TDMS Study 96001-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest STODDARD SOLVENT (TYPE IIC) DATE: 01/08/03
EXPERIMENT: 96001 TEST: 05 TIME: 12:16:03
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C96001
PATHOLOGIST: RENNE, ROGER CAS: 64742-88-7
------------------------------------------------------------------------------------------------------------------------------------
FINAL/RATS
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: 01/08/03
EXPERIMENT: 96001 TEST: 05 TIME: 12:16:03
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C96001
PATHOLOGIST: RENNE, ROGER CAS: 64742-88-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF STODDARD SOLVENT (TYPE IIC)
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Vacuolization Cytoplasmic
Adrenal Medulla Hyperplasia
Necrosis
Heart Cardiomyopathy
Heart: Atrium Thrombosis
Kidney Cyst
Nephropathy Chronic
Kidney: Cortex, Renal Tubule Casts Granular
Hyperplasia
Kidney: Papilla Mineralization
Kidney: Pelvis, Transitional Epithelium
Hyperplasia
Lung Inflammation
Lung: Alveolar Epithelium Hyperplasia
Lung: Alveolus Infiltration Cellular Histiocyte
Nose: Goblet Cell Hyperplasia
Nose: Olfactory Epithelium Degeneration Hyaline
Pituitary Gland: Pars Distalis Hemorrhage
Pleura Fibrosis
Inflammation Chronic
Spleen Fibrosis
Necrosis
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Vacuolization Cytoplasmic
Kidney Nephropathy Chronic
Kidney: Papilla Mineralization
Kidney: Pelvis, Transitional Epithelium
Mineralization
Larynx Inflammation Chronic
Liver Clear Cell Focus
Liver: Hepatocyte Regeneration
Lung: Alveolus Infiltration Cellular Histiocyte
Nose: Olfactory Epithelium Degeneration Hyaline
Pleura Fibrosis
Inflammation Chronic
Thyroid Gland: C-Cell Hyperplasia
Uterus Necrosis
===============================================================
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/45.09 1/38.81 1/41.36 0/39.41 |1/45.31 1/44.39 0/44.80 2/41.33 |
|POLY-3 PERCENT (g) | 2.2% 2.6% 2.4% 0.0% |2.2% 2.3% 0.0% 4.8% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 717 625 726 --- |495 575 --- 625 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.380N P=0.692 P=0.696 P=0.608N |P=0.342 P=0.760N P=0.504N P=0.469 |
|POLY 3 | P=0.324N P=0.726 P=0.741 P=0.527N |P=0.349 P=0.756 P=0.502N P=0.468 |
|POLY 1.5 | P=0.315N P=0.742 P=0.749 P=0.515N |P=0.356 P=0.758 P=0.502N P=0.480 |
|POLY 6 | P=0.339N P=0.703 P=0.731 P=0.544N |P=0.342 P=0.753 P=0.504N P=0.452 |
|LOGISTIC REGRESSION| P=0.315N P=0.757N P=0.722 P=0.568N |P=0.520 P=0.774N P=0.390N P=0.631 |
|COCH-ARM / FISHERS | P=0.304N P=0.753N P=0.753N P=0.500N |P=0.366 P=0.753N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.325N (e) (e) (e) |P=0.240 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 5/50 (10%) 14/50 (28%) 10/50 (20%) |9/50 (18%) 4/50 (8%) 15/50 (30%) 12/50 (24%) |
|POLY-3 RATE (b) | 15/47.06 5/38.76 14/43.46 10/40.97 |9/45.39 4/44.30 15/45.22 12/42.40 |
|POLY-3 PERCENT (g) | 31.9% 12.9% 32.2% 24.4% |19.8% 9.0% 33.2% 28.3% |
|TERMINAL (d) | 7/29 (24%) 4/19 (21%) 7/21 (33%) 4/16 (25%) |7/36 (19%) 3/30 (10%) 12/32 (38%) 7/25 (28%) |
|FIRST INCIDENCE | 476 642 546 522 |582 606 683 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.253 P=0.114N P=0.390 P=0.546 |P=0.021 * P=0.182N P=0.080 P=0.114 |
|POLY 3 | P=0.535N P=0.033N* P=0.576 P=0.294N |P=0.061 P=0.123N P=0.113 P=0.248 |
|POLY 1.5 | P=0.516N P=0.020N* P=0.562N P=0.239N |P=0.072 P=0.120N P=0.115 P=0.273 |
|POLY 6 | P=0.513 P=0.063N P=0.528 P=0.385N |P=0.050 P=0.131N P=0.109 P=0.215 |
|LOGISTIC REGRESSION| P=0.530 P=0.022N* P=0.487N P=0.189N |P=0.062 P=0.120N P=0.121 P=0.271 |
|COCH-ARM / FISHERS | P=0.500N P=0.011N* P=0.500N P=0.178N |P=0.094 P=0.117N P=0.121 P=0.312 |
|ORDER RESTRICTED | P=0.283N (e) (e) (e) |P=0.044 * (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 14/50 (28%) 23/50 (46%) 15/50 (30%) |4/50 (8%) 2/50 (4%) 7/50 (14%) 4/50 (8%) |
|POLY-3 RATE (b) | 12/46.14 14/41.83 23/43.82 15/42.29 |4/44.90 2/44.19 7/45.55 4/41.89 |
|POLY-3 PERCENT (g) | 26.0% 33.5% 52.5% 35.5% |8.9% 4.5% 15.4% 9.6% |
|TERMINAL (d) | 7/29 (24%) 6/19 (32%) 10/21 (48%) 6/16 (38%) |3/36 (8%) 0/30 (0%) 3/32 (9%) 1/25 (4%) |
|FIRST INCIDENCE | 621 537 541 432 |656 656 610 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046 * P=0.128 P=0.004 ** P=0.056 |P=0.283 P=0.392N P=0.237 P=0.508 |
|POLY 3 | P=0.138 P=0.296 P=0.007 ** P=0.230 |P=0.366 P=0.344N P=0.269 P=0.605 |
|POLY 1.5 | P=0.171 P=0.344 P=0.010 * P=0.271 |P=0.384 P=0.341N P=0.265 P=0.620 |
|POLY 6 | P=0.097 P=0.233 P=0.005 ** P=0.177 |P=0.343 P=0.351N P=0.273 P=0.584 |
|LOGISTIC REGRESSION| P=0.181 P=0.412 P=0.008 ** P=0.297 |P=0.420 P=0.341N P=0.262 P=0.630N |
|COCH-ARM / FISHERS | P=0.218 P=0.410 P=0.018 * P=0.326 |P=0.415 P=0.339N P=0.262 P=0.643N |
|ORDER RESTRICTED | P=0.047 * (e) (e) (e) |P=0.285 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 0/41.34 2/39.69 |0/44.62 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- --- 673 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035 * (e) (e) P=0.161 |(e) (e) (e) (e) |
|POLY 3 | P=0.040 * (e) (e) P=0.210 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.041 * (e) (e) P=0.222 |(e) (e) (e) (e) |
|POLY 6 | P=0.039 * (e) (e) P=0.194 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.039 * (e) (e) P=0.213 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.021 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Brain |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 15/50 (30%) 10/50 (20%) 9/50 (18%) |9/49 (18%) 8/50 (16%) 3/50 (6%) 6/50 (12%) |
|POLY-3 RATE (b) | 13/47.02 15/43.98 10/42.92 9/42.20 |9/45.08 8/44.95 3/45.29 6/41.61 |
|POLY-3 PERCENT (g) | 27.7% 34.1% 23.3% 21.3% |20.0% 17.8% 6.6% 14.4% |
|TERMINAL (d) | 4/29 (14%) 2/19 (11%) 4/21 (19%) 2/16 (13%) |6/36 (17%) 3/30 (10%) 2/32 (6%) 2/25 (8%) |
|FIRST INCIDENCE | 576 403 529 529 |509 481 581 506 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.281N P=0.142 P=0.536N P=0.569N |P=0.341N P=0.586 P=0.090N P=0.517N |
|POLY 3 | P=0.154N P=0.329 P=0.409N P=0.328N |P=0.203N P=0.503N P=0.057N P=0.346N |
|POLY 1.5 | P=0.129N P=0.366 P=0.369N P=0.285N |P=0.190N P=0.493N P=0.057N P=0.316N |
|POLY 6 | P=0.199N P=0.277 P=0.467N P=0.396N |P=0.221N P=0.519N P=0.059N P=0.388N |
|LOGISTIC REGRESSION| P=0.062N P=0.427N P=0.291N P=0.132N |P=0.166N P=0.479N P=0.057N P=0.295N |
|COCH-ARM / FISHERS | P=0.102N P=0.412 P=0.318N P=0.235N |P=0.169N P=0.482N P=0.056N P=0.274N |
|ORDER RESTRICTED | P=0.244N (e) (e) (e) |P=0.162N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 5/50 (10%) 3/50 (6%) |4/49 (8%) 3/50 (6%) 6/50 (12%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/46.29 4/40.21 5/42.41 3/40.67 |4/45.06 3/44.31 6/46.45 1/40.96 |
|POLY-3 PERCENT (g) | 8.6% 10.0% 11.8% 7.4% |8.9% 6.8% 12.9% 2.4% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |1/36 (3%) 1/30 (3%) 2/32 (6%) 0/25 (0%) |
|FIRST INCIDENCE | 476 403 556 465 |495 606 433 647 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.527N P=0.478 P=0.400 P=0.624N |P=0.290N P=0.557N P=0.354 P=0.262N |
|POLY 3 | P=0.490N P=0.564 P=0.445 P=0.570N |P=0.246N P=0.509N P=0.389 P=0.209N |
|POLY 1.5 | P=0.464N P=0.599 P=0.467 P=0.540N |P=0.224N P=0.500N P=0.386 P=0.194N |
|POLY 6 | P=0.528N P=0.511 P=0.421 P=0.613N |P=0.276N P=0.523N P=0.390 P=0.230N |
|LOGISTIC REGRESSION| P=0.328N P=0.306N P=0.639 P=0.224N |P=0.134N P=0.473N P=0.400 P=0.136N |
|COCH-ARM / FISHERS | P=0.433N P=0.643N P=0.500 P=0.500N |P=0.193N P=0.489N P=0.383 P=0.175N |
|ORDER RESTRICTED | P=0.523N (e) (e) (e) |P=0.177N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/49 (4%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | |2/43.62 3/43.87 3/44.88 1/40.65 |
|POLY-3 PERCENT (g) | |4.6% 6.8% 6.7% 2.5% |
|TERMINAL (d) | |2/35 (6%) 3/30 (10%) 2/32 (6%) 1/25 (4%) |
|FIRST INCIDENCE | |730 (T) 730 (T) 710 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.469N P=0.429 P=0.460 P=0.617N |
|POLY 3 | |P=0.378N P=0.503 P=0.513 P=0.525N |
|POLY 1.5 | |P=0.362N P=0.506 P=0.511 P=0.512N |
|POLY 6 | |P=0.400N P=0.496 P=0.514 P=0.543N |
|LOGISTIC REGRESSION| |P=0.440N P=0.429 P=0.504 P=0.617N |
|COCH-ARM / FISHERS | |P=0.336N P=0.510 P=0.510 P=0.492N |
|ORDER RESTRICTED | |P=0.371N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Eye: Lens |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/50 (2%) 3/49 (6%) 2/50 (4%) |3/49 (6%) 2/50 (4%) 1/50 (2%) 4/49 (8%) |
|POLY-3 RATE (b) | 6/45.25 1/38.44 3/40.62 2/39.59 |3/44.22 2/43.87 1/44.80 4/40.56 |
|POLY-3 PERCENT (g) | 13.3% 2.6% 7.4% 5.1% |6.8% 4.6% 2.2% 9.9% |
|TERMINAL (d) | 5/29 (17%) 1/19 (5%) 2/21 (10%) 1/16 (6%) |3/36 (8%) 2/30 (7%) 1/32 (3%) 2/25 (8%) |
|FIRST INCIDENCE | 674 729 (T) 712 683 |730 (T) 730 (T) 730 (T) 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.391N P=0.160N P=0.402N P=0.348N |P=0.250 P=0.583N P=0.348N P=0.347 |
|POLY 3 | P=0.222N P=0.086N P=0.297N P=0.179N |P=0.345 P=0.504N P=0.300N P=0.453 |
|POLY 1.5 | P=0.221N P=0.072N P=0.279N P=0.158N |P=0.353 P=0.498N P=0.300N P=0.471 |
|POLY 6 | P=0.225N P=0.113N P=0.321N P=0.214N |P=0.335 P=0.514N P=0.302N P=0.430 |
|LOGISTIC REGRESSION| P=0.312N P=0.153N P=0.341N P=0.254N |P=0.320 P=0.583N P=0.348N P=0.458 |
|COCH-ARM / FISHERS | P=0.224N P=0.056N P=0.254N P=0.134N |P=0.368 P=0.490N P=0.301N P=0.500 |
|ORDER RESTRICTED | P=0.106N (e) (e) (e) |P=0.237 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 4/50 (8%) 5/50 (10%) 9/50 (18%) |1/49 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 13/45.98 4/39.15 5/42.71 9/41.38 |1/44.71 0/43.87 1/44.90 2/41.13 |
|POLY-3 PERCENT (g) | 28.3% 10.2% 11.7% 21.8% |2.2% 0.0% 2.2% 4.9% |
|TERMINAL (d) | 10/29 (35%) 2/19 (11%) 1/21 (5%) 2/16 (13%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | 576 605 509 581 |582 --- 705 589 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.410 P=0.105N P=0.112N P=0.524 |P=0.206 P=0.500N P=0.754 P=0.445 |
|POLY 3 | P=0.420N P=0.033N* P=0.044N* P=0.324N |P=0.232 P=0.504N P=0.760N P=0.471 |
|POLY 1.5 | P=0.424N P=0.023N* P=0.039N* P=0.284N |P=0.240 P=0.500N P=0.758N P=0.486 |
|POLY 6 | P=0.417N P=0.053N P=0.052N P=0.382N |P=0.224 P=0.509N P=0.759 P=0.451 |
|LOGISTIC REGRESSION| P=0.455N P=0.040N* P=0.034N* P=0.289N |P=0.298 P=0.478N P=0.748N P=0.584 |
|COCH-ARM / FISHERS | P=0.431N P=0.016N* P=0.033N* P=0.235N |P=0.251 P=0.495N P=0.747N P=0.508 |
|ORDER RESTRICTED | P=0.066N (e) (e) (e) |P=0.199 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 5/50 (10%) |2/49 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/45.04 0/38.44 1/41.55 5/40.13 |2/45.18 1/44.16 2/44.81 1/40.79 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.4% 12.5% |4.4% 2.3% 4.5% 2.5% |
|TERMINAL (d) | 1/29 (3%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- 675 667 |495 652 726 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** P=0.584N P=0.715 P=0.039 * |P=0.516N P=0.505N P=0.674 P=0.549N |
|POLY 3 | P=0.007 ** P=0.531N P=0.743 P=0.076 |P=0.473N P=0.508N P=0.691 P=0.536N |
|POLY 1.5 | P=0.008 ** P=0.518N P=0.750 P=0.087 |P=0.460N P=0.501N P=0.693N P=0.518N |
|POLY 6 | P=0.007 ** P=0.552N P=0.734 P=0.064 |P=0.490N P=0.517N P=0.685 P=0.558N |
|LOGISTIC REGRESSION| P=0.007 ** (e) P=0.748 P=0.071 |P=0.384N P=0.464N P=0.675N P=0.388N |
|COCH-ARM / FISHERS | P=0.009 ** P=0.500N P=0.753N P=0.102 |P=0.438N P=0.492N P=0.684N P=0.492N |
|ORDER RESTRICTED | P=0.005 ** (e) (e) (e) |P=0.490N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 0/41.34 2/39.73 |0/44.22 2/43.87 0/44.80 1/40.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.0% |0.0% 4.6% 0.0% 2.5% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 1/16 (6%) |0/36 (0%) 2/30 (7%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | --- --- --- 642 |--- 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029 * (e) (e) P=0.160 |P=0.457 P=0.199 (e) P=0.427 |
|POLY 3 | P=0.040 * (e) (e) P=0.210 |P=0.508 P=0.235 (e) P=0.483 |
|POLY 1.5 | P=0.041 * (e) (e) P=0.222 |P=0.522 P=0.238 (e) P=0.492 |
|POLY 6 | P=0.039 * (e) (e) P=0.194 |P=0.489 P=0.230 (e) P=0.472 |
|LOGISTIC REGRESSION| P=0.041 * (e) (e) P=0.225 |(e) P=0.199 (e) P=0.427 |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |P=0.543 P=0.253 (e) P=0.505 |
|ORDER RESTRICTED | P=0.021 * (e) (e) (e) |P=0.309 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 49/50 (98%) 50/50 (100%) 50/50 (100%)|42/49 (86%) 44/50 (88%) 46/50 (92%) 44/50 (88%) |
|POLY-3 RATE (b) | 50/50.00 49/49.19 50/50.00 50/50.00 |42/45.91 44/46.62 46/47.66 44/45.98 |
|POLY-3 PERCENT (g) | 100.0% 99.6% 100.0% 100.0% |91.5% 94.4% 96.5% 95.7% |
|TERMINAL (d) | 29/29 (100%) 19/19 (100%) 21/21 (100%) 16/16 (100%)|34/36 (94%) 30/30 (100%) 32/32 (100%) 25/25 (100%) |
|FIRST INCIDENCE | 476 403 396 432 |582 537 563 506 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.024 * P=0.010 * (e) (e) |P=0.003 ** P=0.063 P=0.073 P=0.004 ** |
|POLY 3 | P=0.996 P=1.000N (e) (e) |P=0.201 P=0.434 P=0.239 P=0.310 |
|POLY 1.5 | P=0.772 P=0.897N (e) (e) |P=0.275 P=0.463 P=0.227 P=0.374 |
|POLY 6 | P=1.000 P=1.000N (e) (e) |P=0.140 P=0.372 P=0.286 P=0.256 |
|LOGISTIC REGRESSION| P=0.470 P=0.986N (e) (e) |P=0.031 * P=0.350 P=0.196 P=0.072 |
|COCH-ARM / FISHERS | P=0.468 P=0.500N (e) (e) |P=0.414 P=0.484 P=0.251 P=0.484 |
|ORDER RESTRICTED | P=0.379 (e) (e) (e) |P=0.163 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Cortex |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.45 1/39.25 1/41.90 2/39.91 |1/44.71 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 4.4% 2.6% 2.4% 5.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/19 (0%) 0/21 (0%) 1/16 (6%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 611 421 556 581 |582 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.447 P=0.569N P=0.565N P=0.549 |P=0.313N P=0.500N P=0.500N P=0.514N |
|POLY 3 | P=0.507 P=0.551N P=0.528N P=0.646 |P=0.288N P=0.504N P=0.500N P=0.519N |
|POLY 1.5 | P=0.516 P=0.528N P=0.517N P=0.667 |P=0.295N P=0.500N P=0.498N P=0.510N |
|POLY 6 | P=0.492 P=0.586N P=0.543N P=0.615 |P=0.278N P=0.509N P=0.502N P=0.532N |
|LOGISTIC REGRESSION| P=0.604 P=0.252N P=0.382N P=0.643N |P=0.226N P=0.478N P=0.457N P=0.403N |
|COCH-ARM / FISHERS | P=0.527 P=0.500N P=0.500N P=0.691N |P=0.303N P=0.495N P=0.495N P=0.495N |
|ORDER RESTRICTED | P=0.508 (e) (e) (e) |P=0.138N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Cortex, Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.27 5/41.19 3/43.31 2/40.74 |0/44.22 0/43.87 0/44.80 1/41.23 |
|POLY-3 PERCENT (g) | 4.3% 12.1% 6.9% 4.9% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 476 403 396 432 |--- --- --- 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.381N P=0.174 P=0.471 P=0.669 |P=0.190 (e) (e) P=0.491 |
|POLY 3 | P=0.413N P=0.171 P=0.470 P=0.647 |P=0.190 (e) (e) P=0.486 |
|POLY 1.5 | P=0.385N P=0.191 P=0.483 P=0.668 |P=0.194 (e) (e) P=0.493 |
|POLY 6 | P=0.455N P=0.145 P=0.454 P=0.616 |P=0.185 (e) (e) P=0.476 |
|LOGISTIC REGRESSION| P=0.102N P=0.659N P=0.348N P=0.199N |P=0.291 (e) (e) P=0.631 |
|COCH-ARM / FISHERS | P=0.351N P=0.218 P=0.500 P=0.691N |P=0.200 (e) (e) P=0.505 |
|ORDER RESTRICTED | P=0.398 (e) (e) (e) |P=0.108 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Cortex, Renal Tubule |
| Casts Granular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 1/38.94 1/41.34 3/40.66 |0/44.22 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 2.4% 7.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 1/21 (5%) 1/16 (6%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- 579 729 (T) 522 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.039 * P=0.487 P=0.436 P=0.087 |(e) (e) (e) (e) |
|POLY 3 | P=0.050 P=0.471 P=0.483 P=0.101 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.054 P=0.484 P=0.490 P=0.109 |(e) (e) (e) (e) |
|POLY 6 | P=0.045 * P=0.452 P=0.474 P=0.090 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.075 P=0.660 P=0.436 P=0.236 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.059 P=0.500 P=0.500 P=0.121 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Cortex, Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 8/50 (16%) 23/50 (46%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 1/38.45 8/41.34 23/41.68 |0/44.22 0/43.87 1/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 19.4% 55.2% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 8/21 (38%) 10/16 (63%) |0/36 (0%) 0/30 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | --- 726 729 (T) 563 |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.419 P<0.001 ** P<0.001 ** |P=0.657 (e) P=0.477 (e) |
|POLY 3 | P<0.001 ** P=0.469 P=0.002 ** P<0.001 ** |P=0.652 (e) P=0.503 (e) |
|POLY 1.5 | P<0.001 ** P=0.482 P=0.003 ** P<0.001 ** |P=0.671 (e) P=0.503 (e) |
|POLY 6 | P<0.001 ** P=0.448 P=0.002 ** P<0.001 ** |P=0.626 (e) P=0.501 (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.404 P<0.001 ** P<0.001 ** |(e) (e) P=0.477 (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.003 ** P<0.001 ** |P=0.697 (e) P=0.505 (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.384 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Medulla |
| Casts Granular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 3/39.78 1/41.82 3/39.87 |0/44.22 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 7.5% 2.4% 7.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 2/16 (13%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- 472 589 593 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152 P=0.096 P=0.478 P=0.056 |(e) (e) (e) (e) |
|POLY 3 | P=0.179 P=0.098 P=0.485 P=0.098 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.196 P=0.107 P=0.491 P=0.107 |(e) (e) (e) (e) |
|POLY 6 | P=0.156 P=0.085 P=0.478 P=0.086 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.266 P=0.259 P=0.622 P=0.111 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.220 P=0.121 P=0.500 P=0.121 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.059 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Papilla |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 8/50 (16%) 30/50 (60%) 39/50 (78%) |3/49 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.04 8/39.96 30/46.16 39/48.11 |3/44.22 1/43.87 1/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 20.0% 65.0% 81.1% |6.8% 2.3% 2.2% 0.0% |
|TERMINAL (d) | 1/29 (3%) 3/19 (16%) 13/21 (62%) 12/16 (75%) |3/36 (8%) 1/30 (3%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) 621 509 432 |730 (T) 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |P=0.108N P=0.372N P=0.348N P=0.192N |
|POLY 3 | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |P=0.076N P=0.308N P=0.300N P=0.134N |
|POLY 1.5 | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P=0.074N P=0.303N P=0.300N P=0.126N |
|POLY 6 | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P=0.079N P=0.316N P=0.302N P=0.146N |
|LOGISTIC REGRESSION| P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** |P=0.108N P=0.372N P=0.348N (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** |P=0.071N P=0.301N P=0.301N P=0.117N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.046N* (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Pelvis, Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 8/50 (16%) 5/50 (10%) |4/49 (8%) 3/50 (6%) 7/50 (14%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/45.04 2/38.72 8/42.46 5/39.88 |4/44.22 3/43.92 7/45.45 3/40.65 |
|POLY-3 PERCENT (g) | 0.0% 5.2% 18.8% 12.5% |9.1% 6.8% 15.4% 7.4% |
|TERMINAL (d) | 0/29 (0%) 1/19 (5%) 3/21 (14%) 2/16 (13%) |4/36 (11%) 2/30 (7%) 5/32 (16%) 3/25 (12%) |
|FIRST INCIDENCE | --- 652 618 684 |730 (T) 719 563 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.008 ** P=0.157 P=0.003 ** P=0.010 * |P=0.428 P=0.591N P=0.212 P=0.617 |
|POLY 3 | P=0.012 * P=0.205 P=0.003 ** P=0.021 * |P=0.551 P=0.504N P=0.276 P=0.546N |
|POLY 1.5 | P=0.015 * P=0.219 P=0.003 ** P=0.025 * |P=0.550N P=0.497N P=0.275 P=0.523N |
|POLY 6 | P=0.008 ** P=0.186 P=0.002 ** P=0.017 * |P=0.509 P=0.515N P=0.277 P=0.577N |
|LOGISTIC REGRESSION| P=0.016 * P=0.207 P=0.004 ** P=0.017 * |P=0.534 P=0.553N P=0.268 P=0.617 |
|COCH-ARM / FISHERS | P=0.022 * P=0.247 P=0.003 ** P=0.028 * |P=0.507N P=0.489N P=0.274 P=0.489N |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) |P=0.454 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Pelvis, Transitional Epithelium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |25/49 (51%) 23/50 (46%) 27/50 (54%) 27/50 (54%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 0/41.34 0/39.41 |25/44.69 23/44.62 27/45.21 27/42.53 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |55.9% 51.6% 59.7% 63.5% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |23/36 (64%) 17/30 (57%) 22/32 (69%) 18/25 (72%) |
|FIRST INCIDENCE | --- --- --- --- |634 656 695 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.015 * P=0.425 P=0.212 P=0.027 * |
|POLY 3 | (e) (e) (e) (e) |P=0.192 P=0.417N P=0.439 P=0.302 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.239 P=0.400N P=0.448 P=0.362 |
|POLY 6 | (e) (e) (e) (e) |P=0.148 P=0.446N P=0.425 P=0.240 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.066 P=0.504N P=0.412 P=0.145 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.329 P=0.383N P=0.462 P=0.462 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.274 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Larynx |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |2/49 (4%) 1/50 (2%) 2/50 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/45.11 2/38.97 2/41.77 3/39.99 |2/44.88 1/43.87 2/44.83 1/39.65 |
|POLY-3 PERCENT (g) | 2.2% 5.1% 4.8% 7.5% |4.5% 2.3% 4.5% 2.5% |
|TERMINAL (d) | 0/29 (0%) 1/19 (5%) 0/21 (0%) 0/16 (0%) |1/36 (3%) 1/30 (3%) 1/32 (3%) 1/24 (4%) |
|FIRST INCIDENCE | 712 565 647 645 |509 730 (T) 722 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.183 P=0.384 P=0.440 P=0.190 |P=0.552N P=0.545N P=0.664 P=0.595N |
|POLY 3 | P=0.212 P=0.449 P=0.473 P=0.263 |P=0.480N P=0.508N P=0.694 P=0.543N |
|POLY 1.5 | P=0.226 P=0.472 P=0.484 P=0.281 |P=0.467N P=0.501N P=0.691N P=0.526N |
|POLY 6 | P=0.192 P=0.416 P=0.461 P=0.239 |P=0.497N P=0.518N P=0.690 P=0.566N |
|LOGISTIC REGRESSION| P=0.245 P=0.535 P=0.506 P=0.288 |P=0.450N P=0.477N P=0.682N P=0.457N |
|COCH-ARM / FISHERS | P=0.243 P=0.500 P=0.500 P=0.309 |P=0.446N P=0.492N P=0.684N P=0.500N |
|ORDER RESTRICTED | P=0.198 (e) (e) (e) |P=0.500N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Larynx |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/45.04 2/38.97 0/41.34 2/40.71 |0/44.22 0/43.87 0/44.80 0/39.65 |
|POLY-3 PERCENT (g) | 0.0% 5.1% 0.0% 4.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/19 (5%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- 565 --- 432 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.271 P=0.188 (e) P=0.228 |(e) (e) (e) (e) |
|POLY 3 | P=0.279 P=0.206 (e) P=0.215 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.294 P=0.220 (e) P=0.225 |(e) (e) (e) (e) |
|POLY 6 | P=0.256 P=0.188 (e) P=0.201 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.379 P=0.285 (e) P=0.528 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.313 P=0.247 (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.100 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Larynx |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |3/49 (6%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 2/41.80 0/39.41 |3/44.22 1/43.87 0/44.80 0/39.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% |6.8% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 1/21 (5%) 0/16 (0%) |3/36 (8%) 1/30 (3%) 0/32 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- --- 593 --- |730 (T) 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.484 (e) P=0.191 (e) |P=0.066N P=0.372N P=0.142N P=0.201N |
|POLY 3 | P=0.500 (e) P=0.221 (e) |P=0.043N* P=0.308N P=0.116N P=0.139N |
|POLY 1.5 | P=0.522 (e) P=0.227 (e) |P=0.043N* P=0.303N P=0.116N P=0.131N |
|POLY 6 | P=0.465 (e) P=0.213 (e) |P=0.042N* P=0.316N P=0.117N P=0.152N |
|LOGISTIC REGRESSION| P=0.557 (e) P=0.266 (e) |P=0.066N P=0.372N (e) (e) |
|COCH-ARM / FISHERS | P=0.546 (e) P=0.247 (e) |P=0.043N* P=0.301N P=0.117N P=0.121N |
|ORDER RESTRICTED | P=0.235 (e) (e) (e) |P=0.028N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/49 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 1/41.44 0/39.41 |1/44.22 2/43.89 2/44.92 2/40.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 0.0% |2.3% 4.6% 4.5% 4.9% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |1/36 (3%) 1/30 (3%) 1/32 (3%) 2/25 (8%) |
|FIRST INCIDENCE | --- --- 705 --- |730 (T) 726 698 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.622 (e) P=0.462 (e) |P=0.301 P=0.448 P=0.470 P=0.373 |
|POLY 3 | P=0.621 (e) P=0.483 (e) |P=0.382 P=0.497 P=0.506 P=0.471 |
|POLY 1.5 | P=0.638 (e) P=0.490 (e) |P=0.401 P=0.502 P=0.506 P=0.486 |
|POLY 6 | P=0.593 (e) P=0.475 (e) |P=0.357 P=0.490 P=0.504 P=0.450 |
|LOGISTIC REGRESSION| P=0.640 (e) P=0.481 (e) |P=0.340 P=0.465 P=0.502 P=0.373 |
|COCH-ARM / FISHERS | P=0.657 (e) P=0.500 (e) |P=0.429 P=0.508 P=0.508 P=0.508 |
|ORDER RESTRICTED | P=0.367 (e) (e) (e) |P=0.428 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/49 (4%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/45.14 0/38.44 0/41.34 0/39.41 |2/44.22 3/44.13 1/44.90 1/40.73 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |4.5% 6.8% 2.2% 2.5% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |2/36 (6%) 1/30 (3%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 705 --- --- --- |730 (T) 691 703 712 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.378N P=0.612N P=0.538N P=0.593N |P=0.376N P=0.437 P=0.530N P=0.618N |
|POLY 3 | P=0.318N P=0.532N P=0.517N P=0.527N |P=0.301N P=0.499 P=0.495N P=0.529N |
|POLY 1.5 | P=0.329N P=0.518N P=0.510N P=0.515N |P=0.290N P=0.504 P=0.494N P=0.514N |
|POLY 6 | P=0.302N P=0.553N P=0.527N P=0.544N |P=0.314N P=0.492 P=0.496N P=0.548N |
|LOGISTIC REGRESSION| P=0.360N P=0.552N P=0.519N P=0.540N |P=0.313N P=0.489 P=0.498N P=0.576N |
|COCH-ARM / FISHERS | P=0.343N P=0.500N P=0.500N P=0.500N |P=0.274N P=0.510 P=0.492N P=0.492N |
|ORDER RESTRICTED | P=0.146N (e) (e) (e) |P=0.354N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 3/50 (6%) 3/50 (6%) |9/49 (18%) 7/50 (14%) 7/50 (14%) 3/50 (6%) |
|POLY-3 RATE (b) | 6/45.04 4/38.76 3/41.34 3/39.80 |9/45.00 7/44.74 7/45.65 3/40.65 |
|POLY-3 PERCENT (g) | 13.3% 10.3% 7.3% 7.5% |20.0% 15.7% 15.3% 7.4% |
|TERMINAL (d) | 6/29 (21%) 3/19 (16%) 3/21 (14%) 1/16 (6%) |7/36 (19%) 4/30 (13%) 4/32 (13%) 3/25 (12%) |
|FIRST INCIDENCE | 729 (T) 642 729 (T) 642 |509 481 563 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.414N P=0.636N P=0.418N P=0.554N |P=0.136N P=0.515N P=0.458N P=0.172N |
|POLY 3 | P=0.221N P=0.467N P=0.285N P=0.306N |P=0.072N P=0.397N P=0.380N P=0.084N |
|POLY 1.5 | P=0.212N P=0.423N P=0.267N P=0.277N |P=0.062N P=0.387N P=0.380N P=0.071N |
|POLY 6 | P=0.237N P=0.531N P=0.308N P=0.349N |P=0.088N P=0.414N P=0.381N P=0.105N |
|LOGISTIC REGRESSION| P=0.292N P=0.620 P=0.418N P=0.427N |P=0.056N P=0.376N P=0.376N P=0.083N |
|COCH-ARM / FISHERS | P=0.201N P=0.370N P=0.243N P=0.243N |P=0.047N* P=0.376N P=0.376N P=0.056N |
|ORDER RESTRICTED | P=0.280N (e) (e) (e) |P=0.078N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) 5/50 (10%) 3/50 (6%) |5/49 (10%) 9/50 (18%) 5/50 (10%) 6/50 (12%) |
|POLY-3 RATE (b) | 7/45.81 3/39.31 5/42.36 3/39.60 |5/45.53 9/44.30 5/44.80 6/41.28 |
|POLY-3 PERCENT (g) | 15.3% 7.6% 11.8% 7.6% |11.0% 20.3% 11.2% 14.5% |
|TERMINAL (d) | 4/29 (14%) 1/19 (5%) 2/21 (10%) 1/16 (6%) |3/36 (8%) 8/30 (27%) 5/32 (16%) 2/25 (8%) |
|FIRST INCIDENCE | 626 582 509 684 |481 606 730 (T) 647 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.393N P=0.348N P=0.547N P=0.397N |P=0.389 P=0.127 P=0.570 P=0.329 |
|POLY 3 | P=0.253N P=0.226N P=0.435N P=0.222N |P=0.519 P=0.176 P=0.620 P=0.431 |
|POLY 1.5 | P=0.239N P=0.194N P=0.411N P=0.192N |P=0.555 P=0.188 P=0.628 P=0.464 |
|POLY 6 | P=0.278N P=0.278N P=0.466N P=0.271N |P=0.476 P=0.161 P=0.609 P=0.393 |
|LOGISTIC REGRESSION| P=0.239N P=0.158N P=0.364N P=0.233N |P=0.545N P=0.210 P=0.613N P=0.544 |
|COCH-ARM / FISHERS | P=0.225N P=0.159N P=0.380N P=0.159N |P=0.502N P=0.205 P=0.617N P=0.514 |
|ORDER RESTRICTED | P=0.193N (e) (e) (e) |P=0.446 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.04 0/38.44 0/41.34 1/39.59 |0/44.22 0/43.87 2/45.63 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 2.5% |0.0% 0.0% 4.4% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 684 |--- --- 610 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.493 P=0.584N P=0.564N P=0.662 |P=0.583 (e) P=0.249 (e) |
|POLY 3 | P=0.548 P=0.531N P=0.517N P=0.731 |P=0.539 (e) P=0.244 (e) |
|POLY 1.5 | P=0.548 P=0.518N P=0.510N P=0.744 |P=0.564 (e) P=0.243 (e) |
|POLY 6 | P=0.548 P=0.552N P=0.526N P=0.712 |P=0.505 (e) P=0.246 (e) |
|LOGISTIC REGRESSION| P=0.517 (e) (e) P=0.720 |P=0.683 (e) P=0.262 (e) |
|COCH-ARM / FISHERS | P=0.546 P=0.500N P=0.500N P=0.753N |P=0.598 (e) P=0.253 (e) |
|ORDER RESTRICTED | P=0.371 (e) (e) (e) |P=0.254 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |2/49 (4%) 5/50 (10%) 6/50 (12%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/45.77 3/39.52 1/41.69 2/39.74 |2/44.78 5/44.27 6/46.01 1/40.87 |
|POLY-3 PERCENT (g) | 6.6% 7.6% 2.4% 5.0% |4.5% 11.3% 13.0% 2.5% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 1/30 (3%) 2/32 (6%) 0/25 (0%) |
|FIRST INCIDENCE | 576 621 633 667 |582 670 565 674 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.393N P=0.536 P=0.371N P=0.652N |P=0.439N P=0.192 P=0.128 P=0.557N |
|POLY 3 | P=0.352N P=0.593 P=0.339N P=0.564N |P=0.390N P=0.211 P=0.142 P=0.532N |
|POLY 1.5 | P=0.338N P=0.623 P=0.325N P=0.536N |P=0.357N P=0.217 P=0.141 P=0.516N |
|POLY 6 | P=0.373N P=0.549 P=0.357N P=0.603N |P=0.434N P=0.202 P=0.142 P=0.553N |
|LOGISTIC REGRESSION| P=0.287N P=0.525N P=0.226N P=0.450N |P=0.289N P=0.227 P=0.146 P=0.450N |
|COCH-ARM / FISHERS | P=0.321N P=0.661N P=0.309N P=0.500N |P=0.311N P=0.226 P=0.141 P=0.492N |
|ORDER RESTRICTED | P=0.391N (e) (e) (e) |P=0.174N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 3/42.04 2/39.71 |0/44.22 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.1% 5.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 1/21 (5%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- 558 675 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058 (e) P=0.094 P=0.170 |(e) (e) (e) (e) |
|POLY 3 | P=0.064 (e) P=0.106 P=0.210 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.070 (e) P=0.111 P=0.222 |(e) (e) (e) (e) |
|POLY 6 | P=0.056 (e) P=0.101 P=0.195 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.079 (e) P=0.143 P=0.217 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.078 (e) P=0.121 P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.072 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 0/41.34 1/39.73 |0/44.22 0/43.87 0/44.80 3/41.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.5% |0.0% 0.0% 0.0% 7.3% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | --- --- --- 642 |--- --- --- 606 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179 (e) (e) P=0.465 |P=0.007 ** (e) (e) P=0.083 |
|POLY 3 | P=0.180 (e) (e) P=0.475 |P=0.010 * (e) (e) P=0.106 |
|POLY 1.5 | P=0.184 (e) (e) P=0.486 |P=0.011 * (e) (e) P=0.112 |
|POLY 6 | P=0.175 (e) (e) P=0.460 |P=0.010 * (e) (e) P=0.098 |
|LOGISTIC REGRESSION| P=0.198 (e) (e) P=0.564 |P=0.012 * (e) (e) P=0.120 |
|COCH-ARM / FISHERS | P=0.188 (e) (e) P=0.500 |P=0.012 * (e) (e) P=0.125 |
|ORDER RESTRICTED | P=0.101 (e) (e) (e) |P=0.006 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver: Periportal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.25 0/38.44 2/41.34 0/39.41 |0/44.22 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 4.8% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 2/21 (10%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 674 --- 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.601N P=0.628N P=0.410 P=0.551N |(e) (e) (e) (e) |
|POLY 3 | P=0.532N P=0.532N P=0.469 P=0.527N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.525N P=0.518N P=0.482 P=0.515N |(e) (e) (e) (e) |
|POLY 6 | P=0.545N P=0.553N P=0.452 P=0.545N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.561N P=0.489N P=0.456 P=0.485N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.518N P=0.500N P=0.500 P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.321N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 6/50 (12%) 4/49 (8%) |1/49 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/45.04 5/40.17 6/42.31 4/39.14 |1/44.71 2/43.87 1/44.80 1/40.65 |
|POLY-3 PERCENT (g) | 11.1% 12.5% 14.2% 10.2% |2.2% 4.6% 2.2% 2.5% |
|TERMINAL (d) | 5/29 (17%) 1/19 (5%) 0/21 (0%) 1/16 (6%) |0/36 (0%) 2/30 (7%) 1/32 (3%) 1/25 (4%) |
|FIRST INCIDENCE | 729 (T) 537 642 683 |582 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.495 P=0.430 P=0.340 P=0.470 |P=0.621N P=0.458 P=0.747 P=0.712 |
|POLY 3 | P=0.514N P=0.557 P=0.456 P=0.587N |P=0.556N P=0.493 P=0.760N P=0.739 |
|POLY 1.5 | P=0.488N P=0.589 P=0.473 P=0.555N |P=0.544N P=0.500 P=0.758N P=0.750 |
|POLY 6 | P=0.550N P=0.511 P=0.440 P=0.631N |P=0.572N P=0.483 P=0.758 P=0.724 |
|LOGISTIC REGRESSION| P=0.478N P=0.622N P=0.431 P=0.579 |P=0.543N P=0.514 P=0.751N P=0.737N |
|COCH-ARM / FISHERS | P=0.454N P=0.630N P=0.500 P=0.513N |P=0.525N P=0.508 P=0.747N P=0.747N |
|ORDER RESTRICTED | P=0.581N (e) (e) (e) |P=0.605N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 0/41.34 2/39.18 |0/44.22 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- --- 645 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044 * (e) (e) P=0.193 |(e) (e) (e) (e) |
|POLY 3 | P=0.039 * (e) (e) P=0.207 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.040 * (e) (e) P=0.218 |(e) (e) (e) (e) |
|POLY 6 | P=0.038 * (e) (e) P=0.193 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.043 * (e) (e) P=0.256 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.242 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.020 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 3/50 (6%) 6/50 (12%) 7/49 (14%) |3/49 (6%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 10/45.49 3/38.76 6/41.34 7/40.21 |3/44.95 1/44.34 1/44.80 3/40.65 |
|POLY-3 PERCENT (g) | 22.0% 7.7% 14.5% 17.4% |6.7% 2.3% 2.2% 7.4% |
|TERMINAL (d) | 8/29 (28%) 2/19 (11%) 6/21 (29%) 3/16 (19%) |1/36 (3%) 0/30 (0%) 1/32 (3%) 3/25 (12%) |
|FIRST INCIDENCE | 670 642 729 (T) 522 |537 593 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.305 P=0.157N P=0.433N P=0.521 |P=0.394 P=0.330N P=0.327N P=0.516 |
|POLY 3 | P=0.532N P=0.065N P=0.267N P=0.398N |P=0.475 P=0.310N P=0.306N P=0.615 |
|POLY 1.5 | P=0.530N P=0.050N P=0.241N P=0.360N |P=0.488 P=0.305N P=0.303N P=0.639 |
|POLY 6 | P=0.541N P=0.094N P=0.306N P=0.455N |P=0.460 P=0.319N P=0.311N P=0.583 |
|LOGISTIC REGRESSION| P=0.486 P=0.118N P=0.331N P=0.389N |P=0.517 P=0.274N P=0.291N P=0.658 |
|COCH-ARM / FISHERS | P=0.530N P=0.036N* P=0.207N P=0.314N |P=0.507 P=0.301N P=0.301N P=0.651N |
|ORDER RESTRICTED | P=0.203N (e) (e) (e) |P=0.339 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 2/41.47 0/38.70 |0/44.22 1/44.34 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 1/21 (5%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- 696 --- |--- 593 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.473 (e) P=0.193 (e) |P=0.579N P=0.504 (e) (e) |
|POLY 3 | P=0.498 (e) P=0.219 (e) |P=0.570N P=0.501 (e) (e) |
|POLY 1.5 | P=0.518 (e) P=0.226 (e) |P=0.568N P=0.502 (e) (e) |
|POLY 6 | P=0.466 (e) P=0.210 (e) |P=0.572N P=0.497 (e) (e) |
|LOGISTIC REGRESSION| P=0.508 (e) P=0.207 (e) |P=0.486N P=0.521 (e) (e) |
|COCH-ARM / FISHERS | P=0.541 (e) P=0.247 (e) |P=0.565N P=0.505 (e) (e) |
|ORDER RESTRICTED | P=0.233 (e) (e) (e) |P=0.396N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |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) | 13/50 (26%) 11/50 (22%) 7/50 (14%) 5/49 (10%) |22/49 (45%) 14/50 (28%) 13/50 (26%) 15/50 (30%) |
|POLY-3 RATE (b) | 13/46.26 11/39.07 7/42.98 5/38.85 |22/45.12 14/45.47 13/45.06 15/43.99 |
|POLY-3 PERCENT (g) | 28.1% 28.2% 16.3% 12.9% |48.8% 30.8% 28.9% 34.1% |
|TERMINAL (d) | 7/29 (24%) 9/19 (47%) 4/21 (19%) 4/16 (25%) |18/36 (50%) 8/30 (27%) 11/32 (34%) 7/25 (28%) |
|FIRST INCIDENCE | 576 642 509 691 |606 481 689 285 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.096N P=0.322 P=0.265N P=0.244N |P=0.436N P=0.195N P=0.096N P=0.453N |
|POLY 3 | P=0.026N* P=0.594 P=0.137N P=0.072N |P=0.136N P=0.059N P=0.039N* P=0.113N |
|POLY 1.5 | P=0.022N* P=0.513N P=0.123N P=0.053N |P=0.126N P=0.058N P=0.038N* P=0.102N |
|POLY 6 | P=0.034N* P=0.468 P=0.160N P=0.109N |P=0.152N P=0.064N P=0.042N* P=0.136N |
|LOGISTIC REGRESSION| P=0.030N* P=0.467 P=0.095N P=0.091N |P=0.149N P=0.070N P=0.038N* P=0.111N |
|COCH-ARM / FISHERS | P=0.018N* P=0.408N P=0.105N P=0.037N* |P=0.117N P=0.062N P=0.039N* P=0.093N |
|ORDER RESTRICTED | P=0.060N (e) (e) (e) |P=0.058N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 2/50 (4%) 1/49 (2%) |2/49 (4%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/45.05 5/40.23 2/41.34 1/38.77 |2/44.82 2/44.85 2/44.88 2/40.93 |
|POLY-3 PERCENT (g) | 2.2% 12.4% 4.8% 2.6% |4.5% 4.5% 4.5% 4.9% |
|TERMINAL (d) | 0/29 (0%) 1/19 (5%) 2/21 (10%) 0/16 (0%) |1/36 (3%) 0/30 (0%) 1/32 (3%) 1/25 (4%) |
|FIRST INCIDENCE | 726 421 729 (T) 712 |537 575 710 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.354N P=0.055 P=0.390 P=0.626 |P=0.515 P=0.681 P=0.668 P=0.608 |
|POLY 3 | P=0.312N P=0.077 P=0.470 P=0.726 |P=0.553 P=0.694N P=0.693N P=0.661 |
|POLY 1.5 | P=0.285N P=0.087 P=0.482 P=0.740 |P=0.572 P=0.690N P=0.691N P=0.677 |
|POLY 6 | P=0.353N P=0.063 P=0.455 P=0.707 |P=0.528 P=0.689 P=0.691 P=0.639 |
|LOGISTIC REGRESSION| P=0.235N P=0.192 P=0.405 P=0.681 |P=0.523N P=0.667N P=0.683N P=0.659N |
|COCH-ARM / FISHERS | P=0.254N P=0.102 P=0.500 P=0.747 |P=0.590N P=0.684N P=0.684N P=0.684N |
|ORDER RESTRICTED | P=0.291N (e) (e) (e) |P=0.703 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 1/12 (8%) 0/16 (0%) 0/13 (0%) |0/12 (0%) 0/7 (0%) 2/8 (25%) 0/11 (0%) |
|POLY-3 RATE (b) | 1/13.77 1/10.20 0/12.55 0/11.23 |0/9.43 0/5.24 2/6.96 0/8.09 |
|POLY-3 PERCENT (g) | 7.3% 9.8% 0.0% 0.0% |0.0% 0.0% 28.7% 0.0% |
|TERMINAL (d) | 0/7 (0%) 1/5 (20%) 0/4 (0%) 0/4 (0%) |0/7 (0%) 0/3 (0%) 2/5 (40%) 0/3 (0%) |
|FIRST INCIDENCE | 674 729 (T) --- --- |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256N P=0.648 P=0.527N P=0.551N |P=0.455 (e) P=0.158 (e) |
|POLY 3 | P=0.226N P=0.693 P=0.518N P=0.541N |P=0.553 (e) P=0.149 (e) |
|POLY 1.5 | P=0.220N P=0.701 P=0.505N P=0.535N |P=0.577 (e) P=0.143 (e) |
|POLY 6 | P=0.236N P=0.680 P=0.537N P=0.551N |P=0.506 (e) P=0.153 (e) |
|LOGISTIC REGRESSION| P=0.223N P=0.708 P=0.462N P=0.480N |(e) (e) P=0.158 (e) |
|COCH-ARM / FISHERS | P=0.209N P=0.701 P=0.484N P=0.536N |P=0.595 (e) P=0.147 (e) |
|ORDER RESTRICTED | P=0.238N (e) (e) (e) |P=0.166 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/42 (0%) 0/44 (0%) 2/43 (5%) 0/40 (0%) |0/45 (0%) 1/39 (3%) 0/42 (0%) 0/45 (0%) |
|POLY-3 RATE (b) | 0/38.05 0/35.31 2/35.13 0/31.74 |0/40.22 1/33.18 0/37.39 0/37.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.7% 0.0% |0.0% 3.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/19 (0%) 2/16 (13%) 0/14 (0%) |0/32 (0%) 1/22 (5%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.418 (e) P=0.132 (e) |P=0.596N P=0.425 (e) (e) |
|POLY 3 | P=0.485 (e) P=0.219 (e) |P=0.569N P=0.462 (e) (e) |
|POLY 1.5 | P=0.505 (e) P=0.229 (e) |P=0.565N P=0.466 (e) (e) |
|POLY 6 | P=0.455 (e) P=0.206 (e) |P=0.573N P=0.455 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.132 (e) |(e) P=0.425 (e) (e) |
|COCH-ARM / FISHERS | P=0.532 (e) P=0.253 (e) |P=0.560N P=0.464 (e) (e) |
|ORDER RESTRICTED | P=0.235 (e) (e) (e) |P=0.363N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 2/42.04 0/39.41 |0/44.62 0/43.87 0/44.80 1/40.30 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- 558 --- |--- --- --- 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.524 (e) P=0.216 (e) |P=0.190 (e) (e) P=0.491 |
|POLY 3 | P=0.499 (e) P=0.222 (e) |P=0.186 (e) (e) P=0.480 |
|POLY 1.5 | P=0.521 (e) P=0.228 (e) |P=0.190 (e) (e) P=0.486 |
|POLY 6 | P=0.464 (e) P=0.215 (e) |P=0.182 (e) (e) P=0.471 |
|LOGISTIC REGRESSION| P=0.579 (e) P=0.312 (e) |P=0.284 (e) (e) P=0.614 |
|COCH-ARM / FISHERS | P=0.546 (e) P=0.247 (e) |P=0.195 (e) (e) P=0.495 |
|ORDER RESTRICTED | P=0.236 (e) (e) (e) |P=0.104 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/45.55 2/38.66 3/41.36 2/39.83 |1/44.62 0/43.87 2/44.81 2/40.65 |
|POLY-3 PERCENT (g) | 6.6% 5.2% 7.3% 5.0% |2.2% 0.0% 4.5% 4.9% |
|TERMINAL (d) | 2/29 (7%) 1/19 (5%) 2/21 (10%) 1/16 (6%) |1/36 (3%) 0/30 (0%) 1/32 (3%) 2/25 (8%) |
|FIRST INCIDENCE | 576 670 726 610 |730 (T) --- 726 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.512 P=0.667N P=0.524 P=0.673 |P=0.161 P=0.536N P=0.463 P=0.373 |
|POLY 3 | P=0.511N P=0.574N P=0.617 P=0.561N |P=0.218 P=0.503N P=0.501 P=0.468 |
|POLY 1.5 | P=0.496N P=0.542N P=0.636 P=0.534N |P=0.229 P=0.502N P=0.501 P=0.481 |
|POLY 6 | P=0.535N P=0.620N P=0.593 P=0.598N |P=0.205 P=0.507N P=0.501 P=0.449 |
|LOGISTIC REGRESSION| P=0.519N P=0.529N P=0.626 P=0.468N |P=0.164 (e) P=0.480 P=0.373 |
|COCH-ARM / FISHERS | P=0.479N P=0.500N P=0.661N P=0.500N |P=0.245 P=0.500N P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.594N (e) (e) (e) |P=0.240 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Mesentery |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/7 (100%) 11/11 (100%) 11/11 (100%) 12/13 (92%) |11/11 (100%) 15/15 (100%) 23/23 (100%) 13/14 (93%) |
|POLY-3 RATE (b) | 7/7.00 11/11.00 11/11.00 12/12.46 |11/11.00 15/15.00 23/23.00 13/13.79 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 96.3% |100.0% 100.0% 100.0% 94.3% |
|TERMINAL (d) | 4/4 (100%) 5/5 (100%) 3/3 (100%) 5/5 (100%) |8/8 (100%) 8/8 (100%) 15/15 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 621 565 509 465 |495 593 565 506 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.115 (e) (e) P=0.084 |P=0.278 (e) (e) P=0.272 |
|POLY 3 | P=0.501N (e) (e) P=0.928N |P=0.255N (e) (e) P=0.648N |
|POLY 1.5 | P=0.340N (e) (e) P=0.781N |P=0.223N (e) (e) P=0.596N |
|POLY 6 | P=0.933N (e) (e) P=1.000N |P=0.341N (e) (e) P=0.762N |
|LOGISTIC REGRESSION| P=0.361N (e) (e) P=0.909N |P=0.194N (e) (e) P=0.537N |
|COCH-ARM / FISHERS | P=0.239N (e) (e) P=0.650N |P=0.196N (e) (e) P=0.560N |
|ORDER RESTRICTED | P=0.265N (e) (e) (e) |P=0.164N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |2/49 (4%) 2/50 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.41 3/39.28 1/41.47 2/39.51 |2/44.65 2/43.98 0/43.98 0/40.65 |
|POLY-3 PERCENT (g) | 4.4% 7.6% 2.4% 5.1% |4.5% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/19 (0%) 0/21 (0%) 1/16 (6%) |1/36 (3%) 1/30 (3%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 626 621 698 705 |606 703 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.553N P=0.345 P=0.567N P=0.523 |P=0.113N P=0.652 P=0.250N P=0.288N |
|POLY 3 | P=0.494N P=0.434 P=0.532N P=0.643 |P=0.090N P=0.689 P=0.240N P=0.259N |
|POLY 1.5 | P=0.476N P=0.463 P=0.519N P=0.666 |P=0.088N P=0.693N P=0.239N P=0.248N |
|POLY 6 | P=0.521N P=0.395 P=0.548N P=0.609 |P=0.093N P=0.679 P=0.242N P=0.274N |
|LOGISTIC REGRESSION| P=0.462N P=0.569 P=0.492N P=0.655 |P=0.084N P=0.686N P=0.232N P=0.213N |
|COCH-ARM / FISHERS | P=0.454N P=0.500 P=0.500N P=0.691N |P=0.085N P=0.684N P=0.247N P=0.242N |
|ORDER RESTRICTED | P=0.501N (e) (e) (e) |P=0.131N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 2/50 (4%) 5/50 (10%) |1/49 (2%) 5/50 (10%) 3/49 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/45.41 4/39.06 2/41.94 5/40.45 |1/44.22 5/43.98 3/43.98 0/40.65 |
|POLY-3 PERCENT (g) | 8.8% 10.2% 4.8% 12.4% |2.3% 11.4% 6.8% 0.0% |
|TERMINAL (d) | 3/29 (10%) 2/19 (11%) 0/21 (0%) 1/16 (6%) |1/36 (3%) 4/30 (13%) 3/32 (9%) 0/25 (0%) |
|FIRST INCIDENCE | 626 621 589 581 |730 (T) 703 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.305 P=0.435 P=0.445N P=0.264 |P=0.297N P=0.071 P=0.263 P=0.573N |
|POLY 3 | P=0.422 P=0.558 P=0.374N P=0.428 |P=0.235N P=0.100 P=0.303 P=0.517N |
|POLY 1.5 | P=0.438 P=0.596 P=0.359N P=0.459 |P=0.215N P=0.103 P=0.304 P=0.508N |
|POLY 6 | P=0.398 P=0.503 P=0.393N P=0.385 |P=0.263N P=0.095 P=0.302 P=0.528N |
|LOGISTIC REGRESSION| P=0.446 P=0.567 P=0.320N P=0.489 |P=0.266N P=0.087 P=0.263 (e) |
|COCH-ARM / FISHERS | P=0.457 P=0.643N P=0.339N P=0.500 |P=0.190N P=0.107 P=0.309 P=0.495N |
|ORDER RESTRICTED | P=0.371 (e) (e) (e) |P=0.122N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Goblet Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |1/49 (2%) 3/50 (6%) 3/49 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/45.04 1/38.67 1/41.45 4/39.56 |1/44.22 3/43.87 3/43.98 1/40.65 |
|POLY-3 PERCENT (g) | 2.2% 2.6% 2.4% 10.1% |2.3% 6.8% 6.8% 2.5% |
|TERMINAL (d) | 1/29 (3%) 0/19 (0%) 0/21 (0%) 3/16 (19%) |1/36 (3%) 3/30 (10%) 3/32 (9%) 1/25 (4%) |
|FIRST INCIDENCE | 729 (T) 667 702 691 |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029 * P=0.654 P=0.707 P=0.056 |P=0.562 P=0.242 P=0.263 P=0.678 |
|POLY 3 | P=0.056 P=0.726 P=0.742 P=0.141 |P=0.548N P=0.302 P=0.303 P=0.742 |
|POLY 1.5 | P=0.060 P=0.741 P=0.750 P=0.157 |P=0.527N P=0.307 P=0.304 P=0.751 |
|POLY 6 | P=0.051 P=0.702 P=0.733 P=0.120 |P=0.577N P=0.294 P=0.302 P=0.728 |
|LOGISTIC REGRESSION| P=0.044 * P=0.731 P=0.730 P=0.076 |P=0.562 P=0.242 P=0.263 P=0.678 |
|COCH-ARM / FISHERS | P=0.065 P=0.753N P=0.753N P=0.181 |P=0.494N P=0.316 P=0.309 P=0.747N |
|ORDER RESTRICTED | P=0.049 * (e) (e) (e) |P=0.391 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/49 (4%) 0/50 (0%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/45.04 0/38.44 0/41.34 0/39.41 |2/44.22 0/43.87 1/43.98 1/41.13 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |4.5% 0.0% 2.3% 2.4% |
|TERMINAL (d) | 1/29 (3%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |2/36 (6%) 0/30 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |730 (T) --- 730 (T) 589 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.405N P=0.584N P=0.564N P=0.619N |P=0.576N P=0.279N P=0.541N P=0.589N |
|POLY 3 | P=0.318N P=0.531N P=0.517N P=0.527N |P=0.504N P=0.239N P=0.502N P=0.525N |
|POLY 1.5 | P=0.329N P=0.518N P=0.510N P=0.515N |P=0.501N P=0.236N P=0.501N P=0.512N |
|POLY 6 | P=0.302N P=0.552N P=0.526N P=0.543N |P=0.505N P=0.244N P=0.503N P=0.543N |
|LOGISTIC REGRESSION| P=0.405N (e) (e) (e) |P=0.503N (e) P=0.541N P=0.491N |
|COCH-ARM / FISHERS | P=0.343N P=0.500N P=0.500N P=0.500N |P=0.496N P=0.242N P=0.500N P=0.492N |
|ORDER RESTRICTED | P=0.145N (e) (e) (e) |P=0.292N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 8/50 (16%) 2/50 (4%) 3/50 (6%) |12/49 (24%) 18/50 (36%) 15/49 (31%) 28/50 (56%) |
|POLY-3 RATE (b) | 2/45.04 8/40.75 2/41.39 3/39.71 |12/46.19 18/45.33 15/45.52 28/46.89 |
|POLY-3 PERCENT (g) | 4.4% 19.6% 4.8% 7.6% |26.0% 39.7% 33.0% 59.7% |
|TERMINAL (d) | 2/29 (7%) 2/19 (11%) 1/21 (5%) 1/16 (6%) |9/36 (25%) 13/30 (43%) 10/32 (31%) 14/25 (56%) |
|FIRST INCIDENCE | 729 (T) 565 717 675 |481 481 581 285 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.433N P=0.017 * P=0.580 P=0.288 |P<0.001 ** P=0.068 P=0.253 P<0.001 ** |
|POLY 3 | P=0.349N P=0.030 * P=0.663 P=0.443 |P<0.001 ** P=0.117 P=0.307 P<0.001 ** |
|POLY 1.5 | P=0.317N P=0.036 * P=0.676 P=0.468 |P<0.001 ** P=0.131 P=0.312 P<0.001 ** |
|POLY 6 | P=0.395N P=0.023 * P=0.648 P=0.408 |P<0.001 ** P=0.100 P=0.309 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.285N P=0.066 P=0.614 P=0.368 |P=0.002 ** P=0.156 P=0.330 P=0.004 ** |
|COCH-ARM / FISHERS | P=0.281N P=0.046 * P=0.691N P=0.500 |P<0.001 ** P=0.152 P=0.326 P<0.001 ** |
|ORDER RESTRICTED | P=0.243 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/45.41 1/38.82 1/41.34 1/39.41 |0/44.22 0/43.87 0/43.98 0/40.65 |
|POLY-3 PERCENT (g) | 8.8% 2.6% 2.4% 2.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/29 (10%) 0/19 (0%) 1/21 (5%) 1/16 (6%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 626 621 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.271N P=0.288N P=0.275N P=0.359N |(e) (e) (e) (e) |
|POLY 3 | P=0.167N P=0.230N P=0.208N P=0.224N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.167N P=0.206N P=0.196N P=0.204N |(e) (e) (e) (e) |
|POLY 6 | P=0.169N P=0.267N P=0.225N P=0.257N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.192N P=0.188N P=0.213N P=0.249N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.169N P=0.181N P=0.181N P=0.181N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.109N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 0/41.34 0/39.41 |0/44.22 2/43.87 0/43.98 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 2/30 (7%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.469N P=0.199 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.421N P=0.235 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.413N P=0.238 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.432N P=0.230 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.199 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.402N P=0.253 (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.262N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |8/50 (16%) 9/50 (18%) 8/50 (16%) 5/50 (10%) |
|POLY-3 RATE (b) | |8/45.78 9/44.10 8/44.96 5/40.73 |
|POLY-3 PERCENT (g) | |17.5% 20.4% 17.8% 12.3% |
|TERMINAL (d) | |5/36 (14%) 8/30 (27%) 7/32 (22%) 4/25 (16%) |
|FIRST INCIDENCE | |540 670 689 712 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.400N P=0.370 P=0.529 P=0.498N |
|POLY 3 | |P=0.265N P=0.466 P=0.593 P=0.355N |
|POLY 1.5 | |P=0.235N P=0.482 P=0.598 P=0.322N |
|POLY 6 | |P=0.309N P=0.442 P=0.583 P=0.403N |
|LOGISTIC REGRESSION| |P=0.263N P=0.490 P=0.606N P=0.323N |
|COCH-ARM / FISHERS | |P=0.192N P=0.500 P=0.607N P=0.277N |
|ORDER RESTRICTED | |P=0.331N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |2/49 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.05 2/38.82 1/41.34 2/39.59 |2/44.22 1/43.89 1/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 4.4% 5.2% 2.4% 5.1% |4.5% 2.3% 2.2% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/19 (5%) 1/21 (5%) 1/16 (6%) |2/36 (6%) 0/30 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | 726 621 729 (T) 684 |730 (T) 726 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.490 P=0.566 P=0.610N P=0.497 |P=0.209N P=0.552N P=0.541N P=0.322N |
|POLY 3 | P=0.585N P=0.639 P=0.530N P=0.647 |P=0.162N P=0.503N P=0.495N P=0.256N |
|POLY 1.5 | P=0.574N P=0.664 P=0.518N P=0.668 |P=0.158N P=0.498N P=0.495N P=0.247N |
|POLY 6 | P=0.579 P=0.602 P=0.545N P=0.616 |P=0.167N P=0.510N P=0.497N P=0.270N |
|LOGISTIC REGRESSION| P=0.581 P=0.623 P=0.595N P=0.572 |P=0.198N P=0.535N P=0.541N (e) |
|COCH-ARM / FISHERS | P=0.561N P=0.691N P=0.500N P=0.691N |P=0.150N P=0.492N P=0.492N P=0.242N |
|ORDER RESTRICTED | P=0.628N (e) (e) (e) |P=0.134N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/49 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 0/41.34 0/39.41 |2/45.48 0/43.87 2/45.59 2/40.97 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 4.4% 4.9% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- --- --- |509 --- 433 682 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.397 P=0.240N P=0.683 P=0.645 |
|POLY 3 | (e) (e) (e) (e) |P=0.414 P=0.245N P=0.693N P=0.656 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.428 P=0.240N P=0.690N P=0.674 |
|POLY 6 | (e) (e) (e) (e) |P=0.398 P=0.253N P=0.690 P=0.632 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.601N P=0.189N P=0.642N P=0.569N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.450 P=0.242N P=0.684N P=0.684N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.400 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |5/49 (10%) 3/50 (6%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/45.45 0/38.44 1/41.43 1/39.53 |5/44.71 3/44.30 3/45.59 3/41.07 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.4% 2.5% |11.2% 6.8% 6.6% 7.3% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |4/36 (11%) 2/30 (7%) 2/32 (6%) 2/25 (8%) |
|FIRST INCIDENCE | 611 --- 708 698 |582 606 433 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.417 P=0.531N P=0.721 P=0.686 |P=0.451N P=0.434N P=0.408N P=0.522N |
|POLY 3 | P=0.468 P=0.533N P=0.740 P=0.729 |P=0.348N P=0.361N P=0.346N P=0.404N |
|POLY 1.5 | P=0.475 P=0.519N P=0.748 P=0.743 |P=0.334N P=0.354N P=0.345N P=0.380N |
|POLY 6 | P=0.457 P=0.555N P=0.729 P=0.707 |P=0.366N P=0.373N P=0.349N P=0.436N |
|LOGISTIC REGRESSION| P=0.484 P=0.389N P=0.732N P=0.723N |P=0.289N P=0.345N P=0.336N P=0.374N |
|COCH-ARM / FISHERS | P=0.482 P=0.500N P=0.753N P=0.753N |P=0.311N P=0.346N P=0.346N P=0.346N |
|ORDER RESTRICTED | P=0.506 (e) (e) (e) |P=0.373N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.04 1/38.97 1/41.40 3/40.50 |0/44.22 0/43.87 0/44.80 1/40.84 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 2.4% 7.4% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- 565 715 578 |--- --- --- 682 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.045 * P=0.487 P=0.459 P=0.091 |P=0.179 (e) (e) P=0.468 |
|POLY 3 | P=0.050 P=0.471 P=0.483 P=0.100 |P=0.189 (e) (e) P=0.484 |
|POLY 1.5 | P=0.054 P=0.484 P=0.490 P=0.108 |P=0.193 (e) (e) P=0.492 |
|POLY 6 | P=0.045 * P=0.453 P=0.475 P=0.091 |P=0.183 (e) (e) P=0.473 |
|LOGISTIC REGRESSION| P=0.072 P=0.682 P=0.470 P=0.189 |P=0.202 (e) (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.059 P=0.500 P=0.500 P=0.121 |P=0.200 (e) (e) P=0.505 |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) |P=0.107 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |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) | 4/50 (8%) 5/50 (10%) 6/50 (12%) 5/50 (10%) |9/49 (18%) 9/50 (18%) 8/50 (16%) 8/50 (16%) |
|POLY-3 RATE (b) | 4/45.41 5/39.05 6/42.91 5/40.28 |9/45.17 9/45.04 8/45.41 8/41.69 |
|POLY-3 PERCENT (g) | 8.8% 12.8% 14.0% 12.4% |19.9% 20.0% 17.6% 19.2% |
|TERMINAL (d) | 3/29 (10%) 3/19 (16%) 2/21 (10%) 2/16 (13%) |6/36 (17%) 6/30 (20%) 5/32 (16%) 4/25 (16%) |
|FIRST INCIDENCE | 626 621 509 548 |537 537 610 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.260 P=0.278 P=0.249 P=0.251 |P=0.441 P=0.484 P=0.566N P=0.458 |
|POLY 3 | P=0.381 P=0.406 P=0.334 P=0.425 |P=0.493N P=0.601 P=0.495N P=0.573N |
|POLY 1.5 | P=0.408 P=0.447 P=0.348 P=0.458 |P=0.461N P=0.596N P=0.490N P=0.536N |
|POLY 6 | P=0.341 P=0.348 P=0.318 P=0.379 |P=0.533N P=0.585 P=0.503N P=0.595 |
|LOGISTIC REGRESSION| P=0.430 P=0.382 P=0.431 P=0.469 |P=0.445N P=0.583N P=0.484N P=0.527N |
|COCH-ARM / FISHERS | P=0.440 P=0.500 P=0.370 P=0.500 |P=0.409N P=0.584N P=0.482N P=0.482N |
|ORDER RESTRICTED | P=0.417 (e) (e) (e) |P=0.657N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pleura |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 12/50 (24%) 5/50 (10%) 1/50 (2%) |18/48 (38%) 6/50 (12%) 9/50 (18%) 12/50 (24%) |
|POLY-3 RATE (b) | 2/45.04 12/40.34 5/41.86 1/39.48 |18/44.09 6/44.40 9/45.00 12/43.35 |
|POLY-3 PERCENT (g) | 4.4% 29.8% 12.0% 2.5% |40.8% 13.5% 20.0% 27.7% |
|TERMINAL (d) | 2/29 (7%) 7/19 (37%) 3/21 (14%) 0/16 (0%) |17/36 (47%) 4/30 (13%) 7/32 (22%) 6/25 (24%) |
|FIRST INCIDENCE | 729 (T) 579 618 712 |656 575 689 285 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.122N P<0.001 ** P=0.126 P=0.694N |P=0.545 P=0.015N* P=0.064N P=0.463N |
|POLY 3 | P=0.065N P<0.001 ** P=0.187 P=0.546N |P=0.242N P=0.003N** P=0.025N* P=0.139N |
|POLY 1.5 | P=0.050N P=0.002 ** P=0.199 P=0.526N |P=0.233N P=0.003N** P=0.025N* P=0.124N |
|POLY 6 | P=0.093N P<0.001 ** P=0.173 P=0.575N |P=0.257N P=0.003N** P=0.026N* P=0.167N |
|LOGISTIC REGRESSION| P=0.052N P=0.002 ** P=0.171 P=0.653N |P=0.278N P=0.005N** P=0.032N* P=0.134N |
|COCH-ARM / FISHERS | P=0.041N* P=0.004 ** P=0.218 P=0.500N |P=0.226N P=0.003N** P=0.026N* P=0.109N |
|ORDER RESTRICTED | P=0.027N* (e) (e) (e) |P=0.016N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pleura |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 2/50 (4%) 1/50 (2%) 5/50 (10%) |21/48 (44%) 20/50 (40%) 13/50 (26%) 5/50 (10%) |
|POLY-3 RATE (b) | 11/46.66 2/38.76 1/41.92 5/40.12 |21/44.58 20/45.36 13/45.06 5/41.90 |
|POLY-3 PERCENT (g) | 23.6% 5.2% 2.4% 12.5% |47.1% 44.1% 28.9% 11.9% |
|TERMINAL (d) | 5/29 (17%) 1/19 (5%) 0/21 (0%) 2/16 (13%) |17/36 (47%) 15/30 (50%) 11/32 (34%) 2/25 (8%) |
|FIRST INCIDENCE | 576 642 546 581 |634 481 689 285 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.275N P=0.059N P=0.011N* P=0.330N |P=0.002N** P=0.407 P=0.135N P=0.007N** |
|POLY 3 | P=0.122N P=0.018N* P=0.003N** P=0.145N |P<0.001N** P=0.470N P=0.055N P<0.001N** |
|POLY 1.5 | P=0.127N P=0.012N* P=0.003N** P=0.116N |P<0.001N** P=0.450N P=0.053N P<0.001N** |
|POLY 6 | P=0.119N P=0.032N* P=0.005N** P=0.198N |P<0.001N** P=0.510N P=0.062N P<0.001N** |
|LOGISTIC REGRESSION| P=0.149N P=0.009N** P<0.001N** P=0.093N |P<0.001N** P=0.502N P=0.058N P<0.001N** |
|COCH-ARM / FISHERS | P=0.143N P=0.007N** P=0.002N** P=0.086N |P<0.001N** P=0.432N P=0.051N P<0.001N** |
|ORDER RESTRICTED | P=0.006N** (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 RATE (b) | 1/45.11 1/38.82 0/41.34 2/39.94 | |
|POLY-3 PERCENT (g) | 2.2% 2.6% 0.0% 5.0% | |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) | |
|FIRST INCIDENCE | 712 621 --- 642 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.332 P=0.689 P=0.546N P=0.394 | |
|POLY 3 | P=0.356 P=0.726 P=0.517N P=0.458 | |
|POLY 1.5 | P=0.364 P=0.742 P=0.510N P=0.476 | |
|POLY 6 | P=0.345 P=0.702 P=0.526N P=0.432 | |
|LOGISTIC REGRESSION| P=0.386 P=0.749N P=0.527N P=0.521 | |
|COCH-ARM / FISHERS | P=0.373 P=0.753N P=0.500N P=0.500 | |
|ORDER RESTRICTED | P=0.241 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 4/50 (8%) 0/50 (0%) | |
|POLY-3 RATE (b) | 0/45.04 0/38.44 4/43.09 0/39.41 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 9.3% 0.0% | |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) | |
|FIRST INCIDENCE | --- --- 556 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.404 (e) P=0.052 (e) | |
|POLY 3 | P=0.372 (e) P=0.054 (e) | |
|POLY 1.5 | P=0.401 (e) P=0.057 (e) | |
|POLY 6 | P=0.326 (e) P=0.052 (e) | |
|LOGISTIC REGRESSION| P=0.498 (e) P=0.125 (e) | |
|COCH-ARM / FISHERS | P=0.436 (e) P=0.059 (e) | |
|ORDER RESTRICTED | P=0.104 (e) (e) (e) | |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | |
|POLY-3 RATE (b) | 1/45.04 1/38.72 0/41.34 3/39.92 | |
|POLY-3 PERCENT (g) | 2.2% 2.6% 0.0% 7.5% | |
|TERMINAL (d) | 1/29 (3%) 0/19 (0%) 0/21 (0%) 1/16 (6%) | |
|FIRST INCIDENCE | 729 (T) 652 --- 581 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.101 P=0.668 P=0.564N P=0.159 | |
|POLY 3 | P=0.152 P=0.726 P=0.517N P=0.263 | |
|POLY 1.5 | P=0.157 P=0.741 P=0.510N P=0.281 | |
|POLY 6 | P=0.145 P=0.702 P=0.526N P=0.238 | |
|LOGISTIC REGRESSION| P=0.155 P=0.750 (e) P=0.275 | |
|COCH-ARM / FISHERS | P=0.163 P=0.753N P=0.500N P=0.309 | |
|ORDER RESTRICTED | P=0.081 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 10/50 (20%) 14/50 (28%) 12/50 (24%) | |
|POLY-3 RATE (b) | 10/46.65 10/42.64 14/44.71 12/41.80 | |
|POLY-3 PERCENT (g) | 21.4% 23.5% 31.3% 28.7% | |
|TERMINAL (d) | 2/29 (7%) 1/19 (5%) 5/21 (24%) 3/16 (19%) | |
|FIRST INCIDENCE | 576 421 546 563 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.127 P=0.342 P=0.128 P=0.117 | |
|POLY 3 | P=0.202 P=0.510 P=0.201 P=0.293 | |
|POLY 1.5 | P=0.236 P=0.550 P=0.216 P=0.340 | |
|POLY 6 | P=0.161 P=0.449 P=0.185 P=0.234 | |
|LOGISTIC REGRESSION| P=0.365 P=0.262N P=0.346 P=0.453 | |
|COCH-ARM / FISHERS | P=0.285 P=0.598N P=0.241 P=0.405 | |
|ORDER RESTRICTED | P=0.281 (e) (e) (e) | |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/45.45 2/38.78 2/41.43 3/39.41 |0/44.62 1/43.87 1/44.80 1/40.73 |
|POLY-3 PERCENT (g) | 11.0% 5.2% 4.8% 7.6% |0.0% 2.3% 2.2% 2.5% |
|TERMINAL (d) | 4/29 (14%) 1/19 (5%) 1/21 (5%) 3/16 (19%) |0/36 (0%) 1/30 (3%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | 611 636 708 729 (T) |--- 730 (T) 730 (T) 712 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.559 P=0.377N P=0.343N P=0.632 |P=0.308 P=0.464 P=0.477 P=0.441 |
|POLY 3 | P=0.402N P=0.285N P=0.255N P=0.437N |P=0.350 P=0.497 P=0.501 P=0.482 |
|POLY 1.5 | P=0.394N P=0.254N P=0.239N P=0.401N |P=0.364 P=0.498 P=0.500 P=0.489 |
|POLY 6 | P=0.416N P=0.334N P=0.276N P=0.491N |P=0.331 P=0.493 P=0.501 P=0.472 |
|LOGISTIC REGRESSION| P=0.466N P=0.288N P=0.264N P=0.526N |P=0.332 P=0.464 P=0.477 P=0.474 |
|COCH-ARM / FISHERS | P=0.387N P=0.218N P=0.218N P=0.357N |P=0.384 P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.284N (e) (e) (e) |P=0.311 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.27 0/38.44 1/41.66 2/39.65 |1/45.28 0/43.87 1/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.4% 5.0% |2.2% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | 670 --- 642 684 |509 --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179 P=0.608N P=0.724 P=0.375 |P=0.438N P=0.504N P=0.747 P=0.504N |
|POLY 3 | P=0.202 P=0.532N P=0.742 P=0.454 |P=0.417N P=0.506N P=0.758 P=0.521N |
|POLY 1.5 | P=0.206 P=0.518N P=0.750 P=0.474 |P=0.413N P=0.503N P=0.759 P=0.513N |
|POLY 6 | P=0.195 P=0.554N P=0.732 P=0.425 |P=0.422N P=0.511N P=0.757 P=0.533N |
|LOGISTIC REGRESSION| P=0.206 P=0.482N P=0.728N P=0.483 |P=0.338N P=0.488N P=0.755N P=0.338N |
|COCH-ARM / FISHERS | P=0.209 P=0.500N P=0.753N P=0.500 |P=0.405N P=0.500N P=0.753N P=0.500N |
|ORDER RESTRICTED | P=0.192 (e) (e) (e) |P=0.273N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 2/42.40 0/39.41 |0/44.62 0/43.87 0/44.80 1/40.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | --- --- 396 --- |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.546 (e) P=0.228 (e) |P=0.160 (e) (e) P=0.427 |
|POLY 3 | P=0.498 (e) P=0.224 (e) |P=0.188 (e) (e) P=0.481 |
|POLY 1.5 | P=0.520 (e) P=0.230 (e) |P=0.192 (e) (e) P=0.489 |
|POLY 6 | P=0.462 (e) P=0.216 (e) |P=0.182 (e) (e) P=0.471 |
|LOGISTIC REGRESSION| P=0.609 (e) P=0.443 (e) |(e) (e) (e) P=0.427 |
|COCH-ARM / FISHERS | P=0.546 (e) P=0.247 (e) |P=0.198 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.237 (e) (e) (e) |P=0.105 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Spleen |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |1/49 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.04 0/38.44 3/41.55 1/39.95 |1/44.82 0/43.87 2/45.71 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 7.2% 2.5% |2.2% 0.0% 4.4% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/19 (0%) 1/21 (5%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- 691 563 |537 --- 401 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.301 P=0.584N P=0.227 P=0.686 |P=0.489N P=0.496N P=0.496 P=0.509N |
|POLY 3 | P=0.375 P=0.531N P=0.277 P=0.733 |P=0.488N P=0.504N P=0.507 P=0.519N |
|POLY 1.5 | P=0.387 P=0.518N P=0.288 P=0.746 |P=0.475N P=0.501N P=0.507 P=0.510N |
|POLY 6 | P=0.356 P=0.552N P=0.263 P=0.715 |P=0.503N P=0.510N P=0.505 P=0.532N |
|LOGISTIC REGRESSION| P=0.386 (e) P=0.250 P=0.710N |P=0.259N P=0.475N P=0.590 P=0.356N |
|COCH-ARM / FISHERS | P=0.400 P=0.500N P=0.309 P=0.753N |P=0.457N P=0.495N P=0.508 P=0.495N |
|ORDER RESTRICTED | P=0.248 (e) (e) (e) |P=0.345N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 4/50 (8%) 6/50 (12%) |0/49 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.19 3/39.04 4/42.39 6/39.97 |0/44.22 1/44.54 1/45.34 1/40.84 |
|POLY-3 PERCENT (g) | 4.4% 7.7% 9.4% 15.0% |0.0% 2.3% 2.2% 2.5% |
|TERMINAL (d) | 1/29 (3%) 2/19 (11%) 1/21 (5%) 3/16 (19%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 691 537 546 667 |--- 506 563 682 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.036 * P=0.331 P=0.263 P=0.039 * |P=0.367 P=0.500 P=0.513 P=0.468 |
|POLY 3 | P=0.062 P=0.434 P=0.308 P=0.096 |P=0.350 P=0.501 P=0.505 P=0.484 |
|POLY 1.5 | P=0.070 P=0.463 P=0.320 P=0.111 |P=0.365 P=0.503 P=0.504 P=0.492 |
|POLY 6 | P=0.051 P=0.390 P=0.294 P=0.077 |P=0.331 P=0.498 P=0.505 P=0.473 |
|LOGISTIC REGRESSION| P=0.072 P=0.487 P=0.380 P=0.073 |P=0.536 P=0.530 P=0.556 P=0.506 |
|COCH-ARM / FISHERS | P=0.081 P=0.500 P=0.339 P=0.134 |P=0.388 P=0.505 P=0.505 P=0.505 |
|ORDER RESTRICTED | P=0.062 (e) (e) (e) |P=0.314 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |2/49 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.11 0/38.44 2/41.80 0/39.41 |2/45.28 1/43.89 2/45.66 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 4.8% 0.0% |4.4% 2.3% 4.4% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 1/21 (5%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 712 --- 593 --- |481 726 401 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.599N P=0.606N P=0.421 P=0.606N |P=0.241N P=0.510N P=0.680 P=0.261N |
|POLY 3 | P=0.532N P=0.532N P=0.473 P=0.527N |P=0.223N P=0.511N P=0.691N P=0.262N |
|POLY 1.5 | P=0.525N P=0.518N P=0.484 P=0.515N |P=0.212N P=0.503N P=0.689N P=0.250N |
|POLY 6 | P=0.544N P=0.552N P=0.460 P=0.544N |P=0.237N P=0.522N P=0.693 P=0.279N |
|LOGISTIC REGRESSION| P=0.521N P=0.568N P=0.521 P=0.555N |P=0.095N P=0.467N P=0.643N P=0.108N |
|COCH-ARM / FISHERS | P=0.518N P=0.500N P=0.500 P=0.500N |P=0.196N P=0.492N P=0.684N P=0.242N |
|ORDER RESTRICTED | P=0.323N (e) (e) (e) |P=0.175N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Spleen |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |1/49 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.31 2/38.89 4/42.29 1/39.48 |1/44.91 1/44.30 2/45.41 1/40.72 |
|POLY-3 PERCENT (g) | 4.4% 5.1% 9.5% 2.5% |2.2% 2.3% 4.4% 2.5% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 1/21 (5%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 670 667 558 712 |495 606 565 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.544N P=0.496 P=0.253 P=0.655N |P=0.547 P=0.758 P=0.493 P=0.727 |
|POLY 3 | P=0.495N P=0.638 P=0.305 P=0.548N |P=0.543 P=0.758 P=0.504 P=0.738 |
|POLY 1.5 | P=0.472N P=0.663 P=0.318 P=0.527N |P=0.564 P=0.760N P=0.505 P=0.749 |
|POLY 6 | P=0.531N P=0.600 P=0.290 P=0.578N |P=0.516 P=0.753 P=0.503 P=0.724 |
|LOGISTIC REGRESSION| P=0.444N P=0.699 P=0.381 P=0.551N |P=0.524N P=0.750N P=0.558 P=0.690N |
|COCH-ARM / FISHERS | P=0.445N P=0.691N P=0.339 P=0.500N |P=0.596 P=0.747N P=0.508 P=0.747N |
|ORDER RESTRICTED | P=0.350N (e) (e) (e) |P=0.574 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |2/49 (4%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/46.45 0/38.44 3/42.53 0/39.41 |2/44.91 1/44.10 0/44.80 3/42.63 |
|POLY-3 PERCENT (g) | 6.5% 0.0% 7.1% 0.0% |4.5% 2.3% 0.0% 7.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |1/36 (3%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 476 --- 509 --- |495 670 --- 451 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.276N P=0.163N P=0.605 P=0.159N |P=0.308 P=0.526N P=0.255N P=0.458 |
|POLY 3 | P=0.238N P=0.156N P=0.621 P=0.151N |P=0.332 P=0.506N P=0.238N P=0.476 |
|POLY 1.5 | P=0.233N P=0.139N P=0.638 P=0.136N |P=0.336 P=0.501N P=0.236N P=0.490 |
|POLY 6 | P=0.249N P=0.185N P=0.600 P=0.174N |P=0.326 P=0.514N P=0.240N P=0.457 |
|LOGISTIC REGRESSION| P=0.164N P=0.018N* P=0.383N P=0.019N* |P=0.569 P=0.471N P=0.204N P=0.629N |
|COCH-ARM / FISHERS | P=0.232N P=0.121N P=0.661N P=0.121N |P=0.342 P=0.492N P=0.242N P=0.510 |
|ORDER RESTRICTED | P=0.078N (e) (e) (e) |P=0.168 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/49 (4%) 1/50 (2%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/45.47 3/39.57 2/40.95 1/39.51 |0/44.22 2/44.26 0/44.80 2/40.84 |
|POLY-3 PERCENT (g) | 4.4% 7.6% 4.9% 2.5% |0.0% 4.5% 0.0% 4.9% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 670 605 633 705 |--- 656 --- 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.344N P=0.355 P=0.629 P=0.616N |P=0.191 P=0.228 (e) P=0.180 |
|POLY 3 | P=0.327N P=0.437 P=0.656 P=0.549N |P=0.227 P=0.237 (e) P=0.220 |
|POLY 1.5 | P=0.307N P=0.464 P=0.668 P=0.527N |P=0.236 P=0.239 (e) P=0.228 |
|POLY 6 | P=0.358N P=0.398 P=0.640 P=0.580N |P=0.215 P=0.234 (e) P=0.209 |
|LOGISTIC REGRESSION| P=0.260N P=0.642 P=0.676N P=0.500N |P=0.245 P=0.246 (e) P=0.217 |
|COCH-ARM / FISHERS | P=0.283N P=0.500 P=0.684 P=0.500N |P=0.251 P=0.253 (e) P=0.253 |
|ORDER RESTRICTED | P=0.374N (e) (e) (e) |P=0.104 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/49 (6%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 1/38.66 3/41.32 0/39.41 |0/44.22 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 7.3% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- 670 556 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.577 P=0.392 P=0.101 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.562 P=0.470 P=0.104 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.592 P=0.483 P=0.108 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.513 P=0.450 P=0.099 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.611N P=0.518 P=0.144 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.626 P=0.500 P=0.117 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.204 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/49 (2%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 1/38.45 1/40.90 2/39.74 |0/44.22 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 2.4% 5.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- 726 633 667 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123 P=0.419 P=0.476 P=0.164 |(e) (e) (e) (e) |
|POLY 3 | P=0.143 P=0.469 P=0.481 P=0.210 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.153 P=0.482 P=0.487 P=0.222 |(e) (e) (e) (e) |
|POLY 6 | P=0.130 P=0.448 P=0.474 P=0.195 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.158 P=0.404 P=0.562 P=0.224 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.165 P=0.500 P=0.495 P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.099 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 RATE (b) | 2/45.42 2/38.87 1/41.34 2/39.56 | |
|POLY-3 PERCENT (g) | 4.4% 5.2% 2.4% 5.1% | |
|TERMINAL (d) | 1/29 (3%) 1/19 (5%) 1/21 (5%) 1/16 (6%) | |
|FIRST INCIDENCE | 621 605 729 (T) 691 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.505 P=0.592 P=0.590N P=0.531 | |
|POLY 3 | P=0.587N P=0.637 P=0.533N P=0.643 | |
|POLY 1.5 | P=0.575N P=0.662 P=0.519N P=0.666 | |
|POLY 6 | P=0.573 P=0.597 P=0.550N P=0.610 | |
|LOGISTIC REGRESSION| P=0.586N P=0.676N P=0.509N P=0.672 | |
|COCH-ARM / FISHERS | P=0.561N P=0.691N P=0.500N P=0.691N | |
|ORDER RESTRICTED | P=0.625 (e) (e) (e) | |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 9/50 (18%) 15/50 (30%) 11/50 (22%) | |
|POLY-3 RATE (b) | 11/45.57 9/39.47 15/42.43 11/40.40 | |
|POLY-3 PERCENT (g) | 24.1% 22.8% 35.4% 27.2% | |
|TERMINAL (d) | 8/29 (28%) 5/19 (26%) 9/21 (43%) 3/16 (19%) | |
|FIRST INCIDENCE | 621 605 633 636 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.101 P=0.414 P=0.075 P=0.151 | |
|POLY 3 | P=0.296 P=0.544N P=0.177 P=0.468 | |
|POLY 1.5 | P=0.335 P=0.481N P=0.204 P=0.524 | |
|POLY 6 | P=0.245 P=0.570 P=0.149 P=0.392 | |
|LOGISTIC REGRESSION| P=0.234 P=0.528 P=0.132 P=0.328 | |
|COCH-ARM / FISHERS | P=0.383 P=0.402N P=0.247 P=0.595N | |
|ORDER RESTRICTED | P=0.319 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 2/50 (4%) 2/50 (4%) | |
|POLY-3 RATE (b) | 5/45.70 4/41.08 2/41.72 2/40.30 | |
|POLY-3 PERCENT (g) | 10.9% 9.7% 4.8% 5.0% | |
|TERMINAL (d) | 2/29 (7%) 0/19 (0%) 1/21 (5%) 0/16 (0%) | |
|FIRST INCIDENCE | 611 421 621 593 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.200N P=0.613 P=0.320N P=0.388N | |
|POLY 3 | P=0.152N P=0.567N P=0.254N P=0.270N | |
|POLY 1.5 | P=0.142N P=0.536N P=0.238N P=0.246N | |
|POLY 6 | P=0.166N P=0.616N P=0.275N P=0.307N | |
|LOGISTIC REGRESSION| P=0.077N P=0.168N P=0.211N P=0.156N | |
|COCH-ARM / FISHERS | P=0.129N P=0.500N P=0.218N P=0.218N | |
|ORDER RESTRICTED | P=0.229N (e) (e) (e) | |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 4/50 (8%) 6/50 (12%) 11/50 (22%) |11/49 (22%) 6/50 (12%) 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 8/46.03 4/39.62 6/42.00 11/42.27 |11/44.25 6/43.87 4/44.85 5/41.07 |
|POLY-3 PERCENT (g) | 17.4% 10.1% 14.3% 26.0% |24.9% 13.7% 8.9% 12.2% |
|TERMINAL (d) | 4/29 (14%) 1/19 (5%) 4/21 (19%) 2/16 (13%) |10/36 (28%) 6/30 (20%) 3/32 (9%) 4/25 (16%) |
|FIRST INCIDENCE | 576 590 558 465 |722 730 (T) 718 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * P=0.379N P=0.588N P=0.094 |P=0.179N P=0.247N P=0.073N P=0.262N |
|POLY 3 | P=0.092 P=0.257N P=0.458N P=0.232 |P=0.075N P=0.143N P=0.040N* P=0.109N |
|POLY 1.5 | P=0.097 P=0.220N P=0.428N P=0.264 |P=0.070N P=0.138N P=0.040N* P=0.095N |
|POLY 6 | P=0.084 P=0.315N P=0.498N P=0.191 |P=0.082N P=0.153N P=0.040N* P=0.130N |
|LOGISTIC REGRESSION| P=0.108 P=0.154N P=0.412N P=0.415 |P=0.124N P=0.199N P=0.053N P=0.162N |
|COCH-ARM / FISHERS | P=0.101 P=0.178N P=0.387N P=0.306 |P=0.063N P=0.133N P=0.041N* P=0.079N |
|ORDER RESTRICTED | P=0.093 (e) (e) (e) |P=0.044N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Tongue: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 1/1 (100%) 1/3 (33%) 0/0 (0%) |0/1 (0%) 3/3 (100%) 0/0 (0%) 1/1 (100%) |
|POLY-3 RATE (b) | 1/1.00 1/1.00 1/2.92 0/0.00 |0/1.00 3/3.00 0/0.00 1/1.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 34.3% 0.0% |0.0% 100.0% 0.0% 100.0% |
|TERMINAL (d) | 1/1 (100%) 1/1 (100%) 1/2 (50%) 0/0 (0%) |0/1 (0%) 2/2 (100%) 0/0 (0%) 1/1 (100%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- 703 --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.556N (e) P=0.638N (e) |P=0.514 P=0.152 (e) P=0.500 |
|POLY 3 | (e) (e) P=0.509N (e) |(e) P=0.250N (e) P=1.000 |
|POLY 1.5 | (e) (e) P=0.504N (e) |(e) P=0.250N (e) P=1.000 |
|POLY 6 | (e) (e) P=0.517N (e) |(e) P=0.250N (e) P=1.000 |
|LOGISTIC REGRESSION| P=0.556N (e) P=0.638N (e) |(e) (e) (e) P=0.250 |
|COCH-ARM / FISHERS | P=0.338N (e) P=0.500N (e) |P=0.371 P=0.250 (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/49 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 0/41.34 1/39.71 |1/44.49 0/43.87 2/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.5% |2.3% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 2/32 (6%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- --- 647 |656 --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.180 (e) (e) P=0.454 |P=0.528N P=0.505N P=0.475 P=0.531N |
|POLY 3 | P=0.180 (e) (e) P=0.475 |P=0.486N P=0.503N P=0.502 P=0.518N |
|POLY 1.5 | P=0.184 (e) (e) P=0.486 |P=0.475N P=0.500N P=0.504 P=0.509N |
|POLY 6 | P=0.175 (e) (e) P=0.459 |P=0.502N P=0.508N P=0.499 P=0.530N |
|LOGISTIC REGRESSION| P=0.196 (e) (e) P=0.557 |P=0.476N P=0.487N P=0.506 P=0.471N |
|COCH-ARM / FISHERS | P=0.188 (e) (e) P=0.500 |P=0.457N P=0.495N P=0.508 P=0.495N |
|ORDER RESTRICTED | P=0.101 (e) (e) (e) |P=0.342N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Uterus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | |1/44.29 1/44.30 1/44.96 3/40.82 |
|POLY-3 PERCENT (g) | |2.3% 2.3% 2.2% 7.4% |
|TERMINAL (d) | |0/36 (0%) 0/30 (0%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | |712 606 689 696 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.112 P=0.745 P=0.751 P=0.202 |
|POLY 3 | |P=0.148 P=0.761N P=0.757N P=0.276 |
|POLY 1.5 | |P=0.155 P=0.758N P=0.757N P=0.291 |
|POLY 6 | |P=0.139 P=0.757 P=0.758N P=0.258 |
|LOGISTIC REGRESSION| |P=0.161 P=0.750N P=0.758N P=0.255 |
|COCH-ARM / FISHERS | |P=0.167 P=0.747N P=0.747N P=0.316 |
|ORDER RESTRICTED | |P=0.158 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Uterus |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/44.22 0/43.87 0/44.80 2/40.93 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 0.0% 4.9% |
|TERMINAL (d) | |0/36 (0%) 0/30 (0%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | |--- --- --- 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.032 * (e) (e) P=0.185 |
|POLY 3 | |P=0.043 * (e) (e) P=0.220 |
|POLY 1.5 | |P=0.044 * (e) (e) P=0.229 |
|POLY 6 | |P=0.042 * (e) (e) P=0.209 |
|LOGISTIC REGRESSION| |P=0.044 * (e) (e) P=0.230 |
|COCH-ARM / FISHERS | |P=0.047 * (e) (e) P=0.253 |
|ORDER RESTRICTED | |P=0.024 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 5/50 (10%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | |1/44.22 5/44.53 2/44.80 0/40.65 |
|POLY-3 PERCENT (g) | |2.3% 11.2% 4.5% 0.0% |
|TERMINAL (d) | |1/36 (3%) 2/30 (7%) 2/32 (6%) 0/25 (0%) |
|FIRST INCIDENCE | |730 (T) 606 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.239N P=0.084 P=0.459 P=0.573N |
|POLY 3 | |P=0.194N P=0.102 P=0.505 P=0.517N |
|POLY 1.5 | |P=0.179N P=0.104 P=0.505 P=0.508N |
|POLY 6 | |P=0.216N P=0.099 P=0.503 P=0.528N |
|LOGISTIC REGRESSION| |P=0.179N P=0.106 P=0.459 (e) |
|COCH-ARM / FISHERS | |P=0.160N P=0.107 P=0.508 P=0.495N |
|ORDER RESTRICTED | |P=0.105N (e) (e) (e) |
|=================================================================================================================================|
(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).