TDMS Study 96001-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest STODDARD SOLVENT (TYPE IIC) DATE: 09/25/02
EXPERIMENT: 96001 TEST: 06 TIME: 11:12:26
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C96001
PATHOLOGIST: GRUMBEIN, SONDR CAS: 64742-88-7
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest STODDARD SOLVENT (TYPE IIC) DATE: 09/25/02
EXPERIMENT: 96001 TEST: 06 TIME: 11:12:26
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C96001
PATHOLOGIST: GRUMBEIN, SONDR CAS: 64742-88-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF STODDARD SOLVENT (TYPE IIC)
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hypertrophy
Liver Basophilic Focus
Eosinophilic Focus
Lymph Node: Lumbar Infiltration Cellular Plasma Cell
Skin Inflammation Chronic
Stomach, Forestomach Hyperplasia
Inflammation Chronic
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Kidney Nephropathy
Liver Eosinophilic Focus
Necrosis
Mesentery: Fat Necrosis
Pituitary Gland: Pars Distalis Hyperplasia
Spleen Hematopoietic Cell Proliferation
===============================================================
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/49 (27%) 10/50 (20%) 7/49 (14%) 15/50 (30%) |4/50 (8%) 3/50 (6%) 3/49 (6%) 6/50 (12%) |
|POLY-3 RATE (b) | 13/44.15 10/43.81 7/40.92 15/44.28 |4/45.31 3/43.78 3/42.51 6/44.68 |
|POLY-3 PERCENT (g) | 29.4% 22.8% 17.1% 33.9% |8.8% 6.9% 7.1% 13.4% |
|TERMINAL (d) | 11/34 (32%) 8/32 (25%) 5/27 (19%) 10/32 (31%) |4/36 (11%) 2/34 (6%) 2/27 (7%) 6/34 (18%) |
|FIRST INCIDENCE | 534 646 703 557 |730 (T) 620 600 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.261 P=0.360N P=0.225N P=0.357 |P=0.217 P=0.528N P=0.634N P=0.331 |
|POLY 3 | P=0.306 P=0.321N P=0.137N P=0.413 |P=0.237 P=0.519N P=0.535N P=0.360 |
|POLY 1.5 | P=0.312 P=0.314N P=0.128N P=0.420 |P=0.236 P=0.512N P=0.528N P=0.361 |
|POLY 6 | P=0.303 P=0.327N P=0.146N P=0.410 |P=0.240 P=0.527N P=0.549N P=0.363 |
|LOGISTIC REGRESSION| P=0.287 P=0.314N P=0.134N P=0.406 |P=0.241 P=0.528N P=0.544N P=0.331 |
|COCH-ARM / FISHERS | P=0.327 P=0.298N P=0.105N P=0.437 |P=0.240 P=0.500N P=0.511N P=0.370 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 30/49 (61%) 29/50 (58%) 20/49 (41%) 20/50 (40%) |2/50 (4%) 3/50 (6%) 2/49 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 30/43.81 29/43.79 20/41.93 20/43.23 |2/45.31 3/43.40 2/42.07 3/44.68 |
|POLY-3 PERCENT (g) | 68.5% 66.2% 47.7% 46.3% |4.4% 6.9% 4.8% 6.7% |
|TERMINAL (d) | 27/34 (79%) 26/32 (81%) 16/27 (59%) 18/32 (56%) |2/36 (6%) 3/34 (9%) 2/27 (7%) 3/34 (9%) |
|FIRST INCIDENCE | 651 659 478 593 |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.018N* P=0.542 P=0.189N P=0.045N* |P=0.423 P=0.474 P=0.588 P=0.474 |
|POLY 3 | P=0.007N** P=0.501N P=0.034N* P=0.023N* |P=0.451 P=0.480 P=0.667 P=0.494 |
|POLY 1.5 | P=0.008N** P=0.483N P=0.036N* P=0.024N* |P=0.450 P=0.488 P=0.673 P=0.494 |
|POLY 6 | P=0.006N** P=0.526N P=0.030N* P=0.023N* |P=0.454 P=0.471 P=0.655 P=0.496 |
|LOGISTIC REGRESSION| P=0.012N* P=0.522N P=0.049N* P=0.033N* |P=0.423 P=0.474 P=0.588 P=0.474 |
|COCH-ARM / FISHERS | P=0.011N* P=0.452N P=0.034N* P=0.028N* |P=0.455 P=0.500 P=0.684 P=0.500 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/48 (6%) 4/49 (8%) 3/49 (6%) 1/50 (2%) |2/49 (4%) 3/50 (6%) 4/48 (8%) 2/49 (4%) |
|POLY-3 RATE (b) | 3/43.18 4/43.65 3/40.94 1/42.54 |2/44.60 3/43.40 4/41.50 2/43.82 |
|POLY-3 PERCENT (g) | 7.0% 9.2% 7.3% 2.4% |4.5% 6.9% 9.6% 4.6% |
|TERMINAL (d) | 2/34 (6%) 2/32 (6%) 1/27 (4%) 1/32 (3%) |2/36 (6%) 3/34 (9%) 2/27 (7%) 2/34 (6%) |
|FIRST INCIDENCE | 628 403 681 729 (T) |730 (T) 730 (T) 708 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.214N P=0.480 P=0.585 P=0.329N |P=0.571 P=0.474 P=0.224 P=0.675 |
|POLY 3 | P=0.197N P=0.506 P=0.638 P=0.310N |P=0.573N P=0.487 P=0.304 P=0.688 |
|POLY 1.5 | P=0.188N P=0.508 P=0.647 P=0.302N |P=0.573N P=0.496 P=0.312 P=0.688 |
|POLY 6 | P=0.208N P=0.503 P=0.629 P=0.320N |P=0.568N P=0.476 P=0.290 P=0.689 |
|LOGISTIC REGRESSION| P=0.173N P=0.542 P=0.646 P=0.303N |P=0.563N P=0.474 P=0.265 P=0.675 |
|COCH-ARM / FISHERS | P=0.174N P=0.512 P=0.651N P=0.293N |P=0.567N P=0.510 P=0.329 P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 1/1 (100%) 0/1 (0%) |1/1 (100%) 0/0 (0%) 0/0 (0%) 2/2 (100%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 1/1.00 0/0.54 |1/1.00 0/0.00 0/0.00 2/2.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 0.0% |100.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 723 --- |649 --- --- 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Brain: Meninges |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |6/50 (12%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/43.60 0/43.29 1/41.34 0/42.54 |6/45.31 2/43.40 2/43.13 3/44.68 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 0.0% |13.2% 4.6% 4.6% 6.7% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 1/27 (4%) 0/32 (0%) |6/36 (17%) 2/34 (6%) 1/27 (4%) 3/34 (9%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |730 (T) 730 (T) 639 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.681 (e) P=0.454 (e) |P=0.266N P=0.151N P=0.231N P=0.268N |
|POLY 3 | P=0.688 (e) P=0.489 (e) |P=0.231N P=0.147N P=0.149N P=0.249N |
|POLY 1.5 | P=0.691 (e) P=0.492 (e) |P=0.234N P=0.141N P=0.144N P=0.249N |
|POLY 6 | P=0.684 (e) P=0.487 (e) |P=0.226N P=0.153N P=0.159N P=0.245N |
|LOGISTIC REGRESSION| (e) (e) P=0.454 (e) |P=0.234N P=0.151N P=0.168N P=0.268N |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.234N P=0.134N P=0.134N P=0.243N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Epididymis |
| Granuloma Sperm |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 3/50 (6%) 2/50 (4%) | |
|POLY-3 RATE (b) | 3/43.91 0/43.29 3/41.42 2/42.54 | |
|POLY-3 PERCENT (g) | 6.8% 0.0% 7.2% 4.7% | |
|TERMINAL (d) | 2/34 (6%) 0/32 (0%) 2/27 (7%) 2/32 (6%) | |
|FIRST INCIDENCE | 644 --- 709 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.569 P=0.127N P=0.577 P=0.524N | |
|POLY 3 | P=0.585 P=0.121N P=0.635 P=0.514N | |
|POLY 1.5 | P=0.590 P=0.120N P=0.642 P=0.509N | |
|POLY 6 | P=0.579 P=0.122N P=0.628 P=0.522N | |
|LOGISTIC REGRESSION| P=0.579 P=0.121N P=0.635 P=0.514N | |
|COCH-ARM / FISHERS | P=0.596 P=0.121N P=0.661N P=0.500N | |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 0/46 (0%) 0/47 (0%) 0/46 (0%) |1/46 (2%) 2/49 (4%) 2/45 (4%) 0/46 (0%) |
|POLY-3 RATE (b) | 0/41.94 0/40.91 0/40.06 0/40.93 |1/43.38 2/43.31 2/39.69 0/42.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 4.6% 5.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |1/36 (3%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 675 634 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.299N P=0.467 P=0.445 P=0.511N |
|POLY 3 | (e) (e) (e) (e) |P=0.310N P=0.499 P=0.469 P=0.505N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.309N P=0.508 P=0.476 P=0.504N |
|POLY 6 | (e) (e) (e) (e) |P=0.310N P=0.490 P=0.458 P=0.505N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.297N P=0.534 P=0.503 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.302N P=0.524 P=0.492 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Eye: Cornea |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 3/46 (7%) 1/47 (2%) 1/46 (2%) |0/46 (0%) 1/49 (2%) 1/45 (2%) 2/46 (4%) |
|POLY-3 RATE (b) | 0/41.94 3/41.11 1/40.06 1/40.93 |0/43.38 1/42.90 1/39.24 2/42.33 |
|POLY-3 PERCENT (g) | 0.0% 7.3% 2.5% 2.4% |0.0% 2.3% 2.6% 4.7% |
|TERMINAL (d) | 0/34 (0%) 2/32 (6%) 1/27 (4%) 1/32 (3%) |0/36 (0%) 1/34 (3%) 1/27 (4%) 2/34 (6%) |
|FIRST INCIDENCE | --- 675 729 (T) 729 (T) |--- 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.565 P=0.116 P=0.454 P=0.488 |P=0.147 P=0.489 P=0.443 P=0.226 |
|POLY 3 | P=0.577 P=0.115 P=0.491 P=0.495 |P=0.145 P=0.498 P=0.480 P=0.232 |
|POLY 1.5 | P=0.584 P=0.116 P=0.494 P=0.497 |P=0.146 P=0.504 P=0.485 P=0.233 |
|POLY 6 | P=0.570 P=0.114 P=0.487 P=0.492 |P=0.146 P=0.491 P=0.472 P=0.231 |
|LOGISTIC REGRESSION| P=0.578 P=0.116 P=0.454 P=0.488 |(e) P=0.489 P=0.443 P=0.226 |
|COCH-ARM / FISHERS | P=0.592 P=0.121 P=0.505 P=0.500 |P=0.147 P=0.516 P=0.495 P=0.247 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 1/50 (2%) 1/49 (2%) |4/49 (8%) 3/49 (6%) 4/49 (8%) 7/49 (14%) |
|POLY-3 RATE (b) | 3/43.60 4/43.68 1/41.96 1/42.31 |4/44.60 3/43.60 4/42.55 7/44.47 |
|POLY-3 PERCENT (g) | 6.9% 9.2% 2.4% 2.4% |9.0% 6.9% 9.4% 15.7% |
|TERMINAL (d) | 3/34 (9%) 3/32 (9%) 0/27 (0%) 0/32 (0%) |4/36 (11%) 1/34 (3%) 1/27 (4%) 5/34 (15%) |
|FIRST INCIDENCE | 729 (T) 618 527 669 |730 (T) 666 634 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.158N P=0.473 P=0.376N P=0.328N |P=0.136 P=0.539N P=0.512 P=0.233 |
|POLY 3 | P=0.144N P=0.501 P=0.319N P=0.316N |P=0.138 P=0.512N P=0.617 P=0.259 |
|POLY 1.5 | P=0.144N P=0.499 P=0.317N P=0.315N |P=0.137 P=0.507N P=0.625 P=0.257 |
|POLY 6 | P=0.144N P=0.504 P=0.320N P=0.316N |P=0.141 P=0.519N P=0.602 P=0.263 |
|LOGISTIC REGRESSION| P=0.142N P=0.496 P=0.304N P=0.319N |P=0.135 P=0.519N P=0.604 P=0.253 |
|COCH-ARM / FISHERS | P=0.141N P=0.500 P=0.309N P=0.316N |P=0.139 P=0.500N P=0.643N P=0.262 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 12/50 (24%) 21/50 (42%) 19/50 (38%) |6/50 (12%) 6/50 (12%) 6/50 (12%) 9/50 (18%) |
|POLY-3 RATE (b) | 15/44.98 12/44.52 21/44.20 19/45.19 |6/46.11 6/43.97 6/44.25 9/44.68 |
|POLY-3 PERCENT (g) | 33.4% 27.0% 47.5% 42.0% |13.0% 13.6% 13.6% 20.2% |
|TERMINAL (d) | 12/34 (35%) 8/32 (25%) 12/27 (44%) 11/32 (34%) |5/36 (14%) 4/34 (12%) 2/27 (7%) 9/34 (27%) |
|FIRST INCIDENCE | 525 576 509 563 |424 637 563 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.100 P=0.379N P=0.059 P=0.223 |P=0.188 P=0.579 P=0.480 P=0.246 |
|POLY 3 | P=0.112 P=0.334N P=0.121 P=0.261 |P=0.197 P=0.587 P=0.592 P=0.264 |
|POLY 1.5 | P=0.111 P=0.333N P=0.123 P=0.259 |P=0.199 P=0.599 P=0.599 P=0.269 |
|POLY 6 | P=0.119 P=0.331N P=0.124 P=0.273 |P=0.197 P=0.577 P=0.579 P=0.263 |
|LOGISTIC REGRESSION| P=0.107 P=0.331N P=0.120 P=0.250 |P=0.208 P=0.616N P=0.585N P=0.279 |
|COCH-ARM / FISHERS | P=0.117 P=0.326N P=0.149 P=0.263 |P=0.211 P=0.620N P=0.620N P=0.288 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |3/50 (6%) 4/50 (8%) 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/43.74 2/43.47 2/41.47 1/43.05 |3/46.76 4/44.94 0/42.80 4/45.68 |
|POLY-3 PERCENT (g) | 2.3% 4.6% 4.8% 2.3% |6.4% 8.9% 0.0% 8.8% |
|TERMINAL (d) | 0/34 (0%) 1/32 (3%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 1/34 (3%) 0/27 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 694 683 702 575 |492 455 --- 408 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.572N P=0.487 P=0.471 P=0.751 |P=0.514 P=0.479 P=0.131N P=0.492 |
|POLY 3 | P=0.564N P=0.498 P=0.481 P=0.757 |P=0.507 P=0.478 P=0.135N P=0.487 |
|POLY 1.5 | P=0.561N P=0.498 P=0.486 P=0.758 |P=0.511 P=0.487 P=0.129N P=0.491 |
|POLY 6 | P=0.567N P=0.498 P=0.477 P=0.756 |P=0.502 P=0.468 P=0.146N P=0.486 |
|LOGISTIC REGRESSION| P=0.557N P=0.498 P=0.481 P=0.746N |P=0.576 P=0.631 P=0.064N P=0.599 |
|COCH-ARM / FISHERS | P=0.556N P=0.500 P=0.500 P=0.753N |P=0.521 P=0.500 P=0.121N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.60 1/43.50 1/41.44 1/42.73 |2/46.73 0/43.40 0/42.80 0/44.68 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.4% 2.3% |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 673 702 681 |424 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.369 P=0.510 P=0.494 P=0.484 |P=0.119N P=0.244N P=0.242N P=0.249N |
|POLY 3 | P=0.377 P=0.500 P=0.490 P=0.496 |P=0.109N P=0.254N P=0.257N P=0.247N |
|POLY 1.5 | P=0.380 P=0.499 P=0.492 P=0.497 |P=0.111N P=0.248N P=0.250N P=0.245N |
|POLY 6 | P=0.374 P=0.500 P=0.488 P=0.495 |P=0.109N P=0.261N P=0.268N P=0.248N |
|LOGISTIC REGRESSION| P=0.383 P=0.502 P=0.491 P=0.501 |P=0.065N P=0.093N P=0.099N P=0.075N |
|COCH-ARM / FISHERS | P=0.384 P=0.500 P=0.500 P=0.500 |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 3/49 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/43.79 1/43.29 3/40.73 1/42.54 |1/45.45 0/43.40 0/42.07 0/43.78 |
|POLY-3 PERCENT (g) | 6.9% 2.3% 7.4% 2.4% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/34 (6%) 1/32 (3%) 3/27 (11%) 1/32 (3%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 681 729 (T) 729 (T) 729 (T) |694 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.342N P=0.328N P=0.567 P=0.330N |P=0.302N P=0.527N P=0.527N P=0.490N |
|POLY 3 | P=0.325N P=0.309N P=0.629 P=0.315N |P=0.306N P=0.509N P=0.515N P=0.507N |
|POLY 1.5 | P=0.321N P=0.308N P=0.634 P=0.311N |P=0.307N P=0.505N P=0.512N P=0.507N |
|POLY 6 | P=0.330N P=0.310N P=0.624 P=0.320N |P=0.306N P=0.514N P=0.523N P=0.507N |
|LOGISTIC REGRESSION| P=0.331N P=0.307N P=0.625 P=0.317N |P=0.309N P=0.500N P=0.506N P=0.503N |
|COCH-ARM / FISHERS | P=0.314N P=0.309N P=0.651 P=0.309N |P=0.308N P=0.500N P=0.505N P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/49 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/43.68 0/43.29 2/41.71 2/43.55 |0/45.31 0/43.40 0/42.07 1/44.12 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 4.8% 4.6% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 710 --- 527 521 |--- --- --- 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.240 P=0.512N P=0.464 P=0.491 |P=0.205 (e) (e) P=0.504 |
|POLY 3 | P=0.246 P=0.502N P=0.484 P=0.499 |P=0.198 (e) (e) P=0.495 |
|POLY 1.5 | P=0.246 P=0.501N P=0.484 P=0.499 |P=0.196 (e) (e) P=0.494 |
|POLY 6 | P=0.246 P=0.502N P=0.486 P=0.499 |P=0.200 (e) (e) P=0.497 |
|LOGISTIC REGRESSION| P=0.259 P=0.501N P=0.549 P=0.541 |P=0.198 (e) (e) P=0.525 |
|COCH-ARM / FISHERS | P=0.245 P=0.500N P=0.492 P=0.500 |P=0.196 (e) (e) P=0.495 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 1/49 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 3/43.60 4/43.29 0/40.73 2/42.62 |0/45.31 2/43.56 1/42.17 2/43.78 |
|POLY-3 PERCENT (g) | 6.9% 9.2% 0.0% 4.7% |0.0% 4.6% 2.4% 4.6% |
|TERMINAL (d) | 3/34 (9%) 4/32 (13%) 0/27 (0%) 1/32 (3%) |0/36 (0%) 1/34 (3%) 0/27 (0%) 2/34 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 710 |--- 688 703 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.292N P=0.466 P=0.164N P=0.525N |P=0.250 P=0.222 P=0.478 P=0.226 |
|POLY 3 | P=0.273N P=0.496 P=0.131N P=0.510N |P=0.234 P=0.228 P=0.486 P=0.229 |
|POLY 1.5 | P=0.270N P=0.497 P=0.129N P=0.507N |P=0.235 P=0.232 P=0.489 P=0.230 |
|POLY 6 | P=0.275N P=0.496 P=0.132N P=0.514N |P=0.236 P=0.224 P=0.480 P=0.231 |
|LOGISTIC REGRESSION| P=0.280N P=0.466 (e) P=0.520N |P=0.242 P=0.229 P=0.490 P=0.226 |
|COCH-ARM / FISHERS | P=0.264N P=0.500 P=0.125N P=0.500N |P=0.239 P=0.247 P=0.495 P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/49 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/43.60 0/43.29 0/40.73 0/42.54 |1/45.60 1/43.73 0/42.07 2/43.86 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 2.3% 0.0% 4.6% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 1/34 (3%) |
|FIRST INCIDENCE | --- --- --- --- |649 637 --- 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.366 P=0.747 P=0.514N P=0.491 |
|POLY 3 | (e) (e) (e) (e) |P=0.357 P=0.751 P=0.516N P=0.486 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.357 P=0.755 P=0.512N P=0.487 |
|POLY 6 | (e) (e) (e) (e) |P=0.357 P=0.747 P=0.524N P=0.487 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.362 P=0.738N P=0.483N P=0.493 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.360 P=0.753N P=0.505N P=0.492 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 44/50 (88%) 43/50 (86%) 42/49 (86%) 44/50 (88%) |39/50 (78%) 32/50 (64%) 33/49 (67%) 40/49 (82%) |
|POLY-3 RATE (b) | 44/47.43 43/47.53 42/46.12 44/46.66 |39/46.82 32/48.39 33/45.98 40/46.07 |
|POLY-3 PERCENT (g) | 92.8% 90.5% 91.1% 94.3% |83.3% 66.1% 71.8% 86.8% |
|TERMINAL (d) | 33/34 (97%) 32/32 (100%) 25/27 (93%) 32/32 (100%)|32/36 (89%) 21/34 (62%) 21/27 (78%) 30/34 (88%) |
|FIRST INCIDENCE | 534 398 400 557 |590 366 506 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.324 P=0.505 P=0.214 P=0.387 |P=0.222 P=0.242N P=0.374 P=0.354 |
|POLY 3 | P=0.399 P=0.485N P=0.534N P=0.556 |P=0.177 P=0.038N* P=0.127N P=0.422 |
|POLY 1.5 | P=0.447 P=0.484N P=0.558N P=0.586 |P=0.182 P=0.054N P=0.152N P=0.399 |
|POLY 6 | P=0.350 P=0.542N P=0.499N P=0.503 |P=0.188 P=0.027N* P=0.112N P=0.482 |
|LOGISTIC REGRESSION| P=0.432 P=0.551N P=0.543 P=0.534 |P=0.197 P=0.111N P=0.241N P=0.329 |
|COCH-ARM / FISHERS | P=0.530 P=0.500N P=0.484N P=0.620N |P=0.231 P=0.093N P=0.168N P=0.421 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.60 1/43.29 0/40.73 2/43.58 |0/45.31 1/43.85 0/42.07 0/43.78 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 4.6% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 1/32 (3%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 550 |--- 597 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.141 P=0.488 (e) P=0.239 |P=0.566N P=0.496 (e) (e) |
|POLY 3 | P=0.139 P=0.499 (e) P=0.237 |P=0.578N P=0.493 (e) (e) |
|POLY 1.5 | P=0.139 P=0.499 (e) P=0.237 |P=0.576N P=0.496 (e) (e) |
|POLY 6 | P=0.139 P=0.498 (e) P=0.237 |P=0.581N P=0.491 (e) (e) |
|LOGISTIC REGRESSION| P=0.142 P=0.488 (e) P=0.282 |P=0.556N P=0.549 (e) (e) |
|COCH-ARM / FISHERS | P=0.140 P=0.500 (e) P=0.247 |P=0.571N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/43.60 1/43.90 0/40.73 0/42.54 |0/45.31 0/43.40 0/42.07 0/43.78 |
|POLY-3 PERCENT (g) | 4.6% 2.3% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/34 (6%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 534 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.112N P=0.514N P=0.290N P=0.252N |(e) (e) (e) (e) |
|POLY 3 | P=0.104N P=0.498N P=0.252N P=0.242N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.103N P=0.499N P=0.250N P=0.241N |(e) (e) (e) (e) |
|POLY 6 | P=0.105N P=0.495N P=0.254N P=0.245N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.098N P=0.492N (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.253N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/43.60 2/43.96 0/40.73 0/42.54 |0/45.31 0/43.40 0/42.07 1/43.86 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 0.0% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 582 --- --- |--- --- --- 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.419N P=0.234 (e) (e) |P=0.208 (e) (e) P=0.500 |
|POLY 3 | P=0.412N P=0.239 (e) (e) |P=0.197 (e) (e) P=0.494 |
|POLY 1.5 | P=0.410N P=0.238 (e) (e) |P=0.196 (e) (e) P=0.493 |
|POLY 6 | P=0.413N P=0.241 (e) (e) |P=0.199 (e) (e) P=0.495 |
|LOGISTIC REGRESSION| P=0.393N P=0.251 (e) (e) |P=0.197 (e) (e) P=0.494 |
|COCH-ARM / FISHERS | P=0.406N P=0.247 (e) (e) |P=0.196 (e) (e) P=0.495 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.60 0/43.29 1/41.35 2/43.73 |0/45.31 0/43.40 0/42.07 0/43.78 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 4.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 527 521 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.074 (e) P=0.487 P=0.242 |(e) (e) (e) (e) |
|POLY 3 | P=0.071 (e) P=0.489 P=0.238 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.071 (e) P=0.490 P=0.237 |(e) (e) (e) (e) |
|POLY 6 | P=0.071 (e) P=0.489 P=0.238 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.065 (e) P=0.598 P=0.298 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.070 (e) P=0.495 P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 13/50 (26%) 17/50 (34%) 11/50 (22%) |4/50 (8%) 5/50 (10%) 8/50 (16%) 4/50 (8%) |
|POLY-3 RATE (b) | 9/44.04 13/43.99 17/42.56 11/43.44 |4/45.31 5/43.90 8/42.80 4/44.68 |
|POLY-3 PERCENT (g) | 20.4% 29.6% 39.9% 25.3% |8.8% 11.4% 18.7% 9.0% |
|TERMINAL (d) | 8/34 (24%) 9/32 (28%) 12/27 (44%) 8/32 (25%) |4/36 (11%) 3/34 (9%) 8/27 (30%) 4/34 (12%) |
|FIRST INCIDENCE | 603 659 470 563 |730 (T) 637 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.327 P=0.202 P=0.016 * P=0.351 |P=0.502 P=0.462 P=0.065 P=0.613 |
|POLY 3 | P=0.364 P=0.228 P=0.037 * P=0.386 |P=0.540 P=0.480 P=0.149 P=0.636 |
|POLY 1.5 | P=0.374 P=0.229 P=0.040 * P=0.391 |P=0.538 P=0.487 P=0.159 P=0.636 |
|POLY 6 | P=0.355 P=0.231 P=0.034 * P=0.382 |P=0.547 P=0.473 P=0.132 P=0.639 |
|LOGISTIC REGRESSION| P=0.349 P=0.224 P=0.036 * P=0.372 |P=0.552 P=0.467 P=0.065 P=0.613 |
|COCH-ARM / FISHERS | P=0.391 P=0.235 P=0.055 P=0.402 |P=0.547 P=0.500 P=0.178 P=0.643N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 11/50 (22%) 15/50 (30%) 10/50 (20%) |4/50 (8%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 13/43.60 11/43.29 15/41.42 10/42.77 |4/45.70 0/43.40 2/42.80 2/44.68 |
|POLY-3 PERCENT (g) | 29.8% 25.4% 36.2% 23.4% |8.8% 0.0% 4.7% 4.5% |
|TERMINAL (d) | 13/34 (38%) 11/32 (34%) 14/27 (52%) 9/32 (28%) |3/36 (8%) 0/34 (0%) 2/27 (7%) 2/34 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 709 669 |618 --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.411N P=0.472N P=0.149 P=0.372N |P=0.432N P=0.072N P=0.456N P=0.360N |
|POLY 3 | P=0.359N P=0.413N P=0.344 P=0.332N |P=0.399N P=0.067N P=0.368N P=0.348N |
|POLY 1.5 | P=0.352N P=0.413N P=0.361 P=0.327N |P=0.402N P=0.064N P=0.357N P=0.346N |
|POLY 6 | P=0.365N P=0.412N P=0.328 P=0.335N |P=0.394N P=0.071N P=0.388N P=0.348N |
|LOGISTIC REGRESSION| P=0.380N P=0.472N P=0.195 P=0.352N |P=0.405N P=0.065N P=0.366N P=0.342N |
|COCH-ARM / FISHERS | P=0.338N P=0.408N P=0.412 P=0.318N |P=0.404N P=0.059N P=0.339N P=0.339N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 7/50 (14%) 14/50 (28%) 9/50 (18%) |4/50 (8%) 9/50 (18%) 6/50 (12%) 11/50 (22%) |
|POLY-3 RATE (b) | 5/44.04 7/43.80 14/41.72 9/43.29 |4/45.31 9/43.60 6/42.92 11/45.26 |
|POLY-3 PERCENT (g) | 11.4% 16.0% 33.6% 20.8% |8.8% 20.6% 14.0% 24.3% |
|TERMINAL (d) | 4/34 (12%) 5/32 (16%) 11/27 (41%) 7/32 (22%) |4/36 (11%) 8/34 (24%) 4/27 (15%) 9/34 (27%) |
|FIRST INCIDENCE | 603 646 681 593 |730 (T) 677 708 554 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.109 P=0.353 P=0.006 ** P=0.166 |P=0.051 P=0.093 P=0.211 P=0.036 * |
|POLY 3 | P=0.116 P=0.375 P=0.011 * P=0.180 |P=0.058 P=0.099 P=0.335 P=0.042 * |
|POLY 1.5 | P=0.122 P=0.375 P=0.013 * P=0.185 |P=0.058 P=0.106 P=0.347 P=0.042 * |
|POLY 6 | P=0.110 P=0.376 P=0.010 * P=0.176 |P=0.060 P=0.092 P=0.314 P=0.044 * |
|LOGISTIC REGRESSION| P=0.113 P=0.374 P=0.012 * P=0.180 |P=0.064 P=0.082 P=0.245 P=0.043 * |
|COCH-ARM / FISHERS | P=0.135 P=0.380 P=0.020 * P=0.194 |P=0.062 P=0.117 P=0.370 P=0.045 * |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.77 0/43.29 1/41.42 0/42.54 |0/45.31 2/44.41 2/43.65 0/44.68 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.4% 0.0% |0.0% 4.5% 4.6% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 687 --- 707 --- |--- 470 557 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.416N P=0.511N P=0.741 P=0.517N |P=0.504N P=0.232 P=0.235 (e) |
|POLY 3 | P=0.410N P=0.502N P=0.749 P=0.506N |P=0.507N P=0.233 P=0.229 (e) |
|POLY 1.5 | P=0.408N P=0.502N P=0.751 P=0.503N |P=0.507N P=0.234 P=0.231 (e) |
|POLY 6 | P=0.411N P=0.503N P=0.746 P=0.509N |P=0.505N P=0.230 P=0.223 (e) |
|LOGISTIC REGRESSION| P=0.409N P=0.500N P=0.754 P=0.500N |P=0.457N P=0.303 P=0.278 (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.753N P=0.500N |P=0.500N P=0.247 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.60 1/43.29 0/41.34 1/42.54 |0/45.31 0/43.40 1/43.27 1/44.68 |
|POLY-3 PERCENT (g) | 4.6% 2.3% 0.0% 2.4% |0.0% 0.0% 2.3% 2.2% |
|TERMINAL (d) | 2/34 (6%) 1/32 (3%) 0/27 (0%) 1/32 (3%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- --- 590 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.388N P=0.521N P=0.290N P=0.521N |P=0.232 (e) P=0.491 P=0.489 |
|POLY 3 | P=0.372N P=0.503N P=0.249N P=0.509N |P=0.237 (e) P=0.491 P=0.497 |
|POLY 1.5 | P=0.371N P=0.502N P=0.246N P=0.505N |P=0.236 (e) P=0.494 P=0.497 |
|POLY 6 | P=0.374N P=0.503N P=0.252N P=0.512N |P=0.241 (e) P=0.485 P=0.498 |
|LOGISTIC REGRESSION| P=0.388N P=0.521N (e) P=0.521N |P=0.238 (e) P=0.555 P=0.489 |
|COCH-ARM / FISHERS | P=0.366N P=0.500N P=0.247N P=0.500N |P=0.236 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 2/50 (4%) 4/50 (8%) |3/50 (6%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/43.68 4/44.64 2/41.98 4/43.41 |3/46.33 3/44.85 1/43.41 0/44.68 |
|POLY-3 PERCENT (g) | 9.2% 9.0% 4.8% 9.2% |6.5% 6.7% 2.3% 0.0% |
|TERMINAL (d) | 3/34 (9%) 1/32 (3%) 0/27 (0%) 1/32 (3%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 710 534 527 521 |590 470 535 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.563N P=0.624 P=0.432N P=0.616 |P=0.057N P=0.635 P=0.335N P=0.128N |
|POLY 3 | P=0.548N P=0.632N P=0.355N P=0.640 |P=0.055N P=0.647 P=0.329N P=0.125N |
|POLY 1.5 | P=0.544N P=0.637N P=0.352N P=0.641 |P=0.054N P=0.653 P=0.320N P=0.124N |
|POLY 6 | P=0.552N P=0.623N P=0.358N P=0.641 |P=0.057N P=0.639 P=0.345N P=0.127N |
|LOGISTIC REGRESSION| P=0.527N P=0.639N P=0.349N P=0.639 |P=0.033N* P=0.568N P=0.224N P=0.090N |
|COCH-ARM / FISHERS | P=0.537N P=0.643N P=0.339N P=0.643N |P=0.052N P=0.661N P=0.309N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Tension Lipidosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/43.68 3/43.29 1/41.34 2/42.55 |2/45.31 0/43.40 1/42.91 2/45.35 |
|POLY-3 PERCENT (g) | 4.6% 6.9% 2.4% 4.7% |4.4% 0.0% 2.3% 4.4% |
|TERMINAL (d) | 1/34 (3%) 3/32 (9%) 1/27 (4%) 1/32 (3%) |2/36 (6%) 0/34 (0%) 0/27 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 710 729 (T) 729 (T) 728 |730 (T) --- 703 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.525N P=0.473 P=0.579N P=0.676 |P=0.461 P=0.251N P=0.579N P=0.676 |
|POLY 3 | P=0.513N P=0.496 P=0.519N P=0.685 |P=0.478 P=0.247N P=0.519N P=0.694N |
|POLY 1.5 | P=0.508N P=0.497 P=0.515N P=0.688 |P=0.473 P=0.243N P=0.513N P=0.692 |
|POLY 6 | P=0.518N P=0.495 P=0.524N P=0.681 |P=0.485 P=0.252N P=0.531N P=0.690N |
|LOGISTIC REGRESSION| P=0.520N P=0.490 P=0.531N P=0.681 |P=0.473 (e) P=0.545N P=0.682N |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.500N P=0.691N |P=0.469 P=0.247N P=0.500N P=0.691N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.95 0/43.29 0/41.34 1/43.05 |1/45.50 2/43.56 0/42.80 0/44.68 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 2.3% |2.2% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 1/34 (3%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 632 --- --- 575 |681 688 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.585 P=0.495N P=0.505N P=0.752 |P=0.196N P=0.464 P=0.536N P=0.500N |
|POLY 3 | P=0.592 P=0.503N P=0.512N P=0.756 |P=0.194N P=0.485 P=0.512N P=0.504N |
|POLY 1.5 | P=0.593 P=0.502N P=0.509N P=0.758 |P=0.192N P=0.491 P=0.508N P=0.503N |
|POLY 6 | P=0.591 P=0.504N P=0.516N P=0.754 |P=0.196N P=0.477 P=0.520N P=0.503N |
|LOGISTIC REGRESSION| P=0.616 P=0.485N P=0.474N P=0.733N |P=0.190N P=0.495 P=0.495N P=0.495N |
|COCH-ARM / FISHERS | P=0.595 P=0.500N P=0.500N P=0.753N |P=0.188N P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.04 1/42.94 2/43.07 0/42.54 |1/45.31 0/43.40 0/42.80 0/44.68 |
|POLY-3 PERCENT (g) | 2.3% 2.3% 4.6% 0.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |1/36 (3%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 603 618 75 --- |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.378N P=0.760N P=0.492 P=0.519N |P=0.320N P=0.511N P=0.557N P=0.511N |
|POLY 3 | P=0.377N P=0.755 P=0.492 P=0.507N |P=0.304N P=0.509N P=0.511N P=0.503N |
|POLY 1.5 | P=0.372N P=0.755 P=0.495 P=0.504N |P=0.304N P=0.505N P=0.507N P=0.503N |
|POLY 6 | P=0.384N P=0.756 P=0.489 P=0.510N |P=0.304N P=0.513N P=0.519N P=0.502N |
|LOGISTIC REGRESSION| P=0.259N P=0.745N P=0.673N P=0.468N |P=0.320N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.365N P=0.747 P=0.500 P=0.500N |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/49 (8%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/43.60 4/42.69 0/41.34 2/43.05 |1/45.31 3/43.40 1/42.80 3/44.68 |
|POLY-3 PERCENT (g) | 0.0% 9.4% 0.0% 4.7% |2.2% 6.9% 2.3% 6.7% |
|TERMINAL (d) | 0/34 (0%) 3/32 (9%) 0/27 (0%) 1/32 (3%) |1/36 (3%) 3/34 (9%) 1/27 (4%) 3/34 (9%) |
|FIRST INCIDENCE | --- 695 --- 575 |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.425 P=0.059 (e) P=0.231 |P=0.290 P=0.284 P=0.697 P=0.284 |
|POLY 3 | P=0.437 P=0.057 (e) P=0.234 |P=0.306 P=0.290 P=0.748 P=0.300 |
|POLY 1.5 | P=0.440 P=0.057 (e) P=0.235 |P=0.307 P=0.296 P=0.752 P=0.301 |
|POLY 6 | P=0.435 P=0.058 (e) P=0.233 |P=0.307 P=0.282 P=0.740 P=0.302 |
|LOGISTIC REGRESSION| P=0.440 P=0.059 (e) P=0.248 |P=0.290 P=0.284 P=0.697 P=0.284 |
|COCH-ARM / FISHERS | P=0.447 P=0.056 (e) P=0.247 |P=0.313 P=0.309 P=0.753N P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/44.00 1/42.77 3/41.91 1/43.21 |0/45.31 0/43.40 1/42.94 1/44.68 |
|POLY-3 PERCENT (g) | 4.6% 2.3% 7.2% 2.3% |0.0% 0.0% 2.3% 2.2% |
|TERMINAL (d) | 1/34 (3%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 617 673 628 506 |--- --- 695 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.494N P=0.501N P=0.470 P=0.513N |P=0.243 (e) P=0.478 P=0.489 |
|POLY 3 | P=0.479N P=0.510N P=0.478 P=0.506N |P=0.237 (e) P=0.489 P=0.497 |
|POLY 1.5 | P=0.476N P=0.509N P=0.482 P=0.504N |P=0.236 (e) P=0.493 P=0.497 |
|POLY 6 | P=0.484N P=0.510N P=0.475 P=0.510N |P=0.241 (e) P=0.483 P=0.498 |
|LOGISTIC REGRESSION| P=0.458N P=0.503N P=0.503 P=0.458N |P=0.237 (e) P=0.498 P=0.489 |
|COCH-ARM / FISHERS | P=0.471N P=0.508N P=0.500 P=0.500N |P=0.236 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Bronchiole |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.89 0/42.55 0/41.34 0/42.54 |0/45.31 0/43.40 0/42.80 0/44.68 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/34 (3%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 651 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.124N P=0.241N P=0.268N P=0.249N |(e) (e) (e) (e) |
|POLY 3 | P=0.113N P=0.244N P=0.251N P=0.244N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.114N P=0.243N P=0.247N P=0.241N |(e) (e) (e) (e) |
|POLY 6 | P=0.113N P=0.244N P=0.254N P=0.247N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.116N P=0.242N P=0.242N P=0.238N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.253N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/0 (0%) 0/1 (0%) 0/3 (0%) |0/5 (0%) 0/7 (0%) 0/9 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/1.00 0/0.00 0/0.82 0/2.35 |0/4.29 0/6.06 0/7.77 2/9.67 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 20.7% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |0/3 (0%) 0/5 (0%) 0/4 (0%) 2/7 (29%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.101 (e) (e) P=0.435 |
|POLY 3 | (e) (e) (e) (e) |P=0.089 (e) (e) P=0.429 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.085 (e) (e) P=0.418 |
|POLY 6 | (e) (e) (e) (e) |P=0.095 (e) (e) P=0.435 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.435 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.081 (e) (e) P=0.429 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lymph Node: Lumbar |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/0 (0%) 0/1 (0%) 2/3 (67%) |0/5 (0%) 0/7 (0%) 0/9 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/1.00 0/0.00 0/0.82 2/3.00 |0/4.29 0/6.06 0/7.77 0/9.67 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 66.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |0/3 (0%) 0/5 (0%) 0/4 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- 550 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.048 * (e) (e) P=0.231 |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) P=0.500 |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) P=0.500 |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) P=0.500 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.336 (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.212 (e) (e) P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/0 (0%) 0/1 (0%) 0/3 (0%) |1/5 (20%) 2/7 (29%) 1/9 (11%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/1.00 0/0.00 0/0.82 0/2.35 |1/4.29 2/6.06 1/7.77 1/9.67 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |23.3% 33.0% 12.9% 10.3% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |1/3 (33%) 2/5 (40%) 1/4 (25%) 1/7 (14%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.277N P=0.702 P=0.712N P=0.565N |
|POLY 3 | (e) (e) (e) (e) |P=0.281N P=0.630 P=0.626N P=0.570N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.296N P=0.630 P=0.623N P=0.580N |
|POLY 6 | (e) (e) (e) (e) |P=0.266N P=0.620 P=0.642N P=0.564N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.277N P=0.702 P=0.712N P=0.565N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.311N P=0.636 P=0.604N P=0.571N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/6 (67%) 5/6 (83%) 5/7 (71%) 5/5 (100%) |3/4 (75%) 10/15 (67%) 15/21 (71%) 9/11 (82%) |
|POLY-3 RATE (b) | 4/4.94 5/5.47 5/5.93 5/5.00 |3/3.99 10/14.50 15/19.06 9/10.03 |
|POLY-3 PERCENT (g) | 81.0% 91.4% 84.3% 100.0% |75.2% 69.0% 78.7% 89.7% |
|TERMINAL (d) | 4/4 (100%) 4/4 (100%) 4/4 (100%) 3/3 (100%) |3/3 (100%) 7/10 (70%) 8/9 (89%) 5/5 (100%) |
|FIRST INCIDENCE | 729 (T) 398 617 593 |730 (T) 470 535 695 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.147 P=0.500 P=0.500 P=0.229 |P=0.059 P=0.382 P=0.018 * P=0.067 |
|POLY 3 | P=0.339 P=0.698 P=0.776 P=0.532 |P=0.195 P=0.644N P=0.710 P=0.560 |
|POLY 1.5 | P=0.254 P=0.586 P=0.699 P=0.367 |P=0.240 P=0.627N P=0.739 P=0.601 |
|POLY 6 | P=0.583 P=0.933 P=0.903N P=0.918 |P=0.157 P=0.671N P=0.658 P=0.522 |
|LOGISTIC REGRESSION| P=0.273 P=0.383 P=0.819 P=0.421 |P=0.272 P=0.578N P=0.642 P=0.315 |
|COCH-ARM / FISHERS | P=0.202 P=0.500 P=0.657 P=0.273 |P=0.328 P=0.627N P=0.758 P=0.637 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/48 (4%) 1/50 (2%) 2/50 (4%) |0/49 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 3/43.84 2/42.04 1/41.36 2/43.01 |0/44.60 1/43.68 1/43.09 1/43.82 |
|POLY-3 PERCENT (g) | 6.8% 4.8% 2.4% 4.7% |0.0% 2.3% 2.3% 2.3% |
|TERMINAL (d) | 1/34 (3%) 2/32 (6%) 0/27 (0%) 1/32 (3%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 687 729 (T) 723 593 |--- 653 652 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.430N P=0.527N P=0.372N P=0.525N |P=0.382 P=0.490 P=0.490 P=0.489 |
|POLY 3 | P=0.408N P=0.519N P=0.326N P=0.509N |P=0.378 P=0.496 P=0.493 P=0.496 |
|POLY 1.5 | P=0.405N P=0.520N P=0.321N P=0.505N |P=0.378 P=0.499 P=0.497 P=0.497 |
|POLY 6 | P=0.413N P=0.518N P=0.332N P=0.513N |P=0.380 P=0.492 P=0.486 P=0.497 |
|LOGISTIC REGRESSION| P=0.410N P=0.513N P=0.327N P=0.502N |P=0.385 P=0.525 P=0.524 P=0.489 |
|COCH-ARM / FISHERS | P=0.398N P=0.520N P=0.309N P=0.500N |P=0.382 P=0.505 P=0.505 P=0.500 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/48 (2%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/43.68 1/42.04 2/41.34 0/42.54 |0/44.60 0/43.40 0/42.80 0/43.82 |
|POLY-3 PERCENT (g) | 6.9% 2.4% 4.8% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/34 (6%) 1/32 (3%) 2/27 (7%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 710 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.120N P=0.328N P=0.603N P=0.132N |(e) (e) (e) (e) |
|POLY 3 | P=0.107N P=0.319N P=0.525N P=0.123N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.105N P=0.320N P=0.519N P=0.122N |(e) (e) (e) (e) |
|POLY 6 | P=0.109N P=0.316N P=0.532N P=0.125N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.112N P=0.313N P=0.549N P=0.127N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.102N P=0.324N P=0.500N P=0.121N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/49 (4%) 0/50 (0%) 0/48 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | |2/44.32 0/43.40 0/41.15 0/43.78 |
|POLY-3 PERCENT (g) | |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | |1/35 (3%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | |727 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.130N P=0.252N P=0.305N P=0.252N |
|POLY 3 | |P=0.112N P=0.242N P=0.254N P=0.240N |
|POLY 1.5 | |P=0.113N P=0.238N P=0.250N P=0.240N |
|POLY 6 | |P=0.112N P=0.246N P=0.261N P=0.238N |
|LOGISTIC REGRESSION| |P=0.121N P=0.252N P=0.285N P=0.236N |
|COCH-ARM / FISHERS | |P=0.116N P=0.242N P=0.253N P=0.247N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |12/49 (24%) 12/50 (24%) 9/48 (19%) 6/49 (12%) |
|POLY-3 RATE (b) | |12/45.01 12/44.07 9/41.99 6/44.20 |
|POLY-3 PERCENT (g) | |26.7% 27.2% 21.4% 13.6% |
|TERMINAL (d) | |9/35 (26%) 10/34 (29%) 6/27 (22%) 4/34 (12%) |
|FIRST INCIDENCE | |590 620 506 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.074N P=0.549 P=0.535N P=0.112N |
|POLY 3 | |P=0.057N P=0.571 P=0.375N P=0.099N |
|POLY 1.5 | |P=0.059N P=0.588 P=0.360N P=0.100N |
|POLY 6 | |P=0.054N P=0.549 P=0.406N P=0.096N |
|LOGISTIC REGRESSION| |P=0.058N P=0.564 P=0.373N P=0.099N |
|COCH-ARM / FISHERS | |P=0.057N P=0.570N P=0.331N P=0.096N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/49 (2%) 0/49 (0%) 0/50 (0%) |0/49 (0%) 2/50 (4%) 0/48 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/43.20 1/42.82 0/40.73 0/42.54 |0/44.60 2/43.40 0/41.17 0/43.78 |
|POLY-3 PERCENT (g) | 2.3% 2.3% 0.0% 0.0% |0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 1/34 (3%) 1/32 (3%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 2/34 (6%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252N P=0.748 P=0.546N P=0.512N |P=0.422N P=0.226 (e) (e) |
|POLY 3 | P=0.238N P=0.759 P=0.512N P=0.503N |P=0.420N P=0.231 (e) (e) |
|POLY 1.5 | P=0.237N P=0.759 P=0.509N P=0.500N |P=0.416N P=0.235 (e) (e) |
|POLY 6 | P=0.240N P=0.759 P=0.514N P=0.506N |P=0.425N P=0.225 (e) (e) |
|LOGISTIC REGRESSION| P=0.252N P=0.748 (e) (e) |(e) P=0.226 (e) (e) |
|COCH-ARM / FISHERS | P=0.233N P=0.753N P=0.500N P=0.495N |P=0.407N P=0.253 (e) (e) |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |0/49 (0%) 2/50 (4%) 0/48 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/43.20 0/42.82 0/40.73 0/42.54 |0/44.60 2/44.27 0/41.17 1/43.78 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.5% 0.0% 2.3% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 1/34 (3%) 0/27 (0%) 1/34 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- 366 --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.524 P=0.233 (e) P=0.489 |
|POLY 3 | (e) (e) (e) (e) |P=0.527 P=0.235 (e) P=0.496 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.529 P=0.238 (e) P=0.497 |
|POLY 6 | (e) (e) (e) (e) |P=0.525 P=0.231 (e) P=0.497 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.566 P=0.315 (e) P=0.489 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.537 P=0.253 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Penis |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 2/3 (67%) 0/0 (0%) 1/1 (100%) | |
|POLY-3 RATE (b) | 0/0.00 2/3.00 0/0.00 1/1.00 | |
|POLY-3 PERCENT (g) | 0.0% 66.7% 0.0% 100.0% | |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | --- 646 --- 626 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.527 P=0.240 (e) (e) | |
|POLY 3 | (e) (e) (e) (e) | |
|POLY 1.5 | (e) (e) (e) (e) | |
|POLY 6 | (e) (e) (e) (e) | |
|LOGISTIC REGRESSION| (e) (e) (e) (e) | |
|COCH-ARM / FISHERS | P=0.588 P=1.000 (e) (e) | |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/49 (0%) 2/48 (4%) 2/46 (4%) |10/47 (21%) 12/49 (24%) 16/49 (33%) 16/48 (33%) |
|POLY-3 RATE (b) | 2/43.28 0/42.55 2/40.08 2/40.39 |10/44.03 12/43.10 16/43.47 16/43.27 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 5.0% 5.0% |22.7% 27.8% 36.8% 37.0% |
|TERMINAL (d) | 2/34 (6%) 0/32 (0%) 2/27 (7%) 0/29 (0%) |9/35 (26%) 10/33 (30%) 12/27 (44%) 14/34 (41%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 575 |530 578 506 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.400 P=0.252N P=0.610 P=0.658 |P=0.076 P=0.345 P=0.035 * P=0.107 |
|POLY 3 | P=0.420 P=0.241N P=0.666 P=0.669 |P=0.073 P=0.381 P=0.111 P=0.109 |
|POLY 1.5 | P=0.421 P=0.240N P=0.671 P=0.670 |P=0.077 P=0.406 P=0.123 P=0.115 |
|POLY 6 | P=0.419 P=0.241N P=0.663 P=0.668 |P=0.074 P=0.354 P=0.092 P=0.107 |
|LOGISTIC REGRESSION| P=0.421 (e) P=0.610 P=0.689 |P=0.082 P=0.383 P=0.121 P=0.116 |
|COCH-ARM / FISHERS | P=0.419 P=0.247N P=0.684 P=0.667 |P=0.093 P=0.448 P=0.153 P=0.138 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 3/49 (6%) 2/50 (4%) 1/48 (2%) | |
|POLY-3 RATE (b) | 2/42.95 3/42.47 2/41.81 1/41.73 | |
|POLY-3 PERCENT (g) | 4.7% 7.1% 4.8% 2.4% | |
|TERMINAL (d) | 1/33 (3%) 3/32 (9%) 0/27 (0%) 1/32 (3%) | |
|FIRST INCIDENCE | 632 729 (T) 650 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.335N P=0.491 P=0.667 P=0.513N | |
|POLY 3 | P=0.324N P=0.495 P=0.685 P=0.510N | |
|POLY 1.5 | P=0.323N P=0.496 P=0.688 P=0.509N | |
|POLY 6 | P=0.326N P=0.494 P=0.683 P=0.512N | |
|LOGISTIC REGRESSION| P=0.321N P=0.499 P=0.685N P=0.507N | |
|COCH-ARM / FISHERS | P=0.319N P=0.500 P=0.684N P=0.508N | |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) 11/50 (22%) 18/50 (36%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/43.99 7/44.90 11/42.78 18/46.56 |1/45.39 0/43.40 1/43.41 1/45.24 |
|POLY-3 PERCENT (g) | 13.6% 15.6% 25.7% 38.7% |2.2% 0.0% 2.3% 2.2% |
|TERMINAL (d) | 4/34 (12%) 0/32 (0%) 5/27 (19%) 10/32 (31%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 644 576 527 365 |708 --- 535 554 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.490 P=0.088 P=0.006 ** |P=0.536 P=0.522N P=0.737 P=0.758 |
|POLY 3 | P<0.001 ** P=0.516 P=0.124 P=0.005 ** |P=0.546 P=0.509N P=0.751 P=0.760 |
|POLY 1.5 | P<0.001 ** P=0.507 P=0.126 P=0.005 ** |P=0.541 P=0.505N P=0.754 P=0.759 |
|POLY 6 | P<0.001 ** P=0.532 P=0.124 P=0.006 ** |P=0.553 P=0.514N P=0.744 P=0.759N |
|LOGISTIC REGRESSION| P<0.001 ** P=0.501 P=0.122 P=0.006 ** |P=0.571 P=0.507N P=0.731N P=0.735N |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.143 P=0.005 ** |P=0.539 P=0.500N P=0.753N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 3/49 (6%) 3/49 (6%) 2/50 (4%) |2/49 (4%) 8/50 (16%) 5/48 (10%) 3/47 (6%) |
|POLY-3 RATE (b) | 0/43.20 3/43.13 3/41.71 2/43.46 |2/44.69 8/45.73 5/43.14 3/43.83 |
|POLY-3 PERCENT (g) | 0.0% 7.0% 7.2% 4.6% |4.5% 17.5% 11.6% 6.8% |
|TERMINAL (d) | 0/34 (0%) 1/32 (3%) 0/27 (0%) 0/32 (0%) |1/36 (3%) 3/34 (9%) 1/27 (4%) 1/34 (3%) |
|FIRST INCIDENCE | --- 683 478 521 |708 470 506 408 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.303 P=0.119 P=0.110 P=0.240 |P=0.489N P=0.046 * P=0.166 P=0.490 |
|POLY 3 | P=0.312 P=0.118 P=0.112 P=0.238 |P=0.484N P=0.049 * P=0.201 P=0.491 |
|POLY 1.5 | P=0.315 P=0.118 P=0.113 P=0.240 |P=0.494N P=0.049 * P=0.203 P=0.486 |
|POLY 6 | P=0.309 P=0.119 P=0.112 P=0.237 |P=0.471N P=0.048 * P=0.195 P=0.499 |
|LOGISTIC REGRESSION| P=0.339 P=0.119 P=0.142 P=0.289 |P=0.468N P=0.065 P=0.249 P=0.524 |
|COCH-ARM / FISHERS | P=0.321 P=0.121 P=0.121 P=0.253 |P=0.501N P=0.049 * P=0.209 P=0.480 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 3/48 (6%) 0/49 (0%) 4/49 (8%) |2/49 (4%) 2/50 (4%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/44.27 3/43.72 0/40.73 4/43.22 |2/45.22 2/44.69 1/42.51 1/44.68 |
|POLY-3 PERCENT (g) | 11.3% 6.9% 0.0% 9.3% |4.4% 4.5% 2.4% 2.2% |
|TERMINAL (d) | 2/34 (6%) 0/32 (0%) 0/27 (0%) 1/32 (3%) |1/36 (3%) 0/34 (0%) 0/27 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 525 398 --- 593 |530 470 600 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.448N P=0.368N P=0.047N* P=0.531N |P=0.354N P=0.683 P=0.536N P=0.518N |
|POLY 3 | P=0.434N P=0.363N P=0.038N* P=0.515N |P=0.343N P=0.690 P=0.522N P=0.504N |
|POLY 1.5 | P=0.428N P=0.365N P=0.036N* P=0.510N |P=0.341N P=0.693N P=0.514N P=0.501N |
|POLY 6 | P=0.440N P=0.361N P=0.040N* P=0.520N |P=0.345N P=0.683 P=0.534N P=0.506N |
|LOGISTIC REGRESSION| P=0.380N P=0.302N P=0.028N* P=0.468N |P=0.289N P=0.587N P=0.435N P=0.470N |
|COCH-ARM / FISHERS | P=0.417N P=0.369N P=0.028N* P=0.500N |P=0.333N P=0.684N P=0.500N P=0.492N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 1/48 (2%) 0/49 (0%) 2/49 (4%) |0/49 (0%) 2/50 (4%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/44.04 1/42.87 0/40.73 2/42.30 |0/44.60 2/44.69 1/42.51 0/44.68 |
|POLY-3 PERCENT (g) | 11.4% 2.3% 0.0% 4.7% |0.0% 4.5% 2.4% 0.0% |
|TERMINAL (d) | 2/34 (6%) 0/32 (0%) 0/27 (0%) 1/32 (3%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 617 398 --- 681 |--- 470 600 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.186N P=0.114N P=0.047N* P=0.248N |P=0.467N P=0.237 P=0.496 (e) |
|POLY 3 | P=0.167N P=0.107N P=0.037N* P=0.232N |P=0.466N P=0.237 P=0.490 (e) |
|POLY 1.5 | P=0.165N P=0.107N P=0.035N* P=0.226N |P=0.464N P=0.239 P=0.493 (e) |
|POLY 6 | P=0.170N P=0.108N P=0.040N* P=0.241N |P=0.468N P=0.235 P=0.484 (e) |
|LOGISTIC REGRESSION| P=0.151N P=0.086N P=0.033N* P=0.216N |P=0.401N P=0.332 P=0.549 (e) |
|COCH-ARM / FISHERS | P=0.163N P=0.107N P=0.028N* P=0.218N |P=0.457N P=0.253 P=0.500 (e) |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/48 (2%) 0/49 (0%) 2/49 (4%) |1/49 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.73 1/42.87 0/40.73 2/42.30 |1/44.79 0/43.40 1/42.35 0/44.68 |
|POLY-3 PERCENT (g) | 4.6% 2.3% 0.0% 4.7% |2.2% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 1/32 (3%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 617 398 --- 681 |683 --- 652 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.570 P=0.503N P=0.248N P=0.667 |P=0.401N P=0.526N P=0.737 P=0.495N |
|POLY 3 | P=0.581 P=0.507N P=0.253N P=0.682 |P=0.400N P=0.506N P=0.748 P=0.500N |
|POLY 1.5 | P=0.585 P=0.507N P=0.249N P=0.687 |P=0.402N P=0.502N P=0.752 P=0.500N |
|POLY 6 | P=0.576 P=0.508N P=0.258N P=0.677 |P=0.397N P=0.512N P=0.740 P=0.501N |
|LOGISTIC REGRESSION| P=0.617 P=0.416N P=0.218N P=0.691N |P=0.396N P=0.490N P=0.753N P=0.491N |
|COCH-ARM / FISHERS | P=0.593 P=0.508N P=0.247N P=0.691N |P=0.402N P=0.495N P=0.753N P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/44 (2%) 0/49 (0%) 0/48 (0%) |0/47 (0%) 1/49 (2%) 1/47 (2%) 1/47 (2%) |
|POLY-3 RATE (b) | 2/42.48 1/39.16 0/40.73 0/41.12 |0/43.64 1/43.18 1/40.55 1/42.82 |
|POLY-3 PERCENT (g) | 4.7% 2.6% 0.0% 0.0% |0.0% 2.3% 2.5% 2.3% |
|TERMINAL (d) | 2/34 (6%) 1/32 (3%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 1/27 (4%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- 653 730 (T) 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.114N P=0.521N P=0.290N P=0.252N |P=0.383 P=0.490 P=0.443 P=0.500 |
|POLY 3 | P=0.101N P=0.528N P=0.246N P=0.244N |P=0.376 P=0.498 P=0.485 P=0.496 |
|POLY 1.5 | P=0.100N P=0.530N P=0.243N P=0.241N |P=0.376 P=0.502 P=0.490 P=0.497 |
|POLY 6 | P=0.103N P=0.524N P=0.250N P=0.248N |P=0.379 P=0.494 P=0.478 P=0.497 |
|LOGISTIC REGRESSION| P=0.114N P=0.521N (e) (e) |P=0.379 P=0.548 P=0.443 P=0.498 |
|COCH-ARM / FISHERS | P=0.098N P=0.533N P=0.242N P=0.247N |P=0.380 P=0.510 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/44 (0%) 1/49 (2%) 1/48 (2%) |0/47 (0%) 1/49 (2%) 1/47 (2%) 3/47 (6%) |
|POLY-3 RATE (b) | 2/42.72 0/39.16 1/41.09 1/41.43 |0/43.64 1/43.29 1/40.90 3/44.58 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 2.4% 2.4% |0.0% 2.3% 2.5% 6.7% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 687 --- 628 645 |--- 620 634 408 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.516N P=0.252N P=0.535N P=0.513N |P=0.059 P=0.495 P=0.495 P=0.124 |
|POLY 3 | P=0.499N P=0.256N P=0.514N P=0.511N |P=0.055 P=0.498 P=0.487 P=0.122 |
|POLY 1.5 | P=0.495N P=0.257N P=0.508N P=0.506N |P=0.053 P=0.502 P=0.491 P=0.120 |
|POLY 6 | P=0.503N P=0.254N P=0.519N P=0.516N |P=0.057 P=0.494 P=0.481 P=0.126 |
|LOGISTIC REGRESSION| P=0.484N P=0.257N P=0.487N P=0.495N |P=0.058 P=0.581 P=0.539 P=0.239 |
|COCH-ARM / FISHERS | P=0.491N P=0.269N P=0.492N P=0.500N |P=0.052 P=0.510 P=0.500 P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 RATE (b) | 2/43.60 1/43.68 1/41.34 2/42.54 | |
|POLY-3 PERCENT (g) | 4.6% 2.3% 2.4% 4.7% | |
|TERMINAL (d) | 2/34 (6%) 0/32 (0%) 1/27 (4%) 2/32 (6%) | |
|FIRST INCIDENCE | 729 (T) 618 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.530 P=0.511N P=0.581N P=0.674 | |
|POLY 3 | P=0.545 P=0.499N P=0.519N P=0.685 | |
|POLY 1.5 | P=0.549 P=0.500N P=0.514N P=0.688 | |
|POLY 6 | P=0.539 P=0.497N P=0.523N P=0.682 | |
|LOGISTIC REGRESSION| P=0.543 P=0.501N P=0.581N P=0.674 | |
|COCH-ARM / FISHERS | P=0.556 P=0.500N P=0.500N P=0.691N | |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |
|POLY-3 RATE (b) | 2/43.60 0/43.29 0/41.34 0/42.54 | |
|POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 0.0% | |
|TERMINAL (d) | 2/34 (6%) 0/32 (0%) 0/27 (0%) 0/32 (0%) | |
|FIRST INCIDENCE | 729 (T) --- --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.127N P=0.252N P=0.290N P=0.252N | |
|POLY 3 | P=0.114N P=0.239N P=0.249N P=0.242N | |
|POLY 1.5 | P=0.114N P=0.238N P=0.246N P=0.241N | |
|POLY 6 | P=0.114N P=0.238N P=0.252N P=0.245N | |
|LOGISTIC REGRESSION| P=0.127N (e) (e) (e) | |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/41 (0%) 0/39 (0%) 0/40 (0%) 0/42 (0%) |0/43 (0%) 0/45 (0%) 2/47 (4%) 0/46 (0%) |
|POLY-3 RATE (b) | 0/36.75 0/33.90 0/34.05 0/37.66 |0/39.89 0/40.31 2/41.52 0/41.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.8% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/28 (0%) 0/24 (0%) 0/30 (0%) |0/34 (0%) 0/33 (0%) 0/26 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 15 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.595 (e) P=0.237 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.605 (e) P=0.246 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.603 (e) P=0.251 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.612 (e) P=0.237 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.677N (e) P=0.539 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.608 (e) P=0.270 (e) |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
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| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/48 (4%) 3/47 (6%) 2/50 (4%) |0/50 (0%) 2/49 (4%) 1/47 (2%) 3/48 (6%) |
|POLY-3 RATE (b) | 3/43.20 2/42.00 3/38.85 2/42.54 |0/45.31 2/42.95 1/40.23 3/43.47 |
|POLY-3 PERCENT (g) | 7.0% 4.8% 7.7% 4.7% |0.0% 4.7% 2.5% 6.9% |
|TERMINAL (d) | 3/34 (9%) 1/31 (3%) 3/26 (12%) 2/32 (6%) |0/36 (0%) 2/34 (6%) 1/27 (4%) 2/34 (6%) |
|FIRST INCIDENCE | 729 (T) 673 729 (T) 729 (T) |--- 730 (T) 730 (T) 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.489N P=0.529N P=0.534 P=0.528N |P=0.101 P=0.226 P=0.443 P=0.116 |
|POLY 3 | P=0.464N P=0.513N P=0.613 P=0.507N |P=0.096 P=0.225 P=0.476 P=0.111 |
|POLY 1.5 | P=0.457N P=0.513N P=0.620 P=0.501N |P=0.096 P=0.228 P=0.480 P=0.110 |
|POLY 6 | P=0.473N P=0.512N P=0.607 P=0.514N |P=0.099 P=0.222 P=0.470 P=0.113 |
|LOGISTIC REGRESSION| P=0.477N P=0.517N P=0.534 P=0.528N |P=0.108 P=0.226 P=0.443 P=0.115 |
|COCH-ARM / FISHERS | P=0.446N P=0.510N P=0.641 P=0.490N |P=0.097 P=0.242 P=0.485 P=0.114 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/46 (0%) 1/49 (2%) 2/50 (4%) |0/48 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/43.27 0/40.78 1/41.35 2/43.49 |0/44.22 0/43.40 0/42.07 0/43.52 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.4% 4.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 710 --- 527 521 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.247 P=0.512N P=0.728 P=0.497 |(e) (e) (e) (e) |
|POLY 3 | P=0.255 P=0.512N P=0.751 P=0.502 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.257 P=0.513N P=0.752 P=0.504 |(e) (e) (e) (e) |
|POLY 6 | P=0.252 P=0.510N P=0.749 P=0.500 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.277 P=0.511N P=0.730N P=0.556 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.259 P=0.516N P=0.753N P=0.508 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |5/49 (10%) 3/50 (6%) 9/49 (18%) 8/49 (16%) |
|POLY-3 RATE (b) | |5/44.70 3/43.73 9/42.44 8/45.02 |
|POLY-3 PERCENT (g) | |11.2% 6.9% 21.2% 17.8% |
|TERMINAL (d) | |3/36 (8%) 2/34 (6%) 6/27 (22%) 4/34 (12%) |
|FIRST INCIDENCE | |708 637 675 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.116 P=0.395N P=0.086 P=0.266 |
|POLY 3 | |P=0.120 P=0.368N P=0.162 P=0.280 |
|POLY 1.5 | |P=0.114 P=0.359N P=0.173 P=0.275 |
|POLY 6 | |P=0.131 P=0.380N P=0.146 P=0.290 |
|LOGISTIC REGRESSION| |P=0.110 P=0.377N P=0.127 P=0.274 |
|COCH-ARM / FISHERS | |P=0.113 P=0.346N P=0.194 P=0.276 |
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(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).