TDMS Study 93005-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: NCTR MALACHITE GREEN DATE: 06/18/03 EXPERIMENT: 93005 TEST: 03 TIME: 14:24:19 TEST TYPE: CHRONIC PAGE: 1 CONT: 224-93-00001 ROUTE: DOSED FEED NTP C#: C93005 PATHOLOGIST: MELLICK, PAUL CAS: 569-64-2 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: NCTR MALACHITE GREEN DATE: 06/18/03 EXPERIMENT: 93005 TEST: 03 TIME: 14:24:19 TEST TYPE: CHRONIC CONT: 224-93-00001 ROUTE: DOSED FEED NTP C#: C93005 PATHOLOGIST: MELLICK, PAUL CAS: 569-64-2 Rats(FISCHER 344) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED. --------------- Adrenal Cortex Adrenal Medulla Brain Clitoral/Preputial Gland Islets, Pancreatic Liver Lung Ovary Pituitary Gland Spleen Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: NCTR MALACHITE GREEN DATE: 06/18/03 EXPERIMENT: 93005 TEST: 03 TIME: 14:24:19 TEST TYPE: CHRONIC CONT: 224-93-00001 ROUTE: DOSED FEED NTP C#: C93005 PATHOLOGIST: MELLICK, PAUL CAS: 569-64-2 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF MALACHITE GREEN =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Skin Sarcoma Uterus Polyp Stromal Sarcoma Stromal or Polyp Stromal All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant and Benign Tumors =============================================================== Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/48 (4%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | |POLY-3 RATE (b) | 2/40.06 0/38.24 0/43.37 0/37.18 | |POLY-3 PERCENT (g) | 5.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/29 (7%) 0/23 (0%) 0/32 (0%) 0/25 (0%) | |FIRST INCIDENCE | 728 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.138N P=0.290N P=0.216N P=0.271N | |POLY 3 | P=0.125N P=0.247N P=0.220N P=0.254N | |POLY 1.5 | P=0.130N P=0.242N P=0.226N P=0.249N | |POLY 6 | P=0.118N P=0.255N P=0.213N P=0.259N | |LOGISTIC REGRESSION| P=0.138N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.139N P=0.247N P=0.247N P=0.247N | |ORDER RESTRICTED | P=0.035N* (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/48 (15%) 5/48 (10%) 8/47 (17%) 8/47 (17%) | |POLY-3 RATE (b) | 7/40.76 5/38.26 8/42.57 8/37.97 | |POLY-3 PERCENT (g) | 17.2% 13.1% 18.8% 21.1% | |TERMINAL (d) | 5/29 (17%) 4/23 (17%) 6/31 (19%) 4/25 (16%) | |FIRST INCIDENCE | 533 722 692 570 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.275 P=0.527N P=0.561 P=0.394 | |POLY 3 | P=0.282 P=0.423N P=0.537 P=0.439 | |POLY 1.5 | P=0.276 P=0.402N P=0.516 P=0.447 | |POLY 6 | P=0.297 P=0.455N P=0.558 P=0.438 | |LOGISTIC REGRESSION| P=0.261 P=0.437N P=0.562 P=0.440 | |COCH-ARM / FISHERS | P=0.293 P=0.379N P=0.482 P=0.482 | |ORDER RESTRICTED | P=0.394 (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 5/48 (10%) 2/48 (4%) 6/47 (13%) 5/47 (11%) | |POLY-3 RATE (b) | 5/41.66 2/38.24 6/43.74 5/38.71 | |POLY-3 PERCENT (g) | 12.0% 5.2% 13.7% 12.9% | |TERMINAL (d) | 3/29 (10%) 2/23 (9%) 4/31 (13%) 1/25 (4%) | |FIRST INCIDENCE | 401 728 (T) 484 323 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.324 P=0.288N P=0.534 P=0.560 | |POLY 3 | P=0.337 P=0.251N P=0.534 P=0.584 | |POLY 1.5 | P=0.330 P=0.236N P=0.514 P=0.591 | |POLY 6 | P=0.349 P=0.271N P=0.556 P=0.579 | |LOGISTIC REGRESSION| P=0.439 P=0.201N P=0.287 P=0.513N | |COCH-ARM / FISHERS | P=0.337 P=0.218N P=0.485 P=0.616 | |ORDER RESTRICTED | P=0.408 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 12/48 (25%) 7/48 (15%) 14/47 (30%) 12/47 (26%) | |POLY-3 RATE (b) | 12/42.37 7/38.26 14/43.93 12/39.78 | |POLY-3 PERCENT (g) | 28.3% 18.3% 31.9% 30.2% | |TERMINAL (d) | 8/29 (28%) 6/23 (26%) 10/31 (32%) 5/25 (20%) | |FIRST INCIDENCE | 401 722 484 323 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.259 P=0.285N P=0.485 P=0.460 | |POLY 3 | P=0.287 P=0.211N P=0.451 P=0.524 | |POLY 1.5 | P=0.270 P=0.184N P=0.424 P=0.530 | |POLY 6 | P=0.317 P=0.250N P=0.481 P=0.526 | |LOGISTIC REGRESSION| P=0.274 P=0.165N P=0.325 P=0.576N | |COCH-ARM / FISHERS | P=0.277 P=0.153N P=0.385 P=0.570 | |ORDER RESTRICTED | P=0.352 (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 2/48 (4%) 1/48 (2%) 1/48 (2%) | |POLY-3 RATE (b) | 0/40.06 2/38.24 1/43.37 1/37.18 | |POLY-3 PERCENT (g) | 0.0% 5.2% 2.3% 2.7% | |TERMINAL (d) | 0/29 (0%) 2/23 (9%) 1/32 (3%) 1/25 (4%) | |FIRST INCIDENCE | --- 728 (T) 728 (T) 728 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.534 P=0.188 P=0.520 P=0.470 | |POLY 3 | P=0.515 P=0.226 P=0.516 P=0.485 | |POLY 1.5 | P=0.522 P=0.232 P=0.510 P=0.489 | |POLY 6 | P=0.505 P=0.218 P=0.522 P=0.480 | |LOGISTIC REGRESSION| (e) P=0.188 P=0.520 P=0.470 | |COCH-ARM / FISHERS | P=0.544 P=0.247 P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.281 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 2/48 (4%) 1/48 (2%) 1/48 (2%) | |POLY-3 RATE (b) | 0/40.06 2/38.24 1/43.37 1/37.18 | |POLY-3 PERCENT (g) | 0.0% 5.2% 2.3% 2.7% | |TERMINAL (d) | 0/29 (0%) 2/23 (9%) 1/32 (3%) 1/25 (4%) | |FIRST INCIDENCE | --- 728 (T) 728 (T) 728 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.534 P=0.188 P=0.520 P=0.470 | |POLY 3 | P=0.515 P=0.226 P=0.516 P=0.485 | |POLY 1.5 | P=0.522 P=0.232 P=0.510 P=0.489 | |POLY 6 | P=0.505 P=0.218 P=0.522 P=0.480 | |LOGISTIC REGRESSION| (e) P=0.188 P=0.520 P=0.470 | |COCH-ARM / FISHERS | P=0.544 P=0.247 P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.281 (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/48 (2%) 1/48 (2%) 3/48 (6%) 4/48 (8%) | |POLY-3 RATE (b) | 1/40.06 1/38.24 3/43.66 4/37.18 | |POLY-3 PERCENT (g) | 2.5% 2.6% 6.9% 10.8% | |TERMINAL (d) | 1/29 (3%) 1/23 (4%) 2/32 (6%) 4/25 (16%) | |FIRST INCIDENCE | 728 (T) 728 (T) 652 728 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.058 P=0.710 P=0.355 P=0.134 | |POLY 3 | P=0.059 P=0.751 P=0.336 P=0.155 | |POLY 1.5 | P=0.061 P=0.755 P=0.324 P=0.162 | |POLY 6 | P=0.058 P=0.743 P=0.350 P=0.147 | |LOGISTIC REGRESSION| P=0.053 P=0.710 P=0.337 P=0.134 | |COCH-ARM / FISHERS | P=0.068 P=0.753N P=0.308 P=0.181 | |ORDER RESTRICTED | P=0.093 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/48 (2%) 1/48 (2%) 3/48 (6%) 4/48 (8%) | |POLY-3 RATE (b) | 1/40.06 1/38.24 3/43.66 4/37.18 | |POLY-3 PERCENT (g) | 2.5% 2.6% 6.9% 10.8% | |TERMINAL (d) | 1/29 (3%) 1/23 (4%) 2/32 (6%) 4/25 (16%) | |FIRST INCIDENCE | 728 (T) 728 (T) 652 728 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.058 P=0.710 P=0.355 P=0.134 | |POLY 3 | P=0.059 P=0.751 P=0.336 P=0.155 | |POLY 1.5 | P=0.061 P=0.755 P=0.324 P=0.162 | |POLY 6 | P=0.058 P=0.743 P=0.350 P=0.147 | |LOGISTIC REGRESSION| P=0.053 P=0.710 P=0.337 P=0.134 | |COCH-ARM / FISHERS | P=0.068 P=0.753N P=0.308 P=0.181 | |ORDER RESTRICTED | P=0.093 (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/48 (2%) 1/48 (2%) 3/48 (6%) 4/48 (8%) | |POLY-3 RATE (b) | 1/40.06 1/38.24 3/43.66 4/37.18 | |POLY-3 PERCENT (g) | 2.5% 2.6% 6.9% 10.8% | |TERMINAL (d) | 1/29 (3%) 1/23 (4%) 2/32 (6%) 4/25 (16%) | |FIRST INCIDENCE | 728 (T) 728 (T) 652 728 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.058 P=0.710 P=0.355 P=0.134 | |POLY 3 | P=0.059 P=0.751 P=0.336 P=0.155 | |POLY 1.5 | P=0.061 P=0.755 P=0.324 P=0.162 | |POLY 6 | P=0.058 P=0.743 P=0.350 P=0.147 | |LOGISTIC REGRESSION| P=0.053 P=0.710 P=0.337 P=0.134 | |COCH-ARM / FISHERS | P=0.068 P=0.753N P=0.308 P=0.181 | |ORDER RESTRICTED | P=0.093 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 2/48 (4%) 2/48 (4%) 1/48 (2%) 5/48 (10%) | |POLY-3 RATE (b) | 2/40.15 2/38.40 1/43.37 5/38.50 | |POLY-3 PERCENT (g) | 5.0% 5.2% 2.3% 13.0% | |TERMINAL (d) | 1/29 (3%) 1/23 (4%) 1/32 (3%) 2/25 (8%) | |FIRST INCIDENCE | 704 686 728 (T) 508 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.100 P=0.632 P=0.470N P=0.174 | |POLY 3 | P=0.113 P=0.679 P=0.473N P=0.197 | |POLY 1.5 | P=0.112 P=0.686 P=0.483N P=0.201 | |POLY 6 | P=0.116 P=0.667 P=0.463N P=0.194 | |LOGISTIC REGRESSION| P=0.108 P=0.664 P=0.457N P=0.211 | |COCH-ARM / FISHERS | P=0.114 P=0.692N P=0.500N P=0.218 | |ORDER RESTRICTED | P=0.079 (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 15/48 (31%) 13/48 (27%) 12/48 (25%) 9/48 (19%) | |POLY-3 RATE (b) | 15/42.20 13/40.47 12/44.52 9/38.15 | |POLY-3 PERCENT (g) | 35.5% 32.1% 27.0% 23.6% | |TERMINAL (d) | 11/29 (38%) 7/23 (30%) 7/32 (22%) 5/25 (20%) | |FIRST INCIDENCE | 401 494 626 620 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.132N P=0.551 P=0.239N P=0.225N | |POLY 3 | P=0.127N P=0.461N P=0.263N P=0.175N | |POLY 1.5 | P=0.122N P=0.439N P=0.289N P=0.158N | |POLY 6 | P=0.126N P=0.492N P=0.230N P=0.190N | |LOGISTIC REGRESSION| P=0.109N P=0.422N P=0.317N P=0.149N | |COCH-ARM / FISHERS | P=0.097N P=0.411N P=0.325N P=0.119N | |ORDER RESTRICTED | P=0.191N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 16/48 (33%) 14/48 (29%) 12/48 (25%) 14/48 (29%) | |POLY-3 RATE (b) | 16/42.20 14/40.63 12/44.52 14/39.47 | |POLY-3 PERCENT (g) | 37.9% 34.5% 27.0% 35.5% | |TERMINAL (d) | 12/29 (41%) 7/23 (30%) 7/32 (22%) 7/25 (28%) | |FIRST INCIDENCE | 401 494 626 508 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.441N P=0.538 P=0.178N P=0.582 | |POLY 3 | P=0.415N P=0.460N P=0.193N P=0.500N | |POLY 1.5 | P=0.417N P=0.440N P=0.217N P=0.482N | |POLY 6 | P=0.399N P=0.487N P=0.164N P=0.507N | |LOGISTIC REGRESSION| P=0.407N P=0.429N P=0.236N P=0.467N | |COCH-ARM / FISHERS | P=0.378N P=0.413N P=0.250N P=0.413N | |ORDER RESTRICTED | P=0.401N (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 26/48 (54%) 36/47 (77%) 32/46 (70%) 29/45 (64%) | |POLY-3 RATE (b) | 26/42.81 36/43.56 32/44.71 29/38.05 | |POLY-3 PERCENT (g) | 60.7% 82.7% 71.6% 76.2% | |TERMINAL (d) | 16/29 (55%) 21/23 (91%) 22/32 (69%) 21/25 (84%) | |FIRST INCIDENCE | 552 485 603 570 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.469 P=0.008 ** P=0.383 P=0.140 | |POLY 3 | P=0.233 P=0.014 * P=0.193 P=0.092 | |POLY 1.5 | P=0.267 P=0.016 * P=0.146 P=0.121 | |POLY 6 | P=0.205 P=0.011 * P=0.252 P=0.067 | |LOGISTIC REGRESSION| P=0.335 P=0.012 * P=0.187 P=0.116 | |COCH-ARM / FISHERS | P=0.403 P=0.018 * P=0.093 P=0.213 | |ORDER RESTRICTED | P=0.069 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 26/48 (54%) 36/47 (77%) 32/46 (70%) 30/45 (67%) | |POLY-3 RATE (b) | 26/42.81 36/43.56 32/44.71 30/38.22 | |POLY-3 PERCENT (g) | 60.7% 82.7% 71.6% 78.5% | |TERMINAL (d) | 16/29 (55%) 21/23 (91%) 22/32 (69%) 21/25 (84%) | |FIRST INCIDENCE | 552 485 603 570 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.393 P=0.008 ** P=0.383 P=0.105 | |POLY 3 | P=0.162 P=0.014 * P=0.193 P=0.056 | |POLY 1.5 | P=0.190 P=0.016 * P=0.146 P=0.077 | |POLY 6 | P=0.145 P=0.011 * P=0.252 P=0.041 * | |LOGISTIC REGRESSION| P=0.246 P=0.012 * P=0.187 P=0.074 | |COCH-ARM / FISHERS | P=0.313 P=0.018 * P=0.093 P=0.154 | |ORDER RESTRICTED | P=0.043 * (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor | | (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 1/48 (2%) 0/48 (0%) 2/48 (4%) 0/48 (0%) | |POLY-3 RATE (b) | 1/40.06 0/38.24 2/43.37 0/37.18 | |POLY-3 PERCENT (g) | 2.5% 0.0% 4.6% 0.0% | |TERMINAL (d) | 1/29 (3%) 0/23 (0%) 2/32 (6%) 0/25 (0%) | |FIRST INCIDENCE | 728 (T) --- 728 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.510N P=0.546N P=0.535 P=0.530N | |POLY 3 | P=0.515N P=0.509N P=0.528 P=0.515N | |POLY 1.5 | P=0.513N P=0.505N P=0.517 P=0.511N | |POLY 6 | P=0.516N P=0.516N P=0.539 P=0.520N | |LOGISTIC REGRESSION| P=0.510N (e) P=0.535 (e) | |COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.500 P=0.500N | |ORDER RESTRICTED | P=0.339N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/48 (0%) 1/48 (2%) 0/48 (0%) 2/48 (4%) | |POLY-3 RATE (b) | 0/40.06 1/38.24 0/43.37 2/37.80 | |POLY-3 PERCENT (g) | 0.0% 2.6% 0.0% 5.3% | |TERMINAL (d) | 0/29 (0%) 1/23 (4%) 0/32 (0%) 0/25 (0%) | |FIRST INCIDENCE | --- 728 (T) --- 633 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.148 P=0.454 (e) P=0.223 | |POLY 3 | P=0.151 P=0.491 (e) P=0.224 | |POLY 1.5 | P=0.151 P=0.495 (e) P=0.227 | |POLY 6 | P=0.151 P=0.484 (e) P=0.221 | |LOGISTIC REGRESSION| P=0.154 P=0.454 (e) P=0.245 | |COCH-ARM / FISHERS | P=0.155 P=0.500 (e) P=0.247 | |ORDER RESTRICTED | P=0.066 (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Skin | | Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/48 (0%) 2/48 (4%) | |POLY-3 RATE (b) | 0/40.06 0/38.24 0/43.37 2/37.80 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.3% | |TERMINAL (d) | 0/29 (0%) 0/23 (0%) 0/32 (0%) 0/25 (0%) | |FIRST INCIDENCE | --- --- --- 633 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.040 * (e) (e) P=0.223 | |POLY 3 | P=0.043 * (e) (e) P=0.224 | |POLY 1.5 | P=0.042 * (e) (e) P=0.227 | |POLY 6 | P=0.043 * (e) (e) P=0.221 | |LOGISTIC REGRESSION| P=0.050 (e) (e) P=0.245 | |COCH-ARM / FISHERS | P=0.044 * (e) (e) P=0.247 | |ORDER RESTRICTED | P=0.025 * (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 2/48 (4%) 0/48 (0%) | |POLY-3 RATE (b) | 0/40.06 0/38.24 2/43.37 0/37.18 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.6% 0.0% | |TERMINAL (d) | 0/29 (0%) 0/23 (0%) 2/32 (6%) 0/25 (0%) | |FIRST INCIDENCE | --- --- 728 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.555 (e) P=0.260 (e) | |POLY 3 | P=0.516 (e) P=0.255 (e) | |POLY 1.5 | P=0.528 (e) P=0.248 (e) | |POLY 6 | P=0.502 (e) P=0.262 (e) | |LOGISTIC REGRESSION| (e) (e) P=0.260 (e) | |COCH-ARM / FISHERS | P=0.562 (e) P=0.247 (e) | |ORDER RESTRICTED | P=0.264 (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 2/48 (4%) 0/48 (0%) | |POLY-3 RATE (b) | 0/40.06 0/38.24 2/43.37 0/37.18 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.6% 0.0% | |TERMINAL (d) | 0/29 (0%) 0/23 (0%) 2/32 (6%) 0/25 (0%) | |FIRST INCIDENCE | --- --- 728 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.555 (e) P=0.260 (e) | |POLY 3 | P=0.516 (e) P=0.255 (e) | |POLY 1.5 | P=0.528 (e) P=0.248 (e) | |POLY 6 | P=0.502 (e) P=0.262 (e) | |LOGISTIC REGRESSION| (e) (e) P=0.260 (e) | |COCH-ARM / FISHERS | P=0.562 (e) P=0.247 (e) | |ORDER RESTRICTED | P=0.264 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/46 (9%) 5/48 (10%) 3/47 (6%) 3/46 (7%) | |POLY-3 RATE (b) | 4/38.45 5/38.83 3/42.41 3/35.34 | |POLY-3 PERCENT (g) | 10.4% 12.9% 7.1% 8.5% | |TERMINAL (d) | 3/29 (10%) 4/23 (17%) 2/31 (7%) 3/24 (13%) | |FIRST INCIDENCE | 711 539 719 728 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.359N P=0.380 P=0.460N P=0.605N | |POLY 3 | P=0.348N P=0.506 P=0.446N P=0.546N | |POLY 1.5 | P=0.345N P=0.517 P=0.462N P=0.532N | |POLY 6 | P=0.350N P=0.487 P=0.432N P=0.564N | |LOGISTIC REGRESSION| P=0.355N P=0.481 P=0.434N P=0.601N | |COCH-ARM / FISHERS | P=0.327N P=0.527 P=0.488N P=0.500N | |ORDER RESTRICTED | P=0.458N (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/46 (7%) 1/48 (2%) 2/47 (4%) 1/46 (2%) | |POLY-3 RATE (b) | 3/38.68 1/38.83 2/42.41 1/35.34 | |POLY-3 PERCENT (g) | 7.8% 2.6% 4.7% 2.8% | |TERMINAL (d) | 2/29 (7%) 0/23 (0%) 1/31 (3%) 1/24 (4%) | |FIRST INCIDENCE | 647 540 719 728 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.326N P=0.355N P=0.454N P=0.366N | |POLY 3 | P=0.323N P=0.303N P=0.458N P=0.337N | |POLY 1.5 | P=0.322N P=0.296N P=0.470N P=0.327N | |POLY 6 | P=0.322N P=0.315N P=0.448N P=0.351N | |LOGISTIC REGRESSION| P=0.321N P=0.285N P=0.449N P=0.343N | |COCH-ARM / FISHERS | P=0.312N P=0.292N P=0.490N P=0.308N | |ORDER RESTRICTED | P=0.255N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/46 (15%) 6/48 (13%) 4/47 (9%) 4/46 (9%) | |POLY-3 RATE (b) | 7/38.75 6/39.42 4/42.41 4/35.34 | |POLY-3 PERCENT (g) | 18.1% 15.2% 9.4% 11.3% | |TERMINAL (d) | 5/29 (17%) 4/23 (17%) 3/31 (10%) 4/24 (17%) | |FIRST INCIDENCE | 647 539 719 728 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.213N P=0.601 P=0.218N P=0.373N | |POLY 3 | P=0.207N P=0.486N P=0.209N P=0.313N | |POLY 1.5 | P=0.205N P=0.475N P=0.223N P=0.296N | |POLY 6 | P=0.210N P=0.509N P=0.198N P=0.337N | |LOGISTIC REGRESSION| P=0.207N P=0.496N P=0.188N P=0.343N | |COCH-ARM / FISHERS | P=0.188N P=0.467N P=0.249N P=0.261N | |ORDER RESTRICTED | P=0.271N (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/46 (0%) 0/48 (0%) 2/47 (4%) 1/46 (2%) | |POLY-3 RATE (b) | 0/38.38 0/38.24 2/42.37 1/35.34 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 2.8% | |TERMINAL (d) | 0/29 (0%) 0/23 (0%) 2/31 (7%) 1/24 (4%) | |FIRST INCIDENCE | --- --- 728 (T) 728 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.201 (e) P=0.253 P=0.462 | |POLY 3 | P=0.191 (e) P=0.259 P=0.484 | |POLY 1.5 | P=0.198 (e) P=0.253 P=0.488 | |POLY 6 | P=0.184 (e) P=0.266 P=0.477 | |LOGISTIC REGRESSION| (e) (e) P=0.253 P=0.462 | |COCH-ARM / FISHERS | P=0.219 (e) P=0.253 P=0.500 | |ORDER RESTRICTED | P=0.188 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/46 (0%) 0/48 (0%) 3/47 (6%) 2/46 (4%) | |POLY-3 RATE (b) | 0/38.38 0/38.24 3/42.37 2/35.34 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.1% 5.7% | |TERMINAL (d) | 0/29 (0%) 0/23 (0%) 3/31 (10%) 2/24 (8%) | |FIRST INCIDENCE | --- --- 728 (T) 728 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.067 (e) P=0.132 P=0.197 | |POLY 3 | P=0.064 (e) P=0.137 P=0.218 | |POLY 1.5 | P=0.068 (e) P=0.131 P=0.224 | |POLY 6 | P=0.061 (e) P=0.142 P=0.212 | |LOGISTIC REGRESSION| (e) (e) P=0.132 P=0.197 | |COCH-ARM / FISHERS | P=0.080 (e) P=0.125 P=0.247 | |ORDER RESTRICTED | P=0.095 (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 14/48 (29%) 7/48 (15%) 5/48 (10%) 16/48 (33%) | |POLY-3 RATE (b) | 14/41.62 7/39.90 5/44.06 16/39.03 | |POLY-3 PERCENT (g) | 33.6% 17.5% 11.4% 41.0% | |TERMINAL (d) | 10/29 (35%) 3/23 (13%) 3/32 (9%) 11/25 (44%) | |FIRST INCIDENCE | 529 596 603 508 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.169 P=0.165N P=0.013N* P=0.263 | |POLY 3 | P=0.172 P=0.076N P=0.011N* P=0.323 | |POLY 1.5 | P=0.171 P=0.072N P=0.013N* P=0.347 | |POLY 6 | P=0.174 P=0.083N P=0.009N** P=0.299 | |LOGISTIC REGRESSION| P=0.167 P=0.075N P=0.017N* P=0.326 | |COCH-ARM / FISHERS | P=0.190 P=0.069N P=0.019N* P=0.413 | |ORDER RESTRICTED | P=0.021 * (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 2/48 (4%) 1/48 (2%) 1/48 (2%) 0/48 (0%) | |POLY-3 RATE (b) | 2/40.53 1/38.24 1/43.37 0/37.18 | |POLY-3 PERCENT (g) | 4.9% 2.6% 2.3% 0.0% | |TERMINAL (d) | 1/29 (3%) 1/23 (4%) 1/32 (3%) 0/25 (0%) | |FIRST INCIDENCE | 589 728 (T) 728 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.163N P=0.559N P=0.464N P=0.265N | |POLY 3 | P=0.163N P=0.520N P=0.476N P=0.256N | |POLY 1.5 | P=0.164N P=0.511N P=0.485N P=0.250N | |POLY 6 | P=0.162N P=0.535N P=0.468N P=0.264N | |LOGISTIC REGRESSION| P=0.163N P=0.507N P=0.510N P=0.234N | |COCH-ARM / FISHERS | P=0.161N P=0.500N P=0.500N P=0.247N | |ORDER RESTRICTED | P=0.134N (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 16/48 (33%) 8/48 (17%) 6/48 (13%) 16/48 (33%) | |POLY-3 RATE (b) | 16/42.09 8/39.90 6/44.06 16/39.03 | |POLY-3 PERCENT (g) | 38.0% 20.1% 13.6% 41.0% | |TERMINAL (d) | 11/29 (38%) 4/23 (17%) 4/32 (13%) 11/25 (44%) | |FIRST INCIDENCE | 529 596 603 508 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.308 P=0.137N P=0.009N** P=0.411 | |POLY 3 | P=0.319 P=0.057N P=0.007N** P=0.481 | |POLY 1.5 | P=0.319 P=0.052N P=0.009N** P=0.512 | |POLY 6 | P=0.322 P=0.066N P=0.006N** P=0.446 | |LOGISTIC REGRESSION| P=0.309 P=0.054N P=0.012N* P=0.500 | |COCH-ARM / FISHERS | P=0.342 P=0.049N* P=0.014N* P=0.586N | |ORDER RESTRICTED | P=0.055 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 1/48 (2%) 0/48 (0%) 1/48 (2%) 2/48 (4%) | |POLY-3 RATE (b) | 1/40.40 0/38.24 1/43.66 2/38.24 | |POLY-3 PERCENT (g) | 2.5% 0.0% 2.3% 5.2% | |TERMINAL (d) | 0/29 (0%) 0/23 (0%) 0/32 (0%) 0/25 (0%) | |FIRST INCIDENCE | 631 --- 652 562 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.217 P=0.529N P=0.719N P=0.484 | |POLY 3 | P=0.218 P=0.511N P=0.743N P=0.481 | |POLY 1.5 | P=0.216 P=0.506N P=0.750N P=0.485 | |POLY 6 | P=0.222 P=0.519N P=0.736N P=0.476 | |LOGISTIC REGRESSION| P=0.288 P=0.492N P=0.718 P=0.576 | |COCH-ARM / FISHERS | P=0.220 P=0.500N P=0.753N P=0.500 | |ORDER RESTRICTED | P=0.210 (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 19/48 (40%) 17/48 (35%) 10/48 (21%) 1/48 (2%) | |POLY-3 RATE (b) | 19/43.47 17/42.53 10/44.53 1/37.76 | |POLY-3 PERCENT (g) | 43.7% 40.0% 22.5% 2.7% | |TERMINAL (d) | 9/29 (31%) 4/23 (17%) 4/32 (13%) 0/25 (0%) | |FIRST INCIDENCE | 526 443 619 546 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.533 P=0.030N* P<0.001N** | |POLY 3 | P<0.001N** P=0.447N P=0.026N* P<0.001N** | |POLY 1.5 | P<0.001N** P=0.431N P=0.029N* P<0.001N** | |POLY 6 | P<0.001N** P=0.470N P=0.025N* P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.402N P=0.042N* P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.417N P=0.037N* P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 41/48 (85%) 42/48 (88%) 40/48 (83%) 35/48 (73%) | |POLY-3 RATE (b) | 41/45.78 42/45.17 40/46.30 35/41.98 | |POLY-3 PERCENT (g) | 89.6% 93.0% 86.4% 83.4% | |TERMINAL (d) | 26/29 (90%) 23/23 (100%) 28/32 (88%) 21/25 (84%) | |FIRST INCIDENCE | 401 485 603 508 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.195N P=0.120 P=0.226N P=0.500N | |POLY 3 | P=0.114N P=0.407 P=0.439N P=0.279N | |POLY 1.5 | P=0.091N P=0.455 P=0.464N P=0.215N | |POLY 6 | P=0.127N P=0.331 P=0.411N P=0.342N | |LOGISTIC REGRESSION| P=0.075N P=0.441 P=0.312N P=0.205N | |COCH-ARM / FISHERS | P=0.038N* P=0.500 P=0.500N P=0.104N | |ORDER RESTRICTED | P=0.166N (e) (e) (e) | |=================================================================================================================================| Date: 06/18/03 EXPERIMENT: 93005 TEST: 03 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - MALACHITE GREEN Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 29/48 (60%) 24/48 (50%) 21/48 (44%) 23/48 (48%) | |POLY-3 RATE (b) | 29/46.60 24/43.53 21/46.18 23/43.75 | |POLY-3 PERCENT (g) | 62.2% 55.1% 45.5% 52.6% | |TERMINAL (d) | 13/29 (45%) 9/23 (39%) 12/32 (38%) 9/25 (36%) | |FIRST INCIDENCE | 401 443 484 323 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.265N P=0.487N P=0.065N P=0.378N | |POLY 3 | P=0.186N P=0.317N P=0.076N P=0.235N | |POLY 1.5 | P=0.183N P=0.268N P=0.074N P=0.211N | |POLY 6 | P=0.191N P=0.378N P=0.082N P=0.262N | |LOGISTIC REGRESSION| P=0.121N P=0.173N P=0.147N P=0.109N | |COCH-ARM / FISHERS | P=0.157N P=0.206N P=0.076N P=0.153N | |ORDER RESTRICTED | P=0.152N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 100 PPM 300 PPM 600 PPM | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 47/48 (98%) 48/48 (100%) 46/48 (96%) 42/48 (88%) | |POLY-3 RATE (b) | 47/48.00 48/48.00 46/48.00 42/44.74 | |POLY-3 PERCENT (g) | 97.9% 100.0% 95.8% 93.9% | |TERMINAL (d) | 28/29 (97%) 23/23 (100%) 30/32 (94%) 24/25 (96%) | |FIRST INCIDENCE | 401 443 484 323 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.282N P=0.129 P=0.216N P=0.526 | |POLY 3 | P=0.084N P=0.500 P=0.500N P=0.306N | |POLY 1.5 | P=0.034N* P=0.500 P=0.500N P=0.187N | |POLY 6 | P=0.172N P=0.500 P=0.500N P=0.463N | |LOGISTIC REGRESSION| P=0.013N* (e) (e) P=0.123N | |COCH-ARM / FISHERS | P=0.004N** P=0.500 P=0.500N P=0.056N | |ORDER RESTRICTED | P=0.100N (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).