There was no evidence of reactions indicative of skin sensitisation to the notified polymer under the conditions of the test. Aventis (2002d) Genotoxicity bacteria – Notified polymer OECD TG 471 Bacterial Reverse Mutation Test. Plate incorporation procedure Species/Strain TA97a, TA98, TA100, TA102, TA1535 S. typhimurium: Metabolic Activation System S9 fraction from induced rat liver phenobarbital/β-naphthoflavone in a) With metabolic activation: 5-500 µg/plate Main Test b) Without metabolic activation: 5-500 µg/plate Vehicle Water Remarks - Method Due to the solubility the test substance and the formation of gel at concentrations > 500 µg/plate the highest concentration level was set at 500 µg/plate. No preliminary study was conducted. E. coli strain was not tested. Vehicle and positive controls were used in parallel with the test material. Positive controls: i) without S9: ICR 191 acridine mutagen dihydrochloride (TA97a), 4-nitro-1,2-phenylenediamine (TA98), nitrofurantoine (TA100), cumene hydroperoxide (TA102) and (TA1535); ii) with S9: 2-aminoanthracene (TA97a, TA98, TA100, TA1535) and danthron (TA102). Metabolic Test Substance Concentration (µg/plate) Resulting in: Activation Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 > 500 > 500 negative Test 2 > 500 negative > 500 Present Test 1 > 500 > 500 negative Test 2 > 500 negative > 500 Remarks - Results The test substance did not cause a visible reduction in the growth of the bacterial background lawn or a substantial reduction in the frequency of revertant colonies at 500 µg/plate both in the presence and absence of ≤ metabolic activation The controls produced satisfactory responses, thus confirming the activity of the metabolic activation and the sensitivity of the bacterial strains. The notified polymer was not mutagenic to bacteria under the conditions of the test. Dr U Noack (2002a)
There was no evidence of reactions indicative of skin sensitisation to the notified polymer under the conditions of the test. Aventis (2002d) Genotoxicity – bacteria Notified polymer OECD TG 471 Bacterial Reverse Mutation Test. Plate incorporation procedure Species/Strain S. typhimurium: TA97a, TA98, TA100, TA102, TA1535 Metabolic Activation System S9 fraction from phenobarbital/β-naphthoflavone induced rat liver in Main Test a) With metabolic activation: 5-500 µg/plate b) Without metabolic activation: 5-500 µg/plate Vehicle Water Remarks - Method Due to the solubility the test substance and the formation of gel at concentrations > 500 µg/plate the highest concentration level was set at 500 µg/plate. No preliminary study was conducted. E. coli strain was not tested. Vehicle and positive controls were used in parallel with the test material. Positive controls: i) without S9: ICR 191 acridine mutagen dihydrochloride (TA97a), 4-nitro-1,2-phenylenediamine (TA98), nitrofurantoine (TA100), cumene hydroperoxide (TA102) and (TA1535); ii) with S9: 2-aminoanthracene (TA97a, TA98, TA100, TA1535) and danthron (TA102). Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 > 500 > 500 negative Test 2 > 500 > 500 negative Present Test 1 > 500 > 500 negative Test 2 > 500 > 500 negative Remarks - Results The test substance did not cause a visible reduction in the growth of the bacterial background lawn or a substantial reduction in the frequency of revertant colonies at ≤ 500 µg/plate both in the presence and absence of metabolic activation The controls produced satisfactory responses, thus confirming the activity of the metabolic activation and the sensitivity of the bacterial strains. The notified polymer was not mutagenic to bacteria under the conditions of the test. Dr U Noack (2002a)