Metabolic Test Substance Concentration (µg/mL) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect Preliminary Test Main Test Absent Test 1 5000 > 2000 1500 negative ≥ Test 2 5000 1500 1500 negative ≥ ≥ Present Test 1 5000 > 2000 1500 negative ≥ Remarks - Results Preliminary toxicity assay Precipitation was observed at concentrations 1500 µg/mL. ≥ Substantial toxicity was observed at 5000 µg/mL with and without S9 activation and with a 4-hour exposure, and without activation with a exposure. Main study There was an absence of a concentration-related increase in mutant frequency. The notified polymer was not clastogenic to mouse lymphocytes treated in vitro under the conditions of the test. BioReliance (2008)
Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 5000 > 2000 ≥ 1500 negative Test 2 5000 ≥ 1500 ≥ 1500 negative Present Test 1 5000 > 2000 ≥ 1500 negative Remarks - Results Preliminary toxicity assay Precipitation was observed at concentrations ≥ 1500 µg/mL. Substantial toxicity was observed at 5000 µg/mL with and without S9 activation and with a 4-hour exposure, and without activation with a exposure. Main study There was an absence of a concentration-related increase in mutant frequency. The notified polymer was not clastogenic to mouse lymphocytes treated in vitro under the conditions of the test. BioReliance (2008)