TDMS Study 56348-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus CITRAL DATE: 12/19/00
EXPERIMENT: 56348 TEST: 04 TIME: 14:40:03
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: C56348
PATHOLOGIST: DR. M. RYAN CAS: 5392-40-5
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF CITRAL
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex: Subcapsular Hyperplasia
Bone Marrow Hyperplasia
Kidney Infarct
Kidney: Renal Tubule Mineralization
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Bone Fibrosis
Bone Marrow Hyperplasia
===============================================================
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 25/50 (50%) | 3/50 (6%) 3/49 (6%) |
|POLY-3 RATE (b) | 25/49.16 25/47.12 | 3/43.96 3/46.22 |
|POLY-3 PERCENT (g) | 50.9% 53.1% | 6.8% 6.5% |
|TERMINAL (d) | 24/48 (50%) 23/43 (54%) | 3/40 (8%) 3/41 (7%) |
|FIRST INCIDENCE | 626 530 | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.372 | P=0.652N |
|POLY 3 | P=0.497 | P=0.635N |
|POLY 1.5 | P=0.515 | P=0.639N |
|POLY 6 | P=0.477 | P=0.636N |
|LOGISTIC REGRESSION| P=0.496 | P=0.652N |
|COCH-ARM / FISHERS | P=0.579N | P=0.651 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 42/50 (84%) | 47/50 (94%) 49/49 (100%) |
|POLY-3 RATE (b) | 36/48.80 42/48.08 | 47/47.48 49/49.00 |
|POLY-3 PERCENT (g) | 73.8% 87.4% | 99.0% 100.0% |
|TERMINAL (d) | 36/48 (75%) 37/43 (86%) | 40/40 (100%) 41/41 (100%) |
|FIRST INCIDENCE | 727 (T) 530 | 242 441 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.019 * | P=0.529 |
|POLY 3 | P=0.074 | P=0.872 |
|POLY 1.5 | P=0.072 | P=0.571 |
|POLY 6 | P=0.081 | P=1.000 |
|LOGISTIC REGRESSION| P=0.047 * | P=0.566 |
|COCH-ARM / FISHERS | P=0.114 | P=0.125 |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Bone |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) | 19/50 (38%) 11/49 (22%) |
|POLY-3 RATE (b) | 0/48.80 1/46.15 | 19/44.00 11/46.39 |
|POLY-3 PERCENT (g) | 0.0% 2.2% | 43.2% 23.7% |
|TERMINAL (d) | 0/48 (0%) 1/43 (2%) | 18/40 (45%) 10/41 (24%) |
|FIRST INCIDENCE | --- 727 (T) | 722 688 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.478 | P=0.052N |
|POLY 3 | P=0.501 | P=0.038N* |
|POLY 1.5 | P=0.500 | P=0.042N* |
|POLY 6 | P=0.501 | P=0.037N* |
|LOGISTIC REGRESSION| P=0.478 | P=0.043N* |
|COCH-ARM / FISHERS | P=0.500 | P=0.071N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 19/50 (38%) | 2/50 (4%) 11/49 (22%) |
|POLY-3 RATE (b) | 9/48.80 19/48.29 | 2/44.05 11/48.39 |
|POLY-3 PERCENT (g) | 18.4% 39.3% | 4.5% 22.7% |
|TERMINAL (d) | 9/48 (19%) 16/43 (37%) | 1/40 (3%) 6/41 (15%) |
|FIRST INCIDENCE | 727 (T) 310 | 709 441 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * | P=0.014 * |
|POLY 3 | P=0.018 * | P=0.011 * |
|POLY 1.5 | P=0.019 * | P=0.010 * |
|POLY 6 | P=0.018 * | P=0.012 * |
|LOGISTIC REGRESSION| P=0.026 * | P=0.005 ** |
|COCH-ARM / FISHERS | P=0.022 * | P=0.007 ** |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 3/50 (6%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/48.80 2/46.32 | 3/44.55 1/47.00 |
|POLY-3 PERCENT (g) | 2.1% 4.3% | 6.7% 2.1% |
|TERMINAL (d) | 1/48 (2%) 1/43 (2%) | 2/40 (5%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 682 | 544 441 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.467 | P=0.296N |
|POLY 3 | P=0.488 | P=0.282N |
|POLY 1.5 | P=0.491 | P=0.285N |
|POLY 6 | P=0.485 | P=0.283N |
|LOGISTIC REGRESSION| P=0.494 | P=0.399N |
|COCH-ARM / FISHERS | P=0.500 | P=0.316N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Heart: Valve |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 2/50 (4%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/48.80 2/47.68 | 2/45.11 2/47.05 |
|POLY-3 PERCENT (g) | 0.0% 4.2% | 4.4% 4.3% |
|TERMINAL (d) | 0/48 (0%) 0/43 (0%) | 0/40 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 310 | 544 470 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.235 | P=0.678N |
|POLY 3 | P=0.235 | P=0.675N |
|POLY 1.5 | P=0.235 | P=0.676N |
|POLY 6 | P=0.234 | P=0.678N |
|LOGISTIC REGRESSION| P=0.467 | P=0.545 |
|COCH-ARM / FISHERS | P=0.247 | P=0.684 |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum: Epithelium |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/48.80 0/46.15 | 0/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 4.1% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 2/48 (4%) 0/43 (0%) | 0/40 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.263N | (e) |
|POLY 3 | P=0.257N | (e) |
|POLY 1.5 | P=0.252N | (e) |
|POLY 6 | P=0.263N | (e) |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | P=0.247N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum: Peyer's Patch |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/48.80 1/46.15 | 2/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 0.0% 2.2% | 4.6% 0.0% |
|TERMINAL (d) | 0/48 (0%) 1/43 (2%) | 2/40 (5%) 0/41 (0%) |
|FIRST INCIDENCE | --- 727 (T) | 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.478 | P=0.233N |
|POLY 3 | P=0.501 | P=0.221N |
|POLY 1.5 | P=0.500 | P=0.223N |
|POLY 6 | P=0.501 | P=0.222N |
|LOGISTIC REGRESSION| P=0.478 | (e) |
|COCH-ARM / FISHERS | P=0.500 | P=0.253N |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum: Serosa |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/48.80 2/46.15 | 0/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 2.1% 4.3% | 0.0% 0.0% |
|TERMINAL (d) | 1/48 (2%) 2/43 (5%) | 0/40 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.462 | (e) |
|POLY 3 | P=0.487 | (e) |
|POLY 1.5 | P=0.491 | (e) |
|POLY 6 | P=0.484 | (e) |
|LOGISTIC REGRESSION| P=0.462 | (e) |
|COCH-ARM / FISHERS | P=0.500 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 18/50 (36%) | 2/50 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 15/48.80 18/47.12 | 2/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 30.7% 38.2% | 4.6% 0.0% |
|TERMINAL (d) | 15/48 (31%) 16/43 (37%) | 2/40 (5%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 530 | 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.215 | P=0.233N |
|POLY 3 | P=0.292 | P=0.221N |
|POLY 1.5 | P=0.299 | P=0.223N |
|POLY 6 | P=0.285 | P=0.222N |
|LOGISTIC REGRESSION| P=0.285 | (e) |
|COCH-ARM / FISHERS | P=0.335 | P=0.253N |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 8/50 (16%) | 4/50 (8%) 1/49 (2%) |
|POLY-3 RATE (b) | 2/48.80 8/46.76 | 4/45.11 1/46.22 |
|POLY-3 PERCENT (g) | 4.1% 17.1% | 8.9% 2.2% |
|TERMINAL (d) | 2/48 (4%) 7/43 (16%) | 2/40 (5%) 1/41 (2%) |
|FIRST INCIDENCE | 727 (T) 530 | 544 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035 * | P=0.174N |
|POLY 3 | P=0.039 * | P=0.170N |
|POLY 1.5 | P=0.041 * | P=0.169N |
|POLY 6 | P=0.038 * | P=0.175N |
|LOGISTIC REGRESSION| P=0.046 * | P=0.210N |
|COCH-ARM / FISHERS | P=0.046 * | P=0.187N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) | 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/48.80 3/46.51 | 0/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 4.1% 6.5% | 0.0% 0.0% |
|TERMINAL (d) | 2/48 (4%) 2/43 (5%) | 0/40 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 626 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.455 | (e) |
|POLY 3 | P=0.483 | (e) |
|POLY 1.5 | P=0.487 | (e) |
|POLY 6 | P=0.479 | (e) |
|LOGISTIC REGRESSION| P=0.500 | (e) |
|COCH-ARM / FISHERS | P=0.500 | (e) |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 46/50 (92%) | 13/50 (26%) 9/49 (18%) |
|POLY-3 RATE (b) | 45/48.80 46/48.08 | 13/45.61 9/46.58 |
|POLY-3 PERCENT (g) | 92.2% 95.7% | 28.5% 19.3% |
|TERMINAL (d) | 45/48 (94%) 41/43 (95%) | 10/40 (25%) 8/41 (20%) |
|FIRST INCIDENCE | 727 (T) 530 | 243 633 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060 | P=0.219N |
|POLY 3 | P=0.385 | P=0.215N |
|POLY 1.5 | P=0.369 | P=0.216N |
|POLY 6 | P=0.429 | P=0.218N |
|LOGISTIC REGRESSION| P=0.218 | P=0.245N |
|COCH-ARM / FISHERS | P=0.500 | P=0.251N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 4/50 (8%) | 1/50 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 8/48.80 4/46.51 | 1/43.96 1/46.22 |
|POLY-3 PERCENT (g) | 16.4% 8.6% | 2.3% 2.2% |
|TERMINAL (d) | 8/48 (17%) 3/43 (7%) | 1/40 (3%) 1/41 (2%) |
|FIRST INCIDENCE | 727 (T) 626 | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.235N | P=0.756N |
|POLY 3 | P=0.204N | P=0.744N |
|POLY 1.5 | P=0.198N | P=0.746N |
|POLY 6 | P=0.210N | P=0.744N |
|LOGISTIC REGRESSION| P=0.197N | P=0.756N |
|COCH-ARM / FISHERS | P=0.178N | P=0.747 |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/48.80 0/46.15 | 0/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 4.1% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 2/48 (4%) 0/43 (0%) | 0/40 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.263N | (e) |
|POLY 3 | P=0.257N | (e) |
|POLY 1.5 | P=0.252N | (e) |
|POLY 6 | P=0.263N | (e) |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | P=0.247N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 48/50 (96%) | 3/50 (6%) 4/49 (8%) |
|POLY-3 RATE (b) | 45/49.64 48/48.08 | 3/44.92 4/46.58 |
|POLY-3 PERCENT (g) | 90.7% 99.8% | 6.7% 8.6% |
|TERMINAL (d) | 44/48 (92%) 43/43 (100%) | 2/40 (5%) 3/41 (7%) |
|FIRST INCIDENCE | 397 530 | 243 633 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014 * | P=0.518 |
|POLY 3 | P=0.043 * | P=0.517 |
|POLY 1.5 | P=0.054 | P=0.514 |
|POLY 6 | P=0.046 * | P=0.518 |
|LOGISTIC REGRESSION| P=0.060 | P=0.412 |
|COCH-ARM / FISHERS | P=0.218 | P=0.489 |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 9/50 (18%) | 3/50 (6%) 0/49 (0%) |
|POLY-3 RATE (b) | 8/48.80 9/46.15 | 3/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 16.4% 19.5% | 6.8% 0.0% |
|TERMINAL (d) | 8/48 (17%) 9/43 (21%) | 3/40 (8%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) | 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.401 | P=0.117N |
|POLY 3 | P=0.453 | P=0.107N |
|POLY 1.5 | P=0.465 | P=0.109N |
|POLY 6 | P=0.440 | P=0.108N |
|LOGISTIC REGRESSION| P=0.401 | (e) |
|COCH-ARM / FISHERS | P=0.500 | P=0.125N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) | 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/48.80 4/46.15 | 0/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 6.2% 8.7% | 0.0% 0.0% |
|TERMINAL (d) | 3/48 (6%) 4/43 (9%) | 0/40 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.440 | (e) |
|POLY 3 | P=0.474 | (e) |
|POLY 1.5 | P=0.481 | (e) |
|POLY 6 | P=0.467 | (e) |
|LOGISTIC REGRESSION| P=0.440 | (e) |
|COCH-ARM / FISHERS | P=0.500 | (e) |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 16/50 (32%) 18/49 (37%) |
|POLY-3 RATE (b) | 2/48.80 1/46.15 | 16/43.96 18/46.58 |
|POLY-3 PERCENT (g) | 4.1% 2.2% | 36.4% 38.7% |
|TERMINAL (d) | 2/48 (4%) 1/43 (2%) | 16/40 (40%) 17/41 (42%) |
|FIRST INCIDENCE | 727 (T) 727 (T) | 733 (T) 633 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.538N | P=0.451 |
|POLY 3 | P=0.526N | P=0.496 |
|POLY 1.5 | P=0.519N | P=0.481 |
|POLY 6 | P=0.534N | P=0.502 |
|LOGISTIC REGRESSION| P=0.538N | P=0.482 |
|COCH-ARM / FISHERS | P=0.500N | P=0.388 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 7/50 (14%) | 20/50 (40%) 14/49 (29%) |
|POLY-3 RATE (b) | 9/48.80 7/46.15 | 20/45.02 14/46.60 |
|POLY-3 PERCENT (g) | 18.4% 15.2% | 44.4% 30.0% |
|TERMINAL (d) | 9/48 (19%) 7/43 (16%) | 18/40 (45%) 13/41 (32%) |
|FIRST INCIDENCE | 727 (T) 727 (T) | 242 625 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.487N | P=0.125N |
|POLY 3 | P=0.443N | P=0.111N |
|POLY 1.5 | P=0.430N | P=0.117N |
|POLY 6 | P=0.458N | P=0.109N |
|LOGISTIC REGRESSION| P=0.487N | P=0.118N |
|COCH-ARM / FISHERS | P=0.393N | P=0.162N |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 10/50 (20%) | 4/50 (8%) 5/49 (10%) |
|POLY-3 RATE (b) | 9/48.80 10/46.76 | 4/43.96 5/46.22 |
|POLY-3 PERCENT (g) | 18.4% 21.4% | 9.1% 10.8% |
|TERMINAL (d) | 9/48 (19%) 9/43 (21%) | 4/40 (10%) 5/41 (12%) |
|FIRST INCIDENCE | 727 (T) 530 | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.400 | P=0.516 |
|POLY 3 | P=0.461 | P=0.528 |
|POLY 1.5 | P=0.470 | P=0.524 |
|POLY 6 | P=0.452 | P=0.527 |
|LOGISTIC REGRESSION| P=0.467 | P=0.516 |
|COCH-ARM / FISHERS | P=0.500 | P=0.487 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) | 2/50 (4%) 3/49 (6%) |
|POLY-3 RATE (b) | 3/48.80 1/46.15 | 2/45.89 3/47.13 |
|POLY-3 PERCENT (g) | 6.2% 2.2% | 4.4% 6.4% |
|TERMINAL (d) | 3/48 (6%) 1/43 (2%) | 0/40 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 727 (T) 727 (T) | 242 470 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.346N | P=0.514 |
|POLY 3 | P=0.331N | P=0.510 |
|POLY 1.5 | P=0.325N | P=0.507 |
|POLY 6 | P=0.339N | P=0.511 |
|LOGISTIC REGRESSION| P=0.346N | P=0.158 |
|COCH-ARM / FISHERS | P=0.309N | P=0.490 |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 11/50 (22%) | 4/50 (8%) 3/49 (6%) |
|POLY-3 RATE (b) | 6/48.80 11/46.50 | 4/44.92 3/46.22 |
|POLY-3 PERCENT (g) | 12.3% 23.7% | 8.9% 6.5% |
|TERMINAL (d) | 6/48 (13%) 9/43 (21%) | 3/40 (8%) 3/41 (7%) |
|FIRST INCIDENCE | 727 (T) 682 | 242 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.100 | P=0.489N |
|POLY 3 | P=0.120 | P=0.482N |
|POLY 1.5 | P=0.125 | P=0.484N |
|POLY 6 | P=0.116 | P=0.484N |
|LOGISTIC REGRESSION| P=0.116 | P=0.564N |
|COCH-ARM / FISHERS | P=0.143 | P=0.511N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 2/50 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/48.80 1/46.15 | 2/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 4.1% 2.2% | 4.6% 0.0% |
|TERMINAL (d) | 2/48 (4%) 1/43 (2%) | 2/40 (5%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) | 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.538N | P=0.233N |
|POLY 3 | P=0.526N | P=0.221N |
|POLY 1.5 | P=0.519N | P=0.223N |
|POLY 6 | P=0.534N | P=0.222N |
|LOGISTIC REGRESSION| P=0.538N | (e) |
|COCH-ARM / FISHERS | P=0.500N | P=0.253N |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung: Serosa |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/48.80 0/46.15 | 0/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 4.1% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 2/48 (4%) 0/43 (0%) | 0/40 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.263N | (e) |
|POLY 3 | P=0.257N | (e) |
|POLY 1.5 | P=0.252N | (e) |
|POLY 6 | P=0.263N | (e) |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | P=0.247N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/47 (0%) | 3/49 (6%) 2/47 (4%) |
|POLY-3 RATE (b) | 1/46.80 0/44.76 | 3/43.55 2/44.59 |
|POLY-3 PERCENT (g) | 2.1% 0.0% | 6.9% 4.5% |
|TERMINAL (d) | 1/46 (2%) 0/42 (0%) | 3/40 (8%) 2/41 (5%) |
|FIRST INCIDENCE | 727 (T) --- | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.518N | P=0.489N |
|POLY 3 | P=0.518N | P=0.487N |
|POLY 1.5 | P=0.515N | P=0.490N |
|POLY 6 | P=0.523N | P=0.488N |
|LOGISTIC REGRESSION| (e) | P=0.489N |
|COCH-ARM / FISHERS | P=0.505N | P=0.520N |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/6 (50%) 1/3 (33%) | 1/5 (20%) 0/3 (0%) |
|POLY-3 RATE (b) | 3/5.64 1/3.00 | 1/4.07 0/2.22 |
|POLY-3 PERCENT (g) | 53.2% 33.3% | 24.6% 0.0% |
|TERMINAL (d) | 3/5 (60%) 1/3 (33%) | 1/2 (50%) 0/2 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) | 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500N | P=0.500N |
|POLY 3 | P=0.629N | P=0.740N |
|POLY 1.5 | P=0.646N | P=0.732N |
|POLY 6 | P=0.604N | P=0.717N |
|LOGISTIC REGRESSION| P=0.500N | (e) |
|COCH-ARM / FISHERS | P=0.595N | P=0.625N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/6 (17%) 1/3 (33%) | 3/5 (60%) 2/3 (67%) |
|POLY-3 RATE (b) | 1/5.64 1/3.00 | 3/4.73 2/2.22 |
|POLY-3 PERCENT (g) | 17.7% 33.3% | 63.4% 90.2% |
|TERMINAL (d) | 1/5 (20%) 1/3 (33%) | 1/2 (50%) 2/2 (100%) |
|FIRST INCIDENCE | 727 (T) 727 (T) | 557 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.653 | P=0.497N |
|POLY 3 | P=0.697 | P=0.716 |
|POLY 1.5 | P=0.696 | P=0.722 |
|POLY 6 | P=0.699 | P=0.724 |
|LOGISTIC REGRESSION| P=0.653 | P=0.649 |
|COCH-ARM / FISHERS | P=0.583 | P=0.714 |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 12/50 (24%) | 20/50 (40%) 14/49 (29%) |
|POLY-3 RATE (b) | 6/48.80 12/46.15 | 20/45.11 14/46.73 |
|POLY-3 PERCENT (g) | 12.3% 26.0% | 44.3% 30.0% |
|TERMINAL (d) | 6/48 (13%) 12/43 (28%) | 18/40 (45%) 11/41 (27%) |
|FIRST INCIDENCE | 727 (T) 727 (T) | 545 633 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058 | P=0.131N |
|POLY 3 | P=0.075 | P=0.111N |
|POLY 1.5 | P=0.080 | P=0.114N |
|POLY 6 | P=0.069 | P=0.113N |
|LOGISTIC REGRESSION| P=0.058 | P=0.113N |
|COCH-ARM / FISHERS | P=0.096 | P=0.162N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 9/50 (18%) | 6/50 (12%) 6/49 (12%) |
|POLY-3 RATE (b) | 4/48.80 9/46.15 | 6/44.55 6/46.58 |
|POLY-3 PERCENT (g) | 8.2% 19.5% | 13.5% 12.9% |
|TERMINAL (d) | 4/48 (8%) 9/43 (21%) | 5/40 (13%) 5/41 (12%) |
|FIRST INCIDENCE | 727 (T) 727 (T) | 545 633 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.080 | P=0.598N |
|POLY 3 | P=0.097 | P=0.587N |
|POLY 1.5 | P=0.102 | P=0.590N |
|POLY 6 | P=0.092 | P=0.588N |
|LOGISTIC REGRESSION| P=0.080 | P=0.610N |
|COCH-ARM / FISHERS | P=0.117 | P=0.606 |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 19/50 (38%) 20/49 (41%) |
|POLY-3 RATE (b) | | 19/43.96 20/46.60 |
|POLY-3 PERCENT (g) | | 43.2% 42.9% |
|TERMINAL (d) | | 19/40 (48%) 19/41 (46%) |
|FIRST INCIDENCE | | 733 (T) 625 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.544 |
|POLY 3 | | P=0.570N |
|POLY 1.5 | | P=0.575 |
|POLY 6 | | P=0.564N |
|LOGISTIC REGRESSION| | P=0.578 |
|COCH-ARM / FISHERS | | P=0.468 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/48.80 0/46.15 | 2/44.05 1/46.22 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 4.5% 2.2% |
|TERMINAL (d) | 0/48 (0%) 0/43 (0%) | 1/40 (3%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- | 709 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.492N |
|POLY 3 | (e) | P=0.478N |
|POLY 1.5 | (e) | P=0.481N |
|POLY 6 | (e) | P=0.480N |
|LOGISTIC REGRESSION| (e) | P=0.483N |
|COCH-ARM / FISHERS | (e) | P=0.508N |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) | 7/49 (14%) 7/48 (15%) |
|POLY-3 RATE (b) | 0/48.80 0/44.15 | 7/43.05 7/45.22 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 16.3% 15.5% |
|TERMINAL (d) | 0/48 (0%) 0/41 (0%) | 6/39 (15%) 7/40 (18%) |
|FIRST INCIDENCE | --- --- | 709 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.594N |
|POLY 3 | (e) | P=0.573N |
|POLY 1.5 | (e) | P=0.578N |
|POLY 6 | (e) | P=0.576N |
|LOGISTIC REGRESSION| (e) | P=0.583N |
|COCH-ARM / FISHERS | (e) | P=0.597 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 14/50 (28%) | |
|POLY-3 RATE (b) | 17/49.16 14/46.15 | |
|POLY-3 PERCENT (g) | 34.6% 30.3% | |
|TERMINAL (d) | 16/48 (33%) 14/43 (33%) | |
|FIRST INCIDENCE | 626 727 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.472N | |
|POLY 3 | P=0.415N | |
|POLY 1.5 | P=0.391N | |
|POLY 6 | P=0.443N | |
|LOGISTIC REGRESSION| P=0.414N | |
|COCH-ARM / FISHERS | P=0.333N | |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) | |
|POLY-3 RATE (b) | 2/48.80 3/46.51 | |
|POLY-3 PERCENT (g) | 4.1% 6.5% | |
|TERMINAL (d) | 2/48 (4%) 2/43 (5%) | |
|FIRST INCIDENCE | 727 (T) 626 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.455 | |
|POLY 3 | P=0.483 | |
|POLY 1.5 | P=0.487 | |
|POLY 6 | P=0.479 | |
|LOGISTIC REGRESSION| P=0.500 | |
|COCH-ARM / FISHERS | P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) | |
|POLY-3 RATE (b) | 0/48.80 3/46.15 | |
|POLY-3 PERCENT (g) | 0.0% 6.5% | |
|TERMINAL (d) | 0/48 (0%) 3/43 (7%) | |
|FIRST INCIDENCE | --- 727 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.103 | |
|POLY 3 | P=0.113 | |
|POLY 1.5 | P=0.114 | |
|POLY 6 | P=0.111 | |
|LOGISTIC REGRESSION| P=0.103 | |
|COCH-ARM / FISHERS | P=0.121 | |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/48.80 0/46.15 | 0/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 4.1% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 2/48 (4%) 0/43 (0%) | 0/40 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.263N | (e) |
|POLY 3 | P=0.257N | (e) |
|POLY 1.5 | P=0.252N | (e) |
|POLY 6 | P=0.263N | (e) |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | P=0.247N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 13/50 (26%) | 17/50 (34%) 14/49 (29%) |
|POLY-3 RATE (b) | 17/49.64 13/48.29 | 17/45.93 14/47.60 |
|POLY-3 PERCENT (g) | 34.3% 26.9% | 37.0% 29.4% |
|TERMINAL (d) | 16/48 (33%) 10/43 (23%) | 12/40 (30%) 10/41 (24%) |
|FIRST INCIDENCE | 397 310 | 9 470 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.375N | P=0.314N |
|POLY 3 | P=0.287N | P=0.287N |
|POLY 1.5 | P=0.282N | P=0.298N |
|POLY 6 | P=0.294N | P=0.286N |
|LOGISTIC REGRESSION| P=0.195N | P=0.386N |
|COCH-ARM / FISHERS | P=0.257N | P=0.358N |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) | 8/50 (16%) 4/49 (8%) |
|POLY-3 RATE (b) | 3/49.64 4/47.93 | 8/47.58 4/47.34 |
|POLY-3 PERCENT (g) | 6.0% 8.4% | 16.8% 8.5% |
|TERMINAL (d) | 2/48 (4%) 1/43 (2%) | 2/40 (5%) 2/41 (5%) |
|FIRST INCIDENCE | 397 121 | 242 470 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.466 | P=0.178N |
|POLY 3 | P=0.484 | P=0.180N |
|POLY 1.5 | P=0.489 | P=0.179N |
|POLY 6 | P=0.479 | P=0.182N |
|LOGISTIC REGRESSION| P=0.584N | P=0.430N |
|COCH-ARM / FISHERS | P=0.500 | P=0.188N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 8/50 (16%) | 8/50 (16%) 14/49 (29%) |
|POLY-3 RATE (b) | 6/48.80 8/46.51 | 8/43.96 14/46.39 |
|POLY-3 PERCENT (g) | 12.3% 17.2% | 18.2% 30.2% |
|TERMINAL (d) | 6/48 (13%) 7/43 (16%) | 8/40 (20%) 13/41 (32%) |
|FIRST INCIDENCE | 727 (T) 626 | 733 (T) 688 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309 | P=0.125 |
|POLY 3 | P=0.353 | P=0.138 |
|POLY 1.5 | P=0.361 | P=0.134 |
|POLY 6 | P=0.346 | P=0.138 |
|LOGISTIC REGRESSION| P=0.350 | P=0.132 |
|COCH-ARM / FISHERS | P=0.387 | P=0.103 |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/48.80 2/46.32 | 0/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 0.0% 4.3% | 0.0% 0.0% |
|TERMINAL (d) | 0/48 (0%) 1/43 (2%) | 0/40 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 682 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.221 | (e) |
|POLY 3 | P=0.232 | (e) |
|POLY 1.5 | P=0.233 | (e) |
|POLY 6 | P=0.231 | (e) |
|LOGISTIC REGRESSION| P=0.237 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/48.80 2/46.15 | 0/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 0.0% 4.3% | 0.0% 0.0% |
|TERMINAL (d) | 0/48 (0%) 2/43 (5%) | 0/40 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 727 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.215 | (e) |
|POLY 3 | P=0.231 | (e) |
|POLY 1.5 | P=0.233 | (e) |
|POLY 6 | P=0.230 | (e) |
|LOGISTIC REGRESSION| P=0.215 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) | 3/50 (6%) 2/49 (4%) |
|POLY-3 RATE (b) | 1/48.80 5/46.50 | 3/44.00 2/46.22 |
|POLY-3 PERCENT (g) | 2.1% 10.8% | 6.8% 4.3% |
|TERMINAL (d) | 1/48 (2%) 3/43 (7%) | 2/40 (5%) 2/41 (5%) |
|FIRST INCIDENCE | 727 (T) 682 | 722 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.087 | P=0.491N |
|POLY 3 | P=0.093 | P=0.473N |
|POLY 1.5 | P=0.095 | P=0.477N |
|POLY 6 | P=0.091 | P=0.475N |
|LOGISTIC REGRESSION| P=0.098 | P=0.481N |
|COCH-ARM / FISHERS | P=0.102 | P=0.510N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/48.80 0/46.15 | 0/43.96 0/46.22 |
|POLY-3 PERCENT (g) | 4.1% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 2/48 (4%) 0/43 (0%) | 0/40 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.263N | (e) |
|POLY 3 | P=0.257N | (e) |
|POLY 1.5 | P=0.252N | (e) |
|POLY 6 | P=0.263N | (e) |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | P=0.247N | (e) |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) | |
|POLY-3 RATE (b) | 4/48.80 2/46.32 | |
|POLY-3 PERCENT (g) | 8.2% 4.3% | |
|TERMINAL (d) | 4/48 (8%) 1/43 (2%) | |
|FIRST INCIDENCE | 727 (T) 682 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.386N | |
|POLY 3 | P=0.366N | |
|POLY 1.5 | P=0.359N | |
|POLY 6 | P=0.373N | |
|LOGISTIC REGRESSION| P=0.357N | |
|COCH-ARM / FISHERS | P=0.339N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 43/49 (88%) | 26/47 (55%) 31/48 (65%) |
|POLY-3 RATE (b) | 41/49.16 43/49.00 | 26/46.00 31/47.21 |
|POLY-3 PERCENT (g) | 83.4% 87.8% | 56.5% 65.7% |
|TERMINAL (d) | 40/48 (83%) 36/42 (86%) | 19/39 (49%) 25/40 (63%) |
|FIRST INCIDENCE | 626 121 | 242 441 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.081 | P=0.291 |
|POLY 3 | P=0.372 | P=0.244 |
|POLY 1.5 | P=0.351 | P=0.256 |
|POLY 6 | P=0.385 | P=0.234 |
|LOGISTIC REGRESSION| P=0.297 | P=0.216 |
|COCH-ARM / FISHERS | P=0.303 | P=0.238 |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) | 11/47 (23%) 7/48 (15%) |
|POLY-3 RATE (b) | 0/48.80 0/45.15 | 11/42.19 7/45.22 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 26.1% 15.5% |
|TERMINAL (d) | 0/48 (0%) 0/42 (0%) | 11/39 (28%) 7/40 (18%) |
|FIRST INCIDENCE | --- --- | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.195N |
|POLY 3 | (e) | P=0.167N |
|POLY 1.5 | (e) | P=0.168N |
|POLY 6 | (e) | P=0.170N |
|LOGISTIC REGRESSION| (e) | P=0.195N |
|COCH-ARM / FISHERS | (e) | P=0.202N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/48 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/48.80 0/46.15 | 2/43.11 0/46.22 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 4.6% 0.0% |
|TERMINAL (d) | 0/48 (0%) 0/43 (0%) | 2/40 (5%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- | 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.233N |
|POLY 3 | (e) | P=0.215N |
|POLY 1.5 | (e) | P=0.214N |
|POLY 6 | (e) | P=0.219N |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | (e) | P=0.242N |
|=================================================================================================================================|
Date: 12/19/00 EXPERIMENT: 56348 TEST: 04 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 43/50 (86%) 45/49 (92%) |
|POLY-3 RATE (b) | | 43/45.55 45/47.68 |
|POLY-3 PERCENT (g) | | 94.4% 94.4% |
|TERMINAL (d) | | 38/40 (95%) 40/41 (98%) |
|FIRST INCIDENCE | | 544 441 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.516 |
|POLY 3 | | P=0.681N |
|POLY 1.5 | | P=0.640 |
|POLY 6 | | P=0.662 |
|LOGISTIC REGRESSION| | P=0.625N |
|COCH-ARM / FISHERS | | P=0.274 |
|=================================================================================================================================|
(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).