TDMS Study 96017-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID) DATE: 05/19/04 EXPERIMENT: 96017 TEST: 06 TIME: 09:19:53 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96017 PATHOLOGIST: HEATH, JAMES CAS: 631-64-1 ------------------------------------------------------------------------------------------------------------------------------------ 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 (DIBROMOACETIC ACID) DATE: 05/19/04 EXPERIMENT: 96017 TEST: 06 TIME: 09:19:53 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96017 PATHOLOGIST: HEATH, JAMES CAS: 631-64-1 Mice(B6C3F1) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED. --------------- Adrenal Cortex Adrenal Medulla Bone Marrow Heart Islets, Pancreatic Kidney Liver Lung Ovary Pancreas Pituitary Gland Spleen Testes Thyroid Gland NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID) DATE: 05/19/04 EXPERIMENT: 96017 TEST: 06 TIME: 09:19:53 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96017 PATHOLOGIST: HEATH, JAMES CAS: 631-64-1 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF WATER DISINFECTION BYPRODUCTS (DIBROMOAC =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex Adenoma Intestine Small: Jejunum Carcinoma Intestine Small: Site Unspecified Carcinoma Liver Hepatoblastoma Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Spleen Hemangiosarcoma All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Liver Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Skin Fibrous Histiocytoma Thyroid Gland: Follicular Cell Adenoma Tongue Squamous Cell Carcinoma or Papilloma Squamous All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant and Benign Tumors =============================================================== Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 4/50 (8%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 3/42.26 4/46.25 2/43.74 0/43.55 |0/45.94 0/45.44 1/44.30 0/45.07 | |POLY-3 PERCENT (g) | 7.1% 8.7% 4.6% 0.0% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 3/31 (10%) 3/38 (8%) 2/34 (6%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 659 729 (T) --- |--- --- 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.050N P=0.607 P=0.458N P=0.120N |P=0.611 (e) P=0.466 (e) | |POLY 3 | P=0.042N* P=0.549 P=0.484N P=0.113N |P=0.637 (e) P=0.493 (e) | |POLY 1.5 | P=0.041N* P=0.533 P=0.487N P=0.113N |P=0.636 (e) P=0.496 (e) | |POLY 6 | P=0.045N* P=0.569 P=0.482N P=0.114N |P=0.637 (e) P=0.487 (e) | |LOGISTIC REGRESSION| P=0.046N* P=0.564 P=0.458N (e) |(e) (e) P=0.466 (e) | |COCH-ARM / FISHERS | P=0.041N* P=0.511 P=0.490N P=0.117N |P=0.631 (e) P=0.500 (e) | |ORDER RESTRICTED | P=0.075N (e) (e) (e) |P=0.374 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 5/50 (10%) 7/50 (14%) |9/50 (18%) 4/50 (8%) 8/50 (16%) 8/50 (16%) | |POLY-3 RATE (b) | 3/42.29 5/46.02 5/43.80 7/43.64 |9/46.71 4/46.54 8/45.08 8/45.43 | |POLY-3 PERCENT (g) | 7.1% 10.9% 11.4% 16.0% |19.3% 8.6% 17.8% 17.6% | |TERMINAL (d) | 3/31 (10%) 4/38 (11%) 4/34 (12%) 6/31 (19%) |6/38 (16%) 2/35 (6%) 5/32 (16%) 5/32 (16%) | |FIRST INCIDENCE | 729 (T) 721 714 706 |591 487 622 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.109 P=0.474 P=0.405 P=0.154 |P=0.278 P=0.149N P=0.584 P=0.586 | |POLY 3 | P=0.151 P=0.404 P=0.375 P=0.169 |P=0.334 P=0.116N P=0.532N P=0.525N | |POLY 1.5 | P=0.156 P=0.387 P=0.371 P=0.168 |P=0.344 P=0.117N P=0.517N P=0.517N | |POLY 6 | P=0.141 P=0.423 P=0.379 P=0.166 |P=0.318 P=0.117N P=0.558N P=0.540N | |LOGISTIC REGRESSION| P=0.109 P=0.457 P=0.383 P=0.147 |P=0.361 P=0.108N P=0.509N P=0.513N | |COCH-ARM / FISHERS | P=0.153 P=0.357 P=0.357 P=0.159 |P=0.362 P=0.117N P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.152 (e) (e) (e) |P=0.426N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 0/42.29 0/45.99 0/43.74 0/43.55 |1/45.94 2/45.98 2/44.44 1/45.39 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 4.4% 4.5% 2.2% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |1/38 (3%) 0/35 (0%) 1/32 (3%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 615 692 659 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.543N P=0.491 P=0.446 P=0.747 | |POLY 3 | (e) (e) (e) (e) |P=0.517N P=0.500 P=0.488 P=0.758 | |POLY 1.5 | (e) (e) (e) (e) |P=0.515N P=0.499 P=0.494 P=0.758 | |POLY 6 | (e) (e) (e) (e) |P=0.522N P=0.502 P=0.479 P=0.757 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.503N P=0.511 P=0.480 P=0.761N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.510N P=0.500 P=0.500 P=0.753N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.540 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 5/50 (10%) 7/50 (14%) |10/50 (20%) 5/50 (10%) 10/50 (20%) 9/50 (18%) | |POLY-3 RATE (b) | 3/42.29 5/46.02 5/43.80 7/43.64 |10/46.71 5/46.68 10/45.22 9/45.69 | |POLY-3 PERCENT (g) | 7.1% 10.9% 11.4% 16.0% |21.4% 10.7% 22.1% 19.7% | |TERMINAL (d) | 3/31 (10%) 4/38 (11%) 4/34 (12%) 6/31 (19%) |7/38 (18%) 2/35 (6%) 6/32 (19%) 5/32 (16%) | |FIRST INCIDENCE | 729 (T) 721 714 706 |591 487 622 659 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.109 P=0.474 P=0.405 P=0.154 |P=0.263 P=0.168N P=0.462 P=0.576 | |POLY 3 | P=0.151 P=0.404 P=0.375 P=0.169 |P=0.324 P=0.129N P=0.568 P=0.521N | |POLY 1.5 | P=0.156 P=0.387 P=0.371 P=0.168 |P=0.333 P=0.130N P=0.582 P=0.515N | |POLY 6 | P=0.141 P=0.423 P=0.379 P=0.166 |P=0.309 P=0.129N P=0.543 P=0.532N | |LOGISTIC REGRESSION| P=0.109 P=0.457 P=0.383 P=0.147 |P=0.350 P=0.123N P=0.584 P=0.512N | |COCH-ARM / FISHERS | P=0.153 P=0.357 P=0.357 P=0.159 |P=0.350 P=0.131N P=0.598N P=0.500N | |ORDER RESTRICTED | P=0.152 (e) (e) (e) |P=0.434 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Intestine Small: Duodenum | | Polyp Adenomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.29 1/45.99 2/43.74 1/44.25 |0/45.94 2/45.70 0/44.30 0/45.13 | |POLY-3 PERCENT (g) | 0.0% 2.2% 4.6% 2.3% |0.0% 4.4% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 1/38 (3%) 2/34 (6%) 0/31 (0%) |0/38 (0%) 1/35 (3%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 489 |--- 659 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.357 P=0.541 P=0.259 P=0.513 |P=0.241N P=0.236 (e) (e) | |POLY 3 | P=0.387 P=0.517 P=0.245 P=0.509 |P=0.230N P=0.236 (e) (e) | |POLY 1.5 | P=0.387 P=0.511 P=0.243 P=0.507 |P=0.229N P=0.236 (e) (e) | |POLY 6 | P=0.382 P=0.523 P=0.246 P=0.509 |P=0.233N P=0.236 (e) (e) | |LOGISTIC REGRESSION| P=0.372 P=0.541 P=0.259 P=0.346 |P=0.226N P=0.239 (e) (e) | |COCH-ARM / FISHERS | P=0.377 P=0.500 P=0.247 P=0.500 |P=0.227N P=0.247 (e) (e) | |ORDER RESTRICTED | P=0.233 (e) (e) (e) |P=0.250N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/42.29 2/45.99 0/43.74 3/43.55 |0/45.94 0/45.44 0/44.30 1/45.13 | |POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 6.9% |0.0% 0.0% 0.0% 2.2% | |TERMINAL (d) | 0/31 (0%) 2/38 (5%) 0/34 (0%) 3/31 (10%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- 729 (T) --- 729 (T) |--- --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.129 P=0.284 (e) P=0.120 |P=0.167 (e) (e) P=0.466 | |POLY 3 | P=0.157 P=0.256 (e) P=0.124 |P=0.183 (e) (e) P=0.496 | |POLY 1.5 | P=0.157 P=0.249 (e) P=0.123 |P=0.183 (e) (e) P=0.497 | |POLY 6 | P=0.156 P=0.264 (e) P=0.122 |P=0.181 (e) (e) P=0.494 | |LOGISTIC REGRESSION| (e) P=0.284 (e) P=0.120 |(e) (e) (e) P=0.466 | |COCH-ARM / FISHERS | P=0.153 P=0.247 (e) P=0.121 |P=0.184 (e) (e) P=0.500 | |ORDER RESTRICTED | P=0.039 * (e) (e) (e) |P=0.116 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/42.29 2/45.99 0/43.74 4/43.55 |0/45.94 0/45.44 0/44.30 1/45.13 | |POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 9.2% |0.0% 0.0% 0.0% 2.2% | |TERMINAL (d) | 0/31 (0%) 2/38 (5%) 0/34 (0%) 4/31 (13%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- 729 (T) --- 729 (T) |--- --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.045 * P=0.284 (e) P=0.062 |P=0.167 (e) (e) P=0.466 | |POLY 3 | P=0.059 P=0.256 (e) P=0.064 |P=0.183 (e) (e) P=0.496 | |POLY 1.5 | P=0.059 P=0.249 (e) P=0.063 |P=0.183 (e) (e) P=0.497 | |POLY 6 | P=0.058 P=0.264 (e) P=0.062 |P=0.181 (e) (e) P=0.494 | |LOGISTIC REGRESSION| (e) P=0.284 (e) P=0.062 |(e) (e) (e) P=0.466 | |COCH-ARM / FISHERS | P=0.059 P=0.247 (e) P=0.059 |P=0.184 (e) (e) P=0.500 | |ORDER RESTRICTED | P=0.012 * (e) (e) (e) |P=0.116 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Polyp Adenomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/42.29 3/45.99 2/43.74 1/44.25 |0/45.94 2/45.70 0/44.30 0/45.13 | |POLY-3 PERCENT (g) | 2.4% 6.5% 4.6% 2.3% |0.0% 4.4% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 3/38 (8%) 2/34 (6%) 0/31 (0%) |0/38 (0%) 1/35 (3%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 489 |--- 659 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.413N P=0.380 P=0.532 P=0.753N |P=0.241N P=0.236 (e) (e) | |POLY 3 | P=0.371N P=0.336 P=0.512 P=0.751N |P=0.230N P=0.236 (e) (e) | |POLY 1.5 | P=0.373N P=0.325 P=0.509 P=0.753N |P=0.229N P=0.236 (e) (e) | |POLY 6 | P=0.374N P=0.348 P=0.514 P=0.751N |P=0.233N P=0.236 (e) (e) | |LOGISTIC REGRESSION| P=0.383N P=0.380 P=0.532 P=0.724 |P=0.226N P=0.239 (e) (e) | |COCH-ARM / FISHERS | P=0.383N P=0.309 P=0.500 P=0.753N |P=0.227N P=0.247 (e) (e) | |ORDER RESTRICTED | P=0.467N (e) (e) (e) |P=0.250N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/46 (0%) 3/50 (6%) 4/50 (8%) 3/49 (6%) |1/49 (2%) 0/49 (0%) 2/49 (4%) 2/46 (4%) | |POLY-3 RATE (b) | 0/40.18 3/46.02 4/44.19 3/43.10 |1/45.58 0/44.88 2/44.58 2/42.85 | |POLY-3 PERCENT (g) | 0.0% 6.5% 9.1% 7.0% |2.2% 0.0% 4.5% 4.7% | |TERMINAL (d) | 0/31 (0%) 2/38 (5%) 3/34 (9%) 3/31 (10%) |1/38 (3%) 0/35 (0%) 1/32 (3%) 2/32 (6%) | |FIRST INCIDENCE | --- 721 596 729 (T) |729 (T) --- 553 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.172 P=0.163 P=0.074 P=0.120 |P=0.154 P=0.516N P=0.460 P=0.440 | |POLY 3 | P=0.211 P=0.144 P=0.073 P=0.131 |P=0.169 P=0.503N P=0.492 P=0.478 | |POLY 1.5 | P=0.215 P=0.140 P=0.072 P=0.132 |P=0.168 P=0.502N P=0.496 P=0.478 | |POLY 6 | P=0.201 P=0.148 P=0.072 P=0.128 |P=0.168 P=0.504N P=0.484 P=0.477 | |LOGISTIC REGRESSION| P=0.201 P=0.151 P=0.074 P=0.120 |P=0.161 (e) P=0.517 P=0.440 | |COCH-ARM / FISHERS | P=0.215 P=0.137 P=0.069 P=0.133 |P=0.165 P=0.500N P=0.500 P=0.476 | |ORDER RESTRICTED | P=0.094 (e) (e) (e) |P=0.249 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/46 (0%) 3/50 (6%) 4/50 (8%) 3/49 (6%) |1/49 (2%) 0/49 (0%) 3/49 (6%) 2/46 (4%) | |POLY-3 RATE (b) | 0/40.18 3/46.02 4/44.19 3/43.10 |1/45.58 0/44.88 3/44.92 2/42.85 | |POLY-3 PERCENT (g) | 0.0% 6.5% 9.1% 7.0% |2.2% 0.0% 6.7% 4.7% | |TERMINAL (d) | 0/31 (0%) 2/38 (5%) 3/34 (9%) 3/31 (10%) |1/38 (3%) 0/35 (0%) 1/32 (3%) 2/32 (6%) | |FIRST INCIDENCE | --- 721 596 729 (T) |729 (T) --- 553 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.172 P=0.163 P=0.074 P=0.120 |P=0.149 P=0.516N P=0.274 P=0.440 | |POLY 3 | P=0.211 P=0.144 P=0.073 P=0.131 |P=0.158 P=0.503N P=0.300 P=0.478 | |POLY 1.5 | P=0.215 P=0.140 P=0.072 P=0.132 |P=0.157 P=0.502N P=0.303 P=0.478 | |POLY 6 | P=0.201 P=0.148 P=0.072 P=0.128 |P=0.157 P=0.504N P=0.293 P=0.477 | |LOGISTIC REGRESSION| P=0.201 P=0.151 P=0.074 P=0.120 |P=0.146 (e) P=0.321 P=0.440 | |COCH-ARM / FISHERS | P=0.215 P=0.137 P=0.069 P=0.133 |P=0.154 P=0.500N P=0.309 P=0.476 | |ORDER RESTRICTED | P=0.094 (e) (e) (e) |P=0.182 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |1/49 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) | |POLY-3 RATE (b) | 1/42.26 2/45.99 0/43.74 2/43.55 |1/45.87 1/45.44 2/44.76 0/45.07 | |POLY-3 PERCENT (g) | 2.4% 4.4% 0.0% 4.6% |2.2% 2.2% 4.5% 0.0% | |TERMINAL (d) | 1/31 (3%) 2/38 (5%) 0/34 (0%) 2/31 (7%) |0/38 (0%) 1/35 (3%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |653 729 (T) 617 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.505 P=0.571 P=0.482N P=0.500 |P=0.395N P=0.751 P=0.473 P=0.500N | |POLY 3 | P=0.541 P=0.529 P=0.493N P=0.510 |P=0.382N P=0.758 P=0.491 P=0.503N | |POLY 1.5 | P=0.543 P=0.520 P=0.494N P=0.510 |P=0.380N P=0.760N P=0.499 P=0.502N | |POLY 6 | P=0.536 P=0.541 P=0.492N P=0.508 |P=0.387N P=0.756 P=0.480 P=0.507N | |LOGISTIC REGRESSION| P=0.505 P=0.571 (e) P=0.500 |P=0.382N P=0.753N P=0.548 P=0.493N | |COCH-ARM / FISHERS | P=0.543 P=0.508 P=0.495N P=0.508 |P=0.379N P=0.747N P=0.508 P=0.500N | |ORDER RESTRICTED | P=0.415 (e) (e) (e) |P=0.271N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 4/50 (8%) 6/50 (12%) 18/50 (36%) |1/49 (2%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 0/42.26 4/46.04 6/45.11 18/46.03 |1/45.58 0/45.44 1/44.48 1/45.07 | |POLY-3 PERCENT (g) | 0.0% 8.7% 13.3% 39.1% |2.2% 0.0% 2.3% 2.2% | |TERMINAL (d) | 0/31 (0%) 3/38 (8%) 3/34 (9%) 9/31 (29%) |1/38 (3%) 0/35 (0%) 0/32 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- 717 573 469 |729 (T) --- 680 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.094 P=0.024 * P<0.001 ** |P=0.418 P=0.516N P=0.730 P=0.723 | |POLY 3 | P<0.001 ** P=0.072 P=0.019 * P<0.001 ** |P=0.450 P=0.501N P=0.755 P=0.758 | |POLY 1.5 | P<0.001 ** P=0.068 P=0.018 * P<0.001 ** |P=0.450 P=0.499N P=0.760 P=0.759 | |POLY 6 | P<0.001 ** P=0.077 P=0.020 * P<0.001 ** |P=0.447 P=0.502N P=0.748 P=0.755 | |LOGISTIC REGRESSION| P<0.001 ** P=0.083 P=0.018 * P<0.001 ** |P=0.446 (e) P=0.762N P=0.723 | |COCH-ARM / FISHERS | P<0.001 ** P=0.061 P=0.014 * P<0.001 ** |P=0.448 P=0.495N P=0.747N P=0.753N | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.530 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/49 (37%) 37/50 (74%) 37/50 (74%) 42/50 (84%) |19/49 (39%) 26/50 (52%) 32/50 (64%) 35/49 (71%) | |POLY-3 RATE (b) | 18/43.32 37/47.46 37/46.19 42/47.33 |19/45.87 26/45.74 32/45.91 35/46.13 | |POLY-3 PERCENT (g) | 41.6% 78.0% 80.1% 88.7% |41.4% 56.8% 69.7% 75.9% | |TERMINAL (d) | 14/31 (45%) 31/38 (82%) 29/34 (85%) 29/31 (94%) |18/38 (47%) 22/35 (63%) 26/32 (81%) 28/32 (88%) | |FIRST INCIDENCE | 596 573 573 469 |653 694 573 636 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.055 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.098 P=0.004 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.109 P=0.006 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.089 P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.083 P=0.002 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.131 P=0.010 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/49 (29%) 9/50 (18%) 19/50 (38%) 26/50 (52%) |3/49 (6%) 3/50 (6%) 12/50 (24%) 8/49 (16%) | |POLY-3 RATE (b) | 14/44.73 9/46.45 19/46.69 26/47.37 |3/45.93 3/45.58 12/44.94 8/45.29 | |POLY-3 PERCENT (g) | 31.3% 19.4% 40.7% 54.9% |6.5% 6.6% 26.7% 17.7% | |TERMINAL (d) | 6/31 (19%) 6/38 (16%) 10/34 (29%) 14/31 (45%) |1/38 (3%) 2/35 (6%) 9/32 (28%) 7/32 (22%) | |FIRST INCIDENCE | 451 659 573 476 |658 694 617 671 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.097N P=0.284 P=0.031 * |P=0.013 * P=0.637 P=0.007 ** P=0.069 | |POLY 3 | P<0.001 ** P=0.141N P=0.236 P=0.016 * |P=0.019 * P=0.659 P=0.009 ** P=0.094 | |POLY 1.5 | P<0.001 ** P=0.147N P=0.227 P=0.015 * |P=0.020 * P=0.661N P=0.010 * P=0.096 | |POLY 6 | P<0.001 ** P=0.137N P=0.249 P=0.018 * |P=0.017 * P=0.654 P=0.007 ** P=0.088 | |LOGISTIC REGRESSION| P<0.001 ** P=0.160N P=0.213 P=0.014 * |P=0.021 * P=0.658N P=0.011 * P=0.096 | |COCH-ARM / FISHERS | P<0.001 ** P=0.157N P=0.217 P=0.015 * |P=0.022 * P=0.651N P=0.013 * P=0.100 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.019 * (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/49 (29%) 11/50 (22%) 23/50 (46%) 37/50 (74%) |4/49 (8%) 3/50 (6%) 13/50 (26%) 9/49 (18%) | |POLY-3 RATE (b) | 14/44.73 11/46.45 23/47.04 37/49.04 |4/45.93 3/45.58 13/45.13 9/45.29 | |POLY-3 PERCENT (g) | 31.3% 23.7% 48.9% 75.5% |8.7% 6.6% 28.8% 19.9% | |TERMINAL (d) | 6/31 (19%) 8/38 (21%) 13/34 (38%) 20/31 (65%) |2/38 (5%) 2/35 (6%) 9/32 (28%) 8/32 (25%) | |FIRST INCIDENCE | 451 659 573 469 |658 694 617 671 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.189N P=0.108 P<0.001 ** |P=0.010 * P=0.529N P=0.009 ** P=0.075 | |POLY 3 | P<0.001 ** P=0.281N P=0.063 P<0.001 ** |P=0.015 * P=0.504N P=0.012 * P=0.109 | |POLY 1.5 | P<0.001 ** P=0.289N P=0.059 P<0.001 ** |P=0.016 * P=0.499N P=0.014 * P=0.113 | |POLY 6 | P<0.001 ** P=0.275N P=0.072 P<0.001 ** |P=0.014 * P=0.510N P=0.010 * P=0.102 | |LOGISTIC REGRESSION| P<0.001 ** P=0.298N P=0.055 P<0.001 ** |P=0.017 * P=0.497N P=0.014 * P=0.110 | |COCH-ARM / FISHERS | P<0.001 ** P=0.301N P=0.056 P<0.001 ** |P=0.018 * P=0.489N P=0.017 * P=0.116 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.017 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/49 (57%) 41/50 (82%) 42/50 (84%) 47/50 (94%) |22/49 (45%) 28/50 (56%) 37/50 (74%) 37/49 (76%) | |POLY-3 RATE (b) | 28/45.72 41/47.77 42/47.58 47/48.97 |22/46.21 28/45.74 37/46.56 37/46.35 | |POLY-3 PERCENT (g) | 61.2% 85.8% 88.3% 96.0% |47.6% 61.2% 79.5% 79.8% | |TERMINAL (d) | 17/31 (55%) 33/38 (87%) 30/34 (88%) 30/31 (97%) |19/38 (50%) 24/35 (69%) 28/32 (88%) 29/32 (91%) | |FIRST INCIDENCE | 451 573 573 469 |653 694 573 636 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.157 P=0.039 * P=0.002 ** |P<0.001 ** P=0.084 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.131 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.004 ** P=0.002 ** P<0.001 ** |P<0.001 ** P=0.149 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.005 ** P=0.002 ** P<0.001 ** |P<0.001 ** P=0.112 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.012 * P=0.003 ** P<0.001 ** |P<0.001 ** P=0.127 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.006 ** P=0.003 ** P<0.001 ** |P<0.001 ** P=0.183 P=0.003 ** P=0.002 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 9 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/49 (57%) 41/50 (82%) 43/50 (86%) 48/50 (96%) |22/49 (45%) 28/50 (56%) 37/50 (74%) 37/49 (76%) | |POLY-3 RATE (b) | 28/45.72 41/47.77 43/47.58 48/49.30 |22/46.21 28/45.74 37/46.56 37/46.35 | |POLY-3 PERCENT (g) | 61.2% 85.8% 90.4% 97.4% |47.6% 61.2% 79.5% 79.8% | |TERMINAL (d) | 17/31 (55%) 33/38 (87%) 31/34 (91%) 30/31 (97%) |19/38 (50%) 24/35 (69%) 28/32 (88%) 29/32 (91%) | |FIRST INCIDENCE | 451 573 573 469 |653 694 573 636 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.157 P=0.026 * P=0.002 ** |P<0.001 ** P=0.084 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.131 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.149 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.112 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.127 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.183 P=0.003 ** P=0.002 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/49 (14%) 5/50 (10%) 17/50 (34%) 12/50 (24%) |1/50 (2%) 3/50 (6%) 3/50 (6%) 6/50 (12%) | |POLY-3 RATE (b) | 7/43.05 5/46.44 17/44.31 12/45.15 |1/45.94 3/46.14 3/44.93 6/45.51 | |POLY-3 PERCENT (g) | 16.3% 10.8% 38.4% 26.6% |2.2% 6.5% 6.7% 13.2% | |TERMINAL (d) | 5/31 (16%) 4/38 (11%) 15/34 (44%) 8/31 (26%) |1/38 (3%) 2/35 (6%) 1/32 (3%) 4/32 (13%) | |FIRST INCIDENCE | 482 596 604 489 |729 (T) 490 553 636 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.013 * P=0.269N P=0.030 * P=0.162 |P=0.035 * P=0.283 P=0.265 P=0.042 * | |POLY 3 | P=0.019 * P=0.326N P=0.016 * P=0.178 |P=0.044 * P=0.307 P=0.297 P=0.054 | |POLY 1.5 | P=0.021 * P=0.344N P=0.017 * P=0.174 |P=0.044 * P=0.306 P=0.302 P=0.055 | |POLY 6 | P=0.016 * P=0.306N P=0.016 * P=0.179 |P=0.042 * P=0.307 P=0.289 P=0.053 | |LOGISTIC REGRESSION| P=0.022 * P=0.360N P=0.021 * P=0.166 |P=0.049 * P=0.321 P=0.317 P=0.055 | |COCH-ARM / FISHERS | P=0.025 * P=0.365N P=0.019 * P=0.166 |P=0.047 * P=0.309 P=0.309 P=0.056 | |ORDER RESTRICTED | P=0.020 * (e) (e) (e) |P=0.027 * (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 10 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 8/50 (16%) 8/50 (16%) 7/50 (14%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 5/42.59 8/46.17 8/43.94 7/43.93 |1/45.94 2/45.58 2/44.68 2/45.13 | |POLY-3 PERCENT (g) | 11.7% 17.3% 18.2% 15.9% |2.2% 4.4% 4.5% 4.4% | |TERMINAL (d) | 3/31 (10%) 6/38 (16%) 6/34 (18%) 5/31 (16%) |1/38 (3%) 1/35 (3%) 1/32 (3%) 2/32 (6%) | |FIRST INCIDENCE | 662 691 699 652 |729 (T) 694 622 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.356 P=0.410 P=0.326 P=0.374 |P=0.398 P=0.481 P=0.460 P=0.440 | |POLY 3 | P=0.436 P=0.329 P=0.294 P=0.400 |P=0.440 P=0.497 P=0.490 P=0.494 | |POLY 1.5 | P=0.446 P=0.312 P=0.293 P=0.400 |P=0.443 P=0.498 P=0.495 P=0.496 | |POLY 6 | P=0.417 P=0.349 P=0.295 P=0.396 |P=0.433 P=0.497 P=0.482 P=0.490 | |LOGISTIC REGRESSION| P=0.403 P=0.353 P=0.299 P=0.396 |P=0.443 P=0.496 P=0.505 P=0.440 | |COCH-ARM / FISHERS | P=0.451 P=0.290 P=0.290 P=0.394 |P=0.448 P=0.500 P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.394 (e) (e) (e) |P=0.455 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/49 (24%) 12/50 (24%) 22/50 (44%) 17/50 (34%) |2/50 (4%) 5/50 (10%) 5/50 (10%) 7/50 (14%) | |POLY-3 RATE (b) | 12/43.38 12/46.62 22/44.52 17/45.53 |2/45.94 5/46.27 5/45.31 7/45.51 | |POLY-3 PERCENT (g) | 27.7% 25.7% 49.4% 37.3% |4.4% 10.8% 11.0% 15.4% | |TERMINAL (d) | 8/31 (26%) 9/38 (24%) 18/34 (53%) 11/31 (36%) |2/38 (5%) 3/35 (9%) 2/32 (6%) 5/32 (16%) | |FIRST INCIDENCE | 482 596 604 489 |729 (T) 490 553 636 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.039 * P=0.398N P=0.057 P=0.200 |P=0.074 P=0.196 P=0.176 P=0.054 | |POLY 3 | P=0.066 P=0.513N P=0.027 * P=0.226 |P=0.095 P=0.219 P=0.210 P=0.076 | |POLY 1.5 | P=0.071 P=0.538N P=0.028 * P=0.220 |P=0.097 P=0.218 P=0.214 P=0.077 | |POLY 6 | P=0.058 P=0.482N P=0.025 * P=0.229 |P=0.092 P=0.221 P=0.204 P=0.075 | |LOGISTIC REGRESSION| P=0.063 P=0.523N P=0.034 * P=0.211 |P=0.103 P=0.222 P=0.227 P=0.075 | |COCH-ARM / FISHERS | P=0.075 P=0.570N P=0.033 * P=0.207 |P=0.101 P=0.218 P=0.218 P=0.080 | |ORDER RESTRICTED | P=0.071 (e) (e) (e) |P=0.061 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 11 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.29 0/45.99 0/43.74 0/43.55 |0/45.94 2/45.50 1/44.30 0/45.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 2.3% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 1/35 (3%) 1/32 (3%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 715 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.359N P=0.225 P=0.466 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.333N P=0.235 P=0.493 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.331N P=0.236 P=0.496 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.337N P=0.234 P=0.487 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.343N P=0.234 P=0.466 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.326N P=0.247 P=0.500 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.320 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.29 0/45.99 0/43.74 0/43.55 |2/46.48 1/45.44 0/44.30 0/45.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.3% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |1/38 (3%) 1/35 (3%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |563 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.120N P=0.519N P=0.259N P=0.256N | |POLY 3 | (e) (e) (e) (e) |P=0.109N P=0.508N P=0.248N P=0.244N | |POLY 1.5 | (e) (e) (e) (e) |P=0.108N P=0.505N P=0.243N P=0.242N | |POLY 6 | (e) (e) (e) (e) |P=0.111N P=0.511N P=0.256N P=0.248N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.101N P=0.486N P=0.220N P=0.205N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.107N P=0.500N P=0.247N P=0.247N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.078N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 12 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |0/49 (0%) 2/47 (4%) 1/47 (2%) 0/49 (0%) | |POLY-3 RATE (b) | |0/44.94 2/42.71 1/41.30 0/45.07 | |POLY-3 PERCENT (g) | |0.0% 4.7% 2.4% 0.0% | |TERMINAL (d) | |0/37 (0%) 2/34 (6%) 1/29 (3%) 0/32 (0%) | |FIRST INCIDENCE | |--- 729 (T) 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.362N P=0.220 P=0.451 (e) | |POLY 3 | |P=0.325N P=0.226 P=0.483 (e) | |POLY 1.5 | |P=0.324N P=0.226 P=0.487 (e) | |POLY 6 | |P=0.329N P=0.226 P=0.476 (e) | |LOGISTIC REGRESSION| |(e) P=0.220 P=0.451 (e) | |COCH-ARM / FISHERS | |P=0.324N P=0.237 P=0.490 (e) | |ORDER RESTRICTED | |P=0.307N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/45 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) |2/47 (4%) 4/49 (8%) 0/49 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 0/39.54 0/45.99 0/42.09 0/42.44 |2/43.62 4/44.58 0/43.30 1/44.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.6% 9.0% 0.0% 2.3% | |TERMINAL (d) | 0/30 (0%) 0/38 (0%) 0/33 (0%) 0/31 (0%) |1/36 (3%) 3/34 (9%) 0/31 (0%) 1/31 (3%) | |FIRST INCIDENCE | --- --- --- --- |720 694 --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.146N P=0.316 P=0.278N P=0.553N | |POLY 3 | (e) (e) (e) (e) |P=0.114N P=0.347 P=0.239N P=0.496N | |POLY 1.5 | (e) (e) (e) (e) |P=0.112N P=0.350 P=0.234N P=0.493N | |POLY 6 | (e) (e) (e) (e) |P=0.118N P=0.344 P=0.247N P=0.502N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.122N P=0.341 P=0.256N P=0.520N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.109N P=0.359 P=0.237N P=0.484N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.135N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 13 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/45 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) |1/47 (2%) 0/49 (0%) 2/49 (4%) 0/49 (0%) | |POLY-3 RATE (b) | 0/39.54 0/45.99 0/42.09 0/42.44 |1/43.58 0/44.44 2/43.69 0/44.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 0.0% 4.6% 0.0% | |TERMINAL (d) | 0/30 (0%) 0/38 (0%) 0/33 (0%) 0/31 (0%) |1/36 (3%) 0/34 (0%) 1/31 (3%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) --- 618 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.572N P=0.511N P=0.465 P=0.530N | |POLY 3 | (e) (e) (e) (e) |P=0.548N P=0.496N P=0.501 P=0.498N | |POLY 1.5 | (e) (e) (e) (e) |P=0.547N P=0.495N P=0.507 P=0.496N | |POLY 6 | (e) (e) (e) (e) |P=0.552N P=0.498N P=0.491 P=0.501N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.540N (e) P=0.525 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.543N P=0.490N P=0.516 P=0.490N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.322N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Skeletal Muscle | | Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/42.29 1/46.44 0/43.74 0/43.55 |1/45.94 1/45.44 0/44.30 2/45.13 | |POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |2.2% 2.2% 0.0% 4.4% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |1/38 (3%) 1/35 (3%) 0/32 (0%) 2/32 (6%) | |FIRST INCIDENCE | --- 596 --- --- |729 (T) 729 (T) --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.414N P=0.509 (e) (e) |P=0.331 P=0.743 P=0.534N P=0.440 | |POLY 3 | P=0.399N P=0.519 (e) (e) |P=0.372 P=0.758 P=0.507N P=0.494 | |POLY 1.5 | P=0.404N P=0.512 (e) (e) |P=0.375 P=0.759 P=0.504N P=0.496 | |POLY 6 | P=0.393N P=0.526 (e) (e) |P=0.368 P=0.758 P=0.513N P=0.490 | |LOGISTIC REGRESSION| P=0.443N P=0.447 (e) (e) |P=0.331 P=0.743 (e) P=0.440 | |COCH-ARM / FISHERS | P=0.414N P=0.500 (e) (e) |P=0.377 P=0.753N P=0.500N P=0.500 | |ORDER RESTRICTED | P=0.392N (e) (e) (e) |P=0.268 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 14 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |4/50 (8%) 3/50 (6%) 3/50 (6%) 6/50 (12%) | |POLY-3 RATE (b) | 1/42.73 1/45.99 0/43.74 1/43.81 |4/46.02 3/46.30 3/45.07 6/45.44 | |POLY-3 PERCENT (g) | 2.3% 2.2% 0.0% 2.3% |8.7% 6.5% 6.7% 13.2% | |TERMINAL (d) | 0/31 (0%) 1/38 (3%) 0/34 (0%) 0/31 (0%) |3/38 (8%) 0/35 (0%) 1/32 (3%) 2/32 (6%) | |FIRST INCIDENCE | 601 729 (T) --- 659 |710 490 573 682 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.591N P=0.733N P=0.495N P=0.752N |P=0.181 P=0.535N P=0.568N P=0.295 | |POLY 3 | P=0.580N P=0.744N P=0.495N P=0.755N |P=0.210 P=0.497N P=0.511N P=0.361 | |POLY 1.5 | P=0.579N P=0.750N P=0.496N P=0.755N |P=0.214 P=0.499N P=0.506N P=0.363 | |POLY 6 | P=0.584N P=0.738N P=0.496N P=0.757N |P=0.204 P=0.494N P=0.522N P=0.357 | |LOGISTIC REGRESSION| P=0.586N P=0.750 P=0.536N P=0.738 |P=0.224 P=0.489N P=0.493N P=0.351 | |COCH-ARM / FISHERS | P=0.579N P=0.753N P=0.500N P=0.753N |P=0.219 P=0.500N P=0.500N P=0.370 | |ORDER RESTRICTED | P=0.527N (e) (e) (e) |P=0.252 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 0/42.29 1/45.99 0/43.74 0/43.55 |1/46.02 2/46.23 2/44.81 2/45.17 | |POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |2.2% 4.3% 4.5% 4.4% | |TERMINAL (d) | 0/31 (0%) 1/38 (3%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 1/32 (3%) 1/32 (3%) | |FIRST INCIDENCE | --- 729 (T) --- --- |710 490 573 719 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.427N P=0.541 (e) (e) |P=0.411 P=0.483 P=0.462 P=0.450 | |POLY 3 | P=0.400N P=0.517 (e) (e) |P=0.437 P=0.502 P=0.491 P=0.494 | |POLY 1.5 | P=0.405N P=0.511 (e) (e) |P=0.441 P=0.501 P=0.495 P=0.495 | |POLY 6 | P=0.395N P=0.523 (e) (e) |P=0.430 P=0.502 P=0.482 P=0.490 | |LOGISTIC REGRESSION| (e) P=0.541 (e) (e) |P=0.474 P=0.544 P=0.517 P=0.490 | |COCH-ARM / FISHERS | P=0.414N P=0.500 (e) (e) |P=0.448 P=0.500 P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.391N (e) (e) (e) |P=0.455 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 15 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |4/50 (8%) 3/50 (6%) 3/50 (6%) 6/50 (12%) | |POLY-3 RATE (b) | 0/42.29 1/45.99 0/43.74 1/43.81 |4/46.02 3/46.30 3/45.07 6/45.44 | |POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 2.3% |8.7% 6.5% 6.7% 13.2% | |TERMINAL (d) | 0/31 (0%) 1/38 (3%) 0/34 (0%) 0/31 (0%) |3/38 (8%) 0/35 (0%) 1/32 (3%) 2/32 (6%) | |FIRST INCIDENCE | --- 729 (T) --- 659 |710 490 573 682 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.467 P=0.541 (e) P=0.510 |P=0.181 P=0.535N P=0.568N P=0.295 | |POLY 3 | P=0.491 P=0.517 (e) P=0.507 |P=0.210 P=0.497N P=0.511N P=0.361 | |POLY 1.5 | P=0.490 P=0.511 (e) P=0.506 |P=0.214 P=0.499N P=0.506N P=0.363 | |POLY 6 | P=0.491 P=0.523 (e) P=0.507 |P=0.204 P=0.494N P=0.522N P=0.357 | |LOGISTIC REGRESSION| P=0.483 P=0.541 (e) P=0.489 |P=0.224 P=0.489N P=0.493N P=0.351 | |COCH-ARM / FISHERS | P=0.482 P=0.500 (e) P=0.500 |P=0.219 P=0.500N P=0.500N P=0.370 | |ORDER RESTRICTED | P=0.258 (e) (e) (e) |P=0.252 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Skin | | Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.29 0/45.99 0/43.74 1/43.81 |3/45.94 0/45.44 0/44.30 0/45.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.3% |6.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |3/38 (8%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- 659 |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.180 (e) (e) P=0.510 |P=0.112N P=0.136N P=0.153N P=0.153N | |POLY 3 | P=0.183 (e) (e) P=0.507 |P=0.092N P=0.121N P=0.125N P=0.122N | |POLY 1.5 | P=0.185 (e) (e) P=0.506 |P=0.091N P=0.120N P=0.122N P=0.121N | |POLY 6 | P=0.181 (e) (e) P=0.507 |P=0.093N P=0.121N P=0.131N P=0.124N | |LOGISTIC REGRESSION| P=0.179 (e) (e) P=0.489 |P=0.112N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.184 (e) (e) P=0.500 |P=0.094N P=0.121N P=0.121N P=0.121N | |ORDER RESTRICTED | P=0.127 (e) (e) (e) |P=0.009N** (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 16 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Skin | | Neurofibrosarcoma or Schwannoma (malignant or NOS) | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/42.29 0/45.99 0/43.74 0/43.55 |0/45.94 2/46.42 0/44.30 1/45.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 2.2% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- --- --- --- |--- 383 --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.631N P=0.237 (e) P=0.466 | |POLY 3 | (e) (e) (e) (e) |P=0.611N P=0.240 (e) P=0.496 | |POLY 1.5 | (e) (e) (e) (e) |P=0.609N P=0.239 (e) P=0.497 | |POLY 6 | (e) (e) (e) (e) |P=0.616N P=0.240 (e) P=0.494 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.536N P=0.321 (e) P=0.466 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.606N P=0.247 (e) P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.322 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Skin | | Neurofibrosarcoma, Neurofibroma, or Schwannoma (benign, | | malignant or NOS) | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/42.29 0/45.99 0/43.74 0/43.55 |0/45.94 2/46.42 0/44.30 2/45.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 4.4% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 2/32 (6%) | |FIRST INCIDENCE | --- --- --- --- |--- 383 --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.323 P=0.237 (e) P=0.201 | |POLY 3 | (e) (e) (e) (e) |P=0.347 P=0.240 (e) P=0.233 | |POLY 1.5 | (e) (e) (e) (e) |P=0.349 P=0.239 (e) P=0.234 | |POLY 6 | (e) (e) (e) (e) |P=0.342 P=0.240 (e) P=0.231 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.398 P=0.321 (e) P=0.201 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.354 P=0.247 (e) P=0.247 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.113 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 17 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Skin | | Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 4/50 (8%) | |POLY-3 RATE (b) | 0/42.29 0/45.99 0/43.74 0/43.55 |1/45.94 1/45.52 1/44.56 4/45.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 2.2% 2.2% 8.8% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |1/38 (3%) 0/35 (0%) 0/32 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 710 659 682 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.056 P=0.743 P=0.736 P=0.152 | |POLY 3 | (e) (e) (e) (e) |P=0.063 P=0.759 P=0.754 P=0.175 | |POLY 1.5 | (e) (e) (e) (e) |P=0.064 P=0.759 P=0.757 P=0.176 | |POLY 6 | (e) (e) (e) (e) |P=0.062 P=0.758 P=0.748 P=0.173 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.064 P=0.760 P=0.760N P=0.173 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.065 P=0.753N P=0.753N P=0.181 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.073 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/47 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | |POLY-3 RATE (b) | 2/40.70 3/45.99 0/43.74 0/43.55 |0/45.94 0/45.44 0/44.30 0/44.12 | |POLY-3 PERCENT (g) | 4.9% 6.5% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/30 (7%) 3/38 (8%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.045N* P=0.608 P=0.211N P=0.231N |(e) (e) (e) (e) | |POLY 3 | P=0.039N* P=0.555 P=0.221N P=0.222N |(e) (e) (e) (e) | |POLY 1.5 | P=0.039N* P=0.544 P=0.222N P=0.222N |(e) (e) (e) (e) | |POLY 6 | P=0.040N* P=0.568 P=0.221N P=0.224N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.045N* P=0.608 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.039N* P=0.530 P=0.232N P=0.232N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.089N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 18 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 1/42.56 1/45.99 0/43.74 1/43.55 |1/45.94 1/45.44 3/44.34 1/45.13 | |POLY-3 PERCENT (g) | 2.4% 2.2% 0.0% 2.3% |2.2% 2.2% 6.8% 2.2% | |TERMINAL (d) | 0/31 (0%) 1/38 (3%) 0/34 (0%) 1/31 (3%) |1/38 (3%) 1/35 (3%) 2/32 (6%) 1/32 (3%) | |FIRST INCIDENCE | 655 729 (T) --- 729 (T) |729 (T) 729 (T) 718 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.601N P=0.721N P=0.505N P=0.757N |P=0.453 P=0.743 P=0.249 P=0.723 | |POLY 3 | P=0.580N P=0.743N P=0.495N P=0.756N |P=0.503 P=0.758 P=0.293 P=0.757 | |POLY 1.5 | P=0.579N P=0.749N P=0.496N P=0.756N |P=0.505 P=0.759 P=0.299 P=0.758 | |POLY 6 | P=0.584N P=0.737N P=0.495N P=0.758N |P=0.498 P=0.758 P=0.282 P=0.754 | |LOGISTIC REGRESSION| P=0.580N P=0.763N P=0.510N P=0.760N |P=0.470 P=0.743 P=0.258 P=0.723 | |COCH-ARM / FISHERS | P=0.579N P=0.753N P=0.500N P=0.753N |P=0.510 P=0.753N P=0.309 P=0.753N | |ORDER RESTRICTED | P=0.527N (e) (e) (e) |P=0.428 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.29 0/45.99 0/43.74 1/43.55 |1/45.94 1/45.44 2/44.34 0/45.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.3% |2.2% 2.2% 4.5% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 1/31 (3%) |1/38 (3%) 1/35 (3%) 1/32 (3%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- 729 (T) |729 (T) 729 (T) 718 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.170 (e) (e) P=0.500 |P=0.421N P=0.743 P=0.442 P=0.534N | |POLY 3 | P=0.183 (e) (e) P=0.506 |P=0.383N P=0.758 P=0.488 P=0.504N | |POLY 1.5 | P=0.184 (e) (e) P=0.505 |P=0.381N P=0.759 P=0.494 P=0.503N | |POLY 6 | P=0.179 (e) (e) P=0.505 |P=0.387N P=0.758 P=0.478 P=0.506N | |LOGISTIC REGRESSION| (e) (e) (e) P=0.500 |P=0.404N P=0.743 P=0.458 (e) | |COCH-ARM / FISHERS | P=0.184 (e) (e) P=0.500 |P=0.377N P=0.753N P=0.500 P=0.500N | |ORDER RESTRICTED | P=0.126 (e) (e) (e) |P=0.269N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 19 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | |POLY-3 RATE (b) | 0/42.26 2/45.99 0/43.74 1/43.55 | | |POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 2.3% | | |TERMINAL (d) | 0/31 (0%) 2/38 (5%) 0/34 (0%) 1/31 (3%) | | |FIRST INCIDENCE | --- 729 (T) --- 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.634N P=0.284 (e) P=0.500 | | |POLY 3 | P=0.594N P=0.256 (e) P=0.506 | | |POLY 1.5 | P=0.598N P=0.250 (e) P=0.506 | | |POLY 6 | P=0.591N P=0.264 (e) P=0.505 | | |LOGISTIC REGRESSION| (e) P=0.284 (e) P=0.500 | | |COCH-ARM / FISHERS | P=0.603N P=0.253 (e) P=0.505 | | |ORDER RESTRICTED | P=0.330 (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/41.70 0/45.99 1/43.74 1/43.55 |3/46.00 0/45.44 0/44.30 0/45.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 2.3% |6.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 1/34 (3%) 1/31 (3%) |2/38 (5%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 729 (T) |714 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.183 (e) P=0.518 P=0.500 |P=0.111N P=0.138N P=0.156N P=0.151N | |POLY 3 | P=0.199 (e) P=0.509 P=0.509 |P=0.091N P=0.121N P=0.126N P=0.122N | |POLY 1.5 | P=0.203 (e) P=0.509 P=0.509 |P=0.091N P=0.120N P=0.122N P=0.121N | |POLY 6 | P=0.193 (e) P=0.509 P=0.506 |P=0.093N P=0.122N P=0.131N P=0.124N | |LOGISTIC REGRESSION| (e) (e) P=0.518 P=0.500 |P=0.102N P=0.123N P=0.138N P=0.129N | |COCH-ARM / FISHERS | P=0.205 (e) P=0.510 P=0.510 |P=0.094N P=0.121N P=0.121N P=0.121N | |ORDER RESTRICTED | P=0.259 (e) (e) (e) |P=0.009N** (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 20 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma or Papilloma Squamous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.29 0/45.99 0/43.74 0/43.55 |2/46.48 0/45.44 0/44.30 0/45.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |1/38 (3%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |563 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.188N P=0.249N P=0.259N P=0.256N | |POLY 3 | (e) (e) (e) (e) |P=0.176N P=0.242N P=0.248N P=0.244N | |POLY 1.5 | (e) (e) (e) (e) |P=0.175N P=0.241N P=0.243N P=0.242N | |POLY 6 | (e) (e) (e) (e) |P=0.177N P=0.244N P=0.256N P=0.248N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.160N P=0.212N P=0.220N P=0.205N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.178N P=0.247N P=0.247N P=0.247N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.032N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 0/42.29 1/45.99 2/43.85 0/43.55 |3/45.94 1/45.44 2/44.56 1/45.13 | |POLY-3 PERCENT (g) | 0.0% 2.2% 4.6% 0.0% |6.5% 2.2% 4.5% 2.2% | |TERMINAL (d) | 0/31 (0%) 1/38 (3%) 1/34 (3%) 0/31 (0%) |3/38 (8%) 1/35 (3%) 1/32 (3%) 1/32 (3%) | |FIRST INCIDENCE | --- 729 (T) 699 --- |729 (T) 729 (T) 659 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.606N P=0.541 P=0.253 (e) |P=0.399N P=0.335N P=0.567N P=0.368N | |POLY 3 | P=0.575N P=0.517 P=0.245 (e) |P=0.353N P=0.309N P=0.514N P=0.312N | |POLY 1.5 | P=0.573N P=0.511 P=0.243 (e) |P=0.351N P=0.308N P=0.507N P=0.310N | |POLY 6 | P=0.580N P=0.523 P=0.247 (e) |P=0.357N P=0.310N P=0.525N P=0.315N | |LOGISTIC REGRESSION| P=0.591N P=0.541 P=0.245 (e) |P=0.361N P=0.335N P=0.523N P=0.368N | |COCH-ARM / FISHERS | P=0.579N P=0.500 P=0.247 (e) |P=0.347N P=0.309N P=0.500N P=0.309N | |ORDER RESTRICTED | P=0.331 (e) (e) (e) |P=0.226N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 21 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 4/42.29 4/45.99 0/43.74 2/43.55 |1/46.22 2/45.44 2/44.76 1/45.49 | |POLY-3 PERCENT (g) | 9.5% 8.7% 0.0% 4.6% |2.2% 4.4% 4.5% 2.2% | |TERMINAL (d) | 4/31 (13%) 4/38 (11%) 0/34 (0%) 2/31 (7%) |0/38 (0%) 2/35 (6%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |653 729 (T) 617 629 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.146N P=0.528N P=0.051N P=0.335N |P=0.531N P=0.481 P=0.473 P=0.755N | |POLY 3 | P=0.127N P=0.597N P=0.056N P=0.323N |P=0.516N P=0.494 P=0.489 P=0.757 | |POLY 1.5 | P=0.125N P=0.613N P=0.057N P=0.325N |P=0.514N P=0.496 P=0.494 P=0.758 | |POLY 6 | P=0.130N P=0.578N P=0.055N P=0.325N |P=0.521N P=0.491 P=0.479 P=0.755 | |LOGISTIC REGRESSION| P=0.146N P=0.528N (e) P=0.335N |P=0.497N P=0.499 P=0.521 P=0.737N | |COCH-ARM / FISHERS | P=0.126N P=0.643N P=0.059N P=0.339N |P=0.510N P=0.500 P=0.500 P=0.753N | |ORDER RESTRICTED | P=0.118N (e) (e) (e) |P=0.536 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 5/50 (10%) 2/50 (4%) 2/50 (4%) |4/50 (8%) 3/50 (6%) 4/50 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 4/42.29 5/45.99 2/43.85 2/43.55 |4/46.22 3/45.44 4/45.02 2/45.49 | |POLY-3 PERCENT (g) | 9.5% 10.9% 4.6% 4.6% |8.7% 6.6% 8.9% 4.4% | |TERMINAL (d) | 4/31 (13%) 5/38 (13%) 1/34 (3%) 2/31 (7%) |3/38 (8%) 3/35 (9%) 1/32 (3%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 699 729 (T) |653 729 (T) 617 629 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.165N P=0.628 P=0.301N P=0.335N |P=0.379N P=0.538N P=0.574 P=0.389N | |POLY 3 | P=0.138N P=0.552 P=0.320N P=0.323N |P=0.331N P=0.509N P=0.629 P=0.345N | |POLY 1.5 | P=0.136N P=0.534 P=0.325N P=0.325N |P=0.330N P=0.506N P=0.636 P=0.343N | |POLY 6 | P=0.143N P=0.573 P=0.316N P=0.325N |P=0.335N P=0.514N P=0.617 P=0.349N | |LOGISTIC REGRESSION| P=0.162N P=0.628 P=0.315N P=0.335N |P=0.326N P=0.507N P=0.638N P=0.336N | |COCH-ARM / FISHERS | P=0.137N P=0.500 P=0.339N P=0.339N |P=0.325N P=0.500N P=0.643N P=0.339N | |ORDER RESTRICTED | P=0.259N (e) (e) (e) |P=0.341N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 22 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 5/50 (10%) 3/50 (6%) 2/50 (4%) |27/50 (54%) 24/50 (48%) 17/50 (34%) 14/50 (28%) | |POLY-3 RATE (b) | 0/42.29 5/45.99 3/45.77 2/43.55 |27/46.69 24/46.42 17/45.30 14/46.14 | |POLY-3 PERCENT (g) | 0.0% 10.9% 6.6% 4.6% |57.8% 51.7% 37.5% 30.3% | |TERMINAL (d) | 0/31 (0%) 5/38 (13%) 0/34 (0%) 2/31 (7%) |25/38 (66%) 21/35 (60%) 12/32 (38%) 11/32 (34%) | |FIRST INCIDENCE | --- 729 (T) 367 729 (T) |474 490 618 430 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.572N P=0.053 P=0.127 P=0.238 |P=0.015N* P=0.496N P=0.133N P=0.034N* | |POLY 3 | P=0.518N P=0.038 * P=0.133 P=0.244 |P=0.002N** P=0.348N P=0.036N* P=0.005N** | |POLY 1.5 | P=0.522N P=0.035 * P=0.129 P=0.243 |P=0.002N** P=0.351N P=0.035N* P=0.006N** | |POLY 6 | P=0.520N P=0.041 * P=0.137 P=0.242 |P=0.002N** P=0.341N P=0.040N* P=0.005N** | |LOGISTIC REGRESSION| P=0.562N P=0.053 P=0.034 * P=0.238 |P=0.003N** P=0.360N P=0.050N P=0.008N** | |COCH-ARM / FISHERS | P=0.540N P=0.028 * P=0.121 P=0.247 |P=0.003N** P=0.345N P=0.035N* P=0.007N** | |ORDER RESTRICTED | P=0.108 (e) (e) (e) |P=0.003N** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 25/50 (50%) 38/50 (76%) 42/50 (84%) 46/50 (92%) |29/50 (58%) 33/50 (66%) 41/50 (82%) 38/50 (76%) | |POLY-3 RATE (b) | 25/44.13 38/47.73 42/46.46 46/48.58 |29/47.59 33/47.80 41/47.98 38/46.23 | |POLY-3 PERCENT (g) | 56.7% 79.6% 90.4% 94.7% |60.9% 69.0% 85.5% 82.2% | |TERMINAL (d) | 19/31 (61%) 31/38 (82%) 32/34 (94%) 31/31 (100%)|23/38 (61%) 25/35 (71%) 28/32 (88%) 30/32 (94%) | |FIRST INCIDENCE | 482 573 573 469 |563 487 553 636 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.118 P=0.005 ** P<0.001 ** |P=0.005 ** P=0.178 P=0.003 ** P=0.006 ** | |POLY 3 | P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |P=0.005 ** P=0.267 P=0.004 ** P=0.015 * | |POLY 1.5 | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** |P=0.008 ** P=0.266 P=0.005 ** P=0.022 * | |POLY 6 | P<0.001 ** P=0.018 * P<0.001 ** P<0.001 ** |P=0.002 ** P=0.264 P=0.004 ** P=0.009 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.019 * P<0.001 ** P<0.001 ** |P=0.014 * P=0.251 P=0.005 ** P=0.028 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P=0.022 * P=0.268 P=0.008 ** P=0.044 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.005 ** (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 23 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 23/50 (46%) 28/50 (56%) 32/50 (64%) 43/50 (86%) |36/50 (72%) 37/50 (74%) 34/50 (68%) 32/50 (64%) | |POLY-3 RATE (b) | 23/45.18 28/47.09 32/49.55 43/49.30 |36/48.25 37/48.14 34/48.06 32/48.45 | |POLY-3 PERCENT (g) | 50.9% 59.5% 64.6% 87.2% |74.6% 76.9% 70.8% 66.0% | |TERMINAL (d) | 12/31 (39%) 22/38 (58%) 17/34 (50%) 25/31 (81%) |29/38 (76%) 27/35 (77%) 19/32 (59%) 18/32 (56%) | |FIRST INCIDENCE | 451 596 367 469 |474 383 573 430 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.538 P=0.162 P=0.002 ** |P=0.481N P=0.324 P=0.376 P=0.539 | |POLY 3 | P<0.001 ** P=0.267 P=0.125 P<0.001 ** |P=0.124N P=0.491 P=0.421N P=0.240N | |POLY 1.5 | P<0.001 ** P=0.250 P=0.096 P<0.001 ** |P=0.139N P=0.495 P=0.422N P=0.256N | |POLY 6 | P<0.001 ** P=0.274 P=0.156 P<0.001 ** |P=0.106N P=0.484 P=0.410N P=0.220N | |LOGISTIC REGRESSION| P<0.001 ** P=0.305 P=0.051 P<0.001 ** |P=0.155N P=0.482 P=0.443N P=0.271N | |COCH-ARM / FISHERS | P<0.001 ** P=0.212 P=0.054 P<0.001 ** |P=0.147N P=0.500 P=0.414N P=0.260N | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.221N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 37/50 (74%) 44/50 (88%) 49/50 (98%) 50/50 (100%)|42/50 (84%) 43/50 (86%) 46/50 (92%) 48/50 (96%) | |POLY-3 RATE (b) | 37/46.78 44/48.04 49/50.00 50/50.00 |42/49.36 43/48.89 46/48.62 48/49.06 | |POLY-3 PERCENT (g) | 79.1% 91.6% 98.0% 100.0% |85.1% 88.0% 94.6% 97.9% | |TERMINAL (d) | 23/31 (74%) 35/38 (92%) 33/34 (97%) 31/31 (100%)|31/38 (82%) 31/35 (89%) 30/32 (94%) 31/32 (97%) | |FIRST INCIDENCE | 451 573 367 469 |474 383 553 430 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.004 ** P=0.550N P=0.094 P=0.031 * |P=0.019 * P=0.308 P=0.059 P=0.033 * | |POLY 3 | P<0.001 ** P=0.067 P=0.002 ** P<0.001 ** |P=0.008 ** P=0.452 P=0.103 P=0.025 * | |POLY 1.5 | P<0.001 ** P=0.065 P<0.001 ** P<0.001 ** |P=0.009 ** P=0.477 P=0.126 P=0.025 * | |POLY 6 | P<0.001 ** P=0.066 P=0.004 ** P<0.001 ** |P=0.010 * P=0.406 P=0.089 P=0.028 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.140 P<0.001 ** P<0.001 ** |P=0.015 * P=0.492 P=0.151 P=0.035 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.062 P<0.001 ** P<0.001 ** |P=0.022 * P=0.500 P=0.178 P=0.046 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.012 * (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).