TDMS Study 05203-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 08 TIME: 09:16:35
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: HEATH, JAMES E. CAS: 88-72-2
------------------------------------------------------------------------------------------------------------------------------------
RATS, FINAL#1; 14 WEEK SSAC
REASONS FOR REMOVAL: 25017 Scheduled Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 PPM
INCLUDE 009 2000 PPM(STOP)
INCLUDE 010 5000 PPM(STOP)
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 08 TIME: 09:16:35
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: HEATH, JAMES E. CAS: 88-72-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF O-NITROTOLUENE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Epididymis Atrophy
Atypia Cellular
Islets, Pancreatic Hyperplasia
Kidney Nephropathy
Kidney: Renal Tubule Degeneration Hyaline
Liver: Hepatocyte Vacuolization Cytoplasmic
Nose: Olfactory Epithelium Degeneration
Preputial Gland Atrophy
Salivary Glands Atrophy
Spleen Congestion
Hematopoietic Cell Proliferation
Testes Mineralization
Testes: Germinal Epithelium Atrophy
===============================================================
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 2/10 (20%) |
|POLY-3 RATE (b) | 1/1.01 2/2.01 2/2.01 |
|POLY-3 PERCENT (g) | 99.3% 99.7% 99.7% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 2/10 (20%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.423 P=0.500 P=0.500 |
|POLY 3 | P=0.322 P=0.299 P=0.299 |
|POLY 1.5 | P=0.324 P=0.305 P=0.305 |
|POLY 6 | P=0.321 P=0.299 P=0.299 |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.421 P=0.500 P=0.500 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Epididymis |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/0.01 0/0.01 5/5.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 99.9% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** (e) P=0.022 * |
|POLY 3 | P<0.001 ** (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.002 ** (e) P=0.016 * |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Epididymis |
| Atypia Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.01 2/2.01 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 99.7% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.234 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.067 P=1.000N |
|POLY 1.5 | P<0.001 ** P=0.070 P=1.000N |
|POLY 6 | P<0.001 ** P=0.067 P=1.000N |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.237 P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 3/10 (30%) 6/10 (60%) |
|POLY-3 RATE (b) | 5/5.00 3/3.01 6/6.00 |
|POLY-3 PERCENT (g) | 99.9% 99.8% 100.0% |
|INT SACRIFICE 1 (c)| 5/10 (50%) 3/10 (30%) 6/10 (60%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.374 P=0.328N P=0.500 |
|POLY 3 | P=0.328 P=0.233N P=0.422 |
|POLY 1.5 | P=0.329 P=0.236N P=0.424 |
|POLY 6 | P=0.328 P=0.233N P=0.422 |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.372 P=0.325N P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 8/10 (80%) |
|POLY-3 RATE (b) | 0/0.01 0/0.01 8/8.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 8/10 (80%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 8/10 (80%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/0.01 8/8.00 0/0.01 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 8/10 (80%) 0/10 (0%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (I) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.409N P<0.001 ** (e) |
|POLY 3 | P=0.165N P<0.001 ** (e) |
|POLY 1.5 | P=0.169N P<0.001 ** (e) |
|POLY 6 | P=0.165N P<0.001 ** (e) |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.407N P<0.001 ** (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 1/1.01 0/0.01 10/10.00 |
|POLY-3 PERCENT (g) | 99.3% 0.0% 100.0% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (I) --- 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500N P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.159N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.167N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.159N P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/0.01 1/1.01 2/2.01 |
|POLY-3 PERCENT (g) | 0.0% 99.3% 99.7% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 2/10 (20%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.154 P=0.500 P=0.234 |
|POLY 3 | P=0.080 P=0.159 P=0.067 |
|POLY 1.5 | P=0.082 P=0.167 P=0.070 |
|POLY 6 | P=0.080 P=0.159 P=0.067 |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.150 P=0.500 P=0.237 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.01 0/0.01 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** |
|POLY 3 | P=1.000N (e) P=1.000N |
|POLY 1.5 | P=1.000N (e) P=1.000N |
|POLY 6 | P=1.000N (e) P=1.000N |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 4/10 (40%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.01 4/4.01 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 99.9% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 4/10 (40%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.051 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.007 ** P=1.000N |
|POLY 1.5 | P<0.001 ** P=0.008 ** P=1.000N |
|POLY 6 | P<0.001 ** P=0.007 ** P=1.000N |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.043 * P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Preputial Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 8/10 (80%) |
|POLY-3 RATE (b) | 0/0.01 1/1.01 8/8.00 |
|POLY-3 PERCENT (g) | 0.0% 99.3% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 8/10 (80%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.159 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.167 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.159 P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.01 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=1.000N P=1.000N P=1.000N |
|POLY 1.5 | P=1.000N P=1.000N P=1.000N |
|POLY 6 | P=1.000N P=1.000N P=1.000N |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Spleen |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 3/10 (30%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.01 3/3.01 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 99.8% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 3/10 (30%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.111 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.025 * P=1.000N |
|POLY 1.5 | P<0.001 ** P=0.026 * P=1.000N |
|POLY 6 | P<0.001 ** P=0.025 * P=1.000N |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.105 P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.01 2/2.01 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 99.7% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.234 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.067 P=1.000N |
|POLY 1.5 | P<0.001 ** P=0.070 P=1.000N |
|POLY 6 | P<0.001 ** P=0.067 P=1.000N |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.237 P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Testes |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/0.01 0/0.01 5/5.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 99.9% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** (e) P=0.022 * |
|POLY 3 | P<0.001 ** (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.002 ** (e) P=0.016 * |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/0.01 1/1.01 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 99.3% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 9/10 (90%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.159 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.167 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.159 P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 1/1.01 0/0.01 2/2.01 |
|POLY-3 PERCENT (g) | 99.3% 0.0% 99.7% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 2/10 (20%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (I) --- 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.331 P=0.500N P=0.500 |
|POLY 3 | P=0.207 P=0.159N P=0.299 |
|POLY 1.5 | P=0.208 P=0.167N P=0.305 |
|POLY 6 | P=0.207 P=0.159N P=0.299 |
|LOGISTIC REGRESSION| (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.328 P=0.500N P=0.500 |
|=================================================================================================================================|
(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).
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