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EC number: 947-763-4
CAS number: -
Based on the in vitro Ames study results,
the test substance, 'mono- and di- C16-18 PSE and C16-18
AE20 PSE', was determined to be non-genotoxic with and without metabolic
study was conducted to determine the in vitro genetic toxicity of the
test substance, 'mono- and di- C16 -18 PSE and C16 -18 AE20 PSE', using
bacterial reverse mutation assay (Ames test), according to OECD
Guideline 471, in compliance with GLP. Salmonella typhimurium strains TA
98, TA100, TA 1535 and TA 1537 as well as Escherichia coli strain WP2
uvr A were used in this experiment. The assay was performed in two
phases, using the plate incorporation method. In the first phase, a
preliminary toxicity assay was conducted to establish the dose-range for
the mutagenicity assay. In the second phase, the mutagenicity assay was
conducted to evaluate the mutagenic potential of the test substance. In
the preliminary toxicity-mutation assay, the maximum dose tested was
5000 μg per plate; this dose was achieved using a concentration of 100
mg/mL (in ethanol) and a 50 μL plating aliquot. The tested dose levels
in this assay included 6.7, 10, 33, 67, 100, 333, 667, 1000, 3333 and
5000 μg per plate with and without metabolic activation (S9 -mix).
Precipitate was observed at 1000 and 3333 μg per plate. No background
lawn toxicity was observed but reductions in revertant counts were
observed with tester strains TA1535 and TA1537 in the absence of S9
activation beginning at 1000 or at 5000 µg per plate. Based on the
findings of the preliminary toxicity assay, the maximum dose plated in
the confirmatory mutagenicity assay was 5000 μg per plate. In the
mutagenicity assay, the tested dose levels included 15, 50, 150, 500,
1500 and 5000 μg per plate with and without metabolic activation. No
positive mutagenic responses were observed in any of the tester strains,
with and without metabolic condition. Precipitate was observed at 1500
and 5000 μg per plate. No background lawn toxicity was observed but
reductions in revertant counts were observed with strains TA1535 and
TA1537 and WP2 uvrA in the absence of S9 activation beginning at 1500 or
at 5000 µg per plate. All criteria for a valid study were met as
described in the protocol. Under the study conditions, the test
substance was determined to be non-genotoxic with and without metabolic
activation (BioReliance, 2007).
on the in vitro Ames test results, the test substance, 'mono-
and di- C16-18 PSE and C16-18 AE20 PSE', does not warrant classification
according to the EU CLP criteria (Regulation 1272/2008/EC).
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