Metabolic Test Substance Concentration Exposure Harvest (μg/mL) Activation Period Time Absent Test 1 0*, 19.53, 39.06*. 78.13*, 156.25, 312.5*, 625, 937.5*, 4 24 1250 Test 2 0*, 15, 30, 60*, 120*, 240*, 360* 24 24 Present Test 1 0*, 19.53, 39.06*. 78.13*, 156.25, 312.5*, 625, 937.5*, 4 24 1250 Test 2 0*, 30, 60*, 120, 240*, 480*, 960* 4 24 *Cultures selected for metaphase analysis. Metabolic Test Substance Concentration (µg/mL) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect Preliminary Test Main Test Absent Test 1 1,250 > 937.5 156.25 negative ≥ ≥ Test 2 312.5 > 360 120 negative ≥ ≥ Present Test 1 1,250 > 937.5 156.25 negative ≥ ≥ Test 2 1,250 > 960 120 negative ≥ ≥ Remarks - Results In both tests 1 and 2, the test substance did not induce a significant increase in the numbers of polyploid cells or in the frequency of cells with chromosome aberrations at any dose level in either of the exposure groups. The vehicle control and positive control cultures gave values of chromosome aberrations within the expected range, indicating that the metabolic activation system and test method were satisfactory. The notified chemical was not clastogenic to human lymphocytes treated in vitro under the conditions of the test. Harlan (2012)
Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 0*, 19.53, 39.06*. 78.13*, 156.25, 312.5*, 625, 937.5*, 1250 4 24 Test 2 0*, 15, 30, 60*, 120*, 240*, 360* 24 24 Present Test 1 0*, 19.53, 39.06*. 78.13*, 156.25, 312.5*, 625, 937.5*, 1250 4 24 Test 2 0*, 30, 60*, 120, 240*, 480*, 960* 4 24 *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 ≥ 1,250 > 937.5 ≥ 156.25 negative Test 2 ≥ 312.5 > 360 ≥ 120 negative Present Test 1 ≥ 1,250 > 937.5 ≥ 156.25 negative Test 2 ≥ 1,250 > 960 ≥ 120 negative Remarks - Results In both tests 1 and 2, the test substance did not induce a significant increase in the numbers of polyploid cells or in the frequency of cells with chromosome aberrations at any dose level in either of the exposure groups. The vehicle control and positive control cultures gave values of chromosome aberrations within the expected range, indicating that the metabolic activation system and test method were satisfactory. The notified chemical was not clastogenic to human lymphocytes treated in vitro under the conditions of the test. Harlan (2012)