TDMS Study 88139-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: BIORELIANCE BENZYLTRIMETHYL AMMONIUM CHLORIDE DATE: 10/25/04
EXPERIMENT: 88139 TEST: 05 TIME: 10:34:54
TEST TYPE: SUBCHRON 90-DAY PAGE: 1
CONT: NO1-ES-15319 ROUTE: GAVAGE NTP C#: 88139C
PATHOLOGIST: MISSING CAS: 56-93-9
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: BIORELIANCE BENZYLTRIMETHYL AMMONIUM CHLORIDE DATE: 10/25/04
EXPERIMENT: 88139 TEST: 05 TIME: 10:34:54
TEST TYPE: SUBCHRON 90-DAY
CONT: NO1-ES-15319 ROUTE: GAVAGE NTP C#: 88139C
PATHOLOGIST: MISSING CAS: 56-93-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF BENZYLTRIMETHYL AMMONIUM CHLORI
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Lung Inflammation Focal
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Uterus Cyst
Uterus: Bilateral Cyst
===============================================================
Date: 10/25/04 EXPERIMENT: 88139 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZYLTRIMETHYL AMMONIUM CHLORI
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/10 (80%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 8/10.00 0/0.00 0/0.00 0/0.00 5/10.00 |
|POLY-3 PERCENT (g) | 80.0% 0.0% 0.0% 0.0% 50.0% |
|TERMINAL (d) | 8/10 (80%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.127N P=1.000 P=1.000N P=1.000 P=0.180N |
|POLY 3 | (e) (e) (e) (e) P=0.174N |
|POLY 1.5 | (e) (e) (e) (e) P=0.174N |
|POLY 6 | (e) (e) (e) (e) P=0.174N |
|LOGISTIC REGRESSION| P=0.127N (e) (e) (e) P=0.180N |
|COCH-ARM / FISHERS | P=0.121N P=1.000 P=1.000 P=1.000 P=0.175N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/0 (0%) 1/1 (100%) 0/0 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 5/10.00 0/0.00 1/1.00 0/0.00 4/9.18 |
|POLY-3 PERCENT (g) | 50.0% 0.0% 100.0% 0.0% 43.6% |
|TERMINAL (d) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/8 (50%) |
|FIRST INCIDENCE | 92 (T) --- 83 --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.548N P=1.000 P=0.500 P=1.000N P=0.678 |
|POLY 3 | (e) (e) P=0.536 (e) P=0.568N |
|POLY 1.5 | (e) (e) P=0.536 (e) P=0.538N |
|POLY 6 | (e) (e) P=0.536 (e) P=0.606N |
|LOGISTIC REGRESSION| P=0.448N (e) (e) (e) P=0.678 |
|COCH-ARM / FISHERS | P=0.367N P=1.000 P=0.545 P=1.000 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 88139 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZYLTRIMETHYL AMMONIUM CHLORI
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/10 (40%) 0/2 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 4/10.00 0/2.00 0/0.00 0/0.00 5/10.00 |
|POLY-3 PERCENT (g) | 40.0% 0.0% 0.0% 0.0% 50.0% |
|TERMINAL (d) | 4/10 (40%) 0/2 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.315 P=0.397N P=1.000N P=1.000 P=0.500 |
|POLY 3 | (e) P=0.396N (e) (e) P=0.500 |
|POLY 1.5 | (e) P=0.396N (e) (e) P=0.500 |
|POLY 6 | (e) P=0.396N (e) (e) P=0.500 |
|LOGISTIC REGRESSION| P=0.315 (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.311 P=0.424N P=1.000 P=1.000 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 5/10.00 0/1.00 0/0.73 0/0.00 4/9.18 |
|POLY-3 PERCENT (g) | 50.0% 0.0% 0.0% 0.0% 43.6% |
|TERMINAL (d) | 5/10 (50%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 4/8 (50%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.536 P=0.536N P=1.000N P=1.000N P=0.678 |
|POLY 3 | (e) P=0.536N P=0.623N (e) P=0.568N |
|POLY 1.5 | (e) P=0.536N P=0.583N (e) P=0.538N |
|POLY 6 | (e) P=0.536N P=0.685N (e) P=0.606N |
|LOGISTIC REGRESSION| P=0.536 (e) (e) (e) P=0.678 |
|COCH-ARM / FISHERS | P=0.502N P=0.545N P=0.545N P=1.000 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 88139 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZYLTRIMETHYL AMMONIUM CHLORI
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 0/0 (0%) 0/0 (0%) 1/10 (10%) 5/10 (50%) |
|POLY-3 RATE (b) | 6/10.00 0/0.00 0/0.00 1/10.00 5/10.00 |
|POLY-3 PERCENT (g) | 60.0% 0.0% 0.0% 10.0% 50.0% |
|TERMINAL (d) | 6/10 (60%) 0/0 (0%) 0/0 (0%) 1/10 (10%) 5/10 (50%) |
|FIRST INCIDENCE | 92 (T) --- --- 92 (T) 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.411N P=1.000N P=1.000N P=0.034N* P=0.500N |
|POLY 3 | (e) (e) (e) P=0.018N* P=0.500N |
|POLY 1.5 | (e) (e) (e) P=0.018N* P=0.500N |
|POLY 6 | (e) (e) (e) P=0.018N* P=0.500N |
|LOGISTIC REGRESSION| P=0.411N (e) (e) P=0.034N* P=0.500N |
|COCH-ARM / FISHERS | P=0.410N P=1.000 P=1.000 P=0.029N* P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/0 (0%) 1/1 (100%) 3/10 (30%) 6/10 (60%) |
|POLY-3 RATE (b) | 3/10.00 0/0.00 1/1.00 3/10.00 6/10.00 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 100.0% 30.0% 60.0% |
|TERMINAL (d) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 3/10 (30%) 4/8 (50%) |
|FIRST INCIDENCE | 92 (T) --- 83 92 (T) 70 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.070 P=1.000N P=0.500 P=0.683 P=0.133 |
|POLY 3 | (e) (e) P=0.384 P=0.678 P=0.186 |
|POLY 1.5 | (e) (e) P=0.384 P=0.678 P=0.186 |
|POLY 6 | (e) (e) P=0.384 P=0.678 P=0.186 |
|LOGISTIC REGRESSION| P=0.070 (e) (e) P=0.683 (e) |
|COCH-ARM / FISHERS | P=0.160 P=1.000 P=0.364 P=0.686N P=0.185 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 88139 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZYLTRIMETHYL AMMONIUM CHLORI
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.138N P=1.000N P=1.000N P=1.000N P=0.234N |
|POLY 3 | (e) (e) (e) (e) P=0.227N |
|POLY 1.5 | (e) (e) (e) (e) P=0.227N |
|POLY 6 | (e) (e) (e) (e) P=0.227N |
|LOGISTIC REGRESSION| P=0.138N (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.132N P=1.000 P=1.000 P=1.000 P=0.237N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/9.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 88139 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZYLTRIMETHYL AMMONIUM CHLORI
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 3/10.00 0/0.00 0/0.00 0/0.00 4/10.00 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 40.0% |
|TERMINAL (d) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.410 P=1.000N P=1.000N P=1.000N P=0.500 |
|POLY 3 | (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | (e) (e) (e) (e) P=0.500 |
|POLY 6 | (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| P=0.410 (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.407 P=1.000 P=1.000 P=1.000 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 0/0.00 1/1.00 0/0.00 0/9.18 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 100.0% 0.0% 0.0% |
|TERMINAL (d) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 92 (T) --- 83 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.306N P=1.000 P=0.500 P=1.000 P=0.545N |
|POLY 3 | (e) (e) P=0.146 (e) P=0.517N |
|POLY 1.5 | (e) (e) P=0.146 (e) P=0.510N |
|POLY 6 | (e) (e) P=0.146 (e) P=0.527N |
|LOGISTIC REGRESSION| P=0.157N (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.235N P=1.000 P=0.182 P=1.000 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 88139 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZYLTRIMETHYL AMMONIUM CHLORI
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/0.00 1/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.380N P=1.000N P=1.000N P=1.000N P=0.500N |
|POLY 3 | (e) (e) (e) (e) P=0.500N |
|POLY 1.5 | (e) (e) (e) (e) P=0.500N |
|POLY 6 | (e) (e) (e) (e) P=0.500N |
|LOGISTIC REGRESSION| P=0.380N (e) (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.377N P=1.000 P=1.000 P=1.000 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 0/0.00 0/0.73 0/0.00 0/9.18 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.348N P=1.000N P=1.000N P=1.000N P=0.545N |
|POLY 3 | (e) (e) P=0.923N (e) P=0.517N |
|POLY 1.5 | (e) (e) P=0.919N (e) P=0.510N |
|POLY 6 | (e) (e) P=0.930N (e) P=0.527N |
|LOGISTIC REGRESSION| P=0.348N (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.310N P=1.000 P=0.909N P=1.000 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 88139 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZYLTRIMETHYL AMMONIUM CHLORI
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|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 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 2/2 (100%) 0/1 (0%) 1/1 (100%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 2/2.00 0/0.73 1/1.00 0/9.18 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 100.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 2/2 (100%) 0/0 (0%) 1/1 (100%) 0/8 (0%) |
|FIRST INCIDENCE | --- 92 (T) --- 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.373N P=0.010 * (e) P=0.077 (e) |
|POLY 3 | P<0.001N** P=0.015N* (e) P=0.091N (e) |
|POLY 1.5 | P<0.001N** P=0.015N* (e) P=0.091N (e) |
|POLY 6 | P<0.001N** P=0.015N* (e) P=0.091N (e) |
|LOGISTIC REGRESSION| (e) P=0.010 * (e) P=0.077 (e) |
|COCH-ARM / FISHERS | P=0.311N P=0.015 * (e) P=0.091 (e) |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 88139 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZYLTRIMETHYL AMMONIUM CHLORI
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|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 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/2 (0%) 0/1 (0%) 0/1 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 2/10.00 0/2.00 0/0.73 0/1.00 2/9.18 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 21.8% |
|TERMINAL (d) | 2/10 (20%) 0/2 (0%) 0/0 (0%) 0/1 (0%) 2/8 (25%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.462 P=0.630N P=1.000N P=0.795N P=0.621 |
|POLY 3 | P=0.507 P=0.627N P=0.816N P=0.786N P=0.671 |
|POLY 1.5 | P=0.519 P=0.627N P=0.802N P=0.786N P=0.685 |
|POLY 6 | P=0.490 P=0.627N P=0.836N P=0.786N P=0.652 |
|LOGISTIC REGRESSION| P=0.462 (e) (e) (e) P=0.621 |
|COCH-ARM / FISHERS | P=0.539 P=0.682N P=0.818N P=0.818N P=0.709N |
|ORDER RESTRICTED | P=0.489 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 88139 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZYLTRIMETHYL AMMONIUM CHLORI
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus: Bilateral |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|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 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus: Bilateral |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 2/2 (100%) 0/1 (0%) 1/1 (100%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 2/2.00 0/0.73 1/1.00 0/9.18 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 100.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 2/2 (100%) 0/0 (0%) 1/1 (100%) 0/8 (0%) |
|FIRST INCIDENCE | --- 92 (T) --- 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.373N P=0.010 * (e) P=0.077 (e) |
|POLY 3 | P<0.001N** P=0.015N* (e) P=0.091N (e) |
|POLY 1.5 | P<0.001N** P=0.015N* (e) P=0.091N (e) |
|POLY 6 | P<0.001N** P=0.015N* (e) P=0.091N (e) |
|LOGISTIC REGRESSION| (e) P=0.010 * (e) P=0.077 (e) |
|COCH-ARM / FISHERS | P=0.311N P=0.015 * (e) P=0.091 (e) |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 88139 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZYLTRIMETHYL AMMONIUM CHLORI
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus: Bilateral |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|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 12.5 25.0 50.0 100.0 |
| | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus: Bilateral |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/2 (0%) 0/1 (0%) 0/1 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 2/10.00 0/2.00 0/0.73 0/1.00 2/9.18 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 21.8% |
|TERMINAL (d) | 2/10 (20%) 0/2 (0%) 0/0 (0%) 0/1 (0%) 2/8 (25%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.462 P=0.630N P=1.000N P=0.795N P=0.621 |
|POLY 3 | P=0.507 P=0.627N P=0.816N P=0.786N P=0.671 |
|POLY 1.5 | P=0.519 P=0.627N P=0.802N P=0.786N P=0.685 |
|POLY 6 | P=0.490 P=0.627N P=0.836N P=0.786N P=0.652 |
|LOGISTIC REGRESSION| P=0.462 (e) (e) (e) P=0.621 |
|COCH-ARM / FISHERS | P=0.539 P=0.682N P=0.818N P=0.818N P=0.709N |
|ORDER RESTRICTED | P=0.489 (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).