TDMS Study 88138-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus BENZOPHENONE DATE: 06/24/03 EXPERIMENT: 88138 TEST: 04 TIME: 08:31:44 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B PATHOLOGIST: MISSING CAS: 119-61-9 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#1/MICE REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus BENZOPHENONE DATE: 06/24/03 EXPERIMENT: 88138 TEST: 04 TIME: 08:31:44 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 Mice(B6C3F1) ----------------------------- 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. --------------- Adrenal Cortex Adrenal Medulla Bone Marrow Heart Islets, Pancreatic Liver Lung Nose Ovary Pituitary Gland Prostate Spleen Testes Thymus Thyroid Gland NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus BENZOPHENONE DATE: 06/24/03 EXPERIMENT: 88138 TEST: 04 TIME: 08:31:44 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 Mice ------------ Organ Morphology ----- ---------- Liver Hepatoblastoma Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Malignant Tumors =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Uterus Polyp Stromal Sarcoma Stromal or Polyp Stromal All Organs Histiocytic Sarcoma Malignant Tumors Malignant and Benign Tumors =============================================================== Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/49 (4%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |1/46.52 1/46.76 0/46.69 2/42.51 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 2.1% 0.0% 4.7% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |1/40 (3%) 1/42 (2%) 0/41 (0%) 2/31 (7%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.287 P=0.751N P=0.495N P=0.411 | |POLY 3 | (e) (e) (e) (e) |P=0.346 P=0.759N P=0.499N P=0.469 | |POLY 1.5 | (e) (e) (e) (e) |P=0.352 P=0.760N P=0.500N P=0.478 | |POLY 6 | (e) (e) (e) (e) |P=0.341 P=0.758N P=0.498N P=0.457 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.287 P=0.751N (e) P=0.411 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.360 P=0.753N P=0.500N P=0.492 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.238 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 6/50 (12%) 4/50 (8%) 4/50 (8%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 3/50 (6%) | |POLY-3 RATE (b) | 6/48.36 6/47.66 4/48.93 4/48.51 |1/46.52 3/46.76 2/46.69 3/44.33 | |POLY-3 PERCENT (g) | 12.4% 12.6% 8.2% 8.3% |2.2% 6.4% 4.3% 6.8% | |TERMINAL (d) | 4/44 (9%) 5/44 (11%) 2/44 (5%) 4/45 (9%) |1/40 (3%) 3/42 (7%) 2/41 (5%) 1/31 (3%) | |FIRST INCIDENCE | 652 606 585 730 (T) |729 (T) 729 (T) 729 (T) 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.254N P=0.611 P=0.371N P=0.360N |P=0.217 P=0.323 P=0.509 P=0.257 | |POLY 3 | P=0.258N P=0.610 P=0.363N P=0.368N |P=0.281 P=0.307 P=0.501 P=0.288 | |POLY 1.5 | P=0.259N P=0.614 P=0.365N P=0.368N |P=0.289 P=0.306 P=0.499 P=0.294 | |POLY 6 | P=0.259N P=0.605 P=0.363N P=0.371N |P=0.272 P=0.309 P=0.503 P=0.281 | |LOGISTIC REGRESSION| P=0.279N P=0.615N P=0.403N P=0.371N |P=0.305 P=0.323 P=0.509 P=0.345 | |COCH-ARM / FISHERS | P=0.262N P=0.620N P=0.370N P=0.370N |P=0.302 P=0.309 P=0.500 P=0.309 | |ORDER RESTRICTED | P=0.390N (e) (e) (e) |P=0.249 (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 7/50 (14%) 4/50 (8%) 4/50 (8%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 4/50 (8%) | |POLY-3 RATE (b) | 7/48.47 7/47.66 4/48.93 4/48.51 |1/46.52 3/46.76 2/46.69 4/44.33 | |POLY-3 PERCENT (g) | 14.4% 14.7% 8.2% 8.3% |2.2% 6.4% 4.3% 9.0% | |TERMINAL (d) | 4/44 (9%) 6/44 (14%) 2/44 (5%) 4/45 (9%) |1/40 (3%) 3/42 (7%) 2/41 (5%) 2/31 (7%) | |FIRST INCIDENCE | 652 606 585 730 (T) |729 (T) 729 (T) 729 (T) 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.157N P=0.602 P=0.268N P=0.257N |P=0.098 P=0.323 P=0.509 P=0.136 | |POLY 3 | P=0.158N P=0.600 P=0.257N P=0.261N |P=0.147 P=0.307 P=0.501 P=0.164 | |POLY 1.5 | P=0.158N P=0.605 P=0.258N P=0.261N |P=0.153 P=0.306 P=0.499 P=0.170 | |POLY 6 | P=0.159N P=0.592 P=0.258N P=0.265N |P=0.141 P=0.309 P=0.503 P=0.158 | |LOGISTIC REGRESSION| P=0.172N P=0.608N P=0.290N P=0.265N |P=0.160 P=0.323 P=0.509 P=0.198 | |COCH-ARM / FISHERS | P=0.160N P=0.613N P=0.262N P=0.262N |P=0.162 P=0.309 P=0.500 P=0.181 | |ORDER RESTRICTED | P=0.258N (e) (e) (e) |P=0.116 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Intestine Small: Duodenum | | Polyp Adenomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 1/48.44 0/48.51 |1/46.52 0/46.76 3/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 0.0% |2.2% 0.0% 6.4% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |1/40 (3%) 0/42 (0%) 3/41 (7%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 722 --- |729 (T) --- 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.697 (e) P=0.504 (e) |P=0.580N P=0.490N P=0.314 P=0.551N | |POLY 3 | P=0.700 (e) P=0.502 (e) |P=0.533N P=0.499N P=0.307 P=0.514N | |POLY 1.5 | P=0.698 (e) P=0.502 (e) |P=0.520N P=0.500N P=0.305 P=0.508N | |POLY 6 | P=0.702 (e) P=0.502 (e) |P=0.549N P=0.498N P=0.309 P=0.520N | |LOGISTIC REGRESSION| P=0.696 (e) P=0.501 (e) |P=0.580N (e) P=0.314 (e) | |COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.500N P=0.500N P=0.309 P=0.500N | |ORDER RESTRICTED | P=0.383 (e) (e) (e) |P=0.282N (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Polyp Adenomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 1/48.44 0/48.51 |1/46.52 0/46.76 3/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 0.0% |2.2% 0.0% 6.4% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |1/40 (3%) 0/42 (0%) 3/41 (7%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 722 --- |729 (T) --- 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.697 (e) P=0.504 (e) |P=0.580N P=0.490N P=0.314 P=0.551N | |POLY 3 | P=0.700 (e) P=0.502 (e) |P=0.533N P=0.499N P=0.307 P=0.514N | |POLY 1.5 | P=0.698 (e) P=0.502 (e) |P=0.520N P=0.500N P=0.305 P=0.508N | |POLY 6 | P=0.702 (e) P=0.502 (e) |P=0.549N P=0.498N P=0.309 P=0.520N | |LOGISTIC REGRESSION| P=0.696 (e) P=0.501 (e) |P=0.580N (e) P=0.314 (e) | |COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.500N P=0.500N P=0.309 P=0.500N | |ORDER RESTRICTED | P=0.383 (e) (e) (e) |P=0.282N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 1/47.23 1/48.41 3/48.94 |0/46.52 0/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 2.1% 2.1% 6.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/44 (0%) 1/44 (2%) 1/44 (2%) 2/45 (4%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- 730 (T) 730 (T) 606 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.058 P=0.500 P=0.500 P=0.127 |(e) (e) (e) (e) | |POLY 3 | P=0.057 P=0.497 P=0.502 P=0.123 |(e) (e) (e) (e) | |POLY 1.5 | P=0.056 P=0.498 P=0.501 P=0.122 |(e) (e) (e) (e) | |POLY 6 | P=0.058 P=0.496 P=0.502 P=0.124 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.047 * P=0.500 P=0.500 P=0.092 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.054 P=0.500 P=0.500 P=0.121 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.039 * (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 15/50 (30%) 23/50 (46%) 23/50 (46%) |5/50 (10%) 4/50 (8%) 10/50 (20%) 8/50 (16%) | |POLY-3 RATE (b) | 11/48.02 15/47.66 23/49.09 23/49.32 |5/46.52 4/46.95 10/46.69 8/44.20 | |POLY-3 PERCENT (g) | 22.9% 31.5% 46.9% 46.6% |10.8% 8.5% 21.4% 18.1% | |TERMINAL (d) | 10/44 (23%) 14/44 (32%) 21/44 (48%) 21/45 (47%) |5/40 (13%) 3/42 (7%) 10/41 (24%) 7/31 (23%) | |FIRST INCIDENCE | 703 606 585 568 |729 (T) 680 729 (T) 435 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.007 ** P=0.248 P=0.011 * P=0.014 * |P=0.046 * P=0.471N P=0.139 P=0.143 | |POLY 3 | P=0.006 ** P=0.239 P=0.010 * P=0.011 * |P=0.109 P=0.494N P=0.131 P=0.243 | |POLY 1.5 | P=0.005 ** P=0.242 P=0.010 * P=0.010 * |P=0.120 P=0.498N P=0.129 P=0.256 | |POLY 6 | P=0.007 ** P=0.236 P=0.011 * P=0.012 * |P=0.095 P=0.489N P=0.133 P=0.225 | |LOGISTIC REGRESSION| P=0.006 ** P=0.230 P=0.011 * P=0.011 * |P=0.107 P=0.494N P=0.139 P=0.250 | |COCH-ARM / FISHERS | P=0.005 ** P=0.247 P=0.010 * P=0.010 * |P=0.139 P=0.500N P=0.131 P=0.277 | |ORDER RESTRICTED | P=0.009 ** (e) (e) (e) |P=0.134 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 5/50 (10%) 6/50 (12%) 6/50 (12%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 8/48.51 5/48.70 6/48.60 6/48.93 |0/46.52 1/46.76 0/46.69 1/43.48 | |POLY-3 PERCENT (g) | 16.5% 10.3% 12.3% 12.3% |0.0% 2.1% 0.0% 2.3% | |TERMINAL (d) | 7/44 (16%) 2/44 (5%) 5/44 (11%) 4/45 (9%) |0/40 (0%) 1/42 (2%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 540 449 679 656 |--- 729 (T) --- 712 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.385N P=0.282N P=0.387N P=0.372N |P=0.355 P=0.510 (e) P=0.463 | |POLY 3 | P=0.396N P=0.274N P=0.386N P=0.381N |P=0.389 P=0.501 (e) P=0.487 | |POLY 1.5 | P=0.398N P=0.275N P=0.386N P=0.383N |P=0.395 P=0.500 (e) P=0.492 | |POLY 6 | P=0.394N P=0.273N P=0.387N P=0.377N |P=0.381 P=0.502 (e) P=0.480 | |LOGISTIC REGRESSION| P=0.474N P=0.228N P=0.401N P=0.414N |P=0.384 P=0.510 (e) P=0.488 | |COCH-ARM / FISHERS | P=0.400N P=0.277N P=0.387N P=0.387N |P=0.405 P=0.500 (e) P=0.500 | |ORDER RESTRICTED | P=0.378N (e) (e) (e) |P=0.239 (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 6/50 (12%) 6/50 (12%) 9/50 (18%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 8/48.51 6/48.70 6/48.60 9/49.35 |0/46.52 1/46.76 0/46.69 1/43.48 | |POLY-3 PERCENT (g) | 16.5% 12.3% 12.3% 18.2% |0.0% 2.1% 0.0% 2.3% | |TERMINAL (d) | 7/44 (16%) 3/44 (7%) 5/44 (11%) 6/45 (13%) |0/40 (0%) 1/42 (2%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 540 449 679 606 |--- 729 (T) --- 712 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.404 P=0.390N P=0.387N P=0.520 |P=0.355 P=0.510 (e) P=0.463 | |POLY 3 | P=0.393 P=0.384N P=0.386N P=0.515 |P=0.389 P=0.501 (e) P=0.487 | |POLY 1.5 | P=0.388 P=0.385N P=0.386N P=0.509 |P=0.395 P=0.500 (e) P=0.492 | |POLY 6 | P=0.399 P=0.383N P=0.387N P=0.524 |P=0.381 P=0.502 (e) P=0.480 | |LOGISTIC REGRESSION| P=0.302 P=0.339N P=0.401N P=0.458 |P=0.384 P=0.510 (e) P=0.488 | |COCH-ARM / FISHERS | P=0.380 P=0.387N P=0.387N P=0.500 |P=0.405 P=0.500 (e) P=0.500 | |ORDER RESTRICTED | P=0.421 (e) (e) (e) |P=0.239 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 20/50 (40%) 25/50 (50%) 27/50 (54%) |5/50 (10%) 5/50 (10%) 10/50 (20%) 9/50 (18%) | |POLY-3 RATE (b) | 18/48.62 20/49.13 25/49.09 27/49.45 |5/46.52 5/46.95 10/46.69 9/44.27 | |POLY-3 PERCENT (g) | 37.0% 40.7% 50.9% 54.6% |10.8% 10.7% 21.4% 20.3% | |TERMINAL (d) | 16/44 (36%) 16/44 (36%) 23/44 (52%) 24/45 (53%) |5/40 (13%) 4/42 (10%) 10/41 (24%) 7/31 (23%) | |FIRST INCIDENCE | 540 449 585 568 |729 (T) 680 729 (T) 435 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.048 * P=0.422 P=0.121 P=0.076 |P=0.031 * P=0.601N P=0.139 P=0.090 | |POLY 3 | P=0.034 * P=0.434 P=0.118 P=0.060 |P=0.081 P=0.624N P=0.131 P=0.165 | |POLY 1.5 | P=0.033 * P=0.429 P=0.116 P=0.057 |P=0.089 P=0.627N P=0.129 P=0.176 | |POLY 6 | P=0.036 * P=0.441 P=0.118 P=0.063 |P=0.070 P=0.619N P=0.133 P=0.151 | |LOGISTIC REGRESSION| P=0.027 * P=0.436 P=0.115 P=0.054 |P=0.077 P=0.625N P=0.139 P=0.170 | |COCH-ARM / FISHERS | P=0.030 * P=0.418 P=0.113 P=0.054 |P=0.105 P=0.630N P=0.131 P=0.194 | |ORDER RESTRICTED | P=0.057 (e) (e) (e) |P=0.144 (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 20/50 (40%) 25/50 (50%) 29/50 (58%) |5/50 (10%) 5/50 (10%) 10/50 (20%) 9/50 (18%) | |POLY-3 RATE (b) | 18/48.62 20/49.13 25/49.09 29/49.88 |5/46.52 5/46.95 10/46.69 9/44.27 | |POLY-3 PERCENT (g) | 37.0% 40.7% 50.9% 58.1% |10.8% 10.7% 21.4% 20.3% | |TERMINAL (d) | 16/44 (36%) 16/44 (36%) 23/44 (52%) 25/45 (56%) |5/40 (13%) 4/42 (10%) 10/41 (24%) 7/31 (23%) | |FIRST INCIDENCE | 540 449 585 568 |729 (T) 680 729 (T) 435 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.020 * P=0.422 P=0.121 P=0.038 * |P=0.031 * P=0.601N P=0.139 P=0.090 | |POLY 3 | P=0.013 * P=0.434 P=0.118 P=0.027 * |P=0.081 P=0.624N P=0.131 P=0.165 | |POLY 1.5 | P=0.012 * P=0.429 P=0.116 P=0.024 * |P=0.089 P=0.627N P=0.129 P=0.176 | |POLY 6 | P=0.015 * P=0.441 P=0.118 P=0.030 * |P=0.070 P=0.619N P=0.133 P=0.151 | |LOGISTIC REGRESSION| P=0.009 ** P=0.436 P=0.115 P=0.021 * |P=0.077 P=0.625N P=0.139 P=0.170 | |COCH-ARM / FISHERS | P=0.011 * P=0.418 P=0.113 P=0.022 * |P=0.105 P=0.630N P=0.131 P=0.194 | |ORDER RESTRICTED | P=0.023 * (e) (e) (e) |P=0.144 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 11/50 (22%) 6/50 (12%) 9/50 (18%) |0/50 (0%) 5/50 (10%) 2/50 (4%) 3/50 (6%) | |POLY-3 RATE (b) | 14/48.07 11/48.05 6/48.44 9/48.51 |0/46.52 5/47.68 2/46.69 3/43.73 | |POLY-3 PERCENT (g) | 29.1% 22.9% 12.4% 18.6% |0.0% 10.5% 4.3% 6.9% | |TERMINAL (d) | 13/44 (30%) 9/44 (21%) 5/44 (11%) 9/45 (20%) |0/40 (0%) 4/42 (10%) 2/41 (5%) 1/31 (3%) | |FIRST INCIDENCE | 690 606 722 730 (T) |--- 316 729 (T) 672 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.108N P=0.330N P=0.042N* P=0.156N |P=0.207 P=0.038 * P=0.244 P=0.095 | |POLY 3 | P=0.110N P=0.322N P=0.036N* P=0.163N |P=0.260 P=0.033 * P=0.238 P=0.108 | |POLY 1.5 | P=0.111N P=0.323N P=0.037N* P=0.166N |P=0.271 P=0.032 * P=0.237 P=0.112 | |POLY 6 | P=0.110N P=0.320N P=0.036N* P=0.163N |P=0.247 P=0.033 * P=0.239 P=0.103 | |LOGISTIC REGRESSION| P=0.108N P=0.330N P=0.037N* P=0.158N |P=0.321 P=0.032 * P=0.244 P=0.115 | |COCH-ARM / FISHERS | P=0.116N P=0.322N P=0.039N* P=0.171N |P=0.292 P=0.028 * P=0.247 P=0.121 | |ORDER RESTRICTED | P=0.072N (e) (e) (e) |P=0.100 (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/48.11 0/47.23 1/48.41 0/48.51 |1/46.93 0/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 4.2% 0.0% 2.1% 0.0% |2.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/44 (2%) 0/44 (0%) 1/44 (2%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 679 --- 730 (T) --- |610 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.187N P=0.245N P=0.500N P=0.237N |P=0.310N P=0.500N P=0.496N P=0.509N | |POLY 3 | P=0.185N P=0.241N P=0.498N P=0.235N |P=0.297N P=0.501N P=0.501N P=0.516N | |POLY 1.5 | P=0.186N P=0.240N P=0.498N P=0.236N |P=0.301N P=0.501N P=0.501N P=0.509N | |POLY 6 | P=0.184N P=0.244N P=0.499N P=0.236N |P=0.292N P=0.501N P=0.501N P=0.523N | |LOGISTIC REGRESSION| P=0.191N P=0.233N P=0.507N P=0.248N |P=0.274N P=0.480N P=0.464N P=0.442N | |COCH-ARM / FISHERS | P=0.188N P=0.247N P=0.500N P=0.247N |P=0.306N P=0.500N P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.073N (e) (e) (e) |P=0.135N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 11/50 (22%) 7/50 (14%) 9/50 (18%) |1/50 (2%) 5/50 (10%) 2/50 (4%) 3/50 (6%) | |POLY-3 RATE (b) | 16/48.27 11/48.05 7/48.44 9/48.51 |1/46.93 5/47.68 2/46.69 3/43.73 | |POLY-3 PERCENT (g) | 33.2% 22.9% 14.5% 18.6% |2.1% 10.5% 4.3% 6.9% | |TERMINAL (d) | 14/44 (32%) 9/44 (21%) 6/44 (14%) 9/45 (20%) |0/40 (0%) 4/42 (10%) 2/41 (5%) 1/31 (3%) | |FIRST INCIDENCE | 679 606 722 730 (T) |610 316 729 (T) 672 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.058N P=0.196N P=0.032N* P=0.077N |P=0.342 P=0.115 P=0.508 P=0.260 | |POLY 3 | P=0.057N P=0.186N P=0.025N* P=0.078N |P=0.396 P=0.105 P=0.498 P=0.280 | |POLY 1.5 | P=0.058N P=0.185N P=0.026N* P=0.079N |P=0.411 P=0.105 P=0.498 P=0.290 | |POLY 6 | P=0.058N P=0.186N P=0.026N* P=0.079N |P=0.378 P=0.105 P=0.498 P=0.269 | |LOGISTIC REGRESSION| P=0.057N P=0.188N P=0.026N* P=0.076N |P=0.482 P=0.101 P=0.505 P=0.323 | |COCH-ARM / FISHERS | P=0.062N P=0.184N P=0.028N* P=0.083N |P=0.438 P=0.102 P=0.500 P=0.309 | |ORDER RESTRICTED | P=0.032N* (e) (e) (e) |P=0.245 (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/49 (2%) 3/50 (6%) 3/50 (6%) 2/50 (4%) | |POLY-3 RATE (b) | |1/46.42 3/46.76 3/46.69 2/43.51 | |POLY-3 PERCENT (g) | |2.2% 6.4% 6.4% 4.6% | |TERMINAL (d) | |0/40 (0%) 3/42 (7%) 3/41 (7%) 1/31 (3%) | |FIRST INCIDENCE | |708 729 (T) 729 (T) 705 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.363 P=0.318 P=0.309 P=0.422 | |POLY 3 | |P=0.433 P=0.308 P=0.307 P=0.477 | |POLY 1.5 | |P=0.452 P=0.309 P=0.308 P=0.488 | |POLY 6 | |P=0.411 P=0.308 P=0.308 P=0.465 | |LOGISTIC REGRESSION| |P=0.420 P=0.308 P=0.308 P=0.479 | |COCH-ARM / FISHERS | |P=0.484 P=0.316 P=0.316 P=0.508 | |ORDER RESTRICTED | |P=0.338 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 2/49 (4%) 3/47 (6%) | |POLY-3 RATE (b) | 0/45.92 0/46.80 0/48.41 0/48.51 |2/46.52 0/46.76 2/45.69 3/41.76 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.3% 0.0% 4.4% 7.2% | |TERMINAL (d) | 0/42 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |2/40 (5%) 0/42 (0%) 2/40 (5%) 0/30 (0%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) --- 729 (T) 672 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.165 P=0.228N P=0.695 P=0.411 | |POLY 3 | (e) (e) (e) (e) |P=0.202 P=0.236N P=0.687 P=0.451 | |POLY 1.5 | (e) (e) (e) (e) |P=0.207 P=0.237N P=0.685 P=0.459 | |POLY 6 | (e) (e) (e) (e) |P=0.196 P=0.235N P=0.689 P=0.441 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.204 (e) P=0.695 P=0.463 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.215 P=0.247N P=0.684 P=0.470 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.176 (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 9 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 4/50 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |1/46.60 1/46.76 4/47.76 2/43.61 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 2.1% 8.4% 4.6% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 1/42 (2%) 2/41 (5%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |709 729 (T) 204 704 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.242 P=0.755N P=0.185 P=0.433 | |POLY 3 | (e) (e) (e) (e) |P=0.275 P=0.760N P=0.187 P=0.477 | |POLY 1.5 | (e) (e) (e) (e) |P=0.289 P=0.760N P=0.184 P=0.486 | |POLY 6 | (e) (e) (e) (e) |P=0.258 P=0.759N P=0.189 P=0.466 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.371 P=0.761N P=0.206 P=0.487 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.313 P=0.753N P=0.181 P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.245 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 4/50 (8%) 1/50 (2%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |1/46.60 0/46.76 4/47.76 1/43.52 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 8.4% 2.3% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 2/41 (5%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |709 --- 204 704 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.379 P=0.500N P=0.185 P=0.718 | |POLY 3 | (e) (e) (e) (e) |P=0.397 P=0.499N P=0.187 P=0.745 | |POLY 1.5 | (e) (e) (e) (e) |P=0.415 P=0.500N P=0.184 P=0.751 | |POLY 6 | (e) (e) (e) (e) |P=0.375 P=0.499N P=0.189 P=0.738 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.519 P=0.500N P=0.206 P=0.755 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.444 P=0.500N P=0.181 P=0.753N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.188 (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 10 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 4/50 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |1/46.60 0/46.76 4/47.76 2/43.61 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 8.4% 4.6% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 2/41 (5%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |709 --- 204 704 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.182 P=0.500N P=0.185 P=0.433 | |POLY 3 | (e) (e) (e) (e) |P=0.204 P=0.499N P=0.187 P=0.477 | |POLY 1.5 | (e) (e) (e) (e) |P=0.216 P=0.500N P=0.184 P=0.486 | |POLY 6 | (e) (e) (e) (e) |P=0.190 P=0.499N P=0.189 P=0.466 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.294 P=0.500N P=0.206 P=0.487 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.237 P=0.500N P=0.181 P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.136 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Skin | | Schwannoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/48.66 0/47.23 0/48.41 0/48.51 |1/46.52 2/47.39 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 0.0% |2.2% 4.2% 0.0% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |1/40 (3%) 1/42 (2%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 463 --- --- --- |729 (T) 522 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.306N P=0.504N P=0.500N P=0.500N |P=0.215N P=0.514 P=0.495N P=0.551N | |POLY 3 | P=0.303N P=0.506N P=0.501N P=0.501N |P=0.194N P=0.506 P=0.499N P=0.514N | |POLY 1.5 | P=0.304N P=0.504N P=0.501N P=0.500N |P=0.192N P=0.503 P=0.500N P=0.508N | |POLY 6 | P=0.302N P=0.508N P=0.502N P=0.501N |P=0.196N P=0.510 P=0.498N P=0.520N | |LOGISTIC REGRESSION| P=0.769N P=0.433N (e) (e) |P=0.167N P=0.508 (e) (e) | |COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.188N P=0.500 P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.121N (e) (e) (e) |P=0.185N (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 11 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 4/50 (8%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 1/47.92 3/47.23 4/48.59 0/48.51 |2/46.52 0/46.76 2/46.78 1/43.42 | |POLY-3 PERCENT (g) | 2.1% 6.4% 8.2% 0.0% |4.3% 0.0% 4.3% 2.3% | |TERMINAL (d) | 1/44 (2%) 3/44 (7%) 3/44 (7%) 0/45 (0%) |2/40 (5%) 0/42 (0%) 1/41 (2%) 1/31 (3%) | |FIRST INCIDENCE | 730 (T) 730 (T) 683 --- |729 (T) --- 704 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.305N P=0.305 P=0.182 P=0.496N |P=0.613N P=0.228N P=0.689N P=0.589N | |POLY 3 | P=0.304N P=0.300 P=0.183 P=0.498N |P=0.551N P=0.236N P=0.692N P=0.524N | |POLY 1.5 | P=0.306N P=0.303 P=0.182 P=0.498N |P=0.543N P=0.237N P=0.693 P=0.515N | |POLY 6 | P=0.302N P=0.298 P=0.184 P=0.497N |P=0.560N P=0.235N P=0.689N P=0.536N | |LOGISTIC REGRESSION| P=0.306N P=0.305 P=0.180 (e) |P=0.574N (e) P=0.693N P=0.589N | |COCH-ARM / FISHERS | P=0.313N P=0.309 P=0.181 P=0.500N |P=0.531N P=0.247N P=0.691N P=0.500N | |ORDER RESTRICTED | P=0.130N (e) (e) (e) |P=0.431N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 1/47.92 3/47.23 3/48.41 0/48.51 |1/46.52 0/46.76 2/46.78 1/43.42 | |POLY-3 PERCENT (g) | 2.1% 6.4% 6.2% 0.0% |2.2% 0.0% 4.3% 2.3% | |TERMINAL (d) | 1/44 (2%) 3/44 (7%) 3/44 (7%) 0/45 (0%) |1/40 (3%) 0/42 (0%) 1/41 (2%) 1/31 (3%) | |FIRST INCIDENCE | 730 (T) 730 (T) 730 (T) --- |729 (T) --- 704 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.272N P=0.305 P=0.305 P=0.496N |P=0.428 P=0.490N P=0.503 P=0.704 | |POLY 3 | P=0.272N P=0.300 P=0.309 P=0.498N |P=0.467 P=0.499N P=0.502 P=0.745 | |POLY 1.5 | P=0.274N P=0.303 P=0.308 P=0.498N |P=0.480 P=0.500N P=0.500 P=0.751 | |POLY 6 | P=0.271N P=0.298 P=0.309 P=0.497N |P=0.451 P=0.498N P=0.505 P=0.737 | |LOGISTIC REGRESSION| P=0.272N P=0.305 P=0.305 (e) |P=0.466 (e) P=0.502 P=0.704 | |COCH-ARM / FISHERS | P=0.279N P=0.309 P=0.309 P=0.500N |P=0.500 P=0.500N P=0.500 P=0.753N | |ORDER RESTRICTED | P=0.154N (e) (e) (e) |P=0.374 (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 12 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |0/46.52 1/47.30 2/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.1% 4.3% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 2/41 (5%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 561 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.648 P=0.500 P=0.244 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.644N P=0.503 P=0.238 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.633N P=0.502 P=0.237 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.630 P=0.505 P=0.239 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.594N P=0.539 P=0.244 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.616N P=0.500 P=0.247 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.327 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 1/47.92 0/47.23 1/48.41 0/48.51 |0/46.52 1/47.30 2/46.69 1/44.02 | |POLY-3 PERCENT (g) | 2.1% 0.0% 2.1% 0.0% |0.0% 2.1% 4.3% 2.3% | |TERMINAL (d) | 1/44 (2%) 0/44 (0%) 1/44 (2%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 2/41 (5%) 0/31 (0%) | |FIRST INCIDENCE | 730 (T) --- 730 (T) --- |--- 561 729 (T) 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.401N P=0.500N P=0.762 P=0.496N |P=0.320 P=0.500 P=0.244 P=0.492 | |POLY 3 | P=0.401N P=0.503N P=0.758N P=0.498N |P=0.338 P=0.503 P=0.238 P=0.489 | |POLY 1.5 | P=0.403N P=0.502N P=0.759N P=0.498N |P=0.349 P=0.502 P=0.237 P=0.493 | |POLY 6 | P=0.400N P=0.504N P=0.758N P=0.497N |P=0.324 P=0.505 P=0.239 P=0.484 | |LOGISTIC REGRESSION| P=0.401N (e) P=0.762 (e) |P=0.418 P=0.539 P=0.244 P=0.615 | |COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.753N P=0.500N |P=0.366 P=0.500 P=0.247 P=0.500 | |ORDER RESTRICTED | P=0.249N (e) (e) (e) |P=0.226 (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 13 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |4/50 (8%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | |4/46.52 1/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | |8.6% 2.1% 0.0% 0.0% | |TERMINAL (d) | |4/40 (10%) 1/42 (2%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | |729 (T) 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.025N* P=0.165N P=0.060N P=0.099N | |POLY 3 | |P=0.019N* P=0.177N P=0.060N P=0.070N | |POLY 1.5 | |P=0.018N* P=0.179N P=0.061N P=0.066N | |POLY 6 | |P=0.019N* P=0.176N P=0.059N P=0.074N | |LOGISTIC REGRESSION| |P=0.025N* P=0.165N (e) (e) | |COCH-ARM / FISHERS | |P=0.019N* P=0.181N P=0.059N P=0.059N | |ORDER RESTRICTED | |P=0.008N** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |5/50 (10%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | |5/46.60 1/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | |10.7% 2.1% 0.0% 0.0% | |TERMINAL (d) | |4/40 (10%) 1/42 (2%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | |709 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.012N* P=0.096N P=0.033N* P=0.060N | |POLY 3 | |P=0.008N** P=0.101N P=0.030N* P=0.037N* | |POLY 1.5 | |P=0.008N** P=0.102N P=0.031N* P=0.034N* | |POLY 6 | |P=0.008N** P=0.100N P=0.030N* P=0.040N* | |LOGISTIC REGRESSION| |P=0.010N* P=0.100N P=0.032N* P=0.046N* | |COCH-ARM / FISHERS | |P=0.009N** P=0.102N P=0.028N* P=0.028N* | |ORDER RESTRICTED | |P=0.002N** (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 14 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |0/46.52 2/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 2/42 (5%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.455N P=0.249 (e) (e) | |POLY 3 | (e) (e) (e) (e) |P=0.413N P=0.238 (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.410N P=0.238 (e) (e) | |POLY 6 | (e) (e) (e) (e) |P=0.417N P=0.239 (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.249 (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.405N P=0.247 (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.261N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 3/48.40 2/47.62 1/48.41 0/48.51 |1/46.60 0/46.76 2/46.80 2/44.04 | |POLY-3 PERCENT (g) | 6.2% 4.2% 2.1% 0.0% |2.2% 0.0% 4.3% 4.5% | |TERMINAL (d) | 1/44 (2%) 1/44 (2%) 1/44 (2%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 1/41 (2%) 0/31 (0%) | |FIRST INCIDENCE | 652 620 730 (T) --- |708 --- 700 606 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.062N P=0.513N P=0.308N P=0.123N |P=0.199 P=0.505N P=0.497 P=0.449 | |POLY 3 | P=0.061N P=0.507N P=0.306N P=0.119N |P=0.227 P=0.499N P=0.501 P=0.480 | |POLY 1.5 | P=0.061N P=0.504N P=0.305N P=0.119N |P=0.234 P=0.500N P=0.500 P=0.487 | |POLY 6 | P=0.061N P=0.511N P=0.308N P=0.119N |P=0.219 P=0.499N P=0.504 P=0.472 | |LOGISTIC REGRESSION| P=0.073N P=0.477N P=0.332N P=0.139N |P=0.260 P=0.500N P=0.500 P=0.537 | |COCH-ARM / FISHERS | P=0.062N P=0.500N P=0.309N P=0.121N |P=0.245 P=0.500N P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.057N (e) (e) (e) |P=0.250 (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 15 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 3/48.40 2/47.62 1/48.41 0/48.51 |1/46.60 2/46.76 2/46.80 2/44.04 | |POLY-3 PERCENT (g) | 6.2% 4.2% 2.1% 0.0% |2.2% 4.3% 4.3% 4.5% | |TERMINAL (d) | 1/44 (2%) 1/44 (2%) 1/44 (2%) 0/45 (0%) |0/40 (0%) 2/42 (5%) 1/41 (2%) 0/31 (0%) | |FIRST INCIDENCE | 652 620 730 (T) --- |708 729 (T) 700 606 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.062N P=0.513N P=0.308N P=0.123N |P=0.346 P=0.509 P=0.497 P=0.449 | |POLY 3 | P=0.061N P=0.507N P=0.306N P=0.119N |P=0.395 P=0.501 P=0.501 P=0.480 | |POLY 1.5 | P=0.061N P=0.504N P=0.305N P=0.119N |P=0.405 P=0.500 P=0.500 P=0.487 | |POLY 6 | P=0.061N P=0.511N P=0.308N P=0.119N |P=0.384 P=0.502 P=0.504 P=0.472 | |LOGISTIC REGRESSION| P=0.073N P=0.477N P=0.332N P=0.139N |P=0.428 P=0.503 P=0.500 P=0.537 | |COCH-ARM / FISHERS | P=0.062N P=0.500N P=0.309N P=0.121N |P=0.423 P=0.500 P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.057N (e) (e) (e) |P=0.442 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 5/50 (10%) 3/50 (6%) | |POLY-3 RATE (b) | 1/47.92 0/47.23 0/48.41 0/48.51 |0/46.52 0/46.76 5/46.73 3/43.70 | |POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 0.0% |0.0% 0.0% 10.7% 6.9% | |TERMINAL (d) | 1/44 (2%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 4/41 (10%) 2/31 (7%) | |FIRST INCIDENCE | 730 (T) --- --- --- |--- --- 718 651 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.304N P=0.500N P=0.500N P=0.496N |P=0.021 * (e) P=0.037 * P=0.091 | |POLY 3 | P=0.305N P=0.503N P=0.498N P=0.498N |P=0.032 * (e) P=0.031 * P=0.108 | |POLY 1.5 | P=0.306N P=0.502N P=0.499N P=0.498N |P=0.035 * (e) P=0.031 * P=0.112 | |POLY 6 | P=0.305N P=0.504N P=0.498N P=0.497N |P=0.028 * (e) P=0.031 * P=0.103 | |LOGISTIC REGRESSION| P=0.304N (e) (e) (e) |P=0.034 * (e) P=0.034 * P=0.114 | |COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.044 * (e) P=0.028 * P=0.121 | |ORDER RESTRICTED | P=0.118N (e) (e) (e) |P=0.026 * (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 16 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |8/50 (16%) 9/50 (18%) 5/50 (10%) 10/50 (20%) | |POLY-3 RATE (b) | 2/48.07 0/47.23 2/48.41 3/48.63 |8/47.74 9/47.68 5/46.99 10/45.12 | |POLY-3 PERCENT (g) | 4.2% 0.0% 4.1% 6.2% |16.8% 18.9% 10.6% 22.2% | |TERMINAL (d) | 1/44 (2%) 0/44 (0%) 2/44 (5%) 2/45 (4%) |5/40 (13%) 6/42 (14%) 4/41 (10%) 5/31 (16%) | |FIRST INCIDENCE | 690 --- 730 (T) 700 |414 522 645 435 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.248 P=0.242N P=0.691 P=0.510 |P=0.241 P=0.531 P=0.269N P=0.260 | |POLY 3 | P=0.245 P=0.241N P=0.691N P=0.505 |P=0.352 P=0.499 P=0.286N P=0.347 | |POLY 1.5 | P=0.242 P=0.240N P=0.691N P=0.504 |P=0.367 P=0.497 P=0.286N P=0.364 | |POLY 6 | P=0.247 P=0.243N P=0.692N P=0.506 |P=0.335 P=0.504 P=0.285N P=0.328 | |LOGISTIC REGRESSION| P=0.239 P=0.236N P=0.694N P=0.495 |P=0.438 P=0.501 P=0.268N P=0.460 | |COCH-ARM / FISHERS | P=0.237 P=0.247N P=0.691N P=0.500 |P=0.397 P=0.500 P=0.277N P=0.398 | |ORDER RESTRICTED | P=0.224 (e) (e) (e) |P=0.311 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 27/50 (54%) 23/50 (46%) 30/50 (60%) 27/50 (54%) |15/50 (30%) 17/50 (34%) 19/50 (38%) 19/50 (38%) | |POLY-3 RATE (b) | 27/48.47 23/48.05 30/49.12 27/49.32 |15/46.60 17/47.86 19/46.78 19/46.69 | |POLY-3 PERCENT (g) | 55.7% 47.9% 61.1% 54.8% |32.2% 35.5% 40.6% 40.7% | |TERMINAL (d) | 24/44 (55%) 21/44 (48%) 27/44 (61%) 25/45 (56%) |14/40 (35%) 15/42 (36%) 18/41 (44%) 10/31 (32%) | |FIRST INCIDENCE | 652 606 585 568 |708 316 704 344 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.450 P=0.288N P=0.353 P=0.531N |P=0.050 P=0.475 P=0.285 P=0.097 | |POLY 3 | P=0.446 P=0.285N P=0.370 P=0.543N |P=0.214 P=0.451 P=0.264 P=0.261 | |POLY 1.5 | P=0.429 P=0.281N P=0.363 P=0.554N |P=0.218 P=0.439 P=0.259 P=0.262 | |POLY 6 | P=0.456 P=0.292N P=0.370 P=0.537N |P=0.207 P=0.462 P=0.270 P=0.257 | |LOGISTIC REGRESSION| P=0.430 P=0.296N P=0.365 P=0.558N |P=0.204 P=0.417 P=0.267 P=0.264 | |COCH-ARM / FISHERS | P=0.396 P=0.274N P=0.343 P=0.579N |P=0.226 P=0.415 P=0.263 P=0.263 | |ORDER RESTRICTED | P=0.429 (e) (e) (e) |P=0.314 (e) (e) (e) | |=================================================================================================================================| Date: 06/24/03 EXPERIMENT: 88138 TEST: 04 Page 17 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 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 | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 17/50 (34%) 10/50 (20%) 11/50 (22%) 13/50 (26%) |16/50 (32%) 13/50 (26%) 19/50 (38%) 21/50 (42%) | |POLY-3 RATE (b) | 17/50.00 10/49.09 11/48.78 13/49.47 |16/48.40 13/48.55 19/48.95 21/46.29 | |POLY-3 PERCENT (g) | 34.0% 20.4% 22.6% 26.3% |33.1% 26.8% 38.8% 45.4% | |TERMINAL (d) | 11/44 (25%) 6/44 (14%) 9/44 (21%) 9/45 (20%) |9/40 (23%) 8/42 (19%) 13/41 (32%) 10/31 (32%) | |FIRST INCIDENCE | 463 449 679 606 |414 522 204 435 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.310N P=0.113N P=0.152N P=0.258N |P=0.029 * P=0.313N P=0.375 P=0.091 | |POLY 3 | P=0.326N P=0.097N P=0.150N P=0.269N |P=0.064 P=0.326N P=0.352 P=0.154 | |POLY 1.5 | P=0.324N P=0.093N P=0.142N P=0.264N |P=0.072 P=0.331N P=0.348 P=0.169 | |POLY 6 | P=0.328N P=0.102N P=0.160N P=0.274N |P=0.057 P=0.319N P=0.354 P=0.143 | |LOGISTIC REGRESSION| P=0.393N P=0.045N* P=0.147N P=0.278N |P=0.125 P=0.330N P=0.336 P=0.226 | |COCH-ARM / FISHERS | P=0.321N P=0.088N P=0.133N P=0.257N |P=0.091 P=0.330N P=0.338 P=0.204 | |ORDER RESTRICTED | P=0.164N (e) (e) (e) |P=0.090 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 38/50 (76%) 30/50 (60%) 34/50 (68%) 35/50 (70%) |25/50 (50%) 28/50 (56%) 32/50 (64%) 30/50 (60%) | |POLY-3 RATE (b) | 38/50.00 30/49.52 34/49.30 35/50.00 |25/48.40 28/49.46 32/48.95 30/48.01 | |POLY-3 PERCENT (g) | 76.0% 60.6% 69.0% 70.0% |51.7% 56.6% 65.4% 62.5% | |TERMINAL (d) | 32/44 (73%) 25/44 (57%) 30/44 (68%) 30/45 (67%) |18/40 (45%) 22/42 (52%) 26/41 (63%) 16/31 (52%) | |FIRST INCIDENCE | 463 449 585 568 |414 316 204 344 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.413N P=0.109N P=0.285N P=0.305N |P=0.027 * P=0.433 P=0.173 P=0.063 | |POLY 3 | P=0.463N P=0.074N P=0.288N P=0.327N |P=0.145 P=0.387 P=0.119 P=0.191 | |POLY 1.5 | P=0.466N P=0.070N P=0.272N P=0.327N |P=0.153 P=0.371 P=0.117 P=0.196 | |POLY 6 | P=0.460N P=0.079N P=0.311N P=0.327N |P=0.141 P=0.402 P=0.119 P=0.191 | |LOGISTIC REGRESSION| P=0.499N P=0.056N P=0.260N (e) |P=0.210 P=0.340 P=0.113 P=0.237 | |COCH-ARM / FISHERS | P=0.470N P=0.066N P=0.252N P=0.326N |P=0.173 P=0.344 P=0.113 P=0.211 | |ORDER RESTRICTED | P=0.241N (e) (e) (e) |P=0.170 (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).