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EC number: 252-104-2
CAS number: 34590-94-8
substance, dipropylene glycol methyl ether (DPM) was tested for
mutagenic potential using histidine dependent auxotrophic mutants of Salmonella
typhimurium, strains TA 98, TA100, TA1535 and TA1537, and a
tryptophan dependent mutant of Escherichia coli, strain WP2uvrA
in two independent mutation tests in the presence (with metabolic
activity) and absence (without metabolic activity) of liver preparations
(S9-mix) by preincubation method.
dissolved in the distilled water for injection (Japan Pharmacopoeia) up
to 5000 μg/plate were tested, and 6 dose levels were separated by 4 of
common ratio in the preliminary study. Based on the dose rangefinding
study, in the definitive study, 5000 μg/plate was a highest dose level
and then 5 dose levels were selected by 2 common ratio as set those in
the preliminary test.
of mutagenic activity to show the increases in the reverse mutation
colonies exceeding 2 folds of those of negative control value was seen
at any dose level of DPM in either mutation test.
calculated for the concurrent negative and positive controls of each
strain were within the range of the background data.
It can be
concluded that DPM shows no evidence of mutagenic activity in this
All in vitro genoxicity studies conducted
with dipropylene glycol methyl ether are of high quality and reliable
without restrictions. The results of all studies were consistent.
Dipropylene glycol methyl ether did not induce gene mutations in
bacterial cells and in yeast. No increase in chromosomal aberrations and
UDS was observed with this test material.
No gene mutation study in mammalian cells is
available for dipropylene glycol methyl ether (DPGME). Therefore,
studies on propylene glycol methyl ether (PGME) and tripropylene glycol
methyl ether (TPGME) are used as surrogates for DPGME. The glycol ethers
PGME, DPGME and TPGME are closely related in molecular structure and
physicochemical properties and thus, the potential for toxicological
effects. They are liquids with similar boiling points, moderate
volatility, and high water solubility. Increasing boiling point and
vapor pressure are consistent with increasing molecular weight. No
differences in gene mutation potential have been observed between other
glycol ethers families (e.g. mono- and di-propylene glycol n-propyl
ethers and mono-, di- and tri-propylene glycol n-butyl ethers). The
results of propylene glycol ethers were consistently negative in gene
mutation studies. Therefore, it is justified to use the gene mutation
studies conducted with PGME and TPGME for read-across purposes to fill
the data gap for DPGME. Negative results were obtained in the gene
mutation studies in mammalian cells conducted with PGME and TPGME.
No in vivo studies are available.
Dipropylene glycol methyl ether was not
mutagenic in bacteria (Salmonella typhimuriumTA 1535, TA 1537, TA 1538,
TA 98, and TA 100) and in yeast, and no cytogenetic effect were observed
in mammalian cells. The data available indicates that dipropylene glycol
methyl ether is not genotoxic.
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