TDMS Study 97006-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 05/11/04
EXPERIMENT: 97006 TEST: 01 TIME: 09:02:01
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006
PATHOLOGIST: RENNE, ROGER CAS: 108-10-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1/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 METHYL ISOBUTYL KETONE DATE: 05/11/04
EXPERIMENT: 97006 TEST: 01 TIME: 09:02:01
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006
PATHOLOGIST: RENNE, ROGER CAS: 108-10-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF METHYL ISOBUTYL KETONE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Hyperplasia
Eye: Lens Cataract
Kidney Infarct
Nephropathy
Kidney: Papilla Mineralization
Kidney: Pelvis, Transitional Epithelium
Hyperplasia
Kidney: Renal Tubule Accumulation, Hyaline Droplet
Hyperplasia
Liver Basophilic Focus
Degeneration Cystic
Eosinophilic Focus
Hepatodiaphragmatic Nodule
Necrosis
Vacuolization Cytoplasmic
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Regeneration
Lung Inflammation Chronic
Lung: Alveolus Emphysema
Lymph Node: Pancreatic Ectasia
Mammary Gland Galactocele
Nose Foreign Body
Inflammation
Nose: Goblet Cell Hyperplasia
Pituitary Gland Hemorrhage
Pleura Fibrosis
Inflammation Chronic
Skin Inflammation Granulomatous
Spleen Fibrosis
Stomach, Forestomach Ulcer
Testes: Germinal Epithelium Atrophy
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Kidney Nephropathy
Kidney: Pelvis, Transitional Epithelium
Mineralization
Liver Basophilic Focus
Necrosis
Lung Inflammation Chronic
Lung: Alveolus Infiltration Cellular Histiocyte
Nose Inflammation
Nose: Nasolacrimal Duct Inflammation
Pleura Fibrosis
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 05/11/04
EXPERIMENT: 97006 TEST: 01 TIME: 09:02:01
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006
PATHOLOGIST: RENNE, ROGER CAS: 108-10-1
Inflammation Chronic
===============================================================
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/48 (6%) 6/50 (12%) 3/50 (6%) |9/50 (18%) 4/50 (8%) 13/50 (26%) 9/50 (18%) |
|POLY-3 RATE (b) | 7/45.31 3/40.91 6/42.42 3/41.95 |9/45.20 4/45.36 13/44.44 9/43.50 |
|POLY-3 PERCENT (g) | 15.5% 7.3% 14.2% 7.2% |19.9% 8.8% 29.3% 20.7% |
|TERMINAL (d) | 4/32 (13%) 1/28 (4%) 4/25 (16%) 0/19 (0%) |7/35 (20%) 2/34 (6%) 6/26 (23%) 7/32 (22%) |
|FIRST INCIDENCE | 588 618 637 623 |643 539 513 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.391N P=0.226N P=0.583 P=0.344N |P=0.255 P=0.131N P=0.108 P=0.527 |
|POLY 3 | P=0.215N P=0.201N P=0.551N P=0.189N |P=0.274 P=0.113N P=0.216 P=0.568 |
|POLY 1.5 | P=0.200N P=0.192N P=0.537N P=0.173N |P=0.289 P=0.115N P=0.228 P=0.580 |
|POLY 6 | P=0.250N P=0.212N P=0.575N P=0.225N |P=0.260 P=0.110N P=0.195 P=0.560 |
|LOGISTIC REGRESSION| P=0.204N P=0.176N P=0.538N P=0.158N |P=0.305 P=0.118N P=0.227 P=0.562 |
|COCH-ARM / FISHERS | P=0.190N P=0.176N P=0.500N P=0.159N |P=0.319 P=0.117N P=0.235 P=0.602N |
|ORDER RESTRICTED | P=0.165N (e) (e) (e) |P=0.156 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 18/48 (38%) 18/50 (36%) 24/50 (48%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 13/45.31 18/42.20 18/43.63 24/45.14 |0/44.82 2/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 28.7% 42.7% 41.3% 53.2% |0.0% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 10/32 (31%) 11/28 (39%) 8/25 (32%) 9/19 (47%) |0/35 (0%) 2/34 (6%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 588 420 637 498 |--- 727 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.107 P=0.083 P<0.001 ** |P=0.431N P=0.232 (e) (e) |
|POLY 3 | P=0.014 * P=0.123 P=0.151 P=0.012 * |P=0.416N P=0.236 (e) (e) |
|POLY 1.5 | P=0.017 * P=0.134 P=0.158 P=0.015 * |P=0.411N P=0.236 (e) (e) |
|POLY 6 | P=0.010 * P=0.114 P=0.143 P=0.008 ** |P=0.422N P=0.236 (e) (e) |
|LOGISTIC REGRESSION| P=0.013 * P=0.121 P=0.140 P=0.014 * |(e) P=0.232 (e) (e) |
|COCH-ARM / FISHERS | P=0.020 * P=0.157 P=0.194 P=0.019 * |P=0.405N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.009 ** (e) (e) (e) |P=0.254N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 8/49 (16%) 3/50 (6%) 6/50 (12%) |8/50 (16%) 11/50 (22%) 10/50 (20%) 7/50 (14%) |
|POLY-3 RATE (b) | 8/46.16 8/42.44 3/42.32 6/43.07 |8/45.70 11/47.04 10/45.27 7/44.39 |
|POLY-3 PERCENT (g) | 17.3% 18.9% 7.1% 13.9% |17.5% 23.4% 22.1% 15.8% |
|TERMINAL (d) | 3/32 (9%) 3/28 (11%) 2/25 (8%) 1/19 (5%) |2/35 (6%) 4/34 (12%) 1/26 (4%) 3/32 (9%) |
|FIRST INCIDENCE | 505 618 660 498 |606 455 513 489 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.442N P=0.498 P=0.170N P=0.605N |P=0.442N P=0.316 P=0.275 P=0.555N |
|POLY 3 | P=0.276N P=0.536 P=0.127N P=0.441N |P=0.392N P=0.329 P=0.388 P=0.525N |
|POLY 1.5 | P=0.258N P=0.554 P=0.119N P=0.413N |P=0.378N P=0.320 P=0.397 P=0.516N |
|POLY 6 | P=0.315N P=0.519 P=0.142N P=0.495N |P=0.408N P=0.340 P=0.366 P=0.533N |
|LOGISTIC REGRESSION| P=0.232N P=0.586N P=0.093N P=0.325N |P=0.300N P=0.311 P=0.450 P=0.498N |
|COCH-ARM / FISHERS | P=0.242N P=0.590 P=0.100N P=0.387N |P=0.354N P=0.306 P=0.398 P=0.500N |
|ORDER RESTRICTED | P=0.241N (e) (e) (e) |P=0.424N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/49 (6%) 6/50 (12%) 4/50 (8%) |5/50 (10%) 4/50 (8%) 10/50 (20%) 5/50 (10%) |
|POLY-3 RATE (b) | 5/45.66 3/41.36 6/44.67 4/42.21 |5/45.54 4/45.66 10/44.29 5/44.02 |
|POLY-3 PERCENT (g) | 11.0% 7.3% 13.4% 9.5% |11.0% 8.8% 22.6% 11.4% |
|TERMINAL (d) | 0/32 (0%) 1/28 (4%) 1/25 (4%) 0/19 (0%) |1/35 (3%) 1/34 (3%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 554 621 205 638 |606 562 546 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.467 P=0.430N P=0.439 P=0.609 |P=0.387 P=0.509N P=0.079 P=0.590 |
|POLY 3 | P=0.563N P=0.412N P=0.484 P=0.549N |P=0.405 P=0.498N P=0.115 P=0.609 |
|POLY 1.5 | P=0.543N P=0.395N P=0.488 P=0.524N |P=0.417 P=0.499N P=0.124 P=0.615 |
|POLY 6 | P=0.519 P=0.432N P=0.473 P=0.595N |P=0.397 P=0.497N P=0.102 P=0.605 |
|LOGISTIC REGRESSION| P=0.509N P=0.339N P=0.619N P=0.464N |P=0.475 P=0.493N P=0.147 P=0.628N |
|COCH-ARM / FISHERS | P=0.529N P=0.369N P=0.500 P=0.500N |P=0.442 P=0.500N P=0.131 P=0.630N |
|ORDER RESTRICTED | P=0.564 (e) (e) (e) |P=0.254 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.48 0/40.90 0/42.07 0/41.33 |0/44.82 0/44.54 1/42.16 2/43.74 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.4% 4.6% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 674 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.073 (e) P=0.457 P=0.240 |
|POLY 3 | (e) (e) (e) (e) |P=0.067 (e) P=0.488 P=0.232 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.068 (e) P=0.494 P=0.233 |
|POLY 6 | (e) (e) (e) (e) |P=0.067 (e) P=0.477 P=0.232 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.075 (e) P=0.505 P=0.251 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.070 (e) P=0.500 P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.071 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | |2/45.10 3/44.62 1/41.95 1/43.18 |
|POLY-3 PERCENT (g) | |4.4% 6.7% 2.4% 2.3% |
|TERMINAL (d) | |1/35 (3%) 2/34 (6%) 1/26 (4%) 1/32 (3%) |
|FIRST INCIDENCE | |650 707 727 (T) 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.323N P=0.494 P=0.589N P=0.521N |
|POLY 3 | |P=0.297N P=0.495 P=0.525N P=0.515N |
|POLY 1.5 | |P=0.290N P=0.497 P=0.512N P=0.510N |
|POLY 6 | |P=0.305N P=0.494 P=0.547N P=0.520N |
|LOGISTIC REGRESSION| |P=0.299N P=0.498 P=0.520N P=0.508N |
|COCH-ARM / FISHERS | |P=0.279N P=0.500 P=0.500N P=0.500N |
|ORDER RESTRICTED | |P=0.346N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | |1/44.82 3/44.99 1/41.95 1/43.18 |
|POLY-3 PERCENT (g) | |2.2% 6.7% 2.4% 2.3% |
|TERMINAL (d) | |1/35 (3%) 2/34 (6%) 1/26 (4%) 1/32 (3%) |
|FIRST INCIDENCE | |727 (T) 594 727 (T) 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.483N P=0.297 P=0.694 P=0.742 |
|POLY 3 | |P=0.462N P=0.307 P=0.746 P=0.752 |
|POLY 1.5 | |P=0.455N P=0.306 P=0.753 P=0.755 |
|POLY 6 | |P=0.470N P=0.309 P=0.733 P=0.750 |
|LOGISTIC REGRESSION| |P=0.459N P=0.305 P=0.694 P=0.742 |
|COCH-ARM / FISHERS | |P=0.444N P=0.309 P=0.753N P=0.753N |
|ORDER RESTRICTED | |P=0.459N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/45 (0%) 0/46 (0%) 0/48 (0%) |0/49 (0%) 1/50 (2%) 2/48 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.48 0/38.08 0/38.15 0/39.38 |0/43.89 1/44.77 2/41.30 0/42.51 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 4.8% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/26 (0%) 0/22 (0%) 0/18 (0%) |0/35 (0%) 0/34 (0%) 1/25 (4%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 665 489 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.628N P=0.505 P=0.207 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.631N P=0.504 P=0.224 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.627N P=0.504 P=0.229 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.634N P=0.505 P=0.213 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.585N P=0.506 P=0.211 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.618N P=0.505 P=0.242 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.314 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Lens |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 6/45 (13%) 3/46 (7%) 2/48 (4%) |2/49 (4%) 3/50 (6%) 4/48 (8%) 4/49 (8%) |
|POLY-3 RATE (b) | 7/43.94 6/38.11 3/38.27 2/39.41 |2/44.31 3/45.13 4/41.15 4/42.51 |
|POLY-3 PERCENT (g) | 15.9% 15.7% 7.8% 5.1% |4.5% 6.7% 9.7% 9.4% |
|TERMINAL (d) | 6/31 (19%) 5/26 (19%) 2/22 (9%) 1/18 (6%) |1/35 (3%) 2/34 (6%) 2/25 (8%) 4/32 (13%) |
|FIRST INCIDENCE | 592 720 695 719 |606 537 581 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.155N P=0.617 P=0.297N P=0.244N |P=0.225 P=0.488 P=0.247 P=0.301 |
|POLY 3 | P=0.051N P=0.610N P=0.218N P=0.106N |P=0.237 P=0.508 P=0.303 P=0.318 |
|POLY 1.5 | P=0.046N* P=0.593N P=0.209N P=0.094N |P=0.245 P=0.509 P=0.316 P=0.325 |
|POLY 6 | P=0.065N P=0.607 P=0.233N P=0.132N |P=0.228 P=0.509 P=0.280 P=0.312 |
|LOGISTIC REGRESSION| P=0.090N P=0.611 P=0.226N P=0.142N |P=0.257 P=0.514 P=0.334 P=0.324 |
|COCH-ARM / FISHERS | P=0.041N* P=0.567N P=0.185N P=0.084N |P=0.260 P=0.510 P=0.329 P=0.339 |
|ORDER RESTRICTED | P=0.082N (e) (e) (e) |P=0.297 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 9/49 (18%) 12/50 (24%) 8/50 (16%) |1/50 (2%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 14/44.68 9/41.14 12/44.06 8/41.41 |1/44.82 1/44.54 3/42.77 2/43.18 |
|POLY-3 PERCENT (g) | 31.3% 21.9% 27.2% 19.3% |2.2% 2.3% 7.0% 4.6% |
|TERMINAL (d) | 12/32 (38%) 8/28 (29%) 8/25 (32%) 7/19 (37%) |1/35 (3%) 1/34 (3%) 1/26 (4%) 2/32 (6%) |
|FIRST INCIDENCE | 679 720 57 706 |727 (T) 727 (T) 581 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.531 P=0.276N P=0.519 P=0.554N |P=0.296 P=0.755 P=0.251 P=0.469 |
|POLY 3 | P=0.164N P=0.227N P=0.424N P=0.148N |P=0.307 P=0.759 P=0.288 P=0.487 |
|POLY 1.5 | P=0.146N P=0.211N P=0.421N P=0.128N |P=0.313 P=0.759 P=0.297 P=0.491 |
|POLY 6 | P=0.211N P=0.247N P=0.437N P=0.199N |P=0.302 P=0.760 P=0.273 P=0.484 |
|LOGISTIC REGRESSION| P=0.187N P=0.275N P=0.428N P=0.455N |P=0.319 P=0.755 P=0.317 P=0.469 |
|COCH-ARM / FISHERS | P=0.137N P=0.185N P=0.410N P=0.114N |P=0.324 P=0.753N P=0.309 P=0.500 |
|ORDER RESTRICTED | P=0.150N (e) (e) (e) |P=0.310 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/49 (8%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.41 4/42.47 3/42.49 1/41.65 |0/44.82 1/44.56 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 4.4% 9.4% 7.1% 2.4% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 588 420 670 638 |--- 722 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.381N P=0.309 P=0.457 P=0.498N |P=0.574N P=0.500 (e) (e) |
|POLY 3 | P=0.333N P=0.306 P=0.470 P=0.530N |P=0.574N P=0.499 (e) (e) |
|POLY 1.5 | P=0.311N P=0.314 P=0.478 P=0.515N |P=0.571N P=0.499 (e) (e) |
|POLY 6 | P=0.375N P=0.297 P=0.457 P=0.558N |P=0.579N P=0.499 (e) (e) |
|LOGISTIC REGRESSION| P=0.272N P=0.450 P=0.537 P=0.514N |P=0.578N P=0.500 (e) (e) |
|COCH-ARM / FISHERS | P=0.289N P=0.329 P=0.500 P=0.500N |P=0.567N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.293N (e) (e) (e) |P=0.386N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 1/48 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.50 1/40.84 0/42.07 2/41.85 |0/44.82 0/44.13 0/41.61 0/42.84 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 0.0% 4.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 551 --- 638 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.130 P=0.500 (e) P=0.201 |(e) (e) (e) (e) |
|POLY 3 | P=0.135 P=0.487 (e) P=0.228 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.141 P=0.492 (e) P=0.237 |(e) (e) (e) (e) |
|POLY 6 | P=0.124 P=0.482 (e) P=0.213 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.145 P=0.628 (e) P=0.267 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.147 P=0.500 (e) P=0.258 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.068 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 4/50 (8%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/44.48 0/41.74 4/43.08 3/41.92 |0/44.82 0/44.54 0/41.95 1/43.36 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 9.3% 7.2% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- 544 645 |--- --- --- 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.021 * (e) P=0.056 P=0.079 |P=0.199 (e) (e) P=0.495 |
|POLY 3 | P=0.033 * (e) P=0.056 P=0.108 |P=0.195 (e) (e) P=0.493 |
|POLY 1.5 | P=0.036 * (e) P=0.057 P=0.114 |P=0.196 (e) (e) P=0.495 |
|POLY 6 | P=0.027 * (e) P=0.055 P=0.098 |P=0.194 (e) (e) P=0.492 |
|LOGISTIC REGRESSION| P=0.040 * (e) P=0.068 P=0.126 |P=0.199 (e) (e) P=0.502 |
|COCH-ARM / FISHERS | P=0.040 * (e) P=0.059 P=0.121 |P=0.198 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.034 * (e) (e) (e) |P=0.114 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 45/50 (90%) 47/50 (94%) 50/50 (100%)|19/50 (38%) 35/50 (70%) 38/50 (76%) 44/50 (88%) |
|POLY-3 RATE (b) | 42/47.30 45/47.55 47/48.09 50/50.00 |19/45.28 35/47.90 38/47.30 44/46.18 |
|POLY-3 PERCENT (g) | 88.8% 94.6% 97.7% 100.0% |42.0% 73.1% 80.3% 95.3% |
|TERMINAL (d) | 29/32 (91%) 28/28 (100%) 25/25 (100%) 19/19 (100%)|14/35 (40%) 24/34 (71%) 20/26 (77%) 31/32 (97%) |
|FIRST INCIDENCE | 505 405 205 498 |685 455 513 499 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.090 P=0.020 * P<0.001 ** |P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.003 ** P=0.225 P=0.061 P=0.011 * |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.002 ** P=0.238 P=0.055 P=0.006 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.007 ** P=0.213 P=0.078 P=0.030 * |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.110 P=0.026 * P=0.002 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.002 ** P=0.277 P=0.100 P=0.003 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Papilla |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 22/50 (44%) 29/50 (58%) |3/50 (6%) 5/50 (10%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/44.48 6/42.40 22/44.54 29/46.28 |3/44.86 5/44.75 3/42.34 3/43.86 |
|POLY-3 PERCENT (g) | 2.3% 14.2% 49.4% 62.7% |6.7% 11.2% 7.1% 6.8% |
|TERMINAL (d) | 1/32 (3%) 3/28 (11%) 11/25 (44%) 12/19 (63%) |2/35 (6%) 3/34 (9%) 1/26 (4%) 2/32 (6%) |
|FIRST INCIDENCE | 726 (T) 621 544 544 |716 693 636 499 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.045 * P<0.001 ** P<0.001 ** |P=0.525N P=0.355 P=0.545 P=0.625 |
|POLY 3 | P<0.001 ** P=0.048 * P<0.001 ** P<0.001 ** |P=0.480N P=0.355 P=0.636 P=0.652 |
|POLY 1.5 | P<0.001 ** P=0.051 P<0.001 ** P<0.001 ** |P=0.474N P=0.355 P=0.649 P=0.655 |
|POLY 6 | P<0.001 ** P=0.045 * P<0.001 ** P<0.001 ** |P=0.487N P=0.357 P=0.612 P=0.650 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.049 * P<0.001 ** P<0.001 ** |P=0.478N P=0.353 P=0.621 P=0.663N |
|COCH-ARM / FISHERS | P<0.001 ** P=0.056 P<0.001 ** P<0.001 ** |P=0.463N P=0.357 P=0.661N P=0.661N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.561N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Pelvis, Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 6/50 (12%) 19/50 (38%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.48 5/41.74 6/42.19 19/42.56 |1/44.82 1/44.67 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 2.3% 12.0% 14.2% 44.7% |2.2% 2.2% 0.0% 2.3% |
|TERMINAL (d) | 1/32 (3%) 5/28 (18%) 4/25 (16%) 12/19 (63%) |1/35 (3%) 0/34 (0%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 702 609 |727 (T) 693 --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.073 P=0.030 * P<0.001 ** |P=0.645N P=0.760 P=0.559N P=0.742 |
|POLY 3 | P<0.001 ** P=0.087 P=0.047 * P<0.001 ** |P=0.623N P=0.760 P=0.513N P=0.752 |
|POLY 1.5 | P<0.001 ** P=0.092 P=0.049 * P<0.001 ** |P=0.619N P=0.760 P=0.506N P=0.755 |
|POLY 6 | P<0.001 ** P=0.080 P=0.044 * P<0.001 ** |P=0.629N P=0.761N P=0.525N P=0.750 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.073 P=0.034 * P<0.001 ** |P=0.631N P=0.761 (e) P=0.742 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.102 P=0.056 P<0.001 ** |P=0.616N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.551N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Pelvis, Transitional Epithelium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |9/50 (18%) 6/50 (12%) 7/50 (14%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.48 0/41.74 0/42.07 0/41.33 |9/45.43 6/45.88 7/42.99 2/43.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |19.8% 13.1% 16.3% 4.6% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |6/35 (17%) 4/34 (12%) 3/26 (12%) 2/32 (6%) |
|FIRST INCIDENCE | --- --- --- --- |606 455 616 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.049N* P=0.310N P=0.589N P=0.042N* |
|POLY 3 | (e) (e) (e) (e) |P=0.035N* P=0.279N P=0.439N P=0.030N* |
|POLY 1.5 | (e) (e) (e) (e) |P=0.032N* P=0.283N P=0.415N P=0.028N* |
|POLY 6 | (e) (e) (e) (e) |P=0.038N* P=0.277N P=0.480N P=0.032N* |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.028N* P=0.285N P=0.427N P=0.031N* |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.028N* P=0.288N P=0.393N P=0.026N* |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.024N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 0/41.74 2/43.66 2/42.43 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.6% 4.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- 57 544 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.094 (e) P=0.242 P=0.249 |(e) (e) (e) (e) |
|POLY 3 | P=0.081 (e) P=0.233 P=0.227 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.084 (e) P=0.234 P=0.233 |(e) (e) (e) (e) |
|POLY 6 | P=0.072 (e) P=0.229 P=0.214 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.041 * (e) P=0.598 P=0.141 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.086 (e) P=0.247 P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.108 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 11/50 (22%) 3/50 (6%) 18/50 (36%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.48 11/42.25 3/42.17 18/42.93 |1/44.90 1/44.54 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 2.3% 26.0% 7.1% 41.9% |2.2% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 1/32 (3%) 9/28 (32%) 2/25 (8%) 9/19 (47%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 658 702 609 |707 727 (T) --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P=0.231 P<0.001 ** |P=0.647N P=0.760 P=0.559N P=0.735 |
|POLY 3 | P<0.001 ** P<0.001 ** P=0.286 P<0.001 ** |P=0.623N P=0.759 P=0.514N P=0.752 |
|POLY 1.5 | P<0.001 ** P<0.001 ** P=0.291 P<0.001 ** |P=0.619N P=0.759 P=0.507N P=0.755 |
|POLY 6 | P<0.001 ** P<0.001 ** P=0.278 P<0.001 ** |P=0.629N P=0.759 P=0.525N P=0.750 |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P=0.255 P<0.001 ** |P=0.633N P=0.762 P=0.518N P=0.753 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P=0.309 P<0.001 ** |P=0.616N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.550N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Larynx |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/48 (6%) 6/50 (12%) 4/50 (8%) |1/50 (2%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/44.85 3/40.51 6/43.42 4/41.78 |1/44.82 2/44.99 3/42.23 2/43.77 |
|POLY-3 PERCENT (g) | 4.5% 7.4% 13.8% 9.6% |2.2% 4.5% 7.1% 4.6% |
|TERMINAL (d) | 1/32 (3%) 2/28 (7%) 2/25 (8%) 2/19 (11%) |1/35 (3%) 1/34 (3%) 2/26 (8%) 0/32 (0%) |
|FIRST INCIDENCE | 624 664 539 636 |727 (T) 594 653 548 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.131 P=0.437 P=0.108 P=0.202 |P=0.374 P=0.491 P=0.218 P=0.479 |
|POLY 3 | P=0.218 P=0.454 P=0.122 P=0.304 |P=0.389 P=0.501 P=0.284 P=0.492 |
|POLY 1.5 | P=0.239 P=0.464 P=0.123 P=0.322 |P=0.394 P=0.500 P=0.295 P=0.494 |
|POLY 6 | P=0.180 P=0.443 P=0.118 P=0.273 |P=0.386 P=0.504 P=0.266 P=0.491 |
|LOGISTIC REGRESSION| P=0.253 P=0.468 P=0.145 P=0.327 |P=0.411 P=0.502 P=0.268 P=0.514 |
|COCH-ARM / FISHERS | P=0.255 P=0.480 P=0.134 P=0.339 |P=0.404 P=0.500 P=0.309 P=0.500 |
|ORDER RESTRICTED | P=0.177 (e) (e) (e) |P=0.331 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Larynx |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/48 (4%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.48 2/41.37 2/42.73 2/42.06 |0/44.82 0/44.54 1/41.95 2/43.77 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 4.7% 4.8% |0.0% 0.0% 2.4% 4.6% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 1/26 (4%) 0/32 (0%) |
|FIRST INCIDENCE | --- 338 633 609 |--- --- 727 (T) 548 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.231 P=0.216 P=0.237 P=0.240 |P=0.068 (e) P=0.441 P=0.229 |
|POLY 3 | P=0.224 P=0.221 P=0.228 P=0.225 |P=0.067 (e) P=0.487 P=0.232 |
|POLY 1.5 | P=0.237 P=0.224 P=0.230 P=0.231 |P=0.068 (e) P=0.494 P=0.233 |
|POLY 6 | P=0.201 P=0.218 P=0.225 P=0.212 |P=0.067 (e) P=0.475 P=0.231 |
|LOGISTIC REGRESSION| P=0.245 P=0.394 P=0.259 P=0.235 |P=0.074 (e) P=0.441 P=0.257 |
|COCH-ARM / FISHERS | P=0.247 P=0.237 P=0.247 P=0.247 |P=0.070 (e) P=0.500 P=0.247 |
|ORDER RESTRICTED | P=0.177 (e) (e) (e) |P=0.071 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Larynx: Epiglottis |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/48 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.48 1/40.47 0/42.07 0/41.33 |0/44.82 1/44.54 2/42.16 2/43.75 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 0.0% 0.0% |0.0% 2.3% 4.7% 4.6% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 1/34 (3%) 1/26 (4%) 1/32 (3%) |
|FIRST INCIDENCE | --- 677 --- --- |--- 727 (T) 674 548 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.612N P=0.457 (e) (e) |P=0.147 P=0.494 P=0.185 P=0.223 |
|POLY 3 | P=0.577N P=0.481 (e) (e) |P=0.153 P=0.499 P=0.224 P=0.232 |
|POLY 1.5 | P=0.573N P=0.485 (e) (e) |P=0.155 P=0.499 P=0.231 P=0.233 |
|POLY 6 | P=0.583N P=0.478 (e) (e) |P=0.152 P=0.499 P=0.212 P=0.231 |
|LOGISTIC REGRESSION| P=0.565N P=0.496 (e) (e) |P=0.162 P=0.494 P=0.224 P=0.257 |
|COCH-ARM / FISHERS | P=0.565N P=0.490 (e) (e) |P=0.160 P=0.500 P=0.247 P=0.247 |
|ORDER RESTRICTED | P=0.378N (e) (e) (e) |P=0.145 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 5/50 (10%) 13/50 (26%) 4/50 (8%) |36/50 (72%) 24/50 (48%) 26/50 (52%) 20/50 (40%) |
|POLY-3 RATE (b) | 11/44.66 5/41.74 13/42.29 4/41.58 |36/46.85 24/44.73 26/44.53 20/43.64 |
|POLY-3 PERCENT (g) | 24.6% 12.0% 30.7% 9.6% |76.8% 53.7% 58.4% 45.8% |
|TERMINAL (d) | 10/32 (31%) 5/28 (18%) 11/25 (44%) 3/19 (16%) |28/35 (80%) 22/34 (65%) 17/26 (65%) 18/32 (56%) |
|FIRST INCIDENCE | 679 726 (T) 695 659 |370 693 590 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.430N P=0.135N P=0.175 P=0.240N |P=0.018N* P=0.018N* P=0.426N P=0.005N** |
|POLY 3 | P=0.120N P=0.106N P=0.345 P=0.057N |P=0.003N** P=0.012N* P=0.038N* P<0.001N** |
|POLY 1.5 | P=0.107N P=0.098N P=0.360 P=0.050N |P=0.003N** P=0.012N* P=0.033N* P<0.001N** |
|POLY 6 | P=0.157N P=0.118N P=0.318 P=0.076N |P=0.004N** P=0.014N* P=0.054N P<0.001N** |
|LOGISTIC REGRESSION| P=0.304N P=0.136N P=0.236 P=0.143N |P=0.004N** P=0.009N** P=0.059N P<0.001N** |
|COCH-ARM / FISHERS | P=0.105N P=0.086N P=0.408 P=0.045N* |P=0.003N** P=0.012N* P=0.032N* P<0.001N** |
|ORDER RESTRICTED | P=0.050N (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 13/50 (26%) 17/50 (34%) 9/50 (18%) |11/50 (22%) 10/50 (20%) 11/50 (22%) 7/50 (14%) |
|POLY-3 RATE (b) | 14/44.48 13/41.93 17/42.20 9/41.33 |11/44.82 10/44.60 11/43.31 7/43.36 |
|POLY-3 PERCENT (g) | 31.5% 31.0% 40.3% 21.8% |24.5% 22.4% 25.4% 16.1% |
|TERMINAL (d) | 14/32 (44%) 12/28 (43%) 16/25 (64%) 9/19 (47%) |11/35 (31%) 9/34 (27%) 8/26 (31%) 6/32 (19%) |
|FIRST INCIDENCE | 726 (T) 677 695 726 (T) |727 (T) 712 581 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.327 P=0.516 P=0.071 P=0.516 |P=0.277N P=0.528N P=0.324 P=0.275N |
|POLY 3 | P=0.220N P=0.574N P=0.261 P=0.218N |P=0.214N P=0.505N P=0.561 P=0.237N |
|POLY 1.5 | P=0.190N P=0.547N P=0.279 P=0.191N |P=0.206N P=0.504N P=0.580 P=0.231N |
|POLY 6 | P=0.301N P=0.583 P=0.231 P=0.282N |P=0.219N P=0.502N P=0.524 P=0.240N |
|LOGISTIC REGRESSION| P=0.408 P=0.508 P=0.089 P=0.516 |P=0.234N P=0.491N P=0.492 P=0.256N |
|COCH-ARM / FISHERS | P=0.172N P=0.500N P=0.333 P=0.171N |P=0.191N P=0.500N P=0.595N P=0.218N |
|ORDER RESTRICTED | P=0.157N (e) (e) (e) |P=0.271N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.48 0/41.74 1/42.29 3/41.66 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.4% 7.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/28 (0%) 0/25 (0%) 1/19 (5%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) --- 670 653 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047 * P=0.527N P=0.718 P=0.168 |(e) (e) (e) (e) |
|POLY 3 | P=0.092 P=0.513N P=0.749 P=0.282 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.095 P=0.508N P=0.752 P=0.294 |(e) (e) (e) (e) |
|POLY 6 | P=0.085 P=0.518N P=0.745 P=0.258 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.087 (e) P=0.754 P=0.254 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.097 P=0.500N P=0.753N P=0.309 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.070 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 10/50 (20%) 9/50 (18%) |3/50 (6%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/44.48 6/41.74 10/42.62 9/41.41 |3/44.90 0/44.54 1/41.95 2/43.55 |
|POLY-3 PERCENT (g) | 4.5% 14.4% 23.5% 21.7% |6.7% 0.0% 2.4% 4.6% |
|TERMINAL (d) | 2/32 (6%) 6/28 (21%) 6/25 (24%) 8/19 (42%) |2/35 (6%) 0/34 (0%) 1/26 (4%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 660 705 |707 --- 727 (T) 667 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.091 P=0.006 ** P<0.001 ** |P=0.593N P=0.125N P=0.417N P=0.533N |
|POLY 3 | P=0.016 * P=0.112 P=0.010 * P=0.017 * |P=0.564N P=0.120N P=0.330N P=0.514N |
|POLY 1.5 | P=0.021 * P=0.120 P=0.011 * P=0.021 * |P=0.560N P=0.120N P=0.317N P=0.510N |
|POLY 6 | P=0.009 ** P=0.103 P=0.009 ** P=0.011 * |P=0.568N P=0.120N P=0.352N P=0.515N |
|LOGISTIC REGRESSION| P=0.003 ** P=0.091 P=0.009 ** P=0.002 ** |P=0.572N P=0.120N P=0.382N P=0.513N |
|COCH-ARM / FISHERS | P=0.027 * P=0.134 P=0.014 * P=0.026 * |P=0.556N P=0.121N P=0.309N P=0.500N |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) |P=0.200N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 7/50 (14%) 7/50 (14%) |8/50 (16%) 12/50 (24%) 9/50 (18%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/45.00 6/42.16 7/42.29 7/41.79 |8/47.36 12/45.13 9/43.73 5/44.19 |
|POLY-3 PERCENT (g) | 6.7% 14.2% 16.6% 16.8% |16.9% 26.6% 20.6% 11.3% |
|TERMINAL (d) | 1/32 (3%) 4/28 (14%) 5/25 (20%) 4/19 (21%) |4/35 (11%) 9/34 (27%) 3/26 (12%) 3/32 (9%) |
|FIRST INCIDENCE | 624 659 695 659 |370 562 581 364 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.034 * P=0.180 P=0.100 P=0.050 |P=0.207N P=0.225 P=0.355 P=0.326N |
|POLY 3 | P=0.120 P=0.210 P=0.132 P=0.127 |P=0.180N P=0.189 P=0.428 P=0.322N |
|POLY 1.5 | P=0.139 P=0.222 P=0.139 P=0.143 |P=0.164N P=0.201 P=0.459 P=0.306N |
|POLY 6 | P=0.090 P=0.196 P=0.121 P=0.101 |P=0.197N P=0.181 P=0.388 P=0.336N |
|LOGISTIC REGRESSION| P=0.097 P=0.218 P=0.133 P=0.120 |P=0.117N P=0.232 P=0.579 P=0.194N |
|COCH-ARM / FISHERS | P=0.156 P=0.243 P=0.159 P=0.159 |P=0.140N P=0.227 P=0.500 P=0.277N |
|ORDER RESTRICTED | P=0.127 (e) (e) (e) |P=0.156N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.48 0/41.74 2/42.07 1/41.33 |1/44.82 3/44.57 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 4.8% 2.4% |2.2% 6.7% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/28 (0%) 2/25 (8%) 1/19 (5%) |1/35 (3%) 2/34 (6%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) --- 726 (T) 726 (T) |727 (T) 718 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.348 P=0.527N P=0.414 P=0.641 |P=0.178N P=0.304 P=0.559N P=0.518N |
|POLY 3 | P=0.480 P=0.513N P=0.481 P=0.744 |P=0.160N P=0.303 P=0.513N P=0.507N |
|POLY 1.5 | P=0.493 P=0.508N P=0.485 P=0.753 |P=0.156N P=0.304 P=0.506N P=0.505N |
|POLY 6 | P=0.450 P=0.518N P=0.472 P=0.727 |P=0.164N P=0.304 P=0.525N P=0.509N |
|LOGISTIC REGRESSION| P=0.348 (e) P=0.414 P=0.641 |P=0.173N P=0.307 (e) (e) |
|COCH-ARM / FISHERS | P=0.500 P=0.500N P=0.500 P=0.753N |P=0.153N P=0.309 P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.363 (e) (e) (e) |P=0.120N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/44.69 6/43.90 1/42.07 0/41.33 |0/44.82 0/44.54 2/42.94 3/44.64 |
|POLY-3 PERCENT (g) | 2.2% 13.7% 2.4% 0.0% |0.0% 0.0% 4.7% 6.7% |
|TERMINAL (d) | 0/32 (0%) 2/28 (7%) 1/25 (4%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 671 405 726 (T) --- |--- --- 509 454 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.176N P=0.048 * P=0.715 P=0.567N |P=0.026 * (e) P=0.234 P=0.113 |
|POLY 3 | P=0.129N P=0.052 P=0.747 P=0.516N |P=0.027 * (e) P=0.228 P=0.118 |
|POLY 1.5 | P=0.117N P=0.054 P=0.751 P=0.507N |P=0.027 * (e) P=0.233 P=0.118 |
|POLY 6 | P=0.153N P=0.050 P=0.741 P=0.532N |P=0.027 * (e) P=0.218 P=0.119 |
|LOGISTIC REGRESSION| P=0.098N P=0.096 P=0.754 P=0.492N |P=0.044 * (e) P=0.200 P=0.155 |
|COCH-ARM / FISHERS | P=0.111N P=0.056 P=0.753N P=0.500N |P=0.028 * (e) P=0.247 P=0.121 |
|ORDER RESTRICTED | P=0.054N (e) (e) (e) |P=0.036 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |3/50 (6%) 3/50 (6%) 5/50 (10%) 4/50 (8%) |
|POLY-3 RATE (b) | 4/45.00 2/42.57 2/42.59 0/41.33 |3/45.08 3/45.36 5/42.97 4/44.06 |
|POLY-3 PERCENT (g) | 8.9% 4.7% 4.7% 0.0% |6.7% 6.6% 11.6% 9.1% |
|TERMINAL (d) | 2/32 (6%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 2/26 (8%) 2/32 (6%) |
|FIRST INCIDENCE | 588 595 637 --- |685 594 621 454 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.070N P=0.376N P=0.414N P=0.124N |P=0.338 P=0.654N P=0.257 P=0.461 |
|POLY 3 | P=0.049N* P=0.363N P=0.363N P=0.071N |P=0.357 P=0.660N P=0.330 P=0.488 |
|POLY 1.5 | P=0.046N* P=0.354N P=0.357N P=0.066N |P=0.364 P=0.661N P=0.344 P=0.492 |
|POLY 6 | P=0.057N P=0.373N P=0.372N P=0.084N |P=0.348 P=0.656N P=0.307 P=0.484 |
|LOGISTIC REGRESSION| P=0.041N* P=0.303N P=0.333N P=0.063N |P=0.398 P=0.660N P=0.360 P=0.514 |
|COCH-ARM / FISHERS | P=0.044N* P=0.339N P=0.339N P=0.059N |P=0.375 P=0.661N P=0.357 P=0.500 |
|ORDER RESTRICTED | P=0.034N* (e) (e) (e) |P=0.420 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 4/50 (8%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 3/41.85 4/42.49 4/42.03 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 7.2% 9.4% 9.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 1/28 (4%) 1/25 (4%) 1/19 (5%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 705 670 609 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027 * P=0.104 P=0.049 * P=0.032 * |(e) (e) (e) (e) |
|POLY 3 | P=0.065 P=0.108 P=0.054 P=0.053 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.072 P=0.112 P=0.056 P=0.057 |(e) (e) (e) (e) |
|POLY 6 | P=0.052 P=0.103 P=0.052 P=0.046 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.068 P=0.100 P=0.057 P=0.065 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.078 P=0.121 P=0.059 P=0.059 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.049 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.95 1/42.31 1/42.07 4/42.71 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 2.2% 2.4% 2.4% 9.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 1/25 (4%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 588 551 726 (T) 498 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054 P=0.755 P=0.725 P=0.156 |(e) (e) (e) (e) |
|POLY 3 | P=0.062 P=0.747 P=0.746 P=0.163 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.065 P=0.752 P=0.750 P=0.172 |(e) (e) (e) (e) |
|POLY 6 | P=0.056 P=0.741 P=0.739 P=0.146 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.065 P=0.673N P=0.753N P=0.170 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.067 P=0.753N P=0.753N P=0.181 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.064 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 4/50 (8%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.48 2/41.74 1/42.07 4/42.18 |1/44.90 1/44.54 2/42.05 2/43.31 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 2.4% 9.5% |2.2% 2.3% 4.8% 4.6% |
|TERMINAL (d) | 0/32 (0%) 2/28 (7%) 1/25 (4%) 1/19 (5%) |0/35 (0%) 1/34 (3%) 1/26 (4%) 1/32 (3%) |
|FIRST INCIDENCE | --- 726 (T) 726 (T) 621 |707 727 (T) 702 695 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.016 * P=0.209 P=0.451 P=0.038 * |P=0.295 P=0.760 P=0.402 P=0.462 |
|POLY 3 | P=0.034 * P=0.223 P=0.489 P=0.053 |P=0.323 P=0.759 P=0.477 P=0.487 |
|POLY 1.5 | P=0.037 * P=0.228 P=0.492 P=0.057 |P=0.328 P=0.759 P=0.489 P=0.492 |
|POLY 6 | P=0.030 * P=0.217 P=0.484 P=0.047 * |P=0.318 P=0.759 P=0.458 P=0.485 |
|LOGISTIC REGRESSION| P=0.036 * P=0.209 P=0.451 P=0.068 |P=0.318 P=0.762 P=0.457 P=0.487 |
|COCH-ARM / FISHERS | P=0.040 * P=0.247 P=0.500 P=0.059 |P=0.337 P=0.753N P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.016 * (e) (e) (e) |P=0.417 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/49 (10%) 5/50 (10%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.10 5/43.38 5/43.71 0/41.33 |0/44.82 0/44.54 0/41.95 1/43.51 |
|POLY-3 PERCENT (g) | 4.4% 11.5% 11.4% 0.0% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 2/25 (8%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 588 405 205 --- |--- --- --- 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.232N P=0.191 P=0.178 P=0.277N |P=0.202 (e) (e) P=0.500 |
|POLY 3 | P=0.195N P=0.200 P=0.203 P=0.257N |P=0.195 (e) (e) P=0.494 |
|POLY 1.5 | P=0.173N P=0.203 P=0.207 P=0.247N |P=0.196 (e) (e) P=0.496 |
|POLY 6 | P=0.243N P=0.195 P=0.194 P=0.278N |P=0.195 (e) (e) P=0.493 |
|LOGISTIC REGRESSION| P=0.131N P=0.343 P=0.308 P=0.227N |P=0.211 (e) (e) P=0.520 |
|COCH-ARM / FISHERS | P=0.155N P=0.210 P=0.218 P=0.247N |P=0.198 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.070N (e) (e) (e) |P=0.115 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 2/42.11 1/42.17 0/41.33 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 2.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 420 702 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.517N P=0.212 P=0.470 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.488N P=0.225 P=0.489 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.474N P=0.228 P=0.492 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.514N P=0.222 P=0.485 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.446N P=0.343 P=0.490 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.459N P=0.242 P=0.500 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.316 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/49 (0%) 2/50 (4%) 0/50 (0%) |2/50 (4%) 10/50 (20%) 7/50 (14%) 4/50 (8%) |
|POLY-3 RATE (b) | 4/44.48 0/41.12 2/42.07 0/41.33 |2/45.31 10/44.73 7/42.94 4/43.32 |
|POLY-3 PERCENT (g) | 9.0% 0.0% 4.8% 0.0% |4.4% 22.4% 16.3% 9.2% |
|TERMINAL (d) | 4/32 (13%) 0/28 (0%) 2/25 (8%) 0/19 (0%) |0/35 (0%) 8/34 (24%) 4/26 (15%) 3/32 (9%) |
|FIRST INCIDENCE | 726 (T) --- 726 (T) --- |606 693 509 691 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123N P=0.080N P=0.455N P=0.145N |P=0.493 P=0.017 * P=0.049 * P=0.305 |
|POLY 3 | P=0.061N P=0.070N P=0.363N P=0.070N |P=0.526 P=0.012 * P=0.066 P=0.316 |
|POLY 1.5 | P=0.059N P=0.068N P=0.357N P=0.065N |P=0.544 P=0.013 * P=0.073 P=0.324 |
|POLY 6 | P=0.066N P=0.074N P=0.374N P=0.081N |P=0.509 P=0.012 * P=0.055 P=0.310 |
|LOGISTIC REGRESSION| P=0.123N (e) P=0.455N (e) |P=0.547 P=0.015 * P=0.086 P=0.328 |
|COCH-ARM / FISHERS | P=0.061N P=0.061N P=0.339N P=0.059N |P=0.545N P=0.014 * P=0.080 P=0.339 |
|ORDER RESTRICTED | P=0.014N* (e) (e) (e) |P=0.074 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 7/49 (14%) 4/50 (8%) 4/50 (8%) |3/50 (6%) 5/50 (10%) 2/50 (4%) 6/50 (12%) |
|POLY-3 RATE (b) | 4/44.48 7/41.79 4/42.09 4/41.83 |3/45.45 5/44.54 2/42.26 6/43.64 |
|POLY-3 PERCENT (g) | 9.0% 16.8% 9.5% 9.6% |6.6% 11.2% 4.7% 13.8% |
|TERMINAL (d) | 4/32 (13%) 4/28 (14%) 3/25 (12%) 2/19 (11%) |2/35 (6%) 5/34 (15%) 1/26 (4%) 3/32 (9%) |
|FIRST INCIDENCE | 726 (T) 609 721 622 |523 727 (T) 642 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.426 P=0.198 P=0.503 P=0.394 |P=0.200 P=0.343 P=0.593N P=0.213 |
|POLY 3 | P=0.457N P=0.224 P=0.613 P=0.610 |P=0.218 P=0.345 P=0.533N P=0.222 |
|POLY 1.5 | P=0.435N P=0.233 P=0.620 P=0.627 |P=0.226 P=0.349 P=0.517N P=0.228 |
|POLY 6 | P=0.503N P=0.217 P=0.600 P=0.573 |P=0.211 P=0.342 P=0.559N P=0.218 |
|LOGISTIC REGRESSION| P=0.516N P=0.208 P=0.514 P=0.541 |P=0.225 P=0.354 P=0.484N P=0.238 |
|COCH-ARM / FISHERS | P=0.415N P=0.251 P=0.643N P=0.643N |P=0.240 P=0.357 P=0.500N P=0.243 |
|ORDER RESTRICTED | P=0.499N (e) (e) (e) |P=0.185 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Emphysema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.95 0/41.12 0/42.07 0/41.33 |1/45.24 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 588 --- --- --- |606 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.137N P=0.257N P=0.275N P=0.293N |P=0.311N P=0.514N P=0.509N P=0.509N |
|POLY 3 | P=0.108N P=0.257N P=0.252N P=0.256N |P=0.305N P=0.503N P=0.515N P=0.509N |
|POLY 1.5 | P=0.110N P=0.252N P=0.248N P=0.246N |P=0.304N P=0.502N P=0.507N P=0.506N |
|POLY 6 | P=0.105N P=0.264N P=0.259N P=0.276N |P=0.307N P=0.504N P=0.528N P=0.512N |
|LOGISTIC REGRESSION| P=0.110N P=0.220N P=0.220N P=0.225N |P=0.285N P=0.491N P=0.506N P=0.468N |
|COCH-ARM / FISHERS | P=0.115N P=0.253N P=0.247N P=0.247N |P=0.306N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.036N* (e) (e) (e) |P=0.129N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 5/49 (10%) 6/50 (12%) 6/50 (12%) |13/50 (26%) 2/50 (4%) 5/50 (10%) 11/50 (22%) |
|POLY-3 RATE (b) | 10/44.82 5/41.84 6/42.20 6/42.40 |13/45.22 2/44.54 5/42.28 11/43.82 |
|POLY-3 PERCENT (g) | 22.3% 12.0% 14.2% 14.2% |28.8% 4.5% 11.8% 25.1% |
|TERMINAL (d) | 8/32 (25%) 3/28 (11%) 5/25 (20%) 2/19 (11%) |10/35 (29%) 2/34 (6%) 4/26 (15%) 8/32 (25%) |
|FIRST INCIDENCE | 679 595 695 622 |650 727 (T) 636 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.533N P=0.204N P=0.367N P=0.531N |P=0.371 P=0.003N** P=0.118N P=0.495N |
|POLY 3 | P=0.247N P=0.160N P=0.242N P=0.239N |P=0.438 P=0.002N** P=0.042N* P=0.441N |
|POLY 1.5 | P=0.235N P=0.153N P=0.234N P=0.221N |P=0.446 P=0.002N** P=0.037N* P=0.431N |
|POLY 6 | P=0.278N P=0.168N P=0.260N P=0.279N |P=0.430 P=0.002N** P=0.055N P=0.445N |
|LOGISTIC REGRESSION| P=0.288N P=0.171N P=0.286N P=0.276N |P=0.406 P=0.002N** P=0.065N P=0.455N |
|COCH-ARM / FISHERS | P=0.227N P=0.140N P=0.207N P=0.207N |P=0.461 P=0.002N** P=0.033N* P=0.408N |
|ORDER RESTRICTED | P=0.195N (e) (e) (e) |P=0.038N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Bronchiole |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/44.48 0/41.12 0/42.07 1/41.33 |1/44.82 2/44.67 2/41.95 3/43.32 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.4% |2.2% 4.5% 4.8% 6.9% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 1/19 (5%) |1/35 (3%) 1/34 (3%) 2/26 (8%) 2/32 (6%) |
|FIRST INCIDENCE | --- --- --- 726 (T) |727 (T) 693 727 (T) 692 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.139 (e) (e) P=0.396 |P=0.199 P=0.496 P=0.396 P=0.276 |
|POLY 3 | P=0.193 (e) (e) P=0.485 |P=0.218 P=0.499 P=0.477 P=0.293 |
|POLY 1.5 | P=0.197 (e) (e) P=0.493 |P=0.224 P=0.499 P=0.489 P=0.297 |
|POLY 6 | P=0.184 (e) (e) P=0.470 |P=0.214 P=0.500 P=0.457 P=0.290 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.396 |P=0.211 P=0.498 P=0.396 P=0.287 |
|COCH-ARM / FISHERS | P=0.200 (e) (e) P=0.500 |P=0.232 P=0.500 P=0.500 P=0.309 |
|ORDER RESTRICTED | P=0.108 (e) (e) (e) |P=0.232 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 3/50 (6%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/44.48 0/41.12 3/42.66 1/41.70 |2/45.17 2/44.54 2/42.27 1/43.32 |
|POLY-3 PERCENT (g) | 4.5% 0.0% 7.0% 2.4% |4.4% 4.5% 4.7% 2.3% |
|TERMINAL (d) | 2/32 (6%) 0/28 (0%) 2/25 (8%) 0/19 (0%) |0/35 (0%) 2/34 (6%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) --- 539 622 |643 727 (T) 642 692 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.552 P=0.268N P=0.413 P=0.622N |P=0.409N P=0.687 P=0.621 P=0.518N |
|POLY 3 | P=0.567N P=0.255N P=0.481 P=0.523N |P=0.391N P=0.689 P=0.670 P=0.515N |
|POLY 1.5 | P=0.557N P=0.250N P=0.484 P=0.511N |P=0.384N P=0.691 P=0.682 P=0.510N |
|POLY 6 | P=0.589N P=0.260N P=0.473 P=0.546N |P=0.398N P=0.687 P=0.649 P=0.519N |
|LOGISTIC REGRESSION| P=0.553N (e) P=0.491 P=0.511N |P=0.380N P=0.694 P=0.691N P=0.498N |
|COCH-ARM / FISHERS | P=0.553N P=0.253N P=0.500 P=0.500N |P=0.373N P=0.691N P=0.691N P=0.500N |
|ORDER RESTRICTED | P=0.429 (e) (e) (e) |P=0.467N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/11 (27%) 2/13 (15%) 1/12 (8%) 0/7 (0%) |2/9 (22%) 0/12 (0%) 0/8 (0%) 0/7 (0%) |
|POLY-3 RATE (b) | 3/10.54 2/11.27 1/11.08 0/5.29 |2/8.08 0/10.62 0/6.90 0/5.64 |
|POLY-3 PERCENT (g) | 28.5% 17.8% 9.0% 0.0% |24.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/7 (29%) 1/6 (17%) 0/5 (0%) 0/2 (0%) |1/4 (25%) 0/8 (0%) 0/4 (0%) 0/4 (0%) |
|FIRST INCIDENCE | 588 621 702 --- |716 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.128N P=0.550N P=0.382N P=0.270N |P=0.128N P=0.166N P=0.267N P=0.246N |
|POLY 3 | P=0.099N P=0.467N P=0.273N P=0.255N |P=0.117N P=0.161N P=0.260N P=0.311N |
|POLY 1.5 | P=0.094N P=0.450N P=0.267N P=0.224N |P=0.118N P=0.164N P=0.257N P=0.302N |
|POLY 6 | P=0.107N P=0.483N P=0.284N P=0.309N |P=0.119N P=0.152N P=0.260N P=0.312N |
|LOGISTIC REGRESSION| P=0.081N P=0.390N P=0.272N P=0.157N |P=0.135N P=0.139N P=0.251N P=0.281N |
|COCH-ARM / FISHERS | P=0.087N P=0.415N P=0.261N P=0.202N |P=0.133N P=0.171N P=0.265N P=0.300N |
|ORDER RESTRICTED | P=0.182N (e) (e) (e) |P=0.061N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/11 (0%) 0/13 (0%) 0/12 (0%) 0/7 (0%) |0/9 (0%) 2/12 (17%) 0/8 (0%) 0/7 (0%) |
|POLY-3 RATE (b) | 0/10.07 0/10.89 0/10.98 0/5.29 |0/8.03 2/11.07 0/6.90 0/5.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 18.1% 0.0% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/6 (0%) 0/5 (0%) 0/2 (0%) |0/4 (0%) 1/8 (13%) 0/4 (0%) 0/4 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 594 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.436N P=0.314 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.492N P=0.305 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.488N P=0.297 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.490N P=0.323 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.458N P=0.311 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.477N P=0.314 (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.377N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/11 (9%) 1/13 (8%) 0/12 (0%) 0/7 (0%) |1/9 (11%) 2/12 (17%) 0/8 (0%) 0/7 (0%) |
|POLY-3 RATE (b) | 1/10.07 1/10.89 0/10.98 0/5.29 |1/8.03 2/11.07 0/6.90 0/5.64 |
|POLY-3 PERCENT (g) | 9.9% 9.2% 0.0% 0.0% |12.5% 18.1% 0.0% 0.0% |
|TERMINAL (d) | 1/7 (14%) 1/6 (17%) 0/5 (0%) 0/2 (0%) |1/4 (25%) 1/8 (13%) 0/4 (0%) 0/4 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- --- |727 (T) 594 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.405N P=0.735 P=0.567N P=0.748N |P=0.211N P=0.660 P=0.500N P=0.500N |
|POLY 3 | P=0.277N P=0.745N P=0.483N P=0.624N |P=0.250N P=0.614 P=0.530N P=0.570N |
|POLY 1.5 | P=0.285N P=0.737N P=0.482N P=0.608N |P=0.246N P=0.604 P=0.528N P=0.563N |
|POLY 6 | P=0.263N P=0.753N P=0.485N P=0.649N |P=0.252N P=0.638 P=0.531N P=0.570N |
|LOGISTIC REGRESSION| P=0.405N P=0.735 (e) (e) |P=0.232N P=0.612 (e) (e) |
|COCH-ARM / FISHERS | P=0.287N P=0.717N P=0.478N P=0.611N |P=0.234N P=0.612 P=0.529N P=0.563N |
|ORDER RESTRICTED | P=0.402N (e) (e) (e) |P=0.305N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/7 (29%) 0/7 (0%) 0/12 (0%) 0/15 (0%) |0/1 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) |
|POLY-3 RATE (b) | 2/6.13 0/6.44 0/9.79 0/11.89 |0/0.69 0/1.92 0/1.38 0/2.17 |
|POLY-3 PERCENT (g) | 32.6% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/3 (33%) 0/3 (0%) 0/2 (0%) 0/4 (0%) |0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 671 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123N P=0.263N P=0.302N P=0.242N |(e) (e) (e) (e) |
|POLY 3 | P=0.035N* P=0.202N P=0.111N P=0.077N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.035N* P=0.210N P=0.109N P=0.073N |(e) (e) (e) (e) |
|POLY 6 | P=0.035N* P=0.191N P=0.116N P=0.085N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.057N P=0.200N P=0.125N P=0.104N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.049N* P=0.231N P=0.123N P=0.091N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.004N** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 0/49 (0%) 1/50 (2%) 3/50 (6%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/44.25 0/41.12 1/42.07 3/42.01 |1/44.82 1/44.60 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 11.3% 0.0% 2.4% 7.1% |2.2% 2.2% 0.0% 2.3% |
|TERMINAL (d) | 4/32 (13%) 0/28 (0%) 1/25 (4%) 1/19 (5%) |1/35 (3%) 0/34 (0%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 505 --- 726 (T) 609 |727 (T) 712 --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.589N P=0.045N* P=0.156N P=0.555N |P=0.642N P=0.760 P=0.559N P=0.742 |
|POLY 3 | P=0.417N P=0.037N* P=0.113N P=0.385N |P=0.623N P=0.760 P=0.513N P=0.752 |
|POLY 1.5 | P=0.417N P=0.034N* P=0.109N P=0.365N |P=0.619N P=0.760 P=0.506N P=0.755 |
|POLY 6 | P=0.423N P=0.040N* P=0.120N P=0.424N |P=0.629N P=0.760 P=0.525N P=0.750 |
|LOGISTIC REGRESSION| P=0.423N P=0.032N* P=0.102N P=0.327N |P=0.635N P=0.762 (e) P=0.742 |
|COCH-ARM / FISHERS | P=0.421N P=0.028N* P=0.098N P=0.346N |P=0.616N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.064N (e) (e) (e) |P=0.551N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/10 (100%) 12/12 (100%) 9/9 (100%) 7/7 (100%) |18/18 (100%) 15/17 (88%) 15/15 (100%) 14/15 (93%) |
|POLY-3 RATE (b) | 10/10.00 12/12.00 9/9.00 7/7.00 |18/18.00 15/16.12 15/15.00 14/14.24 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |100.0% 93.1% 100.0% 98.3% |
|TERMINAL (d) | 7/7 (100%) 6/6 (100%) 6/6 (100%) 2/2 (100%) |13/13 (100%) 12/13 (92%) 10/10 (100%) 12/12 (100%) |
|FIRST INCIDENCE | 492 595 667 498 |616 594 513 364 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.314N P=0.257N (e) P=0.257N |
|POLY 3 | (e) (e) (e) (e) |P=0.718 P=0.429N (e) P=0.998N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.647N P=0.348N (e) P=0.819N |
|POLY 6 | (e) (e) (e) (e) |P=0.635 P=0.471N (e) P=1.000N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.556 P=0.455N (e) P=0.948N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.490N P=0.229N (e) P=0.455N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.409N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/49 (6%) 4/50 (8%) 7/50 (14%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/45.15 3/41.12 4/42.66 7/42.00 |0/44.82 2/44.99 2/42.23 1/43.18 |
|POLY-3 PERCENT (g) | 2.2% 7.3% 9.4% 16.7% |0.0% 4.5% 4.7% 2.3% |
|TERMINAL (d) | 0/32 (0%) 3/28 (11%) 3/25 (12%) 5/19 (26%) |0/35 (0%) 1/34 (3%) 1/26 (4%) 1/32 (3%) |
|FIRST INCIDENCE | 505 726 (T) 540 622 |--- 594 653 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.268 P=0.141 P=0.009 ** |P=0.443 P=0.234 P=0.191 P=0.482 |
|POLY 3 | P=0.012 * P=0.272 P=0.161 P=0.022 * |P=0.448 P=0.238 P=0.224 P=0.493 |
|POLY 1.5 | P=0.014 * P=0.282 P=0.166 P=0.026 * |P=0.456 P=0.237 P=0.231 P=0.495 |
|POLY 6 | P=0.009 ** P=0.262 P=0.154 P=0.017 * |P=0.443 P=0.240 P=0.213 P=0.491 |
|LOGISTIC REGRESSION| P=0.016 * P=0.309 P=0.203 P=0.036 * |P=0.470 P=0.240 P=0.234 P=0.482 |
|COCH-ARM / FISHERS | P=0.017 * P=0.301 P=0.181 P=0.030 * |P=0.469 P=0.247 P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.010 * (e) (e) (e) |P=0.221 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/49 (16%) 4/50 (8%) 10/50 (20%) |0/50 (0%) 1/50 (2%) 6/50 (12%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/45.16 8/41.75 4/42.15 10/42.95 |0/44.82 1/44.54 6/42.56 0/43.18 |
|POLY-3 PERCENT (g) | 8.9% 19.2% 9.5% 23.3% |0.0% 2.3% 14.1% 0.0% |
|TERMINAL (d) | 2/32 (6%) 6/28 (21%) 3/25 (12%) 5/19 (26%) |0/35 (0%) 1/34 (3%) 4/26 (15%) 0/32 (0%) |
|FIRST INCIDENCE | 505 621 707 604 |--- 727 (T) 636 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.018 * P=0.129 P=0.524 P=0.021 * |P=0.491 P=0.494 P=0.008 ** (e) |
|POLY 3 | P=0.072 P=0.139 P=0.605 P=0.057 |P=0.497 P=0.499 P=0.012 * (e) |
|POLY 1.5 | P=0.081 P=0.149 P=0.615 P=0.065 |P=0.506 P=0.499 P=0.014 * (e) |
|POLY 6 | P=0.057 P=0.130 P=0.589 P=0.044 * |P=0.493 P=0.499 P=0.010 * (e) |
|LOGISTIC REGRESSION| P=0.079 P=0.154 P=0.624 P=0.081 |P=0.511 P=0.494 P=0.014 * (e) |
|COCH-ARM / FISHERS | P=0.091 P=0.168 P=0.643N P=0.074 |P=0.526 P=0.500 P=0.013 * (e) |
|ORDER RESTRICTED | P=0.036 * (e) (e) (e) |P=0.061 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Goblet Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 0/50 (0%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.48 1/41.12 0/42.07 5/41.83 |0/44.82 0/44.54 2/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 2.3% 2.4% 0.0% 12.0% |0.0% 0.0% 4.8% 2.3% |
|TERMINAL (d) | 1/32 (3%) 1/28 (4%) 0/25 (0%) 3/19 (16%) |0/35 (0%) 0/34 (0%) 2/26 (8%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- 645 |--- --- 727 (T) 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.732 P=0.549N P=0.035 * |P=0.227 (e) P=0.175 P=0.482 |
|POLY 3 | P=0.019 * P=0.743 P=0.511N P=0.087 |P=0.234 (e) P=0.223 P=0.493 |
|POLY 1.5 | P=0.020 * P=0.748 P=0.508N P=0.095 |P=0.237 (e) P=0.230 P=0.495 |
|POLY 6 | P=0.017 * P=0.738 P=0.516N P=0.074 |P=0.232 (e) P=0.210 P=0.491 |
|LOGISTIC REGRESSION| P=0.015 * P=0.732 (e) P=0.072 |(e) (e) P=0.175 P=0.482 |
|COCH-ARM / FISHERS | P=0.022 * P=0.747 P=0.500N P=0.102 |P=0.246 (e) P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.009 ** (e) (e) (e) |P=0.155 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 1/50 (2%) 1/50 (2%) |5/50 (10%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 1/41.12 1/42.41 1/42.00 |5/44.82 2/44.54 2/42.27 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 2.4% 2.4% |11.2% 4.5% 4.7% 0.0% |
|TERMINAL (d) | 0/32 (0%) 1/28 (4%) 0/25 (0%) 0/19 (0%) |5/35 (14%) 2/34 (6%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 726 (T) 633 498 |727 (T) 727 (T) 642 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.348 P=0.473 P=0.500 P=0.508 |P=0.032N* P=0.226N P=0.335N P=0.041N* |
|POLY 3 | P=0.366 P=0.484 P=0.490 P=0.489 |P=0.023N* P=0.218N P=0.240N P=0.034N* |
|POLY 1.5 | P=0.378 P=0.488 P=0.492 P=0.495 |P=0.022N* P=0.218N P=0.228N P=0.033N* |
|POLY 6 | P=0.341 P=0.479 P=0.487 P=0.475 |P=0.024N* P=0.217N P=0.261N P=0.034N* |
|LOGISTIC REGRESSION| P=0.391 P=0.473 P=0.527 P=0.249 |P=0.027N* P=0.226N P=0.274N (e) |
|COCH-ARM / FISHERS | P=0.386 P=0.495 P=0.500 P=0.500 |P=0.022N* P=0.218N P=0.218N P=0.028N* |
|ORDER RESTRICTED | P=0.315 (e) (e) (e) |P=0.011N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.48 0/41.12 0/42.07 0/41.33 |1/45.13 0/44.54 1/42.16 2/43.79 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 2.4% 4.6% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- --- |643 --- 674 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.248 P=0.505N P=0.716 P=0.500 |
|POLY 3 | (e) (e) (e) (e) |P=0.241 P=0.503N P=0.745 P=0.490 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.244 P=0.502N P=0.753 P=0.493 |
|POLY 6 | (e) (e) (e) (e) |P=0.240 P=0.503N P=0.732 P=0.488 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.266 P=0.495N P=0.754N P=0.530 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.247 P=0.500N P=0.753N P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.215 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |9/50 (18%) 3/50 (6%) 8/50 (16%) 9/50 (18%) |
|POLY-3 RATE (b) | 0/44.48 0/41.12 0/42.07 0/41.33 |9/45.21 3/44.71 8/43.04 9/44.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |19.9% 6.7% 18.6% 20.4% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |8/35 (23%) 0/34 (0%) 4/26 (15%) 6/32 (19%) |
|FIRST INCIDENCE | --- --- --- --- |616 707 546 489 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.265 P=0.071N P=0.491 P=0.531 |
|POLY 3 | (e) (e) (e) (e) |P=0.310 P=0.061N P=0.545N P=0.583 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.317 P=0.061N P=0.521N P=0.588 |
|POLY 6 | (e) (e) (e) (e) |P=0.304 P=0.060N P=0.585N P=0.581 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.307 P=0.062N P=0.553N P=0.579 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.330 P=0.061N P=0.500N P=0.602N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.289 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/49 (2%) 3/50 (6%) 3/50 (6%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/45.15 1/41.12 3/42.66 3/42.05 |0/44.82 2/44.99 2/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 8.9% 2.4% 7.0% 7.1% |0.0% 4.5% 4.8% 0.0% |
|TERMINAL (d) | 3/32 (9%) 1/28 (4%) 2/25 (8%) 1/19 (5%) |0/35 (0%) 1/34 (3%) 2/26 (8%) 0/32 (0%) |
|FIRST INCIDENCE | 505 726 (T) 540 604 |--- 594 727 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.447 P=0.217N P=0.595N P=0.645 |P=0.529N P=0.234 P=0.175 (e) |
|POLY 3 | P=0.573N P=0.208N P=0.531N P=0.539N |P=0.518N P=0.238 P=0.223 (e) |
|POLY 1.5 | P=0.564N P=0.200N P=0.524N P=0.519N |P=0.512N P=0.237 P=0.230 (e) |
|POLY 6 | P=0.561 P=0.218N P=0.543N P=0.575N |P=0.524N P=0.240 P=0.210 (e) |
|LOGISTIC REGRESSION| P=0.554N P=0.182N P=0.482N P=0.471N |P=0.505N P=0.240 P=0.175 (e) |
|COCH-ARM / FISHERS | P=0.559N P=0.187N P=0.500N P=0.500N |P=0.500N P=0.247 P=0.247 (e) |
|ORDER RESTRICTED | P=0.418N (e) (e) (e) |P=0.264 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |7/50 (14%) 10/50 (20%) 7/50 (14%) 4/50 (8%) |
|POLY-3 RATE (b) | |7/45.24 10/45.11 7/44.45 4/43.19 |
|POLY-3 PERCENT (g) | |15.5% 22.2% 15.8% 9.3% |
|TERMINAL (d) | |6/35 (17%) 8/34 (24%) 1/26 (4%) 3/32 (9%) |
|FIRST INCIDENCE | |606 562 546 726 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.192N P=0.279 P=0.478 P=0.312N |
|POLY 3 | |P=0.158N P=0.293 P=0.600 P=0.288N |
|POLY 1.5 | |P=0.149N P=0.294 P=0.608 P=0.278N |
|POLY 6 | |P=0.167N P=0.294 P=0.583 P=0.296N |
|LOGISTIC REGRESSION| |P=0.139N P=0.292 P=0.581N P=0.286N |
|COCH-ARM / FISHERS | |P=0.135N P=0.298 P=0.613N P=0.262N |
|ORDER RESTRICTED | |P=0.168N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 7/48 (15%) 5/50 (10%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/44.48 7/40.75 5/42.07 2/41.38 |1/45.58 1/44.54 1/42.23 0/43.18 |
|POLY-3 PERCENT (g) | 9.0% 17.2% 11.9% 4.8% |2.2% 2.3% 2.4% 0.0% |
|TERMINAL (d) | 4/32 (13%) 5/28 (18%) 5/25 (20%) 1/19 (5%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 618 726 (T) 712 |454 727 (T) 653 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.428N P=0.196 P=0.344 P=0.588N |P=0.327N P=0.757 P=0.745 P=0.504N |
|POLY 3 | P=0.209N P=0.211 P=0.465 P=0.371N |P=0.325N P=0.756 P=0.744 P=0.511N |
|POLY 1.5 | P=0.190N P=0.220 P=0.473 P=0.353N |P=0.321N P=0.757 P=0.752 P=0.507N |
|POLY 6 | P=0.251N P=0.203 P=0.450 P=0.406N |P=0.331N P=0.755 P=0.730 P=0.514N |
|LOGISTIC REGRESSION| P=0.311N P=0.190 P=0.344 P=0.556N |P=0.274N P=0.756N P=0.738 P=0.402N |
|COCH-ARM / FISHERS | P=0.174N P=0.239 P=0.500 P=0.339N |P=0.311N P=0.753N P=0.753N P=0.500N |
|ORDER RESTRICTED | P=0.170N (e) (e) (e) |P=0.326N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 0/50 (0%) 1/50 (2%) |3/49 (6%) 6/50 (12%) 4/50 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/44.48 1/41.12 0/42.07 1/41.70 |3/44.58 6/44.79 4/42.28 3/43.31 |
|POLY-3 PERCENT (g) | 2.3% 2.4% 0.0% 2.4% |6.7% 13.4% 9.5% 6.9% |
|TERMINAL (d) | 1/32 (3%) 1/28 (4%) 0/25 (0%) 0/19 (0%) |2/34 (6%) 4/34 (12%) 3/26 (12%) 2/32 (6%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- 621 |454 665 637 695 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.615 P=0.732 P=0.549N P=0.704 |P=0.480N P=0.248 P=0.392 P=0.633 |
|POLY 3 | P=0.620N P=0.743 P=0.511N P=0.746 |P=0.457N P=0.244 P=0.471 P=0.649 |
|POLY 1.5 | P=0.617N P=0.748 P=0.508N P=0.754 |P=0.444N P=0.246 P=0.490 P=0.656 |
|POLY 6 | P=0.625N P=0.738 P=0.516N P=0.731 |P=0.469N P=0.244 P=0.441 P=0.645 |
|LOGISTIC REGRESSION| P=0.622N P=0.732 (e) P=0.755N |P=0.435N P=0.253 P=0.524 P=0.646N |
|COCH-ARM / FISHERS | P=0.614N P=0.747 P=0.500N P=0.753N |P=0.420N P=0.254 P=0.511 P=0.651N |
|ORDER RESTRICTED | P=0.539N (e) (e) (e) |P=0.472 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/49 (2%) 0/50 (0%) 1/50 (2%) |0/49 (0%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 4/45.19 1/41.28 0/42.07 1/41.33 |0/43.82 2/45.08 2/42.16 3/43.74 |
|POLY-3 PERCENT (g) | 8.9% 2.4% 0.0% 2.4% |0.0% 4.4% 4.7% 6.9% |
|TERMINAL (d) | 1/32 (3%) 0/28 (0%) 0/25 (0%) 1/19 (5%) |0/34 (0%) 0/34 (0%) 1/26 (4%) 1/32 (3%) |
|FIRST INCIDENCE | 554 685 --- 726 (T) |--- 569 674 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.169N P=0.226N P=0.090N P=0.316N |P=0.105 P=0.235 P=0.188 P=0.121 |
|POLY 3 | P=0.102N P=0.207N P=0.070N P=0.206N |P=0.104 P=0.243 P=0.228 P=0.118 |
|POLY 1.5 | P=0.101N P=0.199N P=0.067N P=0.192N |P=0.107 P=0.243 P=0.235 P=0.119 |
|POLY 6 | P=0.104N P=0.217N P=0.074N P=0.236N |P=0.104 P=0.245 P=0.217 P=0.118 |
|LOGISTIC REGRESSION| P=0.105N P=0.177N P=0.059N P=0.177N |P=0.115 P=0.245 P=0.228 P=0.126 |
|COCH-ARM / FISHERS | P=0.103N P=0.187N P=0.059N P=0.181N |P=0.111 P=0.253 P=0.253 P=0.125 |
|ORDER RESTRICTED | P=0.035N* (e) (e) (e) |P=0.076 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 8/49 (16%) 9/50 (18%) 9/50 (18%) |11/49 (22%) 11/50 (22%) 8/50 (16%) 10/50 (20%) |
|POLY-3 RATE (b) | 8/45.22 8/44.23 9/43.56 9/42.52 |11/45.73 11/45.44 8/42.26 10/44.42 |
|POLY-3 PERCENT (g) | 17.7% 18.1% 20.7% 21.2% |24.1% 24.2% 18.9% 22.5% |
|TERMINAL (d) | 7/32 (22%) 3/28 (11%) 5/25 (20%) 4/19 (21%) |8/34 (24%) 9/34 (27%) 7/26 (27%) 6/32 (19%) |
|FIRST INCIDENCE | 468 338 539 623 |370 356 642 398 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.180 P=0.527 P=0.335 P=0.188 |P=0.492N P=0.593N P=0.515N P=0.552N |
|POLY 3 | P=0.366 P=0.589 P=0.466 P=0.444 |P=0.441N P=0.590 P=0.373N P=0.530N |
|POLY 1.5 | P=0.397 P=0.589 P=0.470 P=0.472 |P=0.423N P=0.592N P=0.334N P=0.514N |
|POLY 6 | P=0.313 P=0.591 P=0.459 P=0.393 |P=0.457N P=0.583 P=0.432N P=0.539N |
|LOGISTIC REGRESSION| P=0.447 P=0.514N P=0.491 P=0.469 |P=0.390N P=0.570N P=0.285N P=0.453N |
|COCH-ARM / FISHERS | P=0.431 P=0.590 P=0.500 P=0.500 |P=0.389N P=0.574N P=0.288N P=0.479N |
|ORDER RESTRICTED | P=0.534 (e) (e) (e) |P=0.549N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Pleura |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |12/50 (24%) 7/50 (14%) 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/44.95 0/41.12 0/42.07 0/41.33 |12/45.75 7/44.56 4/42.01 5/43.94 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 0.0% 0.0% |26.2% 15.7% 9.5% 11.4% |
|TERMINAL (d) | 2/32 (6%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |8/35 (23%) 6/34 (18%) 2/26 (8%) 4/32 (13%) |
|FIRST INCIDENCE | 588 --- --- --- |606 722 714 454 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066N P=0.140N P=0.158N P=0.186N |P=0.065N P=0.176N P=0.093N P=0.084N |
|POLY 3 | P=0.042N* P=0.135N P=0.131N P=0.134N |P=0.040N* P=0.166N P=0.038N* P=0.062N |
|POLY 1.5 | P=0.043N* P=0.130N P=0.128N P=0.126N |P=0.038N* P=0.161N P=0.031N* P=0.058N |
|POLY 6 | P=0.041N* P=0.141N P=0.136N P=0.151N |P=0.043N* P=0.172N P=0.052N P=0.066N |
|LOGISTIC REGRESSION| P=0.047N* P=0.120N P=0.119N P=0.116N |P=0.044N* P=0.155N P=0.043N* P=0.058N |
|COCH-ARM / FISHERS | P=0.047N* P=0.125N P=0.121N P=0.121N |P=0.037N* P=0.154N P=0.027N* P=0.054N |
|ORDER RESTRICTED | P=0.011N* (e) (e) (e) |P=0.025N* (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Pleura |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 0/49 (0%) 6/50 (12%) 4/50 (8%) |7/50 (14%) 7/50 (14%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/44.95 0/41.12 6/43.07 4/41.98 |7/45.68 7/45.14 1/41.95 1/43.31 |
|POLY-3 PERCENT (g) | 13.4% 0.0% 13.9% 9.5% |15.3% 15.5% 2.4% 2.3% |
|TERMINAL (d) | 5/32 (16%) 0/28 (0%) 5/25 (20%) 1/19 (5%) |4/35 (11%) 5/34 (15%) 1/26 (4%) 0/32 (0%) |
|FIRST INCIDENCE | 588 --- 57 652 |606 562 727 (T) 695 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.335 P=0.025N* P=0.467 P=0.622N |P=0.013N* P=0.591 P=0.068N P=0.046N* |
|POLY 3 | P=0.555 P=0.020N* P=0.591 P=0.413N |P=0.007N** P=0.604 P=0.040N* P=0.036N* |
|POLY 1.5 | P=0.570 P=0.019N* P=0.602 P=0.390N |P=0.007N** P=0.607 P=0.035N* P=0.034N* |
|POLY 6 | P=0.521 P=0.022N* P=0.571 P=0.456N |P=0.008N** P=0.602 P=0.049N* P=0.038N* |
|LOGISTIC REGRESSION| P=0.556N P=0.022N* P=0.583N P=0.402N |P=0.008N** P=0.612 P=0.035N* P=0.033N* |
|COCH-ARM / FISHERS | P=0.566N P=0.014N* P=0.620N P=0.370N |P=0.007N** P=0.613N P=0.030N* P=0.030N* |
|ORDER RESTRICTED | P=0.299N (e) (e) (e) |P=0.018N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | |
|POLY-3 RATE (b) | 1/44.48 2/41.57 0/42.07 0/41.33 | |
|POLY-3 PERCENT (g) | 2.3% 4.8% 0.0% 0.0% | |
|TERMINAL (d) | 1/32 (3%) 1/28 (4%) 0/25 (0%) 0/19 (0%) | |
|FIRST INCIDENCE | 726 (T) 595 --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.240N P=0.472 P=0.549N P=0.604N | |
|POLY 3 | P=0.199N P=0.476 P=0.511N P=0.515N | |
|POLY 1.5 | P=0.194N P=0.482 P=0.508N P=0.507N | |
|POLY 6 | P=0.209N P=0.471 P=0.516N P=0.530N | |
|LOGISTIC REGRESSION| P=0.189N P=0.494 (e) (e) | |
|COCH-ARM / FISHERS | P=0.187N P=0.492 P=0.500N P=0.500N | |
|ORDER RESTRICTED | P=0.169N (e) (e) (e) | |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 3/50 (6%) | |
|POLY-3 RATE (b) | 1/44.48 2/41.49 0/42.07 3/41.95 | |
|POLY-3 PERCENT (g) | 2.3% 4.8% 0.0% 7.2% | |
|TERMINAL (d) | 1/32 (3%) 1/28 (4%) 0/25 (0%) 1/19 (5%) | |
|FIRST INCIDENCE | 726 (T) 621 --- 621 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.166 P=0.458 P=0.549N P=0.200 | |
|POLY 3 | P=0.229 P=0.476 P=0.511N P=0.284 | |
|POLY 1.5 | P=0.237 P=0.482 P=0.508N P=0.295 | |
|POLY 6 | P=0.215 P=0.470 P=0.516N P=0.262 | |
|LOGISTIC REGRESSION| P=0.243 P=0.485 (e) P=0.306 | |
|COCH-ARM / FISHERS | P=0.244 P=0.492 P=0.500N P=0.309 | |
|ORDER RESTRICTED | P=0.165 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/49 (2%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 RATE (b) | 3/44.96 1/41.57 0/42.07 2/41.54 | |
|POLY-3 PERCENT (g) | 6.7% 2.4% 0.0% 4.8% | |
|TERMINAL (d) | 1/32 (3%) 0/28 (0%) 0/25 (0%) 0/19 (0%) | |
|FIRST INCIDENCE | 588 595 --- 694 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.542N P=0.335N P=0.161N P=0.656N | |
|POLY 3 | P=0.447N P=0.334N P=0.131N P=0.536N | |
|POLY 1.5 | P=0.444N P=0.326N P=0.128N P=0.517N | |
|POLY 6 | P=0.453N P=0.342N P=0.137N P=0.571N | |
|LOGISTIC REGRESSION| P=0.439N P=0.281N P=0.118N P=0.505N | |
|COCH-ARM / FISHERS | P=0.442N P=0.316N P=0.121N P=0.500N | |
|ORDER RESTRICTED | P=0.218N (e) (e) (e) | |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/49 (6%) 0/50 (0%) 4/50 (8%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/44.48 3/41.37 0/42.07 4/41.41 |1/44.87 1/44.54 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 6.7% 7.3% 0.0% 9.7% |2.2% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 3/32 (9%) 2/28 (7%) 0/25 (0%) 3/19 (16%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 658 --- 705 |714 727 (T) --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.245 P=0.600 P=0.167N P=0.241 |P=0.642N P=0.757 P=0.549N P=0.741 |
|POLY 3 | P=0.437 P=0.629 P=0.129N P=0.461 |P=0.623N P=0.759 P=0.513N P=0.752 |
|POLY 1.5 | P=0.448 P=0.637 P=0.126N P=0.481 |P=0.619N P=0.759 P=0.507N P=0.755 |
|POLY 6 | P=0.413 P=0.620 P=0.133N P=0.421 |P=0.629N P=0.759 P=0.525N P=0.750 |
|LOGISTIC REGRESSION| P=0.328 P=0.611 (e) P=0.270 |P=0.635N P=0.762 P=0.528N P=0.752 |
|COCH-ARM / FISHERS | P=0.460 P=0.651 P=0.121N P=0.500 |P=0.616N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.257 (e) (e) (e) |P=0.550N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 1/50 (2%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.15 1/41.12 1/42.07 3/41.48 |1/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 2.2% 2.4% 2.4% 7.2% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 1/28 (4%) 1/25 (4%) 1/19 (5%) |1/35 (3%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 505 726 (T) 726 (T) 694 |727 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.087 P=0.741 P=0.733 P=0.198 |P=0.325N P=0.506N P=0.559N P=0.518N |
|POLY 3 | P=0.151 P=0.740 P=0.745 P=0.275 |P=0.306N P=0.501N P=0.513N P=0.507N |
|POLY 1.5 | P=0.159 P=0.746 P=0.749 P=0.290 |P=0.305N P=0.501N P=0.506N P=0.505N |
|POLY 6 | P=0.137 P=0.733 P=0.738 P=0.249 |P=0.309N P=0.501N P=0.525N P=0.509N |
|LOGISTIC REGRESSION| P=0.163 P=0.722N P=0.730N P=0.324 |P=0.325N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.165 P=0.747 P=0.753N P=0.309 |P=0.306N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.157 (e) (e) (e) |P=0.127N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 1/41.12 0/42.07 0/41.33 |0/44.82 2/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 0.0% |0.0% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 1/28 (4%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 2/34 (6%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 726 (T) --- --- |--- 727 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.645N P=0.473 (e) (e) |P=0.431N P=0.232 (e) (e) |
|POLY 3 | P=0.579N P=0.484 (e) (e) |P=0.416N P=0.236 (e) (e) |
|POLY 1.5 | P=0.574N P=0.488 (e) (e) |P=0.411N P=0.236 (e) (e) |
|POLY 6 | P=0.585N P=0.479 (e) (e) |P=0.422N P=0.236 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.473 (e) (e) |(e) P=0.232 (e) (e) |
|COCH-ARM / FISHERS | P=0.566N P=0.495 (e) (e) |P=0.405N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.380N (e) (e) (e) |P=0.254N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 0/41.12 1/42.22 2/41.33 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 4.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 2/19 (11%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- 688 726 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035 * (e) P=0.489 P=0.132 |(e) (e) (e) (e) |
|POLY 3 | P=0.065 (e) P=0.490 P=0.221 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.069 (e) P=0.492 P=0.229 |(e) (e) (e) (e) |
|POLY 6 | P=0.058 (e) P=0.486 P=0.205 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.049 * (e) P=0.496 P=0.132 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.071 (e) P=0.500 P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.064 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.48 0/41.12 0/42.07 0/41.33 |1/44.89 1/44.99 0/41.95 2/43.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 2.2% 0.0% 4.6% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 2/32 (6%) |
|FIRST INCIDENCE | --- --- --- --- |709 594 --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.340 P=0.758 P=0.554N P=0.466 |
|POLY 3 | (e) (e) (e) (e) |P=0.355 P=0.760N P=0.514N P=0.486 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.360 P=0.760N P=0.507N P=0.491 |
|POLY 6 | (e) (e) (e) (e) |P=0.348 P=0.759N P=0.525N P=0.483 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.364 P=0.759N P=0.521N P=0.482 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.366 P=0.753N P=0.500N P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.260 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.17 1/41.74 0/42.07 1/41.78 |0/44.82 0/44.54 1/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 4.4% 2.4% 0.0% 2.4% |0.0% 0.0% 2.4% 2.3% |
|TERMINAL (d) | 1/32 (3%) 1/28 (4%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 1/26 (4%) 1/32 (3%) |
|FIRST INCIDENCE | 492 726 (T) --- 595 |--- --- 727 (T) 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.429N P=0.538N P=0.269N P=0.549N |P=0.222 (e) P=0.441 P=0.482 |
|POLY 3 | P=0.371N P=0.527N P=0.253N P=0.527N |P=0.227 (e) P=0.487 P=0.493 |
|POLY 1.5 | P=0.369N P=0.517N P=0.249N P=0.513N |P=0.230 (e) P=0.494 P=0.495 |
|POLY 6 | P=0.375N P=0.540N P=0.260N P=0.553N |P=0.226 (e) P=0.475 P=0.491 |
|LOGISTIC REGRESSION| P=0.355N P=0.459N P=0.183N P=0.516N |(e) (e) P=0.441 P=0.482 |
|COCH-ARM / FISHERS | P=0.366N P=0.500N P=0.247N P=0.500N |P=0.236 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.252N (e) (e) (e) |P=0.238 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) 8/50 (16%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.30 5/42.75 3/42.13 8/42.18 |0/44.82 1/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 4.4% 11.7% 7.1% 19.0% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 3/28 (11%) 2/25 (8%) 3/19 (16%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 588 420 713 609 |--- 727 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * P=0.183 P=0.427 P=0.017 * |P=0.583N P=0.494 (e) (e) |
|POLY 3 | P=0.029 * P=0.193 P=0.467 P=0.033 * |P=0.574N P=0.499 (e) (e) |
|POLY 1.5 | P=0.034 * P=0.202 P=0.476 P=0.039 * |P=0.571N P=0.499 (e) (e) |
|POLY 6 | P=0.022 * P=0.180 P=0.451 P=0.025 * |P=0.579N P=0.499 (e) (e) |
|LOGISTIC REGRESSION| P=0.039 * P=0.269 P=0.505 P=0.050 |(e) P=0.494 (e) (e) |
|COCH-ARM / FISHERS | P=0.040 * P=0.218 P=0.500 P=0.046 * |P=0.567N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.016 * (e) (e) (e) |P=0.386N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.93 2/42.20 2/42.45 1/41.60 |1/45.30 0/44.54 1/42.05 0/43.18 |
|POLY-3 PERCENT (g) | 4.5% 4.7% 4.7% 2.4% |2.2% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 1/25 (4%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 629 602 619 652 |583 --- 702 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.458N P=0.658 P=0.649 P=0.579N |P=0.430N P=0.509N P=0.726 P=0.513N |
|POLY 3 | P=0.398N P=0.671 P=0.674 P=0.527N |P=0.412N P=0.503N P=0.744 P=0.510N |
|POLY 1.5 | P=0.385N P=0.680 P=0.678 P=0.513N |P=0.410N P=0.502N P=0.752 P=0.506N |
|POLY 6 | P=0.425N P=0.661 P=0.665 P=0.554N |P=0.415N P=0.504N P=0.730 P=0.513N |
|LOGISTIC REGRESSION| P=0.366N P=0.675N P=0.687N P=0.481N |P=0.385N P=0.488N P=0.755N P=0.458N |
|COCH-ARM / FISHERS | P=0.373N P=0.691N P=0.691N P=0.500N |P=0.405N P=0.500N P=0.753N P=0.500N |
|ORDER RESTRICTED | P=0.475N (e) (e) (e) |P=0.260N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 6/50 (12%) 4/50 (8%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/45.82 4/42.30 6/43.55 4/42.12 |1/44.90 0/44.54 0/41.95 1/43.20 |
|POLY-3 PERCENT (g) | 8.7% 9.5% 13.8% 9.5% |2.2% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 468 659 539 649 |707 --- --- 723 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.374 P=0.564 P=0.330 P=0.496 |P=0.570 P=0.495N P=0.559N P=0.742 |
|POLY 3 | P=0.482 P=0.599 P=0.338 P=0.597 |P=0.588 P=0.502N P=0.514N P=0.752 |
|POLY 1.5 | P=0.509 P=0.615 P=0.344 P=0.620 |P=0.591 P=0.501N P=0.507N P=0.755 |
|POLY 6 | P=0.430 P=0.580 P=0.328 P=0.555 |P=0.585 P=0.502N P=0.525N P=0.750 |
|LOGISTIC REGRESSION| P=0.546 P=0.596N P=0.432 P=0.609N |P=0.582 P=0.501N P=0.518N P=0.753 |
|COCH-ARM / FISHERS | P=0.533 P=0.643N P=0.370 P=0.643N |P=0.595 P=0.500N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.512 (e) (e) (e) |P=0.392 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 0/40.28 1/42.17 1/42.00 |0/44.82 2/44.65 2/42.44 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 2.4% |0.0% 4.5% 4.7% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- 702 498 |--- 707 616 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.209 (e) P=0.470 P=0.508 |P=0.533N P=0.249 P=0.206 (e) |
|POLY 3 | P=0.229 (e) P=0.489 P=0.489 |P=0.518N P=0.236 P=0.225 (e) |
|POLY 1.5 | P=0.236 (e) P=0.492 P=0.495 |P=0.512N P=0.236 P=0.231 (e) |
|POLY 6 | P=0.212 (e) P=0.485 P=0.475 |P=0.523N P=0.237 P=0.215 (e) |
|LOGISTIC REGRESSION| P=0.234 (e) P=0.490 P=0.249 |P=0.500N P=0.236 P=0.246 (e) |
|COCH-ARM / FISHERS | P=0.239 (e) P=0.500 P=0.500 |P=0.500N P=0.247 P=0.247 (e) |
|ORDER RESTRICTED | P=0.240 (e) (e) (e) |P=0.265 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/48 (2%) 6/50 (12%) 6/50 (12%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/45.16 1/40.28 6/43.21 6/43.40 |2/44.87 0/44.54 1/42.26 1/43.19 |
|POLY-3 PERCENT (g) | 6.6% 2.5% 13.9% 13.8% |4.5% 0.0% 2.4% 2.3% |
|TERMINAL (d) | 0/32 (0%) 1/28 (4%) 0/25 (0%) 0/19 (0%) |1/35 (3%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 588 726 (T) 637 498 |714 --- 642 726 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.042 * P=0.354N P=0.203 P=0.162 |P=0.525N P=0.243N P=0.576N P=0.527N |
|POLY 3 | P=0.078 P=0.347N P=0.220 P=0.222 |P=0.508N P=0.239N P=0.521N P=0.513N |
|POLY 1.5 | P=0.082 P=0.337N P=0.224 P=0.234 |P=0.504N P=0.238N P=0.510N P=0.509N |
|POLY 6 | P=0.067 P=0.360N P=0.214 P=0.196 |P=0.512N P=0.239N P=0.539N P=0.517N |
|LOGISTIC REGRESSION| P=0.086 P=0.313N P=0.251 P=0.268 |P=0.510N P=0.238N P=0.509N P=0.519N |
|COCH-ARM / FISHERS | P=0.083 P=0.324N P=0.243 P=0.243 |P=0.500N P=0.247N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.098 (e) (e) (e) |P=0.285N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/48 (2%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.83 1/41.08 2/42.98 3/42.21 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 2.2% 2.4% 4.7% 7.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 629 420 544 638 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.157 P=0.745 P=0.492 P=0.266 |(e) (e) (e) (e) |
|POLY 3 | P=0.156 P=0.741 P=0.485 P=0.284 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.164 P=0.745 P=0.488 P=0.295 |(e) (e) (e) (e) |
|POLY 6 | P=0.141 P=0.736 P=0.480 P=0.262 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.165 P=0.630N P=0.579 P=0.322 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.169 P=0.742 P=0.500 P=0.309 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.194 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 8/50 (16%) 8/50 (16%) 15/50 (30%) | |
|POLY-3 RATE (b) | 10/45.22 8/42.57 8/43.17 15/44.17 | |
|POLY-3 PERCENT (g) | 22.1% 18.8% 18.5% 34.0% | |
|TERMINAL (d) | 5/32 (16%) 4/28 (14%) 3/25 (12%) 4/19 (21%) | |
|FIRST INCIDENCE | 671 637 633 567 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.018 * P=0.538N P=0.555N P=0.039 * | |
|POLY 3 | P=0.083 P=0.452N P=0.439N P=0.153 | |
|POLY 1.5 | P=0.088 P=0.432N P=0.431N P=0.167 | |
|POLY 6 | P=0.071 P=0.477N P=0.454N P=0.127 | |
|LOGISTIC REGRESSION| P=0.080 P=0.455N P=0.437N P=0.169 | |
|COCH-ARM / FISHERS | P=0.091 P=0.398N P=0.398N P=0.178 | |
|ORDER RESTRICTED | P=0.081 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 1/50 (2%) 3/50 (6%) | |
|POLY-3 RATE (b) | 4/45.78 3/42.95 1/42.56 3/42.45 | |
|POLY-3 PERCENT (g) | 8.7% 7.0% 2.4% 7.1% | |
|TERMINAL (d) | 1/32 (3%) 1/28 (4%) 0/25 (0%) 0/19 (0%) | |
|FIRST INCIDENCE | 468 405 580 544 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.470N P=0.543N P=0.220N P=0.598N | |
|POLY 3 | P=0.418N P=0.535N P=0.201N P=0.541N | |
|POLY 1.5 | P=0.408N P=0.521N P=0.195N P=0.521N | |
|POLY 6 | P=0.439N P=0.551N P=0.211N P=0.579N | |
|LOGISTIC REGRESSION| P=0.375N P=0.350N P=0.118N P=0.480N | |
|COCH-ARM / FISHERS | P=0.397N P=0.500N P=0.181N P=0.500N | |
|ORDER RESTRICTED | P=0.346N (e) (e) (e) | |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/48 (6%) 5/50 (10%) 1/50 (2%) |4/50 (8%) 2/50 (4%) 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 4/44.73 3/40.28 5/42.74 1/41.33 |4/44.82 2/44.54 2/42.44 5/44.06 |
|POLY-3 PERCENT (g) | 8.9% 7.5% 11.7% 2.4% |8.9% 4.5% 4.7% 11.4% |
|TERMINAL (d) | 2/32 (6%) 3/28 (11%) 1/25 (4%) 1/19 (5%) |4/35 (11%) 2/34 (6%) 1/26 (4%) 3/32 (9%) |
|FIRST INCIDENCE | 687 726 (T) 637 726 (T) |727 (T) 727 (T) 582 454 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.358N P=0.580N P=0.401 P=0.346N |P=0.283 P=0.349N P=0.458N P=0.448 |
|POLY 3 | P=0.201N P=0.557N P=0.471 P=0.203N |P=0.321 P=0.340N P=0.362N P=0.489 |
|POLY 1.5 | P=0.185N P=0.544N P=0.477 P=0.190N |P=0.325 P=0.339N P=0.349N P=0.492 |
|POLY 6 | P=0.236N P=0.572N P=0.462 P=0.230N |P=0.317 P=0.339N P=0.386N P=0.489 |
|LOGISTIC REGRESSION| P=0.221N P=0.575N P=0.472 P=0.254N |P=0.325 P=0.349N P=0.365N P=0.494 |
|COCH-ARM / FISHERS | P=0.174N P=0.523N P=0.500 P=0.181N |P=0.331 P=0.339N P=0.339N P=0.500 |
|ORDER RESTRICTED | P=0.171N (e) (e) (e) |P=0.270 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Tongue: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |1/1 (100%) 1/1 (100%) 3/3 (100%) 2/2 (100%) |
|POLY-3 RATE (b) | 1/1.00 1/1.00 0/0.00 0/0.00 |1/1.00 1/1.00 3/3.00 2/2.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 0.0% 0.0% |100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 1/1 (100%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |1/1 (100%) 1/1 (100%) 1/1 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- --- |727 (T) 727 (T) 621 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Trachea |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/48 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 2/41.43 0/42.07 0/41.33 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 338 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.430N P=0.226 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.422N P=0.221 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.413N P=0.224 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.438N P=0.218 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.373N P=0.409 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.403N P=0.237 (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.248N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Calculus Micro Observation Only |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/48 (4%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.48 2/40.28 2/42.91 0/41.33 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 2.3% 5.0% 4.7% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 2/28 (7%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 539 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.396N P=0.453 P=0.466 P=0.604N |(e) (e) (e) (e) |
|POLY 3 | P=0.319N P=0.465 P=0.487 P=0.515N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.305N P=0.473 P=0.489 P=0.507N |(e) (e) (e) (e) |
|POLY 6 | P=0.347N P=0.458 P=0.483 P=0.530N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.291N P=0.453 P=0.537 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.293N P=0.485 P=0.500 P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.223N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | |1/45.69 0/44.54 1/42.14 2/44.14 |
|POLY-3 PERCENT (g) | |2.2% 0.0% 2.4% 4.5% |
|TERMINAL (d) | |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | |370 --- 677 398 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.239 P=0.504N P=0.733 P=0.486 |
|POLY 3 | |P=0.242 P=0.505N P=0.742 P=0.488 |
|POLY 1.5 | |P=0.244 P=0.504N P=0.751 P=0.492 |
|POLY 6 | |P=0.240 P=0.506N P=0.729 P=0.486 |
|LOGISTIC REGRESSION| |P=0.336 P=0.434N P=0.713 P=0.662 |
|COCH-ARM / FISHERS | |P=0.247 P=0.500N P=0.753N P=0.500 |
|ORDER RESTRICTED | |P=0.215 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | |2/44.82 0/44.54 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | |4.5% 0.0% 0.0% 2.3% |
|TERMINAL (d) | |2/35 (6%) 0/34 (0%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | |727 (T) --- --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.492N P=0.245N P=0.306N P=0.531N |
|POLY 3 | |P=0.464N P=0.238N P=0.252N P=0.513N |
|POLY 1.5 | |P=0.462N P=0.238N P=0.244N P=0.509N |
|POLY 6 | |P=0.470N P=0.238N P=0.265N P=0.516N |
|LOGISTIC REGRESSION| |P=0.492N (e) (e) P=0.531N |
|COCH-ARM / FISHERS | |P=0.461N P=0.247N P=0.247N P=0.500N |
|ORDER RESTRICTED | |P=0.140N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 2/50 (4%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | |1/44.82 2/44.54 3/42.05 3/43.18 |
|POLY-3 PERCENT (g) | |2.2% 4.5% 7.1% 7.0% |
|TERMINAL (d) | |1/35 (3%) 2/34 (6%) 2/26 (8%) 3/32 (9%) |
|FIRST INCIDENCE | |727 (T) 727 (T) 702 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.190 P=0.490 P=0.210 P=0.273 |
|POLY 3 | |P=0.210 P=0.498 P=0.282 P=0.292 |
|POLY 1.5 | |P=0.217 P=0.498 P=0.294 P=0.296 |
|POLY 6 | |P=0.205 P=0.498 P=0.264 P=0.288 |
|LOGISTIC REGRESSION| |P=0.197 P=0.490 P=0.235 P=0.273 |
|COCH-ARM / FISHERS | |P=0.227 P=0.500 P=0.309 P=0.309 |
|ORDER RESTRICTED | |P=0.244 (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).