TDMS Study 55301-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: TSI Mason Research PYRIDINE DATE: 09/26/97
EXPERIMENT: 55301 TEST: 05 TIME: 13:40:43
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01ES95268 ROUTE: DOSED WATER NTP C#: 55301B
PATHOLOGIST: P. HILDEBRANDT CAS: 110-86-1
Rats(FISCHER 344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Kidney
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: TSI Mason Research PYRIDINE DATE: 09/26/97
EXPERIMENT: 55301 TEST: 05 TIME: 13:40:43
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01ES95268 ROUTE: DOSED WATER NTP C#: 55301B
PATHOLOGIST: P. HILDEBRANDT CAS: 110-86-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF PYRIDINE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Kidney, Renal Tubule (Step Section) Adenoma
Carcinoma and Adenoma
Hyperplasia
Hyperplasia and Adenoma
Hyperplasia, Carcinoma or Adenoma
Kidney, Renal Tubule (Step and Original Sections)
Adenoma
Carcinoma and Adenoma
Hyperplasia
Hyperplasia and Adenoma
Hyperplasia, Carcinoma or Adenoma
Kidney: Renal Tubule Adenoma
Carcinoma or Adenoma
Hyperplasia
Hyperplasia and Adenoma
Hyperplasia, Carcinoma or Adenoma
Date: 09/26/97 EXPERIMENT: 55301 TEST: 05 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 5/50 (10%) 9/50 (18%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 7.4% 12.1% 23.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 2/20 (10%) 3/25 (12%) 5/16 (31%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) 673 627 670 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.235 P=0.105 P=0.002 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.002 ** P=0.301 P=0.101 P=0.005 ** |(e) (e) (e) (e) |
|POLY 1.5 | P=0.002 ** P=0.307 P=0.103 P=0.006 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.286 P=0.098 P=0.004 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.256 P=0.098 P=0.002 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.003 ** P=0.309 P=0.102 P=0.008 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Carcinoma and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 5/50 (10%) 9/50 (18%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 7.4% 12.1% 23.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 2/20 (10%) 3/25 (12%) 5/16 (31%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) 673 627 670 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.235 P=0.105 P=0.002 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.002 ** P=0.301 P=0.101 P=0.005 ** |(e) (e) (e) (e) |
|POLY 1.5 | P=0.002 ** P=0.307 P=0.103 P=0.006 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.286 P=0.098 P=0.004 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.256 P=0.098 P=0.002 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.003 ** P=0.309 P=0.102 P=0.008 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 05 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 7/50 (14%) 11/50 (22%) 15/50 (30%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 21.7% 16.9% 26.8% 36.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 7/25 (28%) 5/20 (25%) 9/25 (36%) 5/16 (31%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 595 604 679 515 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.542N P=0.382 P=0.026 * |(e) (e) (e) (e) |
|POLY 3 | P=0.034 * P=0.394N P=0.386 P=0.100 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.037 * P=0.386N P=0.398 P=0.109 |(e) (e) (e) (e) |
|POLY 6 | P=0.030 * P=0.425N P=0.358 P=0.086 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.022 * P=0.436N P=0.335 P=0.085 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.044 * P=0.393N P=0.402 P=0.121 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Hyperplasia and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 9/50 (18%) 16/50 (32%) 21/50 (42%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 21.7% 21.7% 38.4% 51.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 7/25 (28%) 6/20 (30%) 12/25 (48%) 9/16 (56%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 595 604 627 515 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.440 P=0.073 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P=0.605 P=0.071 P=0.003 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.596N P=0.077 P=0.005 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.576 P=0.061 P=0.002 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.557 P=0.054 P=0.003 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.602N P=0.083 P=0.008 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 05 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Hyperplasia, Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 9/50 (18%) 16/50 (32%) 21/50 (42%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 21.7% 21.7% 38.4% 51.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 7/25 (28%) 6/20 (30%) 12/25 (48%) 9/16 (56%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 595 604 627 515 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.440 P=0.073 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P=0.605 P=0.071 P=0.003 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.596N P=0.077 P=0.005 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.576 P=0.061 P=0.002 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.557 P=0.054 P=0.003 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.602N P=0.083 P=0.008 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 6/50 (12%) 10/50 (20%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 7.4% 14.5% 25.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/25 (8%) 2/20 (10%) 3/25 (12%) 5/16 (31%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) 673 627 644 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.404 P=0.134 P=0.003 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.002 ** P=0.496 P=0.133 P=0.009 ** |(e) (e) (e) (e) |
|POLY 1.5 | P=0.002 ** P=0.502 P=0.135 P=0.011 * |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.477 P=0.128 P=0.006 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.428 P=0.123 P=0.005 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.004 ** P=0.500 P=0.134 P=0.014 * |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 05 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Carcinoma and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 6/50 (12%) 10/50 (20%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 9.8% 14.5% 25.7% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 2/25 (8%) 3/20 (15%) 3/25 (12%) 5/16 (31%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) 673 627 644 |--- 650 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.242 P=0.134 P=0.003 ** |P=0.613N P=0.509 (e) (e) |
|POLY 3 | P=0.003 ** P=0.332 P=0.133 P=0.009 ** |P=0.567N P=0.507 (e) (e) |
|POLY 1.5 | P=0.004 ** P=0.339 P=0.135 P=0.011 * |P=0.567N P=0.504 (e) (e) |
|POLY 6 | P=0.003 ** P=0.312 P=0.128 P=0.006 ** |P=0.567N P=0.512 (e) (e) |
|LOGISTIC REGRESSION| P=0.002 ** P=0.255 P=0.123 P=0.005 ** |P=0.538N P=0.474 (e) (e) |
|COCH-ARM / FISHERS | P=0.006 ** P=0.339 P=0.134 P=0.014 * |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 7/50 (14%) 14/50 (28%) 16/50 (32%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 24.1% 16.9% 33.9% 39.0% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 8/25 (32%) 5/20 (25%) 11/25 (44%) 5/16 (31%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 595 604 648 515 |--- --- --- 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.444N P=0.220 P=0.025 * |P=0.197 (e) (e) P=0.500 |
|POLY 3 | P=0.028 * P=0.296N P=0.226 P=0.106 |P=0.188 (e) (e) P=0.486 |
|POLY 1.5 | P=0.031 * P=0.289N P=0.237 P=0.115 |P=0.193 (e) (e) P=0.492 |
|POLY 6 | P=0.024 * P=0.323N P=0.203 P=0.092 |P=0.181 (e) (e) P=0.477 |
|LOGISTIC REGRESSION| P=0.016 * P=0.341N P=0.181 P=0.085 |P=0.299 (e) (e) P=0.576 |
|COCH-ARM / FISHERS | P=0.038 * P=0.298N P=0.241 P=0.127 |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 05 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Hyperplasia and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 9/50 (18%) 18/50 (36%) 22/50 (44%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 26.5% 21.7% 43.0% 53.3% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 9/25 (36%) 6/20 (30%) 13/25 (52%) 9/16 (56%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 595 604 627 515 |--- --- --- 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.581N P=0.081 P<0.001 ** |P=0.197 (e) (e) P=0.500 |
|POLY 3 | P<0.001 ** P=0.398N P=0.082 P=0.008 ** |P=0.188 (e) (e) P=0.486 |
|POLY 1.5 | P<0.001 ** P=0.391N P=0.088 P=0.011 * |P=0.193 (e) (e) P=0.492 |
|POLY 6 | P<0.001 ** P=0.429N P=0.072 P=0.006 ** |P=0.181 (e) (e) P=0.477 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.461N P=0.060 P=0.005 ** |P=0.299 (e) (e) P=0.576 |
|COCH-ARM / FISHERS | P=0.002 ** P=0.402N P=0.093 P=0.016 * |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Hyperplasia, Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 10/50 (20%) 18/50 (36%) 22/50 (44%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 26.5% 24.1% 43.0% 53.3% |0.0% 2.2% 0.0% 2.4% |
|TERMINAL (d) | 9/25 (36%) 7/20 (35%) 13/25 (52%) 9/16 (56%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 595 604 627 515 |--- 650 --- 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.510 P=0.081 P<0.001 ** |P=0.374 P=0.509 (e) P=0.500 |
|POLY 3 | P<0.001 ** P=0.500N P=0.082 P=0.008 ** |P=0.387 P=0.507 (e) P=0.486 |
|POLY 1.5 | P=0.002 ** P=0.490N P=0.088 P=0.011 * |P=0.396 P=0.504 (e) P=0.492 |
|POLY 6 | P<0.001 ** P=0.535N P=0.072 P=0.006 ** |P=0.375 P=0.512 (e) P=0.477 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.572N P=0.060 P=0.005 ** |P=0.502 P=0.474 (e) P=0.576 |
|COCH-ARM / FISHERS | P=0.003 ** P=0.500N P=0.093 P=0.016 * |P=0.405 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 05 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/48 (0%) 2/50 (4%) 6/49 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 4.9% 15.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/20 (0%) 1/25 (4%) 2/16 (13%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) --- 708 644 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.545N P=0.488 P=0.022 * |(e) (e) (e) (e) |
|POLY 3 | P=0.003 ** P=0.510N P=0.498 P=0.042 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.004 ** P=0.507N P=0.501 P=0.047 * |(e) (e) (e) (e) |
|POLY 6 | P=0.003 ** P=0.518N P=0.490 P=0.035 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.002 ** (e) P=0.471 P=0.031 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.005 ** P=0.510N P=0.500 P=0.053 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/48 (2%) 2/50 (4%) 6/49 (12%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.6% 4.9% 15.9% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 1/20 (5%) 1/25 (4%) 2/16 (13%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 708 644 |--- 650 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.712 P=0.488 P=0.022 * |P=0.613N P=0.509 (e) (e) |
|POLY 3 | P=0.008 ** P=0.750 P=0.498 P=0.042 * |P=0.567N P=0.507 (e) (e) |
|POLY 1.5 | P=0.009 ** P=0.753 P=0.501 P=0.047 * |P=0.567N P=0.504 (e) (e) |
|POLY 6 | P=0.007 ** P=0.742 P=0.490 P=0.035 * |P=0.567N P=0.512 (e) (e) |
|LOGISTIC REGRESSION| P=0.004 ** P=0.712 P=0.471 P=0.031 * |P=0.538N P=0.474 (e) (e) |
|COCH-ARM / FISHERS | P=0.010 * P=0.742 P=0.500 P=0.053 |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 05 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/48 (0%) 4/50 (8%) 7/49 (14%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 9.7% 18.4% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 1/25 (4%) 0/20 (0%) 3/25 (12%) 2/16 (13%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) --- 648 644 |--- --- --- 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.545N P=0.178 P=0.012 * |P=0.197 (e) (e) P=0.500 |
|POLY 3 | P<0.001 ** P=0.510N P=0.177 P=0.021 * |P=0.188 (e) (e) P=0.486 |
|POLY 1.5 | P=0.002 ** P=0.507N P=0.180 P=0.024 * |P=0.193 (e) (e) P=0.492 |
|POLY 6 | P<0.001 ** P=0.518N P=0.171 P=0.017 * |P=0.181 (e) (e) P=0.477 |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.164 P=0.018 * |P=0.299 (e) (e) P=0.576 |
|COCH-ARM / FISHERS | P=0.002 ** P=0.510N P=0.181 P=0.028 * |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/48 (0%) 6/50 (12%) 11/49 (22%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 14.6% 28.7% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 2/25 (8%) 0/20 (0%) 4/25 (16%) 4/16 (25%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) --- 648 644 |--- --- --- 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.288N P=0.130 P=0.002 ** |P=0.197 (e) (e) P=0.500 |
|POLY 3 | P<0.001 ** P=0.248N P=0.131 P=0.004 ** |P=0.188 (e) (e) P=0.486 |
|POLY 1.5 | P<0.001 ** P=0.245N P=0.134 P=0.005 ** |P=0.193 (e) (e) P=0.492 |
|POLY 6 | P<0.001 ** P=0.256N P=0.124 P=0.003 ** |P=0.181 (e) (e) P=0.477 |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.113 P=0.002 ** |P=0.299 (e) (e) P=0.576 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.258N P=0.134 P=0.007 ** |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 05 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia, Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/48 (2%) 6/50 (12%) 11/49 (22%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.9% 2.6% 14.6% 28.7% |0.0% 2.2% 0.0% 2.4% |
|TERMINAL (d) | 2/25 (8%) 1/20 (5%) 4/25 (16%) 4/16 (25%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 648 644 |--- 650 --- 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.579N P=0.130 P=0.002 ** |P=0.374 P=0.509 (e) P=0.500 |
|POLY 3 | P<0.001 ** P=0.517N P=0.131 P=0.004 ** |P=0.387 P=0.507 (e) P=0.486 |
|POLY 1.5 | P<0.001 ** P=0.513N P=0.134 P=0.005 ** |P=0.396 P=0.504 (e) P=0.492 |
|POLY 6 | P<0.001 ** P=0.531N P=0.124 P=0.003 ** |P=0.375 P=0.512 (e) P=0.477 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.579N P=0.113 P=0.002 ** |P=0.502 P=0.474 (e) P=0.576 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.515N P=0.134 P=0.007 ** |P=0.405 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(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.
(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).