Test 1 1000 250 none observed negative ≥ ≥ Test 2 500 250 none observed negative ≥ ≥ Present Test 1 1000 500 none observed negative ≥ ≥ Test 2 500 250 none observed negative ≥ ≥ Remarks - Results In the preliminary test haemolysis was observed for different test conditions at 500 and 1000 and marked toxicity was ≥ μg/mL ≥ μg/mL, noted in all groups. Haemolysis was observed during Test 1 at the end of the exposure period at concentrations 250 in the 4(20)-hour exposure in the ≥ μg/mL absence of metabolic activation and at concentrations 500 in the ≥ μg/mL presence of metabolic activation. Haemolysis was observed during Test 2 at the end of the exposure period at concentrations 250 in both exposure groups in the absence ≥ μg/mL and presence of metabolic activation. The test item did not induce any statistically significant increases in the frequency of cells with aberrations, either in the presence or absence of metabolic activation. Statistically significant increases in aberrations were seen in the positive control groups. Conclusion The notified polymer was not clastogenic to human lymphocytes treated in vitro under the conditions of the test. Test Facility Harlan (2012f)
Test 1 ≥ 1000 ≥ 250 none observed negative Test 2 ≥ 500 ≥ 250 none observed negative Present Test 1 ≥ 1000 ≥ 500 none observed negative Test 2 ≥ 500 ≥ 250 none observed negative Remarks - Results In the preliminary test haemolysis was observed for different test conditions at ≥ 500 μg/mL and ≥ 1000 μg/mL, and marked toxicity was noted in all groups. Haemolysis was observed during Test 1 at the end of the exposure period at concentrations ≥ 250 μg/mL in the 4(20)-hour exposure in the absence of metabolic activation and at concentrations ≥ 500 μg/mL in the presence of metabolic activation. Haemolysis was observed during Test 2 at the end of the exposure period at concentrations ≥ 250 μg/mL in both exposure groups in the absence and presence of metabolic activation. The test item did not induce any statistically significant increases in the frequency of cells with aberrations, either in the presence or absence of metabolic activation. Statistically significant increases in aberrations were seen in the positive control groups. Conclusion The notified polymer was not clastogenic to human lymphocytes treated in vitro under the conditions of the test. Test Facility Harlan (2012f)
STD1483-FR-Final.docx