Metabolic Test Substance Concentration (µg/mL) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect Preliminary Test Main Test Absent Test 1 7.82 > 8 2 Negative ≥ ≥ Test 2 62.5 > 8 1 Negative ≥ ≥ Present Test 1 62.5 > 16 1 Negative ≥ ≥ Test 2 > 16 4 Negative ≥ Remarks - Results The test substance did not induce any statistically significant increases in the frequency of cells with aberrations in any of the exposure groups. The test substance is not clastogenic to human lymphocytes treated in vitro under the conditions of the test. Harlan (2012e)
Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 ≥ 7.82 > 8 ≥ 2 Negative Test 2 ≥ 62.5 > 8 ≥ 1 Negative Present Test 1 ≥ 62.5 > 16 ≥ 1 Negative Test 2 > 16 ≥ 4 Negative Remarks - Results The test substance did not induce any statistically significant increases in the frequency of cells with aberrations in any of the exposure groups. The test substance is not clastogenic to human lymphocytes treated in vitro under the conditions of the test. Harlan (2012e)