TDMS Study 88138-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus BENZOPHENONE DATE: 05/13/04
EXPERIMENT: 88138 TEST: 03 TIME: 09:37:21
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B
PATHOLOGIST: MISSING CAS: 119-61-9
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 THE NUMBER OF ANIMALS NECROPSIED.
---------------
Kidney
Kidney, Renal Tubule (Step Section)
Kidney, Renal Tubule (Step and Original Sections)
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus BENZOPHENONE DATE: 05/13/04
EXPERIMENT: 88138 TEST: 03 TIME: 09:37:21
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B
PATHOLOGIST: MISSING CAS: 119-61-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF BENZOPHENONE
===============================================================
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
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Kidney, Renal Tubule (Step Section) Hyperplasia
Hyperplasia and Adenoma
Hyperplasia, Carcinoma or Adenoma
Kidney, Renal Tubule (Step and Original Sections)
Hyperplasia
Hyperplasia and Adenoma
Hyperplasia, Carcinoma or Adenoma
===============================================================
Date: 05/13/04 EXPERIMENT: 88138 TEST: 03 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 5/50 (10%) 4/50 (8%) |3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.26 1/41.56 5/44.77 4/33.10 |3/44.22 0/47.49 2/47.41 1/45.95 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 11.2% 12.1% |6.8% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 1/27 (4%) 4/31 (13%) 0/2 (0%) |1/32 (3%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 680 729 (T) 590 624 |708 --- 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.738N P=0.175 P=0.023 * |P=0.345N P=0.107N P=0.469N P=0.306N |
|POLY 3 | P=0.034 * P=0.757 P=0.114 P=0.113 |P=0.343N P=0.106N P=0.468N P=0.292N |
|POLY 1.5 | P=0.051 P=0.757 P=0.108 P=0.142 |P=0.340N P=0.110N P=0.478N P=0.295N |
|POLY 6 | P=0.018 * P=0.760 P=0.125 P=0.075 |P=0.346N P=0.104N P=0.462N P=0.292N |
|LOGISTIC REGRESSION| P=0.037 * P=0.762 P=0.109 P=0.129 |P=0.334N P=0.105N P=0.473N P=0.294N |
|COCH-ARM / FISHERS | P=0.078 P=0.753N P=0.102 P=0.181 |P=0.337N P=0.121N P=0.500N P=0.309N |
|ORDER RESTRICTED | P=0.083 (e) (e) (e) |P=0.169N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Carcinoma and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 5/50 (10%) 4/50 (8%) |3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.26 2/41.56 5/44.77 4/33.10 |3/44.22 0/47.49 2/47.41 1/45.95 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 11.2% 12.1% |6.8% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 4/31 (13%) 0/2 (0%) |1/32 (3%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 680 729 (T) 590 624 |708 --- 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.547 P=0.175 P=0.023 * |P=0.345N P=0.107N P=0.469N P=0.306N |
|POLY 3 | P=0.052 P=0.494 P=0.114 P=0.113 |P=0.343N P=0.106N P=0.468N P=0.292N |
|POLY 1.5 | P=0.077 P=0.495 P=0.108 P=0.142 |P=0.340N P=0.110N P=0.478N P=0.295N |
|POLY 6 | P=0.028 * P=0.498 P=0.125 P=0.075 |P=0.346N P=0.104N P=0.462N P=0.292N |
|LOGISTIC REGRESSION| P=0.049 * P=0.505 P=0.109 P=0.129 |P=0.334N P=0.105N P=0.473N P=0.294N |
|COCH-ARM / FISHERS | P=0.114 P=0.500 P=0.102 P=0.181 |P=0.337N P=0.121N P=0.500N P=0.309N |
|ORDER RESTRICTED | P=0.096 (e) (e) (e) |P=0.169N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/04 EXPERIMENT: 88138 TEST: 03 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 8/50 (16%) 26/50 (52%) 37/50 (74%) |1/50 (2%) 7/50 (14%) 10/50 (20%) 7/50 (14%) |
|POLY-3 RATE (b) | 2/42.65 8/41.56 26/45.36 37/44.55 |1/44.20 7/47.57 10/47.49 7/46.27 |
|POLY-3 PERCENT (g) | 4.7% 19.3% 57.3% 83.1% |2.3% 14.7% 21.1% 15.1% |
|TERMINAL (d) | 0/22 (0%) 8/27 (30%) 19/31 (61%) 2/2 (100%) |0/32 (0%) 6/38 (16%) 7/37 (19%) 3/34 (9%) |
|FIRST INCIDENCE | 582 729 (T) 613 488 |708 710 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.081 P<0.001 ** P<0.001 ** |P=0.072 P=0.054 P=0.011 * P=0.042 * |
|POLY 3 | P<0.001 ** P=0.039 * P<0.001 ** P<0.001 ** |P=0.079 P=0.039 * P=0.006 ** P=0.035 * |
|POLY 1.5 | P<0.001 ** P=0.041 * P<0.001 ** P<0.001 ** |P=0.077 P=0.036 * P=0.005 ** P=0.034 * |
|POLY 6 | P<0.001 ** P=0.039 * P<0.001 ** P<0.001 ** |P=0.079 P=0.040 * P=0.006 ** P=0.035 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.048 * P<0.001 ** P<0.001 ** |P=0.069 P=0.043 * P=0.007 ** P=0.036 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.046 * P<0.001 ** P<0.001 ** |P=0.069 P=0.030 * P=0.004 ** P=0.030 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.018 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Hyperplasia and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 9/50 (18%) 28/50 (56%) 38/50 (76%) |3/50 (6%) 7/50 (14%) 10/50 (20%) 7/50 (14%) |
|POLY-3 RATE (b) | 3/42.83 9/41.56 28/45.83 38/44.80 |3/44.22 7/47.57 10/47.49 7/46.27 |
|POLY-3 PERCENT (g) | 7.0% 21.7% 61.1% 84.8% |6.8% 14.7% 21.1% 15.1% |
|TERMINAL (d) | 0/22 (0%) 9/27 (33%) 20/31 (65%) 2/2 (100%) |1/32 (3%) 6/38 (16%) 7/37 (19%) 3/34 (9%) |
|FIRST INCIDENCE | 582 729 (T) 590 488 |708 710 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.106 P<0.001 ** P<0.001 ** |P=0.176 P=0.227 P=0.065 P=0.182 |
|POLY 3 | P<0.001 ** P=0.050 P<0.001 ** P<0.001 ** |P=0.192 P=0.189 P=0.047 * P=0.176 |
|POLY 1.5 | P<0.001 ** P=0.053 P<0.001 ** P<0.001 ** |P=0.188 P=0.180 P=0.043 * P=0.172 |
|POLY 6 | P<0.001 ** P=0.049 * P<0.001 ** P<0.001 ** |P=0.192 P=0.195 P=0.049 * P=0.177 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.061 P<0.001 ** P<0.001 ** |P=0.174 P=0.197 P=0.050 P=0.172 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.061 P<0.001 ** P<0.001 ** |P=0.173 P=0.159 P=0.036 * P=0.159 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.099 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/04 EXPERIMENT: 88138 TEST: 03 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step Section) |
| Hyperplasia, Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 10/50 (20%) 28/50 (56%) 38/50 (76%) |3/50 (6%) 7/50 (14%) 10/50 (20%) 7/50 (14%) |
|POLY-3 RATE (b) | 3/42.83 10/41.56 28/45.83 38/44.80 |3/44.22 7/47.57 10/47.49 7/46.27 |
|POLY-3 PERCENT (g) | 7.0% 24.1% 61.1% 84.8% |6.8% 14.7% 21.1% 15.1% |
|TERMINAL (d) | 0/22 (0%) 10/27 (37%) 20/31 (65%) 2/2 (100%) |1/32 (3%) 6/38 (16%) 7/37 (19%) 3/34 (9%) |
|FIRST INCIDENCE | 582 729 (T) 590 488 |708 710 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.069 P<0.001 ** P<0.001 ** |P=0.176 P=0.227 P=0.065 P=0.182 |
|POLY 3 | P<0.001 ** P=0.028 * P<0.001 ** P<0.001 ** |P=0.192 P=0.189 P=0.047 * P=0.176 |
|POLY 1.5 | P<0.001 ** P=0.030 * P<0.001 ** P<0.001 ** |P=0.188 P=0.180 P=0.043 * P=0.172 |
|POLY 6 | P<0.001 ** P=0.027 * P<0.001 ** P<0.001 ** |P=0.192 P=0.195 P=0.049 * P=0.177 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** |P=0.174 P=0.197 P=0.050 P=0.172 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** |P=0.173 P=0.159 P=0.036 * P=0.159 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.099 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 7/50 (14%) 8/50 (16%) |3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.34 2/41.56 7/44.93 8/34.27 |3/44.22 0/47.49 2/47.41 1/45.95 |
|POLY-3 PERCENT (g) | 4.7% 4.8% 15.6% 23.3% |6.8% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 5/31 (16%) 0/2 (0%) |1/32 (3%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 680 729 (T) 590 537 |708 --- 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.643N P=0.165 P<0.001 ** |P=0.345N P=0.107N P=0.469N P=0.306N |
|POLY 3 | P=0.004 ** P=0.688 P=0.093 P=0.017 * |P=0.343N P=0.106N P=0.468N P=0.292N |
|POLY 1.5 | P=0.006 ** P=0.688 P=0.086 P=0.028 * |P=0.340N P=0.110N P=0.478N P=0.295N |
|POLY 6 | P=0.002 ** P=0.692 P=0.105 P=0.007 ** |P=0.346N P=0.104N P=0.462N P=0.292N |
|LOGISTIC REGRESSION| P=0.004 ** P=0.692N P=0.090 P=0.025 * |P=0.334N P=0.105N P=0.473N P=0.294N |
|COCH-ARM / FISHERS | P=0.012 * P=0.691N P=0.080 P=0.046 * |P=0.337N P=0.121N P=0.500N P=0.309N |
|ORDER RESTRICTED | P=0.009 ** (e) (e) (e) |P=0.169N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/04 EXPERIMENT: 88138 TEST: 03 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Carcinoma and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 7/50 (14%) 8/50 (16%) |3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.34 3/41.56 7/44.93 8/34.27 |3/44.22 0/47.49 2/47.41 1/45.95 |
|POLY-3 PERCENT (g) | 4.7% 7.2% 15.6% 23.3% |6.8% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 3/27 (11%) 5/31 (16%) 0/2 (0%) |1/32 (3%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 680 729 (T) 590 537 |708 --- 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.568 P=0.165 P<0.001 ** |P=0.345N P=0.107N P=0.469N P=0.306N |
|POLY 3 | P=0.006 ** P=0.491 P=0.093 P=0.017 * |P=0.343N P=0.106N P=0.468N P=0.292N |
|POLY 1.5 | P=0.010 * P=0.493 P=0.086 P=0.028 * |P=0.340N P=0.110N P=0.478N P=0.295N |
|POLY 6 | P=0.003 ** P=0.496 P=0.105 P=0.007 ** |P=0.346N P=0.104N P=0.462N P=0.292N |
|LOGISTIC REGRESSION| P=0.005 ** P=0.511 P=0.090 P=0.025 * |P=0.334N P=0.105N P=0.473N P=0.294N |
|COCH-ARM / FISHERS | P=0.019 * P=0.500 P=0.080 P=0.046 * |P=0.337N P=0.121N P=0.500N P=0.309N |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) |P=0.169N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 11/50 (22%) 30/50 (60%) 40/50 (80%) |1/50 (2%) 8/50 (16%) 10/50 (20%) 7/50 (14%) |
|POLY-3 RATE (b) | 3/42.80 11/41.56 30/45.81 40/45.64 |1/44.20 8/47.57 10/47.49 7/46.27 |
|POLY-3 PERCENT (g) | 7.0% 26.5% 65.5% 87.7% |2.3% 16.8% 21.1% 15.1% |
|TERMINAL (d) | 0/22 (0%) 11/27 (41%) 21/31 (68%) 2/2 (100%) |0/32 (0%) 7/38 (18%) 7/37 (19%) 3/34 (9%) |
|FIRST INCIDENCE | 582 729 (T) 613 488 |708 710 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.045 * P<0.001 ** P<0.001 ** |P=0.092 P=0.033 * P=0.011 * P=0.042 * |
|POLY 3 | P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** |P=0.102 P=0.021 * P=0.006 ** P=0.035 * |
|POLY 1.5 | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |P=0.098 P=0.020 * P=0.005 ** P=0.034 * |
|POLY 6 | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |P=0.102 P=0.022 * P=0.006 ** P=0.035 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.021 * P<0.001 ** P<0.001 ** |P=0.089 P=0.025 * P=0.007 ** P=0.036 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.020 * P<0.001 ** P<0.001 ** |P=0.089 P=0.015 * P=0.004 ** P=0.030 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.020 * (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/04 EXPERIMENT: 88138 TEST: 03 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Hyperplasia and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 13/50 (26%) 33/50 (66%) 41/50 (82%) |3/50 (6%) 8/50 (16%) 10/50 (20%) 7/50 (14%) |
|POLY-3 RATE (b) | 4/42.99 13/41.56 33/46.45 41/45.89 |3/44.22 8/47.57 10/47.49 7/46.27 |
|POLY-3 PERCENT (g) | 9.3% 31.3% 71.1% 89.4% |6.8% 16.8% 21.1% 15.1% |
|TERMINAL (d) | 0/22 (0%) 13/27 (48%) 22/31 (71%) 2/2 (100%) |1/32 (3%) 7/38 (18%) 7/37 (19%) 3/34 (9%) |
|FIRST INCIDENCE | 582 729 (T) 590 488 |708 710 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.037 * P<0.001 ** P<0.001 ** |P=0.208 P=0.157 P=0.065 P=0.182 |
|POLY 3 | P<0.001 ** P=0.010 * P<0.001 ** P<0.001 ** |P=0.229 P=0.123 P=0.047 * P=0.176 |
|POLY 1.5 | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P=0.224 P=0.116 P=0.043 * P=0.172 |
|POLY 6 | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |P=0.229 P=0.128 P=0.049 * P=0.177 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |P=0.206 P=0.130 P=0.050 P=0.172 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |P=0.204 P=0.100 P=0.036 * P=0.159 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.103 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Hyperplasia, Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 14/50 (28%) 33/50 (66%) 41/50 (82%) |3/50 (6%) 8/50 (16%) 10/50 (20%) 7/50 (14%) |
|POLY-3 RATE (b) | 4/42.99 14/41.56 33/46.45 41/45.89 |3/44.22 8/47.57 10/47.49 7/46.27 |
|POLY-3 PERCENT (g) | 9.3% 33.7% 71.1% 89.4% |6.8% 16.8% 21.1% 15.1% |
|TERMINAL (d) | 0/22 (0%) 14/27 (52%) 22/31 (71%) 2/2 (100%) |1/32 (3%) 7/38 (18%) 7/37 (19%) 3/34 (9%) |
|FIRST INCIDENCE | 582 729 (T) 590 488 |708 710 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.023 * P<0.001 ** P<0.001 ** |P=0.208 P=0.157 P=0.065 P=0.182 |
|POLY 3 | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |P=0.229 P=0.123 P=0.047 * P=0.176 |
|POLY 1.5 | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P=0.224 P=0.116 P=0.043 * P=0.172 |
|POLY 6 | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P=0.229 P=0.128 P=0.049 * P=0.177 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |P=0.206 P=0.130 P=0.050 P=0.172 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |P=0.204 P=0.100 P=0.036 * P=0.159 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.103 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/04 EXPERIMENT: 88138 TEST: 03 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.16 1/41.56 2/44.46 4/33.18 |0/44.12 0/47.49 2/47.41 1/45.95 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 4.5% 12.1% |0.0% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 1/27 (4%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 709 729 (T) 687 537 |--- --- 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.722N P=0.591 P=0.015 * |P=0.242 (e) P=0.257 P=0.514 |
|POLY 3 | P=0.046 * P=0.758 P=0.519 P=0.114 |P=0.250 (e) P=0.254 P=0.508 |
|POLY 1.5 | P=0.056 P=0.758 P=0.510 P=0.143 |P=0.250 (e) P=0.249 P=0.506 |
|POLY 6 | P=0.036 * P=0.761 P=0.534 P=0.075 |P=0.247 (e) P=0.257 P=0.508 |
|LOGISTIC REGRESSION| P=0.047 * P=0.754N P=0.526 P=0.142 |P=0.239 (e) P=0.240 P=0.489 |
|COCH-ARM / FISHERS | P=0.072 P=0.753N P=0.500 P=0.181 |P=0.246 (e) P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.047 * (e) (e) (e) |P=0.182 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.16 2/41.56 2/44.46 4/33.18 |0/44.12 0/47.49 2/47.41 1/45.95 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 4.5% 12.1% |0.0% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 709 729 (T) 687 537 |--- --- 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.563 P=0.591 P=0.015 * |P=0.242 (e) P=0.257 P=0.514 |
|POLY 3 | P=0.073 P=0.495 P=0.519 P=0.114 |P=0.250 (e) P=0.254 P=0.508 |
|POLY 1.5 | P=0.090 P=0.495 P=0.510 P=0.143 |P=0.250 (e) P=0.249 P=0.506 |
|POLY 6 | P=0.057 P=0.500 P=0.534 P=0.075 |P=0.247 (e) P=0.257 P=0.508 |
|LOGISTIC REGRESSION| P=0.065 P=0.525 P=0.526 P=0.142 |P=0.239 (e) P=0.240 P=0.489 |
|COCH-ARM / FISHERS | P=0.113 P=0.500 P=0.500 P=0.181 |P=0.246 (e) P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.060 (e) (e) (e) |P=0.182 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/04 EXPERIMENT: 88138 TEST: 03 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 20/50 (40%) 23/50 (46%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.23 5/41.56 20/45.31 23/39.89 |0/44.12 1/47.49 1/47.30 1/45.95 |
|POLY-3 PERCENT (g) | 2.4% 12.0% 44.1% 57.7% |0.0% 2.1% 2.1% 2.2% |
|TERMINAL (d) | 0/22 (0%) 5/27 (19%) 14/31 (45%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 690 729 (T) 624 529 |--- 729 (T) 709 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.149 P<0.001 ** P<0.001 ** |P=0.386 P=0.534 P=0.516 P=0.514 |
|POLY 3 | P<0.001 ** P=0.096 P<0.001 ** P<0.001 ** |P=0.397 P=0.515 P=0.514 P=0.508 |
|POLY 1.5 | P<0.001 ** P=0.097 P<0.001 ** P<0.001 ** |P=0.395 P=0.510 P=0.510 P=0.506 |
|POLY 6 | P<0.001 ** P=0.098 P<0.001 ** P<0.001 ** |P=0.396 P=0.518 P=0.517 P=0.508 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.116 P<0.001 ** P<0.001 ** |P=0.384 P=0.534 P=0.508 P=0.489 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.102 P<0.001 ** P<0.001 ** |P=0.384 P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.336 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 21/50 (42%) 23/50 (46%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.31 6/41.56 21/45.48 23/39.89 |0/44.12 1/47.49 2/47.41 1/45.95 |
|POLY-3 PERCENT (g) | 4.7% 14.4% 46.2% 57.7% |0.0% 2.1% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 6/27 (22%) 14/31 (45%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 690 729 (T) 624 529 |--- 729 (T) 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.200 P<0.001 ** P<0.001 ** |P=0.365 P=0.534 P=0.257 P=0.514 |
|POLY 3 | P<0.001 ** P=0.125 P<0.001 ** P<0.001 ** |P=0.380 P=0.515 P=0.254 P=0.508 |
|POLY 1.5 | P<0.001 ** P=0.127 P<0.001 ** P<0.001 ** |P=0.378 P=0.510 P=0.249 P=0.506 |
|POLY 6 | P<0.001 ** P=0.127 P<0.001 ** P<0.001 ** |P=0.377 P=0.518 P=0.257 P=0.508 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.150 P<0.001 ** P<0.001 ** |P=0.366 P=0.534 P=0.240 P=0.489 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.134 P<0.001 ** P<0.001 ** |P=0.366 P=0.500 P=0.247 P=0.500 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.241 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/04 EXPERIMENT: 88138 TEST: 03 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia, Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 7/50 (14%) 21/50 (42%) 23/50 (46%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.31 7/41.56 21/45.48 23/39.89 |0/44.12 1/47.49 2/47.41 1/45.95 |
|POLY-3 PERCENT (g) | 4.7% 16.8% 46.2% 57.7% |0.0% 2.1% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 7/27 (26%) 14/31 (45%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 690 729 (T) 624 529 |--- 729 (T) 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.132 P<0.001 ** P<0.001 ** |P=0.365 P=0.534 P=0.257 P=0.514 |
|POLY 3 | P<0.001 ** P=0.073 P<0.001 ** P<0.001 ** |P=0.380 P=0.515 P=0.254 P=0.508 |
|POLY 1.5 | P<0.001 ** P=0.074 P<0.001 ** P<0.001 ** |P=0.378 P=0.510 P=0.249 P=0.506 |
|POLY 6 | P<0.001 ** P=0.073 P<0.001 ** P<0.001 ** |P=0.377 P=0.518 P=0.257 P=0.508 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.093 P<0.001 ** P<0.001 ** |P=0.366 P=0.534 P=0.240 P=0.489 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.080 P<0.001 ** P<0.001 ** |P=0.366 P=0.500 P=0.247 P=0.500 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.241 (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).