TDMS Study 93026-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest DECALIN DATE: 04/11/02
EXPERIMENT: 93026 TEST: 06 TIME: 09:27:48
TEST TYPE: CHRONIC PAGE: 1
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C93026
PATHOLOGIST: grumbein, sondra CAS: 91-17-8
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Final#1, Revision#2
REASONS FOR REMOVAL: 25022 Accidently Killed
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest DECALIN DATE: 04/11/02
EXPERIMENT: 93026 TEST: 06 TIME: 09:27:48
TEST TYPE: CHRONIC
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C93026
PATHOLOGIST: grumbein, sondra CAS: 91-17-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DECALIN
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia
Hypertrophy
Gallbladder Degeneration Hyaline
Kidney Nephropathy
Liver Basophilic Focus
Eosinophilic Focus
Erythrophagocytosis
Necrosis
Syncytial Alteration
Liver: Centrilobular Hypertrophy
Necrosis
Stomach, Forestomach Hyperplasia
Necrosis
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Nose: Glands Dilatation
Ovary Cyst
Pituitary Gland: Pars Distalis Hyperplasia
===============================================================
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/49 (47%) 16/50 (32%) 13/50 (26%) 14/50 (28%) |6/49 (12%) 7/50 (14%) 5/50 (10%) 5/49 (10%) |
|POLY-3 RATE (b) | 23/45.57 16/45.02 13/45.43 14/45.04 |6/45.51 7/43.56 5/45.07 5/45.44 |
|POLY-3 PERCENT (g) | 50.5% 35.5% 28.6% 31.1% |13.2% 16.1% 11.1% 11.0% |
|TERMINAL (d) | 20/40 (50%) 16/41 (39%) 10/36 (28%) 10/34 (29%) |4/37 (11%) 5/28 (18%) 4/35 (11%) 4/36 (11%) |
|FIRST INCIDENCE | 588 733 (T) 654 605 |610 488 723 686 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.292N P=0.092N P=0.068N P=0.143N |P=0.338N P=0.341 P=0.528N P=0.506N |
|POLY 3 | P=0.118N P=0.108N P=0.025N* P=0.045N* |P=0.383N P=0.466 P=0.507N P=0.501N |
|POLY 1.5 | P=0.113N P=0.102N P=0.023N* P=0.040N* |P=0.393N P=0.487 P=0.504N P=0.503N |
|POLY 6 | P=0.131N P=0.116N P=0.029N* P=0.054N |P=0.367N P=0.438 P=0.511N P=0.496N |
|LOGISTIC REGRESSION| P=0.147N P=0.094N P=0.026N* P=0.049N* |P=0.390N P=0.524 P=0.496N P=0.500N |
|COCH-ARM / FISHERS | P=0.118N P=0.094N P=0.025N* P=0.041N* |P=0.402N P=0.516 P=0.486N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 37/49 (76%) 42/50 (84%) 30/50 (60%) 26/50 (52%) |3/49 (6%) 8/50 (16%) 2/50 (4%) 6/49 (12%) |
|POLY-3 RATE (b) | 37/47.99 42/47.18 30/46.85 26/45.66 |3/45.34 8/44.76 2/45.02 6/45.61 |
|POLY-3 PERCENT (g) | 77.1% 89.0% 64.0% 56.9% |6.6% 17.9% 4.4% 13.2% |
|TERMINAL (d) | 31/40 (78%) 37/41 (90%) 24/36 (67%) 23/34 (68%) |2/37 (5%) 2/28 (7%) 2/35 (6%) 5/36 (14%) |
|FIRST INCIDENCE | 384 495 596 467 |568 527 735 (T) 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.042N* P=0.249 P=0.285N P=0.131N |P=0.459 P=0.072 P=0.522N P=0.236 |
|POLY 3 | P<0.001N** P=0.092 P=0.115N P=0.026N* |P=0.408 P=0.094 P=0.503N P=0.245 |
|POLY 1.5 | P<0.001N** P=0.117 P=0.097N P=0.018N* |P=0.402 P=0.098 P=0.502N P=0.242 |
|POLY 6 | P=0.003N** P=0.082 P=0.134N P=0.041N* |P=0.419 P=0.089 P=0.504N P=0.251 |
|LOGISTIC REGRESSION| P<0.001N** P=0.185 P=0.075N P=0.014N* |P=0.389 P=0.143 P=0.491N P=0.242 |
|COCH-ARM / FISHERS | P<0.001N** P=0.212 P=0.075N P=0.013N* |P=0.398 P=0.106 P=0.490N P=0.243 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |1/48 (2%) 2/50 (4%) 2/50 (4%) 2/49 (4%) |
|POLY-3 RATE (b) | 3/44.56 0/45.02 0/45.00 3/44.32 |1/43.88 2/42.88 2/45.16 2/45.26 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 0.0% 6.8% |2.3% 4.7% 4.4% 4.4% |
|TERMINAL (d) | 3/40 (8%) 0/41 (0%) 0/36 (0%) 2/34 (6%) |0/36 (0%) 0/28 (0%) 1/35 (3%) 2/36 (6%) |
|FIRST INCIDENCE | 733 (T) --- --- 692 |714 658 700 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199 P=0.117N P=0.140N P=0.596 |P=0.557 P=0.452 P=0.500 P=0.509 |
|POLY 3 | P=0.245 P=0.117N P=0.117N P=0.660 |P=0.533 P=0.492 P=0.510 P=0.511 |
|POLY 1.5 | P=0.249 P=0.117N P=0.116N P=0.658N |P=0.525 P=0.501 P=0.509 P=0.508 |
|POLY 6 | P=0.240 P=0.116N P=0.119N P=0.650 |P=0.544 P=0.481 P=0.512 P=0.516 |
|LOGISTIC REGRESSION| P=0.230 (e) (e) P=0.644 |P=0.531 P=0.511 P=0.510 P=0.519 |
|COCH-ARM / FISHERS | P=0.251 P=0.117N P=0.117N P=0.651N |P=0.518 P=0.515 P=0.515 P=0.508 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/49 (6%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.23 0/45.02 0/45.00 0/44.16 |3/45.26 3/42.66 2/45.02 2/45.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.6% 7.0% 4.4% 4.4% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |2/37 (5%) 2/28 (7%) 2/35 (6%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- --- |599 714 735 (T) 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.386N P=0.555 P=0.522N P=0.501N |
|POLY 3 | (e) (e) (e) (e) |P=0.416N P=0.635 P=0.502N P=0.497N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.421N P=0.650 P=0.502N P=0.497N |
|POLY 6 | (e) (e) (e) (e) |P=0.406N P=0.615 P=0.503N P=0.494N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.412N P=0.654 P=0.494N P=0.490N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.424N P=0.651N P=0.490N P=0.490N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Granuloma Sperm |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 3/50 (6%) | |
|POLY-3 RATE (b) | 1/45.45 2/45.02 1/45.00 3/44.16 | |
|POLY-3 PERCENT (g) | 2.2% 4.4% 2.2% 6.8% | |
|TERMINAL (d) | 0/40 (0%) 2/41 (5%) 1/36 (3%) 3/34 (9%) | |
|FIRST INCIDENCE | 674 733 (T) 733 (T) 733 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.195 P=0.508 P=0.749 P=0.260 | |
|POLY 3 | P=0.241 P=0.497 P=0.758 P=0.295 | |
|POLY 1.5 | P=0.246 P=0.497 P=0.760 P=0.301 | |
|POLY 6 | P=0.232 P=0.498 P=0.755 P=0.286 | |
|LOGISTIC REGRESSION| P=0.230 P=0.498 P=0.762N P=0.294 | |
|COCH-ARM / FISHERS | P=0.249 P=0.500 P=0.753N P=0.309 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Esophagus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/49 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.23 0/45.02 0/45.00 0/44.16 |2/45.23 0/42.57 0/45.02 0/45.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |1/37 (3%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |610 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.297N P=0.281N P=0.246N P=0.240N |
|POLY 3 | (e) (e) (e) (e) |P=0.290N P=0.251N P=0.238N P=0.236N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.296N P=0.243N P=0.238N P=0.236N |
|POLY 6 | (e) (e) (e) (e) |P=0.281N P=0.261N P=0.238N P=0.235N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.306N P=0.213N P=0.219N P=0.220N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.306N P=0.242N P=0.242N P=0.242N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/3 (67%) 0/3 (0%) 0/2 (0%) 0/1 (0%) |0/2 (0%) 0/1 (0%) 0/2 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 2/2.78 0/3.00 0/2.00 0/1.00 |0/1.76 0/0.51 0/2.00 0/0.00 |
|POLY-3 PERCENT (g) | 72.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/2 (100%) 0/3 (0%) 0/2 (0%) 0/1 (0%) |0/1 (0%) 0/0 (0%) 0/2 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 733 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.454N P=0.122N P=0.193N P=0.362N |(e) (e) (e) (e) |
|POLY 3 | P=0.513N P=0.122N P=0.236N P=0.473N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.507N P=0.139N P=0.258N P=0.487N |(e) (e) (e) (e) |
|POLY 6 | P=0.527N P=0.093N P=0.195N P=0.444N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.454N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.200N P=0.300N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Gallbladder |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/42 (2%) 0/40 (0%) 0/41 (0%) 3/40 (8%) |0/41 (0%) 0/40 (0%) 0/40 (0%) 0/38 (0%) |
|POLY-3 RATE (b) | 1/38.85 0/35.68 0/37.23 3/38.03 |0/37.38 0/35.21 0/37.62 0/34.95 |
|POLY-3 PERCENT (g) | 2.6% 0.0% 0.0% 7.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/33 (0%) 0/31 (0%) 1/33 (3%) |0/31 (0%) 0/26 (0%) 0/31 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 733 (T) --- --- 552 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047 * P=0.512N P=0.524N P=0.287 |(e) (e) (e) (e) |
|POLY 3 | P=0.047 * P=0.517N P=0.509N P=0.297 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.046 * P=0.515N P=0.507N P=0.293 |(e) (e) (e) (e) |
|POLY 6 | P=0.049 * P=0.518N P=0.510N P=0.303 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.037 * (e) (e) P=0.282 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.045 * P=0.512N P=0.506N P=0.289 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 8/50 (16%) 7/50 (14%) 7/50 (14%) |8/49 (16%) 10/50 (20%) 13/50 (26%) 8/50 (16%) |
|POLY-3 RATE (b) | 9/47.00 8/45.02 7/45.77 7/45.83 |8/45.15 10/42.57 13/46.18 8/46.58 |
|POLY-3 PERCENT (g) | 19.2% 17.8% 15.3% 15.3% |17.7% 23.5% 28.2% 17.2% |
|TERMINAL (d) | 5/40 (13%) 8/41 (20%) 6/36 (17%) 4/34 (12%) |7/37 (19%) 10/28 (36%) 7/35 (20%) 6/36 (17%) |
|FIRST INCIDENCE | 421 733 (T) 448 469 |638 735 (T) 612 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.515N P=0.487N P=0.454N P=0.482N |P=0.324N P=0.177 P=0.156 P=0.591 |
|POLY 3 | P=0.398N P=0.539N P=0.415N P=0.414N |P=0.344N P=0.343 P=0.174 P=0.581N |
|POLY 1.5 | P=0.393N P=0.527N P=0.403N P=0.403N |P=0.368N P=0.373 P=0.168 P=0.588N |
|POLY 6 | P=0.411N P=0.549N P=0.436N P=0.432N |P=0.312N P=0.304 P=0.185 P=0.568N |
|LOGISTIC REGRESSION| P=0.392N P=0.500N P=0.400N P=0.379N |P=0.375N P=0.281 P=0.166 P=0.590N |
|COCH-ARM / FISHERS | P=0.394N P=0.500N P=0.393N P=0.393N |P=0.392N P=0.416 P=0.176 P=0.590N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Ileum |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 1/48 (2%) 0/47 (0%) 1/46 (2%) |0/47 (0%) 2/45 (4%) 0/49 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/42.85 1/43.68 0/42.80 1/41.48 |0/43.38 2/40.27 0/45.02 0/43.41 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 2.4% |0.0% 5.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 1/41 (2%) 0/35 (0%) 1/34 (3%) |0/37 (0%) 1/28 (4%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 733 (T) --- 733 (T) |--- 700 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443 P=0.510 (e) P=0.473 |P=0.371N P=0.193 (e) (e) |
|POLY 3 | P=0.466 P=0.504 (e) P=0.494 |P=0.392N P=0.221 (e) (e) |
|POLY 1.5 | P=0.469 P=0.505 (e) P=0.496 |P=0.390N P=0.224 (e) (e) |
|POLY 6 | P=0.462 P=0.504 (e) P=0.490 |P=0.395N P=0.215 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.510 (e) P=0.473 |P=0.386N P=0.220 (e) (e) |
|COCH-ARM / FISHERS | P=0.473 P=0.511 (e) P=0.500 |P=0.387N P=0.237 (e) (e) |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |0/49 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/44.56 2/45.02 0/45.00 0/43.63 |0/44.80 0/40.98 0/45.02 0/45.26 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 2/41 (5%) 0/36 (0%) 0/34 (0%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 733 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.425N P=0.244 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.396N P=0.239 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.394N P=0.240 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.397N P=0.240 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.244 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.392N P=0.253 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/50 (4%) 5/50 (10%) 1/49 (2%) |4/49 (8%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.56 2/45.02 5/45.00 1/43.63 |4/44.94 2/42.61 0/45.02 0/45.46 |
|POLY-3 PERCENT (g) | 6.7% 4.4% 11.1% 2.3% |8.9% 4.7% 0.0% 0.0% |
|TERMINAL (d) | 3/40 (8%) 2/41 (5%) 5/36 (14%) 1/34 (3%) |3/37 (8%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |700 728 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.323N P=0.489N P=0.299 P=0.365N |P=0.059N P=0.451N P=0.069N P=0.066N |
|POLY 3 | P=0.263N P=0.495N P=0.362 P=0.313N |P=0.056N P=0.362N P=0.060N P=0.059N |
|POLY 1.5 | P=0.258N P=0.495N P=0.366 P=0.308N |P=0.058N P=0.348N P=0.060N P=0.059N |
|POLY 6 | P=0.274N P=0.494N P=0.353 P=0.320N |P=0.054N P=0.381N P=0.059N P=0.057N |
|LOGISTIC REGRESSION| P=0.323N P=0.489N P=0.299 P=0.365N |P=0.056N P=0.391N P=0.061N P=0.059N |
|COCH-ARM / FISHERS | P=0.256N P=0.490N P=0.369 P=0.309N |P=0.062N P=0.329N P=0.056N P=0.056N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 3/50 (6%) 5/50 (10%) 2/49 (4%) |4/49 (8%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/44.56 3/45.02 5/45.55 2/43.63 |4/44.88 1/42.57 1/45.02 3/45.46 |
|POLY-3 PERCENT (g) | 6.7% 6.7% 11.0% 4.6% |8.9% 2.4% 2.2% 6.6% |
|TERMINAL (d) | 3/40 (8%) 3/41 (7%) 4/36 (11%) 2/34 (6%) |3/37 (8%) 1/28 (4%) 1/35 (3%) 3/36 (8%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 561 733 (T) |714 735 (T) 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.460N P=0.652N P=0.309 P=0.574N |P=0.550 P=0.264N P=0.195N P=0.507N |
|POLY 3 | P=0.389N P=0.658N P=0.369 P=0.510N |P=0.531 P=0.195N P=0.178N P=0.493N |
|POLY 1.5 | P=0.382N P=0.657N P=0.370 P=0.504N |P=0.521 P=0.186N P=0.178N P=0.494N |
|POLY 6 | P=0.402N P=0.657N P=0.363 P=0.519N |P=0.547 P=0.207N P=0.176N P=0.488N |
|LOGISTIC REGRESSION| P=0.390N P=0.652N P=0.365 P=0.574N |P=0.552 P=0.221N P=0.175N P=0.480N |
|COCH-ARM / FISHERS | P=0.378N P=0.651N P=0.369 P=0.500N |P=0.510 P=0.175N P=0.175N P=0.489N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 47/49 (96%) 46/50 (92%) 47/50 (94%) 41/49 (84%) |45/49 (92%) 40/50 (80%) 40/50 (80%) 41/50 (82%) |
|POLY-3 RATE (b) | 47/49.00 46/48.42 47/49.88 41/47.43 |45/49.00 40/47.40 40/48.70 41/47.86 |
|POLY-3 PERCENT (g) | 95.9% 95.0% 94.2% 86.5% |91.8% 84.4% 82.1% 85.7% |
|TERMINAL (d) | 38/40 (95%) 39/41 (95%) 34/36 (94%) 30/34 (88%) |33/37 (89%) 25/28 (89%) 27/35 (77%) 31/36 (86%) |
|FIRST INCIDENCE | 384 495 448 467 |363 527 356 309 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.527 P=0.421N P=0.285 P=0.577N |P=0.197N P=0.281 P=0.339N P=0.317N |
|POLY 3 | P=0.033N* P=0.608N P=0.530N P=0.088N |P=0.424N P=0.200N P=0.129N P=0.257N |
|POLY 1.5 | P=0.023N* P=0.541N P=0.520N P=0.065N |P=0.392N P=0.145N P=0.123N P=0.204N |
|POLY 6 | P=0.060N P=0.658N P=0.549N P=0.134N |P=0.444N P=0.273N P=0.139N P=0.309N |
|LOGISTIC REGRESSION| P=0.021N* P=0.389N P=0.494N P=0.048N* |P=0.331N P=0.109N P=0.091N P=0.140N |
|COCH-ARM / FISHERS | P=0.025N* P=0.349N P=0.510N P=0.046N* |P=0.339N P=0.080N P=0.080N P=0.125N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.56 0/45.02 0/45.00 2/43.67 |1/45.08 0/42.57 0/45.02 0/45.46 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 4.6% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/41 (0%) 0/36 (0%) 1/34 (3%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 733 (T) --- --- 723 |659 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.147 P=0.495N P=0.521N P=0.453 |P=0.533N P=0.530N P=0.500N P=0.495N |
|POLY 3 | P=0.170 P=0.498N P=0.498N P=0.493 |P=0.534N P=0.511N P=0.500N P=0.498N |
|POLY 1.5 | P=0.172 P=0.498N P=0.496N P=0.497 |P=0.538N P=0.505N P=0.500N P=0.498N |
|POLY 6 | P=0.167 P=0.497N P=0.501N P=0.486 |P=0.529N P=0.520N P=0.500N P=0.497N |
|LOGISTIC REGRESSION| P=0.159 (e) (e) P=0.478 |P=0.546N P=0.472N P=0.479N P=0.480N |
|COCH-ARM / FISHERS | P=0.172 P=0.495N P=0.495N P=0.500 |P=0.545N P=0.495N P=0.495N P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 6/50 (12%) 13/50 (26%) 13/50 (26%) |8/49 (16%) 7/50 (14%) 6/50 (12%) 3/50 (6%) |
|POLY-3 RATE (b) | 9/45.23 6/45.02 13/45.42 13/44.72 |8/45.74 7/43.10 6/45.16 3/45.54 |
|POLY-3 PERCENT (g) | 19.9% 13.3% 28.6% 29.1% |17.5% 16.2% 13.3% 6.6% |
|TERMINAL (d) | 9/40 (23%) 6/41 (15%) 11/36 (31%) 9/34 (27%) |5/37 (14%) 6/28 (21%) 5/35 (14%) 2/36 (6%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 654 634 |599 571 700 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044 * P=0.267N P=0.162 P=0.136 |P=0.063N P=0.532 P=0.417N P=0.109N |
|POLY 3 | P=0.099 P=0.290N P=0.234 P=0.221 |P=0.073N P=0.550N P=0.396N P=0.099N |
|POLY 1.5 | P=0.105 P=0.292N P=0.236 P=0.229 |P=0.076N P=0.522N P=0.393N P=0.098N |
|POLY 6 | P=0.090 P=0.284N P=0.230 P=0.211 |P=0.067N P=0.588N P=0.401N P=0.099N |
|LOGISTIC REGRESSION| P=0.077 P=0.267N P=0.210 P=0.189 |P=0.073N P=0.510N P=0.381N P=0.095N |
|COCH-ARM / FISHERS | P=0.110 P=0.288N P=0.235 P=0.235 |P=0.078N P=0.483N P=0.371N P=0.094N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 21/50 (42%) 16/50 (32%) 21/50 (42%) |2/49 (4%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 17/45.23 21/45.71 16/45.00 21/45.29 |2/44.80 2/42.90 4/45.43 1/45.46 |
|POLY-3 PERCENT (g) | 37.6% 45.9% 35.6% 46.4% |4.5% 4.7% 8.8% 2.2% |
|TERMINAL (d) | 17/40 (43%) 20/41 (49%) 16/36 (44%) 19/34 (56%) |2/37 (5%) 1/28 (4%) 1/35 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 733 (T) 495 733 (T) 467 |735 (T) 644 686 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.097 P=0.293 P=0.524 P=0.096 |P=0.312N P=0.610 P=0.333 P=0.510N |
|POLY 3 | P=0.303 P=0.274 P=0.507N P=0.261 |P=0.334N P=0.678 P=0.344 P=0.495N |
|POLY 1.5 | P=0.315 P=0.267 P=0.500N P=0.269 |P=0.341N P=0.687 P=0.340 P=0.496N |
|POLY 6 | P=0.280 P=0.289 P=0.524N P=0.245 |P=0.322N P=0.667 P=0.349 P=0.491N |
|LOGISTIC REGRESSION| P=0.237 P=0.262 P=0.524 P=0.208 |P=0.338N P=0.683 P=0.339 P=0.510N |
|COCH-ARM / FISHERS | P=0.313 P=0.268 P=0.500N P=0.268 |P=0.345N P=0.684N P=0.349 P=0.492N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 9/50 (18%) 7/50 (14%) 19/50 (38%) |8/49 (16%) 6/50 (12%) 11/50 (22%) 11/50 (22%) |
|POLY-3 RATE (b) | 10/45.45 9/45.57 7/45.46 19/44.90 |8/45.64 6/42.86 11/45.88 11/45.54 |
|POLY-3 PERCENT (g) | 22.0% 19.8% 15.4% 42.3% |17.5% 14.0% 24.0% 24.2% |
|TERMINAL (d) | 9/40 (23%) 8/41 (20%) 6/36 (17%) 18/34 (53%) |6/37 (16%) 5/28 (18%) 8/35 (23%) 10/36 (28%) |
|FIRST INCIDENCE | 674 561 596 467 |610 658 612 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.480N P=0.373N P=0.010 * |P=0.258 P=0.574N P=0.282 P=0.294 |
|POLY 3 | P=0.003 ** P=0.498N P=0.295N P=0.030 * |P=0.203 P=0.436N P=0.308 P=0.302 |
|POLY 1.5 | P=0.003 ** P=0.502N P=0.294N P=0.034 * |P=0.196 P=0.409N P=0.306 P=0.306 |
|POLY 6 | P=0.002 ** P=0.489N P=0.302N P=0.024 * |P=0.218 P=0.471N P=0.313 P=0.301 |
|LOGISTIC REGRESSION| P=0.003 ** P=0.503N P=0.304N P=0.027 * |P=0.213 P=0.414N P=0.313 P=0.318 |
|COCH-ARM / FISHERS | P=0.004 ** P=0.500N P=0.298N P=0.038 * |P=0.193 P=0.371N P=0.323 P=0.323 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Erythrophagocytosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 9/50 (18%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.23 0/45.02 0/45.00 9/44.52 |0/44.80 0/42.57 0/45.02 0/45.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 20.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 8/34 (24%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- 634 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.002 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.002 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 3/50 (6%) |2/49 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/45.23 0/45.02 3/45.42 3/44.16 |2/45.21 0/42.57 2/45.12 2/45.46 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 6.6% 6.8% |4.4% 0.0% 4.4% 4.4% |
|TERMINAL (d) | 1/40 (3%) 0/41 (0%) 2/36 (6%) 3/34 (9%) |1/37 (3%) 0/28 (0%) 1/35 (3%) 2/36 (6%) |
|FIRST INCIDENCE | 733 (T) --- 612 733 (T) |616 --- 710 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.111 P=0.495N P=0.277 P=0.249 |P=0.474 P=0.278N P=0.685 P=0.690 |
|POLY 3 | P=0.142 P=0.501N P=0.307 P=0.297 |P=0.458 P=0.251N P=0.693 P=0.692N |
|POLY 1.5 | P=0.146 P=0.501N P=0.307 P=0.302 |P=0.449 P=0.243N P=0.693 P=0.691N |
|POLY 6 | P=0.134 P=0.500N P=0.305 P=0.289 |P=0.474 P=0.261N P=0.694 P=0.690N |
|LOGISTIC REGRESSION| P=0.143 (e) P=0.305 P=0.249 |P=0.444 P=0.215N P=0.687N P=0.688N |
|COCH-ARM / FISHERS | P=0.149 P=0.500N P=0.309 P=0.309 |P=0.440 P=0.242N P=0.684N P=0.684N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/45.23 0/45.02 1/45.00 0/44.16 |0/44.80 2/42.99 0/45.02 3/45.58 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.2% 0.0% |0.0% 4.7% 0.0% 6.6% |
|TERMINAL (d) | 1/40 (3%) 0/41 (0%) 1/36 (3%) 0/34 (0%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 733 (T) --- 733 (T) --- |--- 658 --- 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.516N P=0.495N P=0.738 P=0.532N |P=0.127 P=0.212 (e) P=0.127 |
|POLY 3 | P=0.482N P=0.501N P=0.760 P=0.505N |P=0.104 P=0.228 (e) P=0.122 |
|POLY 1.5 | P=0.479N P=0.501N P=0.760N P=0.502N |P=0.104 P=0.233 (e) P=0.121 |
|POLY 6 | P=0.488N P=0.500N P=0.757 P=0.509N |P=0.106 P=0.222 (e) P=0.124 |
|LOGISTIC REGRESSION| P=0.516N (e) P=0.738 (e) |P=0.107 P=0.253 (e) P=0.124 |
|COCH-ARM / FISHERS | P=0.478N P=0.500N P=0.753N P=0.500N |P=0.106 P=0.253 (e) P=0.125 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/49 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.23 1/45.02 0/45.00 0/44.16 |1/44.80 2/42.86 0/45.02 0/45.46 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |2.2% 4.7% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 1/41 (2%) 0/36 (0%) 0/34 (0%) |1/37 (3%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 733 (T) --- --- |735 (T) 658 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.637N P=0.505 (e) (e) |P=0.229N P=0.429 P=0.511N P=0.505N |
|POLY 3 | P=0.610N P=0.499 (e) (e) |P=0.240N P=0.485 P=0.499N P=0.497N |
|POLY 1.5 | P=0.610N P=0.499 (e) (e) |P=0.239N P=0.494 P=0.500N P=0.498N |
|POLY 6 | P=0.610N P=0.500 (e) (e) |P=0.240N P=0.474 P=0.498N P=0.495N |
|LOGISTIC REGRESSION| (e) P=0.505 (e) (e) |P=0.236N P=0.492 (e) (e) |
|COCH-ARM / FISHERS | P=0.608N P=0.500 (e) (e) |P=0.238N P=0.508 P=0.495N P=0.495N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) 9/50 (18%) 3/50 (6%) |16/49 (33%) 11/50 (22%) 16/50 (32%) 16/50 (32%) |
|POLY-3 RATE (b) | 5/46.04 6/45.02 9/45.00 3/44.16 |16/45.63 11/44.37 16/45.44 16/45.69 |
|POLY-3 PERCENT (g) | 10.9% 13.3% 20.0% 6.8% |35.1% 24.8% 35.2% 35.0% |
|TERMINAL (d) | 4/40 (10%) 6/41 (15%) 9/36 (25%) 3/34 (9%) |13/37 (35%) 6/28 (21%) 13/35 (37%) 15/36 (42%) |
|FIRST INCIDENCE | 421 733 (T) 733 (T) 733 (T) |616 532 672 674 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.288N P=0.516 P=0.143 P=0.435N |P=0.477 P=0.416N P=0.527 P=0.562 |
|POLY 3 | P=0.214N P=0.484 P=0.179 P=0.379N |P=0.376 P=0.201N P=0.581 P=0.585N |
|POLY 1.5 | P=0.203N P=0.487 P=0.186 P=0.369N |P=0.368 P=0.187N P=0.582 P=0.581N |
|POLY 6 | P=0.231N P=0.486 P=0.170 P=0.393N |P=0.394 P=0.220N P=0.581 P=0.583N |
|LOGISTIC REGRESSION| P=0.209N P=0.498 P=0.193 P=0.354N |P=0.407 P=0.192N P=0.575N P=0.554N |
|COCH-ARM / FISHERS | P=0.195N P=0.500 P=0.194 P=0.357N |P=0.370 P=0.168N P=0.558N P=0.558N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 19/50 (38%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.23 1/45.08 3/45.68 19/44.99 |0/44.80 0/42.57 1/45.02 1/45.54 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 6.6% 42.2% |0.0% 0.0% 2.2% 2.2% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 1/36 (3%) 15/34 (44%) |0/37 (0%) 0/28 (0%) 1/35 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- 718 623 530 |--- --- 735 (T) 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.510 P=0.115 P<0.001 ** |P=0.376 (e) P=0.489 P=0.515 |
|POLY 3 | P<0.001 ** P=0.499 P=0.120 P<0.001 ** |P=0.361 (e) P=0.501 P=0.503 |
|POLY 1.5 | P<0.001 ** P=0.499 P=0.120 P<0.001 ** |P=0.355 (e) P=0.500 P=0.502 |
|POLY 6 | P<0.001 ** P=0.501 P=0.120 P<0.001 ** |P=0.371 (e) P=0.502 P=0.506 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.499 P=0.115 P<0.001 ** |P=0.362 (e) P=0.489 P=0.503 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.121 P<0.001 ** |P=0.351 (e) P=0.505 P=0.505 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Syncytial Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 28/50 (56%) 36/50 (72%) 44/50 (88%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 26/47.18 28/47.26 36/47.17 44/48.70 |0/44.80 0/42.57 0/45.02 0/45.46 |
|POLY-3 PERCENT (g) | 55.1% 59.2% 76.3% 90.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 22/40 (55%) 24/41 (59%) 28/36 (78%) 33/34 (97%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 384 203 468 467 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.463 P=0.015 * P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P=0.421 P=0.021 * P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.422 P=0.024 * P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.422 P=0.018 * P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.415 P=0.030 * P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.421 P=0.032 * P<0.001 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Tension Lipidosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 0/50 (0%) 1/50 (2%) |0/49 (0%) 3/50 (6%) 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/45.23 5/45.71 0/45.00 1/44.17 |0/44.80 3/42.57 0/45.02 4/46.12 |
|POLY-3 PERCENT (g) | 4.4% 10.9% 0.0% 2.3% |0.0% 7.1% 0.0% 8.7% |
|TERMINAL (d) | 2/40 (5%) 4/41 (10%) 0/36 (0%) 0/34 (0%) |0/37 (0%) 3/28 (11%) 0/35 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 733 (T) 495 --- 731 |--- 735 (T) --- 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.243N P=0.230 P=0.262N P=0.553N |P=0.095 P=0.076 (e) P=0.073 |
|POLY 3 | P=0.201N P=0.220 P=0.238N P=0.508N |P=0.072 P=0.110 (e) P=0.064 |
|POLY 1.5 | P=0.198N P=0.217 P=0.237N P=0.504N |P=0.071 P=0.115 (e) P=0.063 |
|POLY 6 | P=0.204N P=0.225 P=0.241N P=0.515N |P=0.075 P=0.103 (e) P=0.067 |
|LOGISTIC REGRESSION| P=0.199N P=0.216 (e) P=0.529N |P=0.075 P=0.076 (e) P=0.067 |
|COCH-ARM / FISHERS | P=0.198N P=0.218 P=0.247N P=0.500N |P=0.073 P=0.125 (e) P=0.061 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 4/50 (8%) 36/50 (72%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.23 0/45.02 4/45.29 36/47.11 |0/44.80 0/42.57 0/45.02 0/45.46 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 8.8% 76.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/40 (5%) 0/41 (0%) 3/36 (8%) 28/34 (82%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 733 (T) --- 654 467 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.233N P=0.299 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P=0.238N P=0.338 P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.239N P=0.339 P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.237N P=0.335 P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.332 P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.247N P=0.339 P<0.001 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 4/50 (8%) 2/50 (4%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.23 0/45.02 4/46.44 2/44.61 |0/44.80 1/42.59 0/45.02 2/46.58 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 8.6% 4.5% |0.0% 2.4% 0.0% 4.3% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 1/34 (3%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 448 602 |--- 731 --- 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.233 (e) P=0.067 P=0.220 |P=0.162 P=0.458 (e) P=0.245 |
|POLY 3 | P=0.240 (e) P=0.064 P=0.234 |P=0.159 P=0.490 (e) P=0.246 |
|POLY 1.5 | P=0.245 (e) P=0.063 P=0.236 |P=0.157 P=0.496 (e) P=0.243 |
|POLY 6 | P=0.232 (e) P=0.064 P=0.231 |P=0.163 P=0.482 (e) P=0.251 |
|LOGISTIC REGRESSION| P=0.225 (e) P=0.044 * P=0.237 |P=0.148 P=0.472 (e) P=0.318 |
|COCH-ARM / FISHERS | P=0.248 (e) P=0.059 P=0.247 |P=0.154 P=0.505 (e) P=0.253 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/45.23 0/45.02 2/45.00 1/44.74 |0/44.80 0/42.57 3/45.02 0/45.46 |
|POLY-3 PERCENT (g) | 6.6% 0.0% 4.4% 2.2% |0.0% 0.0% 6.7% 0.0% |
|TERMINAL (d) | 3/40 (8%) 0/41 (0%) 2/36 (6%) 0/34 (0%) |0/37 (0%) 0/28 (0%) 3/35 (9%) 0/36 (0%) |
|FIRST INCIDENCE | 733 (T) --- 733 (T) 552 |--- --- 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.515N P=0.117N P=0.548N P=0.351N |P=0.557N (e) P=0.111 (e) |
|POLY 3 | P=0.464N P=0.119N P=0.502N P=0.309N |P=0.567N (e) P=0.119 (e) |
|POLY 1.5 | P=0.460N P=0.120N P=0.500N P=0.307N |P=0.575N (e) P=0.119 (e) |
|POLY 6 | P=0.471N P=0.118N P=0.507N P=0.314N |P=0.554N (e) P=0.120 (e) |
|LOGISTIC REGRESSION| P=0.462N (e) P=0.548N P=0.303N |(e) (e) P=0.111 (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.121N P=0.500N P=0.309N |P=0.578N (e) P=0.125 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 2/50 (4%) 6/50 (12%) |4/49 (8%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 5/45.54 2/45.02 2/45.00 6/44.61 |4/45.21 2/42.57 3/45.02 4/45.46 |
|POLY-3 PERCENT (g) | 11.0% 4.4% 4.4% 13.5% |8.9% 4.7% 6.7% 8.8% |
|TERMINAL (d) | 4/40 (10%) 2/41 (5%) 2/36 (6%) 5/34 (15%) |3/37 (8%) 2/28 (7%) 3/35 (9%) 4/36 (11%) |
|FIRST INCIDENCE | 649 733 (T) 733 (T) 602 |616 735 (T) 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123 P=0.210N P=0.257N P=0.401 |P=0.484 P=0.454N P=0.526N P=0.633 |
|POLY 3 | P=0.179 P=0.221N P=0.221N P=0.486 |P=0.458 P=0.365N P=0.502N P=0.640N |
|POLY 1.5 | P=0.184 P=0.221N P=0.218N P=0.494 |P=0.448 P=0.350N P=0.502N P=0.640N |
|POLY 6 | P=0.172 P=0.220N P=0.227N P=0.472 |P=0.474 P=0.386N P=0.503N P=0.638N |
|LOGISTIC REGRESSION| P=0.172 P=0.217N P=0.220N P=0.487 |P=0.473 P=0.359N P=0.497N P=0.635N |
|COCH-ARM / FISHERS | P=0.186 P=0.218N P=0.218N P=0.500 |P=0.439 P=0.329N P=0.489N P=0.631N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |3/49 (6%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/45.23 2/45.02 0/45.00 0/44.16 |3/44.80 0/42.57 1/45.16 3/45.46 |
|POLY-3 PERCENT (g) | 2.2% 4.4% 0.0% 0.0% |6.7% 0.0% 2.2% 6.6% |
|TERMINAL (d) | 1/40 (3%) 2/41 (5%) 0/36 (0%) 0/34 (0%) |3/37 (8%) 0/28 (0%) 0/35 (0%) 3/36 (8%) |
|FIRST INCIDENCE | 733 (T) 733 (T) --- --- |735 (T) --- 700 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.272N P=0.509 P=0.521N P=0.532N |P=0.326 P=0.174N P=0.319N P=0.651 |
|POLY 3 | P=0.243N P=0.498 P=0.501N P=0.505N |P=0.311 P=0.128N P=0.302N P=0.656N |
|POLY 1.5 | P=0.242N P=0.498 P=0.500N P=0.502N |P=0.302 P=0.123N P=0.304N P=0.657N |
|POLY 6 | P=0.245N P=0.501 P=0.503N P=0.509N |P=0.325 P=0.135N P=0.299N P=0.651N |
|LOGISTIC REGRESSION| P=0.272N P=0.509 (e) (e) |P=0.323 (e) P=0.301N P=0.651 |
|COCH-ARM / FISHERS | P=0.240N P=0.500 P=0.500N P=0.500N |P=0.292 P=0.117N P=0.301N P=0.651N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/48 (0%) 0/50 (0%) 0/47 (0%) |0/47 (0%) 1/47 (2%) 2/50 (4%) 2/47 (4%) |
|POLY-3 RATE (b) | 2/44.99 0/43.08 0/45.00 0/42.05 |0/43.26 1/40.27 2/45.26 2/43.36 |
|POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |0.0% 2.5% 4.4% 4.6% |
|TERMINAL (d) | 1/40 (3%) 0/40 (0%) 0/36 (0%) 0/34 (0%) |0/36 (0%) 1/27 (4%) 1/35 (3%) 2/35 (6%) |
|FIRST INCIDENCE | 606 --- --- --- |--- 735 (T) 672 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326N P=0.247N P=0.256N P=0.265N |P=0.298 P=0.443 P=0.242 P=0.232 |
|POLY 3 | P=0.309N P=0.247N P=0.237N P=0.252N |P=0.273 P=0.486 P=0.247 P=0.238 |
|POLY 1.5 | P=0.310N P=0.246N P=0.234N P=0.249N |P=0.268 P=0.492 P=0.247 P=0.236 |
|POLY 6 | P=0.309N P=0.248N P=0.242N P=0.257N |P=0.281 P=0.478 P=0.248 P=0.240 |
|LOGISTIC REGRESSION| P=0.317N P=0.233N P=0.237N P=0.247N |P=0.279 P=0.443 P=0.250 P=0.232 |
|COCH-ARM / FISHERS | P=0.314N P=0.253N P=0.242N P=0.258N |P=0.263 P=0.500 P=0.263 P=0.247 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/48 (0%) 0/50 (0%) 1/47 (2%) |0/47 (0%) 0/47 (0%) 0/50 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 2/44.56 0/43.08 0/45.00 1/42.79 |0/43.26 0/40.27 0/45.02 0/43.36 |
|POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/40 (5%) 0/40 (0%) 0/36 (0%) 0/34 (0%) |0/36 (0%) 0/27 (0%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 733 (T) --- --- 467 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.679 P=0.238N P=0.262N P=0.533N |(e) (e) (e) (e) |
|POLY 3 | P=0.696 P=0.245N P=0.235N P=0.514N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.696 P=0.244N P=0.233N P=0.513N |(e) (e) (e) (e) |
|POLY 6 | P=0.695 P=0.244N P=0.238N P=0.517N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.680 (e) (e) P=0.525N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.693 P=0.253N P=0.242N P=0.516N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/48 (4%) 1/50 (2%) 2/47 (4%) |1/47 (2%) 1/47 (2%) 0/50 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/44.56 2/43.08 1/45.00 2/42.05 |1/43.26 1/40.27 0/45.02 0/43.36 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 2.2% 4.8% |2.3% 2.5% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 2/40 (5%) 1/36 (3%) 2/34 (6%) |1/36 (3%) 1/27 (4%) 0/35 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- 733 (T) 733 (T) 733 (T) |735 (T) 735 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.286 P=0.238 P=0.479 P=0.203 |P=0.333N P=0.697 P=0.506N P=0.506N |
|POLY 3 | P=0.322 P=0.230 P=0.502 P=0.224 |P=0.347N P=0.745 P=0.492N P=0.500N |
|POLY 1.5 | P=0.326 P=0.230 P=0.504 P=0.226 |P=0.348N P=0.751 P=0.492N P=0.501N |
|POLY 6 | P=0.317 P=0.230 P=0.499 P=0.221 |P=0.345N P=0.736 P=0.492N P=0.497N |
|LOGISTIC REGRESSION| (e) P=0.238 P=0.479 P=0.203 |P=0.333N P=0.697 (e) (e) |
|COCH-ARM / FISHERS | P=0.327 P=0.242 P=0.505 P=0.237 |P=0.349N P=0.753N P=0.485N P=0.500N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/0 (0%) 0/3 (0%) 0/1 (0%) |2/5 (40%) 0/2 (0%) 0/4 (0%) 0/1 (0%) |
|POLY-3 RATE (b) | 0/0.65 0/0.00 0/2.43 0/0.43 |2/4.12 0/1.50 0/3.44 0/0.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |48.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |0/2 (0%) 0/0 (0%) 0/2 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- |599 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.301N P=0.276N P=0.246N P=0.243N |
|POLY 3 | (e) (e) (e) (e) |P=0.460N P=0.476N P=0.240N P=0.690N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.499N P=0.454N P=0.239N P=0.656N |
|POLY 6 | (e) (e) (e) (e) |P=0.355N P=0.522N P=0.263N P=0.748N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.524N P=0.438N P=0.259N P=0.652N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.524N P=0.476N P=0.278N P=0.667N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/1 (0%) |2/48 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/1.00 0/1.00 |2/43.88 1/43.06 1/45.03 0/45.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.6% 2.3% 2.2% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/1 (0%) |2/37 (5%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |735 (T) 588 734 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.204N P=0.569N P=0.516N P=0.244N |
|POLY 3 | (e) (e) (e) (e) |P=0.204N P=0.507N P=0.491N P=0.229N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.207N P=0.498N P=0.492N P=0.230N |
|POLY 6 | (e) (e) (e) (e) |P=0.198N P=0.517N P=0.490N P=0.227N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.210N P=0.472N P=0.503N (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.210N P=0.485N P=0.485N P=0.237N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/14 (21%) 1/11 (9%) 2/10 (20%) 3/15 (20%) |2/17 (12%) 0/18 (0%) 0/12 (0%) 2/18 (11%) |
|POLY-3 RATE (b) | 3/12.72 1/9.69 2/9.87 3/14.17 |2/16.38 0/16.36 0/11.33 2/17.37 |
|POLY-3 PERCENT (g) | 23.6% 10.3% 20.3% 21.2% |12.2% 0.0% 0.0% 11.5% |
|TERMINAL (d) | 3/11 (27%) 1/9 (11%) 2/9 (22%) 3/11 (27%) |1/14 (7%) 0/12 (0%) 0/10 (0%) 2/14 (14%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |659 --- --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.471 P=0.371N P=0.600N P=0.680 |P=0.380 P=0.271N P=0.276N P=0.694N |
|POLY 3 | P=0.557 P=0.401N P=0.622N P=0.619N |P=0.389 P=0.232N P=0.319N P=0.676N |
|POLY 1.5 | P=0.547 P=0.398N P=0.637N P=0.627N |P=0.383 P=0.227N P=0.318N P=0.676N |
|POLY 6 | P=0.566 P=0.401N P=0.605N P=0.610N |P=0.397 P=0.241N P=0.319N P=0.679N |
|LOGISTIC REGRESSION| P=0.471 P=0.371N P=0.600N P=0.680 |P=0.369 P=0.201N P=0.297N P=0.697N |
|COCH-ARM / FISHERS | P=0.530 P=0.396N P=0.668N P=0.639N |P=0.372 P=0.229N P=0.335N P=0.677N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/14 (86%) 9/11 (82%) 9/10 (90%) 12/15 (80%) |16/17 (94%) 16/18 (89%) 11/12 (92%) 16/18 (89%) |
|POLY-3 RATE (b) | 12/14.00 9/10.38 9/10.00 12/14.80 |16/16.72 16/17.35 11/12.00 16/18.00 |
|POLY-3 PERCENT (g) | 85.7% 86.7% 90.0% 81.1% |95.7% 92.2% 91.7% 88.9% |
|TERMINAL (d) | 9/11 (82%) 8/9 (89%) 8/9 (89%) 10/11 (91%) |14/14 (100%) 12/12 (100%) 9/10 (90%) 12/14 (86%) |
|FIRST INCIDENCE | 476 495 700 530 |568 588 511 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.468 P=0.450N P=0.461N P=0.623 |P=0.454N P=0.293 P=0.477N P=0.625N |
|POLY 3 | P=0.448N P=0.697 P=0.618 P=0.565N |P=0.407N P=0.626N P=0.640N P=0.454N |
|POLY 1.5 | P=0.452N P=0.692N P=0.618 P=0.549N |P=0.455N P=0.583N P=0.661N P=0.486N |
|POLY 6 | P=0.461N P=0.650 P=0.618 P=0.594N |P=0.344N P=0.662N P=0.599N P=0.401N |
|LOGISTIC REGRESSION| P=0.451N P=0.626N (e) P=0.555N |P=0.444N P=0.656N P=0.703N P=0.493N |
|COCH-ARM / FISHERS | P=0.467N P=0.604N P=0.629 P=0.535N |P=0.517N P=0.522N P=0.665N P=0.522N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 4/50 (8%) 2/48 (4%) |3/49 (6%) 1/50 (2%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/45.66 2/45.99 4/45.73 2/43.27 |3/44.80 1/42.58 0/45.02 1/44.56 |
|POLY-3 PERCENT (g) | 2.2% 4.4% 8.8% 4.6% |6.7% 2.4% 0.0% 2.2% |
|TERMINAL (d) | 0/40 (0%) 1/41 (2%) 1/36 (3%) 1/34 (3%) |3/37 (8%) 0/28 (0%) 0/35 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 606 203 612 552 |735 (T) 733 --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.527 P=0.495 P=0.171 P=0.474 |P=0.382N P=0.406N P=0.131N P=0.315N |
|POLY 3 | P=0.539 P=0.503 P=0.179 P=0.481 |P=0.399N P=0.324N P=0.118N P=0.307N |
|POLY 1.5 | P=0.544 P=0.502 P=0.180 P=0.484 |P=0.405N P=0.313N P=0.118N P=0.309N |
|POLY 6 | P=0.529 P=0.503 P=0.177 P=0.476 |P=0.390N P=0.337N P=0.117N P=0.302N |
|LOGISTIC REGRESSION| P=0.508 P=0.600 P=0.170 P=0.469 |P=0.382N P=0.373N (e) P=0.315N |
|COCH-ARM / FISHERS | P=0.549 P=0.500 P=0.181 P=0.485 |P=0.412N P=0.301N P=0.117N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/48 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/45.23 2/45.99 0/45.00 0/42.69 |0/44.80 0/42.57 0/45.02 0/44.56 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 1/41 (2%) 0/36 (0%) 0/34 (0%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 203 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.408N P=0.242 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.398N P=0.241 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.397N P=0.240 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.398N P=0.243 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.520N P=0.311 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.399N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Glands |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 3/48 (6%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 5/49 (10%) |
|POLY-3 RATE (b) | 2/45.23 2/45.02 1/45.00 3/42.69 |0/44.80 0/42.57 1/45.02 5/44.56 |
|POLY-3 PERCENT (g) | 4.4% 4.4% 2.2% 7.0% |0.0% 0.0% 2.2% 11.2% |
|TERMINAL (d) | 2/40 (5%) 2/41 (5%) 1/36 (3%) 3/34 (9%) |0/37 (0%) 0/28 (0%) 1/35 (3%) 5/36 (14%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |--- --- 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.292 P=0.686N P=0.537N P=0.426 |P=0.002 ** (e) P=0.489 P=0.031 * |
|POLY 3 | P=0.342 P=0.692 P=0.502N P=0.474 |P<0.001 ** (e) P=0.501 P=0.030 * |
|POLY 1.5 | P=0.346 P=0.691 P=0.500N P=0.478 |P<0.001 ** (e) P=0.500 P=0.030 * |
|POLY 6 | P=0.335 P=0.693N P=0.506N P=0.467 |P<0.001 ** (e) P=0.502 P=0.031 * |
|LOGISTIC REGRESSION| P=0.292 P=0.686N P=0.537N P=0.426 |(e) (e) P=0.489 P=0.031 * |
|COCH-ARM / FISHERS | P=0.347 P=0.691N P=0.500N P=0.480 |P<0.001 ** (e) P=0.505 P=0.028 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 0/48 (0%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 1/45.23 1/45.99 3/45.73 0/42.69 |0/44.80 0/42.57 1/45.02 2/44.64 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 6.6% 0.0% |0.0% 0.0% 2.2% 4.5% |
|TERMINAL (d) | 1/40 (3%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |0/37 (0%) 0/28 (0%) 1/35 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 733 (T) 203 612 --- |--- --- 735 (T) 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.330N P=0.758N P=0.291 P=0.532N |P=0.116 (e) P=0.489 P=0.245 |
|POLY 3 | P=0.325N P=0.757N P=0.309 P=0.512N |P=0.099 (e) P=0.501 P=0.236 |
|POLY 1.5 | P=0.320N P=0.758N P=0.309 P=0.510N |P=0.096 (e) P=0.500 P=0.235 |
|POLY 6 | P=0.333N P=0.755N P=0.309 P=0.515N |P=0.104 (e) P=0.502 P=0.239 |
|LOGISTIC REGRESSION| P=0.362N P=0.689N P=0.301 (e) |P=0.106 (e) P=0.489 P=0.238 |
|COCH-ARM / FISHERS | P=0.315N P=0.753N P=0.309 P=0.510N |P=0.095 (e) P=0.505 P=0.247 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/49 (0%) 2/49 (4%) 1/49 (2%) 1/48 (2%) |
|POLY-3 RATE (b) | |0/44.80 2/41.74 1/44.32 1/44.44 |
|POLY-3 PERCENT (g) | |0.0% 4.8% 2.3% 2.3% |
|TERMINAL (d) | |0/37 (0%) 1/27 (4%) 1/35 (3%) 0/35 (0%) |
|FIRST INCIDENCE | |--- 692 735 (T) 686 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.675 P=0.195 P=0.489 P=0.514 |
|POLY 3 | |P=0.653 P=0.222 P=0.498 P=0.498 |
|POLY 1.5 | |P=0.649 P=0.228 P=0.497 P=0.496 |
|POLY 6 | |P=0.659 P=0.214 P=0.500 P=0.502 |
|LOGISTIC REGRESSION| |P=0.654 P=0.221 P=0.489 P=0.499 |
|COCH-ARM / FISHERS | |P=0.648 P=0.247 P=0.500 P=0.495 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |16/49 (33%) 11/49 (22%) 8/49 (16%) 10/48 (21%) |
|POLY-3 RATE (b) | |16/45.83 11/42.77 8/44.67 10/44.29 |
|POLY-3 PERCENT (g) | |34.9% 25.7% 17.9% 22.6% |
|TERMINAL (d) | |12/37 (32%) 7/27 (26%) 6/35 (17%) 9/35 (26%) |
|FIRST INCIDENCE | |568 601 652 727 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.183N P=0.448N P=0.070N P=0.157N |
|POLY 3 | |P=0.229N P=0.238N P=0.053N P=0.144N |
|POLY 1.5 | |P=0.240N P=0.215N P=0.054N P=0.144N |
|POLY 6 | |P=0.215N P=0.271N P=0.052N P=0.142N |
|LOGISTIC REGRESSION| |P=0.216N P=0.229N P=0.053N P=0.129N |
|COCH-ARM / FISHERS | |P=0.254N P=0.183N P=0.049N* P=0.139N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/50 (2%) 3/50 (6%) 3/49 (6%) |20/49 (41%) 20/49 (41%) 20/49 (41%) 12/50 (24%) |
|POLY-3 RATE (b) | 2/43.48 1/45.57 3/45.00 3/43.63 |20/46.77 20/43.53 20/44.85 12/45.73 |
|POLY-3 PERCENT (g) | 4.6% 2.2% 6.7% 6.9% |42.8% 45.9% 44.6% 26.2% |
|TERMINAL (d) | 1/38 (3%) 0/41 (0%) 3/36 (8%) 3/34 (9%) |15/37 (41%) 15/28 (54%) 15/34 (44%) 10/36 (28%) |
|FIRST INCIDENCE | 665 561 733 (T) 733 (T) |363 588 652 686 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.285 P=0.496N P=0.478 P=0.453 |P=0.017N* P=0.238 P=0.483 P=0.081N |
|POLY 3 | P=0.329 P=0.484N P=0.516 P=0.502 |P=0.025N* P=0.463 P=0.513 P=0.071N |
|POLY 1.5 | P=0.336 P=0.486N P=0.518 P=0.506 |P=0.026N* P=0.508 P=0.522 P=0.068N |
|POLY 6 | P=0.316 P=0.480N P=0.509 P=0.493 |P=0.021N* P=0.412 P=0.513 P=0.070N |
|LOGISTIC REGRESSION| P=0.338 P=0.471N P=0.517 P=0.502 |P=0.022N* P=0.533 P=0.558 P=0.059N |
|COCH-ARM / FISHERS | P=0.339 P=0.485N P=0.520 P=0.510 |P=0.026N* P=0.581N P=0.581N P=0.057N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |2/49 (4%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.23 0/45.02 0/45.00 0/43.63 |2/45.49 0/42.28 0/44.02 0/45.46 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |4.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/38 (3%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |0/37 (0%) 0/28 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 733 (T) --- --- --- |616 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.571N P=0.485N P=0.511N P=0.522N |P=0.296N P=0.264N P=0.240N P=0.232N |
|POLY 3 | P=0.547N P=0.492N P=0.492N P=0.498N |P=0.290N P=0.254N P=0.245N P=0.237N |
|POLY 1.5 | P=0.547N P=0.493N P=0.491N P=0.497N |P=0.295N P=0.247N P=0.243N P=0.237N |
|POLY 6 | P=0.548N P=0.490N P=0.494N P=0.501N |P=0.281N P=0.264N P=0.246N P=0.237N |
|LOGISTIC REGRESSION| P=0.571N (e) (e) (e) |P=0.301N P=0.201N P=0.202N P=0.201N |
|COCH-ARM / FISHERS | P=0.547N P=0.490N P=0.490N P=0.495N |P=0.305N P=0.247N P=0.247N P=0.242N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 28/49 (57%) 24/49 (49%) 21/50 (42%) 22/50 (44%) | |
|POLY-3 RATE (b) | 28/46.50 24/47.27 21/47.14 22/47.01 | |
|POLY-3 PERCENT (g) | 60.2% 50.8% 44.5% 46.8% | |
|TERMINAL (d) | 23/40 (58%) 19/41 (46%) 15/36 (42%) 14/34 (41%) | |
|FIRST INCIDENCE | 421 497 468 467 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.496N P=0.263N P=0.236N P=0.382N | |
|POLY 3 | P=0.220N P=0.238N P=0.092N P=0.134N | |
|POLY 1.5 | P=0.205N P=0.257N P=0.090N P=0.129N | |
|POLY 6 | P=0.253N P=0.218N P=0.099N P=0.150N | |
|LOGISTIC REGRESSION| P=0.204N P=0.274N P=0.096N P=0.137N | |
|COCH-ARM / FISHERS | P=0.203N P=0.272N P=0.096N P=0.134N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/49 (2%) 2/50 (4%) 2/50 (4%) | |
|POLY-3 RATE (b) | 1/44.58 1/44.53 2/45.00 2/44.16 | |
|POLY-3 PERCENT (g) | 2.2% 2.3% 4.4% 4.5% | |
|TERMINAL (d) | 1/40 (3%) 1/41 (2%) 2/36 (6%) 2/34 (6%) | |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.343 P=0.756N P=0.463 P=0.443 | |
|POLY 3 | P=0.405 P=0.760 P=0.503 P=0.497 | |
|POLY 1.5 | P=0.413 P=0.759 P=0.506 P=0.502 | |
|POLY 6 | P=0.391 P=0.759N P=0.498 P=0.488 | |
|LOGISTIC REGRESSION| P=0.343 P=0.756N P=0.463 P=0.443 | |
|COCH-ARM / FISHERS | P=0.417 P=0.753N P=0.508 P=0.508 | |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |
|POLY-3 RATE (b) | 0/43.56 2/45.02 0/45.00 0/44.16 | |
|POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 0.0% | |
|TERMINAL (d) | 0/39 (0%) 2/41 (5%) 0/36 (0%) 0/34 (0%) | |
|FIRST INCIDENCE | --- 733 (T) --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.422N P=0.249 (e) (e) | |
|POLY 3 | P=0.390N P=0.244 (e) (e) | |
|POLY 1.5 | P=0.388N P=0.244 (e) (e) | |
|POLY 6 | P=0.392N P=0.245 (e) (e) | |
|LOGISTIC REGRESSION| (e) P=0.249 (e) (e) | |
|COCH-ARM / FISHERS | P=0.386N P=0.258 (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |
|POLY-3 RATE (b) | 0/43.56 0/45.02 2/45.20 0/44.16 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 0.0% | |
|TERMINAL (d) | 0/39 (0%) 0/41 (0%) 0/36 (0%) 0/34 (0%) | |
|FIRST INCIDENCE | --- --- 700 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.668N (e) P=0.234 (e) | |
|POLY 3 | P=0.656N (e) P=0.245 (e) | |
|POLY 1.5 | P=0.650N (e) P=0.247 (e) | |
|POLY 6 | P=0.664N (e) P=0.243 (e) | |
|LOGISTIC REGRESSION| P=0.649N (e) P=0.246 (e) | |
|COCH-ARM / FISHERS | P=0.647N (e) P=0.258 (e) | |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/49 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.23 0/45.02 0/45.00 1/44.16 |1/44.80 2/43.03 1/45.02 1/45.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.3% |2.2% 4.7% 2.2% 2.2% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 1/34 (3%) |1/37 (3%) 1/28 (4%) 1/35 (3%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- 733 (T) |735 (T) 601 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.202 (e) (e) P=0.468 |P=0.521N P=0.428 P=0.749 P=0.756 |
|POLY 3 | P=0.225 (e) (e) P=0.495 |P=0.543N P=0.486 P=0.760N P=0.757N |
|POLY 1.5 | P=0.227 (e) (e) P=0.498 |P=0.545N P=0.494 P=0.760N P=0.758N |
|POLY 6 | P=0.221 (e) (e) P=0.491 |P=0.539N P=0.475 P=0.759N P=0.755N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.468 |P=0.543N P=0.516 P=0.749 P=0.756 |
|COCH-ARM / FISHERS | P=0.228 (e) (e) P=0.500 |P=0.546N P=0.508 P=0.747N P=0.747N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 4/50 (8%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/45.54 2/46.15 2/45.20 4/45.14 |0/44.80 0/42.57 0/45.02 1/45.46 |
|POLY-3 PERCENT (g) | 2.2% 4.3% 4.4% 8.9% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 2/34 (6%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 649 532 700 552 |--- --- --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.120 P=0.492 P=0.491 P=0.158 |P=0.243 (e) (e) P=0.495 |
|POLY 3 | P=0.130 P=0.505 P=0.497 P=0.176 |P=0.234 (e) (e) P=0.503 |
|POLY 1.5 | P=0.133 P=0.501 P=0.500 P=0.178 |P=0.231 (e) (e) P=0.502 |
|POLY 6 | P=0.125 P=0.509 P=0.493 P=0.172 |P=0.239 (e) (e) P=0.505 |
|LOGISTIC REGRESSION| P=0.121 P=0.557 P=0.498 P=0.176 |(e) (e) (e) P=0.495 |
|COCH-ARM / FISHERS | P=0.134 P=0.500 P=0.500 P=0.181 |P=0.229 (e) (e) P=0.505 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 2/50 (4%) 2/49 (4%) |1/49 (2%) 2/47 (4%) 2/50 (4%) 3/48 (6%) |
|POLY-3 RATE (b) | 1/44.56 1/45.02 2/45.00 2/43.69 |1/44.80 2/41.01 2/45.91 3/44.39 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 4.4% 4.6% |2.2% 4.9% 4.4% 6.8% |
|TERMINAL (d) | 1/40 (3%) 1/41 (2%) 2/36 (6%) 1/34 (3%) |1/37 (3%) 1/28 (4%) 1/35 (3%) 2/36 (6%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 718 |735 (T) 728 356 727 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.351 P=0.756N P=0.463 P=0.457 |P=0.317 P=0.415 P=0.487 P=0.299 |
|POLY 3 | P=0.399 P=0.758N P=0.503 P=0.493 |P=0.294 P=0.469 P=0.509 P=0.302 |
|POLY 1.5 | P=0.404 P=0.758N P=0.506 P=0.497 |P=0.288 P=0.476 P=0.506 P=0.299 |
|POLY 6 | P=0.390 P=0.758N P=0.498 P=0.487 |P=0.304 P=0.460 P=0.511 P=0.308 |
|LOGISTIC REGRESSION| P=0.380 P=0.756N P=0.463 P=0.481 |P=0.278 P=0.443 P=0.578 P=0.312 |
|COCH-ARM / FISHERS | P=0.405 P=0.747N P=0.508 P=0.500 |P=0.282 P=0.484 P=0.508 P=0.301 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |1/49 (2%) 2/47 (4%) 0/50 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 0/44.56 0/45.02 0/45.00 1/43.67 |1/44.80 2/41.43 0/45.02 1/44.36 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.3% |2.2% 4.8% 0.0% 2.3% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |1/37 (3%) 1/28 (4%) 0/35 (0%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- 723 |735 (T) 601 --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.216 (e) (e) P=0.484 |P=0.568N P=0.428 P=0.511N P=0.756 |
|POLY 3 | P=0.223 (e) (e) P=0.496 |P=0.593N P=0.473 P=0.499N P=0.758 |
|POLY 1.5 | P=0.225 (e) (e) P=0.498 |P=0.595N P=0.478 P=0.500N P=0.756 |
|POLY 6 | P=0.220 (e) (e) P=0.492 |P=0.590N P=0.466 P=0.498N P=0.759N |
|LOGISTIC REGRESSION| P=0.220 (e) (e) P=0.493 |P=0.596N P=0.495 (e) P=0.756 |
|COCH-ARM / FISHERS | P=0.225 (e) (e) P=0.500 |P=0.597N P=0.484 P=0.495N P=0.747 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 4/50 (8%) 1/49 (2%) 9/50 (18%) |5/49 (10%) 1/49 (2%) 6/50 (12%) 2/47 (4%) |
|POLY-3 RATE (b) | 4/44.99 4/46.55 1/44.55 9/44.95 |5/45.91 1/42.28 6/45.63 2/44.34 |
|POLY-3 PERCENT (g) | 8.9% 8.6% 2.2% 20.0% |10.9% 2.4% 13.2% 4.5% |
|TERMINAL (d) | 3/40 (8%) 2/41 (5%) 1/36 (3%) 5/34 (15%) |3/37 (8%) 1/28 (4%) 4/35 (11%) 1/36 (3%) |
|FIRST INCIDENCE | 606 203 733 (T) 622 |363 735 (T) 612 309 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014 * P=0.639N P=0.211N P=0.081 |P=0.289N P=0.160N P=0.482 P=0.226N |
|POLY 3 | P=0.021 * P=0.624N P=0.181N P=0.114 |P=0.309N P=0.121N P=0.496 P=0.230N |
|POLY 1.5 | P=0.022 * P=0.626N P=0.179N P=0.119 |P=0.325N P=0.113N P=0.495 P=0.233N |
|POLY 6 | P=0.019 * P=0.622N P=0.186N P=0.106 |P=0.287N P=0.132N P=0.500 P=0.225N |
|LOGISTIC REGRESSION| P=0.024 * P=0.594N P=0.179N P=0.121 |P=0.356N P=0.079N P=0.540 P=0.172N |
|COCH-ARM / FISHERS | P=0.025 * P=0.631N P=0.181N P=0.125 |P=0.348N P=0.102N P=0.514 P=0.235N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 1/49 (2%) 4/50 (8%) |1/49 (2%) 0/49 (0%) 1/50 (2%) 2/47 (4%) |
|POLY-3 RATE (b) | 2/45.37 1/45.99 1/44.55 4/44.63 |1/44.80 0/42.28 1/45.02 2/44.52 |
|POLY-3 PERCENT (g) | 4.4% 2.2% 2.2% 9.0% |2.2% 0.0% 2.2% 4.5% |
|TERMINAL (d) | 1/40 (3%) 0/41 (0%) 1/36 (3%) 1/34 (3%) |1/37 (3%) 0/28 (0%) 1/35 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 421 203 733 (T) 622 |735 (T) --- 735 (T) 309 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.100 P=0.497N P=0.522N P=0.302 |P=0.262 P=0.556N P=0.749 P=0.507 |
|POLY 3 | P=0.114 P=0.495N P=0.506N P=0.330 |P=0.245 P=0.512N P=0.760N P=0.498 |
|POLY 1.5 | P=0.117 P=0.494N P=0.503N P=0.337 |P=0.236 P=0.507N P=0.760N P=0.492 |
|POLY 6 | P=0.110 P=0.495N P=0.511N P=0.320 |P=0.258 P=0.518N P=0.759N P=0.506 |
|LOGISTIC REGRESSION| P=0.095 P=0.372N P=0.540N P=0.347 |P=0.212 (e) P=0.749 P=0.565 |
|COCH-ARM / FISHERS | P=0.121 P=0.492N P=0.500N P=0.349 |P=0.224 P=0.500N P=0.747N P=0.484 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/49 (0%) 4/50 (8%) |0/49 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 1/44.86 1/45.71 0/44.55 4/45.30 |0/44.80 0/42.28 0/45.02 0/43.41 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 0.0% 8.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 649 495 --- 530 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033 * P=0.756N P=0.505N P=0.166 |(e) (e) (e) (e) |
|POLY 3 | P=0.037 * P=0.756N P=0.501N P=0.182 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.037 * P=0.757N P=0.500N P=0.184 |(e) (e) (e) (e) |
|POLY 6 | P=0.036 * P=0.756N P=0.505N P=0.177 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.030 * P=0.721N P=0.515N P=0.180 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.038 * P=0.747N P=0.500N P=0.187 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/49 (0%) 1/48 (2%) 0/48 (0%) |0/48 (0%) 2/47 (4%) 3/50 (6%) 1/47 (2%) |
|POLY-3 RATE (b) | 1/44.56 0/44.62 1/44.71 0/42.69 |0/44.15 2/41.09 3/45.44 1/43.41 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.2% 0.0% |0.0% 4.9% 6.6% 2.3% |
|TERMINAL (d) | 1/40 (3%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |0/37 (0%) 2/28 (7%) 2/35 (6%) 1/36 (3%) |
|FIRST INCIDENCE | 733 (T) --- 468 --- |--- 735 (T) 612 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.495N P=0.495N P=0.751 P=0.532N |P=0.581N P=0.179 P=0.118 P=0.495 |
|POLY 3 | P=0.488N P=0.500N P=0.760N P=0.509N |P=0.617N P=0.221 P=0.124 P=0.497 |
|POLY 1.5 | P=0.484N P=0.501N P=0.760 P=0.506N |P=0.621N P=0.226 P=0.123 P=0.495 |
|POLY 6 | P=0.494N P=0.498N P=0.760N P=0.513N |P=0.609N P=0.215 P=0.125 P=0.499 |
|LOGISTIC REGRESSION| P=0.513N (e) P=0.720 (e) |P=0.617N P=0.179 P=0.129 P=0.495 |
|COCH-ARM / FISHERS | P=0.482N P=0.500N P=0.747 P=0.505N |P=0.623N P=0.242 P=0.129 P=0.495 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 2/48 (4%) 0/48 (0%) |1/48 (2%) 0/47 (0%) 1/50 (2%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/44.56 0/44.62 2/44.11 0/42.69 |1/44.15 0/41.09 1/45.02 0/43.41 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% |2.3% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |1/37 (3%) 0/28 (0%) 1/35 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 703 --- |735 (T) --- 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.676N (e) P=0.228 (e) |P=0.459N P=0.556N P=0.749 P=0.505N |
|POLY 3 | P=0.664N (e) P=0.235 (e) |P=0.471N P=0.514N P=0.756N P=0.503N |
|POLY 1.5 | P=0.659N (e) P=0.235 (e) |P=0.476N P=0.510N P=0.756N P=0.505N |
|POLY 6 | P=0.672N (e) P=0.234 (e) |P=0.463N P=0.520N P=0.756N P=0.501N |
|LOGISTIC REGRESSION| P=0.661N (e) P=0.234 (e) |P=0.459N (e) P=0.749 (e) |
|COCH-ARM / FISHERS | P=0.656N (e) P=0.242 (e) |P=0.482N P=0.505N P=0.742N P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |
|POLY-3 RATE (b) | 2/45.23 0/45.02 0/45.00 0/44.16 | |
|POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% | |
|TERMINAL (d) | 2/40 (5%) 0/41 (0%) 0/36 (0%) 0/34 (0%) | |
|FIRST INCIDENCE | 733 (T) --- --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.338N P=0.233N P=0.262N P=0.275N | |
|POLY 3 | P=0.308N P=0.238N P=0.238N P=0.242N | |
|POLY 1.5 | P=0.307N P=0.239N P=0.237N P=0.240N | |
|POLY 6 | P=0.310N P=0.237N P=0.241N P=0.247N | |
|LOGISTIC REGRESSION| P=0.338N (e) (e) (e) | |
|COCH-ARM / FISHERS | P=0.308N P=0.247N P=0.247N P=0.247N | |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/44 (0%) 1/44 (2%) 0/42 (0%) 0/40 (0%) |0/48 (0%) 1/48 (2%) 0/48 (0%) 2/47 (4%) |
|POLY-3 RATE (b) | 0/39.23 1/40.67 0/38.84 0/35.25 |0/43.80 1/41.67 0/43.12 2/44.47 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 0.0% 0.0% |0.0% 2.4% 0.0% 4.5% |
|TERMINAL (d) | 0/34 (0%) 0/37 (0%) 0/34 (0%) 0/27 (0%) |0/36 (0%) 0/27 (0%) 0/34 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- 495 --- --- |--- 305 --- 309 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.606N P=0.504 (e) (e) |P=0.169 P=0.504 (e) P=0.253 |
|POLY 3 | P=0.623N P=0.507 (e) (e) |P=0.155 P=0.490 (e) P=0.240 |
|POLY 1.5 | P=0.624N P=0.503 (e) (e) |P=0.152 P=0.495 (e) P=0.237 |
|POLY 6 | P=0.621N P=0.512 (e) (e) |P=0.159 P=0.483 (e) P=0.246 |
|LOGISTIC REGRESSION| P=0.712N P=0.572 (e) (e) |P=0.115 (e) (e) P=0.300 |
|COCH-ARM / FISHERS | P=0.625N P=0.500 (e) (e) |P=0.148 P=0.500 (e) P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) |1/49 (2%) 2/49 (4%) 1/50 (2%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/43.56 0/43.02 0/44.00 0/43.63 |1/44.80 2/42.39 1/45.69 0/43.26 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 4.7% 2.2% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |1/37 (3%) 0/28 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |735 (T) 532 511 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.238N P=0.445 P=0.754 P=0.517N |
|POLY 3 | (e) (e) (e) (e) |P=0.245N P=0.481 P=0.756N P=0.507N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.247N P=0.488 P=0.758N P=0.508N |
|POLY 6 | (e) (e) (e) (e) |P=0.242N P=0.471 P=0.754N P=0.504N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.247N P=0.536 P=0.729N (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.247N P=0.500 P=0.747N P=0.510N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 21/23 (91%) 26/26 (100%) 22/22 (100%) 20/21 (95%) |3/4 (75%) 1/2 (50%) 1/1 (100%) 1/1 (100%) |
|POLY-3 RATE (b) | 21/23.00 26/26.00 22/22.00 20/21.00 |3/4.00 1/1.99 1/1.00 1/1.00 |
|POLY-3 PERCENT (g) | 91.3% 100.0% 100.0% 95.2% |75.0% 50.2% 100.0% 100.0% |
|TERMINAL (d) | 20/22 (91%) 25/25 (100%) 19/19 (100%) 19/20 (95%) |3/4 (75%) 1/1 (100%) 1/1 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 635 575 596 731 |735 (T) 735 (T) 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.577N P=0.283 P=0.114 P=0.507 |P=0.708 P=0.773 P=0.773 P=0.773 |
|POLY 3 | P=0.670N P=0.208 P=0.245 P=0.532 |P=0.574 P=0.604N P=0.749 P=0.749 |
|POLY 1.5 | P=0.670N P=0.208 P=0.245 P=0.532 |P=0.573 P=0.603N P=0.749 P=0.749 |
|POLY 6 | P=0.670N P=0.208 P=0.245 P=0.532 |P=0.575 P=0.607N P=0.749 P=0.749 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.708 P=0.773 P=0.773 P=0.773 |
|COCH-ARM / FISHERS | P=0.671N P=0.215 P=0.256 P=0.535 |P=0.594 P=0.600N P=0.800 P=0.800 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 2/49 (4%) 2/50 (4%) 3/49 (6%) |
|POLY-3 RATE (b) | |1/44.80 2/42.56 2/45.02 3/45.26 |
|POLY-3 PERCENT (g) | |2.2% 4.7% 4.4% 6.6% |
|TERMINAL (d) | |1/37 (3%) 1/28 (4%) 2/35 (6%) 3/36 (8%) |
|FIRST INCIDENCE | |735 (T) 658 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.322 P=0.425 P=0.481 P=0.295 |
|POLY 3 | |P=0.297 P=0.482 P=0.502 P=0.309 |
|POLY 1.5 | |P=0.291 P=0.489 P=0.501 P=0.306 |
|POLY 6 | |P=0.307 P=0.473 P=0.503 P=0.314 |
|LOGISTIC REGRESSION| |P=0.312 P=0.489 P=0.481 P=0.295 |
|COCH-ARM / FISHERS | |P=0.284 P=0.500 P=0.508 P=0.309 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/49 (6%) 3/49 (6%) 5/50 (10%) 0/49 (0%) |
|POLY-3 RATE (b) | |3/45.96 3/42.30 5/45.21 0/45.26 |
|POLY-3 PERCENT (g) | |6.5% 7.1% 11.1% 0.0% |
|TERMINAL (d) | |1/37 (3%) 2/28 (7%) 4/35 (11%) 0/36 (0%) |
|FIRST INCIDENCE | |363 731 686 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.072N P=0.565 P=0.343 P=0.127N |
|POLY 3 | |P=0.075N P=0.624 P=0.347 P=0.121N |
|POLY 1.5 | |P=0.078N P=0.639 P=0.350 P=0.122N |
|POLY 6 | |P=0.070N P=0.604 P=0.347 P=0.120N |
|LOGISTIC REGRESSION| |P=0.082N P=0.617N P=0.394 P=0.077N |
|COCH-ARM / FISHERS | |P=0.081N P=0.661N P=0.369 P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |7/49 (14%) 5/49 (10%) 4/50 (8%) 8/49 (16%) |
|POLY-3 RATE (b) | |7/44.92 5/42.81 4/45.02 8/45.52 |
|POLY-3 PERCENT (g) | |15.6% 11.7% 8.9% 17.6% |
|TERMINAL (d) | |6/37 (16%) 4/28 (14%) 4/35 (11%) 6/36 (17%) |
|FIRST INCIDENCE | |703 571 735 (T) 674 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.348 P=0.559N P=0.290N P=0.491 |
|POLY 3 | |P=0.304 P=0.413N P=0.259N P=0.511 |
|POLY 1.5 | |P=0.291 P=0.399N P=0.261N P=0.503 |
|POLY 6 | |P=0.325 P=0.433N P=0.257N P=0.526 |
|LOGISTIC REGRESSION| |P=0.322 P=0.428N P=0.253N P=0.525 |
|COCH-ARM / FISHERS | |P=0.279 P=0.380N P=0.251N P=0.500 |
|=================================================================================================================================|
(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).