TDMS Study 05135-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest ISOPRENE DATE: 10/15/04
EXPERIMENT: 05135 TEST: 05 TIME: 13:17:12
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
------------------------------------------------------------------------------------------------------------------------------------
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: 05 TIME: 13:17:12
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 Rats
------------
Organ Morphology
----- ----------
Heart Cardiomyopathy
Cardiomyopathy Focal
Kidney Nephropathy Chronic
Kidney: Bilateral Nephropathy Chronic
Larynx Infiltration Cellular Mixed Cell
Liver Fatty Change
Fatty Change Focal
Hepatodiaphragmatic Nodule
Necrosis Focal
Lung Hemorrhage Focal
Lung: Alveolar Epithelium Hyperplasia
Hyperplasia Focal
Lung: Alveolus Hemorrhage
Infiltration Cellular Focal Histiocyte
Infiltration Cellular Histiocyte
Lung: Peribronchial Hyperplasia Focal Lymphoid
Hyperplasia Lymphoid Focal
Lung: Perivascular Hyperplasia Lymphoid Focal
Lymph Node, Bronchial Congestion
Hyperplasia
Lymph Node, Mandibular Hyperplasia
Lymph Node, Mediastinal Congestion
Hyperplasia
Pigmentation Hemosiderin
Mammary Gland Hyperplasia
Mesentery Necrosis
Pituitary Gland Hyperplasia
Preputial Gland Infiltration Cellular Mixed Cell
Inflammation
Prostate Inflammation
Spleen Accessory Spleen
Testes: Interstitial Cell Hyperplasia
Urinary Bladder Calculus Micro Observation Only
===============================================================
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/5 (80%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/6 (50%) |
|POLY-3 RATE (b) | 4/5.00 0/0.00 0/0.00 0/0.00 0/0.00 3/4.26 |
|POLY-3 PERCENT (g) | 80.0% 0.0% 0.0% 0.0% 0.0% 70.4% |
|INT SACRIFICE 1 (c)| 2/2 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/2 (0%) |
|TERMINAL (d) | 2/3 (67%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/4 (75%) |
|FIRST INCIDENCE | 186 (I) --- --- --- --- 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.275N P=1.000 P=1.000 P=1.000 P=1.000 P=0.339N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.655N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.555N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.704N |
|LOGISTIC REGRESSION| P=0.253N (e) (e) (e) (e) P=0.322N |
|COCH-ARM / FISHERS | P=0.275N P=1.000 P=1.000 P=1.000 P=1.000 P=0.348N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia Lymphoid Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/5 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/6 (50%) |
|POLY-3 RATE (b) | 0/3.26 0/0.00 0/0.00 0/0.00 0/0.00 3/6.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 50.0% |
|INT SACRIFICE 1 (c)| 0/2 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/2 (100%) |
|TERMINAL (d) | 0/3 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/4 (25%) |
|FIRST INCIDENCE | --- --- --- --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.077 (e) (e) (e) (e) P=0.111 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.216 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.174 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.241 |
|LOGISTIC REGRESSION| P=0.055 (e) (e) (e) (e) P=0.085 |
|COCH-ARM / FISHERS | P=0.083 (e) (e) (e) (e) P=0.121 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 12/40 (30%) |
|POLY-3 RATE (b) | 1/31.31 0/1.31 0/1.40 0/1.31 0/1.31 12/33.92 |
|POLY-3 PERCENT (g) | 3.2% 0.0% 0.0% 0.0% 0.0% 35.4% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|TERMINAL (d) | 1/30 (3%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 9/30 (30%) |
|FIRST INCIDENCE | 366 (T) --- --- --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=1.000N P=1.000N P=1.000N P=1.000N P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.856N P=0.846N P=0.856N P=0.856N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.834N P=0.822N P=0.834N P=0.834N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.866N P=0.857N P=0.866N P=0.866N P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.800N P=0.784N P=0.800N P=0.800N 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 |
| | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 16/40 (40%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 2/40 (5%) |
|POLY-3 RATE (b) | 16/37.39 0/1.31 0/1.40 0/1.31 0/1.31 2/32.18 |
|POLY-3 PERCENT (g) | 42.8% 0.0% 0.0% 0.0% 0.0% 6.2% |
|INT SACRIFICE 1 (c)| 7/10 (70%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 9/30 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/30 (3%) |
|FIRST INCIDENCE | 186 (I) --- --- --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004N** P=0.003N** P=0.003N** P=0.003N** P=0.003N** P<0.001N** |
|POLY 3 | P<0.001N** P=0.487N P=0.478N P=0.487N P=0.487N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.244N P=0.227N P=0.244N P=0.244N P<0.001N** |
|POLY 6 | P<0.001N** P=0.622N P=0.617N P=0.622N P=0.622N P<0.001N** |
|LOGISTIC REGRESSION| P=0.004N** P=0.002N** P=0.002N** P=0.002N** P=0.002N** P<0.001N** |
|COCH-ARM / FISHERS | P=0.008N** P=0.013N* P=0.009N** P=0.013N* P=0.013N* P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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) | 4/40 (10%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 6/40 (15%) |
|POLY-3 RATE (b) | 4/31.31 0/1.31 0/1.40 0/1.31 0/1.31 6/31.31 |
|POLY-3 PERCENT (g) | 12.8% 0.0% 0.0% 0.0% 0.0% 19.2% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/30 (13%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/30 (20%) |
|FIRST INCIDENCE | 366 (T) --- --- --- --- 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.326 P=1.000 P=1.000 P=1.000 P=1.000 P=0.366 |
|POLY 3 | P=0.257 P=0.661N P=0.651N P=0.661N P=0.661N P=0.366 |
|POLY 1.5 | P=0.203 P=0.556N P=0.540N P=0.556N P=0.556N P=0.366 |
|POLY 6 | P=0.266 P=0.714N P=0.706N P=0.714N P=0.714N P=0.366 |
|LOGISTIC REGRESSION| P=0.326 (e) (e) (e) (e) P=0.366 |
|COCH-ARM / FISHERS | P=0.075 P=0.397N P=0.366N P=0.397N P=0.397N P=0.369 |
|ORDER RESTRICTED | P=0.100 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/40 (57%) 0/10 (0%) 1/12 (8%) 2/12 (17%) 6/16 (38%) 29/40 (73%) |
|POLY-3 RATE (b) | 23/31.31 0/1.31 1/2.40 2/3.31 6/7.31 29/31.31 |
|POLY-3 PERCENT (g) | 73.5% 0.0% 41.7% 60.4% 82.1% 92.6% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 23/30 (77%) 0/0 (0%) 1/1 (100%) 2/2 (100%) 6/6 (100%) 29/30 (97%) |
|FIRST INCIDENCE | 366 (T) --- 366 (T) 366 (T) 366 (T) 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.031 * P=1.000 P=0.744 P=0.543 P=0.229 P=0.030 * |
|POLY 3 | P=0.004 ** P=0.341N P=0.424N P=0.540N P=0.497 P=0.029 * |
|POLY 1.5 | P<0.001 ** P=0.052N P=0.086N P=0.174N P=0.515N P=0.046 * |
|POLY 6 | P=0.006 ** P=0.637N P=0.643 P=0.566 P=0.304 P=0.026 * |
|LOGISTIC REGRESSION| P=0.030 * (e) P=0.744 P=0.543 P=0.229 P=0.030 * |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001N** P=0.003N** P=0.014N* P=0.145N P=0.120 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Bilateral |
| Nephropathy Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/40 (57%) 0/10 (0%) 1/12 (8%) 1/12 (8%) 6/16 (38%) 29/40 (73%) |
|POLY-3 RATE (b) | 23/31.31 0/1.31 1/2.40 1/3.31 6/7.31 29/31.31 |
|POLY-3 PERCENT (g) | 73.5% 0.0% 41.7% 30.2% 82.1% 92.6% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 23/30 (77%) 0/0 (0%) 1/1 (100%) 1/2 (50%) 6/6 (100%) 29/30 (97%) |
|FIRST INCIDENCE | 366 (T) --- 366 (T) 366 (T) 366 (T) 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.020 * P=1.000 P=0.744 P=0.500N P=0.229 P=0.030 * |
|POLY 3 | P=0.003 ** P=0.341N P=0.424N P=0.237N P=0.497 P=0.029 * |
|POLY 1.5 | P<0.001 ** P=0.052N P=0.086N P=0.047N* P=0.515N P=0.046 * |
|POLY 6 | P=0.006 ** P=0.637N P=0.643 P=0.460N P=0.304 P=0.026 * |
|LOGISTIC REGRESSION| P=0.020 * (e) P=0.744 P=0.500N P=0.229 P=0.030 * |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001N** P=0.003N** P=0.003N** P=0.145N P=0.120 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Larynx |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/40 (8%) |
|POLY-3 RATE (b) | 1/31.31 0/1.31 0/1.31 0/1.31 0/1.31 3/31.31 |
|POLY-3 PERCENT (g) | 3.2% 0.0% 0.0% 0.0% 0.0% 9.6% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/30 (3%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/30 (10%) |
|FIRST INCIDENCE | 366 (T) --- --- --- --- 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.250 P=1.000 P=1.000 P=1.000N P=1.000 P=0.304 |
|POLY 3 | P=0.175 P=0.856N P=0.856N P=0.856N P=0.856N P=0.303 |
|POLY 1.5 | P=0.158 P=0.834N P=0.834N P=0.834N P=0.834N P=0.304 |
|POLY 6 | P=0.176 P=0.866N P=0.866N P=0.866N P=0.866N P=0.303 |
|LOGISTIC REGRESSION| P=0.250 (e) (e) (e) (e) P=0.304 |
|COCH-ARM / FISHERS | P=0.094 P=0.800N P=0.800N P=0.800N P=0.800N P=0.308 |
|ORDER RESTRICTED | P=0.041 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 0/15 (0%) 3/22 (14%) 4/15 (27%) 0/17 (0%) 0/40 (0%) |
|POLY-3 RATE (b) | 1/31.31 0/6.31 3/12.40 4/6.31 0/8.31 0/31.31 |
|POLY-3 PERCENT (g) | 3.2% 0.0% 24.2% 63.4% 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) | 1/30 (3%) 0/5 (0%) 3/11 (27%) 4/5 (80%) 0/7 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 366 (T) --- 366 (T) 366 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.040N* P=0.846N P=0.047 * P<0.001 ** P=0.786N P=0.500N |
|POLY 3 | P=0.062N P=0.765N P=0.065 P<0.001 ** P=0.733N P=0.500N |
|POLY 1.5 | P=0.057N P=0.744N P=0.080 P=0.002 ** P=0.713N P=0.500N |
|POLY 6 | P=0.068N P=0.777N P=0.058 P<0.001 ** P=0.743N P=0.500N |
|LOGISTIC REGRESSION| P=0.040N* (e) P=0.047 * P<0.001 ** (e) (e) |
|COCH-ARM / FISHERS | P=0.069N P=0.727N P=0.124 P=0.017 * P=0.702N P=0.500N |
|ORDER RESTRICTED | P=0.002N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/15 (0%) 2/22 (9%) 1/15 (7%) 1/17 (6%) 0/40 (0%) |
|POLY-3 RATE (b) | 0/31.31 0/6.31 2/12.40 1/6.31 1/8.31 0/31.31 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 16.1% 15.8% 12.0% 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) | 0/30 (0%) 0/5 (0%) 2/11 (18%) 1/5 (20%) 1/7 (14%) 0/30 (0%) |
|FIRST INCIDENCE | --- --- 366 (T) 366 (T) 366 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.223N (e) P=0.060 P=0.154 P=0.214 (e) |
|POLY 3 | P=0.289N (e) P=0.076 P=0.227 P=0.262 (e) |
|POLY 1.5 | P=0.282N (e) P=0.087 P=0.250 P=0.283 (e) |
|POLY 6 | P=0.298N (e) P=0.071 P=0.215 P=0.251 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.060 P=0.154 P=0.214 (e) |
|COCH-ARM / FISHERS | P=0.290N (e) P=0.122 P=0.273 P=0.298 (e) |
|ORDER RESTRICTED | P=0.039 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/40 (13%) 9/15 (60%) 8/22 (36%) 4/15 (27%) 8/17 (47%) 6/40 (15%) |
|POLY-3 RATE (b) | 5/33.92 9/9.79 8/13.27 4/8.92 8/10.92 6/31.31 |
|POLY-3 PERCENT (g) | 14.7% 92.0% 60.3% 44.9% 73.3% 19.2% |
|INT SACRIFICE 1 (c)| 3/10 (30%) 4/10 (40%) 1/10 (10%) 3/10 (30%) 3/10 (30%) 0/10 (0%) |
|TERMINAL (d) | 2/30 (7%) 5/5 (100%) 7/11 (64%) 1/5 (20%) 5/7 (71%) 6/30 (20%) |
|FIRST INCIDENCE | 186 (I) 186 (I) 186 (I) 186 (I) 186 (I) 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.059N P=0.002 ** P=0.020 * P=0.476 P=0.012 * P=0.500 |
|POLY 3 | P=0.053N P<0.001 ** P=0.003 ** P=0.084 P<0.001 ** P=0.443 |
|POLY 1.5 | P=0.054N P<0.001 ** P=0.006 ** P=0.112 P<0.001 ** P=0.460 |
|POLY 6 | P=0.056N P<0.001 ** P=0.002 ** P=0.071 P<0.001 ** P=0.433 |
|LOGISTIC REGRESSION| P=0.060N P=0.002 ** P=0.021 * P=0.476 P=0.011 * P=0.500 |
|COCH-ARM / FISHERS | P=0.081N P<0.001 ** P=0.032 * P=0.193 P=0.008 ** P=0.500 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 0/15 (0%) 0/22 (0%) 0/15 (0%) 0/17 (0%) 1/40 (3%) |
|POLY-3 RATE (b) | 2/31.31 0/6.31 0/12.40 0/6.31 0/8.31 1/32.18 |
|POLY-3 PERCENT (g) | 6.4% 0.0% 0.0% 0.0% 0.0% 3.1% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 2/30 (7%) 0/5 (0%) 0/11 (0%) 0/5 (0%) 0/7 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 366 (T) --- --- --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.677 P=0.670N P=0.476N P=0.670N P=0.588N P=0.500N |
|POLY 3 | P=0.560N P=0.602N P=0.460N P=0.602N P=0.549N P=0.490N |
|POLY 1.5 | P=0.612N P=0.558N P=0.432N P=0.558N P=0.512N P=0.493N |
|POLY 6 | P=0.529N P=0.626N P=0.476N P=0.626N P=0.570N P=0.489N |
|LOGISTIC REGRESSION| P=0.677 (e) (e) (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.662 P=0.525N P=0.412N P=0.525N P=0.489N P=0.500N |
|ORDER RESTRICTED | P=0.095N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 0/15 (0%) 3/22 (14%) 0/15 (0%) 0/17 (0%) 4/40 (10%) |
|POLY-3 RATE (b) | 1/31.31 0/6.31 3/12.40 0/6.31 0/8.31 4/31.31 |
|POLY-3 PERCENT (g) | 3.2% 0.0% 24.2% 0.0% 0.0% 12.8% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/30 (3%) 0/5 (0%) 3/11 (27%) 0/5 (0%) 0/7 (0%) 4/30 (13%) |
|FIRST INCIDENCE | 366 (T) --- 366 (T) --- --- 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.274 P=0.846N P=0.047 * P=0.846N P=0.786N P=0.177 |
|POLY 3 | P=0.209 P=0.765N P=0.065 P=0.765N P=0.733N P=0.175 |
|POLY 1.5 | P=0.190 P=0.744N P=0.080 P=0.744N P=0.713N P=0.176 |
|POLY 6 | P=0.219 P=0.777N P=0.058 P=0.777N P=0.743N P=0.175 |
|LOGISTIC REGRESSION| P=0.274 (e) P=0.047 * (e) (e) P=0.177 |
|COCH-ARM / FISHERS | P=0.153 P=0.727N P=0.124 P=0.727N P=0.702N P=0.179 |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/40 (13%) 10/40 (25%) 11/40 (28%) 10/40 (25%) 10/40 (25%) 5/40 (13%) |
|POLY-3 RATE (b) | 5/31.31 10/40.00 11/39.09 10/40.00 10/40.00 5/32.18 |
|POLY-3 PERCENT (g) | 16.0% 25.0% 28.1% 25.0% 25.0% 15.5% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 1/10 (10%) |
|TERMINAL (d) | 5/30 (17%) 0/30 (0%) 1/29 (3%) 0/30 (0%) 0/30 (0%) 4/30 (13%) |
|FIRST INCIDENCE | 366 (T) 186 (I) 186 (I) 186 (I) 186 (I) 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.074N P=0.102 P=0.060 P=0.102 P=0.102 P=0.632 |
|POLY 3 | P=0.224N P=0.267 P=0.181 P=0.267 P=0.267 P=0.616N |
|POLY 1.5 | P=0.196N P=0.218 P=0.144 P=0.218 P=0.218 P=0.621N |
|POLY 6 | P=0.240N P=0.293 P=0.203 P=0.293 P=0.293 P=0.613N |
|LOGISTIC REGRESSION| P=0.089N P=0.098 P=0.081 P=0.098 P=0.098 P=0.633N |
|COCH-ARM / FISHERS | P=0.139N P=0.126 P=0.081 P=0.126 P=0.126 P=0.631N |
|ORDER RESTRICTED | P=0.412N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 35/40 (88%) 30/40 (75%) 26/40 (65%) 24/40 (60%) 22/40 (55%) 35/40 (88%) |
|POLY-3 RATE (b) | 35/40.00 30/31.31 26/30.40 24/31.31 22/31.31 35/39.13 |
|POLY-3 PERCENT (g) | 87.5% 95.8% 85.5% 76.7% 70.3% 89.4% |
|INT SACRIFICE 1 (c)| 10/10 (100%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) |
|TERMINAL (d) | 25/30 (83%) 30/30 (100%) 26/29 (90%) 24/30 (80%) 22/30 (73%) 26/30 (87%) |
|FIRST INCIDENCE | 186 (I) 366 (T) 366 (T) 366 (T) 366 (T) 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.067 P=0.102N P=0.021N* P=0.004N** P<0.001N** P=0.632 |
|POLY 3 | P=0.474 P=0.193 P=0.546N P=0.182N P=0.061N P=0.532 |
|POLY 1.5 | P=0.284 P=0.560 P=0.236N P=0.062N P=0.017N* P=0.560 |
|POLY 6 | P=0.583 P=0.075 P=0.567 P=0.288N P=0.110N P=0.518 |
|LOGISTIC REGRESSION| P=0.063 P=0.098N P=0.015N* P=0.004N** P<0.001N** P=0.633 |
|COCH-ARM / FISHERS | P=0.088 P=0.126N P=0.017N* P=0.005N** P<0.001N** P=0.631N |
|ORDER RESTRICTED | P=0.075N (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) | 3/40 (8%) 0/40 (0%) 0/40 (0%) 1/40 (3%) 0/40 (0%) 1/40 (3%) |
|POLY-3 RATE (b) | 3/31.31 0/31.31 0/30.40 1/31.31 0/31.31 1/32.18 |
|POLY-3 PERCENT (g) | 9.6% 0.0% 0.0% 3.2% 0.0% 3.1% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 3/30 (10%) 0/30 (0%) 0/29 (0%) 1/30 (3%) 0/30 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 366 (T) --- --- 366 (T) --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.612N P=0.120N P=0.126N P=0.304N P=0.120N P=0.306N |
|POLY 3 | P=0.607N P=0.116N P=0.122N P=0.303N P=0.116N P=0.294N |
|POLY 1.5 | P=0.610N P=0.117N P=0.120N P=0.304N P=0.117N P=0.297N |
|POLY 6 | P=0.605N P=0.116N P=0.122N P=0.303N P=0.116N P=0.292N |
|LOGISTIC REGRESSION| P=0.614N (e) (e) P=0.304N (e) P=0.304N |
|COCH-ARM / FISHERS | P=0.615N P=0.120N P=0.120N P=0.308N P=0.120N P=0.308N |
|ORDER RESTRICTED | P=0.026N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 15/40 (38%) 13/40 (33%) 11/40 (28%) 12/40 (30%) 5/40 (13%) |
|POLY-3 RATE (b) | 2/31.31 15/31.31 13/30.40 11/31.31 12/31.31 5/31.31 |
|POLY-3 PERCENT (g) | 6.4% 47.9% 42.8% 35.1% 38.3% 16.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/30 (7%) 15/30 (50%) 13/29 (45%) 11/30 (37%) 12/30 (40%) 5/30 (17%) |
|FIRST INCIDENCE | 366 (T) 366 (T) 366 (T) 366 (T) 366 (T) 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.066N P<0.001 ** P<0.001 ** P=0.006 ** P=0.003 ** P=0.213 |
|POLY 3 | P=0.061N P<0.001 ** P<0.001 ** P=0.005 ** P=0.002 ** P=0.212 |
|POLY 1.5 | P=0.064N P<0.001 ** P<0.001 ** P=0.005 ** P=0.002 ** P=0.212 |
|POLY 6 | P=0.060N P<0.001 ** P<0.001 ** P=0.005 ** P=0.002 ** P=0.211 |
|LOGISTIC REGRESSION| P=0.066N P<0.001 ** P<0.001 ** P=0.006 ** P=0.003 ** P=0.213 |
|COCH-ARM / FISHERS | P=0.081N P<0.001 ** P=0.002 ** P=0.006 ** P=0.003 ** P=0.216 |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 0/40 (0%) 0/40 (0%) 0/40 (0%) 1/40 (3%) 3/40 (8%) |
|POLY-3 RATE (b) | 2/31.31 0/31.31 0/30.40 0/31.31 1/31.31 3/32.18 |
|POLY-3 PERCENT (g) | 6.4% 0.0% 0.0% 0.0% 3.2% 9.3% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 2/30 (7%) 0/30 (0%) 0/29 (0%) 0/30 (0%) 1/30 (3%) 2/30 (7%) |
|FIRST INCIDENCE | 366 (T) --- --- --- 366 (T) 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.040 * P=0.238N P=0.245N P=0.238N P=0.500N P=0.500 |
|POLY 3 | P=0.041 * P=0.236N P=0.243N P=0.236N P=0.500N P=0.513 |
|POLY 1.5 | P=0.040 * P=0.236N P=0.241N P=0.236N P=0.500N P=0.509 |
|POLY 6 | P=0.041 * P=0.236N P=0.243N P=0.236N P=0.500N P=0.515 |
|LOGISTIC REGRESSION| P=0.039 * (e) (e) (e) P=0.500N P=0.500 |
|COCH-ARM / FISHERS | P=0.039 * P=0.247N P=0.247N P=0.247N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.058 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Focal Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/40 (10%) 17/40 (43%) 19/40 (48%) 17/40 (43%) 16/40 (40%) 19/40 (48%) |
|POLY-3 RATE (b) | 4/33.05 17/31.31 19/30.40 17/31.31 16/31.31 19/31.31 |
|POLY-3 PERCENT (g) | 12.1% 54.3% 62.5% 54.3% 51.1% 60.7% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/30 (7%) 17/30 (57%) 19/29 (66%) 17/30 (57%) 16/30 (53%) 19/30 (63%) |
|FIRST INCIDENCE | 186 (I) 366 (T) 366 (T) 366 (T) 366 (T) 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.063 P<0.001 ** P<0.001 ** P<0.001 ** P=0.002 ** P<0.001 ** |
|POLY 3 | P=0.037 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.044 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.034 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.062 P<0.001 ** P<0.001 ** P<0.001 ** P=0.002 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.076 P<0.001 ** P<0.001 ** P<0.001 ** P=0.002 ** 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 |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/40 (0%) 1/40 (3%) 0/40 (0%) 0/40 (0%) 2/40 (5%) |
|POLY-3 RATE (b) | 0/31.31 0/31.31 1/31.27 0/31.31 0/31.31 2/32.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 3.2% 0.0% 0.0% 6.2% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 0/30 (0%) 0/30 (0%) 0/29 (0%) 0/30 (0%) 0/30 (0%) 1/30 (3%) |
|FIRST INCIDENCE | --- --- 186 (I) --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.058 (e) P=0.500 (e) (e) P=0.240 |
|POLY 3 | P=0.059 (e) P=0.500 (e) (e) P=0.242 |
|POLY 1.5 | P=0.059 (e) P=0.500 (e) (e) P=0.240 |
|POLY 6 | P=0.059 (e) P=0.500 (e) (e) P=0.243 |
|LOGISTIC REGRESSION| P=0.055 (e) P=0.536 (e) (e) P=0.236 |
|COCH-ARM / FISHERS | P=0.058 (e) P=0.500 (e) (e) P=0.247 |
|ORDER RESTRICTED | P=0.033 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Peribronchial |
| Hyperplasia Focal Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 2/40 (5%) 3/40 (8%) 0/40 (0%) 0/40 (0%) 4/40 (10%) |
|POLY-3 RATE (b) | 0/31.31 2/31.31 3/30.40 0/31.31 0/31.31 4/33.92 |
|POLY-3 PERCENT (g) | 0.0% 6.4% 9.9% 0.0% 0.0% 11.8% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|TERMINAL (d) | 0/30 (0%) 2/30 (7%) 3/29 (10%) 0/30 (0%) 0/30 (0%) 1/30 (3%) |
|FIRST INCIDENCE | --- 366 (T) 366 (T) --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.066 P=0.238 P=0.114 (e) (e) P=0.059 |
|POLY 3 | P=0.070 P=0.236 P=0.111 (e) (e) P=0.069 |
|POLY 1.5 | P=0.067 P=0.236 P=0.113 (e) (e) P=0.066 |
|POLY 6 | P=0.071 P=0.236 P=0.110 (e) (e) P=0.071 |
|LOGISTIC REGRESSION| P=0.064 P=0.238 P=0.114 (e) (e) P=0.055 |
|COCH-ARM / FISHERS | P=0.064 P=0.247 P=0.120 (e) (e) P=0.058 |
|ORDER RESTRICTED | P=0.014 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Peribronchial |
| Hyperplasia Lymphoid Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/40 (13%) 8/40 (20%) 7/40 (18%) 7/40 (18%) 4/40 (10%) 1/40 (3%) |
|POLY-3 RATE (b) | 5/35.66 8/31.31 7/30.40 7/31.31 4/31.31 1/31.31 |
|POLY-3 PERCENT (g) | 14.0% 25.6% 23.0% 22.4% 12.8% 3.2% |
|INT SACRIFICE 1 (c)| 5/10 (50%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/30 (0%) 8/30 (27%) 7/29 (24%) 7/30 (23%) 4/30 (13%) 1/30 (3%) |
|FIRST INCIDENCE | 186 (I) 366 (T) 366 (T) 366 (T) 366 (T) 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.013N* P=0.273 P=0.363 P=0.377 P=0.500N P=0.089N |
|POLY 3 | P=0.015N* P=0.191 P=0.268 P=0.287 P=0.582N P=0.132N |
|POLY 1.5 | P=0.014N* P=0.213 P=0.299 P=0.313 P=0.557N P=0.121N |
|POLY 6 | P=0.016N* P=0.179 P=0.253 P=0.273 P=0.595N P=0.138N |
|LOGISTIC REGRESSION| P=0.012N* P=0.270 P=0.392 P=0.376 P=0.500N P=0.084N |
|COCH-ARM / FISHERS | P=0.013N* P=0.273 P=0.378 P=0.378 P=0.500N P=0.100N |
|ORDER RESTRICTED | P=0.032N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Perivascular |
| Hyperplasia Focal Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 1/40 (3%) 0/40 (0%) 2/40 (5%) 2/40 (5%) 2/40 (5%) |
|POLY-3 RATE (b) | 1/32.18 1/32.18 0/30.40 2/31.31 2/31.31 2/32.18 |
|POLY-3 PERCENT (g) | 3.1% 3.1% 0.0% 6.4% 6.4% 6.2% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 0/30 (0%) 0/30 (0%) 0/29 (0%) 2/30 (7%) 2/30 (7%) 1/30 (3%) |
|FIRST INCIDENCE | 186 (I) 186 (I) --- 366 (T) 366 (T) 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.290 P=0.766 P=0.500N P=0.500 P=0.500 P=0.500 |
|POLY 3 | P=0.298 P=0.761 P=0.511N P=0.490 P=0.490 P=0.500 |
|POLY 1.5 | P=0.295 P=0.761 P=0.508N P=0.493 P=0.493 P=0.500 |
|POLY 6 | P=0.300 P=0.761 P=0.513N P=0.489 P=0.489 P=0.500 |
|LOGISTIC REGRESSION| P=0.285 (e) P=0.464N P=0.500 P=0.500 P=0.500 |
|COCH-ARM / FISHERS | P=0.287 P=0.753N P=0.500N P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.361 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Perivascular |
| Hyperplasia Lymphoid Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/40 (38%) 23/40 (57%) 25/40 (63%) 20/40 (50%) 17/40 (43%) 23/40 (57%) |
|POLY-3 RATE (b) | 15/35.66 23/32.18 25/32.14 20/32.18 17/33.92 23/31.31 |
|POLY-3 PERCENT (g) | 42.1% 71.5% 77.8% 62.2% 50.1% 73.5% |
|INT SACRIFICE 1 (c)| 5/10 (50%) 1/10 (10%) 2/10 (20%) 1/10 (10%) 3/10 (30%) 0/10 (0%) |
|TERMINAL (d) | 10/30 (33%) 22/30 (73%) 23/29 (79%) 19/30 (63%) 14/30 (47%) 23/30 (77%) |
|FIRST INCIDENCE | 186 (I) 186 (I) 186 (I) 186 (I) 186 (I) 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.342 P=0.057 P=0.015 * P=0.183 P=0.411 P=0.054 |
|POLY 3 | P=0.176 P=0.011 * P=0.002 ** P=0.076 P=0.333 P=0.007 ** |
|POLY 1.5 | P=0.220 P=0.019 * P=0.004 ** P=0.101 P=0.355 P=0.014 * |
|POLY 6 | P=0.156 P=0.009 ** P<0.001 ** P=0.066 P=0.322 P=0.005 ** |
|LOGISTIC REGRESSION| P=0.337 P=0.055 P=0.017 * P=0.181 P=0.410 P=0.052 |
|COCH-ARM / FISHERS | P=0.335 P=0.058 P=0.022 * P=0.184 P=0.410 P=0.058 |
|ORDER RESTRICTED | P=0.004 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 17/32 (53%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/11 (0%) 19/37 (51%) |
|POLY-3 RATE (b) | 17/32.00 0/1.31 0/1.40 0/1.31 0/2.31 19/35.26 |
|POLY-3 PERCENT (g) | 53.1% 0.0% 0.0% 0.0% 0.0% 53.9% |
|INT SACRIFICE 1 (c)| 9/9 (100%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) |
|TERMINAL (d) | 8/23 (35%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) 11/27 (41%) |
|FIRST INCIDENCE | 186 (I) --- --- --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.022 * P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.563N |
|POLY 3 | P=0.488 P=0.450N P=0.440N P=0.450N P=0.321N P=0.572 |
|POLY 1.5 | P=0.307 P=0.171N P=0.154N P=0.171N P=0.107N P=0.594 |
|POLY 6 | P=0.513 P=0.615N P=0.610N P=0.615N P=0.472N P=0.561 |
|LOGISTIC REGRESSION| P=0.020 * P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.563N |
|COCH-ARM / FISHERS | P=0.011 * P=0.002N** P<0.001N** P=0.002N** P<0.001N** P=0.538N |
|ORDER RESTRICTED | P=0.157 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/32 (3%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 1/11 (9%) 6/37 (16%) |
|POLY-3 RATE (b) | 1/25.05 0/1.31 0/1.40 0/1.31 1/2.31 6/28.31 |
|POLY-3 PERCENT (g) | 4.0% 0.0% 0.0% 0.0% 43.2% 21.2% |
|INT SACRIFICE 1 (c)| 1/9 (11.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/23 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) 6/27 (22%) |
|FIRST INCIDENCE | 186 (I) --- --- --- 366 (T) 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.061 P=0.479N P=0.479N P=0.479N P=0.550 P=0.084 |
|POLY 3 | P=0.025 * P=0.832N P=0.823N P=0.832N P=0.302 P=0.070 |
|POLY 1.5 | P=0.021 * P=0.805N P=0.793N P=0.805N P=0.369 P=0.073 |
|POLY 6 | P=0.025 * P=0.845N P=0.836N P=0.845N P=0.267 P=0.069 |
|LOGISTIC REGRESSION| P=0.059 (e) P=0.450N (e) P=0.552 P=0.082 |
|COCH-ARM / FISHERS | P=0.008 ** P=0.762N P=0.744N P=0.762N P=0.451 P=0.078 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/35 (3%) 0/10 (0%) 0/12 (0%) 1/11 (9%) 0/10 (0%) 3/40 (8%) |
|POLY-3 RATE (b) | 1/27.18 0/1.31 0/2.40 1/3.18 0/1.31 3/33.05 |
|POLY-3 PERCENT (g) | 3.7% 0.0% 0.0% 31.4% 0.0% 9.1% |
|INT SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 2/10 (20%) |
|TERMINAL (d) | 1/26 (4%) 0/0 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 1/30 (3%) |
|FIRST INCIDENCE | 366 (T) --- --- 186 (I) --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.145 P=1.000 P=0.993N P=0.547 P=1.000 P=0.351 |
|POLY 3 | P=0.302 P=0.842N P=0.813N P=0.317 P=0.842N P=0.377 |
|POLY 1.5 | P=0.287 P=0.816N P=0.785N P=0.372 P=0.816N P=0.369 |
|POLY 6 | P=0.309 P=0.853N P=0.826N P=0.288 P=0.853N P=0.381 |
|LOGISTIC REGRESSION| P=0.140 (e) (e) P=0.548 (e) P=0.348 |
|COCH-ARM / FISHERS | P=0.192 P=0.778N P=0.745N P=0.425 P=0.778N P=0.360 |
|ORDER RESTRICTED | P=0.058 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/35 (23%) 0/10 (0%) 1/12 (8%) 0/11 (0%) 0/10 (0%) 5/40 (13%) |
|POLY-3 RATE (b) | 8/28.05 0/1.31 1/2.40 0/2.31 0/1.31 5/31.31 |
|POLY-3 PERCENT (g) | 28.5% 0.0% 41.7% 0.0% 0.0% 16.0% |
|INT SACRIFICE 1 (c)| 1/9 (11.1%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 7/26 (27%) 0/0 (0%) 1/1 (100%) 0/1 (0%) 0/0 (0%) 5/30 (17%) |
|FIRST INCIDENCE | 186 (I) --- 366 (T) --- --- 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.160N P=0.479N P=0.683 P=0.334N P=0.479N P=0.185N |
|POLY 3 | P=0.121N P=0.552N P=0.570 P=0.461N P=0.552N P=0.196N |
|POLY 1.5 | P=0.194N P=0.365N P=0.578N P=0.298N P=0.365N P=0.194N |
|POLY 6 | P=0.111N P=0.654N P=0.459 P=0.558N P=0.654N P=0.199N |
|LOGISTIC REGRESSION| P=0.158N P=0.478N P=0.697 P=0.330N P=0.478N P=0.183N |
|COCH-ARM / FISHERS | P=0.517N P=0.109N P=0.259N P=0.090N P=0.109N P=0.190N |
|ORDER RESTRICTED | P=0.018N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 20/35 (57%) 3/15 (20%) 1/12 (8%) 0/11 (0%) 1/10 (10%) 17/30 (57%) |
|POLY-3 RATE (b) | 20/35.00 3/7.18 1/3.27 0/2.31 1/2.18 17/30.00 |
|POLY-3 PERCENT (g) | 57.1% 41.8% 30.6% 0.0% 45.9% 56.7% |
|INT SACRIFICE 1 (c)| 8/8 (100%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 1/10 (10%) 6/6 (100%) |
|TERMINAL (d) | 12/27 (44%) 2/5 (40%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 11/24 (46%) |
|FIRST INCIDENCE | 186 (I) 186 (I) 186 (I) --- 186 (I) 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.062 P=0.007N** P<0.001N** P<0.001N** P<0.001N** P=0.572 |
|POLY 3 | P=0.492 P=0.394N P=0.419N P=0.298N P=0.578N P=0.583N |
|POLY 1.5 | P=0.303 P=0.194N P=0.162N P=0.085N P=0.278N P=0.583N |
|POLY 6 | P=0.556 P=0.515N P=0.575N P=0.459N P=0.549 P=0.583N |
|LOGISTIC REGRESSION| P=0.058 P=0.006N** P<0.001N** P<0.001N** P<0.001N** (e) |
|COCH-ARM / FISHERS | P=0.030 * P=0.016N* P=0.003N** P<0.001N** P=0.009N** P=0.584N |
|ORDER RESTRICTED | P=0.262N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/35 (14%) 4/15 (27%) 1/12 (8%) 1/11 (9%) 0/10 (0%) 8/30 (27%) |
|POLY-3 RATE (b) | 5/31.53 4/6.31 1/2.40 1/2.31 0/1.31 8/24.79 |
|POLY-3 PERCENT (g) | 15.9% 63.4% 41.7% 43.2% 0.0% 32.3% |
|INT SACRIFICE 1 (c)| 4/8 (50%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|TERMINAL (d) | 1/27 (4%) 4/5 (80%) 1/1 (100%) 1/1 (100%) 0/0 (0%) 8/24 (33%) |
|FIRST INCIDENCE | 186 (I) 366 (T) 366 (T) 366 (T) --- 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.325 P=0.337 P=0.199N P=0.199N P=0.028N* P=0.170 |
|POLY 3 | P=0.154 P=0.049 * P=0.472 P=0.465 P=0.624N P=0.129 |
|POLY 1.5 | P=0.168 P=0.092 P=0.611 P=0.598 P=0.499N P=0.141 |
|POLY 6 | P=0.133 P=0.034 * P=0.399 P=0.395 P=0.685N P=0.123 |
|LOGISTIC REGRESSION| P=0.322 P=0.333 P=0.165N P=0.192N P=0.025N* P=0.166 |
|COCH-ARM / FISHERS | P=0.120 P=0.254 P=0.514N P=0.555N P=0.266N P=0.175 |
|ORDER RESTRICTED | P=0.003 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/35 (17%) 0/15 (0%) 0/12 (0%) 0/11 (0%) 0/10 (0%) 2/30 (7%) |
|POLY-3 RATE (b) | 6/29.79 0/6.31 0/2.40 0/2.31 0/1.31 2/24.79 |
|POLY-3 PERCENT (g) | 20.1% 0.0% 0.0% 0.0% 0.0% 8.1% |
|INT SACRIFICE 1 (c)| 2/8 (25%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|TERMINAL (d) | 4/27 (15%) 0/5 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 2/24 (8%) |
|FIRST INCIDENCE | 186 (I) --- --- --- --- 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.327N P=0.101N P=0.163N P=0.163N P=0.185N P=0.189N |
|POLY 3 | P=0.147N P=0.303N P=0.520N P=0.526N P=0.596N P=0.192N |
|POLY 1.5 | P=0.220N P=0.222N P=0.377N P=0.391N P=0.449N P=0.189N |
|POLY 6 | P=0.123N P=0.354N P=0.597N P=0.600N P=0.672N P=0.194N |
|LOGISTIC REGRESSION| P=0.326N P=0.096N P=0.142N P=0.156N P=0.178N P=0.185N |
|COCH-ARM / FISHERS | P=0.459N P=0.102N P=0.151N P=0.173N P=0.199N P=0.185N |
|ORDER RESTRICTED | P=0.006N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/3 (33%) 0/10 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 2/3 (67%) |
|POLY-3 RATE (b) | 1/3.00 0/1.31 0/1.31 0/2.31 0/1.31 2/2.13 |
|POLY-3 PERCENT (g) | 33.3% 0.0% 0.0% 0.0% 0.0% 93.8% |
|INT SACRIFICE 1 (c)| 1/1 (100%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/2 (50%) |
|TERMINAL (d) | 0/2 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) 1/1 (100%) |
|FIRST INCIDENCE | 186 (I) --- --- --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * P=0.077N P=0.077N P=0.077N P=0.077N P=0.599 |
|POLY 3 | P=0.003 ** P=0.637N P=0.637N P=0.553N P=0.637N P=0.327 |
|POLY 1.5 | P<0.001 ** P=0.456N P=0.456N P=0.394N P=0.456N P=0.383 |
|POLY 6 | P=0.005 ** P=0.727N P=0.727N P=0.644N P=0.727N P=0.297 |
|LOGISTIC REGRESSION| P=0.012 * (e) (e) (e) (e) P=0.620 |
|COCH-ARM / FISHERS | P=0.002 ** P=0.231N P=0.231N P=0.214N P=0.231N P=0.500 |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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%) 0/2 (0%) 2/2 (100%) 2/2 (100%) 0/1 (0%) |
|POLY-3 RATE (b) | 1/1.00 2/2.00 0/0.22 2/2.00 2/2.00 0/0.13 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 0.0% 100.0% 100.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/1 (0%) 1/1 (100%) 0/0 (0%) 0/1 (0%) |
|TERMINAL (d) | 1/1 (100%) 2/2 (100%) 0/0 (0%) 1/1 (100%) 2/2 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (T) 366 (T) --- 186 (I) 366 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.559N (e) P=1.000 (e) (e) P=1.000 |
|POLY 3 | P=1.000N (e) P=1.000N (e) (e) P=1.000 |
|POLY 1.5 | P=0.955N (e) P=1.000N (e) (e) P=1.000 |
|POLY 6 | P=1.000N (e) P=1.000N (e) (e) P=1.000 |
|LOGISTIC REGRESSION| P=0.559N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.365N (e) P=0.333N (e) (e) P=0.500N |
|ORDER RESTRICTED | P=0.014N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/40 (20%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 9/40 (23%) |
|POLY-3 RATE (b) | 8/31.31 0/1.31 0/1.40 0/1.31 0/1.31 9/32.18 |
|POLY-3 PERCENT (g) | 25.6% 0.0% 0.0% 0.0% 0.0% 28.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 8/30 (27%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/30 (27%) |
|FIRST INCIDENCE | 366 (T) --- --- --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.407 P=1.000 P=1.000 P=1.000 P=1.000 P=0.500 |
|POLY 3 | P=0.443 P=0.566N P=0.557N P=0.566N P=0.566N P=0.526 |
|POLY 1.5 | P=0.324 P=0.394N P=0.376N P=0.394N P=0.394N P=0.518 |
|POLY 6 | P=0.468 P=0.660N P=0.654N P=0.660N P=0.660N P=0.531 |
|LOGISTIC REGRESSION| P=0.406 (e) (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.083 P=0.143N P=0.121N P=0.143N P=0.143N P=0.500 |
|ORDER RESTRICTED | P=0.307 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 1/40 (3%) |
|POLY-3 RATE (b) | 2/32.18 0/1.31 0/1.40 0/1.31 0/1.31 1/31.31 |
|POLY-3 PERCENT (g) | 6.2% 0.0% 0.0% 0.0% 0.0% 3.2% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/30 (3%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/30 (3%) |
|FIRST INCIDENCE | 186 (I) --- --- --- --- 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.551N P=0.500N P=0.500N P=0.500N P=0.500N P=0.500N |
|POLY 3 | P=0.392N P=0.758N P=0.748N P=0.758N P=0.758N P=0.510N |
|POLY 1.5 | P=0.450N P=0.703N P=0.689N P=0.703N P=0.703N P=0.507N |
|POLY 6 | P=0.377N P=0.785N P=0.776N P=0.785N P=0.785N P=0.511N |
|LOGISTIC REGRESSION| P=0.553N P=0.500N P=0.482N P=0.500N P=0.500N P=0.500N |
|COCH-ARM / FISHERS | P=0.621N P=0.637N P=0.612N P=0.637N P=0.637N P=0.500N |
|ORDER RESTRICTED | P=0.229N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 2/40 (5%) |
|POLY-3 RATE (b) | 2/31.31 0/1.31 0/1.40 0/1.31 0/1.31 2/33.05 |
|POLY-3 PERCENT (g) | 6.4% 0.0% 0.0% 0.0% 0.0% 6.1% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|TERMINAL (d) | 2/30 (7%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 366 (T) --- --- --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.421 P=1.000 P=1.000 P=1.000 P=1.000 P=0.695 |
|POLY 3 | P=0.612N P=0.757N P=0.747N P=0.757N P=0.757N P=0.675N |
|POLY 1.5 | P=0.595 P=0.702N P=0.688N P=0.702N P=0.702N P=0.681N |
|POLY 6 | P=0.593N P=0.785N P=0.776N P=0.785N P=0.785N P=0.672N |
|LOGISTIC REGRESSION| P=0.417 (e) (e) (e) (e) P=0.698N |
|COCH-ARM / FISHERS | P=0.418 P=0.637N P=0.612N P=0.637N P=0.637N P=0.692N |
|ORDER RESTRICTED | P=0.659N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/40 (28%) 1/18 (6%) 0/14 (0%) 0/14 (0%) 1/14 (7%) 11/40 (28%) |
|POLY-3 RATE (b) | 11/32.18 1/9.31 0/4.40 0/5.31 1/5.31 11/31.31 |
|POLY-3 PERCENT (g) | 34.2% 10.7% 0.0% 0.0% 18.8% 35.1% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 10/30 (33%) 1/8 (13%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 11/30 (37%) |
|FIRST INCIDENCE | 186 (I) 366 (T) --- --- 366 (T) 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.225 P=0.148N P=0.161N P=0.120N P=0.387N P=0.602 |
|POLY 3 | P=0.274 P=0.191N P=0.258N P=0.199N P=0.439N P=0.573 |
|POLY 1.5 | P=0.174 P=0.129N P=0.139N P=0.112N P=0.298N P=0.582 |
|POLY 6 | P=0.332 P=0.235N P=0.344N P=0.265N P=0.525N P=0.568 |
|LOGISTIC REGRESSION| P=0.224 P=0.144N P=0.152N P=0.116N P=0.385N P=0.603N |
|COCH-ARM / FISHERS | P=0.058 P=0.053N P=0.024N* P=0.024N* P=0.111N P=0.599N |
|ORDER RESTRICTED | P=0.082 (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) | 1/40 (3%) 0/18 (0%) 1/14 (7%) 0/14 (0%) 0/14 (0%) 2/40 (5%) |
|POLY-3 RATE (b) | 1/32.18 0/9.31 1/4.40 0/5.31 0/5.31 2/32.18 |
|POLY-3 PERCENT (g) | 3.1% 0.0% 22.7% 0.0% 0.0% 6.2% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 0/30 (0%) 0/8 (0%) 1/3 (33%) 0/4 (0%) 0/4 (0%) 1/30 (3%) |
|FIRST INCIDENCE | 186 (I) --- 366 (T) --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.316 P=0.500N P=0.563 P=0.500N P=0.500N P=0.500 |
|POLY 3 | P=0.383 P=0.720N P=0.341 P=0.784N P=0.784N P=0.500 |
|POLY 1.5 | P=0.376 P=0.701N P=0.396 P=0.762N P=0.762N P=0.500 |
|POLY 6 | P=0.383 P=0.731N P=0.313 P=0.796N P=0.796N P=0.500 |
|LOGISTIC REGRESSION| P=0.312 (e) P=0.580 (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.335 P=0.690N P=0.455 P=0.741N P=0.741N P=0.500 |
|ORDER RESTRICTED | P=0.231 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/39 (5%) 0/10 (0%) 0/10 (0%) 2/12 (17%) 0/10 (0%) 1/40 (3%) |
|POLY-3 RATE (b) | 2/30.31 0/1.31 0/1.31 2/3.31 0/1.31 1/31.31 |
|POLY-3 PERCENT (g) | 6.6% 0.0% 0.0% 60.4% 0.0% 3.2% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/29 (7%) 0/0 (0%) 0/0 (0%) 2/2 (100%) 0/0 (0%) 1/30 (3%) |
|FIRST INCIDENCE | 366 (T) --- --- 366 (T) --- 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.193N P=1.000 P=1.000N P=0.004 ** P=1.000 P=0.488N |
|POLY 3 | P=0.281N P=0.754N P=0.754N P=0.087 P=0.754N P=0.489N |
|POLY 1.5 | P=0.286N P=0.697N P=0.697N P=0.129 P=0.697N P=0.489N |
|POLY 6 | P=0.296N P=0.782N P=0.782N P=0.069 P=0.782N P=0.488N |
|LOGISTIC REGRESSION| P=0.193N (e) (e) P=0.004 ** (e) P=0.488N |
|COCH-ARM / FISHERS | P=0.378N P=0.630N P=0.630N P=0.232 P=0.630N P=0.490N |
|ORDER RESTRICTED | P=0.034N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/39 (8%) 0/10 (0%) 0/10 (0%) 2/12 (17%) 0/10 (0%) 0/40 (0%) |
|POLY-3 RATE (b) | 3/31.18 0/1.31 0/1.31 2/3.31 0/1.31 0/31.31 |
|POLY-3 PERCENT (g) | 9.6% 0.0% 0.0% 60.4% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/29 (7%) 0/0 (0%) 0/0 (0%) 2/2 (100%) 0/0 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 186 (I) --- --- 366 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.052N P=0.500N P=0.500N P=0.139 P=0.500N P=0.119N |
|POLY 3 | P=0.043N* P=0.698N P=0.698N P=0.131 P=0.698N P=0.116N |
|POLY 1.5 | P=0.047N* P=0.615N P=0.615N P=0.193 P=0.615N P=0.115N |
|POLY 6 | P=0.047N* P=0.739N P=0.739N P=0.103 P=0.739N P=0.116N |
|LOGISTIC REGRESSION| P=0.050N P=0.500N P=0.500N P=0.134 P=0.500N P=0.115N |
|COCH-ARM / FISHERS | P=0.093N P=0.496N P=0.496N P=0.335 P=0.496N P=0.116N |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Prostate |
| Corpora Amylacea |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/40 (3%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 2/40 (5%) |
|POLY-3 RATE (b) | 1/32.18 0/1.31 0/1.40 0/1.31 0/1.31 2/33.05 |
|POLY-3 PERCENT (g) | 3.1% 0.0% 0.0% 0.0% 0.0% 6.1% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|TERMINAL (d) | 0/30 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 186 (I) --- --- --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.062 P=0.500N P=0.500N P=0.500N P=0.500N P=0.500 |
|POLY 3 | P=0.372 P=0.856N P=0.847N P=0.856N P=0.856N P=0.509 |
|POLY 1.5 | P=0.347 P=0.835N P=0.823N P=0.835N P=0.835N P=0.506 |
|POLY 6 | P=0.373 P=0.866N P=0.857N P=0.866N P=0.866N P=0.511 |
|LOGISTIC REGRESSION| P=0.056 (e) P=0.470N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.238 P=0.800N P=0.784N P=0.800N P=0.800N P=0.500 |
|ORDER RESTRICTED | P=0.230 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/40 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/10 (0%) 2/40 (5%) |
|POLY-3 RATE (b) | 0/31.31 0/1.31 0/1.40 0/1.31 0/1.31 2/31.31 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 6.4% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/30 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/30 (7%) |
|FIRST INCIDENCE | --- --- --- --- --- 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.174 (e) (e) (e) (e) P=0.238 |
|POLY 3 | P=0.098 (e) (e) (e) (e) P=0.236 |
|POLY 1.5 | P=0.096 (e) (e) (e) (e) P=0.236 |
|POLY 6 | P=0.096 (e) (e) (e) (e) P=0.236 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.238 |
|COCH-ARM / FISHERS | P=0.073 (e) (e) (e) (e) P=0.247 |
|ORDER RESTRICTED | P=0.009 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 1/13 (8%) 1/12 (8%) 2/13 (15%) 3/13 (23%) 2/40 (5%) |
|POLY-3 RATE (b) | 2/31.31 1/4.31 1/2.40 2/4.31 3/4.31 2/31.31 |
|POLY-3 PERCENT (g) | 6.4% 23.2% 41.7% 46.4% 69.6% 6.4% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/30 (7%) 1/3 (33%) 1/1 (100%) 2/3 (67%) 3/3 (100%) 2/30 (7%) |
|FIRST INCIDENCE | 366 (T) 366 (T) 366 (T) 366 (T) 366 (T) 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.174N P=0.319 P=0.086 P=0.019 * P<0.001 ** P=0.696 |
|POLY 3 | P=0.374N P=0.427 P=0.351 P=0.110 P=0.015 * P=0.695 |
|POLY 1.5 | P=0.348N P=0.497 P=0.436 P=0.152 P=0.027 * P=0.695 |
|POLY 6 | P=0.411N P=0.389 P=0.307 P=0.091 P=0.011 * P=0.695 |
|LOGISTIC REGRESSION| P=0.174N P=0.319 P=0.086 P=0.019 * P<0.001 ** P=0.696 |
|COCH-ARM / FISHERS | P=0.408N P=0.578 P=0.553 P=0.249 P=0.088 P=0.692N |
|ORDER RESTRICTED | P=0.013 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 26/40 (65%) 31/40 (78%) 31/40 (78%) 31/40 (78%) 32/39 (82%) 40/40 (100%) |
|POLY-3 RATE (b) | 26/32.18 31/32.18 31/33.01 31/32.18 32/32.92 40/40.00 |
|POLY-3 PERCENT (g) | 80.8% 96.3% 93.9% 96.3% 97.2% 100.0% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 3/10 (30%) 1/10 (10%) 3/10 (30%) 10/10 (100%) |
|TERMINAL (d) | 25/30 (83%) 30/30 (100%) 28/29 (97%) 30/30 (100%) 29/29 (100%) 30/30 (100%) |
|FIRST INCIDENCE | 186 (I) 186 (I) 186 (I) 186 (I) 186 (I) 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.059 P=0.050 P=0.059 P=0.018 * P<0.001 ** |
|POLY 3 | P=0.006 ** P=0.033 * P=0.083 P=0.033 * P=0.022 * P=0.003 ** |
|POLY 1.5 | P<0.001 ** P=0.059 P=0.095 P=0.059 P=0.028 * P<0.001 ** |
|POLY 6 | P=0.056 P=0.028 * P=0.089 P=0.028 * P=0.025 * P=0.011 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.057 P=0.052 P=0.057 P=0.017 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.162 P=0.162 P=0.162 P=0.072 P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 53 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/40 (8%) |
|POLY-3 RATE (b) | 2/33.05 0/1.31 0/1.31 0/1.31 0/1.31 3/32.18 |
|POLY-3 PERCENT (g) | 6.1% 0.0% 0.0% 0.0% 0.0% 9.3% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 0/30 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/30 (7%) |
|FIRST INCIDENCE | 186 (I) --- --- --- --- 186 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.158 P=0.234N P=0.234N P=0.234N P=0.234N P=0.500 |
|POLY 3 | P=0.375 P=0.759N P=0.759N P=0.759N P=0.759N P=0.488 |
|POLY 1.5 | P=0.341 P=0.705N P=0.705N P=0.705N P=0.705N P=0.492 |
|POLY 6 | P=0.376 P=0.784N P=0.784N P=0.784N P=0.784N P=0.486 |
|LOGISTIC REGRESSION| P=0.156 (e) (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.209 P=0.637N P=0.637N P=0.637N P=0.637N P=0.500 |
|ORDER RESTRICTED | P=0.252 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Calculus Micro Observation Only |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/40 (5%) 0/11 (0%) 3/13 (23%) 0/10 (0%) 5/17 (29%) 12/40 (30%) |
|POLY-3 RATE (b) | 2/31.31 0/2.31 3/4.31 0/1.31 5/8.31 12/31.31 |
|POLY-3 PERCENT (g) | 6.4% 0.0% 69.6% 0.0% 60.2% 38.3% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/30 (7%) 0/1 (0%) 3/3 (100%) 0/0 (0%) 5/7 (71%) 12/30 (40%) |
|FIRST INCIDENCE | 366 (T) --- 366 (T) --- 366 (T) 366 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.038 * P=0.962N P<0.001 ** P=1.000N P<0.001 ** P=0.003 ** |
|POLY 3 | P=0.003 ** P=0.724N P=0.015 * P=0.757N P=0.002 ** P=0.002 ** |
|POLY 1.5 | P=0.003 ** P=0.669N P=0.027 * P=0.702N P=0.003 ** P=0.002 ** |
|POLY 6 | P=0.003 ** P=0.752N P=0.011 * P=0.785N P<0.001 ** P=0.002 ** |
|LOGISTIC REGRESSION| P=0.038 * (e) P<0.001 ** (e) P<0.001 ** P=0.003 ** |
|COCH-ARM / FISHERS | P=0.002 ** P=0.612N P=0.088 P=0.637N P=0.020 * P=0.003 ** |
|ORDER RESTRICTED | P<0.001 ** (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).