TDMS Study 89009-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Southern Research Inst PESTICIDE/FERTILIZER CONTAMINATION--MIXTURE 2 DATE: 10/18/04 EXPERIMENT: 89009 TEST: 01 TIME: 10:01:51 TEST TYPE: SUBCHRON 26-WEEK PAGE: 1 CONT: NO1-ES-95275 ROUTE: DOSED WATER NTP C#: C89009 PATHOLOGIST: DR. D. FARNELL CAS: PESTFERTMIX2 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Southern Research Inst PESTICIDE/FERTILIZER CONTAMINATION--MIXTURE 2 DATE: 10/18/04 EXPERIMENT: 89009 TEST: 01 TIME: 10:01:51 TEST TYPE: SUBCHRON 26-WEEK CONT: NO1-ES-95275 ROUTE: DOSED WATER NTP C#: C89009 PATHOLOGIST: DR. D. FARNELL CAS: PESTFERTMIX2 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF PESTICIDE/FERTILIZER CONTAMINATION--M =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Heart: Artery Inflammation Chronic Pancreas Atrophy Focal =============================================================== Date: 10/18/04 EXPERIMENT: 89009 TEST: 01 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Heart: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) 2/20 (10%) | |POLY-3 RATE (b) | 0/11.27 0/11.27 0/11.27 0/11.27 2/11.27 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 17.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) | |FIRST INCIDENCE | --- --- --- --- 183 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.022 * (e) (e) (e) P=0.234 | |POLY 3 | P=0.019 * (e) (e) (e) P=0.228 | |POLY 1.5 | P=0.019 * (e) (e) (e) P=0.229 | |POLY 6 | P=0.019 * (e) (e) (e) P=0.227 | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.228 | |COCH-ARM / FISHERS | P=0.022 * (e) (e) (e) P=0.244 | |ORDER RESTRICTED | P=0.014 * (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Heart: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) | |POLY-3 RATE (b) | 0/11.27 0/11.27 0/11.27 0/11.27 0/11.27 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/18/04 EXPERIMENT: 89009 TEST: 01 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/20 (5%) 4/20 (20%) 1/20 (5%) 2/20 (10%) 2/20 (10%) | |POLY-3 RATE (b) | 1/12.14 4/13.02 1/12.14 2/13.02 2/11.27 | |POLY-3 PERCENT (g) | 8.2% 30.7% 8.2% 15.4% 17.8% | |INT SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 1/10 (10%) 2/10 (20%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) 2/10 (20%) | |FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) 92 (I) 183 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.646N P=0.175 P=0.766 P=0.500 P=0.500 | |POLY 3 | P=0.613 P=0.179 P=0.765 P=0.525 P=0.473 | |POLY 1.5 | P=0.629 P=0.173 P=0.764 P=0.516 P=0.483 | |POLY 6 | P=0.603 P=0.183 P=0.765 P=0.531 P=0.466 | |LOGISTIC REGRESSION| P=0.647N P=0.169 (e) P=0.500 P=0.500 | |COCH-ARM / FISHERS | P=0.647N P=0.171 P=0.756N P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.457 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/20 (5%) 0/20 (0%) 0/19 (0%) 2/20 (10%) 3/20 (15%) | |POLY-3 RATE (b) | 1/12.14 0/11.27 0/11.14 2/12.14 3/13.02 | |POLY-3 PERCENT (g) | 8.2% 0.0% 0.0% 16.5% 23.1% | |INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 2/10 (20%) | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | |FIRST INCIDENCE | 92 (I) --- --- 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.068 P=0.500N P=0.521N P=0.500 P=0.301 | |POLY 3 | P=0.078 P=0.515N P=0.517N P=0.500 P=0.320 | |POLY 1.5 | P=0.072 P=0.509N P=0.515N P=0.500 P=0.312 | |POLY 6 | P=0.083 P=0.519N P=0.519N P=0.500 P=0.326 | |LOGISTIC REGRESSION| P=0.066 (e) (e) P=0.500 P=0.296 | |COCH-ARM / FISHERS | P=0.066 P=0.500N P=0.513N P=0.500 P=0.302 | |ORDER RESTRICTED | P=0.061 (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/18/04 EXPERIMENT: 89009 TEST: 01 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/20 (10%) 1/20 (5%) 0/20 (0%) 1/20 (5%) 2/20 (10%) | |POLY-3 RATE (b) | 2/11.27 1/12.14 0/11.27 1/12.14 2/12.14 | |POLY-3 PERCENT (g) | 17.8% 8.2% 0.0% 8.2% 16.5% | |INT SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |FIRST INCIDENCE | 183 (T) 92 (I) --- 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.367 P=0.500N P=0.234N P=0.500N P=0.699 | |POLY 3 | P=0.381 P=0.473N P=0.228N P=0.473N P=0.677N | |POLY 1.5 | P=0.375 P=0.483N P=0.229N P=0.483N P=0.686N | |POLY 6 | P=0.384 P=0.466N P=0.227N P=0.466N P=0.670N | |LOGISTIC REGRESSION| P=0.366 P=0.500N P=0.228N P=0.500N P=0.704N | |COCH-ARM / FISHERS | P=0.366 P=0.500N P=0.244N P=0.500N P=0.698N | |ORDER RESTRICTED | P=0.401N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/20 (5%) 0/20 (0%) 1/20 (5%) 1/20 (5%) 0/20 (0%) | |POLY-3 RATE (b) | 1/11.27 0/11.27 1/11.27 1/12.14 0/11.27 | |POLY-3 PERCENT (g) | 8.9% 0.0% 8.9% 8.2% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | 183 (T) --- 183 (T) 92 (I) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.437N P=0.500N P=0.766 P=0.760 P=0.500N | |POLY 3 | P=0.441N P=0.500N P=0.766 P=0.748N P=0.500N | |POLY 1.5 | P=0.439N P=0.500N P=0.765 P=0.754N P=0.500N | |POLY 6 | P=0.442N P=0.500N P=0.766 P=0.744N P=0.500N | |LOGISTIC REGRESSION| P=0.436N (e) P=0.772N P=0.766N (e) | |COCH-ARM / FISHERS | P=0.436N P=0.500N P=0.756N P=0.756N P=0.500N | |ORDER RESTRICTED | P=0.306N (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/18/04 EXPERIMENT: 89009 TEST: 01 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/1 (100%) 0/0 (0%) 1/1 (100%) 0/0 (0%) 1/2 (50%) | |POLY-3 RATE (b) | 1/1.00 0/0.00 1/1.00 0/0.00 1/2.00 | |POLY-3 PERCENT (g) | 100.0% 0.0% 100.0% 0.0% 50.0% | |INT SACRIFICE 1 (c)| 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) 1/2 (50%) | |FIRST INCIDENCE | 92 (I) --- 183 (T) --- 183 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.601N (e) (e) (e) P=1.000N | |POLY 3 | (e) (e) (e) (e) P=0.614N | |POLY 1.5 | (e) (e) (e) (e) P=0.614N | |POLY 6 | (e) (e) (e) (e) P=0.614N | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=1.000N | |COCH-ARM / FISHERS | P=0.456N (e) (e) (e) P=0.667N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/0 (0%) 2/2 (100%) 0/0 (0%) 1/1 (100%) 0/1 (0%) | |POLY-3 RATE (b) | 0/0.00 2/2.00 0/0.00 1/1.00 0/1.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 100.0% 0.0% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 0/0 (0%) 2/2 (100%) 0/0 (0%) 1/1 (100%) 0/1 (0%) | |FIRST INCIDENCE | --- 183 (T) --- 183 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.257N (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.225N (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/18/04 EXPERIMENT: 89009 TEST: 01 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Pancreas | | Atrophy Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/20 (15%) 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) | |POLY-3 RATE (b) | 3/13.02 0/11.27 0/11.27 0/11.27 0/11.27 | |POLY-3 PERCENT (g) | 23.1% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | 92 (I) --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.374N P=0.120N P=0.120N P=0.120N P=0.120N | |POLY 3 | P=0.335N P=0.132N P=0.132N P=0.132N P=0.132N | |POLY 1.5 | P=0.346N P=0.122N P=0.122N P=0.122N P=0.122N | |POLY 6 | P=0.329N P=0.139N P=0.139N P=0.139N P=0.139N | |LOGISTIC REGRESSION| P=0.372N P=0.114N P=0.114N P=0.114N P=0.114N | |COCH-ARM / FISHERS | P=0.373N P=0.115N P=0.115N P=0.115N P=0.115N | |ORDER RESTRICTED | P=0.005N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Pancreas | | Atrophy Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) | |POLY-3 RATE (b) | 0/11.27 0/11.27 0/11.27 0/11.27 0/11.27 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/18/04 EXPERIMENT: 89009 TEST: 01 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/20 (10%) 0/20 (0%) 0/20 (0%) 2/20 (10%) 2/20 (10%) | |POLY-3 RATE (b) | 2/11.27 0/11.27 0/11.27 2/13.02 2/12.14 | |POLY-3 PERCENT (g) | 17.8% 0.0% 0.0% 15.4% 16.5% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) | |TERMINAL (d) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |FIRST INCIDENCE | 183 (T) --- --- 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.328 P=0.234N P=0.234N P=0.696 P=0.699 | |POLY 3 | P=0.355 P=0.228N P=0.228N P=0.649N P=0.677N | |POLY 1.5 | P=0.343 P=0.229N P=0.229N P=0.668N P=0.686N | |POLY 6 | P=0.362 P=0.227N P=0.227N P=0.636N P=0.670N | |LOGISTIC REGRESSION| P=0.327 P=0.228N P=0.228N P=0.701N P=0.704N | |COCH-ARM / FISHERS | P=0.327 P=0.244N P=0.244N P=0.698N P=0.698N | |ORDER RESTRICTED | P=0.347 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | | |POLY-3 RATE (b) | | |POLY-3 PERCENT (g) | | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |ORDER RESTRICTED | | |=================================================================================================================================| Date: 10/18/04 EXPERIMENT: 89009 TEST: 01 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Prostate | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/20 (5%) 1/20 (5%) 3/20 (15%) 0/20 (0%) 3/20 (15%) | |POLY-3 RATE (b) | 1/12.14 1/11.27 3/11.27 0/11.27 3/13.89 | |POLY-3 PERCENT (g) | 8.2% 8.9% 26.6% 0.0% 21.6% | |INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) | |TERMINAL (d) | 0/10 (0%) 1/10 (10%) 3/10 (30%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | 92 (I) 183 (T) 183 (T) --- 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.227 P=0.760 P=0.301 P=0.500N P=0.293 | |POLY 3 | P=0.287 P=0.748 P=0.264 P=0.515N P=0.347 | |POLY 1.5 | P=0.261 P=0.754 P=0.277 P=0.509N P=0.329 | |POLY 6 | P=0.305 P=0.744 P=0.257 P=0.519N P=0.358 | |LOGISTIC REGRESSION| P=0.224 P=0.766N P=0.296 (e) (e) | |COCH-ARM / FISHERS | P=0.224 P=0.756N P=0.302 P=0.500N P=0.302 | |ORDER RESTRICTED | P=0.253 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Prostate | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | | |POLY-3 RATE (b) | | |POLY-3 PERCENT (g) | | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |ORDER RESTRICTED | | |=================================================================================================================================| Date: 10/18/04 EXPERIMENT: 89009 TEST: 01 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Thymus | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/20 (10%) 0/20 (0%) 0/20 (0%) 0/20 (0%) 1/20 (5%) | |POLY-3 RATE (b) | 2/13.02 0/11.27 0/11.27 0/11.27 1/12.14 | |POLY-3 PERCENT (g) | 15.4% 0.0% 0.0% 0.0% 8.2% | |INT SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | 92 (I) --- --- --- 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.570 P=0.234N P=0.234N P=0.234N P=0.500N | |POLY 3 | P=0.604 P=0.264N P=0.264N P=0.264N P=0.525N | |POLY 1.5 | P=0.592 P=0.251N P=0.251N P=0.251N P=0.516N | |POLY 6 | P=0.612 P=0.272N P=0.272N P=0.272N P=0.531N | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.500N | |COCH-ARM / FISHERS | P=0.569 P=0.244N P=0.244N P=0.244N P=0.500N | |ORDER RESTRICTED | P=0.092N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Thymus | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/20 (0%) | |POLY-3 RATE (b) | 0/11.27 0/11.27 0/11.27 0/11.27 0/11.27 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/18/04 EXPERIMENT: 89009 TEST: 01 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Thyroid Gland | | Ultimobranchial Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/20 (15%) 0/20 (0%) 0/20 (0%) 2/20 (10%) 2/20 (10%) | |POLY-3 RATE (b) | 3/12.14 0/11.27 0/11.27 2/13.02 2/12.14 | |POLY-3 PERCENT (g) | 24.7% 0.0% 0.0% 15.4% 16.5% | |INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) | |TERMINAL (d) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |FIRST INCIDENCE | 92 (I) --- --- 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.423 P=0.120N P=0.120N P=0.500N P=0.500N | |POLY 3 | P=0.454 P=0.116N P=0.116N P=0.466N P=0.500N | |POLY 1.5 | P=0.442 P=0.113N P=0.113N P=0.478N P=0.500N | |POLY 6 | P=0.462 P=0.119N P=0.119N P=0.458N P=0.500N | |LOGISTIC REGRESSION| P=0.423 P=0.114N P=0.114N P=0.500N P=0.500N | |COCH-ARM / FISHERS | P=0.423 P=0.115N P=0.115N P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.167N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Thyroid Gland | | Ultimobranchial Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/20 (20%) 0/20 (0%) 2/20 (10%) 3/20 (15%) 1/20 (5%) | |POLY-3 RATE (b) | 4/13.02 0/11.27 2/11.27 3/12.14 1/12.14 | |POLY-3 PERCENT (g) | 30.7% 0.0% 17.8% 24.7% 8.2% | |INT SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 2/10 (20%) 0/10 (0%) 2/10 (20%) 2/10 (20%) 0/10 (0%) | |FIRST INCIDENCE | 92 (I) --- 183 (T) 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.351N P=0.062N P=0.331N P=0.500N P=0.175N | |POLY 3 | P=0.313N P=0.062N P=0.395N P=0.543N P=0.179N | |POLY 1.5 | P=0.325N P=0.056N P=0.369N P=0.527N P=0.173N | |POLY 6 | P=0.307N P=0.067N P=0.413N P=0.552N P=0.183N | |LOGISTIC REGRESSION| P=0.350N P=0.057N P=0.327N P=0.500N P=0.169N | |COCH-ARM / FISHERS | P=0.350N P=0.053N P=0.331N P=0.500N P=0.171N | |ORDER RESTRICTED | P=0.090N (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/18/04 EXPERIMENT: 89009 TEST: 01 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - PESTICIDE/FERTILIZER CONTAMINATION--M Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | | |POLY-3 RATE (b) | | |POLY-3 PERCENT (g) | | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |ORDER RESTRICTED | | |=================================================================================================================================| | | | | | Females | |Dose | VEHICLE 0.1X 1X 10X 100X | | | CONTROL | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/20 (20%) 3/20 (15%) 2/20 (10%) 5/20 (25%) 5/20 (25%) | |POLY-3 RATE (b) | 4/14.76 3/12.14 2/12.14 5/14.76 5/13.89 | |POLY-3 PERCENT (g) | 27.1% 24.7% 16.5% 33.9% 36.0% | |INT SACRIFICE 1 (c)| 4/10 (40%) 1/10 (10%) 1/10 (10%) 4/10 (40%) 3/10 (30%) | |TERMINAL (d) | 0/10 (0%) 2/10 (20%) 1/10 (10%) 1/10 (10%) 2/10 (20%) | |FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.288 P=0.500N P=0.327N P=0.500 P=0.500 | |POLY 3 | P=0.323 P=0.616N P=0.425N P=0.500 P=0.457 | |POLY 1.5 | P=0.311 P=0.575N P=0.390N P=0.500 P=0.471 | |POLY 6 | P=0.330 P=0.638N P=0.446N P=0.500 P=0.448 | |LOGISTIC REGRESSION| P=0.286 P=0.500N P=0.322N P=0.500 P=0.500 | |COCH-ARM / FISHERS | P=0.289 P=0.500N P=0.331N P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.375 (e) (e) (e) (e) | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (g) Poly-3 adjusted lifetime tumor incidence. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).