NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus BENZOPHENONE DATE: 10/25/04 EXPERIMENT: 88138 TEST: 01 TIME: 13:30:25 TEST TYPE: SUBCHRON 90-DAY PAGE: 1 CONT: NO1-ES-15320 ROUTE: DOSED FEED NTP C#: C88138 PATHOLOGIST: YARRINGTON, J. YARRINGTON, JOHN CAS: 119-61-9 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus BENZOPHENONE DATE: 10/25/04 EXPERIMENT: 88138 TEST: 01 TIME: 13:30:25 TEST TYPE: SUBCHRON 90-DAY CONT: NO1-ES-15320 ROUTE: DOSED FEED NTP C#: C88138 PATHOLOGIST: YARRINGTON, J. YARRINGTON, JOHN CAS: 119-61-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF BENZOPHENONE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Bone Marrow Atrophy Heart: Myocardium Inflammation Chronic Kidney Inflammation Chronic Mineralization Kidney: Papilla Necrosis Kidney: Renal Tubule Casts Protein Dilatation Regeneration Liver: Bile Duct Hyperplasia Liver: Hepatocyte Hypertrophy Vacuolization Cytoplasmic Lung Inflammation Chronic Preputial Gland Inflammation Chronic Seminal Vesicle Atrophy Testes: Germinal Epithelium Degeneration =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Bone Marrow Atrophy Clitoral Gland Inflammation Chronic Kidney: Papilla Necrosis Kidney: Renal Tubule Casts Protein Dilatation Regeneration Liver Inflammation Chronic Inflammation Granulomatous Liver: Hepatocyte Hypertrophy Vacuolization Cytoplasmic Lung Inflammation Chronic Ovary: Periovarian Tissue Cyst =============================================================== Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Bone Marrow | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001N** | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001N** | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001N** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Bone Marrow | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 10/10 (100%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 2/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 20.0% 100.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 92 (T) 12 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.234 P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.227 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.227 P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.227 P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.234 (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.237 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) 0/9 (0%) | |POLY-3 RATE (b) | 4/10.00 0/0.00 0/0.00 0/0.00 4/10.00 0/0.69 | |POLY-3 PERCENT (g) | 40.0% 0.0% 0.0% 0.0% 40.0% 0.0% | |TERMINAL (d) | 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.672 P=1.000N P=1.000 P=1.000 P=0.672 P=1.000N | |POLY 3 | (e) (e) (e) (e) P=0.667 P=0.591N | |POLY 1.5 | (e) (e) (e) (e) P=0.667 P=0.376N | |POLY 6 | (e) (e) (e) (e) P=0.667 P=0.665N | |LOGISTIC REGRESSION| P=0.672 (e) (e) (e) P=0.672 (e) | |COCH-ARM / FISHERS | P=0.049N* P=1.000 P=1.000 P=1.000 P=0.675N P=0.054N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Heart: Myocardium | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/10 (60%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) 0/10 (0%) | |POLY-3 RATE (b) | 6/10.00 0/0.00 0/0.00 0/0.00 3/10.00 0/0.82 | |POLY-3 PERCENT (g) | 60.0% 0.0% 0.0% 0.0% 30.0% 0.0% | |TERMINAL (d) | 6/10 (60%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.190N P=1.000N P=1.000N P=1.000N P=0.190N P=1.000N | |POLY 3 | (e) (e) (e) (e) P=0.186N P=0.517N | |POLY 1.5 | (e) (e) (e) (e) P=0.186N P=0.185N | |POLY 6 | (e) (e) (e) (e) P=0.186N P=0.656N | |LOGISTIC REGRESSION| P=0.190N (e) (e) (e) P=0.190N (e) | |COCH-ARM / FISHERS | P=0.004N** P=1.000 P=1.000 P=1.000 P=0.185N P=0.005N** | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Heart: Myocardium | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) 1/9 (11%) | |POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 1/10.00 1/1.61 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 10.0% 62.1% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 92 (T) 39 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.050 (e) (e) (e) P=0.500 P=0.479 | |POLY 3 | (e) (e) (e) (e) P=0.500 P=0.256 | |POLY 1.5 | (e) (e) (e) (e) P=0.500 P=0.310 | |POLY 6 | (e) (e) (e) (e) P=0.500 P=0.238 | |LOGISTIC REGRESSION| P=0.500 (e) (e) (e) P=0.500 (e) | |COCH-ARM / FISHERS | P=0.303 (e) (e) (e) P=0.500 P=0.474 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Kidney | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 2/10 (20%) 3/10 (30%) 4/10 (40%) 2/10 (20%) 0/10 (0%) | |POLY-3 RATE (b) | 0/10.00 2/10.00 3/10.00 4/10.00 2/10.00 0/0.82 | |POLY-3 PERCENT (g) | 0.0% 20.0% 30.0% 40.0% 20.0% 0.0% | |TERMINAL (d) | 0/10 (0%) 2/10 (20%) 3/10 (30%) 4/10 (40%) 2/10 (20%) 0/0 (0%) | |FIRST INCIDENCE | --- 92 (T) 92 (T) 92 (T) 92 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.360 P=0.234 P=0.111 P=0.051 P=0.234 (e) | |POLY 3 | P=0.265 P=0.227 P=0.095 P=0.033 * P=0.227 (e) | |POLY 1.5 | P=0.379 P=0.227 P=0.095 P=0.033 * P=0.227 (e) | |POLY 6 | P=0.254 P=0.227 P=0.095 P=0.033 * P=0.227 (e) | |LOGISTIC REGRESSION| (e) P=0.234 P=0.111 P=0.051 P=0.234 (e) | |COCH-ARM / FISHERS | P=0.218N P=0.237 P=0.105 P=0.043 * P=0.237 (e) | |ORDER RESTRICTED | P=0.732 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Kidney | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/10 (20%) 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |POLY-3 RATE (b) | 2/10.00 2/10.00 0/10.00 0/10.00 0/10.00 0/0.69 | |POLY-3 PERCENT (g) | 20.0% 20.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/10 (20%) 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) 92 (T) --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.137N P=0.707 P=0.234N P=0.234N P=0.234N P=1.000N | |POLY 3 | P=0.052N P=0.702 P=0.227N P=0.227N P=0.227N P=0.667N | |POLY 1.5 | P=0.059N P=0.702 P=0.227N P=0.227N P=0.227N P=0.553N | |POLY 6 | P=0.052N P=0.702 P=0.227N P=0.227N P=0.227N P=0.704N | |LOGISTIC REGRESSION| P=0.137N P=0.707 (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.089N P=0.709N P=0.237N P=0.237N P=0.237N P=0.263N | |ORDER RESTRICTED | P=0.745N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) 10/10 (100%) 0/10 (0%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 5/10.00 10/10.00 0/0.82 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 50.0% 100.0% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 92 (T) 92 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.022 * P<0.001 ** (e) | |POLY 3 | P<0.001 ** (e) (e) P=0.008 ** P<0.001 ** (e) | |POLY 1.5 | P<0.001 ** (e) (e) P=0.008 ** P<0.001 ** (e) | |POLY 6 | P<0.001 ** (e) (e) P=0.008 ** P<0.001 ** (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.022 * P<0.001 ** (e) | |COCH-ARM / FISHERS | P=0.158 (e) (e) P=0.016 * P<0.001 ** (e) | |ORDER RESTRICTED | P=0.233 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 9/9 (100%) | |POLY-3 RATE (b) | 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 9/9.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 39 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Kidney: Papilla | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 6/10 (60%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 2/10.00 6/6.33 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 20.0% 94.8% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 92 (T) 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.234 P=0.009 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.227 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.227 P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.227 P<0.001 ** | |LOGISTIC REGRESSION| P=0.063 (e) (e) (e) P=0.234 (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.237 P=0.005 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Kidney: Papilla | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/9 (33%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 3/3.46 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 86.8% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 39 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.093 | |POLY 3 | P=0.003 ** (e) (e) (e) (e) P=0.004 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.010 * | |POLY 6 | P=0.006 ** (e) (e) (e) (e) P=0.002 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.087 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Casts Protein | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 8/10 (80%) 8/10 (80%) 9/10 (90%) 10/10 (100%) 0/10 (0%) | |POLY-3 RATE (b) | 0/10.00 8/10.00 8/10.00 9/10.00 10/10.00 0/0.82 | |POLY-3 PERCENT (g) | 0.0% 80.0% 80.0% 90.0% 100.0% 0.0% | |TERMINAL (d) | 0/10 (0%) 8/10 (80%) 8/10 (80%) 9/10 (90%) 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | --- 92 (T) 92 (T) 92 (T) 92 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** (e) | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** (e) | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** (e) | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** (e) | |LOGISTIC REGRESSION| (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** (e) | |COCH-ARM / FISHERS | P=0.039N* P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** (e) | |ORDER RESTRICTED | P=0.347 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Casts Protein | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) 4/10 (40%) 0/9 (0%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 2/10.00 0/10.00 4/10.00 0/0.69 | |POLY-3 PERCENT (g) | 0.0% 0.0% 20.0% 0.0% 40.0% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) 4/10 (40%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 92 (T) --- 92 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.016 * (e) P=0.234 (e) P=0.051 (e) | |POLY 3 | P=0.002 ** (e) P=0.227 (e) P=0.033 * (e) | |POLY 1.5 | P=0.008 ** (e) P=0.227 (e) P=0.033 * (e) | |POLY 6 | P=0.002 ** (e) P=0.227 (e) P=0.033 * (e) | |LOGISTIC REGRESSION| (e) (e) P=0.234 (e) P=0.051 (e) | |COCH-ARM / FISHERS | P=0.433 (e) P=0.237 (e) P=0.043 * (e) | |ORDER RESTRICTED | P=0.679 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 6/10 (60%) 8/10 (80%) 9/10 (90%) 8/10 (80%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 6/10.00 8/10.00 9/10.00 8/8.16 | |POLY-3 PERCENT (g) | 0.0% 0.0% 60.0% 80.0% 90.0% 98.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 6/10 (60%) 8/10 (80%) 9/10 (90%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 92 (T) 92 (T) 92 (T) 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.009 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.009 ** P<0.001 ** P<0.001 ** (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.005 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 5/9 (56%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 3/10.00 5/5.31 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 30.0% 94.3% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 92 (T) 39 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.111 P=0.015 * | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.095 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.095 P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.095 P<0.001 ** | |LOGISTIC REGRESSION| P=0.010 * (e) (e) (e) P=0.111 (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.105 P=0.011 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Regeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 8/10 (80%) | |POLY-3 RATE (b) | 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 8/8.16 | |POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% 98.0% | |TERMINAL (d) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 3 | P=0.995N (e) (e) (e) (e) P=1.000N | |POLY 1.5 | P=0.111N (e) (e) (e) (e) P=0.823N | |POLY 6 | P=1.000N (e) (e) (e) (e) P=1.000N | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.010N* (e) (e) (e) (e) P=0.237N | |ORDER RESTRICTED | P=0.004N** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Regeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/10 (30%) 8/10 (80%) 6/10 (60%) 6/10 (60%) 9/10 (90%) 7/9 (78%) | |POLY-3 RATE (b) | 3/10.00 8/10.00 6/10.00 6/10.00 9/10.00 7/7.15 | |POLY-3 PERCENT (g) | 30.0% 80.0% 60.0% 60.0% 90.0% 97.9% | |TERMINAL (d) | 3/10 (30%) 8/10 (80%) 6/10 (60%) 6/10 (60%) 9/10 (90%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 39 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.040 * P=0.190 P=0.190 P=0.013 * P=0.002 ** | |POLY 3 | P=0.004 ** P=0.024 * P=0.186 P=0.186 P=0.003 ** P=0.002 ** | |POLY 1.5 | P=0.008 ** P=0.024 * P=0.186 P=0.186 P=0.003 ** P=0.005 ** | |POLY 6 | P=0.003 ** P=0.024 * P=0.186 P=0.186 P=0.003 ** P=0.002 ** | |LOGISTIC REGRESSION| P=0.048 * P=0.040 * P=0.190 P=0.190 P=0.013 * (e) | |COCH-ARM / FISHERS | P=0.064 P=0.035 * P=0.185 P=0.185 P=0.010 * P=0.051 | |ORDER RESTRICTED | P=0.002 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/10 (10%) 2/10 (20%) 3/10 (30%) 2/10 (20%) 1/10 (10%) 1/10 (10%) | |POLY-3 RATE (b) | 1/10.00 2/10.00 3/10.00 2/10.00 1/10.00 1/1.74 | |POLY-3 PERCENT (g) | 10.0% 20.0% 30.0% 20.0% 10.0% 57.5% | |TERMINAL (d) | 1/10 (10%) 2/10 (20%) 3/10 (30%) 2/10 (20%) 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.343 P=0.500 P=0.293 P=0.500 P=0.766 P=0.500 | |POLY 3 | P=0.527N P=0.500 P=0.292 P=0.500 P=0.760 P=0.400 | |POLY 1.5 | P=0.526N P=0.500 P=0.292 P=0.500 P=0.760 P=0.515 | |POLY 6 | P=0.506N P=0.500 P=0.292 P=0.500 P=0.760 P=0.355 | |LOGISTIC REGRESSION| P=0.552N P=0.500 P=0.293 P=0.500 P=0.766 (e) | |COCH-ARM / FISHERS | P=0.314N P=0.500 P=0.291 P=0.500 P=0.763N P=0.763N | |ORDER RESTRICTED | P=0.453 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/10 (10%) 4/10 (40%) 2/10 (20%) 3/10 (30%) 1/10 (10%) 2/9 (22%) | |POLY-3 RATE (b) | 1/10.00 4/10.00 2/10.00 3/10.00 1/10.00 2/2.53 | |POLY-3 PERCENT (g) | 10.0% 40.0% 20.0% 30.0% 10.0% 79.0% | |TERMINAL (d) | 1/10 (10%) 4/10 (40%) 2/10 (20%) 3/10 (30%) 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 39 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.123 P=0.157 P=0.500 P=0.293 P=0.766 P=0.210 | |POLY 3 | P=0.577 P=0.148 P=0.500 P=0.292 P=0.760 P=0.137 | |POLY 1.5 | P=0.529 P=0.148 P=0.500 P=0.292 P=0.760 P=0.207 | |POLY 6 | P=0.568N P=0.148 P=0.500 P=0.292 P=0.760 P=0.115 | |LOGISTIC REGRESSION| P=0.452N P=0.157 P=0.500 P=0.293 P=0.766 (e) | |COCH-ARM / FISHERS | P=0.482N P=0.152 P=0.500 P=0.291 P=0.763N P=0.458 | |ORDER RESTRICTED | P=0.157 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 0/0.82 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 10.0% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 92 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.362 (e) (e) (e) P=0.500 (e) | |POLY 3 | P=0.127 (e) (e) (e) P=0.500 (e) | |POLY 1.5 | P=0.175 (e) (e) (e) P=0.500 (e) | |POLY 6 | P=0.123 (e) (e) (e) P=0.500 (e) | |LOGISTIC REGRESSION| P=0.360 (e) (e) (e) P=0.500 (e) | |COCH-ARM / FISHERS | P=0.585 (e) (e) (e) P=0.500 (e) | |ORDER RESTRICTED | P=0.741 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/10 (30%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |POLY-3 RATE (b) | 3/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/0.69 | |POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/10 (30%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.149N P=0.111N P=0.111N P=0.111N P=0.111N P=1.000N | |POLY 3 | P=0.040N* P=0.095N P=0.095N P=0.095N P=0.095N P=0.622N | |POLY 1.5 | P=0.048N* P=0.095N P=0.095N P=0.095N P=0.095N P=0.456N | |POLY 6 | P=0.039N* P=0.095N P=0.095N P=0.095N P=0.095N P=0.678N | |LOGISTIC REGRESSION| P=0.149N (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.113N P=0.105N P=0.105N P=0.105N P=0.105N P=0.124N | |ORDER RESTRICTED | P=0.661N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/0.82 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/10 (20%) 4/10 (40%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |POLY-3 RATE (b) | 2/10.00 4/10.00 0/10.00 0/10.00 0/10.00 0/0.69 | |POLY-3 PERCENT (g) | 20.0% 40.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/10 (20%) 4/10 (40%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) 92 (T) --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.064N P=0.317 P=0.234N P=0.234N P=0.234N P=1.000N | |POLY 3 | P=0.015N* P=0.318 P=0.227N P=0.227N P=0.227N P=0.667N | |POLY 1.5 | P=0.018N* P=0.318 P=0.227N P=0.227N P=0.227N P=0.553N | |POLY 6 | P=0.014N* P=0.318 P=0.227N P=0.227N P=0.227N P=0.704N | |LOGISTIC REGRESSION| P=0.064N P=0.317 (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.039N* P=0.314 P=0.237N P=0.237N P=0.237N P=0.263N | |ORDER RESTRICTED | P=0.711N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 9/9.08 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 99.1% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/0.69 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) 7/10 (70%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 5/10.00 7/7.25 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 50.0% 96.6% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 92 (T) 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.022 * P=0.003 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.008 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.008 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.008 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.022 * (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.016 * P=0.002 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 2/10 (20%) 8/10 (80%) 10/10 (100%) 10/10 (100%) 7/9 (78%) | |POLY-3 RATE (b) | 0/10.00 2/10.00 8/10.00 10/10.00 10/10.00 7/7.15 | |POLY-3 PERCENT (g) | 0.0% 20.0% 80.0% 100.0% 100.0% 97.9% | |TERMINAL (d) | 0/10 (0%) 2/10 (20%) 8/10 (80%) 10/10 (100%) 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | --- 92 (T) 92 (T) 92 (T) 92 (T) 39 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.234 P<0.001 ** P<0.001 ** P<0.001 ** P=0.002 ** | |POLY 3 | P<0.001 ** P=0.227 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.227 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.227 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.234 P<0.001 ** P<0.001 ** P<0.001 ** (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.237 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/10 (10%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 1/10.00 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 10.0% 100.0% 100.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 1/10 (10%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** (e) | |COCH-ARM / FISHERS | P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) 7/9 (78%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 9/10.00 10/10.00 7/7.15 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 90.0% 100.0% 97.9% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 92 (T) 92 (T) 39 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P=0.002 ** | |POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/10 (10%) 0/0 (0%) 2/2 (100%) 3/3 (100%) 1/10 (10%) 5/10 (50%) | |POLY-3 RATE (b) | 1/10.00 0/0.00 2/2.00 3/3.00 1/10.00 5/5.41 | |POLY-3 PERCENT (g) | 10.0% 0.0% 100.0% 100.0% 10.0% 92.4% | |TERMINAL (d) | 1/10 (10%) 0/0 (0%) 2/2 (100%) 3/3 (100%) 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) --- 92 (T) 92 (T) 92 (T) 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=1.000N P=0.043 * P=0.015 * P=0.766 P=0.022 * | |POLY 3 | (e) (e) P=0.005 ** P<0.001 ** P=0.760 P<0.001 ** | |POLY 1.5 | (e) (e) P=0.005 ** P<0.001 ** P=0.760 P=0.004 ** | |POLY 6 | (e) (e) P=0.005 ** P<0.001 ** P=0.760 P<0.001 ** | |LOGISTIC REGRESSION| P=0.555N (e) P=0.043 * P=0.015 * P=0.766 (e) | |COCH-ARM / FISHERS | P=0.244 P=1.000 P=0.045 * P=0.014 * P=0.763N P=0.070 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 1/1 (100%) 0/0 (0%) 5/5 (100%) 3/10 (30%) 6/9 (67%) | |POLY-3 RATE (b) | 0/10.00 1/1.00 0/0.00 5/5.00 3/10.00 6/6.23 | |POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 100.0% 30.0% 96.3% | |TERMINAL (d) | 0/10 (0%) 1/1 (100%) 0/0 (0%) 5/5 (100%) 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | --- 92 (T) --- 92 (T) 92 (T) 39 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.077 (e) P<0.001 ** P=0.111 P=0.005 ** | |POLY 3 | (e) P=0.091 (e) P<0.001N** P=0.095 P<0.001 ** | |POLY 1.5 | (e) P=0.091 (e) P<0.001N** P=0.095 P<0.001 ** | |POLY 6 | (e) P=0.091 (e) P<0.001N** P=0.095 P<0.001 ** | |LOGISTIC REGRESSION| P=0.242 P=0.077 (e) P<0.001 ** P=0.111 (e) | |COCH-ARM / FISHERS | P=0.037 * P=0.091 (e) P<0.001 ** P=0.105 P=0.003 ** | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Ovary: Periovarian Tissue | | 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 | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Ovary: Periovarian Tissue | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/10 (30%) 2/2 (100%) 1/1 (100%) 0/0 (0%) 0/10 (0%) 0/9 (0%) | |POLY-3 RATE (b) | 3/10.00 2/2.00 1/1.00 0/0.00 0/10.00 0/0.69 | |POLY-3 PERCENT (g) | 30.0% 100.0% 100.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/10 (30%) 2/2 (100%) 1/1 (100%) 0/0 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.046N* P=0.158 P=0.388 P=1.000N P=0.111N P=1.000N | |POLY 3 | (e) P=0.130 P=0.384 (e) P=0.095N P=0.622N | |POLY 1.5 | (e) P=0.130 P=0.384 (e) P=0.095N P=0.456N | |POLY 6 | (e) P=0.130 P=0.384 (e) P=0.095N P=0.678N | |LOGISTIC REGRESSION| P=0.046N* P=0.158 P=0.388 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.007N** P=0.152 P=0.364 P=1.000 P=0.105N P=0.124N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/10 (60%) 4/10 (40%) | |POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/0.00 6/10.00 4/4.49 | |POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 60.0% 89.0% | |TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/10 (60%) 0/0 (0%) | |FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=1.000N P=1.000N P=1.000N P=0.091 P=0.051 | |POLY 3 | (e) (e) (e) (e) P=0.077 P=0.034 * | |POLY 1.5 | (e) (e) (e) (e) P=0.077 P=0.077 | |POLY 6 | (e) (e) (e) (e) P=0.077 P=0.023 * | |LOGISTIC REGRESSION| P=0.085 (e) (e) (e) P=0.091 (e) | |COCH-ARM / FISHERS | P=0.247 P=1.000 P=1.000 P=1.000 P=0.085 P=0.314 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 | | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Seminal Vesicle | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 3/9 (33%) | |POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 3/3.49 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 85.9% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.093 | |POLY 3 | (e) (e) (e) (e) (e) P=0.004 ** | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.011 * | |POLY 6 | (e) (e) (e) (e) (e) P=0.002 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.025 * (e) (e) (e) (e) P=0.087 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Seminal Vesicle | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 | | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Testes: Germinal Epithelium | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Testes: Germinal Epithelium | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 | | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Thyroid Gland | | Ultimobranchial Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 0/0.82 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Thyroid Gland | | Ultimobranchial Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) 0/9 (0%) | |POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 2/10.00 0/0.69 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 20.0% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 92 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.234 (e) (e) (e) P=0.234 (e) | |POLY 3 | (e) (e) (e) (e) P=0.227 (e) | |POLY 1.5 | (e) (e) (e) (e) P=0.227 (e) | |POLY 6 | (e) (e) (e) (e) P=0.227 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.234 (e) | |COCH-ARM / FISHERS | P=0.652 (e) (e) (e) P=0.237 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 88138 TEST: 01 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Ureter: Transitional Epithelium | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/2 (100%) | |POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 0/0.00 0/0.00 2/2.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 40 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0% 0.125% 0.25% 0.5% 1.0% 2.0% | | | | |=================================================================================================================================| | | |Ureter: Transitional Epithelium | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 0/0.00 0/0.00 0/0.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| (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).