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EC number: 931-292-6
CAS number: 308062-28-4
Summary of the findings
Cytotoxicity $ (%)
Mean MNBN Cell Frequency (%)
Historical Control Range # (%)
3+21 hour -S-9
0.20 – 1.00
3+21 hour +S-9
0.20 – 1.07
24+24 hour -S-9
0.10 – 0.90
Vehicle control was water
95thpercentile of the observed range
Based on replication index
Amines, C12-14 (even numbered)-alkyldimethyl, N-oxides was tested in an
in vitro micronucleus assay using duplicate human lymphocyte cultures
prepared from the pooled blood of two female donors in a single
experiment. Treatments covering a broad range of concentrations,
separated by narrow intervals, were performed both in the absence and
presence of metabolic activation (S-9) from Aroclor 1254-induced rats.
The test article was formulated in water (purified water). The highest
concentrations analysed in the Micronucleus Experiment were limited by
toxicity and were determined following a preliminary cytotoxicity
Treatments were conducted 48 hours following mitogen stimulation by
phytohaemagglutinin (PHA). The test article concentrations for
micronucleus analysis were selected by evaluating the effect of Amines,
C12-14 (even numbered)-alkyldimethyl, N-oxides on the replication index
(RI). Micronuclei were analysed at three or four concentrations.
Appropriate negative (vehicle) control cultures were included in the
test system under each treatment condition. The proportion of
micronucleated binucleate (MNBN) cells in the cultures fell within the
95th percentile of the current observed historical vehicle control
(normal) ranges. Mitomycin C (MMC) and Vinblastine (VIN) were employed
as clastogenic and aneugenic positive control chemicals respectively in
the absence of rat liver S-9. Cyclophosphamide (CPA) was employed as a
clastogenic positive control chemical in the presence of rat liver S-9.
Cells receiving these were sampled in the Micronucleus Experiment at 24
hours (CPA, MMC) or 48 hours (VIN) after the start of treatment. One
concentration of all positive control compounds induced statistically
significant increases in the proportion of cells with micronuclei.
All acceptance criteria were considered met and the study was accepted
Treatment of cells with Amines, C12-14 (even numbered)-alkyldimethyl,
N-oxides for 3+21 hours in the absence and presence of S-9 and for 24+24
hours in the absence of S-9 resulted in frequencies of MNBN cells that
were similar to those observed in the concurrent vehicle controls and
which fell within the normal ranges at all concentrations analysed under
each treatment condition. A statistically significant increase in MNBN
cell frequency (p≤0.05) was observed at an intermediate concentration of
20 μg/mL for the 24+24 hour treatment in the absence of S-9 but the MNBN
cell frequency values for both replicates at this concentration were
within the normal range and there was no statistically significant
linear trend, therefore this observation was considered not biologically
It is concluded that Amines, C12-14 (even numbered)-alkyldimethyl,
N-oxides did not induce micronuclei in human peripheral blood
lymphocytes when tested up to toxic concentrations for 3+21 hours in the
absence and presence of a rat liver metabolic activation system (S-9)
and for 24+24 hours in the absence of S-9 under the experimental
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