TDMS Study 96010-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) DATE: 03/26/03 EXPERIMENT: 96010 TEST: 04 TIME: 10:41:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: 96010A PATHOLOGIST: HEATH, JAMES E. CAS: 7775-09-9 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#1/MICE REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) DATE: 03/26/03 EXPERIMENT: 96010 TEST: 04 TIME: 10:41:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: 96010A PATHOLOGIST: HEATH, JAMES E. CAS: 7775-09-9 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 Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Pituitary Gland Spleen Testes Thyroid Gland NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) DATE: 03/26/03 EXPERIMENT: 96010 TEST: 04 TIME: 10:41:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: 96010A PATHOLOGIST: HEATH, JAMES E. CAS: 7775-09-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF WATER DISINFECTION BYPRODUCTS (SODIUM =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Liver Hepatoblastoma Testes Adenoma =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Malignant Islets, Pancreatic Carcinoma or Adenoma Liver Hemangioma Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Ovary Granulosa Cell Tumor Benign Granulosa Cell Tumor: Benign, Malignant, NOS Luteoma Skin Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma Uterus Polyp Stromal All Organs Benign Tumors Malignant Tumors =============================================================== Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/50 (8%) 5/50 (10%) 3/50 (6%) |1/50 (2%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/44.60 4/47.28 5/46.48 3/43.80 |1/43.63 0/44.35 0/42.00 0/43.40 | |POLY-3 PERCENT (g) | 6.7% 8.5% 10.8% 6.9% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/38 (8%) 4/41 (10%) 5/41 (12%) 3/33 (9%) |1/36 (3%) 0/34 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.500 P=0.542 P=0.398 P=0.597 |P=0.313N P=0.511N P=0.530N P=0.506N | |POLY 3 | P=0.566 P=0.532 P=0.379 P=0.654 |P=0.310N P=0.497N P=0.508N P=0.501N | |POLY 1.5 | P=0.566N P=0.519 P=0.372 P=0.658 |P=0.309N P=0.499N P=0.509N P=0.502N | |POLY 6 | P=0.550 P=0.547 P=0.387 P=0.648 |P=0.313N P=0.493N P=0.507N P=0.500N | |LOGISTIC REGRESSION| P=0.500 P=0.542 P=0.398 P=0.597 |P=0.313N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.554N P=0.500 P=0.357 P=0.661N |P=0.306N P=0.505N P=0.505N P=0.500N | |ORDER RESTRICTED | P=0.564 (e) (e) (e) |P=0.121N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) |2/50 (4%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.98 0/45.28 0/45.48 0/42.80 |2/43.88 0/44.35 0/42.00 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/39 (0%) 0/40 (0%) 0/32 (0%) |1/36 (3%) 0/34 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |660 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.119N P=0.233N P=0.256N P=0.237N | |POLY 3 | (e) (e) (e) (e) |P=0.117N P=0.235N P=0.247N P=0.239N | |POLY 1.5 | (e) (e) (e) (e) |P=0.116N P=0.237N P=0.248N P=0.240N | |POLY 6 | (e) (e) (e) (e) |P=0.118N P=0.232N P=0.247N P=0.239N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.116N P=0.241N P=0.245N P=0.238N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.253N P=0.253N P=0.247N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.030N* (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) |3/50 (6%) 0/49 (0%) 0/49 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/43.98 0/45.28 0/45.48 0/42.80 |3/43.88 0/44.35 0/42.00 2/43.58 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.8% 0.0% 0.0% 4.6% | |TERMINAL (d) | 0/38 (0%) 0/39 (0%) 0/40 (0%) 0/32 (0%) |2/36 (6%) 0/34 (0%) 0/31 (0%) 1/35 (3%) | |FIRST INCIDENCE | --- --- --- --- |660 --- --- 681 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.532N P=0.122N P=0.141N P=0.496N | |POLY 3 | (e) (e) (e) (e) |P=0.538N P=0.117N P=0.126N P=0.503N | |POLY 1.5 | (e) (e) (e) (e) |P=0.536N P=0.119N P=0.127N P=0.504N | |POLY 6 | (e) (e) (e) (e) |P=0.541N P=0.114N P=0.127N P=0.501N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.535N P=0.119N P=0.127N P=0.502N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.529N P=0.125N P=0.125N P=0.500N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.102N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Bone | | Osteosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 0/46.48 0/43.80 |0/43.63 1/45.39 1/42.71 2/44.56 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 2.3% 4.5% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 719 622 447 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.154 P=0.505 P=0.495 P=0.247 | |POLY 3 | (e) (e) (e) (e) |P=0.156 P=0.508 P=0.496 P=0.242 | |POLY 1.5 | (e) (e) (e) (e) |P=0.154 P=0.505 P=0.495 P=0.239 | |POLY 6 | (e) (e) (e) (e) |P=0.159 P=0.512 P=0.496 P=0.246 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.167 P=0.511 P=0.520 P=0.273 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.153 P=0.500 P=0.500 P=0.247 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.122 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.53 0/47.28 0/46.48 0/43.80 |1/44.05 1/45.35 2/42.58 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 2.2% 4.7% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 1/35 (3%) 1/31 (3%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |606 729 (T) 662 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.371N P=0.758N P=0.483 P=0.495N | |POLY 3 | (e) (e) (e) (e) |P=0.376N P=0.754N P=0.488 P=0.503N | |POLY 1.5 | (e) (e) (e) (e) |P=0.374N P=0.756N P=0.489 P=0.503N | |POLY 6 | (e) (e) (e) (e) |P=0.377N P=0.752N P=0.487 P=0.503N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.366N P=0.752 P=0.506 P=0.482N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.366N P=0.753N P=0.500 P=0.500N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.274N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 4/50 (8%) 4/50 (8%) 6/50 (12%) |11/50 (22%) 9/50 (18%) 5/50 (10%) 6/50 (12%) | |POLY-3 RATE (b) | 6/45.47 4/47.40 4/47.28 6/44.51 |11/44.13 9/45.61 5/42.40 6/43.85 | |POLY-3 PERCENT (g) | 13.2% 8.4% 8.5% 13.5% |24.9% 19.7% 11.8% 13.7% | |TERMINAL (d) | 4/38 (11%) 3/41 (7%) 2/41 (5%) 3/33 (9%) |10/36 (28%) 7/35 (20%) 4/31 (13%) 5/35 (14%) | |FIRST INCIDENCE | 562 698 543 605 |576 673 712 597 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.422 P=0.323N P=0.333N P=0.556 |P=0.104N P=0.420N P=0.142N P=0.157N | |POLY 3 | P=0.478 P=0.344N P=0.345N P=0.606 |P=0.093N P=0.368N P=0.095N P=0.142N | |POLY 1.5 | P=0.487 P=0.353N P=0.353N P=0.612 |P=0.093N P=0.380N P=0.095N P=0.145N | |POLY 6 | P=0.466 P=0.332N P=0.338N P=0.596 |P=0.092N P=0.351N P=0.097N P=0.137N | |LOGISTIC REGRESSION| P=0.511 P=0.375N P=0.417N P=0.621N |P=0.093N P=0.348N P=0.095N P=0.143N | |COCH-ARM / FISHERS | P=0.500 P=0.370N P=0.370N P=0.620N |P=0.088N P=0.402N P=0.086N P=0.143N | |ORDER RESTRICTED | P=0.473 (e) (e) (e) |P=0.100N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 4/50 (8%) 5/50 (10%) 7/50 (14%) |12/50 (24%) 10/50 (20%) 5/50 (10%) 6/50 (12%) | |POLY-3 RATE (b) | 6/45.47 4/47.40 5/47.28 7/44.97 |12/44.13 10/46.13 5/42.40 6/43.85 | |POLY-3 PERCENT (g) | 13.2% 8.4% 10.6% 15.6% |27.2% 21.7% 11.8% 13.7% | |TERMINAL (d) | 4/38 (11%) 3/41 (7%) 3/41 (7%) 3/33 (9%) |11/36 (31%) 7/35 (20%) 4/31 (13%) 5/35 (14%) | |FIRST INCIDENCE | 562 698 543 595 |576 568 712 597 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.281 P=0.323N P=0.453N P=0.442 |P=0.063N P=0.426N P=0.097N P=0.107N | |POLY 3 | P=0.335 P=0.344N P=0.473N P=0.491 |P=0.053N P=0.358N P=0.060N P=0.094N | |POLY 1.5 | P=0.342 P=0.353N P=0.481N P=0.495 |P=0.053N P=0.375N P=0.061N P=0.096N | |POLY 6 | P=0.326 P=0.332N P=0.465N P=0.485 |P=0.054N P=0.334N P=0.061N P=0.090N | |LOGISTIC REGRESSION| P=0.366 P=0.375N P=0.543N P=0.504 |P=0.054N P=0.365N P=0.060N P=0.095N | |COCH-ARM / FISHERS | P=0.351 P=0.370N P=0.500N P=0.500 |P=0.050N P=0.405N P=0.054N P=0.096N | |ORDER RESTRICTED | P=0.383 (e) (e) (e) |P=0.059N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Intestine Small: Duodenum | | Polyp Adenomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 2/46.48 0/43.80 |0/43.63 0/45.35 0/42.33 1/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.3% 0.0% |0.0% 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 2/41 (5%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 1/35 (3%) | |FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.566 (e) P=0.255 (e) |P=0.199 (e) (e) P=0.494 | |POLY 3 | P=0.573 (e) P=0.246 (e) |P=0.196 (e) (e) P=0.499 | |POLY 1.5 | P=0.582 (e) P=0.243 (e) |P=0.196 (e) (e) P=0.498 | |POLY 6 | P=0.558 (e) P=0.250 (e) |P=0.196 (e) (e) P=0.500 | |LOGISTIC REGRESSION| (e) (e) P=0.255 (e) |(e) (e) (e) P=0.494 | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.198 (e) (e) P=0.500 | |ORDER RESTRICTED | P=0.255 (e) (e) (e) |P=0.119 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/44.60 2/47.28 0/46.48 2/44.39 |0/43.63 0/45.35 0/42.33 0/43.40 | |POLY-3 PERCENT (g) | 4.5% 4.2% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/38 (5%) 2/41 (5%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 570 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.599N P=0.667N P=0.222N P=0.666 |(e) (e) (e) (e) | |POLY 3 | P=0.557N P=0.673N P=0.228N P=0.692 |(e) (e) (e) (e) | |POLY 1.5 | P=0.556N P=0.681N P=0.231N P=0.693 |(e) (e) (e) (e) | |POLY 6 | P=0.559N P=0.663N P=0.225N P=0.690 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.555N P=0.667N (e) P=0.694N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.556N P=0.691N P=0.247N P=0.691N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.437N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/44.60 2/47.28 0/46.48 3/44.39 |0/43.63 0/45.35 0/42.33 0/43.40 | |POLY-3 PERCENT (g) | 4.5% 4.2% 0.0% 6.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/38 (5%) 2/41 (5%) 0/41 (0%) 1/33 (3%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 570 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.373 P=0.667N P=0.222N P=0.461 |(e) (e) (e) (e) | |POLY 3 | P=0.418 P=0.673N P=0.228N P=0.498 |(e) (e) (e) (e) | |POLY 1.5 | P=0.420 P=0.681N P=0.231N P=0.499 |(e) (e) (e) (e) | |POLY 6 | P=0.414 P=0.663N P=0.225N P=0.495 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.420 P=0.667N (e) P=0.499 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.423 P=0.691N P=0.247N P=0.500 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.277 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/44.60 2/47.28 1/46.48 4/44.39 |0/43.63 1/45.45 0/42.33 0/43.40 | |POLY-3 PERCENT (g) | 6.7% 4.2% 2.2% 9.0% |0.0% 2.2% 0.0% 0.0% | |TERMINAL (d) | 3/38 (8%) 2/41 (5%) 1/41 (2%) 2/33 (6%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 570 |--- 706 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.309 P=0.465N P=0.278N P=0.445 |P=0.582N P=0.520 (e) (e) | |POLY 3 | P=0.362 P=0.473N P=0.291N P=0.497 |P=0.565N P=0.508 (e) (e) | |POLY 1.5 | P=0.366 P=0.484N P=0.296N P=0.499 |P=0.567N P=0.505 (e) (e) | |POLY 6 | P=0.356 P=0.461N P=0.286N P=0.494 |P=0.563N P=0.512 (e) (e) | |LOGISTIC REGRESSION| P=0.358 P=0.465N P=0.278N P=0.494 |P=0.570N P=0.505 (e) (e) | |COCH-ARM / FISHERS | P=0.371 P=0.500N P=0.309N P=0.500 |P=0.567N P=0.500 (e) (e) | |ORDER RESTRICTED | P=0.270 (e) (e) (e) |P=0.389N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Polyp Adenomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 2/46.48 0/43.80 |0/43.63 0/45.35 0/42.33 1/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.3% 0.0% |0.0% 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 2/41 (5%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 1/35 (3%) | |FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.566 (e) P=0.255 (e) |P=0.199 (e) (e) P=0.494 | |POLY 3 | P=0.573 (e) P=0.246 (e) |P=0.196 (e) (e) P=0.499 | |POLY 1.5 | P=0.582 (e) P=0.243 (e) |P=0.196 (e) (e) P=0.498 | |POLY 6 | P=0.558 (e) P=0.250 (e) |P=0.196 (e) (e) P=0.500 | |LOGISTIC REGRESSION| (e) (e) P=0.255 (e) |(e) (e) (e) P=0.494 | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.198 (e) (e) P=0.500 | |ORDER RESTRICTED | P=0.255 (e) (e) (e) |P=0.119 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/46 (0%) 2/47 (4%) 2/49 (4%) 3/49 (6%) | |POLY-3 RATE (b) | 1/43.91 0/47.28 0/46.48 1/43.84 |0/42.28 2/44.36 2/42.00 3/43.88 | |POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 2.3% |0.0% 4.5% 4.8% 6.8% | |TERMINAL (d) | 1/38 (3%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 1/35 (3%) 2/31 (7%) 1/35 (3%) | |FIRST INCIDENCE | 729 (T) --- --- 719 |--- 706 729 (T) 475 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.570 P=0.485N P=0.485N P=0.735 |P=0.106 P=0.248 P=0.206 P=0.126 | |POLY 3 | P=0.591 P=0.485N P=0.489N P=0.760 |P=0.112 P=0.248 P=0.235 P=0.125 | |POLY 1.5 | P=0.595 P=0.488N P=0.490N P=0.758N |P=0.113 P=0.245 P=0.238 P=0.125 | |POLY 6 | P=0.585 P=0.481N P=0.487N P=0.756 |P=0.112 P=0.252 P=0.232 P=0.126 | |LOGISTIC REGRESSION| P=0.583 (e) (e) P=0.752 |P=0.127 P=0.248 P=0.206 P=0.171 | |COCH-ARM / FISHERS | P=0.602 P=0.490N P=0.490N P=0.742N |P=0.121 P=0.253 P=0.263 P=0.133 | |ORDER RESTRICTED | P=0.393 (e) (e) (e) |P=0.082 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/46 (0%) 2/47 (4%) 2/49 (4%) 4/49 (8%) | |POLY-3 RATE (b) | 1/43.91 0/47.28 0/46.48 2/43.84 |0/42.28 2/44.36 2/42.00 4/43.88 | |POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 4.6% |0.0% 4.5% 4.8% 9.1% | |TERMINAL (d) | 1/38 (3%) 0/41 (0%) 0/41 (0%) 1/33 (3%) |0/36 (0%) 1/35 (3%) 2/31 (7%) 2/35 (6%) | |FIRST INCIDENCE | 729 (T) --- --- 719 |--- 706 729 (T) 475 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.210 P=0.485N P=0.485N P=0.458 |P=0.043 * P=0.248 P=0.206 P=0.066 | |POLY 3 | P=0.243 P=0.485N P=0.489N P=0.499 |P=0.045 * P=0.248 P=0.235 P=0.065 | |POLY 1.5 | P=0.246 P=0.488N P=0.490N P=0.505 |P=0.046 * P=0.245 P=0.238 P=0.065 | |POLY 6 | P=0.238 P=0.481N P=0.487N P=0.492 |P=0.045 * P=0.252 P=0.232 P=0.065 | |LOGISTIC REGRESSION| P=0.222 (e) (e) P=0.479 |P=0.052 P=0.248 P=0.206 P=0.087 | |COCH-ARM / FISHERS | P=0.252 P=0.490N P=0.490N P=0.515 |P=0.051 P=0.253 P=0.263 P=0.067 | |ORDER RESTRICTED | P=0.128 (e) (e) (e) |P=0.030 * (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/49 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.91 0/47.28 1/46.48 0/43.80 |2/43.57 0/45.35 0/42.00 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |4.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 1/41 (2%) 0/33 (0%) |2/36 (6%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- 729 (T) --- |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.681 (e) P=0.515 (e) |P=0.123N P=0.244N P=0.272N P=0.244N | |POLY 3 | P=0.675 (e) P=0.511 (e) |P=0.114N P=0.228N P=0.245N P=0.238N | |POLY 1.5 | P=0.684 (e) P=0.510 (e) |P=0.114N P=0.231N P=0.246N P=0.238N | |POLY 6 | P=0.662 (e) P=0.513 (e) |P=0.116N P=0.224N P=0.245N P=0.237N | |LOGISTIC REGRESSION| (e) (e) P=0.515 (e) |P=0.123N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.699 (e) P=0.510 (e) |P=0.114N P=0.242N P=0.247N P=0.242N | |ORDER RESTRICTED | P=0.391 (e) (e) (e) |P=0.030N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |1/49 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.91 2/47.28 1/46.48 2/43.80 |1/43.57 2/45.35 0/42.00 0/43.40 | |POLY-3 PERCENT (g) | 2.3% 4.2% 2.2% 4.6% |2.3% 4.4% 0.0% 0.0% | |TERMINAL (d) | 1/38 (3%) 2/41 (5%) 1/41 (2%) 2/33 (6%) |1/36 (3%) 2/35 (6%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.385 P=0.527 P=0.745N P=0.451 |P=0.198N P=0.490 P=0.530N P=0.506N | |POLY 3 | P=0.437 P=0.526 P=0.748N P=0.499 |P=0.190N P=0.514 P=0.507N P=0.501N | |POLY 1.5 | P=0.444 P=0.520 P=0.749N P=0.505 |P=0.190N P=0.510 P=0.508N P=0.501N | |POLY 6 | P=0.428 P=0.533 P=0.746N P=0.492 |P=0.189N P=0.520 P=0.507N P=0.500N | |LOGISTIC REGRESSION| P=0.385 P=0.527 P=0.745N P=0.451 |P=0.198N P=0.490 (e) (e) | |COCH-ARM / FISHERS | P=0.456 P=0.515 P=0.742N P=0.515 |P=0.186N P=0.508 P=0.500N P=0.495N | |ORDER RESTRICTED | P=0.442 (e) (e) (e) |P=0.175N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 9 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/48 (13%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |1/49 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 6/44.45 3/47.85 1/46.71 3/43.84 |1/43.57 0/45.35 0/42.00 0/43.40 | |POLY-3 PERCENT (g) | 13.5% 6.3% 2.1% 6.8% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 5/38 (13%) 1/41 (2%) 0/41 (0%) 2/33 (6%) |1/36 (3%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 561 577 668 719 |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.222N P=0.212N P=0.051N P=0.307N |P=0.313N P=0.506N P=0.530N P=0.506N | |POLY 3 | P=0.179N P=0.207N P=0.048N* P=0.248N |P=0.306N P=0.492N P=0.507N P=0.501N | |POLY 1.5 | P=0.174N P=0.214N P=0.049N* P=0.239N |P=0.305N P=0.494N P=0.508N P=0.501N | |POLY 6 | P=0.186N P=0.197N P=0.047N* P=0.261N |P=0.308N P=0.489N P=0.507N P=0.500N | |LOGISTIC REGRESSION| P=0.158N P=0.238N P=0.054N P=0.239N |P=0.313N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.166N P=0.223N P=0.050N P=0.223N |P=0.304N P=0.495N P=0.500N P=0.495N | |ORDER RESTRICTED | P=0.076N (e) (e) (e) |P=0.121N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/48 (63%) 32/50 (64%) 36/50 (72%) 30/50 (60%) |30/49 (61%) 19/50 (38%) 26/49 (53%) 23/50 (46%) | |POLY-3 RATE (b) | 30/46.51 32/47.31 36/48.04 30/45.77 |30/45.42 19/45.74 26/43.41 23/44.75 | |POLY-3 PERCENT (g) | 64.5% 67.6% 74.9% 65.5% |66.1% 41.5% 59.9% 51.4% | |TERMINAL (d) | 25/38 (66%) 31/41 (76%) 32/41 (78%) 24/33 (73%) |26/36 (72%) 17/35 (49%) 19/31 (61%) 20/35 (57%) | |FIRST INCIDENCE | 484 722 543 535 |524 674 602 475 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.185 P=0.563N P=0.300 P=0.310 |P=0.289N P=0.023N* P=0.537N P=0.132N | |POLY 3 | P=0.478 P=0.459 P=0.184 P=0.546 |P=0.252N P=0.013N* P=0.348N P=0.108N | |POLY 1.5 | P=0.533 P=0.482 P=0.197 P=0.577N |P=0.248N P=0.014N* P=0.350N P=0.108N | |POLY 6 | P=0.417 P=0.438 P=0.172 P=0.492 |P=0.252N P=0.011N* P=0.339N P=0.104N | |LOGISTIC REGRESSION| P=0.500 P=0.584N P=0.228 P=0.549N |P=0.263N P=0.010N* P=0.331N P=0.108N | |COCH-ARM / FISHERS | P=0.449N P=0.522 P=0.216 P=0.482N |P=0.214N P=0.017N* P=0.270N P=0.094N | |ORDER RESTRICTED | P=0.427 (e) (e) (e) |P=0.100N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 10 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 20/48 (42%) 14/50 (28%) 19/50 (38%) 13/50 (26%) |3/49 (6%) 13/50 (26%) 15/49 (31%) 9/50 (18%) | |POLY-3 RATE (b) | 20/46.21 14/48.93 19/48.53 13/45.80 |3/43.65 13/45.65 15/42.18 9/44.29 | |POLY-3 PERCENT (g) | 43.3% 28.6% 39.2% 28.4% |6.9% 28.5% 35.6% 20.3% | |TERMINAL (d) | 14/38 (37%) 10/41 (24%) 14/41 (34%) 5/33 (15%) |2/36 (6%) 9/35 (26%) 12/31 (39%) 7/35 (20%) | |FIRST INCIDENCE | 484 431 558 570 |710 682 711 475 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.276N P=0.110N P=0.400N P=0.200N |P=0.154 P=0.009 ** P<0.001 ** P=0.060 | |POLY 3 | P=0.159N P=0.099N P=0.421N P=0.100N |P=0.158 P=0.007 ** P<0.001 ** P=0.061 | |POLY 1.5 | P=0.144N P=0.105N P=0.427N P=0.091N |P=0.157 P=0.007 ** P<0.001 ** P=0.061 | |POLY 6 | P=0.176N P=0.093N P=0.416N P=0.109N |P=0.164 P=0.008 ** P<0.001 ** P=0.063 | |LOGISTIC REGRESSION| P=0.084N P=0.142N P=0.462N P=0.068N |P=0.150 P=0.009 ** P<0.001 ** P=0.062 | |COCH-ARM / FISHERS | P=0.117N P=0.113N P=0.435N P=0.077N |P=0.179 P=0.007 ** P=0.002 ** P=0.065 | |ORDER RESTRICTED | P=0.104N (e) (e) (e) |P=0.010 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 23/48 (48%) 16/50 (32%) 20/50 (40%) 16/50 (32%) |4/49 (8%) 13/50 (26%) 15/49 (31%) 9/50 (18%) | |POLY-3 RATE (b) | 23/46.76 16/49.00 20/48.76 16/45.84 |4/43.65 13/45.65 15/42.18 9/44.29 | |POLY-3 PERCENT (g) | 49.2% 32.7% 41.0% 34.9% |9.2% 28.5% 35.6% 20.3% | |TERMINAL (d) | 16/38 (42%) 11/41 (27%) 14/41 (34%) 7/33 (21%) |3/36 (8%) 9/35 (26%) 12/31 (39%) 7/35 (20%) | |FIRST INCIDENCE | 484 431 558 570 |710 682 711 475 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.313N P=0.084N P=0.267N P=0.232N |P=0.208 P=0.020 * P=0.002 ** P=0.112 | |POLY 3 | P=0.180N P=0.074N P=0.276N P=0.117N |P=0.219 P=0.018 * P=0.002 ** P=0.119 | |POLY 1.5 | P=0.160N P=0.076N P=0.278N P=0.102N |P=0.217 P=0.017 * P=0.003 ** P=0.118 | |POLY 6 | P=0.203N P=0.070N P=0.272N P=0.133N |P=0.226 P=0.020 * P=0.002 ** P=0.123 | |LOGISTIC REGRESSION| P=0.091N P=0.106N P=0.306N P=0.073N |P=0.207 P=0.022 * P=0.003 ** P=0.116 | |COCH-ARM / FISHERS | P=0.125N P=0.080N P=0.279N P=0.080N |P=0.241 P=0.017 * P=0.005 ** P=0.125 | |ORDER RESTRICTED | P=0.126N (e) (e) (e) |P=0.022 * (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 11 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 41/48 (85%) 42/50 (84%) 44/50 (88%) 40/50 (80%) |31/49 (63%) 26/50 (52%) 31/49 (63%) 26/50 (52%) | |POLY-3 RATE (b) | 41/47.67 42/48.96 44/49.35 40/47.50 |31/45.50 26/45.86 31/43.48 26/44.92 | |POLY-3 PERCENT (g) | 86.0% 85.8% 89.2% 84.2% |68.1% 56.7% 71.3% 57.9% | |TERMINAL (d) | 32/38 (84%) 37/41 (90%) 37/41 (90%) 27/33 (82%) |26/36 (72%) 21/35 (60%) 23/31 (74%) 22/35 (63%) | |FIRST INCIDENCE | 484 431 543 535 |524 674 602 475 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.197 P=0.404N P=0.576N P=0.333 |P=0.340N P=0.239N P=0.292 P=0.249N | |POLY 3 | P=0.477N P=0.604N P=0.434 P=0.517N |P=0.287N P=0.174N P=0.461 P=0.207N | |POLY 1.5 | P=0.416N P=0.574N P=0.450 P=0.455N |P=0.283N P=0.176N P=0.467 P=0.206N | |POLY 6 | P=0.525N P=0.597 P=0.411 P=0.571N |P=0.286N P=0.164N P=0.464 P=0.202N | |LOGISTIC REGRESSION| P=0.371N P=0.523N P=0.466 P=0.394N |P=0.297N P=0.123N P=0.493 P=0.204N | |COCH-ARM / FISHERS | P=0.289N P=0.535N P=0.468 P=0.330N |P=0.237N P=0.176N P=0.583N P=0.176N | |ORDER RESTRICTED | P=0.539N (e) (e) (e) |P=0.233N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 41/48 (85%) 43/50 (86%) 45/50 (90%) 40/50 (80%) |31/49 (63%) 26/50 (52%) 31/49 (63%) 26/50 (52%) | |POLY-3 RATE (b) | 41/47.67 43/49.02 45/49.58 40/47.50 |31/45.50 26/45.86 31/43.48 26/44.92 | |POLY-3 PERCENT (g) | 86.0% 87.7% 90.8% 84.2% |68.1% 56.7% 71.3% 57.9% | |TERMINAL (d) | 32/38 (84%) 37/41 (90%) 37/41 (90%) 27/33 (82%) |26/36 (72%) 21/35 (60%) 23/31 (74%) 22/35 (63%) | |FIRST INCIDENCE | 484 431 543 535 |524 674 602 475 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.212 P=0.481N P=0.508 P=0.333 |P=0.340N P=0.239N P=0.292 P=0.249N | |POLY 3 | P=0.448N P=0.522 P=0.337 P=0.517N |P=0.287N P=0.174N P=0.461 P=0.207N | |POLY 1.5 | P=0.387N P=0.547 P=0.342 P=0.455N |P=0.283N P=0.176N P=0.467 P=0.206N | |POLY 6 | P=0.498N P=0.490 P=0.332 P=0.571N |P=0.286N P=0.164N P=0.464 P=0.202N | |LOGISTIC REGRESSION| P=0.338N P=0.594 P=0.344 P=0.394N |P=0.297N P=0.123N P=0.493 P=0.204N | |COCH-ARM / FISHERS | P=0.259N P=0.581 P=0.351 P=0.330N |P=0.237N P=0.176N P=0.583N P=0.176N | |ORDER RESTRICTED | P=0.440N (e) (e) (e) |P=0.233N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 12 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 4/50 (8%) 7/50 (14%) 6/50 (12%) |3/50 (6%) 1/50 (2%) 0/49 (0%) 3/50 (6%) | |POLY-3 RATE (b) | 6/44.60 4/47.71 7/47.00 6/43.91 |3/43.98 1/45.35 0/41.33 3/43.40 | |POLY-3 PERCENT (g) | 13.5% 8.4% 14.9% 13.7% |6.8% 2.2% 0.0% 6.9% | |TERMINAL (d) | 6/38 (16%) 3/41 (7%) 6/41 (15%) 4/33 (12%) |2/36 (6%) 1/35 (3%) 0/30 (0%) 3/35 (9%) | |FIRST INCIDENCE | 729 (T) 604 570 711 |630 729 (T) --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.354 P=0.324N P=0.556 P=0.528 |P=0.512 P=0.308N P=0.148N P=0.653 | |POLY 3 | P=0.423 P=0.328N P=0.540 P=0.610 |P=0.513 P=0.294N P=0.130N P=0.657 | |POLY 1.5 | P=0.437 P=0.344N P=0.526 P=0.615 |P=0.515 P=0.298N P=0.129N P=0.657 | |POLY 6 | P=0.403 P=0.308N P=0.556 P=0.602 |P=0.509 P=0.290N P=0.132N P=0.657 | |LOGISTIC REGRESSION| P=0.427 P=0.333N P=0.535 P=0.573 |P=0.516 P=0.296N P=0.128N P=0.662 | |COCH-ARM / FISHERS | P=0.455 P=0.370N P=0.500 P=0.620N |P=0.525 P=0.309N P=0.125N P=0.661N | |ORDER RESTRICTED | P=0.496 (e) (e) (e) |P=0.284 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 5/50 (10%) 7/50 (14%) 4/50 (8%) |1/50 (2%) 1/50 (2%) 2/49 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 4/45.19 5/47.28 7/47.72 4/44.15 |1/43.63 1/45.35 2/41.40 1/43.40 | |POLY-3 PERCENT (g) | 8.9% 10.6% 14.7% 9.1% |2.3% 2.2% 4.8% 2.3% | |TERMINAL (d) | 2/38 (5%) 5/41 (12%) 4/41 (10%) 2/33 (6%) |1/36 (3%) 1/35 (3%) 1/30 (3%) 1/35 (3%) | |FIRST INCIDENCE | 638 729 (T) 543 640 |729 (T) 729 (T) 712 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.481 P=0.550 P=0.314 P=0.590 |P=0.575 P=0.756 P=0.455 P=0.756 | |POLY 3 | P=0.534 P=0.528 P=0.293 P=0.631 |P=0.581 P=0.752N P=0.482 P=0.760 | |POLY 1.5 | P=0.547 P=0.518 P=0.282 P=0.636 |P=0.582 P=0.755N P=0.482 P=0.759 | |POLY 6 | P=0.516 P=0.539 P=0.305 P=0.621 |P=0.581 P=0.748N P=0.481 P=0.761N | |LOGISTIC REGRESSION| P=0.559N P=0.522 P=0.219 P=0.641 |P=0.580 P=0.756 P=0.477 P=0.756 | |COCH-ARM / FISHERS | P=0.563 P=0.500 P=0.262 P=0.643N |P=0.590 P=0.753N P=0.492 P=0.753N | |ORDER RESTRICTED | P=0.505 (e) (e) (e) |P=0.563 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 13 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 8/50 (16%) 13/50 (26%) 9/50 (18%) |4/50 (8%) 2/50 (4%) 2/49 (4%) 4/50 (8%) | |POLY-3 RATE (b) | 10/45.19 8/47.71 13/48.25 9/44.27 |4/43.98 2/45.35 2/41.40 4/43.40 | |POLY-3 PERCENT (g) | 22.1% 16.8% 27.0% 20.3% |9.1% 4.4% 4.8% 9.2% | |TERMINAL (d) | 8/38 (21%) 7/41 (17%) 9/41 (22%) 5/33 (15%) |3/36 (8%) 2/35 (6%) 1/30 (3%) 4/35 (11%) | |FIRST INCIDENCE | 638 604 543 640 |630 729 (T) 712 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.418 P=0.331N P=0.398 P=0.590 |P=0.479 P=0.343N P=0.402N P=0.631 | |POLY 3 | P=0.505 P=0.349N P=0.383 P=0.520N |P=0.482 P=0.323N P=0.365N P=0.636 | |POLY 1.5 | P=0.523 P=0.367N P=0.359 P=0.511N |P=0.486 P=0.328N P=0.363N P=0.637 | |POLY 6 | P=0.480 P=0.328N P=0.408 P=0.536N |P=0.478 P=0.317N P=0.369N P=0.636 | |LOGISTIC REGRESSION| P=0.537 P=0.358N P=0.310 P=0.524N |P=0.486 P=0.318N P=0.362N P=0.644 | |COCH-ARM / FISHERS | P=0.548 P=0.398N P=0.318 P=0.500N |P=0.499 P=0.339N P=0.349N P=0.643N | |ORDER RESTRICTED | P=0.488 (e) (e) (e) |P=0.449 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Ovary | | Choriocarcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |0/45 (0%) 0/45 (0%) 2/47 (4%) 0/50 (0%) | |POLY-3 RATE (b) | |0/39.57 0/41.72 2/40.43 0/43.40 | |POLY-3 PERCENT (g) | |0.0% 0.0% 5.0% 0.0% | |TERMINAL (d) | |0/32 (0%) 0/34 (0%) 1/30 (3%) 0/35 (0%) | |FIRST INCIDENCE | |--- --- 683 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.602 (e) P=0.233 (e) | |POLY 3 | |P=0.604 (e) P=0.241 (e) | |POLY 1.5 | |P=0.606 (e) P=0.240 (e) | |POLY 6 | |P=0.604 (e) P=0.244 (e) | |LOGISTIC REGRESSION| |P=0.612 (e) P=0.241 (e) | |COCH-ARM / FISHERS | |P=0.617 (e) P=0.258 (e) | |ORDER RESTRICTED | |P=0.252 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 14 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/45 (2%) 4/45 (9%) 1/47 (2%) 1/50 (2%) | |POLY-3 RATE (b) | |1/39.57 4/41.90 1/40.25 1/43.40 | |POLY-3 PERCENT (g) | |2.5% 9.6% 2.5% 2.3% | |TERMINAL (d) | |1/32 (3%) 3/34 (9%) 1/30 (3%) 1/35 (3%) | |FIRST INCIDENCE | |729 (T) 682 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.353N P=0.204 P=0.748 P=0.742N | |POLY 3 | |P=0.336N P=0.196 P=0.757N P=0.740N | |POLY 1.5 | |P=0.338N P=0.188 P=0.758N P=0.741N | |POLY 6 | |P=0.330N P=0.208 P=0.755N P=0.738N | |LOGISTIC REGRESSION| |P=0.343N P=0.204 P=0.748 P=0.742N | |COCH-ARM / FISHERS | |P=0.332N P=0.180 P=0.742N P=0.726N | |ORDER RESTRICTED | |P=0.305N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/45 (2%) 1/45 (2%) 1/47 (2%) 5/50 (10%) | |POLY-3 RATE (b) | |1/39.57 1/41.72 1/40.25 5/43.40 | |POLY-3 PERCENT (g) | |2.5% 2.4% 2.5% 11.5% | |TERMINAL (d) | |1/32 (3%) 1/34 (3%) 1/30 (3%) 5/35 (14%) | |FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.031 * P=0.748N P=0.748 P=0.123 | |POLY 3 | |P=0.031 * P=0.749N P=0.757N P=0.123 | |POLY 1.5 | |P=0.032 * P=0.754N P=0.758N P=0.122 | |POLY 6 | |P=0.030 * P=0.741N P=0.755N P=0.125 | |LOGISTIC REGRESSION| |P=0.031 * P=0.748N P=0.748 P=0.123 | |COCH-ARM / FISHERS | |P=0.035 * P=0.753N P=0.742N P=0.128 | |ORDER RESTRICTED | |P=0.036 * (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 15 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/45 (2%) 1/45 (2%) 1/47 (2%) 6/50 (12%) | |POLY-3 RATE (b) | |1/39.57 1/41.72 1/40.25 6/44.39 | |POLY-3 PERCENT (g) | |2.5% 2.4% 2.5% 13.5% | |TERMINAL (d) | |1/32 (3%) 1/34 (3%) 1/30 (3%) 5/35 (14%) | |FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 142 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.012 * P=0.748N P=0.748 P=0.073 | |POLY 3 | |P=0.012 * P=0.749N P=0.757N P=0.075 | |POLY 1.5 | |P=0.012 * P=0.754N P=0.758N P=0.075 | |POLY 6 | |P=0.011 * P=0.741N P=0.755N P=0.077 | |LOGISTIC REGRESSION| |P=0.015 * P=0.748N P=0.748 P=0.089 | |COCH-ARM / FISHERS | |P=0.013 * P=0.753N P=0.742N P=0.074 | |ORDER RESTRICTED | |P=0.015 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Ovary | | Luteoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |3/45 (7%) 0/45 (0%) 1/47 (2%) 0/50 (0%) | |POLY-3 RATE (b) | |3/39.78 0/41.72 1/40.25 0/43.40 | |POLY-3 PERCENT (g) | |7.5% 0.0% 2.5% 0.0% | |TERMINAL (d) | |2/32 (6%) 0/34 (0%) 1/30 (3%) 0/35 (0%) | |FIRST INCIDENCE | |674 --- 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.084N P=0.109N P=0.326N P=0.110N | |POLY 3 | |P=0.079N P=0.110N P=0.300N P=0.103N | |POLY 1.5 | |P=0.078N P=0.114N P=0.302N P=0.103N | |POLY 6 | |P=0.082N P=0.105N P=0.298N P=0.101N | |LOGISTIC REGRESSION| |P=0.078N P=0.111N P=0.295N P=0.104N | |COCH-ARM / FISHERS | |P=0.075N P=0.121N P=0.292N P=0.103N | |ORDER RESTRICTED | |P=0.016N* (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 16 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/47 (0%) 1/47 (2%) 0/45 (0%) 0/49 (0%) |3/46 (7%) 2/45 (4%) 4/48 (8%) 4/50 (8%) | |POLY-3 RATE (b) | 0/42.10 1/44.28 0/42.54 0/42.80 |3/41.52 2/41.26 4/40.71 4/43.56 | |POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |7.2% 4.9% 9.8% 9.2% | |TERMINAL (d) | 0/37 (0%) 1/38 (3%) 0/38 (0%) 0/32 (0%) |3/35 (9%) 2/32 (6%) 4/30 (13%) 3/35 (9%) | |FIRST INCIDENCE | --- 729 (T) --- --- |729 (T) 729 (T) 729 (T) 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.591N P=0.505 (e) (e) |P=0.339 P=0.541N P=0.415 P=0.500 | |POLY 3 | P=0.553N P=0.510 (e) (e) |P=0.356 P=0.503N P=0.489 P=0.526 | |POLY 1.5 | P=0.556N P=0.506 (e) (e) |P=0.362 P=0.506N P=0.494 P=0.530 | |POLY 6 | P=0.550N P=0.514 (e) (e) |P=0.352 P=0.497N P=0.484 P=0.526 | |LOGISTIC REGRESSION| (e) P=0.505 (e) (e) |P=0.340 P=0.541N P=0.415 P=0.520 | |COCH-ARM / FISHERS | P=0.561N P=0.500 (e) (e) |P=0.383 P=0.511N P=0.524 P=0.547 | |ORDER RESTRICTED | P=0.387N (e) (e) (e) |P=0.436 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Skeletal Muscle | | Rhabdomyosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 0/46.48 1/44.40 |0/43.63 1/46.10 1/42.33 2/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.3% |0.0% 2.2% 2.4% 4.6% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 1/31 (3%) 2/35 (6%) | |FIRST INCIDENCE | --- --- --- 535 |--- 461 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.197 (e) (e) P=0.500 |P=0.150 P=0.508 P=0.470 P=0.232 | |POLY 3 | P=0.195 (e) (e) P=0.499 |P=0.149 P=0.511 P=0.494 P=0.236 | |POLY 1.5 | P=0.197 (e) (e) P=0.500 |P=0.150 P=0.507 P=0.494 P=0.235 | |POLY 6 | P=0.192 (e) (e) P=0.498 |P=0.149 P=0.516 P=0.493 P=0.237 | |LOGISTIC REGRESSION| P=0.246 (e) (e) P=0.513 |P=0.156 P=0.312 P=0.470 P=0.232 | |COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.153 P=0.500 P=0.500 P=0.247 | |ORDER RESTRICTED | P=0.119 (e) (e) (e) |P=0.116 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 17 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 1/46.48 0/43.80 |0/43.63 1/46.01 0/42.33 3/43.50 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |0.0% 2.2% 0.0% 6.9% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 1/41 (2%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 2/35 (6%) | |FIRST INCIDENCE | --- --- 729 (T) --- |--- 513 --- 705 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.681 (e) P=0.515 (e) |P=0.043 * P=0.500 (e) P=0.118 | |POLY 3 | P=0.677 (e) P=0.508 (e) |P=0.041 * P=0.511 (e) P=0.118 | |POLY 1.5 | P=0.684 (e) P=0.506 (e) |P=0.042 * P=0.507 (e) P=0.117 | |POLY 6 | P=0.666 (e) P=0.511 (e) |P=0.041 * P=0.515 (e) P=0.119 | |LOGISTIC REGRESSION| (e) (e) P=0.515 (e) |P=0.045 * P=0.371 (e) P=0.120 | |COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.044 * P=0.500 (e) P=0.121 | |ORDER RESTRICTED | P=0.389 (e) (e) (e) |P=0.020 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 0/46.48 0/43.80 |0/43.63 1/46.01 0/42.33 2/43.50 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 0.0% 4.6% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 1/35 (3%) | |FIRST INCIDENCE | --- --- --- --- |--- 513 --- 705 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.135 P=0.500 (e) P=0.234 | |POLY 3 | (e) (e) (e) (e) |P=0.137 P=0.511 (e) P=0.236 | |POLY 1.5 | (e) (e) (e) (e) |P=0.137 P=0.507 (e) P=0.236 | |POLY 6 | (e) (e) (e) (e) |P=0.138 P=0.515 (e) P=0.238 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.144 P=0.371 (e) P=0.237 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.140 P=0.500 (e) P=0.247 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.074 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 18 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 1/46.48 0/43.80 |0/43.63 1/46.01 0/42.33 3/43.50 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |0.0% 2.2% 0.0% 6.9% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 1/41 (2%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 2/35 (6%) | |FIRST INCIDENCE | --- --- 729 (T) --- |--- 513 --- 705 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.681 (e) P=0.515 (e) |P=0.043 * P=0.500 (e) P=0.118 | |POLY 3 | P=0.677 (e) P=0.508 (e) |P=0.041 * P=0.511 (e) P=0.118 | |POLY 1.5 | P=0.684 (e) P=0.506 (e) |P=0.042 * P=0.507 (e) P=0.117 | |POLY 6 | P=0.666 (e) P=0.511 (e) |P=0.041 * P=0.515 (e) P=0.119 | |LOGISTIC REGRESSION| (e) (e) P=0.515 (e) |P=0.045 * P=0.371 (e) P=0.120 | |COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.044 * P=0.500 (e) P=0.121 | |ORDER RESTRICTED | P=0.389 (e) (e) (e) |P=0.020 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Skin | | Schwannoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 0/46.48 0/43.80 |3/44.09 1/45.90 0/42.33 1/43.57 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.8% 2.2% 0.0% 2.3% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |2/36 (6%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |591 561 --- 685 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.211N P=0.317N P=0.144N P=0.310N | |POLY 3 | (e) (e) (e) (e) |P=0.207N P=0.291N P=0.126N P=0.309N | |POLY 1.5 | (e) (e) (e) (e) |P=0.206N P=0.296N P=0.125N P=0.309N | |POLY 6 | (e) (e) (e) (e) |P=0.210N P=0.285N P=0.127N P=0.308N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.192N P=0.337N P=0.121N P=0.305N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.200N P=0.309N P=0.121N P=0.309N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.085N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 19 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/49 (4%) 1/48 (2%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.91 0/47.28 1/46.72 0/43.80 |2/44.00 1/44.82 1/42.00 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 0.0% |4.6% 2.2% 2.4% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |1/36 (3%) 0/35 (0%) 1/31 (3%) 0/35 (0%) | |FIRST INCIDENCE | --- --- 667 --- |606 674 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.690 (e) P=0.529 (e) |P=0.159N P=0.484N P=0.535N P=0.240N | |POLY 3 | P=0.675 (e) P=0.512 (e) |P=0.159N P=0.494N P=0.516N P=0.240N | |POLY 1.5 | P=0.684 (e) P=0.511 (e) |P=0.157N P=0.500N P=0.515N P=0.239N | |POLY 6 | P=0.662 (e) P=0.515 (e) |P=0.161N P=0.485N P=0.518N P=0.240N | |LOGISTIC REGRESSION| P=0.721 (e) P=0.492 (e) |P=0.147N P=0.535N P=0.504N P=0.221N | |COCH-ARM / FISHERS | P=0.699 (e) P=0.510 (e) |P=0.149N P=0.508N P=0.500N P=0.242N | |ORDER RESTRICTED | P=0.392 (e) (e) (e) |P=0.120N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 2/46.48 2/44.19 |0/43.63 1/45.35 3/42.84 1/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.3% 4.5% |0.0% 2.2% 7.0% 2.3% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 2/41 (5%) 1/33 (3%) |0/36 (0%) 1/35 (3%) 2/31 (7%) 1/35 (3%) | |FIRST INCIDENCE | --- --- 729 (T) 618 |--- 729 (T) 574 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.067 (e) P=0.255 P=0.222 |P=0.341 P=0.494 P=0.102 P=0.494 | |POLY 3 | P=0.080 (e) P=0.246 P=0.235 |P=0.343 P=0.508 P=0.115 P=0.499 | |POLY 1.5 | P=0.082 (e) P=0.243 P=0.236 |P=0.344 P=0.505 P=0.114 P=0.498 | |POLY 6 | P=0.076 (e) P=0.250 P=0.233 |P=0.344 P=0.511 P=0.116 P=0.500 | |LOGISTIC REGRESSION| P=0.085 (e) P=0.255 P=0.240 |P=0.347 P=0.494 P=0.120 P=0.494 | |COCH-ARM / FISHERS | P=0.086 (e) P=0.247 P=0.247 |P=0.351 P=0.500 P=0.121 P=0.500 | |ORDER RESTRICTED | P=0.114 (e) (e) (e) |P=0.150 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 20 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 2/46.48 2/44.19 |0/43.63 0/45.35 2/42.84 1/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.3% 4.5% |0.0% 0.0% 4.7% 2.3% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 2/41 (5%) 1/33 (3%) |0/36 (0%) 0/35 (0%) 1/31 (3%) 1/35 (3%) | |FIRST INCIDENCE | --- --- 729 (T) 618 |--- --- 574 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.067 (e) P=0.255 P=0.222 |P=0.241 (e) P=0.216 P=0.494 | |POLY 3 | P=0.080 (e) P=0.246 P=0.235 |P=0.239 (e) P=0.233 P=0.499 | |POLY 1.5 | P=0.082 (e) P=0.243 P=0.236 |P=0.240 (e) P=0.232 P=0.498 | |POLY 6 | P=0.076 (e) P=0.250 P=0.233 |P=0.239 (e) P=0.234 P=0.500 | |LOGISTIC REGRESSION| P=0.085 (e) P=0.255 P=0.240 |P=0.247 (e) P=0.244 P=0.494 | |COCH-ARM / FISHERS | P=0.086 (e) P=0.247 P=0.247 |P=0.246 (e) P=0.247 P=0.500 | |ORDER RESTRICTED | P=0.114 (e) (e) (e) |P=0.164 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.60 2/47.28 0/46.48 0/43.80 |0/43.63 0/45.35 0/42.33 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 4.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/38 (0%) 2/41 (5%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- 729 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.434N P=0.255 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.396N P=0.250 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.399N P=0.245 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.394N P=0.257 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.255 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.262N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 21 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | | |POLY-3 RATE (b) | 0/44.60 0/47.28 0/46.48 2/43.80 | | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% | | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 2/33 (6%) | | |FIRST INCIDENCE | --- --- --- 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.033 * (e) (e) P=0.208 | | |POLY 3 | P=0.043 * (e) (e) P=0.233 | | |POLY 1.5 | P=0.044 * (e) (e) P=0.235 | | |POLY 6 | P=0.042 * (e) (e) P=0.230 | | |LOGISTIC REGRESSION| (e) (e) (e) P=0.208 | | |COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 | | |ORDER RESTRICTED | P=0.028 * (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |1/50 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | |POLY-3 RATE (b) | |1/43.63 0/45.35 0/42.33 3/43.40 | |POLY-3 PERCENT (g) | |2.3% 0.0% 0.0% 6.9% | |TERMINAL (d) | |1/36 (3%) 0/35 (0%) 0/31 (0%) 3/35 (9%) | |FIRST INCIDENCE | |729 (T) --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.085 P=0.506N P=0.530N P=0.295 | |POLY 3 | |P=0.081 P=0.492N P=0.506N P=0.303 | |POLY 1.5 | |P=0.082 P=0.495N P=0.506N P=0.302 | |POLY 6 | |P=0.080 P=0.489N P=0.507N P=0.305 | |LOGISTIC REGRESSION| |P=0.085 (e) (e) P=0.295 | |COCH-ARM / FISHERS | |P=0.086 P=0.500N P=0.500N P=0.309 | |ORDER RESTRICTED | |P=0.037 * (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 22 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 1/46.48 0/43.80 |2/43.63 1/45.35 1/42.33 1/43.79 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |4.6% 2.2% 2.4% 2.3% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 1/41 (2%) 0/33 (0%) |2/36 (6%) 1/35 (3%) 1/31 (3%) 0/35 (0%) | |FIRST INCIDENCE | --- --- 729 (T) --- |729 (T) 729 (T) 729 (T) 618 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.681 (e) P=0.515 (e) |P=0.418N P=0.510N P=0.552N P=0.501N | |POLY 3 | P=0.677 (e) P=0.508 (e) |P=0.416N P=0.486N P=0.511N P=0.499N | |POLY 1.5 | P=0.684 (e) P=0.506 (e) |P=0.416N P=0.491N P=0.511N P=0.501N | |POLY 6 | P=0.666 (e) P=0.511 (e) |P=0.416N P=0.480N P=0.512N P=0.495N | |LOGISTIC REGRESSION| (e) (e) P=0.515 (e) |P=0.415N P=0.510N P=0.552N P=0.501N | |COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.409N P=0.500N P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.389 (e) (e) (e) |P=0.412N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |3/50 (6%) 4/50 (8%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 1/44.60 2/47.28 2/46.72 2/43.80 |3/44.05 4/45.56 2/42.58 1/43.40 | |POLY-3 PERCENT (g) | 2.2% 4.2% 4.3% 4.6% |6.8% 8.8% 4.7% 2.3% | |TERMINAL (d) | 1/38 (3%) 2/41 (5%) 1/41 (2%) 2/33 (6%) |2/36 (6%) 3/35 (9%) 1/31 (3%) 1/35 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 667 729 (T) |606 674 662 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.363 P=0.527 P=0.534 P=0.451 |P=0.173N P=0.502 P=0.540N P=0.312N | |POLY 3 | P=0.409 P=0.520 P=0.516 P=0.494 |P=0.170N P=0.518 P=0.515N P=0.310N | |POLY 1.5 | P=0.415 P=0.512 P=0.511 P=0.497 |P=0.169N P=0.512 P=0.515N P=0.310N | |POLY 6 | P=0.399 P=0.530 P=0.522 P=0.489 |P=0.171N P=0.527 P=0.517N P=0.310N | |LOGISTIC REGRESSION| P=0.399 P=0.527 P=0.508 P=0.451 |P=0.167N P=0.512 P=0.508N P=0.307N | |COCH-ARM / FISHERS | P=0.423 P=0.500 P=0.500 P=0.500 |P=0.162N P=0.500 P=0.500N P=0.309N | |ORDER RESTRICTED | P=0.457 (e) (e) (e) |P=0.211N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 23 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |5/50 (10%) 5/50 (10%) 3/50 (6%) 2/50 (4%) | |POLY-3 RATE (b) | 1/44.60 2/47.28 3/46.72 2/43.80 |5/44.05 5/45.56 3/42.58 2/43.79 | |POLY-3 PERCENT (g) | 2.2% 4.2% 6.4% 4.6% |11.4% 11.0% 7.1% 4.6% | |TERMINAL (d) | 1/38 (3%) 2/41 (5%) 2/41 (5%) 2/33 (6%) |4/36 (11%) 4/35 (11%) 2/31 (7%) 1/35 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 667 729 (T) |606 674 662 618 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.339 P=0.527 P=0.340 P=0.451 |P=0.141N P=0.626 P=0.420N P=0.224N | |POLY 3 | P=0.386 P=0.520 P=0.322 P=0.494 |P=0.134N P=0.609N P=0.375N P=0.218N | |POLY 1.5 | P=0.394 P=0.512 P=0.316 P=0.497 |P=0.134N P=0.616N P=0.374N P=0.219N | |POLY 6 | P=0.374 P=0.530 P=0.329 P=0.489 |P=0.134N P=0.599N P=0.377N P=0.215N | |LOGISTIC REGRESSION| P=0.376 P=0.527 P=0.318 P=0.451 |P=0.134N P=0.607N P=0.372N P=0.218N | |COCH-ARM / FISHERS | P=0.404 P=0.500 P=0.309 P=0.500 |P=0.128N P=0.630N P=0.357N P=0.218N | |ORDER RESTRICTED | P=0.365 (e) (e) (e) |P=0.201N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 4/50 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 1/44.86 0/47.28 2/46.48 3/44.39 |0/43.63 1/45.35 4/43.11 2/44.00 | |POLY-3 PERCENT (g) | 2.2% 0.0% 4.3% 6.8% |0.0% 2.2% 9.3% 4.6% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 2/41 (5%) 1/33 (3%) |0/36 (0%) 1/35 (3%) 1/31 (3%) 1/35 (3%) | |FIRST INCIDENCE | 661 --- 729 (T) 595 |--- 729 (T) 503 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.083 P=0.477N P=0.528 P=0.287 |P=0.159 P=0.494 P=0.059 P=0.234 | |POLY 3 | P=0.097 P=0.489N P=0.512 P=0.301 |P=0.163 P=0.508 P=0.058 P=0.239 | |POLY 1.5 | P=0.099 P=0.493N P=0.509 P=0.303 |P=0.161 P=0.505 P=0.058 P=0.237 | |POLY 6 | P=0.093 P=0.485N P=0.516 P=0.298 |P=0.165 P=0.511 P=0.059 P=0.242 | |LOGISTIC REGRESSION| P=0.109 P=0.531N P=0.506 P=0.309 |P=0.169 P=0.494 P=0.064 P=0.247 | |COCH-ARM / FISHERS | P=0.104 P=0.500N P=0.500 P=0.309 |P=0.165 P=0.500 P=0.059 P=0.247 | |ORDER RESTRICTED | P=0.104 (e) (e) (e) |P=0.073 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 24 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |23/50 (46%) 19/50 (38%) 28/50 (56%) 27/50 (54%) | |POLY-3 RATE (b) | 3/45.53 1/47.28 0/46.48 3/44.19 |23/45.56 19/46.35 28/43.89 27/45.42 | |POLY-3 PERCENT (g) | 6.6% 2.1% 0.0% 6.8% |50.5% 41.0% 63.8% 59.5% | |TERMINAL (d) | 2/38 (5%) 1/41 (2%) 0/41 (0%) 2/33 (6%) |19/36 (53%) 16/35 (46%) 23/31 (74%) 22/35 (63%) | |FIRST INCIDENCE | 301 729 (T) --- 616 |440 492 503 447 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.480 P=0.287N P=0.114N P=0.616 |P=0.094 P=0.296N P=0.073 P=0.250 | |POLY 3 | P=0.514 P=0.292N P=0.115N P=0.649 |P=0.089 P=0.238N P=0.138 P=0.254 | |POLY 1.5 | P=0.519 P=0.298N P=0.117N P=0.653 |P=0.093 P=0.249N P=0.149 P=0.253 | |POLY 6 | P=0.508 P=0.283N P=0.113N P=0.644 |P=0.089 P=0.224N P=0.126 P=0.264 | |LOGISTIC REGRESSION| P=0.555 P=0.406N P=0.196N P=0.653N |P=0.095 P=0.232N P=0.161 P=0.259 | |COCH-ARM / FISHERS | P=0.526 P=0.309N P=0.121N P=0.661N |P=0.121 P=0.272N P=0.212 P=0.274 | |ORDER RESTRICTED | P=0.268 (e) (e) (e) |P=0.089 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 0/46.48 0/43.80 |0/43.63 1/45.39 1/42.71 2/44.56 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 2.3% 4.5% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 719 622 447 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.154 P=0.505 P=0.495 P=0.247 | |POLY 3 | (e) (e) (e) (e) |P=0.156 P=0.508 P=0.496 P=0.242 | |POLY 1.5 | (e) (e) (e) (e) |P=0.154 P=0.505 P=0.495 P=0.239 | |POLY 6 | (e) (e) (e) (e) |P=0.159 P=0.512 P=0.496 P=0.246 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.167 P=0.511 P=0.520 P=0.273 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.153 P=0.500 P=0.500 P=0.247 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.122 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 25 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 0/46.48 0/43.80 |0/43.63 1/45.39 1/42.71 2/44.56 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 2.3% 4.5% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 719 622 447 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.154 P=0.505 P=0.495 P=0.247 | |POLY 3 | (e) (e) (e) (e) |P=0.156 P=0.508 P=0.496 P=0.242 | |POLY 1.5 | (e) (e) (e) (e) |P=0.154 P=0.505 P=0.495 P=0.239 | |POLY 6 | (e) (e) (e) (e) |P=0.159 P=0.512 P=0.496 P=0.246 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.167 P=0.511 P=0.520 P=0.273 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.153 P=0.500 P=0.500 P=0.247 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.122 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 34/50 (68%) 38/50 (76%) 37/50 (74%) 34/50 (68%) |38/50 (76%) 27/50 (54%) 33/50 (66%) 31/50 (62%) | |POLY-3 RATE (b) | 34/48.07 38/47.86 37/48.25 34/46.91 |38/46.54 27/46.09 33/44.32 31/45.66 | |POLY-3 PERCENT (g) | 70.7% 79.4% 76.7% 72.5% |81.6% 58.6% 74.5% 67.9% | |TERMINAL (d) | 27/38 (71%) 35/41 (85%) 32/41 (78%) 24/33 (73%) |31/36 (86%) 22/35 (63%) 24/31 (77%) 25/35 (71%) | |FIRST INCIDENCE | 484 604 543 535 |524 673 574 475 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.243 P=0.472 P=0.541 P=0.314 |P=0.307N P=0.028N* P=0.527N P=0.144N | |POLY 3 | P=0.528N P=0.223 P=0.330 P=0.515 |P=0.234N P=0.010N* P=0.273N P=0.090N | |POLY 1.5 | P=0.499N P=0.239 P=0.339 P=0.541 |P=0.238N P=0.011N* P=0.263N P=0.094N | |POLY 6 | P=0.538 P=0.207 P=0.317 P=0.492 |P=0.231N P=0.009N** P=0.293N P=0.085N | |LOGISTIC REGRESSION| P=0.509N P=0.343 P=0.382 P=0.569 |P=0.253N P=0.006N** P=0.234N P=0.094N | |COCH-ARM / FISHERS | P=0.447N P=0.252 P=0.330 P=0.585N |P=0.219N P=0.018N* P=0.189N P=0.097N | |ORDER RESTRICTED | P=0.419 (e) (e) (e) |P=0.075N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 26 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 29/50 (58%) 22/50 (44%) 30/50 (60%) 27/50 (54%) |33/50 (66%) 38/50 (76%) 41/50 (82%) 41/50 (82%) | |POLY-3 RATE (b) | 29/49.08 22/49.00 30/50.00 27/47.63 |33/47.24 38/49.43 41/46.20 41/48.78 | |POLY-3 PERCENT (g) | 59.1% 44.9% 60.0% 56.7% |69.9% 76.9% 88.8% 84.1% | |TERMINAL (d) | 19/38 (50%) 17/41 (42%) 21/41 (51%) 14/33 (42%) |24/36 (67%) 24/35 (69%) 27/31 (87%) 29/35 (83%) | |FIRST INCIDENCE | 301 431 543 535 |440 461 503 142 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.290 P=0.088N P=0.496N P=0.526 |P=0.081 P=0.253 P=0.031 * P=0.097 | |POLY 3 | P=0.435 P=0.113N P=0.544 P=0.487N |P=0.041 * P=0.289 P=0.018 * P=0.073 | |POLY 1.5 | P=0.451 P=0.114N P=0.526 P=0.470N |P=0.040 * P=0.252 P=0.019 * P=0.066 | |POLY 6 | P=0.428 P=0.113N P=0.568 P=0.498N |P=0.043 * P=0.334 P=0.018 * P=0.081 | |LOGISTIC REGRESSION| P=0.525N P=0.175N P=0.400 P=0.405N |P=0.033 * P=0.197 P=0.028 * P=0.053 | |COCH-ARM / FISHERS | P=0.500 P=0.115N P=0.500 P=0.420N |P=0.043 * P=0.189 P=0.055 P=0.055 | |ORDER RESTRICTED | P=0.419 (e) (e) (e) |P=0.025 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 45/50 (90%) 45/50 (90%) 47/50 (94%) 45/50 (90%) |47/50 (94%) 45/50 (90%) 46/50 (92%) 47/50 (94%) | |POLY-3 RATE (b) | 45/49.62 45/49.46 47/50.00 45/48.32 |47/49.05 45/49.43 46/46.71 47/49.24 | |POLY-3 PERCENT (g) | 90.7% 91.0% 94.0% 93.1% |95.8% 91.0% 98.5% 95.4% | |TERMINAL (d) | 34/38 (90%) 38/41 (93%) 38/41 (93%) 30/33 (91%) |34/36 (94%) 31/35 (89%) 31/31 (100%) 33/35 (94%) | |FIRST INCIDENCE | 301 431 543 535 |440 461 503 142 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.123 P=0.312N P=0.478N P=0.252 |P=0.384 P=0.453N P=0.276 P=0.514 | |POLY 3 | P=0.355 P=0.618 P=0.402 P=0.470 |P=0.439 P=0.288N P=0.427 P=0.659N | |POLY 1.5 | P=0.392 P=0.622 P=0.381 P=0.508 |P=0.459 P=0.286N P=0.512 P=0.642N | |POLY 6 | P=0.356 P=0.615 P=0.434 P=0.467 |P=0.414 P=0.312N P=0.315 P=0.684N | |LOGISTIC REGRESSION| P=0.504 P=0.630N P=0.332 P=0.618 |P=0.369 P=0.300N P=0.660 P=0.632 | |COCH-ARM / FISHERS | P=0.533 P=0.630N P=0.357 P=0.630N |P=0.482 P=0.357N P=0.500N P=0.661N | |ORDER RESTRICTED | P=0.465 (e) (e) (e) |P=0.311 (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). --multipart-boundary Content-type: text/plain Range: bytes 234605-234605/234605 --multipart-boundary--