TDMS Study 97006-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 04/29/04
EXPERIMENT: 97006 TEST: 02 TIME: 07:52:12
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006
PATHOLOGIST: GRUMBEIN, SONDRA CAS: 108-10-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 04/29/04
EXPERIMENT: 97006 TEST: 02 TIME: 07:52:12
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006
PATHOLOGIST: GRUMBEIN, SONDRA CAS: 108-10-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF METHYL ISOBUTYL KETONE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hypertrophy
Brain Necrosis
Heart Cardiomyopathy
Heart: Artery Inflammation Chronic
Liver Clear Cell Focus
Eosinophilic Focus
Mesentery: Fat Necrosis
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Eosinophilic Focus
Nose Inflammation
Nose: Olfactory Epithelium Degeneration Hyaline
Nose: Respiratory Epithelium Degeneration Hyaline
Pancreas Atrophy
Stomach, Forestomach: Artery Inflammation Chronic
Stomach, Glandular: Artery Inflammation Chronic
===============================================================
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 18/50 (36%) 13/49 (27%) 9/50 (18%) |4/50 (8%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 13/46.97 18/47.79 13/43.29 9/45.81 |4/44.99 3/46.04 1/45.87 2/46.46 |
|POLY-3 PERCENT (g) | 27.7% 37.7% 30.0% 19.7% |8.9% 6.5% 2.2% 4.3% |
|TERMINAL (d) | 12/40 (30%) 16/42 (38%) 11/35 (31%) 8/37 (22%) |4/35 (11%) 2/37 (5%) 1/39 (3%) 2/38 (5%) |
|FIRST INCIDENCE | 598 680 471 593 |731 (T) 687 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.173N P=0.242 P=0.439 P=0.299N |P=0.194N P=0.472N P=0.148N P=0.299N |
|POLY 3 | P=0.122N P=0.206 P=0.494 P=0.253N |P=0.215N P=0.487N P=0.173N P=0.323N |
|POLY 1.5 | P=0.115N P=0.200 P=0.511 P=0.246N |P=0.217N P=0.493N P=0.175N P=0.327N |
|POLY 6 | P=0.130N P=0.219 P=0.484 P=0.259N |P=0.212N P=0.483N P=0.170N P=0.315N |
|LOGISTIC REGRESSION| P=0.124N P=0.224 P=0.507 P=0.257N |P=0.199N P=0.487N P=0.148N P=0.299N |
|COCH-ARM / FISHERS | P=0.103N P=0.194 P=0.567 P=0.235N |P=0.221N P=0.500N P=0.181N P=0.339N |
|ORDER RESTRICTED | P=0.122N (e) (e) (e) |P=0.184N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 30/50 (60%) 26/49 (53%) 14/50 (28%) |3/50 (6%) 0/50 (0%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 26/46.97 30/48.16 26/44.78 14/45.54 |3/44.99 0/45.87 3/45.87 3/46.86 |
|POLY-3 PERCENT (g) | 55.4% 62.3% 58.1% 30.7% |6.7% 0.0% 6.5% 6.4% |
|TERMINAL (d) | 25/40 (63%) 27/42 (64%) 21/35 (60%) 13/37 (35%) |3/35 (9%) 0/37 (0%) 3/39 (8%) 2/38 (5%) |
|FIRST INCIDENCE | 598 661 471 678 |731 (T) --- 731 (T) 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011N* P=0.367 P=0.314 P=0.020N* |P=0.418 P=0.111N P=0.613N P=0.627N |
|POLY 3 | P=0.003N** P=0.314 P=0.480 P=0.012N* |P=0.400 P=0.115N P=0.653N P=0.643N |
|POLY 1.5 | P=0.003N** P=0.293 P=0.479 P=0.012N* |P=0.396 P=0.117N P=0.657N P=0.650N |
|POLY 6 | P=0.004N** P=0.356 P=0.498 P=0.012N* |P=0.409 P=0.114N P=0.650N P=0.633N |
|LOGISTIC REGRESSION| P=0.005N** P=0.344 P=0.402 P=0.014N* |P=0.399 (e) P=0.613N P=0.655N |
|COCH-ARM / FISHERS | P=0.003N** P=0.273 P=0.538 P=0.012N* |P=0.387 P=0.121N P=0.661N P=0.661N |
|ORDER RESTRICTED | P=0.003N** (e) (e) (e) |P=0.383 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/49 (6%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 1/49 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/46.53 1/47.60 3/41.95 0/45.34 |2/44.99 2/45.87 1/45.18 0/45.46 |
|POLY-3 PERCENT (g) | 2.2% 2.1% 7.2% 0.0% |4.5% 4.4% 2.2% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/42 (0%) 2/35 (6%) 0/37 (0%) |2/35 (6%) 2/37 (5%) 0/38 (0%) 0/37 (0%) |
|FIRST INCIDENCE | 729 (T) 704 701 --- |731 (T) 731 (T) 648 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.440N P=0.747N P=0.263 P=0.516N |P=0.118N P=0.675N P=0.476N P=0.226N |
|POLY 3 | P=0.425N P=0.755N P=0.269 P=0.505N |P=0.125N P=0.687N P=0.499N P=0.235N |
|POLY 1.5 | P=0.419N P=0.758N P=0.276 P=0.503N |P=0.127N P=0.690N P=0.502N P=0.237N |
|POLY 6 | P=0.432N P=0.752N P=0.265 P=0.507N |P=0.123N P=0.686N P=0.495N P=0.231N |
|LOGISTIC REGRESSION| P=0.427N P=0.760N P=0.263 (e) |P=0.126N P=0.675N P=0.506N (e) |
|COCH-ARM / FISHERS | P=0.410N P=0.753N P=0.301 P=0.500N |P=0.129N P=0.691N P=0.508N P=0.253N |
|ORDER RESTRICTED | P=0.218N (e) (e) (e) |P=0.153N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/47.33 0/47.50 0/42.28 0/45.34 |0/44.99 0/45.87 0/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 4.2% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | 612 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.128N P=0.240N P=0.276N P=0.257N |(e) (e) (e) (e) |
|POLY 3 | P=0.117N P=0.236N P=0.263N P=0.247N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.116N P=0.237N P=0.255N P=0.243N |(e) (e) (e) (e) |
|POLY 6 | P=0.118N P=0.235N P=0.271N P=0.251N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.089N P=0.245N P=0.163N P=0.163N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.033N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain: Meninges |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.53 0/47.50 0/42.28 0/45.34 |0/44.99 1/45.87 2/45.87 2/46.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 4.4% 4.3% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 1/37 (3%) 2/39 (5%) 2/38 (5%) |
|FIRST INCIDENCE | --- --- --- --- |--- 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.174 P=0.511 P=0.262 P=0.257 |
|POLY 3 | (e) (e) (e) (e) |P=0.169 P=0.504 P=0.242 P=0.244 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.167 P=0.502 P=0.240 P=0.242 |
|POLY 6 | (e) (e) (e) (e) |P=0.174 P=0.505 P=0.243 P=0.248 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.511 P=0.262 P=0.257 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.160 P=0.500 P=0.247 P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.158 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Granuloma Sperm |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |
|POLY-3 RATE (b) | 2/46.97 0/47.50 2/42.33 1/45.34 | |
|POLY-3 PERCENT (g) | 4.3% 0.0% 4.7% 2.2% | |
|TERMINAL (d) | 1/40 (3%) 0/42 (0%) 1/35 (3%) 1/37 (3%) | |
|FIRST INCIDENCE | 598 --- 717 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.561N P=0.239N P=0.642 P=0.525N | |
|POLY 3 | P=0.546N P=0.235N P=0.656 P=0.512N | |
|POLY 1.5 | P=0.540N P=0.236N P=0.667 P=0.507N | |
|POLY 6 | P=0.553N P=0.233N P=0.647 P=0.517N | |
|LOGISTIC REGRESSION| P=0.532N P=0.249N P=0.693 P=0.481N | |
|COCH-ARM / FISHERS | P=0.531N P=0.247N P=0.691N P=0.500N | |
|ORDER RESTRICTED | P=0.431N (e) (e) (e) | |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Cornea |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/48 (4%) 0/49 (0%) 0/49 (0%) |1/49 (2%) 1/48 (2%) 3/49 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.24 2/45.94 0/41.84 0/44.78 |1/44.41 1/45.52 3/45.40 2/46.46 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 0.0% |2.3% 2.2% 6.6% 4.3% |
|TERMINAL (d) | 0/40 (0%) 2/42 (5%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 1/37 (3%) 2/39 (5%) 2/38 (5%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |715 731 (T) 648 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.428N P=0.249 (e) (e) |P=0.352 P=0.751N P=0.334 P=0.531 |
|POLY 3 | P=0.414N P=0.236 (e) (e) |P=0.341 P=0.755N P=0.313 P=0.516 |
|POLY 1.5 | P=0.411N P=0.234 (e) (e) |P=0.339 P=0.757N P=0.310 P=0.513 |
|POLY 6 | P=0.415N P=0.240 (e) (e) |P=0.346 P=0.755N P=0.316 P=0.519 |
|LOGISTIC REGRESSION| (e) P=0.249 (e) (e) |P=0.339 P=0.756N P=0.306 P=0.523 |
|COCH-ARM / FISHERS | P=0.404N P=0.242 (e) (e) |P=0.335 P=0.747 P=0.309 P=0.508 |
|ORDER RESTRICTED | P=0.252N (e) (e) (e) |P=0.339 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/49 (8%) 1/50 (2%) 2/50 (4%) |1/49 (2%) 1/49 (2%) 2/49 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/46.53 4/47.54 1/42.28 2/45.34 |1/44.34 1/45.60 2/45.09 1/46.46 |
|POLY-3 PERCENT (g) | 6.5% 8.4% 2.4% 4.4% |2.3% 2.2% 4.4% 2.2% |
|TERMINAL (d) | 3/40 (8%) 2/42 (5%) 1/35 (3%) 2/37 (5%) |1/35 (3%) 0/37 (0%) 2/39 (5%) 1/38 (3%) |
|FIRST INCIDENCE | 729 (T) 493 729 (T) 729 (T) |731 (T) 710 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.334N P=0.526 P=0.354N P=0.536N |P=0.618 P=0.748N P=0.538 P=0.743N |
|POLY 3 | P=0.310N P=0.512 P=0.340N P=0.512N |P=0.605 P=0.754N P=0.506 P=0.750N |
|POLY 1.5 | P=0.303N P=0.502 P=0.331N P=0.507N |P=0.603 P=0.757N P=0.503 P=0.752N |
|POLY 6 | P=0.317N P=0.526 P=0.348N P=0.516N |P=0.610 P=0.753N P=0.508 P=0.748N |
|LOGISTIC REGRESSION| P=0.293N P=0.465 P=0.354N P=0.536N |P=0.612 P=0.757N P=0.538 P=0.743N |
|COCH-ARM / FISHERS | P=0.289N P=0.489 P=0.309N P=0.500N |P=0.597 P=0.753N P=0.500 P=0.747N |
|ORDER RESTRICTED | P=0.315N (e) (e) (e) |P=0.594 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 8/50 (16%) 2/50 (4%) 10/50 (20%) |3/50 (6%) 6/50 (12%) 5/50 (10%) 3/50 (6%) |
|POLY-3 RATE (b) | 10/46.90 8/47.75 2/42.40 10/46.15 |3/45.12 6/46.27 5/46.02 3/46.51 |
|POLY-3 PERCENT (g) | 21.3% 16.8% 4.7% 21.7% |6.7% 13.0% 10.9% 6.5% |
|TERMINAL (d) | 9/40 (23%) 7/42 (17%) 1/35 (3%) 7/37 (19%) |1/35 (3%) 4/37 (11%) 4/39 (10%) 2/38 (5%) |
|FIRST INCIDENCE | 622 661 698 593 |715 638 695 719 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.489 P=0.355N P=0.029N* P=0.530 |P=0.399N P=0.269 P=0.403 P=0.615N |
|POLY 3 | P=0.548 P=0.381N P=0.022N* P=0.583 |P=0.429N P=0.254 P=0.367 P=0.648N |
|POLY 1.5 | P=0.549N P=0.389N P=0.019N* P=0.588 |P=0.435N P=0.250 P=0.363 P=0.652N |
|POLY 6 | P=0.539 P=0.368N P=0.024N* P=0.582 |P=0.419N P=0.258 P=0.371 P=0.642N |
|LOGISTIC REGRESSION| P=0.543 P=0.376N P=0.024N* P=0.581 |P=0.429N P=0.249 P=0.370 P=0.641N |
|COCH-ARM / FISHERS | P=0.527N P=0.398N P=0.014N* P=0.598N |P=0.449N P=0.243 P=0.357 P=0.661N |
|ORDER RESTRICTED | P=0.241N (e) (e) (e) |P=0.427N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.63 0/47.50 3/42.56 1/45.68 |0/44.99 0/45.87 0/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 7.1% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | 704 --- 698 637 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.580N P=0.227N P=0.451 P=0.514N |(e) (e) (e) (e) |
|POLY 3 | P=0.570N P=0.233N P=0.459 P=0.507N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.564N P=0.235N P=0.470 P=0.505N |(e) (e) (e) (e) |
|POLY 6 | P=0.575N P=0.230N P=0.452 P=0.509N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.555N P=0.234N P=0.463 P=0.486N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.556N P=0.247N P=0.500 P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.406 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.53 0/47.50 0/42.28 0/45.34 |1/45.86 2/46.20 0/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |2.2% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 2/40 (5%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 1/37 (3%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |368 638 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.126N P=0.228N P=0.268N P=0.256N |P=0.183N P=0.509 P=0.500N P=0.500N |
|POLY 3 | P=0.118N P=0.233N P=0.259N P=0.243N |P=0.187N P=0.503 P=0.500N P=0.497N |
|POLY 1.5 | P=0.116N P=0.235N P=0.253N P=0.241N |P=0.187N P=0.501 P=0.500N P=0.498N |
|POLY 6 | P=0.120N P=0.229N P=0.264N P=0.245N |P=0.185N P=0.505 P=0.499N P=0.495N |
|LOGISTIC REGRESSION| P=0.126N (e) (e) (e) |P=0.205N P=0.513 P=0.455N P=0.678N |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.188N P=0.500 P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.031N* (e) (e) (e) |P=0.167N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum: Peyer's Patch |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/48 (2%) 2/47 (4%) 0/47 (0%) |0/48 (0%) 0/47 (0%) 0/47 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/46.24 1/45.94 2/40.28 0/44.13 |0/43.44 0/44.66 0/43.58 0/45.43 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 5.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 1/42 (2%) 2/34 (6%) 0/37 (0%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.400N P=0.751N P=0.443 P=0.516N |(e) (e) (e) (e) |
|POLY 3 | P=0.383N P=0.759 P=0.452 P=0.509N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.381N P=0.757 P=0.461 P=0.509N |(e) (e) (e) (e) |
|POLY 6 | P=0.384N P=0.758N P=0.447 P=0.509N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.400N P=0.751N P=0.443 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.378N P=0.747 P=0.484 P=0.510N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.263N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 2/49 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.24 2/47.50 0/41.84 1/45.34 |0/44.99 0/45.87 2/45.09 1/46.49 |
|POLY-3 PERCENT (g) | 2.2% 4.2% 0.0% 2.2% |0.0% 0.0% 4.4% 2.2% |
|TERMINAL (d) | 1/40 (3%) 2/42 (5%) 0/35 (0%) 1/37 (3%) |0/35 (0%) 0/37 (0%) 2/39 (5%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- --- 731 (T) 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.534N P=0.517 P=0.527N P=0.744 |P=0.264 (e) P=0.262 P=0.521 |
|POLY 3 | P=0.511N P=0.509 P=0.520N P=0.756 |P=0.256 (e) P=0.238 P=0.507 |
|POLY 1.5 | P=0.506N P=0.508 P=0.514N P=0.759 |P=0.253 (e) P=0.236 P=0.504 |
|POLY 6 | P=0.516N P=0.513 P=0.524N P=0.753 |P=0.262 (e) P=0.240 P=0.510 |
|LOGISTIC REGRESSION| P=0.534N P=0.517 (e) P=0.744 |P=0.262 (e) P=0.262 P=0.508 |
|COCH-ARM / FISHERS | P=0.496N P=0.508 P=0.500N P=0.747N |P=0.246 (e) P=0.242 P=0.500 |
|ORDER RESTRICTED | P=0.399N (e) (e) (e) |P=0.168 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/49 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.53 1/47.72 1/41.89 3/46.69 |0/44.99 0/45.87 0/45.09 0/46.46 |
|POLY-3 PERCENT (g) | 2.2% 2.1% 2.4% 6.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/42 (0%) 0/35 (0%) 1/37 (3%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) 670 717 441 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152 P=0.747N P=0.734 P=0.292 |(e) (e) (e) (e) |
|POLY 3 | P=0.161 P=0.755N P=0.737 P=0.307 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.162 P=0.757N P=0.742 P=0.306 |(e) (e) (e) (e) |
|POLY 6 | P=0.159 P=0.751N P=0.734 P=0.307 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.178 P=0.758 P=0.736 P=0.410 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.163 P=0.753N P=0.747 P=0.309 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.187 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/49 (6%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 3/49 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/46.53 2/47.50 3/42.52 1/45.34 |2/44.99 2/46.04 3/45.09 2/46.46 |
|POLY-3 PERCENT (g) | 4.3% 4.2% 7.1% 2.2% |4.5% 4.3% 6.7% 4.3% |
|TERMINAL (d) | 2/40 (5%) 2/42 (5%) 2/35 (6%) 1/37 (3%) |2/35 (6%) 1/37 (3%) 3/39 (8%) 2/38 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 501 729 (T) |731 (T) 687 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.445N P=0.677N P=0.446 P=0.527N |P=0.579N P=0.676N P=0.550 P=0.665N |
|POLY 3 | P=0.423N P=0.686N P=0.459 P=0.509N |P=0.582 P=0.686N P=0.501 P=0.682N |
|POLY 1.5 | P=0.416N P=0.690N P=0.466 P=0.506N |P=0.577 P=0.689N P=0.497 P=0.686N |
|POLY 6 | P=0.430N P=0.681N P=0.455 P=0.512N |P=0.590 P=0.683N P=0.506 P=0.676N |
|LOGISTIC REGRESSION| P=0.406N P=0.677N P=0.504 P=0.527N |P=0.587N P=0.688N P=0.550 P=0.665N |
|COCH-ARM / FISHERS | P=0.405N P=0.691N P=0.490 P=0.500N |P=0.567 P=0.691N P=0.490 P=0.691N |
|ORDER RESTRICTED | P=0.393N (e) (e) (e) |P=0.633 (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) | 41/50 (82%) 45/50 (90%) 40/49 (82%) 43/50 (86%) |22/50 (44%) 28/50 (56%) 26/49 (53%) 27/50 (54%) |
|POLY-3 RATE (b) | 41/48.92 45/49.32 40/45.99 43/48.00 |22/47.49 28/47.81 26/47.01 27/47.51 |
|POLY-3 PERCENT (g) | 83.8% 91.2% 87.0% 89.6% |46.3% 58.6% 55.3% 56.8% |
|TERMINAL (d) | 35/40 (88%) 39/42 (93%) 30/35 (86%) 33/37 (89%) |16/35 (46%) 19/37 (51%) 21/39 (54%) 24/38 (63%) |
|FIRST INCIDENCE | 482 493 412 593 |368 598 530 535 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.167 P=0.411 P=0.260 P=0.208 |P=0.404 P=0.253 P=0.434 P=0.339 |
|POLY 3 | P=0.321 P=0.200 P=0.441 P=0.288 |P=0.248 P=0.159 P=0.251 P=0.205 |
|POLY 1.5 | P=0.365 P=0.195 P=0.471 P=0.319 |P=0.254 P=0.154 P=0.243 P=0.209 |
|POLY 6 | P=0.312 P=0.216 P=0.443 P=0.287 |P=0.248 P=0.169 P=0.263 P=0.207 |
|LOGISTIC REGRESSION| P=0.355 P=0.210 P=0.414 P=0.301 |P=0.274 P=0.162 P=0.245 P=0.226 |
|COCH-ARM / FISHERS | P=0.475 P=0.194 P=0.584N P=0.393 |P=0.255 P=0.159 P=0.242 P=0.212 |
|ORDER RESTRICTED | P=0.287 (e) (e) (e) |P=0.236 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 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) | 2/50 (4%) 2/50 (4%) 1/49 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.53 2/47.50 1/42.56 0/45.34 |0/44.99 0/45.87 0/45.09 1/46.46 |
|POLY-3 PERCENT (g) | 4.3% 4.2% 2.4% 0.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 2/40 (5%) 2/42 (5%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 1/38 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 480 --- |--- --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.144N P=0.677N P=0.538N P=0.256N |P=0.206 (e) (e) P=0.516 |
|POLY 3 | P=0.134N P=0.686N P=0.531N P=0.243N |P=0.203 (e) (e) P=0.506 |
|POLY 1.5 | P=0.132N P=0.690N P=0.525N P=0.241N |P=0.202 (e) (e) P=0.504 |
|POLY 6 | P=0.136N P=0.681N P=0.534N P=0.245N |P=0.205 (e) (e) P=0.510 |
|LOGISTIC REGRESSION| P=0.117N P=0.677N P=0.447N (e) |(e) (e) (e) P=0.516 |
|COCH-ARM / FISHERS | P=0.126N P=0.691N P=0.508N P=0.247N |P=0.199 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.160N (e) (e) (e) |P=0.126 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/50 (10%) 4/50 (8%) 8/50 (16%) |3/50 (6%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 8/46.53 5/47.50 4/42.54 8/46.25 |3/44.99 2/46.32 1/45.87 3/46.46 |
|POLY-3 PERCENT (g) | 17.2% 10.5% 9.4% 17.3% |6.7% 4.3% 2.2% 6.5% |
|TERMINAL (d) | 8/40 (20%) 5/42 (12%) 3/35 (9%) 5/37 (14%) |3/35 (9%) 1/37 (3%) 1/39 (3%) 3/38 (8%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 659 601 |731 (T) 598 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.403 P=0.243N P=0.248N P=0.546 |P=0.583N P=0.474N P=0.267N P=0.625N |
|POLY 3 | P=0.465 P=0.262N P=0.223N P=0.603 |P=0.576 P=0.487N P=0.298N P=0.647N |
|POLY 1.5 | P=0.471 P=0.269N P=0.210N P=0.603 |P=0.574 P=0.492N P=0.301N P=0.652N |
|POLY 6 | P=0.461 P=0.252N P=0.230N P=0.607 |P=0.581 P=0.482N P=0.296N P=0.640N |
|LOGISTIC REGRESSION| P=0.450 P=0.243N P=0.237N P=0.591 |P=0.579 P=0.498N P=0.267N P=0.625N |
|COCH-ARM / FISHERS | P=0.486 P=0.277N P=0.178N P=0.607N |P=0.569 P=0.500N P=0.309N P=0.661N |
|ORDER RESTRICTED | P=0.393 (e) (e) (e) |P=0.478N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | 22/50 (44%) 13/50 (26%) 13/50 (26%) 20/50 (40%) |3/50 (6%) 4/50 (8%) 5/50 (10%) 2/50 (4%) |
|POLY-3 RATE (b) | 22/46.93 13/47.50 13/42.28 20/46.61 |3/44.99 4/46.15 5/45.87 2/46.84 |
|POLY-3 PERCENT (g) | 46.9% 27.4% 30.8% 42.9% |6.7% 8.7% 10.9% 4.3% |
|TERMINAL (d) | 21/40 (53%) 13/42 (31%) 13/35 (37%) 17/37 (46%) |3/35 (9%) 2/37 (5%) 5/39 (13%) 0/38 (0%) |
|FIRST INCIDENCE | 612 729 (T) 729 (T) 551 |731 (T) 687 731 (T) 643 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.372 P=0.028N* P=0.102N P=0.548N |P=0.348N P=0.527 P=0.416 P=0.465N |
|POLY 3 | P=0.503 P=0.037N* P=0.087N P=0.429N |P=0.366N P=0.514 P=0.367 P=0.482N |
|POLY 1.5 | P=0.515 P=0.041N* P=0.072N P=0.428N |P=0.374N P=0.508 P=0.363 P=0.488N |
|POLY 6 | P=0.495 P=0.033N* P=0.100N P=0.424N |P=0.353N P=0.519 P=0.371 P=0.471N |
|LOGISTIC REGRESSION| P=0.445 P=0.027N* P=0.092N P=0.469N |P=0.374N P=0.512 P=0.416 P=0.493N |
|COCH-ARM / FISHERS | P=0.540 P=0.046N* P=0.046N* P=0.420N |P=0.389N P=0.500 P=0.357 P=0.500N |
|ORDER RESTRICTED | P=0.136N (e) (e) (e) |P=0.332N (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) | 3/50 (6%) 4/50 (8%) 5/50 (10%) 8/50 (16%) |4/50 (8%) 11/50 (22%) 10/50 (20%) 14/50 (28%) |
|POLY-3 RATE (b) | 3/46.72 4/48.03 5/42.28 8/45.34 |4/45.05 11/45.98 10/46.06 14/46.46 |
|POLY-3 PERCENT (g) | 6.4% 8.3% 11.8% 17.6% |8.9% 23.9% 21.7% 30.1% |
|TERMINAL (d) | 2/40 (5%) 3/42 (7%) 5/35 (14%) 8/37 (22%) |3/35 (9%) 10/37 (27%) 9/39 (23%) 14/38 (37%) |
|FIRST INCIDENCE | 678 565 729 (T) 729 (T) |715 702 684 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * P=0.524 P=0.289 P=0.080 |P=0.024 * P=0.059 P=0.107 P=0.014 * |
|POLY 3 | P=0.045 * P=0.515 P=0.303 P=0.089 |P=0.018 * P=0.047 * P=0.078 P=0.009 ** |
|POLY 1.5 | P=0.049 * P=0.508 P=0.318 P=0.093 |P=0.017 * P=0.046 * P=0.076 P=0.009 ** |
|POLY 6 | P=0.041 * P=0.524 P=0.290 P=0.085 |P=0.019 * P=0.047 * P=0.080 P=0.010 * |
|LOGISTIC REGRESSION| P=0.046 * P=0.486 P=0.293 P=0.087 |P=0.025 * P=0.049 * P=0.082 P=0.015 * |
|COCH-ARM / FISHERS | P=0.056 P=0.500 P=0.357 P=0.100 |P=0.016 * P=0.045 * P=0.074 P=0.009 ** |
|ORDER RESTRICTED | P=0.061 (e) (e) (e) |P=0.008 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.53 0/47.50 0/42.28 0/45.34 |0/44.99 0/45.87 2/46.30 0/46.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 648 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.608 (e) P=0.247 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.609 (e) P=0.244 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.605 (e) P=0.241 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.617 (e) P=0.247 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.589 (e) P=0.236 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.595 (e) P=0.247 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.253 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.53 0/47.50 0/42.28 1/45.34 |0/44.99 1/46.23 0/45.87 2/46.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.2% |0.0% 2.2% 0.0% 4.3% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 1/37 (3%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 2/38 (5%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- 628 --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.187 (e) (e) P=0.484 |P=0.148 P=0.504 (e) P=0.257 |
|POLY 3 | P=0.194 (e) (e) P=0.495 |P=0.144 P=0.505 (e) P=0.244 |
|POLY 1.5 | P=0.196 (e) (e) P=0.497 |P=0.143 P=0.503 (e) P=0.242 |
|POLY 6 | P=0.192 (e) (e) P=0.493 |P=0.146 P=0.507 (e) P=0.248 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.484 |P=0.139 P=0.503 (e) P=0.257 |
|COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.140 P=0.500 (e) P=0.247 |
|ORDER RESTRICTED | P=0.115 (e) (e) (e) |P=0.079 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 2/50 (4%) 7/50 (14%) |3/50 (6%) 1/50 (2%) 5/50 (10%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/46.93 1/48.03 2/43.03 7/46.66 |3/45.20 1/45.93 5/47.68 1/46.46 |
|POLY-3 PERCENT (g) | 10.7% 2.1% 4.7% 15.0% |6.6% 2.2% 10.5% 2.2% |
|TERMINAL (d) | 4/40 (10%) 0/42 (0%) 0/35 (0%) 3/37 (8%) |1/35 (3%) 0/37 (0%) 0/39 (0%) 1/38 (3%) |
|FIRST INCIDENCE | 612 565 519 513 |684 715 551 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.130 P=0.101N P=0.276N P=0.345 |P=0.350N P=0.299N P=0.383 P=0.281N |
|POLY 3 | P=0.135 P=0.096N P=0.253N P=0.375 |P=0.358N P=0.300N P=0.386 P=0.296N |
|POLY 1.5 | P=0.139 P=0.099N P=0.243N P=0.377 |P=0.362N P=0.302N P=0.374 P=0.299N |
|POLY 6 | P=0.131 P=0.093N P=0.260N P=0.374 |P=0.351N P=0.299N P=0.401 P=0.291N |
|LOGISTIC REGRESSION| P=0.166 P=0.111N P=0.193N P=0.418 |P=0.386N P=0.300N P=0.350 P=0.294N |
|COCH-ARM / FISHERS | P=0.148 P=0.102N P=0.218N P=0.380 |P=0.371N P=0.309N P=0.357 P=0.309N |
|ORDER RESTRICTED | P=0.073 (e) (e) (e) |P=0.273N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Tension Lipidosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/46.76 3/47.50 3/44.51 1/45.34 |1/44.99 2/45.87 3/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 8.6% 6.3% 6.7% 2.2% |2.2% 4.4% 6.5% 0.0% |
|TERMINAL (d) | 3/40 (8%) 3/42 (7%) 0/35 (0%) 1/37 (3%) |1/35 (3%) 2/37 (5%) 3/39 (8%) 0/38 (0%) |
|FIRST INCIDENCE | 666 729 (T) 412 729 (T) |731 (T) 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.164N P=0.474N P=0.551N P=0.205N |P=0.310N P=0.519 P=0.344 P=0.484N |
|POLY 3 | P=0.148N P=0.492N P=0.527N P=0.188N |P=0.323N P=0.507 P=0.312 P=0.494N |
|POLY 1.5 | P=0.144N P=0.495N P=0.521N P=0.185N |P=0.327N P=0.504 P=0.310 P=0.496N |
|POLY 6 | P=0.153N P=0.485N P=0.531N P=0.192N |P=0.315N P=0.508 P=0.315 P=0.490N |
|LOGISTIC REGRESSION| P=0.105N P=0.486N P=0.315N P=0.187N |P=0.310N P=0.519 P=0.344 (e) |
|COCH-ARM / FISHERS | P=0.135N P=0.500N P=0.500N P=0.181N |P=0.337N P=0.500 P=0.309 P=0.500N |
|ORDER RESTRICTED | P=0.155N (e) (e) (e) |P=0.186N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.73 0/47.50 2/43.52 1/46.12 |0/44.99 0/45.87 0/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 4.6% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | 676 --- 501 441 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.489 P=0.491N P=0.461 P=0.755 |(e) (e) (e) (e) |
|POLY 3 | P=0.492 P=0.497N P=0.475 P=0.758 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.496 P=0.498N P=0.481 P=0.759 |(e) (e) (e) (e) |
|POLY 6 | P=0.487 P=0.494N P=0.471 P=0.756 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.574 P=0.511N P=0.657 P=0.660N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500 P=0.500N P=0.500 P=0.753N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.358 (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: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 5/50 (10%) 2/50 (4%) |1/50 (2%) 5/50 (10%) 3/50 (6%) 5/50 (10%) |
|POLY-3 RATE (b) | 7/46.73 5/47.50 5/42.28 2/45.34 |1/44.99 5/45.87 3/45.87 5/46.49 |
|POLY-3 PERCENT (g) | 15.0% 10.5% 11.8% 4.4% |2.2% 10.9% 6.5% 10.8% |
|TERMINAL (d) | 6/40 (15%) 5/42 (12%) 5/35 (14%) 2/37 (5%) |1/35 (3%) 5/37 (14%) 3/39 (8%) 4/38 (11%) |
|FIRST INCIDENCE | 676 729 (T) 729 (T) 729 (T) |731 (T) 731 (T) 731 (T) 724 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.092N P=0.346N P=0.475N P=0.101N |P=0.177 P=0.115 P=0.344 P=0.125 |
|POLY 3 | P=0.076N P=0.368N P=0.451N P=0.086N |P=0.163 P=0.106 P=0.312 P=0.109 |
|POLY 1.5 | P=0.072N P=0.373N P=0.430N P=0.084N |P=0.160 P=0.104 P=0.310 P=0.107 |
|POLY 6 | P=0.080N P=0.360N P=0.468N P=0.089N |P=0.170 P=0.106 P=0.315 P=0.113 |
|LOGISTIC REGRESSION| P=0.081N P=0.346N P=0.463N P=0.089N |P=0.184 P=0.115 P=0.344 P=0.125 |
|COCH-ARM / FISHERS | P=0.066N P=0.380N P=0.380N P=0.080N |P=0.151 P=0.102 P=0.309 P=0.102 |
|ORDER RESTRICTED | P=0.071N (e) (e) (e) |P=0.094 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 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) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.53 1/47.50 3/42.59 0/45.34 |1/45.98 0/45.87 2/46.45 0/46.46 |
|POLY-3 PERCENT (g) | 2.2% 2.1% 7.0% 0.0% |2.2% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 1/40 (3%) 1/42 (2%) 1/35 (3%) 0/37 (0%) |0/35 (0%) 0/37 (0%) 1/39 (3%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 659 --- |177 --- 551 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443N P=0.751N P=0.266 P=0.516N |P=0.455N P=0.504N P=0.513 P=0.500N |
|POLY 3 | P=0.424N P=0.756N P=0.274 P=0.505N |P=0.457N P=0.500N P=0.504 P=0.498N |
|POLY 1.5 | P=0.418N P=0.758N P=0.282 P=0.503N |P=0.459N P=0.501N P=0.500 P=0.499N |
|POLY 6 | P=0.430N P=0.753N P=0.270 P=0.507N |P=0.452N P=0.500N P=0.508 P=0.495N |
|LOGISTIC REGRESSION| P=0.421N P=0.751N P=0.277 (e) |P=0.533N P=0.341N P=0.510 (e) |
|COCH-ARM / FISHERS | P=0.409N P=0.753N P=0.309 P=0.500N |P=0.461N P=0.500N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.220N (e) (e) (e) |P=0.323N (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) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 4/50 (8%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.53 2/47.50 3/42.28 2/45.34 |0/44.99 4/45.87 2/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 2.2% 4.2% 7.1% 4.4% |0.0% 8.7% 4.4% 0.0% |
|TERMINAL (d) | 1/40 (3%) 2/42 (5%) 3/35 (9%) 2/37 (5%) |0/35 (0%) 4/37 (11%) 2/39 (5%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.357 P=0.517 P=0.258 P=0.473 |P=0.310N P=0.070 P=0.262 (e) |
|POLY 3 | P=0.385 P=0.507 P=0.272 P=0.491 |P=0.318N P=0.063 P=0.242 (e) |
|POLY 1.5 | P=0.393 P=0.504 P=0.281 P=0.494 |P=0.324N P=0.062 P=0.240 (e) |
|POLY 6 | P=0.378 P=0.513 P=0.265 P=0.488 |P=0.309N P=0.063 P=0.243 (e) |
|LOGISTIC REGRESSION| P=0.357 P=0.517 P=0.258 P=0.473 |(e) P=0.070 P=0.262 (e) |
|COCH-ARM / FISHERS | P=0.404 P=0.500 P=0.309 P=0.500 |P=0.337N P=0.059 P=0.247 (e) |
|ORDER RESTRICTED | P=0.322 (e) (e) (e) |P=0.181N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/37 (0%) 0/36 (0%) 1/32 (3%) 0/34 (0%) |0/40 (0%) 2/42 (5%) 0/39 (0%) 0/38 (0%) |
|POLY-3 RATE (b) | 0/34.11 0/33.60 1/28.09 0/30.80 |0/35.88 2/38.14 0/35.63 0/35.77 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 3.6% 0.0% |0.0% 5.2% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/29 (0%) 1/23 (4%) 0/25 (0%) |0/29 (0%) 2/31 (7%) 0/30 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.670 (e) P=0.454 (e) |P=0.395N P=0.253 (e) (e) |
|POLY 3 | P=0.676 (e) P=0.461 (e) |P=0.408N P=0.250 (e) (e) |
|POLY 1.5 | P=0.679 (e) P=0.462 (e) |P=0.411N P=0.250 (e) (e) |
|POLY 6 | P=0.672 (e) P=0.461 (e) |P=0.405N P=0.250 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.454 (e) |(e) P=0.253 (e) (e) |
|COCH-ARM / FISHERS | P=0.681 (e) P=0.464 (e) |P=0.419N P=0.259 (e) (e) |
|ORDER RESTRICTED | P=0.347 (e) (e) (e) |P=0.259N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/9 (100%) 3/3 (100%) 3/3 (100%) 3/4 (75%) |9/11 (82%) 9/11 (82%) 11/13 (85%) 7/8 (88%) |
|POLY-3 RATE (b) | 9/9.00 3/3.00 3/3.00 3/3.58 |9/11.00 9/10.02 11/12.88 7/7.83 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 83.9% |81.8% 89.9% 85.4% 89.4% |
|TERMINAL (d) | 8/8 (100%) 2/2 (100%) 3/3 (100%) 2/2 (100%) |6/8 (75%) 7/7 (100%) 10/11 (91%) 7/7 (100%) |
|FIRST INCIDENCE | 678 661 729 (T) 656 |537 687 673 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.639N (e) (e) P=0.744 |P=0.278N P=0.530 P=0.568N P=0.459N |
|POLY 3 | P=0.238N (e) (e) P=0.631N |P=0.481 P=0.540 P=0.622 P=0.577 |
|POLY 1.5 | P=0.176N (e) (e) P=0.458N |P=0.482 P=0.617 P=0.630 P=0.595 |
|POLY 6 | P=0.470N (e) (e) P=0.953N |P=0.460 P=0.430 P=0.607 P=0.543 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.599N P=0.685 P=0.609 P=0.612 |
|COCH-ARM / FISHERS | P=0.133N (e) (e) P=0.308N |P=0.472 P=0.707N P=0.637 P=0.624 |
|ORDER RESTRICTED | P=0.044N* (e) (e) (e) |P=0.517 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 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%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |4/50 (8%) 3/50 (6%) 2/50 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 4/46.72 1/47.50 3/42.92 2/46.12 |4/46.08 3/47.23 2/45.99 0/45.46 |
|POLY-3 PERCENT (g) | 8.6% 2.1% 7.0% 4.3% |8.7% 6.4% 4.4% 0.0% |
|TERMINAL (d) | 3/40 (8%) 1/42 (2%) 2/35 (6%) 1/37 (3%) |2/35 (6%) 1/37 (3%) 1/39 (3%) 0/37 (0%) |
|FIRST INCIDENCE | 678 729 (T) 520 441 |177 21 701 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.413N P=0.166N P=0.567N P=0.365N |P=0.035N* P=0.485N P=0.316N P=0.060N |
|POLY 3 | P=0.385N P=0.174N P=0.546N P=0.343N |P=0.038N* P=0.486N P=0.338N P=0.062N |
|POLY 1.5 | P=0.380N P=0.176N P=0.534N P=0.341N |P=0.039N* P=0.491N P=0.341N P=0.063N |
|POLY 6 | P=0.392N P=0.170N P=0.555N P=0.347N |P=0.037N* P=0.483N P=0.335N P=0.060N |
|LOGISTIC REGRESSION| P=0.347N P=0.172N P=0.505N P=0.291N |P=0.045N* P=0.536N P=0.338N P=0.081N |
|COCH-ARM / FISHERS | P=0.371N P=0.181N P=0.500N P=0.339N |P=0.038N* P=0.500N P=0.339N P=0.061N |
|ORDER RESTRICTED | P=0.293N (e) (e) (e) |P=0.037N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Glands |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 32/50 (64%) 24/50 (48%) 26/50 (52%) |23/50 (46%) 30/50 (60%) 23/50 (46%) 20/49 (41%) |
|POLY-3 RATE (b) | 33/48.30 32/49.14 24/45.48 26/47.29 |23/47.28 30/47.75 23/46.66 20/45.96 |
|POLY-3 PERCENT (g) | 68.3% 65.1% 52.8% 55.0% |48.7% 62.8% 49.3% 43.5% |
|TERMINAL (d) | 27/40 (68%) 27/42 (64%) 18/35 (51%) 20/37 (54%) |15/35 (43%) 23/37 (62%) 19/39 (49%) 18/37 (49%) |
|FIRST INCIDENCE | 598 493 412 551 |368 515 648 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.198N P=0.390N P=0.217N P=0.240N |P=0.111N P=0.203 P=0.433N P=0.271N |
|POLY 3 | P=0.076N P=0.452N P=0.087N P=0.125N |P=0.177N P=0.115 P=0.557 P=0.386N |
|POLY 1.5 | P=0.068N P=0.471N P=0.077N P=0.119N |P=0.170N P=0.112 P=0.563 P=0.379N |
|POLY 6 | P=0.084N P=0.431N P=0.098N P=0.132N |P=0.181N P=0.115 P=0.547 P=0.390N |
|LOGISTIC REGRESSION| P=0.071N P=0.485N P=0.085N P=0.129N |P=0.147N P=0.119 P=0.564N P=0.351N |
|COCH-ARM / FISHERS | P=0.058N P=0.500N P=0.053N P=0.111N |P=0.170N P=0.115 P=0.579N P=0.376N |
|ORDER RESTRICTED | P=0.108N (e) (e) (e) |P=0.180N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |8/50 (16%) 5/50 (10%) 4/50 (8%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/46.73 1/47.50 2/43.28 0/45.34 |8/46.13 5/45.87 4/46.49 1/45.46 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 4.6% 0.0% |17.3% 10.9% 8.6% 2.2% |
|TERMINAL (d) | 0/40 (0%) 1/42 (2%) 1/35 (3%) 0/37 (0%) |6/35 (17%) 5/37 (14%) 3/39 (8%) 1/37 (3%) |
|FIRST INCIDENCE | 676 729 (T) 26 --- |177 731 (T) 530 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.389N P=0.750N P=0.470 P=0.510N |P=0.010N* P=0.249N P=0.146N P=0.016N* |
|POLY 3 | P=0.380N P=0.757N P=0.473 P=0.506N |P=0.012N* P=0.279N P=0.173N P=0.017N* |
|POLY 1.5 | P=0.375N P=0.758N P=0.483 P=0.504N |P=0.012N* P=0.282N P=0.178N P=0.017N* |
|POLY 6 | P=0.387N P=0.754N P=0.466 P=0.509N |P=0.011N* P=0.278N P=0.168N P=0.016N* |
|LOGISTIC REGRESSION| P=0.282N P=0.759 P=0.731N P=0.483N |P=0.013N* P=0.278N P=0.181N P=0.022N* |
|COCH-ARM / FISHERS | P=0.366N P=0.753N P=0.500 P=0.500N |P=0.013N* P=0.277N P=0.178N P=0.017N* |
|ORDER RESTRICTED | P=0.271N (e) (e) (e) |P=0.009N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | 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%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |24/50 (48%) 19/50 (38%) 20/50 (40%) 13/49 (27%) |
|POLY-3 RATE (b) | 0/46.53 1/47.50 3/42.28 0/45.34 |24/46.43 19/47.21 20/47.65 13/45.66 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 7.1% 0.0% |51.7% 40.3% 42.0% 28.5% |
|TERMINAL (d) | 0/40 (0%) 1/42 (2%) 3/35 (9%) 0/37 (0%) |20/35 (57%) 13/37 (35%) 15/39 (39%) 11/37 (30%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |177 598 75 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.602 P=0.510 P=0.098 (e) |P=0.015N* P=0.170N P=0.173N P=0.012N* |
|POLY 3 | P=0.621 P=0.504 P=0.102 (e) |P=0.020N* P=0.181N P=0.228N P=0.017N* |
|POLY 1.5 | P=0.627 P=0.502 P=0.107 (e) |P=0.021N* P=0.200N P=0.245N P=0.019N* |
|POLY 6 | P=0.615 P=0.507 P=0.099 (e) |P=0.017N* P=0.159N P=0.208N P=0.014N* |
|LOGISTIC REGRESSION| (e) P=0.510 P=0.098 (e) |P=0.022N* P=0.202N P=0.273N P=0.019N* |
|COCH-ARM / FISHERS | P=0.634 P=0.500 P=0.121 (e) |P=0.023N* P=0.210N P=0.273N P=0.022N* |
|ORDER RESTRICTED | P=0.202 (e) (e) (e) |P=0.014N* (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 11/50 (22%) 13/50 (26%) 6/50 (12%) |3/50 (6%) 3/50 (6%) 7/50 (14%) 1/49 (2%) |
|POLY-3 RATE (b) | 9/46.53 11/48.19 13/42.87 6/46.11 |3/45.28 3/46.85 7/46.13 1/45.46 |
|POLY-3 PERCENT (g) | 19.3% 22.8% 30.3% 13.0% |6.6% 6.4% 15.2% 2.2% |
|TERMINAL (d) | 9/40 (23%) 10/42 (24%) 11/35 (31%) 4/37 (11%) |1/35 (3%) 1/37 (3%) 5/39 (13%) 1/37 (3%) |
|FIRST INCIDENCE | 729 (T) 493 639 551 |681 515 695 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.316N P=0.447 P=0.139 P=0.341N |P=0.295N P=0.645N P=0.197 P=0.286N |
|POLY 3 | P=0.245N P=0.435 P=0.168 P=0.293N |P=0.318N P=0.646N P=0.165 P=0.304N |
|POLY 1.5 | P=0.238N P=0.421 P=0.184 P=0.292N |P=0.320N P=0.652N P=0.162 P=0.306N |
|POLY 6 | P=0.248N P=0.455 P=0.160 P=0.292N |P=0.312N P=0.642N P=0.167 P=0.300N |
|LOGISTIC REGRESSION| P=0.255N P=0.417 P=0.145 P=0.303N |P=0.330N P=0.662 P=0.165 P=0.305N |
|COCH-ARM / FISHERS | P=0.225N P=0.402 P=0.235 P=0.288N |P=0.330N P=0.661N P=0.159 P=0.316N |
|ORDER RESTRICTED | P=0.148N (e) (e) (e) |P=0.151N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Turbinate |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/46.53 0/47.50 0/42.28 0/45.34 |0/44.99 0/45.87 2/45.87 0/45.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.4% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 0/37 (0%) 2/39 (5%) 0/37 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.606 (e) P=0.262 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.605 (e) P=0.242 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.601 (e) P=0.240 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.613 (e) P=0.243 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.262 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.591 (e) P=0.247 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.251 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |14/49 (29%) 13/50 (26%) 13/48 (27%) 9/50 (18%) |
|POLY-3 RATE (b) | |14/44.98 13/46.62 13/45.13 9/46.62 |
|POLY-3 PERCENT (g) | |31.1% 27.9% 28.8% 19.3% |
|TERMINAL (d) | |14/35 (40%) 7/37 (19%) 10/38 (26%) 7/38 (18%) |
|FIRST INCIDENCE | |731 (T) 662 530 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.102N P=0.441N P=0.407N P=0.115N |
|POLY 3 | |P=0.121N P=0.456N P=0.496N P=0.143N |
|POLY 1.5 | |P=0.127N P=0.473N P=0.516N P=0.151N |
|POLY 6 | |P=0.110N P=0.433N P=0.467N P=0.129N |
|LOGISTIC REGRESSION| |P=0.121N P=0.471N P=0.523N P=0.108N |
|COCH-ARM / FISHERS | |P=0.132N P=0.475N P=0.525N P=0.157N |
|ORDER RESTRICTED | |P=0.155N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.24 0/47.50 0/41.84 0/45.34 |3/45.09 0/45.87 1/45.09 0/46.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.7% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |2/35 (6%) 0/37 (0%) 1/39 (3%) 0/38 (0%) |
|FIRST INCIDENCE | --- --- --- --- |706 --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.078N P=0.115N P=0.278N P=0.108N |
|POLY 3 | (e) (e) (e) (e) |P=0.085N P=0.116N P=0.305N P=0.113N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.085N P=0.117N P=0.308N P=0.115N |
|POLY 6 | (e) (e) (e) (e) |P=0.084N P=0.115N P=0.302N P=0.111N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.081N P=0.116N P=0.298N P=0.112N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.087N P=0.121N P=0.316N P=0.121N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.019N* (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/47 (0%) 0/48 (0%) 0/49 (0%) |1/50 (2%) 3/49 (6%) 3/48 (6%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/46.53 0/45.01 0/40.84 0/44.34 |1/44.99 3/45.32 3/44.28 2/45.56 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 6.6% 6.8% 4.4% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/34 (0%) 0/36 (0%) |1/35 (3%) 1/36 (3%) 3/39 (8%) 1/38 (3%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) 628 731 (T) 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.516 P=0.319 P=0.344 P=0.533 |
|POLY 3 | (e) (e) (e) (e) |P=0.487 P=0.308 P=0.299 P=0.504 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.481 P=0.304 P=0.296 P=0.501 |
|POLY 6 | (e) (e) (e) (e) |P=0.498 P=0.311 P=0.304 P=0.511 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.479 P=0.298 P=0.344 P=0.513 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.469 P=0.301 P=0.293 P=0.492 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.333 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/47 (0%) 2/48 (4%) 0/49 (0%) |10/50 (20%) 8/49 (16%) 13/48 (27%) 11/49 (22%) |
|POLY-3 RATE (b) | 1/46.53 0/45.01 2/41.57 0/44.34 |10/45.02 8/44.87 13/44.81 11/45.49 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 4.8% 0.0% |22.2% 17.8% 29.0% 24.2% |
|TERMINAL (d) | 1/40 (3%) 0/42 (0%) 1/34 (3%) 0/36 (0%) |9/35 (26%) 8/36 (22%) 12/39 (31%) 11/38 (29%) |
|FIRST INCIDENCE | 729 (T) --- 471 --- |724 731 (T) 567 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.488N P=0.490N P=0.458 P=0.521N |P=0.425 P=0.369N P=0.421 P=0.586 |
|POLY 3 | P=0.476N P=0.507N P=0.461 P=0.510N |P=0.351 P=0.399N P=0.310 P=0.511 |
|POLY 1.5 | P=0.470N P=0.509N P=0.467 P=0.507N |P=0.342 P=0.406N P=0.296 P=0.501 |
|POLY 6 | P=0.483N P=0.502N P=0.457 P=0.512N |P=0.369 P=0.397N P=0.327 P=0.528 |
|LOGISTIC REGRESSION| P=0.436N (e) P=0.550 (e) |P=0.390 P=0.380N P=0.310 P=0.591 |
|COCH-ARM / FISHERS | P=0.462N P=0.515N P=0.485 P=0.505N |P=0.322 P=0.416N P=0.278 P=0.479 |
|ORDER RESTRICTED | P=0.316N (e) (e) (e) |P=0.365 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 1/50 (2%) | |
|POLY-3 RATE (b) | 2/46.73 3/47.60 0/42.28 1/45.34 | |
|POLY-3 PERCENT (g) | 4.3% 6.3% 0.0% 2.2% | |
|TERMINAL (d) | 1/40 (3%) 2/42 (5%) 0/35 (0%) 1/37 (3%) | |
|FIRST INCIDENCE | 676 704 --- 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.273N P=0.524 P=0.268N P=0.524N | |
|POLY 3 | P=0.256N P=0.508 P=0.260N P=0.510N | |
|POLY 1.5 | P=0.251N P=0.504 P=0.253N P=0.506N | |
|POLY 6 | P=0.261N P=0.515 P=0.266N P=0.515N | |
|LOGISTIC REGRESSION| P=0.256N P=0.502 P=0.247N P=0.506N | |
|COCH-ARM / FISHERS | P=0.242N P=0.500 P=0.247N P=0.500N | |
|ORDER RESTRICTED | P=0.205N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 RATE (b) | 0/46.53 1/47.50 0/42.28 2/45.81 | |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 4.4% | |
|TERMINAL (d) | 0/40 (0%) 1/42 (2%) 0/35 (0%) 1/37 (3%) | |
|FIRST INCIDENCE | --- 729 (T) --- 593 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.129 P=0.510 (e) P=0.227 | |
|POLY 3 | P=0.135 P=0.504 (e) P=0.234 | |
|POLY 1.5 | P=0.136 P=0.502 (e) P=0.235 | |
|POLY 6 | P=0.134 P=0.507 (e) P=0.233 | |
|LOGISTIC REGRESSION| P=0.142 P=0.510 (e) P=0.264 | |
|COCH-ARM / FISHERS | P=0.140 P=0.500 (e) P=0.247 | |
|ORDER RESTRICTED | P=0.073 (e) (e) (e) | |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/49 (2%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 5/50 (10%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.53 2/47.52 1/41.99 0/45.34 |2/44.99 2/45.87 5/46.49 2/46.46 |
|POLY-3 PERCENT (g) | 0.0% 4.2% 2.4% 0.0% |4.5% 4.4% 10.8% 4.3% |
|TERMINAL (d) | 0/40 (0%) 1/42 (2%) 0/34 (0%) 0/37 (0%) |2/35 (6%) 2/37 (5%) 4/39 (10%) 2/38 (5%) |
|FIRST INCIDENCE | --- 724 480 --- |731 (T) 731 (T) 530 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.481N P=0.253 P=0.488 (e) |P=0.556 P=0.675N P=0.258 P=0.665N |
|POLY 3 | P=0.472N P=0.242 P=0.480 (e) |P=0.540 P=0.687N P=0.230 P=0.682N |
|POLY 1.5 | P=0.469N P=0.240 P=0.484 (e) |P=0.534 P=0.690N P=0.225 P=0.686N |
|POLY 6 | P=0.475N P=0.245 P=0.477 (e) |P=0.552 P=0.686N P=0.235 P=0.676N |
|LOGISTIC REGRESSION| P=0.436N P=0.250 P=0.669 (e) |P=0.530 P=0.675N P=0.218 P=0.665N |
|COCH-ARM / FISHERS | P=0.462N P=0.247 P=0.495 (e) |P=0.521 P=0.691N P=0.218 P=0.691N |
|ORDER RESTRICTED | P=0.317 (e) (e) (e) |P=0.420 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/49 (2%) 3/49 (6%) |5/50 (10%) 1/50 (2%) 7/49 (14%) 5/50 (10%) |
|POLY-3 RATE (b) | 2/46.53 1/47.50 1/41.84 3/45.58 |5/45.24 1/46.20 7/46.27 5/46.46 |
|POLY-3 PERCENT (g) | 4.3% 2.1% 2.4% 6.6% |11.1% 2.2% 15.1% 10.8% |
|TERMINAL (d) | 2/40 (5%) 1/42 (2%) 1/35 (3%) 1/37 (3%) |3/35 (9%) 0/37 (0%) 3/39 (8%) 5/38 (13%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 513 |691 638 551 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.293 P=0.483N P=0.547N P=0.474 |P=0.384 P=0.101N P=0.429 P=0.577N |
|POLY 3 | P=0.309 P=0.493N P=0.537N P=0.491 |P=0.348 P=0.097N P=0.395 P=0.613N |
|POLY 1.5 | P=0.312 P=0.496N P=0.529N P=0.490 |P=0.346 P=0.099N P=0.382 P=0.618N |
|POLY 6 | P=0.307 P=0.487N P=0.542N P=0.492 |P=0.355 P=0.095N P=0.410 P=0.607N |
|LOGISTIC REGRESSION| P=0.317 P=0.483N P=0.547N P=0.511 |P=0.339 P=0.102N P=0.365 P=0.598N |
|COCH-ARM / FISHERS | P=0.316 P=0.500N P=0.508N P=0.490 |P=0.337 P=0.102N P=0.365 P=0.630N |
|ORDER RESTRICTED | P=0.288 (e) (e) (e) |P=0.240 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/49 (6%) 2/49 (4%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/47.53 3/46.69 2/42.99 1/45.68 |1/45.50 2/46.05 1/45.87 2/46.46 |
|POLY-3 PERCENT (g) | 6.3% 6.4% 4.7% 2.2% |2.2% 4.3% 2.2% 4.3% |
|TERMINAL (d) | 0/40 (0%) 3/42 (7%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 1/37 (3%) 1/39 (3%) 2/38 (5%) |
|FIRST INCIDENCE | 612 729 (T) 480 637 |578 683 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.227N P=0.645N P=0.559N P=0.329N |P=0.467 P=0.512 P=0.751N P=0.519 |
|POLY 3 | P=0.210N P=0.654 P=0.545N P=0.320N |P=0.452 P=0.504 P=0.759N P=0.507 |
|POLY 1.5 | P=0.204N P=0.653 P=0.536N P=0.314N |P=0.451 P=0.503 P=0.759N P=0.505 |
|POLY 6 | P=0.217N P=0.655 P=0.553N P=0.326N |P=0.457 P=0.505 P=0.759N P=0.511 |
|LOGISTIC REGRESSION| P=0.157N P=0.631 P=0.344N P=0.220N |P=0.443 P=0.500 P=0.762 P=0.489 |
|COCH-ARM / FISHERS | P=0.193N P=0.651 P=0.510N P=0.309N |P=0.444 P=0.500 P=0.753N P=0.500 |
|ORDER RESTRICTED | P=0.277N (e) (e) (e) |P=0.452 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 3/49 (6%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/46.90 2/46.69 3/43.63 0/45.34 |0/44.99 1/46.05 0/45.87 2/46.46 |
|POLY-3 PERCENT (g) | 2.1% 4.3% 6.9% 0.0% |0.0% 2.2% 0.0% 4.3% |
|TERMINAL (d) | 0/40 (0%) 2/42 (5%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 2/38 (5%) |
|FIRST INCIDENCE | 622 729 (T) 480 --- |--- 683 --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364N P=0.516 P=0.270 P=0.509N |P=0.151 P=0.505 (e) P=0.257 |
|POLY 3 | P=0.355N P=0.498 P=0.280 P=0.507N |P=0.144 P=0.505 (e) P=0.244 |
|POLY 1.5 | P=0.347N P=0.496 P=0.283 P=0.504N |P=0.143 P=0.503 (e) P=0.242 |
|POLY 6 | P=0.363N P=0.503 P=0.279 P=0.510N |P=0.147 P=0.506 (e) P=0.248 |
|LOGISTIC REGRESSION| P=0.280N P=0.480 P=0.485 P=0.443N |P=0.143 P=0.499 (e) P=0.257 |
|COCH-ARM / FISHERS | P=0.336N P=0.492 P=0.301 P=0.500N |P=0.140 P=0.500 (e) P=0.247 |
|ORDER RESTRICTED | P=0.184N (e) (e) (e) |P=0.079 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 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) | 2/50 (4%) 1/49 (2%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.73 1/47.18 0/41.84 2/46.69 |0/44.99 0/45.87 0/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 4.3% 2.1% 0.0% 4.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | 676 582 --- 441 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.570 P=0.492N P=0.268N P=0.679 |(e) (e) (e) (e) |
|POLY 3 | P=0.582 P=0.497N P=0.263N P=0.693 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.586 P=0.501N P=0.257N P=0.694 |(e) (e) (e) (e) |
|POLY 6 | P=0.578 P=0.490N P=0.267N P=0.693 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.604N P=0.532N P=0.250N P=0.573N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.592 P=0.508N P=0.253N P=0.691N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.425 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.53 0/46.69 0/41.84 0/45.34 |2/45.86 0/45.87 0/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |1/35 (3%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | --- --- --- --- |368 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.112N P=0.234N P=0.228N P=0.231N |
|POLY 3 | (e) (e) (e) (e) |P=0.114N P=0.237N P=0.237N P=0.234N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.114N P=0.238N P=0.238N P=0.236N |
|POLY 6 | (e) (e) (e) (e) |P=0.114N P=0.237N P=0.236N P=0.231N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.121N P=0.216N P=0.224N P=0.291N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.247N P=0.247N P=0.247N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.029N* (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) |2/49 (4%) 0/50 (0%) 0/48 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/46.24 0/46.69 0/41.84 0/45.12 |2/44.54 0/45.87 0/44.28 0/46.37 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |1/35 (3%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | --- --- --- --- |681 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.110N P=0.234N P=0.228N P=0.226N |
|POLY 3 | (e) (e) (e) (e) |P=0.116N P=0.231N P=0.238N P=0.228N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.116N P=0.231N P=0.240N P=0.231N |
|POLY 6 | (e) (e) (e) (e) |P=0.116N P=0.231N P=0.237N P=0.226N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.115N P=0.232N P=0.241N P=0.235N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.116N P=0.242N P=0.253N P=0.247N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.026N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | |
|POLY-3 RATE (b) | 2/46.63 2/47.50 3/42.28 1/45.54 | |
|POLY-3 PERCENT (g) | 4.3% 4.2% 7.1% 2.2% | |
|TERMINAL (d) | 1/40 (3%) 2/42 (5%) 3/35 (9%) 0/37 (0%) | |
|FIRST INCIDENCE | 704 729 (T) 729 (T) 678 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.446N P=0.674N P=0.440 P=0.515N | |
|POLY 3 | P=0.421N P=0.687N P=0.456 P=0.508N | |
|POLY 1.5 | P=0.415N P=0.690N P=0.468 P=0.505N | |
|POLY 6 | P=0.427N P=0.682N P=0.446 P=0.511N | |
|LOGISTIC REGRESSION| P=0.427N P=0.682N P=0.446 P=0.499N | |
|COCH-ARM / FISHERS | P=0.404N P=0.691N P=0.500 P=0.500N | |
|ORDER RESTRICTED | P=0.391N (e) (e) (e) | |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 RATE (b) | 1/46.53 0/47.50 1/42.28 2/45.34 | |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.4% 4.4% | |
|TERMINAL (d) | 1/40 (3%) 0/42 (0%) 1/35 (3%) 2/37 (5%) | |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.221 P=0.490N P=0.732 P=0.473 | |
|POLY 3 | P=0.237 P=0.496N P=0.739 P=0.491 | |
|POLY 1.5 | P=0.242 P=0.498N P=0.745 P=0.494 | |
|POLY 6 | P=0.233 P=0.493N P=0.734 P=0.488 | |
|LOGISTIC REGRESSION| P=0.221 (e) P=0.732 P=0.473 | |
|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 |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/49 (8%) 6/50 (12%) 8/50 (16%) |7/50 (14%) 5/50 (10%) 11/49 (22%) 8/48 (17%) |
|POLY-3 RATE (b) | 4/46.53 4/46.71 6/42.72 8/45.36 |7/45.48 5/46.26 11/45.63 8/44.99 |
|POLY-3 PERCENT (g) | 8.6% 8.6% 14.1% 17.6% |15.4% 10.8% 24.1% 17.8% |
|TERMINAL (d) | 4/40 (10%) 3/42 (7%) 5/35 (14%) 7/37 (19%) |6/35 (17%) 4/37 (11%) 9/38 (24%) 6/37 (16%) |
|FIRST INCIDENCE | 729 (T) 724 602 725 |586 620 567 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.067 P=0.614N P=0.288 P=0.144 |P=0.346 P=0.343N P=0.271 P=0.545 |
|POLY 3 | P=0.085 P=0.641N P=0.317 P=0.164 |P=0.296 P=0.367N P=0.217 P=0.491 |
|POLY 1.5 | P=0.090 P=0.639 P=0.331 P=0.169 |P=0.289 P=0.372N P=0.211 P=0.483 |
|POLY 6 | P=0.079 P=0.631N P=0.308 P=0.159 |P=0.311 P=0.364N P=0.223 P=0.506 |
|LOGISTIC REGRESSION| P=0.079 P=0.610N P=0.305 P=0.154 |P=0.286 P=0.373N P=0.209 P=0.483 |
|COCH-ARM / FISHERS | P=0.100 P=0.631 P=0.370 P=0.178 |P=0.275 P=0.380N P=0.204 P=0.465 |
|ORDER RESTRICTED | P=0.140 (e) (e) (e) |P=0.254 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 2/50 (4%) 1/49 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | |1/44.99 2/45.87 1/45.09 2/46.46 |
|POLY-3 PERCENT (g) | |2.2% 4.4% 2.2% 4.3% |
|TERMINAL (d) | |1/35 (3%) 2/37 (5%) 1/39 (3%) 2/38 (5%) |
|FIRST INCIDENCE | |731 (T) 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.472 P=0.519 P=0.738N P=0.529 |
|POLY 3 | |P=0.456 P=0.507 P=0.760N P=0.511 |
|POLY 1.5 | |P=0.452 P=0.504 P=0.759 P=0.508 |
|POLY 6 | |P=0.463 P=0.508 P=0.758N P=0.517 |
|LOGISTIC REGRESSION| |P=0.472 P=0.519 P=0.738N P=0.529 |
|COCH-ARM / FISHERS | |P=0.444 P=0.500 P=0.747 P=0.500 |
|ORDER RESTRICTED | |P=0.457 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |49/50 (98%) 48/50 (96%) 46/49 (94%) 49/50 (98%) |
|POLY-3 RATE (b) | |49/49.01 48/49.00 46/47.68 49/50.00 |
|POLY-3 PERCENT (g) | |100.0% 98.0% 96.5% 98.0% |
|TERMINAL (d) | |35/35 (100%) 36/37 (97%) 39/39 (100%) 37/38 (97%) |
|FIRST INCIDENCE | |368 515 530 329 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.260N P=0.331N P=0.088N P=0.298N |
|POLY 3 | |P=0.381N P=0.506N P=0.279N P=0.510N |
|POLY 1.5 | |P=0.404N P=0.545N P=0.275N P=0.551N |
|POLY 6 | |P=0.379N P=0.500N P=0.332N P=0.504N |
|LOGISTIC REGRESSION| |P=0.513N P=0.465N P=0.200N P=0.673N |
|COCH-ARM / FISHERS | |P=0.578 P=0.500N P=0.301N P=0.753N |
|ORDER RESTRICTED | |P=0.239N (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).