TDMS Study 60855-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: BIORELIANCE BETA-BROMO-BETA-NITROSTYRENE DATE: 10/19/04
EXPERIMENT: 60855 TEST: 01 TIME: 14:14:02
TEST TYPE: 18-33 DAYS PAGE: 1
CONT: NO1-ES-15319 ROUTE: GAVAGE NTP C#: C60855
PATHOLOGIST: MISSING CAS: 7166-19-0
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: BIORELIANCE BETA-BROMO-BETA-NITROSTYRENE DATE: 10/19/04
EXPERIMENT: 60855 TEST: 01 TIME: 14:14:02
TEST TYPE: 18-33 DAYS
CONT: NO1-ES-15319 ROUTE: GAVAGE NTP C#: C60855
PATHOLOGIST: MISSING CAS: 7166-19-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF BETA-BROMO-BETA-NITROSTYRENE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Intestine Large, Cecum Inflammation
Lung Congestion
Hemorrhage
Inflammation Focal
Lymph Node, Mesenteric Hemorrhage
Nose Congestion
Inflammation
Necrosis
Pancreas Inflammation
Preputial Gland Inflammation
Prostate Inflammation
Spleen: Lymphoid Follicle Depletion Cellular
Stomach, Forestomach Hemorrhage
Inflammation
Necrosis
Ulcer
Stomach, Forestomach: Epithelium Hyperkeratosis
Hyperplasia
Stomach, Glandular Inflammation
Testes Degeneration
Thymus Atrophy
Hemorrhage
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Intestine Large, Cecum Inflammation
Kidney Mineralization
Liver Hepatodiaphragmatic Nodule
Inflammation
Necrosis Focal
Lung Congestion
Hemorrhage
Lymph Node, Mesenteric Hemorrhage
Nose Inflammation
Necrosis
Nose: Respiratory Epithelium Metaplasia
Pancreas Inflammation
Spleen Inflammation
Stomach, Forestomach Hemorrhage
Inflammation
Necrosis
Ulcer
Stomach, Forestomach: Epithelium Hyperkeratosis
Hyperplasia
Stomach, Glandular Inflammation
Thymus Atrophy
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: BIORELIANCE BETA-BROMO-BETA-NITROSTYRENE DATE: 10/19/04
EXPERIMENT: 60855 TEST: 01 TIME: 14:14:02
TEST TYPE: 18-33 DAYS
CONT: NO1-ES-15319 ROUTE: GAVAGE NTP C#: C60855
PATHOLOGIST: MISSING CAS: 7166-19-0
Hemorrhage
Uterus Hydrometra
Uterus: Bilateral Hydrometra
===============================================================
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|INT SACRIFICE 1 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) 1/10 (10%) |
|POLY-3 RATE (b) | 3/10.00 0/0.00 0/0.00 0/0.00 5/10.00 1/1.06 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 50.0% 94.1% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/9 (44%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) --- --- --- 6 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.080 P=1.000N P=1.000N P=1.000N P=0.282 P=0.455 |
|POLY 3 | (e) (e) (e) (e) P=0.329 P=0.457 |
|POLY 1.5 | (e) (e) (e) (e) P=0.329 P=0.531 |
|POLY 6 | (e) (e) (e) (e) P=0.329 P=0.449 |
|LOGISTIC REGRESSION| P=0.656N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.232N P=1.000 P=1.000 P=1.000 P=0.325 P=0.291N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Heart |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/2 (0%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 3/10.00 0/0.00 0/0.00 0/0.06 1/9.11 0/0.03 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 11.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) --- --- --- 29 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.333N P=1.000 P=1.000N P=1.000 P=0.333N P=1.000N |
|POLY 3 | (e) (e) (e) P=0.773N P=0.328N P=0.675N |
|POLY 1.5 | (e) (e) (e) P=0.738N P=0.318N P=0.639N |
|POLY 6 | (e) (e) (e) P=0.780N P=0.332N P=0.678N |
|LOGISTIC REGRESSION| P=0.333N (e) (e) (e) P=0.333N (e) |
|COCH-ARM / FISHERS | P=0.056N P=1.000 P=1.000 P=0.545N P=0.291N P=0.105N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Heart |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 0/0.00 0/0.00 0/0.00 1/9.01 0/0.07 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 11.1% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) --- --- --- 29 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.743 P=1.000N P=1.000N P=1.000N P=0.743 P=1.000N |
|POLY 3 | (e) (e) (e) (e) P=0.737 P=0.759N |
|POLY 1.5 | (e) (e) (e) (e) P=0.739 P=0.742N |
|POLY 6 | (e) (e) (e) (e) P=0.737 P=0.760N |
|LOGISTIC REGRESSION| P=0.749 (e) (e) (e) P=0.749 (e) |
|COCH-ARM / FISHERS | P=0.327N P=1.000 P=1.000 P=1.000 P=0.763N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 4/10 (40%) 6/10 (60%) 9/10 (90%) 2/8 (25%) |
|POLY-3 RATE (b) | 0/10.00 1/10.00 4/10.00 6/10.00 9/10.00 2/2.02 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 40.0% 60.0% 90.0% 99.2% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 4/10 (40%) 4/8 (50%) 8/9 (89%) 0/0 (0%) |
|FIRST INCIDENCE | --- 29 (T) 29 (T) 9 14 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 P=0.051 P=0.008 ** P<0.001 ** P=0.004 ** |
|POLY 3 | P<0.001 ** P=0.500 P=0.033 * P<0.001 ** P<0.001 ** P=0.029 * |
|POLY 1.5 | P<0.001 ** P=0.500 P=0.033 * P<0.001 ** P<0.001 ** P=0.033 * |
|POLY 6 | P<0.001 ** P=0.500 P=0.033 * P<0.001 ** P<0.001 ** P=0.029 * |
|LOGISTIC REGRESSION| P=0.011 * P=0.500 P=0.051 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.075 P=0.500 P=0.043 * P=0.005 ** P<0.001 ** P=0.183 |
|ORDER RESTRICTED | P=0.068 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 8/10.00 1/1.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 80.0% 94.1% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 7/9 (78%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 6 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P=0.455 |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** P=0.245 |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P=0.265 |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P=0.243 |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.026 * (e) (e) (e) P<0.001 ** P=0.500 |
|ORDER RESTRICTED | P=0.096 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.06 0/9.11 0/0.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) 7/10 (70%) |
|POLY-3 RATE (b) | 4/10.00 0/0.00 0/0.00 0/0.00 5/10.00 7/7.01 |
|POLY-3 PERCENT (g) | 40.0% 0.0% 0.0% 0.0% 50.0% 99.9% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/9 (44%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) --- --- --- 6 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=1.000N P=1.000N P=1.000N P=0.431 P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P=0.500 P=0.012 * |
|POLY 1.5 | (e) (e) (e) (e) P=0.500 P=0.015 * |
|POLY 6 | (e) (e) (e) (e) P=0.500 P=0.012 * |
|LOGISTIC REGRESSION| P=0.569 (e) (e) (e) (e) P=0.996 |
|COCH-ARM / FISHERS | P=0.131 P=1.000 P=1.000 P=1.000 P=0.500 P=0.185 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 1/1 (100%) 0/2 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 1/1.00 0/0.06 0/9.11 0/0.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 29 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.722N (e) P=0.077 (e) (e) (e) |
|POLY 3 | (e) (e) P=0.091 (e) (e) (e) |
|POLY 1.5 | (e) (e) P=0.091 (e) (e) (e) |
|POLY 6 | (e) (e) P=0.091 (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.077 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.401N (e) P=0.091 (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/1 (100%) 3/3 (100%) 1/1 (100%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 1/1.00 3/3.00 1/1.00 0/9.01 0/0.07 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 1/1 (100%) 3/3 (100%) 1/1 (100%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 29 (T) 29 (T) 29 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.378N P=0.077 P=0.003 ** P=0.077 (e) (e) |
|POLY 3 | P<0.001N** P=0.091N P=0.003 ** P=0.091 (e) (e) |
|POLY 1.5 | P<0.001N** P=0.091N P=0.003 ** P=0.091 (e) (e) |
|POLY 6 | P<0.001N** P=0.091N P=0.003 ** P=0.091 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.077 P=0.003 ** P=0.077 (e) (e) |
|COCH-ARM / FISHERS | P=0.057N P=0.091 P=0.003 ** P=0.091 (e) (e) |
|ORDER RESTRICTED | P=0.815 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 0/2 (0%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/1.00 0/0.06 1/9.11 0/0.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 11.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 29 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.469 (e) (e) (e) P=0.479 (e) |
|POLY 3 | (e) (e) (e) (e) P=0.481 (e) |
|POLY 1.5 | (e) (e) (e) (e) P=0.486 (e) |
|POLY 6 | (e) (e) (e) (e) P=0.479 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.479 (e) |
|COCH-ARM / FISHERS | P=0.715 (e) (e) (e) P=0.500 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/1 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/1.00 0/3.00 0/1.00 0/9.01 2/2.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 97.4% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/1 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** (e) (e) (e) (e) P=0.185 |
|POLY 3 | P=0.210 (e) (e) (e) (e) P=0.041 * |
|POLY 1.5 | P=0.149 (e) (e) (e) (e) P=0.050 |
|POLY 6 | P=0.218 (e) (e) (e) (e) P=0.040 * |
|LOGISTIC REGRESSION| P=0.707 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.060 (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 0/2 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/1.00 0/0.06 0/9.11 0/0.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/1 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/1.00 0/3.00 0/1.00 0/9.01 2/2.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 97.4% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/1 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** (e) (e) (e) (e) P=0.185 |
|POLY 3 | P=0.210 (e) (e) (e) (e) P=0.041 * |
|POLY 1.5 | P=0.149 (e) (e) (e) (e) P=0.050 |
|POLY 6 | P=0.218 (e) (e) (e) (e) P=0.040 * |
|LOGISTIC REGRESSION| P=0.707 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.060 (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.06 0/9.11 4/4.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 99.2% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.024 * |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.008 ** (e) (e) (e) (e) P=0.043 * |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/9.01 3/3.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 98.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.046 * |
|POLY 3 | (e) (e) (e) (e) (e) P=0.004 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.006 ** |
|POLY 6 | (e) (e) (e) (e) (e) P=0.003 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.031 * (e) (e) (e) (e) P=0.105 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/2 (0%) 2/10 (20%) 3/10 (30%) |
|POLY-3 RATE (b) | 3/10.00 0/0.00 0/0.00 0/0.06 2/9.11 3/3.03 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 22.0% 99.1% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/9 (22%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) --- --- --- 29 (T) 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** P=1.000 P=1.000N P=1.000N P=0.553N P=0.036 * |
|POLY 3 | (e) (e) (e) P=0.773N P=0.546N P=0.131 |
|POLY 1.5 | (e) (e) (e) P=0.738N P=0.534N P=0.156 |
|POLY 6 | (e) (e) (e) P=0.780N P=0.551N P=0.129 |
|LOGISTIC REGRESSION| P=0.593 (e) (e) (e) P=0.553N (e) |
|COCH-ARM / FISHERS | P=0.551 P=1.000 P=1.000 P=0.545N P=0.500N P=0.686N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 2/9.01 1/1.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 22.2% 94.1% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/9 (22%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 29 (T) 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * (e) (e) (e) P=0.210 P=0.455 |
|POLY 3 | (e) (e) (e) (e) P=0.202 P=0.245 |
|POLY 1.5 | (e) (e) (e) (e) P=0.204 P=0.265 |
|POLY 6 | (e) (e) (e) (e) P=0.202 P=0.243 |
|LOGISTIC REGRESSION| P=0.172 (e) (e) (e) P=0.204 (e) |
|COCH-ARM / FISHERS | P=0.355 (e) (e) (e) P=0.237 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 3/10.00 0/0.00 0/0.00 0/0.06 0/9.11 0/0.03 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.129N P=1.000 P=1.000N P=1.000N P=0.129N P=1.000N |
|POLY 3 | (e) (e) (e) P=0.773N P=0.113N P=0.675N |
|POLY 1.5 | (e) (e) (e) P=0.738N P=0.108N P=0.639N |
|POLY 6 | (e) (e) (e) P=0.780N P=0.115N P=0.678N |
|LOGISTIC REGRESSION| P=0.129N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.034N* P=1.000 P=1.000 P=0.545N P=0.105N P=0.105N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/9.01 0/0.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 1/2 (50%) 1/10 (10%) 0/9 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 1/1.03 1/9.11 0/0.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 97.1% 11.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 9 29 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.393 (e) (e) P=0.500 P=0.479 (e) |
|POLY 3 | (e) (e) (e) P=0.065 P=0.481 (e) |
|POLY 1.5 | (e) (e) (e) P=0.072 P=0.486 (e) |
|POLY 6 | (e) (e) (e) P=0.063 P=0.479 (e) |
|LOGISTIC REGRESSION| P=0.522N (e) (e) (e) P=0.479 (e) |
|COCH-ARM / FISHERS | P=0.547N (e) (e) P=0.167 P=0.500 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/9 (22%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 2/9.00 0/0.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 22.2% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/9 (22%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 29 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.210 (e) (e) (e) P=0.210 (e) |
|POLY 3 | (e) (e) (e) (e) P=0.201 (e) |
|POLY 1.5 | (e) (e) (e) (e) P=0.201 (e) |
|POLY 6 | (e) (e) (e) (e) P=0.201 (e) |
|LOGISTIC REGRESSION| P=0.204 (e) (e) (e) P=0.210 (e) |
|COCH-ARM / FISHERS | P=0.670 (e) (e) (e) P=0.211 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/2 (0%) 2/10 (20%) 0/9 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.06 2/10.00 0/0.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 20.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 14 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.143 (e) (e) (e) P=0.228 (e) |
|POLY 3 | (e) (e) (e) (e) P=0.227 (e) |
|POLY 1.5 | (e) (e) (e) (e) P=0.227 (e) |
|POLY 6 | (e) (e) (e) (e) P=0.227 (e) |
|LOGISTIC REGRESSION| P=0.616 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.634 (e) (e) (e) P=0.237 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 1/9.00 0/0.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 11.1% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 29 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.479 (e) (e) (e) P=0.479 (e) |
|POLY 3 | (e) (e) (e) (e) P=0.479 (e) |
|POLY 1.5 | (e) (e) (e) (e) P=0.479 (e) |
|POLY 6 | (e) (e) (e) (e) P=0.479 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.479 (e) |
|COCH-ARM / FISHERS | P=0.730 (e) (e) (e) P=0.474 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/2 (0%) 2/10 (20%) 4/10 (40%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.06 2/9.11 4/4.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 22.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/9 (22%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 29 (T) 5 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.210 P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P=0.204 P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P=0.210 P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P=0.202 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.035 * (e) (e) (e) P=0.210 P=0.861 |
|COCH-ARM / FISHERS | P=0.018 * (e) (e) (e) P=0.237 P=0.043 * |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) 7/10 (70%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 1/9.01 7/7.01 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 11.1% 99.9% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 29 (T) 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.479 P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P=0.479 P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P=0.481 P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P=0.479 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.082 (e) (e) (e) P=0.479 P=0.995 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.500 P=0.002 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Nose |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/8.06 0/9.11 2/2.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 98.4% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004 ** (e) (e) (e) (e) P=0.162 |
|POLY 3 | P=0.154 (e) (e) (e) (e) P=0.041 * |
|POLY 1.5 | P=0.109 (e) (e) (e) (e) P=0.047 * |
|POLY 6 | P=0.156 (e) (e) (e) (e) P=0.040 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Nose |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/9.01 0/0.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 1/10 (10%) 2/10 (20%) 6/10 (60%) 2/10 (20%) 4/10 (40%) |
|POLY-3 RATE (b) | 2/10.00 1/10.00 2/10.00 6/10.00 2/10.00 4/4.03 |
|POLY-3 PERCENT (g) | 20.0% 10.0% 20.0% 60.0% 20.0% 99.3% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 2/10 (20%) 1/10 (10%) 2/10 (20%) 4/8 (50%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) 29 (T) 29 (T) 9 14 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500N P=0.707 P=0.069 P=0.670 P=0.014 * |
|POLY 3 | P=0.038 * P=0.500N P=0.702 P=0.077 P=0.702 P=0.022 * |
|POLY 1.5 | P=0.038 * P=0.500N P=0.702 P=0.077 P=0.702 P=0.029 * |
|POLY 6 | P=0.038 * P=0.500N P=0.702 P=0.077 P=0.702 P=0.022 * |
|LOGISTIC REGRESSION| P=0.207N P=0.500N P=0.707 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.185 P=0.500N P=0.709N P=0.085 P=0.709N P=0.314 |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 3/10 (30%) 4/10 (40%) 6/10 (60%) 3/10 (30%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/10.00 3/10.00 4/10.00 6/10.00 3/10.00 1/1.06 |
|POLY-3 PERCENT (g) | 10.0% 30.0% 40.0% 60.0% 30.0% 94.1% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 1/10 (10%) 3/10 (30%) 4/10 (40%) 6/10 (60%) 2/9 (22%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) 29 (T) 29 (T) 29 (T) 6 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.099 P=0.293 P=0.157 P=0.034 * P=0.272 P=0.455 |
|POLY 3 | P=0.221 P=0.292 P=0.148 P=0.018 * P=0.292 P=0.356 |
|POLY 1.5 | P=0.227 P=0.292 P=0.148 P=0.018 * P=0.292 P=0.397 |
|POLY 6 | P=0.221 P=0.292 P=0.148 P=0.018 * P=0.292 P=0.352 |
|LOGISTIC REGRESSION| P=0.616N P=0.293 P=0.157 P=0.034 * (e) (e) |
|COCH-ARM / FISHERS | P=0.236N P=0.291 P=0.152 P=0.029 * P=0.291 P=0.763N |
|ORDER RESTRICTED | P=0.475 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Nose |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/8.06 1/10.00 2/2.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 10.0% 98.4% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 14 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.500 P=0.162 |
|POLY 3 | P=0.035 * (e) (e) (e) P=0.500 P=0.041 * |
|POLY 1.5 | P=0.025 * (e) (e) (e) P=0.500 P=0.047 * |
|POLY 6 | P=0.036 * (e) (e) (e) P=0.500 P=0.040 * |
|LOGISTIC REGRESSION| P=0.729N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.013 * (e) (e) (e) P=0.500 P=0.237 |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Nose |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 2/10.00 0/0.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 20.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 6 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.232 (e) (e) (e) P=0.228 (e) |
|POLY 3 | P=0.010 * (e) (e) (e) P=0.227 (e) |
|POLY 1.5 | P=0.011 * (e) (e) (e) P=0.227 (e) |
|POLY 6 | P=0.010 * (e) (e) (e) P=0.227 (e) |
|LOGISTIC REGRESSION| P=0.739N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.413 (e) (e) (e) P=0.237 (e) |
|ORDER RESTRICTED | P=0.820 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 2/10 (20%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 2/10.00 2/10.00 1/9.11 0/0.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 20.0% 20.0% 11.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/8 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 29 (T) 9 29 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.393 (e) P=0.234 P=0.237 P=0.479 (e) |
|POLY 3 | P=0.241 (e) P=0.227 P=0.227 P=0.481 (e) |
|POLY 1.5 | P=0.256 (e) P=0.227 P=0.227 P=0.486 (e) |
|POLY 6 | P=0.235 (e) P=0.227 P=0.227 P=0.479 (e) |
|LOGISTIC REGRESSION| P=0.095N (e) P=0.234 (e) P=0.479 (e) |
|COCH-ARM / FISHERS | P=0.438N (e) P=0.237 P=0.237 P=0.500 (e) |
|ORDER RESTRICTED | P=0.828 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 3/10 (30%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 3/10.00 0/10.00 0/10.00 2/9.01 0/0.07 |
|POLY-3 PERCENT (g) | 0.0% 30.0% 0.0% 0.0% 22.2% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 3/10 (30%) 0/10 (0%) 0/10 (0%) 2/9 (22%) 0/0 (0%) |
|FIRST INCIDENCE | --- 29 (T) --- --- 29 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.467 P=0.111 (e) (e) P=0.210 (e) |
|POLY 3 | P=0.328 P=0.095 (e) (e) P=0.202 (e) |
|POLY 1.5 | P=0.338 P=0.095 (e) (e) P=0.204 (e) |
|POLY 6 | P=0.328 P=0.095 (e) (e) P=0.202 (e) |
|LOGISTIC REGRESSION| (e) P=0.111 (e) (e) P=0.204 (e) |
|COCH-ARM / FISHERS | P=0.404N P=0.105 (e) (e) P=0.237 (e) |
|ORDER RESTRICTED | P=0.823 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 1/10.00 0/10.00 1/8.06 0/9.11 0/0.03 |
|POLY-3 PERCENT (g) | 10.0% 10.0% 0.0% 12.4% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 1/8 (13%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) 29 (T) --- 29 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.537N P=0.766 P=0.500N P=0.716 P=0.521N P=1.000N |
|POLY 3 | P=0.355N P=0.760 P=0.500N P=0.711 P=0.518N P=0.760N |
|POLY 1.5 | P=0.348N P=0.760 P=0.500N P=0.719 P=0.514N P=0.750N |
|POLY 6 | P=0.357N P=0.760 P=0.500N P=0.709 P=0.521N P=0.760N |
|LOGISTIC REGRESSION| P=0.537N P=0.766 (e) P=0.721 (e) (e) |
|COCH-ARM / FISHERS | P=0.241N P=0.763N P=0.500N P=0.763N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.829N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 4/10 (40%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 1/10.00 4/10.00 2/9.01 0/0.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 40.0% 22.2% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 4/10 (40%) 2/9 (22%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 29 (T) 29 (T) 29 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.078 (e) P=0.500 P=0.051 P=0.210 (e) |
|POLY 3 | P=0.019 * (e) P=0.500 P=0.033 * P=0.202 (e) |
|POLY 1.5 | P=0.023 * (e) P=0.500 P=0.033 * P=0.204 (e) |
|POLY 6 | P=0.019 * (e) P=0.500 P=0.033 * P=0.202 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.500 P=0.051 P=0.204 (e) |
|COCH-ARM / FISHERS | P=0.554N (e) P=0.500 P=0.043 * P=0.237 (e) |
|ORDER RESTRICTED | P=0.821 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.06 0/9.11 1/1.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 97.6% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** (e) (e) (e) (e) P=0.136 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.244 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.255 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.243 |
|LOGISTIC REGRESSION| P=0.733 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.250 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/9.01 3/3.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 98.5% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.074 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.004 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.005 ** |
|POLY 6 | (e) (e) (e) (e) (e) P=0.003 ** |
|LOGISTIC REGRESSION| P=0.559 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.031 * (e) (e) (e) (e) P=0.105 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/2 (0%) 1/10 (10%) 4/10 (40%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/0.06 1/9.11 4/4.02 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 11.0% 99.4% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) --- --- --- 29 (T) 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=1.000 P=1.000N P=1.000N P=0.539N P=0.008 ** |
|POLY 3 | (e) (e) (e) P=0.807N P=0.533N P=0.022 * |
|POLY 1.5 | (e) (e) (e) P=0.785N P=0.525N P=0.029 * |
|POLY 6 | (e) (e) (e) P=0.811N P=0.537N P=0.022 * |
|LOGISTIC REGRESSION| P=0.591 (e) (e) (e) P=0.539N (e) |
|COCH-ARM / FISHERS | P=0.179 P=1.000 P=1.000 P=0.682N P=0.500N P=0.314 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|INT SACRIFICE 1 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.06 0/9.11 2/2.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 99.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 5 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.017 * |
|POLY 3 | (e) (e) (e) (e) (e) P=0.041 * |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.045 * |
|POLY 6 | (e) (e) (e) (e) (e) P=0.040 * |
|LOGISTIC REGRESSION| P=0.505 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.077 (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|INT SACRIFICE 1 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Spleen |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.06 0/9.11 0/0.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Spleen |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/9.01 2/2.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 97.4% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** (e) (e) (e) (e) P=0.185 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.041 * |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.050 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.040 * |
|LOGISTIC REGRESSION| P=0.709 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.089 (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.06 0/9.11 2/2.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 98.6% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.093 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.041 * |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.046 * |
|POLY 6 | (e) (e) (e) (e) (e) P=0.040 * |
|LOGISTIC REGRESSION| P=0.787 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.077 (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/9.01 0/0.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 6/10 (60%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/8.06 0/9.11 6/6.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.192 (e) (e) (e) (e) P=0.974 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.005 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/9.01 4/4.04 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 99.1% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.028 * |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.414 (e) (e) (e) (e) P=0.999 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.043 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 4/10 (40%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/8.06 4/10.00 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 40.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) 3/9 (33%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 14 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.049 * P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.033 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.033 * P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.033 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.043 * P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 7/10 (70%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 7/10.00 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 70.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 6/9 (67%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 6 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.003 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.002 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/8.06 1/10.00 3/3.01 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 10.0% 99.8% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 14 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.500 P<0.001 ** |
|POLY 3 | P=0.003 ** (e) (e) (e) P=0.500 P=0.003 ** |
|POLY 1.5 | P=0.003 ** (e) (e) (e) P=0.500 P=0.004 ** |
|POLY 6 | P=0.003 ** (e) (e) (e) P=0.500 P=0.003 ** |
|LOGISTIC REGRESSION| P=0.423 (e) (e) (e) (e) P=0.969 |
|COCH-ARM / FISHERS | P=0.002 ** (e) (e) (e) P=0.500 P=0.105 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/9.01 8/8.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.091 (e) (e) (e) (e) P=0.996 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/8.06 3/9.11 0/0.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 32.9% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) 3/9 (33%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 29 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008 ** (e) (e) (e) P=0.093 (e) |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.078 (e) |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.082 (e) |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.076 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.093 (e) |
|COCH-ARM / FISHERS | P=0.313 (e) (e) (e) P=0.105 (e) |
|ORDER RESTRICTED | P=0.823 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 3/10.00 0/0.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 30.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/9 (22%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 6 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.073 (e) (e) (e) P=0.108 (e) |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.095 (e) |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.095 (e) |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.095 (e) |
|LOGISTIC REGRESSION| P=0.559 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.313 (e) (e) (e) P=0.105 (e) |
|ORDER RESTRICTED | P=0.817 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 4/10 (40%) 9/10 (90%) 9/10 (90%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 4/10.00 9/9.03 9/9.11 0/0.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 40.0% 99.7% 98.8% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 4/10 (40%) 8/8 (100%) 9/9 (100%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 29 (T) 9 29 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.051 P<0.001 ** P<0.001 ** (e) |
|POLY 3 | P<0.001 ** (e) P=0.033 * P<0.001 ** P<0.001 ** (e) |
|POLY 1.5 | P<0.001 ** (e) P=0.033 * P<0.001 ** P<0.001 ** (e) |
|POLY 6 | P<0.001 ** (e) P=0.033 * P<0.001 ** P<0.001 ** (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.051 P<0.001 ** P<0.001 ** (e) |
|COCH-ARM / FISHERS | P=0.531 (e) P=0.043 * P<0.001 ** P<0.001 ** (e) |
|ORDER RESTRICTED | P=0.812 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 8/10 (80%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 10/10.00 8/10.00 0/0.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% 80.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 7/9 (78%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 29 (T) 6 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** (e) |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** (e) |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** (e) |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P<0.001 ** (e) (e) |
|COCH-ARM / FISHERS | P=0.359 (e) (e) P<0.001 ** P<0.001 ** (e) |
|ORDER RESTRICTED | P=0.777 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 3/10 (30%) 7/10 (70%) 10/10 (100%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 3/10.00 7/9.03 10/10.00 0/0.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 30.0% 77.5% 100.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 3/10 (30%) 6/8 (75%) 9/9 (100%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 29 (T) 9 14 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.111 P=0.002 ** P<0.001 ** (e) |
|POLY 3 | P<0.001 ** (e) P=0.095 P<0.001 ** P<0.001 ** (e) |
|POLY 1.5 | P<0.001 ** (e) P=0.095 P<0.001 ** P<0.001 ** (e) |
|POLY 6 | P<0.001 ** (e) P=0.095 P<0.001 ** P<0.001 ** (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.111 P=0.002 ** (e) (e) |
|COCH-ARM / FISHERS | P=0.369 (e) P=0.105 P=0.002 ** P<0.001 ** (e) |
|ORDER RESTRICTED | P=0.814 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) 10/10 (100%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 8/10.00 10/10.00 0/0.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 80.0% 100.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) 9/9 (100%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 29 (T) 6 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** (e) |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** (e) |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** (e) |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P<0.001 ** (e) (e) |
|COCH-ARM / FISHERS | P=0.220 (e) (e) P<0.001 ** P<0.001 ** (e) |
|ORDER RESTRICTED | P=0.770 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/8.06 0/9.11 4/4.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 5 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.185 (e) (e) (e) (e) P=0.861 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.043 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 6/10 (60%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/9.01 6/6.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 99.7% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.003 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.226 (e) (e) (e) (e) P=0.996 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.005 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Testes |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/10.00 2/10.00 1/9.11 9/9.01 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 20.0% 11.0% 99.9% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/8 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 9 29 (T) 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.237 P=0.479 P<0.001 ** |
|POLY 3 | (e) (e) (e) P=0.227 P=0.481 P<0.001 ** |
|POLY 1.5 | (e) (e) (e) P=0.227 P=0.486 P<0.001 ** |
|POLY 6 | (e) (e) (e) P=0.227 P=0.479 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.724 (e) (e) (e) P=0.479 (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.237 P=0.500 P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Testes |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|INT SACRIFICE 1 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 1/3 (33%) 0/10 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 1/2.03 0/9.11 4/4.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 49.3% 0.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 9 --- 5 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.500 (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) P=0.181 (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) P=0.189 (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) P=0.180 (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.727 (e) (e) (e) (e) P=0.861 |
|COCH-ARM / FISHERS | P=0.024 * (e) (e) P=0.231 (e) P=0.043 * |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 1/9.01 2/2.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 11.1% 97.4% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 29 (T) 6 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** (e) (e) (e) P=0.479 P=0.185 |
|POLY 3 | (e) (e) (e) (e) P=0.479 P=0.041 * |
|POLY 1.5 | (e) (e) (e) (e) P=0.481 P=0.050 |
|POLY 6 | (e) (e) (e) (e) P=0.479 P=0.040 * |
|LOGISTIC REGRESSION| P=0.312 (e) (e) (e) P=0.479 (e) |
|COCH-ARM / FISHERS | P=0.132 (e) (e) (e) P=0.500 P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Thymus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/3 (0%) 3/10 (30%) 5/10 (50%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/1.06 3/10.00 5/5.03 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 30.0% 99.4% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/1 (0%) 2/9 (22%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) --- --- --- 14 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=1.000 P=1.000N P=0.795N P=0.460 P=0.009 ** |
|POLY 3 | (e) (e) (e) P=0.693N P=0.500 P=0.005 ** |
|POLY 1.5 | (e) (e) (e) P=0.669N P=0.500 P=0.008 ** |
|POLY 6 | (e) (e) (e) P=0.698N P=0.500 P=0.005 ** |
|LOGISTIC REGRESSION| P=0.524 (e) (e) (e) (e) P=0.977N |
|COCH-ARM / FISHERS | P=0.079 P=1.000 P=1.000 P=0.577N P=0.500 P=0.175 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Thymus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/9.01 2/2.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 96.6% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.102 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.041 * |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.052 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.040 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.089 (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|INT SACRIFICE 1 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/10.00 1/1.00 0/0.00 0/0.00 0/9.01 0/0.07 |
|POLY-3 PERCENT (g) | 20.0% 100.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 2/10 (20%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) 29 (T) --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.178N P=0.305 P=1.000N P=1.000N P=0.257N P=1.000N |
|POLY 3 | (e) P=0.286 (e) (e) P=0.252N P=0.698N |
|POLY 1.5 | (e) P=0.286 (e) (e) P=0.249N P=0.657N |
|POLY 6 | (e) P=0.286 (e) (e) P=0.252N P=0.702N |
|LOGISTIC REGRESSION| P=0.172N P=0.305 (e) (e) P=0.251N (e) |
|COCH-ARM / FISHERS | P=0.044N* P=0.273 P=1.000 P=1.000 P=0.237N P=0.237N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 60855 TEST: 01 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BETA-BROMO-BETA-NITROSTYRENE
Terminal Sacrifice at 5 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Uterus: Bilateral |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|INT SACRIFICE 1 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.037 0.075 0.150 0.300 0.600 |
| | G/KG G/KG G/KG G/KG G/KG |
|=================================================================================================================================|
| |
|Uterus: Bilateral |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/10.00 1/1.00 0/0.00 0/0.00 0/9.01 0/0.07 |
|POLY-3 PERCENT (g) | 20.0% 100.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 2/10 (20%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 29 (T) 29 (T) --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.178N P=0.305 P=1.000N P=1.000N P=0.257N P=1.000N |
|POLY 3 | (e) P=0.286 (e) (e) P=0.252N P=0.698N |
|POLY 1.5 | (e) P=0.286 (e) (e) P=0.249N P=0.657N |
|POLY 6 | (e) P=0.286 (e) (e) P=0.252N P=0.702N |
|LOGISTIC REGRESSION| P=0.172N P=0.305 (e) (e) P=0.251N (e) |
|COCH-ARM / FISHERS | P=0.044N* P=0.273 P=1.000 P=1.000 P=0.237N P=0.237N |
|ORDER RESTRICTED | (e) (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).