changed the method of enzyme induction. This deviation from the study protocol did not adversely affect the evaluation of the study outcome. The four strains were treated with the test substance by S. Typhimurium the Ames test plate incorporation (Test 1) as well as the preincubation method (Test 2). Metabolic Test Substance Concentration (µg/plate) Resulting in: Activation Cytotoxicity in Cytotoxicity in Main Precipitation Genotoxic Effect Preliminary Test Test Absent Test 1 > 5000 (TA98, None Negative TA100) 1000 (TA1535) ≥ 500 (TA1537) ≥ Test 2 > 5000 (TA98, None Negative TA100) > 100 (TA1535) > 500 (TA1537) Present Test 1 > 5000 (TA98, None Negative TA100) 5000 (TA1535) ≥ 1600 (TA1537) ≥ Test 2 > 5000 (TA98, None Negative > 1000 (TA1535) > 500 (TA1537) Remarks - Results All four bacterial strains were mutagenic to the positive control in DMSO). Solvent controls (water) were also tested with each strain and the mean numbers of spontaneous revertants were in an acceptable range. Analogue A was not mutagenic to bacteria the conditions of the test. Hüls (1996)
changed the method of enzyme induction. This deviation from the study protocol did not adversely affect the evaluation of the study outcome. The four S. Typhimurium strains were treated with the test substance by the Ames test plate incorporation (Test 1) as well as the preincubation method (Test 2). Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 > 5000 (TA98, TA100) ≥ 1000 (TA1535) ≥ 500 (TA1537) None Negative Test 2 > 5000 (TA98, TA100) > 100 (TA1535) > 500 (TA1537) None Negative Present Test 1 > 5000 (TA98, TA100) ≥ 5000 (TA1535) ≥ 1600 (TA1537) None Negative Test 2 > 5000 (TA98, > 1000 (TA1535) > 500 (TA1537) None Negative Remarks - Results All four bacterial strains were mutagenic to the positive control in DMSO). Solvent controls (water) were also tested with each strain and the mean numbers of spontaneous revertants were in an acceptable range. Analogue A was not mutagenic to bacteria the conditions of the test. Hüls (1996)
STD1506-FR-Final.docx