Test Facility LPT (2005) A2.7 Genotoxicity - bacteria Test Substance Analogue 2 Method OECD TG 471 Bacterial Reverse Mutation Test Plate incorporation procedure Species/Strain TA1535, TA1537, TA98, TA100 S. typhimurium: Metabolic activation Aroclor 1254-induced rat S9 liver homogenate system Concentration range in a) With metabolic activation: 8-5000 µg/plate main test b) Without metabolic activation: 8-5000 µg/plate Vehicle Purified water Remarks - Method A preliminary test was conducted using the TA100 strain of S. The doses chosen for range finding were the following: typhimurium. 10, 32, 100, 320, 1000, 3200 and 10000 g/plate. In order to improve the solubility, the test substance was subjected to ultrasonic treatment and heated to 40 C for 15 minutes. It was not possible to dissolve the test substance completely due to adhesion of the substance on the walls of the vessel. Therefore, the reported concentrations were based on calculated values. Two concentrations of the metabolic activation system (S9) were used: 4% for Test 1 and 10% for Test 2. Results Metabolic Test substance concentration (µg/plate) resulting in: activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic effect preliminary test main test >32 Absent Test 1 >200 5,000 Negative Test 2 >200 5,000 Negative >32 Present Test 1 >200 5,000 Negative Test 2 >1000 5,000 Negative Conclusion The notified chemical was not mutagenic to bacteria under the conditions of the test. Test Facility International BioResearch (1993) A2.8 Genotoxicity in vitro – Test Substance Notified chemical
Test Facility LPT (2005) A2.7 Genotoxicity - bacteria Test Substance Analogue 2 Method OECD TG 471 Bacterial Reverse Mutation Test Plate incorporation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100 Metabolic activation system Aroclor 1254-induced rat S9 liver homogenate Concentration range in main test a) With metabolic activation: 8-5000 µg/plate b) Without metabolic activation: 8-5000 µg/plate Vehicle Purified water Remarks - Method A preliminary test was conducted using the TA100 strain of S. typhimurium. The doses chosen for range finding were the following: 10, 32, 100, 320, 1000, 3200 and 10000 g/plate. In order to improve the solubility, the test substance was subjected to ultrasonic treatment and heated to 40 C for 15 minutes. It was not possible to dissolve the test substance completely due to adhesion of the substance on the walls of the vessel. Therefore, the reported concentrations were based on calculated values. Two concentrations of the metabolic activation system (S9) were used: 4% for Test 1 and 10% for Test 2. Results Metabolic activation Test substance concentration (µg/plate) resulting in: Cytotoxicity in preliminary test Cytotoxicity in main test Precipitation Genotoxic effect Absent >32 Test 1 >200 5,000 Negative Test 2 >200 5,000 Negative Present >32 Test 1 >200 5,000 Negative Test 2 >1000 5,000 Negative Conclusion The notified chemical was not mutagenic to bacteria under the conditions of the test. Test Facility International BioResearch (1993) A2.8 Genotoxicity – in vitro Test Substance Notified chemical
Ethanaminium,-2-hydroxy-N,N-bis2-hydroxyethyl-N-methyl-,-esters-with-C16-18-and-C18-unsatd.-fatty-acids,-Me-sulfates-saltsSTD-1258S-Final-SNA-report-Oct-2018.DOCX