.282N P=0.055 P=0.602N P=0.602N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 10/50 (20%) 10/50 (20%) 11/50 (22%) |9/50 (18%) 9/50 (18%) 10/50 (20%) 11/50 (22%) |
|POLY-3 RATE (b) | 7/43.64 10/46.43 10/47.40 11/45.72 |9/45.24 9/46.67 10/45.17 11/44.45 |
|POLY-3 PERCENT (g) | 16.0% 21.5% 21.1% 24.1% |19.9% 19.3% 22.1% 24.8% |
|TERMINAL (d) | 6/30 (20%) 6/32 (19%) 10/35 (29%) 10/34 (29%) |8/35 (23%) 7/36 (19%) 10/36 (28%) 9/36 (25%) |
|FIRST INCIDENCE | 674 674 726 (T) 639 |722 515 732 (T) 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.310 P=0.381 P=0.427 P=0.305 |P=0.341 P=0.580N P=0.526 P=0.427 |
|POLY 3 | P=0.242 P=0.346 P=0.364 P=0.247 |P=0.296 P=0.575N P=0.499 P=0.383 |
|POLY 1.5 | P=0.229 P=0.323 P=0.335 P=0.233 |P=0.303 P=0.588N P=0.496 P=0.385 |
|POLY 6 | P=0.263 P=0.383 P=0.405 P=0.273 |P=0.299 P=0.557N P=0.508 P=0.393 |
|LOGISTIC REGRESSION| P=0.277 P=0.378 P=0.498 P=0.301 |P=0.302 P=0.598N P=0.515 P=0.396 |
|COCH-ARM / FISHERS | P=0.214 P=0.298 P=0.298 P=0.218 |P=0.325 P=0.602N P=0.500 P=0.402 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 9/50 (18%) 1/50 (2%) |0/50 (0%) 3/50 (6%) 5/50 (10%) 7/50 (14%) |
|POLY-3 RATE (b) | 4/43.76 2/45.85 9/47.40 1/45.40 |0/45.20 3/45.60 5/45.17 7/44.33 |
|POLY-3 PERCENT (g) | 9.1% 4.4% 19.0% 2.2% |0.0% 6.6% 11.1% 15.8% |
|TERMINAL (d) | 3/30 (10%) 2/32 (6%) 9/35 (26%) 1/34 (3%) |0/35 (0%) 3/36 (8%) 5/36 (14%) 6/36 (17%) |
|FIRST INCIDENCE | 639 726 (T) 726 (T) 726 (T) |--- 732 (T) 732 (T) 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236N P=0.304N P=0.180 P=0.150N |P=0.006 ** P=0.126 P=0.035 * P=0.011 * |
|POLY 3 | P=0.280N P=0.316N P=0.148 P=0.167N |P=0.005 ** P=0.120 P=0.030 * P=0.007 ** |
|POLY 1.5 | P=0.288N P=0.326N P=0.134 P=0.173N |P=0.005 ** P=0.119 P=0.030 * P=0.007 ** |
|POLY 6 | P=0.267N P=0.301N P=0.169 P=0.158N |P=0.005 ** P=0.121 P=0.031 * P=0.007 ** |
|LOGISTIC REGRESSION| P=0.240N P=0.298N P=0.201 P=0.161N |P=0.006 ** P=0.126 P=0.035 * P=0.009 ** |
|COCH-ARM / FISHERS | P=0.299N P=0.339N P=0.117 P=0.181N |P=0.006 ** P=0.121 P=0.028 * P=0.006 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 13/50 (26%) 18/50 (36%) 20/50 (40%) |6/50 (12%) 17/50 (34%) 7/50 (14%) 17/50 (34%) |
|POLY-3 RATE (b) | 17/45.76 13/47.19 18/48.57 20/46.43 |6/45.55 17/46.09 7/46.07 17/44.77 |
|POLY-3 PERCENT (g) | 37.2% 27.6% 37.1% 43.1% |13.2% 36.9% 15.2% 38.0% |
|TERMINAL (d) | 10/30 (33%) 9/32 (28%) 13/35 (37%) 14/34 (41%) |5/35 (14%) 15/36 (42%) 4/36 (11%) 13/36 (36%) |
|FIRST INCIDENCE | 505 505 573 639 |635 645 445 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.316 P=0.195N P=0.444N P=0.513 |P=0.045 * P=0.011 * P=0.516 P=0.012 * |
|POLY 3 | P=0.184 P=0.220N P=0.581N P=0.356 |P=0.028 * P=0.007 ** P=0.509 P=0.005 ** |
|POLY 1.5 | P=0.181 P=0.236N P=0.550 P=0.345 |P=0.029 * P=0.007 ** P=0.504 P=0.006 ** |
|POLY 6 | P=0.196 P=0.198N P=0.532N P=0.382 |P=0.030 * P=0.007 ** P=0.519 P=0.006 ** |
|LOGISTIC REGRESSION| P=0.186 P=0.274N P=0.465 P=0.369 |P=0.031 * P=0.009 ** P=0.501 P=0.007 ** |
|COCH-ARM / FISHERS | P=0.182 P=0.257N P=0.500 P=0.339 |P=0.038 * P=0.008 ** P=0.500 P=0.008 ** |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 5/50 (10%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/43.44 0/45.85 5/47.44 1/45.40 |0/45.20 1/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 6.9% 0.0% 10.5% 2.2% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 3/30 (10%) 0/32 (0%) 3/35 (9%) 1/34 (3%) |0/35 (0%) 1/36 (3%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 726 (T) --- 720 726 (T) |--- 732 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.375N P=0.109N P=0.454 P=0.261N |P=0.564N P=0.506 (e) (e) |
|POLY 3 | P=0.423N P=0.109N P=0.406 P=0.289N |P=0.567N P=0.502 (e) (e) |
|POLY 1.5 | P=0.427N P=0.114N P=0.385 P=0.297N |P=0.567N P=0.501 (e) (e) |
|POLY 6 | P=0.416N P=0.103N P=0.436 P=0.277N |P=0.565N P=0.503 (e) (e) |
|LOGISTIC REGRESSION| P=0.365N (e) P=0.496 P=0.261N |(e) P=0.506 (e) (e) |
|COCH-ARM / FISHERS | P=0.432N P=0.121N P=0.357 P=0.309N |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |3/50 (6%) 2/50 (4%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 0/46.40 0/45.40 |3/45.87 2/45.60 3/45.40 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.5% 4.4% 6.6% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/34 (0%) 0/34 (0%) |1/35 (3%) 2/36 (6%) 2/36 (6%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |627 732 (T) 673 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.110N P=0.484N P=0.642N P=0.124N |
|POLY 3 | (e) (e) (e) (e) |P=0.120N P=0.503N P=0.658 P=0.125N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.117N P=0.502N P=0.658 P=0.124N |
|POLY 6 | (e) (e) (e) (e) |P=0.120N P=0.504N P=0.660 P=0.126N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.111N P=0.500N P=0.658N P=0.103N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.111N P=0.500N P=0.661N P=0.121N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 9/49 (18%) 6/50 (12%) |0/50 (0%) 5/50 (10%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/43.64 5/46.19 9/47.14 6/45.54 |0/45.20 5/45.79 0/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 6.9% 10.8% 19.1% 13.2% |0.0% 10.9% 0.0% 2.3% |
|TERMINAL (d) | 2/30 (7%) 3/32 (9%) 3/34 (9%) 4/34 (12%) |0/35 (0%) 3/36 (8%) 0/36 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 674 671 573 695 |--- 708 --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.270 P=0.418 P=0.123 P=0.317 |P=0.443N P=0.038 * (e) P=0.506 |
|POLY 3 | P=0.213 P=0.388 P=0.078 P=0.263 |P=0.448N P=0.032 * (e) P=0.495 |
|POLY 1.5 | P=0.203 P=0.374 P=0.068 P=0.253 |P=0.448N P=0.031 * (e) P=0.496 |
|POLY 6 | P=0.230 P=0.410 P=0.095 P=0.280 |P=0.443N P=0.032 * (e) P=0.497 |
|LOGISTIC REGRESSION| P=0.210 P=0.392 P=0.063 P=0.293 |P=0.450N P=0.034 * (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.194 P=0.357 P=0.056 P=0.243 |P=0.444N P=0.028 * (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |4/50 (8%) 10/50 (20%) 6/50 (12%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 0/46.40 0/45.40 |4/45.25 10/45.83 6/45.40 3/44.28 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |8.8% 21.8% 13.2% 6.8% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/34 (0%) 0/34 (0%) |3/35 (9%) 8/36 (22%) 5/36 (14%) 2/36 (6%) |
|FIRST INCIDENCE | --- --- --- --- |719 694 673 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.210N P=0.083 P=0.388 P=0.495N |
|POLY 3 | (e) (e) (e) (e) |P=0.227N P=0.075 P=0.371 P=0.512N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.226N P=0.074 P=0.369 P=0.510N |
|POLY 6 | (e) (e) (e) (e) |P=0.222N P=0.077 P=0.380 P=0.508N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.220N P=0.078 P=0.379 P=0.503N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.215N P=0.074 P=0.370 P=0.500N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/8 (88%) 7/11 (64%) 9/11 (82%) 3/5 (60%) |8/10 (80%) 1/1 (100%) 4/5 (80%) 5/7 (71%) |
|POLY-3 RATE (b) | 7/7.94 7/10.14 9/10.88 3/4.84 |8/9.27 1/1.00 4/4.84 5/6.15 |
|POLY-3 PERCENT (g) | 88.1% 69.0% 82.8% 62.0% |86.3% 100.0% 82.7% 81.3% |
|TERMINAL (d) | 4/4 (100%) 4/5 (80%) 5/5 (100%) 2/3 (67%) |8/8 (100%) 1/1 (100%) 2/2 (100%) 4/4 (100%) |
|FIRST INCIDENCE | 610 505 624 695 |732 (T) 732 (T) 694 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.137N P=0.463N P=0.609 P=0.137N |P=0.239 P=1.000N P=0.244 P=0.491 |
|POLY 3 | P=0.316N P=0.342N P=0.627N P=0.347N |P=0.510N P=0.916 P=0.743N P=0.684N |
|POLY 1.5 | P=0.324N P=0.306N P=0.620N P=0.336N |P=0.498N P=0.854 P=0.739N P=0.648N |
|POLY 6 | P=0.314N P=0.392N P=0.642N P=0.367N |P=0.477N P=0.989 P=0.764N P=0.687N |
|LOGISTIC REGRESSION| P=0.303N P=0.283N P=0.644N P=0.336N |P=0.613 P=1.000N (e) P=0.738 |
|COCH-ARM / FISHERS | P=0.336N P=0.267N P=0.624N P=0.315N |P=0.438N P=0.818 P=0.736N P=0.559N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 9/50 (18%) 7/50 (14%) |3/50 (6%) 4/50 (8%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 7/44.87 6/46.14 9/47.73 7/47.17 |3/45.20 4/45.60 1/45.17 3/44.91 |
|POLY-3 PERCENT (g) | 15.6% 13.0% 18.9% 14.8% |6.6% 8.8% 2.2% 6.7% |
|TERMINAL (d) | 3/30 (10%) 3/32 (9%) 6/35 (17%) 4/34 (12%) |3/35 (9%) 4/36 (11%) 1/36 (3%) 2/36 (6%) |
|FIRST INCIDENCE | 505 660 674 397 |732 (T) 732 (T) 732 (T) 473 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.534N P=0.433N P=0.534 P=0.543N |P=0.470N P=0.516 P=0.295N P=0.654N |
|POLY 3 | P=0.530 P=0.478N P=0.445 P=0.574N |P=0.482N P=0.505 P=0.305N P=0.659 |
|POLY 1.5 | P=0.512 P=0.489N P=0.423 P=0.591N |P=0.483N P=0.502 P=0.307N P=0.658 |
|POLY 6 | P=0.552 P=0.462N P=0.477 P=0.552N |P=0.478N P=0.510 P=0.301N P=0.660N |
|LOGISTIC REGRESSION| P=0.458 P=0.521N P=0.348 P=0.556 |P=0.487N P=0.516 P=0.295N P=0.654N |
|COCH-ARM / FISHERS | P=0.486 P=0.500N P=0.393 P=0.613N |P=0.479N P=0.500 P=0.309N P=0.661N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 9/50 (18%) 14/50 (28%) 8/50 (16%) |4/50 (8%) 5/50 (10%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 13/46.24 9/46.46 14/47.74 8/47.29 |4/45.25 5/46.72 2/45.23 3/44.18 |
|POLY-3 PERCENT (g) | 28.1% 19.4% 29.3% 16.9% |8.8% 10.7% 4.4% 6.8% |
|TERMINAL (d) | 5/30 (17%) 5/32 (16%) 10/35 (29%) 4/34 (12%) |3/35 (9%) 3/36 (8%) 1/36 (3%) 3/36 (8%) |
|FIRST INCIDENCE | 505 639 674 397 |719 515 719 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.153N P=0.191N P=0.487N P=0.132N |P=0.321N P=0.506 P=0.334N P=0.491N |
|POLY 3 | P=0.187N P=0.228N P=0.539 P=0.146N |P=0.334N P=0.520 P=0.337N P=0.513N |
|POLY 1.5 | P=0.196N P=0.232N P=0.523 P=0.153N |P=0.331N P=0.511 P=0.339N P=0.511N |
|POLY 6 | P=0.177N P=0.221N P=0.560 P=0.137N |P=0.333N P=0.532 P=0.332N P=0.510N |
|LOGISTIC REGRESSION| P=0.235N P=0.273N P=0.419 P=0.209N |P=0.324N P=0.500 P=0.326N P=0.500N |
|COCH-ARM / FISHERS | P=0.210N P=0.235N P=0.500 P=0.163N |P=0.320N P=0.500 P=0.339N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | |0/45.20 2/45.87 1/45.25 0/44.18 |
|POLY-3 PERCENT (g) | |0.0% 4.4% 2.2% 0.0% |
|TERMINAL (d) | |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | |--- 687 714 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.461N P=0.251 P=0.500 (e) |
|POLY 3 | |P=0.467N P=0.240 P=0.500 (e) |
|POLY 1.5 | |P=0.466N P=0.239 P=0.499 (e) |
|POLY 6 | |P=0.464N P=0.243 P=0.503 (e) |
|LOGISTIC REGRESSION| |P=0.462N P=0.237 P=0.500 (e) |
|COCH-ARM / FISHERS | |P=0.461N P=0.247 P=0.500 (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 6/50 (12%) 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | |3/45.58 6/45.60 4/45.64 5/44.35 |
|POLY-3 PERCENT (g) | |6.6% 13.2% 8.8% 11.3% |
|TERMINAL (d) | |1/35 (3%) 6/36 (17%) 3/36 (8%) 4/36 (11%) |
|FIRST INCIDENCE | |636 732 (T) 595 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.412 P=0.260 P=0.512 P=0.374 |
|POLY 3 | |P=0.382 P=0.242 P=0.501 P=0.341 |
|POLY 1.5 | |P=0.386 P=0.242 P=0.499 P=0.345 |
|POLY 6 | |P=0.384 P=0.242 P=0.506 P=0.343 |
|LOGISTIC REGRESSION| |P=0.386 P=0.249 P=0.502 P=0.345 |
|COCH-ARM / FISHERS | |P=0.401 P=0.243 P=0.500 P=0.357 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/45.20 0/45.60 1/45.17 2/44.18 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 2.2% 4.5% |
|TERMINAL (d) | |0/35 (0%) 0/36 (0%) 1/36 (3%) 2/36 (6%) |
|FIRST INCIDENCE | |--- --- 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.072 (e) P=0.506 P=0.244 |
|POLY 3 | |P=0.067 (e) P=0.500 P=0.232 |
|POLY 1.5 | |P=0.068 (e) P=0.499 P=0.233 |
|POLY 6 | |P=0.067 (e) P=0.502 P=0.233 |
|LOGISTIC REGRESSION| |(e) (e) P=0.506 P=0.244 |
|COCH-ARM / FISHERS | |P=0.070 (e) P=0.500 P=0.247 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 17/50 (34%) 14/50 (28%) 16/50 (32%) |8/50 (16%) 20/50 (40%) 8/50 (16%) 10/50 (20%) |
|POLY-3 RATE (b) | 22/45.67 17/46.85 14/47.75 16/45.51 |8/45.57 20/47.27 8/45.22 10/44.81 |
|POLY-3 PERCENT (g) | 48.2% 36.3% 29.3% 35.2% |17.6% 42.3% 17.7% 22.3% |
|TERMINAL (d) | 15/30 (50%) 13/32 (41%) 12/35 (34%) 13/34 (38%) |7/35 (20%) 14/36 (39%) 7/36 (19%) 7/36 (19%) |
|FIRST INCIDENCE | 450 639 674 709 |627 515 721 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.069N P=0.141N P=0.024N* P=0.075N |P=0.334N P=0.012 * P=0.584N P=0.417 |
|POLY 3 | P=0.137N P=0.168N P=0.045N* P=0.143N |P=0.364N P=0.007 ** P=0.601 P=0.381 |
|POLY 1.5 | P=0.140N P=0.187N P=0.056N P=0.149N |P=0.362N P=0.006 ** P=0.601 P=0.383 |
|POLY 6 | P=0.132N P=0.140N P=0.033N* P=0.131N |P=0.353N P=0.009 ** P=0.607 P=0.390 |
|LOGISTIC REGRESSION| P=0.106N P=0.172N P=0.048N* P=0.106N |P=0.369N P=0.007 ** P=0.595N P=0.378 |
|COCH-ARM / FISHERS | P=0.140N P=0.206N P=0.072N P=0.151N |P=0.345N P=0.007 ** P=0.607N P=0.398 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/43.44 3/45.87 2/47.40 1/45.40 |2/45.25 1/45.68 0/45.17 2/44.18 |
|POLY-3 PERCENT (g) | 2.3% 6.5% 4.2% 2.2% |4.4% 2.2% 0.0% 4.5% |
|TERMINAL (d) | 1/30 (3%) 2/32 (6%) 2/35 (6%) 1/34 (3%) |1/35 (3%) 0/36 (0%) 0/36 (0%) 2/36 (6%) |
|FIRST INCIDENCE | 726 (T) 720 726 (T) 726 (T) |719 712 --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.423N P=0.335 P=0.554 P=0.734N |P=0.590 P=0.512N P=0.239N P=0.691N |
|POLY 3 | P=0.452N P=0.325 P=0.530 P=0.751N |P=0.584 P=0.497N P=0.237N P=0.685 |
|POLY 1.5 | P=0.463N P=0.316 P=0.517 P=0.756N |P=0.586 P=0.499N P=0.238N P=0.687 |
|POLY 6 | P=0.437N P=0.339 P=0.548 P=0.743N |P=0.585 P=0.494N P=0.235N P=0.687 |
|LOGISTIC REGRESSION| P=0.415N P=0.356 P=0.554 P=0.734N |P=0.587 P=0.494N P=0.233N P=0.695 |
|COCH-ARM / FISHERS | P=0.474N P=0.309 P=0.500 P=0.753N |P=0.591 P=0.500N P=0.247N P=0.691N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/43.44 7/45.97 0/47.40 2/45.43 |1/45.20 2/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 6.9% 15.2% 0.0% 4.4% |2.2% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 3/30 (10%) 6/32 (19%) 0/35 (0%) 1/34 (3%) |1/35 (3%) 2/36 (6%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 726 (T) 695 --- 720 |732 (T) 732 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.118N P=0.189 P=0.095N P=0.438N |P=0.184N P=0.510 P=0.494N P=0.494N |
|POLY 3 | P=0.135N P=0.181 P=0.104N P=0.480N |P=0.190N P=0.503 P=0.500N P=0.505N |
|POLY 1.5 | P=0.143N P=0.170 P=0.110N P=0.490N |P=0.190N P=0.501 P=0.501N P=0.504N |
|POLY 6 | P=0.123N P=0.198 P=0.096N P=0.463N |P=0.188N P=0.506 P=0.498N P=0.503N |
|LOGISTIC REGRESSION| P=0.114N P=0.222 (e) P=0.424N |P=0.184N P=0.510 (e) (e) |
|COCH-ARM / FISHERS | P=0.157N P=0.159 P=0.121N P=0.500N |P=0.188N P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.44 0/45.85 0/47.40 0/45.40 |1/45.20 1/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 0.0% |2.2% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |1/35 (3%) 1/36 (3%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 726 (T) --- --- --- |732 (T) 732 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.102N P=0.224N P=0.205N P=0.211N |P=0.232N P=0.756N P=0.494N P=0.494N |
|POLY 3 | P=0.117N P=0.225N P=0.218N P=0.227N |P=0.237N P=0.759N P=0.500N P=0.505N |
|POLY 1.5 | P=0.115N P=0.231N P=0.226N P=0.232N |P=0.237N P=0.760N P=0.501N P=0.504N |
|POLY 6 | P=0.120N P=0.217N P=0.207N P=0.220N |P=0.237N P=0.757N P=0.498N P=0.503N |
|LOGISTIC REGRESSION| P=0.102N (e) (e) (e) |P=0.232N P=0.756N (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.235N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 34
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Pancreas |
| Metaplasia Hepatocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 2/47.70 0/45.40 |0/45.20 0/45.60 0/45.17 1/44.35 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.2% 0.0% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 674 --- |--- --- --- 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.624 (e) P=0.299 (e) |P=0.204 (e) (e) P=0.515 |
|POLY 3 | P=0.606 (e) P=0.259 (e) |P=0.196 (e) (e) P=0.496 |
|POLY 1.5 | P=0.600 (e) P=0.249 (e) |P=0.196 (e) (e) P=0.497 |
|POLY 6 | P=0.618 (e) P=0.273 (e) |P=0.197 (e) (e) P=0.498 |
|LOGISTIC REGRESSION| P=0.589 (e) P=0.205 (e) |P=0.202 (e) (e) P=0.505 |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 3/45.91 0/47.40 2/45.40 |0/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 6.5% 0.0% 4.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 2/32 (6%) 0/35 (0%) 2/34 (6%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 709 --- 726 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.393 P=0.141 (e) P=0.266 |(e) (e) (e) (e) |
|POLY 3 | P=0.373 P=0.129 (e) P=0.247 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.363 P=0.124 (e) P=0.242 |(e) (e) (e) (e) |
|POLY 6 | P=0.390 P=0.136 (e) P=0.255 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.388 P=0.145 (e) P=0.266 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.351 P=0.121 (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 35
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 2/47 (4%) 1/45 (2%) 0/45 (0%) |1/43 (2%) 0/40 (0%) 0/43 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 1/42.13 2/43.06 1/42.40 0/41.20 |1/38.24 0/35.97 0/39.01 0/41.18 |
|POLY-3 PERCENT (g) | 2.4% 4.6% 2.4% 0.0% |2.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 2/31 (7%) 1/30 (3%) 0/31 (0%) |1/29 (3%) 0/28 (0%) 0/31 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 695 726 (T) 726 (T) --- |732 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.229N P=0.538 P=0.724N P=0.461N |P=0.289N P=0.507N P=0.487N P=0.474N |
|POLY 3 | P=0.251N P=0.508 P=0.759N P=0.504N |P=0.293N P=0.512N P=0.496N P=0.485N |
|POLY 1.5 | P=0.257N P=0.501 P=0.755 P=0.509N |P=0.293N P=0.514N P=0.498N P=0.485N |
|POLY 6 | P=0.242N P=0.519 P=0.750N P=0.498N |P=0.295N P=0.510N P=0.492N P=0.483N |
|LOGISTIC REGRESSION| P=0.238N P=0.528 P=0.760N P=0.513N |P=0.289N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.263N P=0.492 P=0.736 P=0.516N |P=0.294N P=0.518N P=0.500N P=0.478N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 4/50 (8%) 2/49 (4%) |1/50 (2%) 2/50 (4%) 3/50 (6%) 3/49 (6%) |
|POLY-3 RATE (b) | 5/43.89 5/46.54 4/47.68 2/45.04 |1/45.20 2/45.60 3/45.17 3/43.97 |
|POLY-3 PERCENT (g) | 11.4% 10.7% 8.4% 4.4% |2.2% 4.4% 6.6% 6.8% |
|TERMINAL (d) | 3/30 (10%) 2/32 (6%) 2/35 (6%) 2/34 (6%) |1/35 (3%) 2/36 (6%) 3/36 (8%) 1/35 (3%) |
|FIRST INCIDENCE | 660 639 660 726 (T) |732 (T) 732 (T) 732 (T) 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.114N P=0.560N P=0.395N P=0.175N |P=0.222 P=0.510 P=0.315 P=0.302 |
|POLY 3 | P=0.138N P=0.593N P=0.448N P=0.205N |P=0.216 P=0.503 P=0.305 P=0.295 |
|POLY 1.5 | P=0.145N P=0.610N P=0.470N P=0.214N |P=0.215 P=0.501 P=0.304 P=0.295 |
|POLY 6 | P=0.131N P=0.567N P=0.419N P=0.193N |P=0.221 P=0.506 P=0.309 P=0.300 |
|LOGISTIC REGRESSION| P=0.147N P=0.628N P=0.469N P=0.194N |P=0.216 P=0.510 P=0.315 P=0.325 |
|COCH-ARM / FISHERS | P=0.152N P=0.630N P=0.500N P=0.226N |P=0.219 P=0.500 P=0.309 P=0.301 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 36
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 24/50 (48%) 19/50 (38%) 18/49 (37%) |27/50 (54%) 31/50 (62%) 23/50 (46%) 27/49 (55%) |
|POLY-3 RATE (b) | 15/44.63 24/48.22 19/48.17 18/45.38 |27/47.57 31/47.82 23/46.17 27/45.35 |
|POLY-3 PERCENT (g) | 33.6% 49.8% 39.5% 39.7% |56.8% 64.8% 49.8% 59.5% |
|TERMINAL (d) | 11/30 (37%) 15/32 (47%) 16/35 (46%) 16/34 (47%) |20/35 (57%) 24/36 (67%) 18/36 (50%) 19/35 (54%) |
|FIRST INCIDENCE | 589 505 624 680 |588 400 510 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.399N P=0.112 P=0.469 P=0.501 |P=0.422N P=0.338 P=0.256N P=0.558 |
|POLY 3 | P=0.512 P=0.082 P=0.356 P=0.352 |P=0.506N P=0.272 P=0.319N P=0.475 |
|POLY 1.5 | P=0.491 P=0.066 P=0.315 P=0.332 |P=0.486N P=0.274 P=0.302N P=0.490 |
|POLY 6 | P=0.540N P=0.111 P=0.416 P=0.385 |P=0.505N P=0.263 P=0.338N P=0.479 |
|LOGISTIC REGRESSION| P=0.528 P=0.058 P=0.388 P=0.436 |P=0.482N P=0.274 P=0.278N P=0.495 |
|COCH-ARM / FISHERS | P=0.466 P=0.050 P=0.263 P=0.310 |P=0.432N P=0.272 P=0.274N P=0.537 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 RATE (b) | 2/43.56 0/44.97 1/47.40 2/45.40 | |
|POLY-3 PERCENT (g) | 4.6% 0.0% 2.1% 4.4% | |
|TERMINAL (d) | 1/30 (3%) 0/32 (0%) 1/35 (3%) 2/34 (6%) | |
|FIRST INCIDENCE | 695 --- 726 (T) 726 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.513 P=0.211N P=0.430N P=0.641N | |
|POLY 3 | P=0.474 P=0.230N P=0.471N P=0.679N | |
|POLY 1.5 | P=0.473 P=0.235N P=0.483N P=0.686N | |
|POLY 6 | P=0.476 P=0.222N P=0.453N P=0.668N | |
|LOGISTIC REGRESSION| P=0.504 P=0.223N P=0.445N P=0.654N | |
|COCH-ARM / FISHERS | P=0.472 P=0.253N P=0.500N P=0.691N | |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 37
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 47/49 (96%) 49/50 (98%) 47/50 (94%) | |
|POLY-3 RATE (b) | 47/49.61 47/48.21 49/49.80 47/49.93 | |
|POLY-3 PERCENT (g) | 94.7% 97.5% 98.4% 94.1% | |
|TERMINAL (d) | 28/30 (93%) 32/32 (100%) 35/35 (100%) 32/34 (94%) | |
|FIRST INCIDENCE | 450 478 573 397 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.204N P=0.313N P=0.216N P=0.246N | |
|POLY 3 | P=0.474N P=0.423 P=0.317 P=0.622N | |
|POLY 1.5 | P=0.517N P=0.457 P=0.312 P=0.640N | |
|POLY 6 | P=0.420N P=0.394 P=0.319 P=0.597N | |
|LOGISTIC REGRESSION| P=0.554N P=0.565 P=0.343 P=0.645 | |
|COCH-ARM / FISHERS | P=0.572N P=0.510 P=0.309 P=0.661N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 1/50 (2%) | |
|POLY-3 RATE (b) | 1/43.56 2/45.22 0/47.40 1/45.40 | |
|POLY-3 PERCENT (g) | 2.3% 4.4% 0.0% 2.2% | |
|TERMINAL (d) | 0/30 (0%) 1/32 (3%) 0/35 (0%) 1/34 (3%) | |
|FIRST INCIDENCE | 695 660 --- 726 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.466N P=0.547 P=0.441N P=0.724N | |
|POLY 3 | P=0.485N P=0.513 P=0.483N P=0.751N | |
|POLY 1.5 | P=0.491N P=0.504 P=0.490N P=0.756N | |
|POLY 6 | P=0.477N P=0.527 P=0.473N P=0.744N | |
|LOGISTIC REGRESSION| P=0.496N P=0.492 P=0.508N P=0.749N | |
|COCH-ARM / FISHERS | P=0.498N P=0.492 P=0.500N P=0.753N | |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 38
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Prostate |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/50 (16%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 RATE (b) | 4/44.47 8/46.21 1/47.40 2/46.24 | |
|POLY-3 PERCENT (g) | 9.0% 17.3% 2.1% 4.3% | |
|TERMINAL (d) | 1/30 (3%) 4/32 (13%) 1/35 (3%) 1/34 (3%) | |
|FIRST INCIDENCE | 589 692 726 (T) 397 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.073N P=0.244 P=0.145N P=0.308N | |
|POLY 3 | P=0.079N P=0.195 P=0.160N P=0.319N | |
|POLY 1.5 | P=0.084N P=0.187 P=0.168N P=0.327N | |
|POLY 6 | P=0.074N P=0.209 P=0.150N P=0.309N | |
|LOGISTIC REGRESSION| P=0.106N P=0.175 P=0.261N P=0.365N | |
|COCH-ARM / FISHERS | P=0.094N P=0.178 P=0.181N P=0.339N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | |
|POLY-3 RATE (b) | 2/43.44 0/45.85 3/47.40 0/45.40 | |
|POLY-3 PERCENT (g) | 4.6% 0.0% 6.3% 0.0% | |
|TERMINAL (d) | 2/30 (7%) 0/32 (0%) 3/35 (9%) 0/34 (0%) | |
|FIRST INCIDENCE | 726 (T) --- 726 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.260N P=0.224N P=0.571 P=0.211N | |
|POLY 3 | P=0.291N P=0.225N P=0.540 P=0.227N | |
|POLY 1.5 | P=0.293N P=0.231N P=0.523 P=0.232N | |
|POLY 6 | P=0.287N P=0.217N P=0.563 P=0.220N | |
|LOGISTIC REGRESSION| P=0.260N (e) P=0.571 (e) | |
|COCH-ARM / FISHERS | P=0.296N P=0.247N P=0.500 P=0.247N | |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 39
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 RATE (b) | 0/43.44 0/45.85 1/47.42 2/45.41 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 4.4% | |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 1/34 (3%) | |
|FIRST INCIDENCE | --- --- 723 723 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.082 (e) P=0.536 P=0.271 | |
|POLY 3 | P=0.073 (e) P=0.517 P=0.247 | |
|POLY 1.5 | P=0.071 (e) P=0.510 P=0.242 | |
|POLY 6 | P=0.075 (e) P=0.528 P=0.255 | |
|LOGISTIC REGRESSION| P=0.078 (e) P=0.547 P=0.274 | |
|COCH-ARM / FISHERS | 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 |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 30/50 (60%) 28/50 (56%) 22/50 (44%) | |
|POLY-3 RATE (b) | 22/46.93 30/48.08 28/49.01 22/47.29 | |
|POLY-3 PERCENT (g) | 46.9% 62.4% 57.1% 46.5% | |
|TERMINAL (d) | 14/30 (47%) 21/32 (66%) 20/35 (57%) 17/34 (50%) | |
|FIRST INCIDENCE | 450 505 573 397 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.206N P=0.187 P=0.413 P=0.407N | |
|POLY 3 | P=0.351N P=0.090 P=0.209 P=0.569N | |
|POLY 1.5 | P=0.360N P=0.084 P=0.185 P=0.575N | |
|POLY 6 | P=0.332N P=0.102 P=0.250 P=0.553N | |
|LOGISTIC REGRESSION| P=0.374N P=0.074 P=0.113 P=0.558 | |
|COCH-ARM / FISHERS | P=0.369N P=0.080 P=0.159 P=0.580N | |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 40
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.44 2/46.16 0/47.40 1/45.40 |2/45.68 0/45.60 0/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 2.3% 4.3% 0.0% 2.2% |4.4% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 1/30 (3%) 1/32 (3%) 0/35 (0%) 1/34 (3%) |1/35 (3%) 0/36 (0%) 0/36 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 726 (T) 639 --- 726 (T) |588 --- --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.471N P=0.528 P=0.469N P=0.734N |P=0.463N P=0.239N P=0.241N P=0.501N |
|POLY 3 | P=0.486N P=0.521 P=0.483N P=0.751N |P=0.461N P=0.238N P=0.240N P=0.512N |
|POLY 1.5 | P=0.492N P=0.511 P=0.490N P=0.756N |P=0.461N P=0.238N P=0.239N P=0.509N |
|POLY 6 | P=0.478N P=0.536 P=0.472N P=0.743N |P=0.461N P=0.237N P=0.239N P=0.512N |
|LOGISTIC REGRESSION| P=0.495N P=0.504 (e) P=0.734N |P=0.449N P=0.226N P=0.217N P=0.488N |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.500N P=0.753N |P=0.461N P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 3/47.40 0/45.40 |1/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.3% 0.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 3/35 (9%) 0/34 (0%) |1/35 (3%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 726 (T) --- |732 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.570 (e) P=0.149 (e) |P=0.303N P=0.494N P=0.494N P=0.494N |
|POLY 3 | P=0.553 (e) P=0.135 (e) |P=0.305N P=0.498N P=0.500N P=0.505N |
|POLY 1.5 | P=0.546 (e) P=0.128 (e) |P=0.305N P=0.499N P=0.501N P=0.504N |
|POLY 6 | P=0.567 (e) P=0.146 (e) |P=0.305N P=0.497N P=0.498N P=0.503N |
|LOGISTIC REGRESSION| (e) (e) P=0.149 (e) |P=0.303N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.539 (e) P=0.121 (e) |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 41
Statistical Analysis of Non-neoplastic Lesions 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 |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/50 (8%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 1/45.89 4/47.40 0/45.40 |1/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 8.4% 0.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 4/35 (11%) 0/34 (0%) |1/35 (3%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 716 726 (T) --- |732 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.609N P=0.531 P=0.083 (e) |P=0.303N P=0.494N P=0.494N P=0.494N |
|POLY 3 | P=0.612 P=0.511 P=0.072 (e) |P=0.305N P=0.498N P=0.500N P=0.505N |
|POLY 1.5 | P=0.602 P=0.506 P=0.067 (e) |P=0.305N P=0.499N P=0.501N P=0.504N |
|POLY 6 | P=0.618N P=0.518 P=0.080 (e) |P=0.305N P=0.497N P=0.498N P=0.503N |
|LOGISTIC REGRESSION| P=0.608N P=0.523 P=0.083 (e) |P=0.303N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.591 P=0.500 P=0.059 (e) |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 0/45.85 2/47.40 0/45.40 |0/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 2/35 (6%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 726 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.620 (e) P=0.273 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.607 (e) P=0.257 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.601 (e) P=0.249 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.618 (e) P=0.270 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.273 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 42
Statistical Analysis of Non-neoplastic Lesions 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: Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.71 0/45.85 0/47.40 0/45.40 |0/45.20 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 653 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.105N P=0.220N P=0.208N P=0.218N |(e) (e) (e) (e) |
|POLY 3 | P=0.116N P=0.227N P=0.220N P=0.229N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.115N P=0.231N P=0.227N P=0.233N |(e) (e) (e) (e) |
|POLY 6 | P=0.119N P=0.220N P=0.210N P=0.222N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.119N P=0.240N P=0.249N P=0.239N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/49 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.44 2/45.97 2/47.40 1/44.40 |1/45.50 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 4.6% 4.4% 4.2% 2.3% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 1/32 (3%) 2/35 (6%) 1/33 (3%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 726 (T) 695 726 (T) 726 (T) |650 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.333N P=0.658N P=0.639N P=0.467N |P=0.304N P=0.486N P=0.490N P=0.495N |
|POLY 3 | P=0.368N P=0.674N P=0.662N P=0.492N |P=0.304N P=0.500N P=0.501N P=0.506N |
|POLY 1.5 | P=0.374N P=0.683N P=0.676N P=0.500N |P=0.304N P=0.500N P=0.501N P=0.504N |
|POLY 6 | P=0.359N P=0.659N P=0.643N P=0.481N |P=0.304N P=0.499N P=0.500N P=0.506N |
|LOGISTIC REGRESSION| P=0.336N P=0.649N P=0.639N P=0.467N |P=0.282N P=0.487N P=0.477N P=0.468N |
|COCH-ARM / FISHERS | P=0.380N P=0.691N P=0.691N P=0.508N |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 43
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) 5/49 (10%) |11/50 (22%) 8/50 (16%) 5/50 (10%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/43.85 2/45.97 4/48.48 5/46.05 |11/46.03 8/45.78 5/47.00 5/44.18 |
|POLY-3 PERCENT (g) | 6.8% 4.4% 8.3% 10.9% |23.9% 17.5% 10.6% 11.3% |
|TERMINAL (d) | 2/30 (7%) 1/32 (3%) 1/35 (3%) 1/33 (3%) |7/35 (20%) 6/36 (17%) 1/36 (3%) 5/36 (14%) |
|FIRST INCIDENCE | 610 695 573 397 |609 708 445 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.237 P=0.461N P=0.569 P=0.407 |P=0.060N P=0.302N P=0.094N P=0.087N |
|POLY 3 | P=0.215 P=0.478N P=0.554 P=0.384 |P=0.060N P=0.308N P=0.076N P=0.097N |
|POLY 1.5 | P=0.205 P=0.488N P=0.531 P=0.367 |P=0.059N P=0.308N P=0.080N P=0.094N |
|POLY 6 | P=0.228 P=0.463N P=0.586 P=0.407 |P=0.060N P=0.308N P=0.071N P=0.099N |
|LOGISTIC REGRESSION| P=0.166 P=0.496N P=0.330 P=0.304 |P=0.055N P=0.294N P=0.075N P=0.092N |
|COCH-ARM / FISHERS | P=0.190 P=0.500N P=0.500 P=0.346 |P=0.055N P=0.306N P=0.086N P=0.086N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 2/49 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.88 0/45.85 1/47.42 2/45.20 |1/45.50 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 2.1% 4.4% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/32 (0%) 0/35 (0%) 0/33 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 600 --- 723 596 |650 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491 P=0.230N P=0.454N P=0.673N |P=0.304N P=0.486N P=0.490N P=0.495N |
|POLY 3 | P=0.469 P=0.227N P=0.473N P=0.683N |P=0.304N P=0.500N P=0.501N P=0.506N |
|POLY 1.5 | P=0.466 P=0.232N P=0.485N P=0.692N |P=0.304N P=0.500N P=0.501N P=0.504N |
|POLY 6 | P=0.474 P=0.221N P=0.457N P=0.669N |P=0.304N P=0.499N P=0.500N P=0.506N |
|LOGISTIC REGRESSION| P=0.451 P=0.257N P=0.554N P=0.673 |P=0.282N P=0.487N P=0.477N P=0.468N |
|COCH-ARM / FISHERS | P=0.462 P=0.247N P=0.500N P=0.684 |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 44
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/49 (2%) |1/50 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 2/46.60 1/47.91 1/45.24 |1/45.20 1/46.02 3/45.37 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 2.1% 2.2% |2.2% 2.2% 6.6% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 0/33 (0%) |1/35 (3%) 0/36 (0%) 1/36 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- 526 573 397 |732 (T) 612 694 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.510 P=0.264 P=0.512 P=0.500 |P=0.409N P=0.755N P=0.320 P=0.494N |
|POLY 3 | P=0.523 P=0.253 P=0.519 P=0.508 |P=0.423N P=0.757N P=0.306 P=0.505N |
|POLY 1.5 | P=0.511 P=0.246 P=0.511 P=0.503 |P=0.419N P=0.759N P=0.305 P=0.504N |
|POLY 6 | P=0.541 P=0.264 P=0.531 P=0.516 |P=0.422N P=0.753N P=0.312 P=0.503N |
|LOGISTIC REGRESSION| P=0.516 P=0.188 P=0.231 (e) |P=0.407N P=0.759N P=0.307 (e) |
|COCH-ARM / FISHERS | P=0.494 P=0.247 P=0.500 P=0.495 |P=0.409N P=0.753N P=0.309 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Spleen: Red Pulp |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.44 2/45.85 0/47.40 0/44.40 |1/45.59 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 0.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 2/32 (6%) 0/35 (0%) 0/33 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 726 (T) --- --- |622 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.385N P=0.252 (e) (e) |P=0.313N P=0.500N P=0.500N P=0.514N |
|POLY 3 | P=0.388N P=0.249 (e) (e) |P=0.303N P=0.500N P=0.502N P=0.506N |
|POLY 1.5 | P=0.397N P=0.244 (e) (e) |P=0.304N P=0.500N P=0.502N P=0.505N |
|POLY 6 | P=0.375N P=0.258 (e) (e) |P=0.303N P=0.499N P=0.501N P=0.506N |
|LOGISTIC REGRESSION| (e) P=0.252 (e) (e) |P=0.264N P=0.470N P=0.455N P=0.440N |
|COCH-ARM / FISHERS | P=0.409N P=0.247 (e) (e) |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 45
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.64 1/46.06 2/47.65 0/45.40 |1/45.59 0/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 2.3% 2.2% 4.2% 0.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 1/35 (3%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 674 671 660 --- |622 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.341N P=0.724N P=0.559 P=0.475N |P=0.313N P=0.500N P=0.500N P=0.514N |
|POLY 3 | P=0.357N P=0.749N P=0.531 P=0.492N |P=0.303N P=0.500N P=0.502N P=0.506N |
|POLY 1.5 | P=0.362N P=0.754N P=0.517 P=0.496N |P=0.304N P=0.500N P=0.502N P=0.505N |
|POLY 6 | P=0.350N P=0.740N P=0.549 P=0.486N |P=0.303N P=0.499N P=0.501N P=0.506N |
|LOGISTIC REGRESSION| P=0.377N P=0.748 P=0.458 P=0.507N |P=0.264N P=0.470N P=0.455N P=0.440N |
|COCH-ARM / FISHERS | P=0.366N P=0.753N P=0.500 P=0.500N |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.44 3/46.37 1/47.91 2/46.69 |0/45.20 1/46.02 0/45.17 1/44.66 |
|POLY-3 PERCENT (g) | 0.0% 6.5% 2.1% 4.3% |0.0% 2.2% 0.0% 2.2% |
|TERMINAL (d) | 0/30 (0%) 1/32 (3%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 639 573 397 |--- 612 --- 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.353 P=0.146 P=0.512 P=0.242 |P=0.396 P=0.504 (e) P=0.487 |
|POLY 3 | P=0.373 P=0.131 P=0.519 P=0.254 |P=0.403 P=0.504 (e) P=0.498 |
|POLY 1.5 | P=0.358 P=0.125 P=0.511 P=0.246 |P=0.402 P=0.502 (e) P=0.497 |
|POLY 6 | P=0.395 P=0.140 P=0.531 P=0.264 |P=0.406 P=0.507 (e) P=0.500 |
|LOGISTIC REGRESSION| P=0.322 P=0.109 P=0.231 P=0.226 |P=0.495 P=0.537 (e) P=0.602 |
|COCH-ARM / FISHERS | P=0.337 P=0.121 P=0.500 P=0.247 |P=0.405 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 46
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 3/50 (6%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.56 2/46.37 3/48.22 3/46.69 |2/46.16 2/46.16 0/45.17 1/44.66 |
|POLY-3 PERCENT (g) | 2.3% 4.3% 6.2% 6.4% |4.3% 4.3% 0.0% 2.2% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 0/35 (0%) 1/34 (3%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 695 639 573 397 |508 612 --- 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252 P=0.556 P=0.379 P=0.339 |P=0.308N P=0.681N P=0.241N P=0.514N |
|POLY 3 | P=0.253 P=0.522 P=0.343 P=0.330 |P=0.303N P=0.694 P=0.242N P=0.512N |
|POLY 1.5 | P=0.243 P=0.512 P=0.327 P=0.320 |P=0.301N P=0.693 P=0.241N P=0.509N |
|POLY 6 | P=0.268 P=0.537 P=0.366 P=0.346 |P=0.303N P=0.692N P=0.242N P=0.511N |
|LOGISTIC REGRESSION| P=0.203 P=0.470 P=0.174 P=0.275 |P=0.192N P=0.665N P=0.134N P=0.319N |
|COCH-ARM / FISHERS | P=0.227 P=0.500 P=0.309 P=0.309 |P=0.296N P=0.691N P=0.247N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 7/50 (14%) 8/50 (16%) 3/50 (6%) |6/50 (12%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.64 7/47.36 8/48.56 3/45.86 |6/47.69 4/46.99 3/45.22 1/44.66 |
|POLY-3 PERCENT (g) | 2.3% 14.8% 16.5% 6.5% |12.6% 8.5% 6.6% 2.2% |
|TERMINAL (d) | 0/30 (0%) 1/32 (3%) 3/35 (9%) 1/34 (3%) |0/35 (0%) 0/36 (0%) 2/36 (6%) 0/36 (0%) |
|FIRST INCIDENCE | 674 526 573 596 |508 515 721 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.515 P=0.056 P=0.037 * P=0.347 |P=0.045N* P=0.360N P=0.246N P=0.073N |
|POLY 3 | P=0.494 P=0.040 * P=0.024 * P=0.323 |P=0.045N* P=0.379N P=0.269N P=0.067N |
|POLY 1.5 | P=0.474 P=0.035 * P=0.020 * P=0.315 |P=0.042N* P=0.376N P=0.259N P=0.063N |
|POLY 6 | P=0.526 P=0.047 * P=0.031 * P=0.337 |P=0.047N* P=0.383N P=0.280N P=0.071N |
|LOGISTIC REGRESSION| P=0.422 P=0.022 * P=0.008 ** P=0.295 |P=0.015N* P=0.366N P=0.190N P=0.013N* |
|COCH-ARM / FISHERS | P=0.452 P=0.030 * P=0.015 * P=0.309 |P=0.038N* P=0.370N P=0.243N P=0.056N |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 47
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/43.70 3/45.87 2/47.67 2/45.92 |2/45.96 1/45.68 4/46.41 2/44.84 |
|POLY-3 PERCENT (g) | 4.6% 6.5% 4.2% 4.4% |4.4% 2.2% 8.6% 4.5% |
|TERMINAL (d) | 0/30 (0%) 2/32 (6%) 0/35 (0%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 674 720 660 628 |622 712 510 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.472N P=0.547 P=0.619N P=0.644N |P=0.468 P=0.503N P=0.353 P=0.682 |
|POLY 3 | P=0.501N P=0.522 P=0.662N P=0.676N |P=0.463 P=0.502N P=0.342 P=0.685 |
|POLY 1.5 | P=0.511N P=0.512 P=0.676N P=0.685N |P=0.466 P=0.502N P=0.339 P=0.687 |
|POLY 6 | P=0.486N P=0.537 P=0.643N P=0.662N |P=0.466 P=0.503N P=0.348 P=0.687 |
|LOGISTIC REGRESSION| P=0.528N P=0.539 P=0.677 P=0.683 |P=0.571 P=0.483N P=0.400 P=0.614N |
|COCH-ARM / FISHERS | P=0.523N P=0.500 P=0.691N P=0.691N |P=0.477 P=0.500N P=0.339 P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 5/50 (10%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/43.97 2/46.17 5/47.46 1/45.98 |0/45.20 0/45.60 1/45.23 0/44.18 |
|POLY-3 PERCENT (g) | 6.8% 4.3% 10.5% 2.2% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/32 (0%) 2/35 (6%) 0/34 (0%) |0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 653 674 720 544 |--- --- 719 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.271N P=0.422N P=0.476 P=0.271N |P=0.690 (e) P=0.495 (e) |
|POLY 3 | P=0.302N P=0.478N P=0.399 P=0.289N |P=0.683 (e) P=0.500 (e) |
|POLY 1.5 | P=0.310N P=0.488N P=0.381 P=0.297N |P=0.686 (e) P=0.499 (e) |
|POLY 6 | P=0.292N P=0.463N P=0.423 P=0.279N |P=0.684 (e) P=0.502 (e) |
|LOGISTIC REGRESSION| P=0.331N P=0.521N P=0.394 P=0.322N |P=0.692 (e) P=0.501 (e) |
|COCH-ARM / FISHERS | P=0.319N P=0.500N P=0.357 P=0.309N |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 48
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) 1/50 (2%) | |
|POLY-3 RATE (b) | 2/43.69 0/45.85 3/47.74 1/45.57 | |
|POLY-3 PERCENT (g) | 4.6% 0.0% 6.3% 2.2% | |
|TERMINAL (d) | 1/30 (3%) 0/32 (0%) 1/35 (3%) 0/34 (0%) | |
|FIRST INCIDENCE | 660 --- 639 684 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.521N P=0.217N P=0.571 P=0.458N | |
|POLY 3 | P=0.550N P=0.226N P=0.540 P=0.485N | |
|POLY 1.5 | P=0.553N P=0.231N P=0.523 P=0.492N | |
|POLY 6 | P=0.545N P=0.219N P=0.564 P=0.474N | |
|LOGISTIC REGRESSION| P=0.562N P=0.237N P=0.479 P=0.502N | |
|COCH-ARM / FISHERS | P=0.556N P=0.247N P=0.500 P=0.500N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 9/50 (18%) 5/50 (10%) | |
|POLY-3 RATE (b) | 4/45.43 4/47.61 9/48.52 5/47.21 | |
|POLY-3 PERCENT (g) | 8.8% 8.4% 18.6% 10.6% | |
|TERMINAL (d) | 1/30 (3%) 0/32 (0%) 4/35 (11%) 1/34 (3%) | |
|FIRST INCIDENCE | 450 478 573 397 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.404 P=0.615N P=0.188 P=0.530 | |
|POLY 3 | P=0.373 P=0.617N P=0.142 P=0.524 | |
|POLY 1.5 | P=0.363 P=0.629N P=0.130 P=0.512 | |
|POLY 6 | P=0.391 P=0.598N P=0.164 P=0.543 | |
|LOGISTIC REGRESSION| P=0.223 P=0.483 P=0.011 * P=0.365 | |
|COCH-ARM / FISHERS | P=0.351 P=0.643N P=0.117 P=0.500 | |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 49
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 47/49 (96%) 44/47 (94%) 45/49 (92%) |45/49 (92%) 45/49 (92%) 44/48 (92%) 46/49 (94%) |
|POLY-3 RATE (b) | 45/48.21 47/48.84 44/46.92 45/48.65 |45/47.00 45/47.89 44/47.07 46/48.15 |
|POLY-3 PERCENT (g) | 93.3% 96.2% 93.8% 92.5% |95.7% 94.0% 93.5% 95.5% |
|TERMINAL (d) | 30/30 (100%) 32/32 (100%) 31/32 (97%) 30/33 (91%) |35/35 (100%) 34/35 (97%) 34/35 (97%) 34/35 (97%) |
|FIRST INCIDENCE | 450 478 573 397 |588 400 445 386 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.217N P=0.445N P=0.208N P=0.283N |P=0.441 P=0.572N P=0.493N P=0.485 |
|POLY 3 | P=0.418N P=0.417 P=0.640 P=0.601N |P=0.580 P=0.535N P=0.486N P=0.698N |
|POLY 1.5 | P=0.501N P=0.315 P=0.521 P=0.629 |P=0.487 P=0.585N P=0.552N P=0.616 |
|POLY 6 | P=0.299N P=0.610 P=0.567N P=0.467N |P=0.482N P=0.468N P=0.405N P=0.560N |
|LOGISTIC REGRESSION| P=0.569 P=0.278 P=0.591 P=0.546 |P=0.255 P=0.629 P=0.551 P=0.276 |
|COCH-ARM / FISHERS | P=0.549 P=0.226 P=0.393 P=0.513 |P=0.412 P=0.643N P=0.631N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 41/50 (82%) 41/50 (82%) 34/50 (68%) |45/50 (90%) 39/50 (78%) 43/50 (86%) 36/50 (72%) |
|POLY-3 RATE (b) | 32/47.86 41/48.66 41/48.52 34/47.38 |45/48.81 39/47.19 43/47.26 36/46.12 |
|POLY-3 PERCENT (g) | 66.9% 84.3% 84.5% 71.8% |92.2% 82.7% 91.0% 78.1% |
|TERMINAL (d) | 19/30 (63%) 28/32 (88%) 32/35 (91%) 26/34 (77%) |33/35 (94%) 32/36 (89%) 34/36 (94%) 31/36 (86%) |
|FIRST INCIDENCE | 450 478 639 397 |519 582 453 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.244N P=0.208 P=0.350 P=0.452N |P=0.046N* P=0.112N P=0.339N P=0.036N* |
|POLY 3 | P=0.490 P=0.033 * P=0.030 * P=0.380 |P=0.049N* P=0.118N P=0.567N P=0.037N* |
|POLY 1.5 | P=0.513 P=0.033 * P=0.032 * P=0.395 |P=0.039N* P=0.102N P=0.488N P=0.028N* |
|POLY 6 | P=0.461 P=0.035 * P=0.031 * P=0.363 |P=0.060N P=0.141N P=0.642N P=0.049N* |
|LOGISTIC REGRESSION| P=0.493N P=0.040 * P=0.061 P=0.441 |P=0.052N P=0.062N P=0.452N P=0.031N* |
|COCH-ARM / FISHERS | P=0.543N P=0.035 * P=0.035 * P=0.417 |P=0.030N* P=0.086N P=0.380N P=0.020N* |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 50
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 4/50 (8%) 3/50 (6%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.44 1/45.85 4/47.85 3/45.43 |0/45.20 2/45.60 0/45.17 0/44.18 |
|POLY-3 PERCENT (g) | 2.3% 2.2% 8.4% 6.6% |0.0% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 1/32 (3%) 2/35 (6%) 2/34 (6%) |0/35 (0%) 2/36 (6%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 600 720 |--- 732 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199 P=0.748N P=0.228 P=0.357 |P=0.400N P=0.244 (e) (e) |
|POLY 3 | P=0.174 P=0.749N P=0.210 P=0.321 |P=0.406N P=0.239 (e) (e) |
|POLY 1.5 | P=0.169 P=0.754N P=0.196 P=0.314 |P=0.407N P=0.238 (e) (e) |
|POLY 6 | P=0.183 P=0.740N P=0.229 P=0.334 |P=0.404N P=0.241 (e) (e) |
|LOGISTIC REGRESSION| P=0.173 P=0.748N P=0.175 P=0.364 |(e) P=0.244 (e) (e) |
|COCH-ARM / FISHERS | P=0.163 P=0.753N P=0.181 P=0.309 |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Tooth |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/1 (0%) 2/2 (100%) 1/2 (50%) |
|POLY-3 RATE (b) | 0/0.75 0/1.00 0/0.00 0/0.00 |0/0.00 0/1.00 2/2.00 1/1.83 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 100.0% 54.7% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/1 (0%) 1/1 (100%) 1/1 (100%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 719 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.384 (e) (e) P=1.000N |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.506 (e) (e) P=1.000N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.728 (e) (e) P=1.000 |
|=================================================================================================================================|
Date: 07/05/01 EXPERIMENT: 56348 TEST: 03 Page 51
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Trachea |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.44 0/45.85 0/47.40 0/45.40 |1/45.20 3/45.60 1/45.17 1/44.18 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |2.2% 6.6% 2.2% 2.3% |
|TERMINAL (d) | 1/30 (3%) 0/32 (0%) 0/35 (0%) 0/34 (0%) |1/35 (3%) 3/36 (8%) 1/36 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 726 (T) --- --- --- |732 (T) 732 (T) 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.290N P=0.487N P=0.469N P=0.475N |P=0.436N P=0.315 P=0.756N P=0.756N |
|POLY 3 | P=0.312N P=0.489N P=0.483N P=0.491N |P=0.452N P=0.308 P=0.760 P=0.756 |
|POLY 1.5 | P=0.309N P=0.494N P=0.490N P=0.495N |P=0.451N P=0.307 P=0.760 P=0.756 |
|POLY 6 | P=0.317N P=0.482N P=0.472N P=0.484N |P=0.449N P=0.311 P=0.759N P=0.757 |
|LOGISTIC REGRESSION| P=0.290N (e) (e) (e) |P=0.436N P=0.315 P=0.756N P=0.756N |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.444N P=0.309 P=0.753N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT 1000 PPM 2000 PPM 4000 PPM |UNTREAT 1000 PPM 2000 PPM 4000 PPM |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |9/50 (18%) 15/50 (30%) 9/50 (18%) 14/50 (28%) |
|POLY-3 RATE (b) | |9/46.26 15/46.65 9/46.15 14/44.50 |
|POLY-3 PERCENT (g) | |19.5% 32.2% 19.5% 31.5% |
|TERMINAL (d) | |5/35 (14%) 12/36 (33%) 7/36 (19%) 12/36 (33%) |
|FIRST INCIDENCE | |595 515 504 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.275 P=0.144 P=0.579N P=0.193 |
|POLY 3 | |P=0.217 P=0.121 P=0.601 P=0.140 |
|POLY 1.5 | |P=0.229 P=0.120 P=0.599 P=0.149 |
|POLY 6 | |P=0.212 P=0.122 P=0.602N P=0.136 |
|LOGISTIC REGRESSION| |P=0.240 P=0.121 P=0.600N P=0.155 |
|COCH-ARM / FISHERS | |P=0.259 P=0.121 P=0.602N P=0.171 |
|=================================================================================================================================|
(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).
--multipart-boundary
Content-type: text/plain
Range: bytes 431427-431427/431427
--multipart-boundary--