The lowest No Observed Adverse Effect Level (NOAEL) for the analogue chemical was established as 250 mg/kg bw/day. JECFA (2006) 7.8. Genotoxicity bacteria – Notified biopolymer In house protocol plate incorporation method. – Species/Strain S. typhimurium: TA1535, TA1537, TA1538, TA98, TA100. Metabolic Activation System Liver fraction (S9 mix) from rats pretreated with Aroclor 1254 Concentration Range in a) With metabolic activation: 0 1000 µg/plate. – Main Test b) Without metabolic activation: 0 - 1000 µg/plate. Vehicle Water Remarks Method Maximum dose selected based on solubility limit of the test substance – observed in the preliminary test. Deviations from OECD TG 471 Bacterial Reverse Mutation test: Strains WP2 uvrA, or WP2 uvrA (pKM101), E. coli E. coli or TA102 not used. These strains can detect S. typhimurium certain cross linking mutagens not detected by the other strains. 2-Aminoanthracene used as the sole indicator of the efficacy of the S9-mix. No other significant deviations. Statement of GLP. Metabolic Test Substance Concentration (µg/plate) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect Preliminary Test Main Test > 1000 Present Test 1 > 1000 not stated negative (all concentrations) Test 2 > 1000 not stated negative (all concentrations) > 1000 Absent Test 1 > 1000 not stated negative (all concentrations) Test 2 > 1000 not stated negative (all concentrations) Remarks Results The test substance did not cause a marked increase in the number of – revertants per plate of any of the tester strains either in the presence or absence of activation. Positive controls confirmed the sensitivity of the test system. The notified biopolymer was non-mutagenic to bacteria the conditions of the test. Rhone-Poulenc (1990) 7.9. Genotoxicity in vitro – Not determined. An mouse micronucleus test has been conducted and therefore an in vivo in chromosome aberration test is not required. vitro
The lowest No Observed Adverse Effect Level (NOAEL) for the analogue chemical was established as 250 mg/kg bw/day. JECFA (2006) 7.8. Genotoxicity – bacteria Notified biopolymer In house protocol – plate incorporation method. Species/Strain S. typhimurium: TA1535, TA1537, TA1538, TA98, TA100. Metabolic Activation System Liver fraction (S9 mix) from rats pretreated with Aroclor 1254 Concentration Range in Main Test a) With metabolic activation: 0 – 1000 µg/plate. b) Without metabolic activation: 0 - 1000 µg/plate. Vehicle Water Remarks – Method Maximum dose selected based on solubility limit of the test substance observed in the preliminary test. Deviations from OECD TG 471 Bacterial Reverse Mutation test: Strains E. coli WP2 uvrA, or E. coli WP2 uvrA (pKM101), or S. typhimurium TA102 not used. These strains can detect certain cross linking mutagens not detected by the other strains. 2-Aminoanthracene used as the sole indicator of the efficacy of the S9-mix. No other significant deviations. Statement of GLP. Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Present > 1000 Test 1 > 1000 not stated negative (all concentrations) Test 2 > 1000 not stated negative (all concentrations) Absent > 1000 Test 1 > 1000 not stated negative (all concentrations) Test 2 > 1000 not stated negative (all concentrations) Remarks – Results The test substance did not cause a marked increase in the number of revertants per plate of any of the tester strains either in the presence or absence of activation. Positive controls confirmed the sensitivity of the test system. The notified biopolymer was non-mutagenic to bacteria the conditions of the test. Rhone-Poulenc (1990) 7.9. Genotoxicity – in vitro Not determined. An in vivo mouse micronucleus test has been conducted and therefore an in vitro chromosome aberration test is not required.
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