TDMS Study 88124-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 10/28/99 EXPERIMENT: 88124 TEST: 03 TIME: 13:55:40 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124 PATHOLOGIST: GRUMBEIN, S. CAS: 22398-80-7 ------------------------------------------------------------------------------------------------------------------------------------ 14 WEEK SSAC REASONS FOR REMOVAL: 25017 Scheduled Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 10/28/99 EXPERIMENT: 88124 TEST: 03 TIME: 13:55:40 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124 PATHOLOGIST: GRUMBEIN, S. CAS: 22398-80-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF INDIUM PHOSPHIDE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Lung Foreign Body Inflammation Chronic Lung: Alveolar Epithelium Hyperplasia Lung: Alveolus Proteinosis Lymph Node, Bronchial Foreign Body Hyperplasia Lymph Node, Mediastinal Foreign Body Hyperplasia =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Liver Hematopoietic Cell Proliferation Lung Foreign Body Inflammation Chronic Lung: Alveolar Epithelium Hyperplasia Lung: Alveolus Proteinosis Lymph Node, Bronchial Foreign Body Hyperplasia Lymph Node, Mediastinal Foreign Body Hyperplasia =============================================================== Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/10 (40%) 0/0 (0%) 0/0 (0%) 2/10 (20%) |2/10 (20%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 ADJUSTED (b)| 99.9% 0.0% 0.0% 99.7% |99.7% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 4/10 (40%) 0/0 (0%) 0/0 (0%) 2/10 (20%) |2/10 (20%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 91 (I) --- --- 91 (I) |92 (I) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.263N P=1.000N P=1.000N P=0.317N |P=0.166N P=1.000N P=1.000N P=0.234N | |POLY 3 | (e) (e) (e) P=0.202N |(e) (e) (e) P=0.067N | |POLY 1.5 | (e) (e) (e) P=0.205N |(e) (e) (e) P=0.070N | |POLY 6 | (e) (e) (e) P=0.202N |(e) (e) (e) P=0.067N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.258N P=1.000 P=1.000 P=0.314N |P=0.160N P=1.000 P=1.000 P=0.237N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 3/10 (30%) |1/10 (10%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 ADJUSTED (b)| 99.8% 0.0% 0.0% 99.8% |99.3% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 3/10 (30%) 0/0 (0%) 0/0 (0%) 3/10 (30%) |1/10 (10%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 91 (I) --- --- 91 (I) |92 (I) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.624 P=1.000N P=1.000N P=0.683 |P=0.369N P=1.000N P=1.000N P=0.500N | |POLY 3 | (e) (e) (e) P=0.555 |(e) (e) (e) P=0.159N | |POLY 1.5 | (e) (e) (e) P=0.559 |(e) (e) (e) P=0.167N | |POLY 6 | (e) (e) (e) P=0.555 |(e) (e) (e) P=0.159N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.628 P=1.000 P=1.000 P=0.686N |P=0.366N P=1.000 P=1.000 P=0.500N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Larynx | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 99.7% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 91 (I) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.368N P=0.234 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.160N P=0.067 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.164N P=0.070 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.160N P=0.067 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.366N P=0.237 (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 0/2 (0%) 0/0 (0%) 0/10 (0%) |0/10 (0%) 0/3 (0%) 0/2 (0%) 2/10 (20%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 99.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/2 (0%) 0/0 (0%) 0/10 (0%) |0/10 (0%) 0/3 (0%) 0/2 (0%) 2/10 (20%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 92 (I) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.111 (e) (e) P=0.234 | |POLY 3 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.067 | |POLY 1.5 | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.070 | |POLY 6 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.067 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.106 (e) (e) P=0.237 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Liver | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 0/2 (0%) 0/0 (0%) 0/10 (0%) |2/10 (20%) 0/3 (0%) 0/2 (0%) 3/10 (30%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |99.7% 0.0% 0.0% 99.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/2 (0%) 0/0 (0%) 0/10 (0%) |2/10 (20%) 0/3 (0%) 0/2 (0%) 3/10 (30%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- |92 (I) --- --- 92 (I) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.310 P=0.527N P=0.630N P=0.500 | |POLY 3 | (e) (e) (e) (e) |P=0.226 P=0.213N P=0.260N P=0.352 | |POLY 1.5 | (e) (e) (e) (e) |P=0.225 P=0.220N P=0.268N P=0.356 | |POLY 6 | (e) (e) (e) (e) |P=0.226 P=0.213N P=0.259N P=0.352 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.306 P=0.577N P=0.682N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Lung | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%)|0/10 (0%) 8/10 (80%) 10/10 (100%) 10/10 (100%) | |POLY-3 ADJUSTED (b)| 0.0% 100.0% 100.0% 100.0% |0.0% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%)|0/10 (0%) 8/10 (80%) 10/10 (100%) 10/10 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 91 (I) 91 (I) 91 (I) |--- 92 (I) 92 (I) 92 (I) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P=1.000N P=1.000N P=1.000N P=1.000N |P<0.001 ** P<0.001 ** P=1.000N P=1.000N | |POLY 1.5 | P=1.000N P=1.000N P=1.000N P=1.000N |P<0.001 ** P<0.001 ** P=1.000N P=1.000N | |POLY 6 | P=1.000N P=1.000N P=1.000N P=1.000N |P<0.001 ** P<0.001 ** P=1.000N P=1.000N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/10 (10%) 10/10 (100%) 10/10 (100%) 10/10 (100%)|2/10 (20%) 10/10 (100%) 10/10 (100%) 10/10 (100%) | |POLY-3 ADJUSTED (b)| 99.3% 100.0% 100.0% 100.0% |99.7% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 1/10 (10%) 10/10 (100%) 10/10 (100%) 10/10 (100%)|2/10 (20%) 10/10 (100%) 10/10 (100%) 10/10 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 91 (I) 91 (I) 91 (I) 91 (I) |92 (I) 92 (I) 92 (I) 92 (I) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.006 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.005 ** P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 7/10 (70%) 10/10 (100%) 10/10 (100%)|0/10 (0%) 5/10 (50%) 1/10 (10%) 7/10 (70%) | |POLY-3 ADJUSTED (b)| 0.0% 100.0% 100.0% 100.0% |0.0% 99.9% 99.3% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 7/10 (70%) 10/10 (100%) 10/10 (100%)|0/10 (0%) 5/10 (50%) 1/10 (10%) 7/10 (70%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 91 (I) 91 (I) 91 (I) |--- 92 (I) 92 (I) 92 (I) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P=0.008 ** P=0.022 * P=0.500 P=0.003 ** | |POLY 3 | P<0.001 ** P<0.001 ** P=1.000N P=1.000N |P<0.001 ** P<0.001 ** P=0.159 P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P=1.000N P=1.000N |P<0.001 ** P<0.001 ** P=0.167 P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P=1.000N P=1.000N |P<0.001 ** P<0.001 ** P=0.159 P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P=0.007 ** P=0.016 * P=0.500 P=0.002 ** | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Lung: Alveolus | | Proteinosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%)|0/10 (0%) 9/10 (90%) 10/10 (100%) 10/10 (100%) | |POLY-3 ADJUSTED (b)| 0.0% 100.0% 100.0% 100.0% |0.0% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%)|0/10 (0%) 9/10 (90%) 10/10 (100%) 10/10 (100%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 91 (I) 91 (I) 91 (I) |--- 92 (I) 92 (I) 92 (I) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P=1.000N P=1.000N P=1.000N P=1.000N |P<0.001 ** P<0.001 ** P=1.000N P=1.000N | |POLY 1.5 | P=1.000N P=1.000N P=1.000N P=1.000N |P<0.001 ** P<0.001 ** P=1.000N P=1.000N | |POLY 6 | P=1.000N P=1.000N P=1.000N P=1.000N |P<0.001 ** P<0.001 ** P=1.000N P=1.000N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Lymph Node, Bronchial | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 4/6 (67%) 2/10 (20%) 7/9 (78%) |0/4 (0%) 5/8 (63%) 7/8 (88%) 4/6 (67%) | |POLY-3 ADJUSTED (b)| 0.0% 100.0% 99.7% 100.0% |0.0% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 4/6 (66.7%) 2/10 (20%) 7/9 (77.8%) |0/4 (0%) 5/8 (62.5%) 7/8 (87.5%) 4/6 (66.7%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 91 (I) 91 (I) 91 (I) |--- 92 (I) 92 (I) 92 (I) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.005 ** P=0.010 * P=0.234 P=0.002 ** |P=0.234 P=0.083 P=0.015 * P=0.085 | |POLY 3 | P<0.001 ** P<0.001 ** P=0.067 P<0.001 ** |P=0.169 P=0.009 ** P<0.001 ** P=0.006 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P=0.070 P<0.001 ** |P=0.169 P=0.010 * P<0.001 ** P=0.006 ** | |POLY 6 | P<0.001 ** P<0.001 ** P=0.067 P<0.001 ** |P=0.168 P=0.009 ** P<0.001 ** P=0.006 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.005 ** P=0.008 ** P=0.237 P<0.001 ** |P=0.230 P=0.071 P=0.010 * P=0.071 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Lymph Node, Bronchial | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 1/6 (17%) 2/10 (20%) 5/9 (56%) |0/4 (0%) 1/8 (13%) 6/8 (75%) 3/6 (50%) | |POLY-3 ADJUSTED (b)| 0.0% 99.6% 99.7% 99.9% |0.0% 99.5% 100.0% 99.9% | |INT SACRIFICE 1 (c)| 0/10 (0%) 1/6 (16.7%) 2/10 (20%) 5/9 (55.6%) |0/4 (0%) 1/8 (12.5%) 6/8 (75%) 3/6 (50%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 91 (I) 91 (I) 91 (I) |--- 92 (I) 92 (I) 92 (I) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.006 ** P=0.398 P=0.234 P=0.015 * |P=0.113 P=0.638 P=0.039 * P=0.175 | |POLY 3 | P<0.001 ** P=0.093 P=0.067 P<0.001 ** |P=0.053 P=0.245 P<0.001 ** P=0.037 * | |POLY 1.5 | P<0.001 ** P=0.099 P=0.070 P<0.001 ** |P=0.054 P=0.255 P<0.001 ** P=0.039 * | |POLY 6 | P<0.001 ** P=0.093 P=0.067 P<0.001 ** |P=0.053 P=0.245 P<0.001 ** P=0.037 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.006 ** P=0.375 P=0.237 P=0.011 * |P=0.109 P=0.667 P=0.030 * P=0.167 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 3/5 (60%) 7/9 (78%) 7/9 (78%) |0/7 (0%) 6/9 (67%) 6/8 (75%) 5/9 (56%) | |POLY-3 ADJUSTED (b)| 0.0% 99.9% 100.0% 100.0% |0.0% 100.0% 100.0% 99.9% | |INT SACRIFICE 1 (c)| 0/10 (0%) 3/5 (60%) 7/9 (77.8%) 7/9 (77.8%) |0/7 (0%) 6/9 (66.7%) 6/8 (75%) 5/9 (55.6%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 91 (I) 91 (I) 91 (I) |--- 92 (I) 92 (I) 92 (I) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.007 ** P=0.024 * P=0.002 ** P=0.002 ** |P=0.246 P=0.016 * P=0.009 ** P=0.038 * | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.178 P<0.001 ** P<0.001 ** P=0.003 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.179 P<0.001 ** P<0.001 ** P=0.003 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.178 P<0.001 ** P<0.001 ** P=0.003 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.007 ** P=0.022 * P<0.001 ** P<0.001 ** |P=0.243 P=0.010 * P=0.006 ** P=0.029 * | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 1/5 (20%) 6/9 (67%) 7/9 (78%) |0/7 (0%) 4/9 (44%) 3/8 (38%) 5/9 (56%) | |POLY-3 ADJUSTED (b)| 0.0% 99.7% 100.0% 100.0% |0.0% 99.9% 99.9% 99.9% | |INT SACRIFICE 1 (c)| 0/10 (0%) 1/5 (20%) 6/9 (66.7%) 7/9 (77.8%) |0/7 (0%) 4/9 (44.4%) 3/8 (37.5%) 5/9 (55.6%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 91 (I) 91 (I) 91 (I) |--- 92 (I) 92 (I) 92 (I) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.362 P=0.005 ** P=0.002 ** |P=0.089 P=0.079 P=0.130 P=0.038 * | |POLY 3 | P<0.001 ** P=0.071 P<0.001 ** P<0.001 ** |P=0.058 P=0.013 * P=0.028 * P=0.003 ** | |POLY 1.5 | P<0.001 ** P=0.076 P<0.001 ** P<0.001 ** |P=0.059 P=0.014 * P=0.030 * P=0.003 ** | |POLY 6 | P<0.001 ** P=0.071 P<0.001 ** P<0.001 ** |P=0.058 P=0.013 * P=0.028 * P=0.003 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.333 P=0.003 ** P<0.001 ** |P=0.086 P=0.069 P=0.123 P=0.029 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 99.7% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 92 (I) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.699N (e) P=0.234 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.462N (e) P=0.067 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.469N (e) P=0.070 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.462N (e) P=0.067 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.701N (e) P=0.237 (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 143 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/10 (40%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |2/10 (20%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |POLY-3 ADJUSTED (b)| 99.9% 0.0% 0.0% 99.9% |99.7% 0.0% 0.0% 99.3% | |INT SACRIFICE 1 (c)| 4/10 (40%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |2/10 (20%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 91 (I) --- --- 91 (I) |92 (I) --- --- 92 (I) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.617 P=1.000N P=1.000N P=0.672 |P=0.419N P=1.000N P=1.000N P=0.500N | |POLY 3 | (e) (e) (e) P=0.569 |(e) (e) (e) P=0.299N | |POLY 1.5 | (e) (e) (e) P=0.572 |(e) (e) (e) P=0.305N | |POLY 6 | (e) (e) (e) P=0.569 |(e) (e) (e) P=0.299N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.620 P=1.000 P=1.000 P=0.675N |P=0.417N P=1.000 P=1.000 P=0.500N | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Poly-3 adjusted lifetime tumor incidence. (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. (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 66054-66054/66054 --multipart-boundary--