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EC number: 203-227-5
CAS number: 104-68-7
Diethylene glycol mono phenyl ether was
tested for its mutagenic potential in the bacterial reverse mutation
assay. The study was conducted using TA98, TA100, TA1535 and TA1537
strains of Salmonella typhimurium and WP2uvrA (pKM 101) strain of
Escherichia coli in two phases. In the first phase, an initial
toxicity-mutation test was performed. The second phase was an
independent confirmatory mutation test. The bacterial tester strains
were exposed to the test substance in the presence and absence of a
metabolic activation system (S-9 fraction prepared from Aroclor 1254
induced rat liver) using a pre-incubation procedure.
Diethylene glycol mono phenyl ether was
found to be insoluble in sterile water (SW) at 50 mg/mL and soluble in
dimethyl sulfoxide (DMSO) at the required concentration of 500 mg/mL.
Diethylene glycol mono phenyl ether was stable in DMSO at 15.2 and
185004 μg/mL after 4 hours.
In the initial toxicity-mutation assay,
diethylene glycol mono phenyl ether was exposed in duplicate at 1.5, 5,
15, 50, 150, 500, 1500 and 5000 μg/plate test doses along with the
vehicle and appropriate positive controls. In the confirmatory mutation
assay, diethylene glycol mono phenyl ether was exposed in triplicate at
100, 266, 707, 1880 and 5000 μg/plate test doses along with the vehicle
and appropriate positive controls.
The test substance did not cause any
precipitation on the basal agar plates. No toxicity was observed as the
intensity of the bacterial background lawn was comparable to the vehicle
control up to 5000 μg/plate, in the presence and absence of metabolic
activation. The mean and standard deviation of revertant colonies were
calculated for each test dose and the controls for all the tester
The results from the initial and
confirmatory assays, indicate the tested doses showed no positive
mutagenic increase in the mean numbers of revertant colonies for all
tester strains when compared to the respective vehicle control plates,
either in the presence or absence of metabolic activation.
In this study, there was a more than 3-fold
increase in the mean numbers of revertant colonies in the positive
controls, demonstrating the sensitivity of the assay.
The analytically-determined concentrations
of diethylene glycol mono phenyl ether in the initial assay dose
formulations ranged from 76.7 to 100.1 % of their respective targets
concentrations. Although the analysis results of the lowest
concentration (15 μg/mL) was not within the specified limit, all
remaining dose levels, including the critical top concentration, were
within the acceptable range of 85 to 115 % of target and < 10 % RSD. The
results of the concentration analysis for the confirmatory mutation
assay were within acceptable limits, as the actual mean concentrations
were between 89.6 and 101.2 % of their respective nominal target
concentrations. The regulatory-required top dose level (5000 μg/plate)
was achieved in both assay and the results support the validity of the
study conclusion. No test substance was detected
in the vehicle control.
criteria for a valid study were met as described in the protocol. The
study indicated that the test substance, diethylene glycol mono phenyl
ether, was negative (non-mutagenic) in this Salmonella- Escherichia
coli/Mammalian-Microsome Reverse Mutation Assay at the doses tested and
the conditions of testing employed
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