TDMS Study 05135-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest ISOPRENE DATE: 10/15/04
EXPERIMENT: 05135 TEST: 06 TIME: 13:31:40
TEST TYPE: SIX MONTH EXPOS. PAGE: 1
CONT: N01-ES-55105 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61825C
PATHOLOGIST: HAILEY, JAMES R. PERSING, RONALD CAS: 78-79-5
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REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest ISOPRENE DATE: 10/15/04
EXPERIMENT: 05135 TEST: 06 TIME: 13:31:40
TEST TYPE: SIX MONTH EXPOS.
CONT: N01-ES-55105 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61825C
PATHOLOGIST: HAILEY, JAMES R. PERSING, RONALD CAS: 78-79-5
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF ISOPRENE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Bone Marrow Hyperplasia
Brain Hemorrhage
Islets, Pancreatic Hyperplasia
Liver Eosinophilic Focus
Mixed Cell Focus
Necrosis
Vacuolization Cytoplasmic
Lung Congestion
Lung: Alveolar Epithelium Hyperplasia
Nose Inflammation
Nose: Turbinate, Olfactory Epithelium Degeneration
Inflammation Chronic
Pancreas Focal Cellular Change
Peripheral Nerve: Sciatic Degeneration
Pituitary Gland: Pars Distalis Cyst
Preputial Gland Inflammation
Prostate Inflammation
Salivary Glands Inflammation
Skeletal Muscle Atrophy
Skin Inflammation
Spinal Cord Degeneration
Spleen Pigmentation Melanin
Stomach, Forestomach: Epithelium Hyperplasia
Stomach, Glandular Hyperplasia
Inflammation
Necrosis
Testes Atrophy
Thymus Necrosis
Urinary Bladder Dilatation
===============================================================
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/40 (15%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 8/39 (21%) 6/38 (16%) |
|POLY-3 RATE (b) | 6/28.81 0/1.54 0/1.78 0/2.94 8/28.36 6/23.81 |
|POLY-3 PERCENT (g) | 20.8% 0.0% 0.0% 0.0% 28.2% 25.2% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 6/27 (22%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/26 (31%) 6/21 (29%) |
|FIRST INCIDENCE | 371 (T) --- --- --- 371 (T) 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.427 P=1.000N P=1.000 P=1.000N P=0.348 P=0.434 |
|POLY 3 | P=0.427 P=0.577N P=0.562N P=0.478N P=0.367 P=0.482 |
|POLY 1.5 | P=0.376 P=0.426N P=0.413N P=0.342N P=0.368 P=0.516 |
|POLY 6 | P=0.426 P=0.664N P=0.653N P=0.569N P=0.362 P=0.458 |
|LOGISTIC REGRESSION| P=0.427 (e) (e) (e) P=0.348 P=0.434 |
|COCH-ARM / FISHERS | P=0.205 P=0.189N P=0.213N P=0.167N P=0.365 P=0.585 |
|ORDER RESTRICTED | P=0.230 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/40 (13%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 6/39 (15%) 4/38 (11%) |
|POLY-3 RATE (b) | 5/28.81 0/1.54 0/1.78 0/2.94 6/28.36 4/24.18 |
|POLY-3 PERCENT (g) | 17.4% 0.0% 0.0% 0.0% 21.2% 16.5% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/27 (19%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/26 (23%) 3/21 (14%) |
|FIRST INCIDENCE | 371 (T) --- --- --- 371 (T) 317 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.555 P=1.000N P=1.000 P=1.000N P=0.472 P=0.630 |
|POLY 3 | P=0.571N P=0.603N P=0.591N P=0.516N P=0.489 P=0.612N |
|POLY 1.5 | P=0.576 P=0.470N P=0.460N P=0.392N P=0.489 P=0.589N |
|POLY 6 | P=0.561N P=0.678N P=0.670N P=0.595N P=0.485 P=0.623N |
|LOGISTIC REGRESSION| P=0.586 (e) (e) (e) P=0.472 P=0.636N |
|COCH-ARM / FISHERS | P=0.381 P=0.253N P=0.280N P=0.229N P=0.482 P=0.533N |
|ORDER RESTRICTED | P=0.492 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 0/12 (0%) 0/11 (0%) 1/13 (8%) 2/40 (5%) 4/38 (11%) |
|POLY-3 RATE (b) | 1/29.33 0/1.54 0/1.78 1/3.28 2/28.80 4/24.63 |
|POLY-3 PERCENT (g) | 3.4% 0.0% 0.0% 30.5% 6.9% 16.2% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/26 (4%) 3/21 (14%) |
|FIRST INCIDENCE | 289 --- --- 324 326 209 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.029 * P=0.500N P=0.493N P=0.748N P=0.496 P=0.123 |
|POLY 3 | P=0.080 P=0.836N P=0.842N P=0.315 P=0.494 P=0.125 |
|POLY 1.5 | P=0.082 P=0.811N P=0.817N P=0.375 P=0.497 P=0.136 |
|POLY 6 | P=0.073 P=0.848N P=0.854N P=0.284 P=0.490 P=0.118 |
|LOGISTIC REGRESSION| P=0.091 P=0.814N P=0.802N P=0.416 P=0.499 P=0.146 |
|COCH-ARM / FISHERS | P=0.064 P=0.769N P=0.784N P=0.434 P=0.500 P=0.164 |
|ORDER RESTRICTED | P=0.015 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/12 (0%) 0/11 (0%) 2/13 (15%) 0/40 (0%) 0/38 (0%) |
|POLY-3 RATE (b) | 0/28.81 0/1.54 0/1.78 2/3.87 0/28.48 0/23.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 51.7% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/26 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- --- 176 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.591N (e) (e) P=0.247 (e) (e) |
|POLY 3 | P=0.570N (e) (e) P=0.013 * (e) (e) |
|POLY 1.5 | P=0.488N (e) (e) P=0.019 * (e) (e) |
|POLY 6 | P=0.626N (e) (e) P=0.011 * (e) (e) |
|LOGISTIC REGRESSION| P=0.406N (e) (e) P=0.043 * (e) (e) |
|COCH-ARM / FISHERS | P=0.403N (e) (e) P=0.057 (e) (e) |
|ORDER RESTRICTED | P=0.051N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Brain |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 2/40 (5%) 0/38 (0%) |
|POLY-3 RATE (b) | 1/28.81 0/1.54 0/1.78 0/2.94 2/28.48 0/23.81 |
|POLY-3 PERCENT (g) | 3.5% 0.0% 0.0% 0.0% 7.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/26 (8%) 0/21 (0%) |
|FIRST INCIDENCE | 371 (T) --- --- --- 371 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.380N P=1.000N P=1.000 P=1.000N P=0.487 P=0.550N |
|POLY 3 | P=0.370N P=0.836N P=0.842N P=0.814N P=0.496 P=0.538N |
|POLY 1.5 | P=0.390N P=0.811N P=0.816N P=0.786N P=0.499 P=0.529N |
|POLY 6 | P=0.370N P=0.848N P=0.854N P=0.828N P=0.493 P=0.544N |
|LOGISTIC REGRESSION| P=0.380N (e) (e) (e) P=0.487 (e) |
|COCH-ARM / FISHERS | P=0.472N P=0.769N P=0.784N P=0.755N P=0.500 P=0.513N |
|ORDER RESTRICTED | P=0.184N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 0/40 (0%) 3/39 (8%) 2/40 (5%) 3/40 (8%) 2/38 (5%) |
|POLY-3 RATE (b) | 1/28.81 0/29.54 3/31.08 2/30.31 3/29.68 2/24.18 |
|POLY-3 PERCENT (g) | 3.5% 0.0% 9.7% 6.6% 10.1% 8.3% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 0/28 (0%) 1/28 (4%) 0/27 (0%) 1/26 (4%) 1/21 (5%) |
|FIRST INCIDENCE | 371 (T) --- 183 (I) 324 183 (I) 317 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.325 P=0.493N P=0.321 P=0.512 P=0.301 P=0.423 |
|POLY 3 | P=0.315 P=0.495N P=0.331 P=0.518 P=0.314 P=0.439 |
|POLY 1.5 | P=0.340 P=0.497N P=0.321 P=0.513 P=0.311 P=0.451 |
|POLY 6 | P=0.303 P=0.494N P=0.339 P=0.522 P=0.316 P=0.432 |
|LOGISTIC REGRESSION| P=0.388 (e) P=0.291 P=0.512 P=0.304 P=0.437 |
|COCH-ARM / FISHERS | P=0.400 P=0.500N P=0.298 P=0.500 P=0.308 P=0.481 |
|ORDER RESTRICTED | P=0.252 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/40 (23%) 9/40 (23%) 12/39 (31%) 12/40 (30%) 16/40 (40%) 13/38 (34%) |
|POLY-3 RATE (b) | 9/28.81 9/29.54 12/29.78 12/29.94 16/28.48 13/23.81 |
|POLY-3 PERCENT (g) | 31.2% 30.5% 40.3% 40.1% 56.2% 54.6% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 9/27 (33%) 9/28 (32%) 12/28 (43%) 12/27 (44%) 16/26 (62%) 13/21 (62%) |
|FIRST INCIDENCE | 371 (T) 371 (T) 371 (T) 371 (T) 371 (T) 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.016 * P=0.576N P=0.328 P=0.290 P=0.039 * P=0.048 * |
|POLY 3 | P=0.032 * P=0.587N P=0.326 P=0.332 P=0.045 * P=0.072 |
|POLY 1.5 | P=0.055 P=0.597N P=0.314 P=0.326 P=0.052 P=0.099 |
|POLY 6 | P=0.022 * P=0.580N P=0.331 P=0.334 P=0.041 * P=0.058 |
|LOGISTIC REGRESSION| P=0.016 * P=0.576N P=0.328 P=0.290 P=0.039 * P=0.048 * |
|COCH-ARM / FISHERS | P=0.154 P=0.605N P=0.282 P=0.306 P=0.074 P=0.185 |
|ORDER RESTRICTED | P=0.060 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 0/40 (0%) 1/38 (3%) |
|POLY-3 RATE (b) | 2/29.69 0/2.54 0/1.78 0/3.94 0/28.48 1/23.81 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 0.0% 0.0% 0.0% 4.2% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 0/1 (0%) 0/0 (0%) 0/1 (0%) 0/26 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 183 (I) --- --- --- --- 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.689N P=0.473N P=0.500N P=0.473N P=0.244N P=0.558N |
|POLY 3 | P=0.575N P=0.703N P=0.736N P=0.661N P=0.245N P=0.577N |
|POLY 1.5 | P=0.604N P=0.644N P=0.675N P=0.602N P=0.241N P=0.558N |
|POLY 6 | P=0.566N P=0.735N P=0.769N P=0.695N P=0.248N P=0.588N |
|LOGISTIC REGRESSION| P=0.667N P=0.494N P=0.526N P=0.461N P=0.237N P=0.525N |
|COCH-ARM / FISHERS | P=0.689N P=0.566N P=0.612N P=0.545N P=0.247N P=0.519N |
|ORDER RESTRICTED | P=0.147N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 1/13 (8%) 0/11 (0%) 1/14 (7%) 1/40 (3%) 1/38 (3%) |
|POLY-3 RATE (b) | 2/29.69 1/2.54 0/1.78 1/3.97 1/29.36 1/23.81 |
|POLY-3 PERCENT (g) | 6.7% 39.4% 0.0% 25.2% 3.4% 4.2% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 1/1 (100%) 0/0 (0%) 0/1 (0%) 0/26 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 183 (I) 371 (T) --- 367 183 (I) 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.463N P=0.551 P=0.500N P=0.733N P=0.504N P=0.558N |
|POLY 3 | P=0.434N P=0.365 P=0.736N P=0.425 P=0.504N P=0.577N |
|POLY 1.5 | P=0.401N P=0.450 P=0.675N P=0.505 P=0.501N P=0.558N |
|POLY 6 | P=0.467N P=0.317 P=0.769N P=0.376 P=0.507N P=0.588N |
|LOGISTIC REGRESSION| P=0.363N P=0.538 P=0.526N P=0.598 P=0.504N P=0.525N |
|COCH-ARM / FISHERS | P=0.396N P=0.578 P=0.612N P=0.602 P=0.500N P=0.519N |
|ORDER RESTRICTED | P=0.166N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Bilateral |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 0/40 (0%) 1/38 (3%) |
|POLY-3 RATE (b) | 2/29.69 0/2.54 0/1.78 0/3.94 0/28.48 1/23.81 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 0.0% 0.0% 0.0% 4.2% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 0/1 (0%) 0/0 (0%) 0/1 (0%) 0/26 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 183 (I) --- --- --- --- 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.689N P=0.473N P=0.500N P=0.473N P=0.244N P=0.558N |
|POLY 3 | P=0.575N P=0.703N P=0.736N P=0.661N P=0.245N P=0.577N |
|POLY 1.5 | P=0.604N P=0.644N P=0.675N P=0.602N P=0.241N P=0.558N |
|POLY 6 | P=0.566N P=0.735N P=0.769N P=0.695N P=0.248N P=0.588N |
|LOGISTIC REGRESSION| P=0.667N P=0.494N P=0.526N P=0.461N P=0.237N P=0.525N |
|COCH-ARM / FISHERS | P=0.689N P=0.566N P=0.612N P=0.545N P=0.247N P=0.519N |
|ORDER RESTRICTED | P=0.147N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Bilateral |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 1/13 (8%) 0/11 (0%) 1/14 (7%) 1/40 (3%) 1/38 (3%) |
|POLY-3 RATE (b) | 2/29.69 1/2.54 0/1.78 1/3.97 1/29.36 1/23.81 |
|POLY-3 PERCENT (g) | 6.7% 39.4% 0.0% 25.2% 3.4% 4.2% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 1/1 (100%) 0/0 (0%) 0/1 (0%) 0/26 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 183 (I) 371 (T) --- 367 183 (I) 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.463N P=0.551 P=0.500N P=0.733N P=0.504N P=0.558N |
|POLY 3 | P=0.434N P=0.365 P=0.736N P=0.425 P=0.504N P=0.577N |
|POLY 1.5 | P=0.401N P=0.450 P=0.675N P=0.505 P=0.501N P=0.558N |
|POLY 6 | P=0.467N P=0.317 P=0.769N P=0.376 P=0.507N P=0.588N |
|LOGISTIC REGRESSION| P=0.363N P=0.538 P=0.526N P=0.598 P=0.504N P=0.525N |
|COCH-ARM / FISHERS | P=0.396N P=0.578 P=0.612N P=0.602 P=0.500N P=0.519N |
|ORDER RESTRICTED | P=0.166N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Bilateral, Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 2/40 (5%) 0/38 (0%) |
|POLY-3 RATE (b) | 1/28.81 0/2.54 0/1.78 0/3.94 2/28.48 0/23.81 |
|POLY-3 PERCENT (g) | 3.5% 0.0% 0.0% 0.0% 7.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 0/1 (0%) 0/0 (0%) 0/1 (0%) 2/26 (8%) 0/21 (0%) |
|FIRST INCIDENCE | 371 (T) --- --- --- 371 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.394N P=0.994N P=1.000 P=0.994N P=0.487 P=0.550N |
|POLY 3 | P=0.377N P=0.818N P=0.842N P=0.795N P=0.496 P=0.538N |
|POLY 1.5 | P=0.400N P=0.792N P=0.816N P=0.768N P=0.499 P=0.529N |
|POLY 6 | P=0.374N P=0.831N P=0.854N P=0.810N P=0.493 P=0.544N |
|LOGISTIC REGRESSION| P=0.394N (e) (e) (e) P=0.487 (e) |
|COCH-ARM / FISHERS | P=0.478N P=0.755N P=0.784N P=0.741N P=0.500 P=0.513N |
|ORDER RESTRICTED | P=0.198N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 2/40 (5%) 0/38 (0%) |
|POLY-3 RATE (b) | 1/28.81 0/2.54 0/1.78 0/3.94 2/28.48 0/23.81 |
|POLY-3 PERCENT (g) | 3.5% 0.0% 0.0% 0.0% 7.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 0/1 (0%) 0/0 (0%) 0/1 (0%) 2/26 (8%) 0/21 (0%) |
|FIRST INCIDENCE | 371 (T) --- --- --- 371 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.394N P=0.994N P=1.000 P=0.994N P=0.487 P=0.550N |
|POLY 3 | P=0.377N P=0.818N P=0.842N P=0.795N P=0.496 P=0.538N |
|POLY 1.5 | P=0.400N P=0.792N P=0.816N P=0.768N P=0.499 P=0.529N |
|POLY 6 | P=0.374N P=0.831N P=0.854N P=0.810N P=0.493 P=0.544N |
|LOGISTIC REGRESSION| P=0.394N (e) (e) (e) P=0.487 (e) |
|COCH-ARM / FISHERS | P=0.478N P=0.755N P=0.784N P=0.741N P=0.500 P=0.513N |
|ORDER RESTRICTED | P=0.198N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 0/39 (0%) 2/40 (5%) 1/40 (3%) 2/38 (5%) |
|POLY-3 RATE (b) | 0/28.81 0/29.54 0/29.78 2/29.94 1/28.48 2/24.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.7% 3.5% 8.3% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 2/27 (7%) 1/26 (4%) 1/21 (5%) |
|FIRST INCIDENCE | --- --- --- 371 (T) 371 (T) 317 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.064 (e) (e) P=0.238 P=0.492 P=0.196 |
|POLY 3 | P=0.075 (e) (e) P=0.244 P=0.498 P=0.198 |
|POLY 1.5 | P=0.082 (e) (e) P=0.243 P=0.499 P=0.206 |
|POLY 6 | P=0.072 (e) (e) P=0.245 P=0.496 P=0.194 |
|LOGISTIC REGRESSION| P=0.069 (e) (e) P=0.238 P=0.492 P=0.202 |
|COCH-ARM / FISHERS | P=0.102 (e) (e) P=0.247 P=0.500 P=0.234 |
|ORDER RESTRICTED | P=0.068 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/40 (8%) 1/40 (3%) 2/39 (5%) 4/40 (10%) 5/40 (13%) 4/38 (11%) |
|POLY-3 RATE (b) | 3/28.81 1/29.54 2/30.66 4/31.70 5/28.48 4/24.69 |
|POLY-3 PERCENT (g) | 10.4% 3.4% 6.5% 12.6% 17.6% 16.2% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 3/27 (11%) 1/28 (4%) 1/28 (4%) 2/27 (7%) 5/26 (19%) 3/21 (14%) |
|FIRST INCIDENCE | 371 (T) 371 (T) 183 (I) 183 (I) 371 (T) 183 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.130 P=0.290N P=0.487N P=0.500 P=0.331 P=0.382 |
|POLY 3 | P=0.132 P=0.294N P=0.471N P=0.553 P=0.346 P=0.414 |
|POLY 1.5 | P=0.152 P=0.298N P=0.482N P=0.539 P=0.351 P=0.432 |
|POLY 6 | P=0.120 P=0.292N P=0.466N P=0.560 P=0.341 P=0.402 |
|LOGISTIC REGRESSION| P=0.171 P=0.290N P=0.500N P=0.502 P=0.331 P=0.413 |
|COCH-ARM / FISHERS | P=0.207 P=0.308N P=0.512N P=0.500 P=0.356 P=0.471 |
|ORDER RESTRICTED | P=0.223 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 0/39 (0%) 2/40 (5%) 0/40 (0%) 1/38 (3%) |
|POLY-3 RATE (b) | 0/28.81 0/29.54 0/29.78 2/29.94 0/28.48 1/23.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.7% 0.0% 4.2% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 2/27 (7%) 0/26 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- --- --- 371 (T) --- 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.345 (e) (e) P=0.238 (e) P=0.450 |
|POLY 3 | P=0.356 (e) (e) P=0.244 (e) P=0.462 |
|POLY 1.5 | P=0.371 (e) (e) P=0.243 (e) P=0.471 |
|POLY 6 | P=0.346 (e) (e) P=0.245 (e) P=0.456 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.238 (e) P=0.450 |
|COCH-ARM / FISHERS | P=0.404 (e) (e) P=0.247 (e) P=0.487 |
|ORDER RESTRICTED | P=0.237 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 0/40 (0%) 0/39 (0%) 6/40 (15%) 5/40 (13%) 3/38 (8%) |
|POLY-3 RATE (b) | 1/28.81 0/29.54 0/29.78 6/29.94 5/28.48 3/23.81 |
|POLY-3 PERCENT (g) | 3.5% 0.0% 0.0% 20.0% 17.6% 12.6% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 0/28 (0%) 0/28 (0%) 6/27 (22%) 5/26 (19%) 3/21 (14%) |
|FIRST INCIDENCE | 371 (T) --- --- 371 (T) 371 (T) 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.084 P=0.493N P=0.493N P=0.054 P=0.091 P=0.217 |
|POLY 3 | P=0.087 P=0.495N P=0.493N P=0.057 P=0.093 P=0.237 |
|POLY 1.5 | P=0.107 P=0.497N P=0.496N P=0.056 P=0.095 P=0.252 |
|POLY 6 | P=0.077 P=0.494N P=0.492N P=0.057 P=0.091 P=0.227 |
|LOGISTIC REGRESSION| P=0.084 (e) (e) P=0.054 P=0.091 P=0.217 |
|COCH-ARM / FISHERS | P=0.166 P=0.500N P=0.506N P=0.054 P=0.100 P=0.288 |
|ORDER RESTRICTED | P=0.034 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 0/39 (0%) 0/40 (0%) 2/40 (5%) 1/38 (3%) |
|POLY-3 RATE (b) | 0/28.81 0/29.54 0/29.78 0/29.94 2/28.80 1/23.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 6.9% 4.2% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) 1/26 (4%) 1/21 (5%) |
|FIRST INCIDENCE | --- --- --- --- 326 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.124 (e) (e) (e) P=0.236 P=0.450 |
|POLY 3 | P=0.120 (e) (e) (e) P=0.236 P=0.462 |
|POLY 1.5 | P=0.134 (e) (e) (e) P=0.236 P=0.471 |
|POLY 6 | P=0.112 (e) (e) (e) P=0.235 P=0.456 |
|LOGISTIC REGRESSION| P=0.137 (e) (e) (e) P=0.235 P=0.450 |
|COCH-ARM / FISHERS | P=0.170 (e) (e) (e) P=0.247 P=0.487 |
|ORDER RESTRICTED | P=0.108 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 1/39 (3%) 1/40 (3%) 2/40 (5%) 3/38 (8%) |
|POLY-3 RATE (b) | 0/28.81 0/29.54 1/29.78 1/29.94 2/28.48 3/23.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 3.4% 3.3% 7.0% 12.6% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 1/28 (4%) 1/27 (4%) 2/26 (8%) 3/21 (14%) |
|FIRST INCIDENCE | --- --- 371 (T) 371 (T) 371 (T) 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * (e) P=0.507 P=0.500 P=0.229 P=0.079 |
|POLY 3 | P=0.016 * (e) P=0.507 P=0.508 P=0.233 P=0.085 |
|POLY 1.5 | P=0.019 * (e) P=0.504 P=0.506 P=0.235 P=0.091 |
|POLY 6 | P=0.015 * (e) P=0.508 P=0.508 P=0.231 P=0.080 |
|LOGISTIC REGRESSION| (e) (e) P=0.507 P=0.500 P=0.229 P=0.079 |
|COCH-ARM / FISHERS | P=0.027 * (e) P=0.494 P=0.500 P=0.247 P=0.111 |
|ORDER RESTRICTED | P=0.018 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 1/39 (3%) 1/40 (3%) 0/40 (0%) 2/38 (5%) |
|POLY-3 RATE (b) | 0/28.81 0/29.54 1/29.78 1/29.97 0/28.48 2/24.77 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 3.4% 3.3% 0.0% 8.1% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 1/28 (4%) 0/27 (0%) 0/26 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- --- 371 (T) 367 --- 128 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.083 (e) P=0.507 P=0.507 (e) P=0.207 |
|POLY 3 | P=0.098 (e) P=0.507 P=0.508 (e) P=0.203 |
|POLY 1.5 | P=0.103 (e) P=0.504 P=0.506 (e) P=0.210 |
|POLY 6 | P=0.095 (e) P=0.508 P=0.509 (e) P=0.198 |
|LOGISTIC REGRESSION| P=0.113 (e) P=0.507 P=0.508 (e) P=0.250 |
|COCH-ARM / FISHERS | P=0.113 (e) P=0.494 P=0.500 (e) P=0.234 |
|ORDER RESTRICTED | P=0.044 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 22/40 (55%) 25/40 (63%) 27/39 (69%) 20/40 (50%) 24/40 (60%) 14/38 (37%) |
|POLY-3 RATE (b) | 22/30.57 25/31.30 27/32.42 20/33.46 24/31.12 14/27.41 |
|POLY-3 PERCENT (g) | 72.0% 79.9% 83.3% 59.8% 77.1% 51.1% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 2/10 (20%) 3/10 (30%) 4/10 (40%) 3/10 (30%) 3/10 (30%) |
|TERMINAL (d) | 20/27 (74%) 23/28 (82%) 24/28 (86%) 16/27 (59%) 21/26 (81%) 10/21 (48%) |
|FIRST INCIDENCE | 183 (I) 183 (I) 183 (I) 183 (I) 183 (I) 128 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.068N P=0.367 P=0.187 P=0.403N P=0.314 P=0.212N |
|POLY 3 | P=0.011N* P=0.326 P=0.205 P=0.217N P=0.428 P=0.077N |
|POLY 1.5 | P=0.008N** P=0.311 P=0.178 P=0.266N P=0.427 P=0.073N |
|POLY 6 | P=0.015N* P=0.338 P=0.222 P=0.196N P=0.417 P=0.085N |
|LOGISTIC REGRESSION| P=0.029N* P=0.336 P=0.173 P=0.352N P=0.382 P=0.135N |
|COCH-ARM / FISHERS | P=0.009N** P=0.325 P=0.142 P=0.412N P=0.411 P=0.083N |
|ORDER RESTRICTED | P=0.012N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/40 (8%) 0/40 (0%) 0/39 (0%) 0/40 (0%) 0/40 (0%) 2/38 (5%) |
|POLY-3 RATE (b) | 3/28.81 0/29.54 0/29.78 0/29.94 0/28.48 2/24.77 |
|POLY-3 PERCENT (g) | 10.4% 0.0% 0.0% 0.0% 0.0% 8.1% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/27 (11%) 0/28 (0%) 0/28 (0%) 0/27 (0%) 0/26 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 371 (T) --- --- --- --- 123 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.217 P=0.113N P=0.113N P=0.120N P=0.126N P=0.594N |
|POLY 3 | P=0.237 P=0.111N P=0.110N P=0.109N P=0.118N P=0.569N |
|POLY 1.5 | P=0.246 P=0.114N P=0.113N P=0.111N P=0.117N P=0.554N |
|POLY 6 | P=0.231 P=0.110N P=0.109N P=0.109N P=0.119N P=0.581N |
|LOGISTIC REGRESSION| P=0.259 (e) (e) (e) (e) P=0.547N |
|COCH-ARM / FISHERS | P=0.271 P=0.120N P=0.125N P=0.120N P=0.120N P=0.525N |
|ORDER RESTRICTED | P=0.041N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/40 (8%) 2/40 (5%) 2/39 (5%) 1/40 (3%) 2/40 (5%) 2/38 (5%) |
|POLY-3 RATE (b) | 3/30.57 2/30.54 2/29.78 1/29.97 2/29.40 2/23.81 |
|POLY-3 PERCENT (g) | 9.8% 6.6% 6.7% 3.3% 6.8% 8.4% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 1/28 (4%) 2/28 (7%) 0/27 (0%) 1/26 (4%) 2/21 (10%) |
|FIRST INCIDENCE | 182 16 371 (T) 367 160 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.552 P=0.493N P=0.488N P=0.305N P=0.509N P=0.580N |
|POLY 3 | P=0.534 P=0.500N P=0.512N P=0.310N P=0.518N P=0.613N |
|POLY 1.5 | P=0.560 P=0.498N P=0.510N P=0.307N P=0.510N P=0.585N |
|POLY 6 | P=0.517 P=0.501N P=0.514N P=0.313N P=0.525N P=0.630N |
|LOGISTIC REGRESSION| P=0.574N P=0.490N P=0.526N P=0.319N P=0.503N P=0.519N |
|COCH-ARM / FISHERS | P=0.603N P=0.500N P=0.512N P=0.308N P=0.500N P=0.525N |
|ORDER RESTRICTED | P=0.548N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 1/40 (3%) 0/39 (0%) 3/40 (8%) 5/40 (13%) 7/38 (18%) |
|POLY-3 RATE (b) | 1/29.69 1/29.54 0/29.78 3/29.94 5/29.36 7/23.81 |
|POLY-3 PERCENT (g) | 3.4% 3.4% 0.0% 10.0% 17.0% 29.4% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 1/28 (4%) 0/28 (0%) 3/27 (11%) 4/26 (15%) 7/21 (33%) |
|FIRST INCIDENCE | 183 (I) 371 (T) --- 371 (T) 183 (I) 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.756N P=0.500N P=0.306 P=0.098 P=0.013 * |
|POLY 3 | P<0.001 ** P=0.760 P=0.499N P=0.306 P=0.094 P=0.010 * |
|POLY 1.5 | P<0.001 ** P=0.760 P=0.500N P=0.307 P=0.096 P=0.013 * |
|POLY 6 | P<0.001 ** P=0.761 P=0.499N P=0.305 P=0.092 P=0.008 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.763 P=0.584N P=0.307 P=0.101 P=0.016 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.753N P=0.506N P=0.308 P=0.100 P=0.024 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Mesentery |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/1 (100%) 2/2 (100%) 0/0 (0%) 2/2 (100%) 2/4 (50%) 2/2 (100%) |
|POLY-3 RATE (b) | 1/1.00 2/2.00 0/0.00 2/2.00 2/3.15 2/2.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 0.0% 100.0% 63.5% 100.0% |
|INT SACRIFICE 1 (c)| 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/0 (0%) 2/2 (100%) 0/0 (0%) 1/1 (100%) 2/2 (100%) 2/2 (100%) |
|FIRST INCIDENCE | 183 (I) 371 (T) --- 367 371 (T) 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.762N (e) (e) (e) P=1.000 (e) |
|POLY 3 | (e) (e) (e) (e) P=0.730N (e) |
|POLY 1.5 | (e) (e) (e) (e) P=0.648N (e) |
|POLY 6 | (e) (e) (e) (e) P=0.892N (e) |
|LOGISTIC REGRESSION| P=0.727N (e) (e) (e) P=0.688N (e) |
|COCH-ARM / FISHERS | P=0.778 (e) (e) (e) P=0.600N (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 0/39 (0%) 0/40 (0%) 0/40 (0%) 2/38 (5%) |
|POLY-3 RATE (b) | 0/28.81 0/29.54 0/29.78 0/29.94 0/28.48 2/24.63 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 8.1% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) 0/26 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- --- --- --- --- 209 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.005 ** (e) (e) (e) (e) P=0.196 |
|POLY 3 | P=0.006 ** (e) (e) (e) (e) P=0.202 |
|POLY 1.5 | P=0.007 ** (e) (e) (e) (e) P=0.208 |
|POLY 6 | P=0.006 ** (e) (e) (e) (e) P=0.197 |
|LOGISTIC REGRESSION| P=0.010 * (e) (e) (e) (e) P=0.229 |
|COCH-ARM / FISHERS | P=0.008 ** (e) (e) (e) (e) P=0.234 |
|ORDER RESTRICTED | P=0.005 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Nose: Turbinate, Olfactory Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 2/40 (5%) 5/39 (13%) 12/40 (30%) 26/40 (65%) 38/38 (100%) |
|POLY-3 RATE (b) | 1/29.79 2/29.54 5/29.78 12/30.82 26/30.60 38/38.00 |
|POLY-3 PERCENT (g) | 3.4% 6.8% 16.8% 38.9% 85.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 10/10 (100%) |
|TERMINAL (d) | 0/27 (0%) 2/28 (7%) 5/28 (18%) 11/27 (41%) 23/26 (89%) 21/21 (100%) |
|FIRST INCIDENCE | 90 371 (T) 371 (T) 183 (I) 160 123 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.505 P=0.110 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.497 P=0.096 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.495 P=0.095 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.498 P=0.097 P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.500 P=0.098 P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.095 P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Nose: Turbinate, Olfactory Epithelium |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 0/39 (0%) 0/40 (0%) 1/40 (3%) 30/38 (79%) |
|POLY-3 RATE (b) | 0/28.81 0/29.54 0/29.78 0/29.94 1/28.48 30/30.74 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 3.5% 97.6% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) 1/26 (4%) 21/21 (100%) |
|FIRST INCIDENCE | --- --- --- --- 371 (T) 128 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.492 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.498 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.499 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.496 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.492 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.500 P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Focal Cellular Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 1/40 (3%) 0/39 (0%) 5/40 (13%) 3/40 (8%) 6/38 (16%) |
|POLY-3 RATE (b) | 2/28.81 1/29.54 0/29.78 5/29.94 3/28.48 6/23.81 |
|POLY-3 PERCENT (g) | 6.9% 3.4% 0.0% 16.7% 10.5% 25.2% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/27 (7%) 1/28 (4%) 0/28 (0%) 5/27 (19%) 3/26 (12%) 6/21 (29%) |
|FIRST INCIDENCE | 371 (T) 371 (T) --- 371 (T) 371 (T) 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.487N P=0.230N P=0.211 P=0.482 P=0.061 |
|POLY 3 | P=0.005 ** P=0.491N P=0.228N P=0.227 P=0.495 P=0.072 |
|POLY 1.5 | P=0.007 ** P=0.495N P=0.232N P=0.224 P=0.498 P=0.083 |
|POLY 6 | P=0.004 ** P=0.489N P=0.227N P=0.227 P=0.491 P=0.065 |
|LOGISTIC REGRESSION| P=0.003 ** P=0.487N (e) P=0.211 P=0.482 P=0.061 |
|COCH-ARM / FISHERS | P=0.013 * P=0.500N P=0.253N P=0.216 P=0.500 P=0.115 |
|ORDER RESTRICTED | P=0.008 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 2/40 (5%) 0/39 (0%) 0/40 (0%) 1/40 (3%) 1/38 (3%) |
|POLY-3 RATE (b) | 0/28.81 2/29.54 0/29.78 0/29.94 1/28.48 1/24.18 |
|POLY-3 PERCENT (g) | 0.0% 6.8% 0.0% 0.0% 3.5% 4.1% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 2/28 (7%) 0/28 (0%) 0/27 (0%) 1/26 (4%) 0/21 (0%) |
|FIRST INCIDENCE | --- 371 (T) --- --- 371 (T) 317 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.415 P=0.246 (e) (e) P=0.492 P=0.468 |
|POLY 3 | P=0.422 P=0.241 (e) (e) P=0.498 P=0.465 |
|POLY 1.5 | P=0.436 P=0.239 (e) (e) P=0.499 P=0.472 |
|POLY 6 | P=0.415 P=0.243 (e) (e) P=0.496 P=0.462 |
|LOGISTIC REGRESSION| P=0.429 P=0.246 (e) (e) P=0.492 P=0.482 |
|COCH-ARM / FISHERS | P=0.475 P=0.247 (e) (e) P=0.500 P=0.487 |
|ORDER RESTRICTED | P=0.307 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Peripheral Nerve: Sciatic |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 0/39 (0%) 1/39 (3%) 1/38 (3%) 5/38 (13%) |
|POLY-3 RATE (b) | 0/28.81 0/29.54 0/29.78 1/28.94 1/27.33 5/27.70 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 3.5% 3.7% 18.1% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 1/26 (4%) 1/26 (4%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- --- 371 (T) 371 (T) 146 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.492 P=0.492 P=0.028 * |
|POLY 3 | P<0.001 ** (e) (e) P=0.501 P=0.489 P=0.024 * |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.500 P=0.489 P=0.024 * |
|POLY 6 | P<0.001 ** (e) (e) P=0.501 P=0.491 P=0.025 * |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.492 P=0.492 P=0.042 * |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.494 P=0.487 P=0.024 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/38 (5%) 0/12 (0%) 1/10 (10%) 0/13 (0%) 0/37 (0%) 0/35 (0%) |
|POLY-3 RATE (b) | 2/27.33 0/1.54 1/2.08 0/2.94 0/27.24 0/21.18 |
|POLY-3 PERCENT (g) | 7.3% 0.0% 48.1% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/8 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/25 (4%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/25 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 289 --- 309 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.233N P=0.500N P=0.748N P=0.493N P=0.240N P=0.293N |
|POLY 3 | P=0.174N P=0.728N P=0.342 P=0.683N P=0.236N P=0.296N |
|POLY 1.5 | P=0.162N P=0.664N P=0.421 P=0.617N P=0.237N P=0.282N |
|POLY 6 | P=0.187N P=0.762N P=0.301 P=0.721N P=0.238N P=0.305N |
|LOGISTIC REGRESSION| P=0.151N P=0.801N P=0.393 P=0.682N P=0.238N P=0.273N |
|COCH-ARM / FISHERS | P=0.178N P=0.574N P=0.512 P=0.551N P=0.253N P=0.268N |
|ORDER RESTRICTED | P=0.012N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 3/13 (23%) 0/11 (0%) 0/16 (0%) 1/39 (3%) 0/37 (0%) |
|POLY-3 RATE (b) | 1/28.81 3/5.08 0/1.78 0/5.94 1/28.01 0/22.81 |
|POLY-3 PERCENT (g) | 3.5% 59.1% 0.0% 0.0% 3.6% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 0/1 (0%) 0/0 (0%) 0/3 (0%) 1/26 (4%) 0/20 (0%) |
|FIRST INCIDENCE | 371 (T) 16 --- --- 371 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.179N P=0.140 P=1.000N P=0.909N P=0.754 P=0.560N |
|POLY 3 | P=0.177N P=0.007 ** P=0.842N P=0.760N P=0.755 P=0.546N |
|POLY 1.5 | P=0.147N P=0.011 * P=0.816N P=0.734N P=0.756 P=0.537N |
|POLY 6 | P=0.200N P=0.005 ** P=0.854N P=0.775N P=0.755 P=0.553N |
|LOGISTIC REGRESSION| P=0.151N P=0.141 (e) (e) P=0.754 (e) |
|COCH-ARM / FISHERS | P=0.134N P=0.042 * P=0.784N P=0.714N P=0.747 P=0.519N |
|ORDER RESTRICTED | P=0.010N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/38 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 2/39 (5%) 0/37 (0%) |
|POLY-3 RATE (b) | 0/27.33 0/1.54 0/1.78 0/2.94 2/27.48 0/22.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.3% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/26 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/25 (8%) 0/20 (0%) |
|FIRST INCIDENCE | --- --- --- --- 371 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.629N (e) (e) (e) P=0.229 (e) |
|POLY 3 | P=0.654N (e) (e) (e) P=0.237 (e) |
|POLY 1.5 | P=0.659N (e) (e) (e) P=0.240 (e) |
|POLY 6 | P=0.662N (e) (e) (e) P=0.232 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.229 (e) |
|COCH-ARM / FISHERS | P=0.699N (e) (e) (e) P=0.253 (e) |
|ORDER RESTRICTED | P=0.190 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/38 (0%) 0/12 (0%) 0/11 (0%) 2/13 (15%) 0/39 (0%) 0/37 (0%) |
|POLY-3 RATE (b) | 0/27.33 0/1.54 0/1.78 2/3.31 0/27.48 0/22.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 60.5% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/26 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/25 (0%) 0/20 (0%) |
|FIRST INCIDENCE | --- --- --- 324 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.605N (e) (e) P=0.252 (e) (e) |
|POLY 3 | P=0.596N (e) (e) P=0.013 * (e) (e) |
|POLY 1.5 | P=0.506N (e) (e) P=0.020 * (e) (e) |
|POLY 6 | P=0.648N (e) (e) P=0.011 * (e) (e) |
|LOGISTIC REGRESSION| P=0.353N (e) (e) P<0.001 ** (e) (e) |
|COCH-ARM / FISHERS | P=0.403N (e) (e) P=0.061 (e) (e) |
|ORDER RESTRICTED | P=0.048N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/40 (0%) 0/38 (0%) |
|POLY-3 RATE (b) | 2/28.81 0/1.54 0/1.78 0/2.94 0/28.48 0/23.81 |
|POLY-3 PERCENT (g) | 6.9% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/27 (7%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/26 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 371 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.216N P=1.000N P=1.000N P=1.000N P=0.246N P=0.294N |
|POLY 3 | P=0.170N P=0.734N P=0.735N P=0.690N P=0.238N P=0.280N |
|POLY 1.5 | P=0.192N P=0.673N P=0.673N P=0.627N P=0.237N P=0.270N |
|POLY 6 | P=0.164N P=0.767N P=0.769N P=0.726N P=0.240N P=0.288N |
|LOGISTIC REGRESSION| P=0.216N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.273N P=0.588N P=0.612N P=0.566N P=0.247N P=0.260N |
|ORDER RESTRICTED | P=0.016N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Skeletal Muscle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 0/39 (0%) 0/40 (0%) 0/40 (0%) 4/38 (11%) |
|POLY-3 RATE (b) | 0/28.81 0/29.54 0/29.78 0/29.94 0/28.48 4/27.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 14.6% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 4/10 (40%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) 0/26 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 183 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.051 |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.050 |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.050 |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.050 |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) (e) P=0.082 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.052 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 2/14 (14%) 0/11 (0%) 0/14 (0%) 0/40 (0%) 1/39 (3%) |
|POLY-3 RATE (b) | 0/28.81 2/4.20 0/1.78 0/3.94 0/28.48 1/24.66 |
|POLY-3 PERCENT (g) | 0.0% 47.6% 0.0% 0.0% 0.0% 4.1% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 1/2 (50%) 0/0 (0%) 0/1 (0%) 0/26 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 259 --- --- --- 209 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.589 P=0.050 (e) (e) (e) P=0.469 |
|POLY 3 | P=0.540 P=0.017 * (e) (e) (e) P=0.469 |
|POLY 1.5 | P=0.603 P=0.023 * (e) (e) (e) P=0.476 |
|POLY 6 | P=0.499 P=0.014 * (e) (e) (e) P=0.465 |
|LOGISTIC REGRESSION| P=0.691 P=0.011 * (e) (e) (e) P=0.547 |
|COCH-ARM / FISHERS | P=0.690 P=0.064 (e) (e) (e) P=0.494 |
|ORDER RESTRICTED | P=0.166 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Skin: Prepuce |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 1/14 (7%) 0/11 (0%) 1/14 (7%) 2/40 (5%) 2/39 (5%) |
|POLY-3 RATE (b) | 2/29.33 1/3.54 0/1.78 1/4.28 2/29.01 2/23.84 |
|POLY-3 PERCENT (g) | 6.8% 28.2% 0.0% 23.4% 6.9% 8.4% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 1/2 (50%) 0/0 (0%) 0/1 (0%) 1/26 (4%) 2/21 (10%) |
|FIRST INCIDENCE | 289 371 (T) --- 324 289 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.557 P=0.589 P=0.493N P=0.725N P=0.686 P=0.606 |
|POLY 3 | P=0.610 P=0.409 P=0.735N P=0.438 P=0.692 P=0.618 |
|POLY 1.5 | P=0.623N P=0.489 P=0.674N P=0.513 P=0.694 P=0.640 |
|POLY 6 | P=0.582 P=0.363 P=0.769N P=0.397 P=0.689 P=0.602 |
|LOGISTIC REGRESSION| P=0.557N P=0.417 P=0.777N P=0.517 P=0.695 P=0.635 |
|COCH-ARM / FISHERS | P=0.612 P=0.602 P=0.612N P=0.602 P=0.692N P=0.683 |
|ORDER RESTRICTED | P=0.581 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Spinal Cord |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/40 (10%) 20/40 (50%) 19/39 (49%) 28/40 (70%) 18/39 (46%) 23/38 (61%) |
|POLY-3 RATE (b) | 4/28.81 20/29.54 19/29.78 28/30.31 18/28.89 23/34.74 |
|POLY-3 PERCENT (g) | 13.9% 67.7% 63.8% 92.4% 62.3% 66.2% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 10/10 (100%) |
|TERMINAL (d) | 4/27 (15%) 20/28 (71%) 19/28 (68%) 26/27 (96%) 17/26 (65%) 10/21 (48%) |
|FIRST INCIDENCE | 371 (T) 371 (T) 371 (T) 324 183 (I) 146 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.163 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.071 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.246 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.023 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 1/15 (7%) 0/11 (0%) 0/13 (0%) 2/40 (5%) 4/38 (11%) |
|POLY-3 RATE (b) | 2/29.33 1/4.54 0/1.78 0/2.94 2/28.80 4/23.81 |
|POLY-3 PERCENT (g) | 6.8% 22.0% 0.0% 0.0% 6.9% 16.8% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 1/3 (33%) 0/0 (0%) 0/0 (0%) 1/26 (4%) 4/21 (19%) |
|FIRST INCIDENCE | 289 371 (T) --- --- 326 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.140 P=0.621 P=0.493N P=0.493N P=0.686 P=0.231 |
|POLY 3 | P=0.164 P=0.450 P=0.735N P=0.691N P=0.689 P=0.242 |
|POLY 1.5 | P=0.163 P=0.522 P=0.674N P=0.629N P=0.692 P=0.264 |
|POLY 6 | P=0.155 P=0.406 P=0.769N P=0.727N P=0.686 P=0.226 |
|LOGISTIC REGRESSION| P=0.199 P=0.480 P=0.777N P=0.689N P=0.695 P=0.248 |
|COCH-ARM / FISHERS | P=0.131 P=0.623 P=0.612N P=0.566N P=0.692N P=0.313 |
|ORDER RESTRICTED | P=0.089 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation Melanin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 3/15 (20%) 0/11 (0%) 1/13 (8%) 1/40 (3%) 0/38 (0%) |
|POLY-3 RATE (b) | 1/28.81 3/5.42 0/1.78 1/3.82 1/29.36 0/23.81 |
|POLY-3 PERCENT (g) | 3.5% 55.4% 0.0% 26.2% 3.4% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 1/27 (4%) 2/3 (67%) 0/0 (0%) 0/0 (0%) 0/26 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 371 (T) 183 (I) --- 183 (I) 183 (I) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.120N P=0.008 ** P=1.000 P=0.500 P=0.756 P=0.550N |
|POLY 3 | P=0.166N P=0.011 * P=0.842N P=0.333 P=0.757N P=0.538N |
|POLY 1.5 | P=0.129N P=0.017 * P=0.816N P=0.389 P=0.758N P=0.529N |
|POLY 6 | P=0.202N P=0.008 ** P=0.854N P=0.299 P=0.758N P=0.544N |
|LOGISTIC REGRESSION| P=0.101N P=0.007 ** (e) P=0.518 P=0.763 (e) |
|COCH-ARM / FISHERS | P=0.101N P=0.057 P=0.784N P=0.434 P=0.753N P=0.513N |
|ORDER RESTRICTED | P=0.010N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 0/39 (0%) 0/40 (0%) 2/40 (5%) 0/38 (0%) |
|POLY-3 RATE (b) | 0/28.81 0/29.54 0/29.78 0/29.94 2/28.48 0/23.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) 2/26 (8%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- --- --- 371 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.615 (e) (e) (e) P=0.229 (e) |
|POLY 3 | P=0.557 (e) (e) (e) P=0.233 (e) |
|POLY 1.5 | P=0.587 (e) (e) (e) P=0.235 (e) |
|POLY 6 | P=0.539 (e) (e) (e) P=0.231 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.229 (e) |
|COCH-ARM / FISHERS | P=0.649 (e) (e) (e) P=0.247 (e) |
|ORDER RESTRICTED | P=0.187 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 2/40 (5%) 0/39 (0%) 16/40 (40%) 19/40 (48%) 15/38 (39%) |
|POLY-3 RATE (b) | 1/28.81 2/29.54 0/29.78 16/38.21 19/38.20 15/33.63 |
|POLY-3 PERCENT (g) | 3.5% 6.8% 0.0% 41.9% 49.7% 44.6% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) 10/10 (100%) 9/10 (90%) |
|TERMINAL (d) | 1/27 (4%) 2/28 (7%) 0/28 (0%) 6/27 (22%) 8/26 (31%) 4/21 (19%) |
|FIRST INCIDENCE | 371 (T) 371 (T) --- 176 160 123 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.513 P=0.493N P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.509 P=0.493N P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.505 P=0.496N P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.511 P=0.492N P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.513 (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.506N P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 1/40 (3%) 0/39 (0%) 3/40 (8%) 2/38 (5%) 4/37 (11%) |
|POLY-3 RATE (b) | 0/28.81 1/29.54 0/29.78 3/29.94 2/27.89 4/23.77 |
|POLY-3 PERCENT (g) | 0.0% 3.4% 0.0% 10.0% 7.2% 16.8% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 1/28 (4%) 0/28 (0%) 3/27 (11%) 2/26 (8%) 4/21 (19%) |
|FIRST INCIDENCE | --- 371 (T) --- 371 (T) 371 (T) 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** P=0.507 (e) P=0.120 P=0.229 P=0.034 * |
|POLY 3 | P=0.010 * P=0.505 (e) P=0.123 P=0.228 P=0.036 * |
|POLY 1.5 | P=0.012 * P=0.503 (e) P=0.122 P=0.227 P=0.040 * |
|POLY 6 | P=0.009 ** P=0.506 (e) P=0.123 P=0.229 P=0.033 * |
|LOGISTIC REGRESSION| (e) P=0.507 (e) P=0.120 P=0.229 P=0.034 * |
|COCH-ARM / FISHERS | P=0.018 * P=0.500 (e) P=0.120 P=0.234 P=0.049 * |
|ORDER RESTRICTED | P=0.009 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 1/40 (3%) 0/39 (0%) 1/40 (3%) 0/38 (0%) 2/37 (5%) |
|POLY-3 RATE (b) | 0/28.81 1/30.42 0/29.78 1/30.28 0/27.89 2/23.77 |
|POLY-3 PERCENT (g) | 0.0% 3.3% 0.0% 3.3% 0.0% 8.4% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) 0/26 (0%) 2/21 (10%) |
|FIRST INCIDENCE | --- 183 (I) --- 324 --- 371 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.091 P=0.500 (e) P=0.514 (e) P=0.184 |
|POLY 3 | P=0.097 P=0.511 (e) P=0.510 (e) P=0.194 |
|POLY 1.5 | P=0.102 P=0.507 (e) P=0.507 (e) P=0.202 |
|POLY 6 | P=0.094 P=0.513 (e) P=0.512 (e) P=0.189 |
|LOGISTIC REGRESSION| P=0.113 P=0.527 (e) P=0.502 (e) P=0.184 |
|COCH-ARM / FISHERS | P=0.114 P=0.500 (e) P=0.500 (e) P=0.228 |
|ORDER RESTRICTED | P=0.040 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 0/39 (0%) 0/40 (0%) 0/38 (0%) 2/37 (5%) |
|POLY-3 RATE (b) | 0/28.81 0/29.54 0/29.78 0/29.94 0/27.89 2/25.67 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 7.8% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) 0/26 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 128 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** (e) (e) (e) (e) P=0.222 |
|POLY 3 | P=0.006 ** (e) (e) (e) (e) P=0.210 |
|POLY 1.5 | P=0.007 ** (e) (e) (e) (e) P=0.214 |
|POLY 6 | P=0.006 ** (e) (e) (e) (e) P=0.206 |
|LOGISTIC REGRESSION| P=0.009 ** (e) (e) (e) (e) P=0.196 |
|COCH-ARM / FISHERS | P=0.008 ** (e) (e) (e) (e) P=0.228 |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 1/39 (3%) 0/40 (0%) 0/40 (0%) 8/39 (21%) |
|POLY-3 RATE (b) | 0/28.81 0/29.54 1/30.66 0/29.94 0/28.48 8/30.96 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 3.3% 0.0% 0.0% 25.8% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) 0/26 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- 183 (I) --- --- 128 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.500 (e) (e) P=0.003 ** |
|POLY 3 | P<0.001 ** (e) P=0.512 (e) (e) P=0.004 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.508 (e) (e) P=0.003 ** |
|POLY 6 | P<0.001 ** (e) P=0.515 (e) (e) P=0.004 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.416 (e) (e) P=0.008 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.494 (e) (e) P=0.002 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Thymus |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 2/12 (17%) 0/11 (0%) 0/13 (0%) 0/39 (0%) 1/36 (3%) |
|POLY-3 RATE (b) | 0/28.81 2/3.20 0/1.78 0/2.94 0/28.36 1/24.66 |
|POLY-3 PERCENT (g) | 0.0% 62.5% 0.0% 0.0% 0.0% 4.1% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/26 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 16 --- --- --- 128 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.509 P=0.244 (e) (e) (e) P=0.484 |
|POLY 3 | P=0.521 P=0.009 ** (e) (e) (e) P=0.469 |
|POLY 1.5 | P=0.602 P=0.014 * (e) (e) (e) P=0.473 |
|POLY 6 | P=0.466 P=0.008 ** (e) (e) (e) P=0.465 |
|LOGISTIC REGRESSION| P=0.510 P=0.246 (e) (e) (e) P=0.430 |
|COCH-ARM / FISHERS | P=0.680 P=0.050 (e) (e) (e) P=0.474 |
|ORDER RESTRICTED | P=0.151 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 2/15 (13%) 0/11 (0%) 1/13 (8%) 0/40 (0%) 0/38 (0%) |
|POLY-3 RATE (b) | 1/29.33 2/4.54 0/1.78 1/3.28 0/28.48 0/23.81 |
|POLY-3 PERCENT (g) | 3.4% 44.1% 0.0% 30.5% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/27 (0%) 2/3 (67%) 0/0 (0%) 0/0 (0%) 0/26 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 289 371 (T) --- 324 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.162N P=0.110 P=0.493N P=0.748N P=0.500N P=0.539N |
|POLY 3 | P=0.238N P=0.071 P=0.842N P=0.315 P=0.506N P=0.541N |
|POLY 1.5 | P=0.183N P=0.098 P=0.817N P=0.375 P=0.503N P=0.531N |
|POLY 6 | P=0.284N P=0.059 P=0.854N P=0.284 P=0.510N P=0.549N |
|LOGISTIC REGRESSION| P=0.105N P=0.035 * P=0.802N P=0.416 P=0.500N P=0.505N |
|COCH-ARM / FISHERS | P=0.133N P=0.177 P=0.784N P=0.434 P=0.500N P=0.513N |
|ORDER RESTRICTED | P=0.011N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 06 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 0/15 (0%) 0/11 (0%) 0/13 (0%) 0/40 (0%) 1/38 (3%) |
|POLY-3 RATE (b) | 2/28.81 0/4.54 0/1.78 0/2.94 0/28.48 1/24.77 |
|POLY-3 PERCENT (g) | 6.9% 0.0% 0.0% 0.0% 0.0% 4.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/27 (7%) 0/3 (0%) 0/0 (0%) 0/0 (0%) 0/26 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 371 (T) --- --- --- --- 128 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.694 P=0.764N P=1.000 P=1.000N P=0.246N P=0.564N |
|POLY 3 | P=0.577N P=0.637N P=0.735N P=0.690N P=0.238N P=0.553N |
|POLY 1.5 | P=0.608N P=0.584N P=0.673N P=0.627N P=0.237N P=0.541N |
|POLY 6 | P=0.565N P=0.668N P=0.769N P=0.726N P=0.240N P=0.562N |
|LOGISTIC REGRESSION| P=0.686N (e) (e) (e) (e) P=0.510N |
|COCH-ARM / FISHERS | P=0.693N P=0.525N P=0.612N P=0.566N P=0.247N P=0.519N |
|ORDER RESTRICTED | P=0.123N (e) (e) (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).