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EC number: 257-861-2
CAS number: 52338-87-1
bisDMAPAU and monoDMAPU were tested in the Ames bacterial reverse mutation assay. Both materials were found to be non-mutagenic under the conditions of this test.
monoDMAPAU was shown to be non-clastogenic to CHL cells in vitro. In Silico Studies (Derek KB 2020 1.0) predicted the registered substance to be negative for gene mutation in vitro in mammalian cells
Based on the presence of approximately 15% of 1,3-bis[3-(dimethylamino)propyl]urea.(bisDMAPAU) in the test item, and according to the attached read-across justification this result is also deemed valid for 1,3-bis[3-(dimethylamino)propyl]urea (bisDMAPU)
For the Mutagenicity in vitro endpoint with the Sarah Model - 2020.1 model, the compound is predicted to be Negative with 44% confidence in the prediction
cultures of Chnese Hamster Lung (CHL) cells were treated with the test
material at several doselevels,
together with vehicle and positive controls. Five exposure groups were
used: Experiment 1 includeda
6(18)-hour exposure, both with and without the addition of an induced
rat liver homogenate metabolizingsystem;
Experiment 2 included a 24-hour continuous exposure, a 48-hour
continuous exposure and a repeatof
the 6(18)-exposure with metabolic activation.The
dose levels evaluated in the main experiments were selected from a range
of dose levels based on theresults
of a preliminary toxicity test and were in the range of 181.5 to 1562
pglml for all of the exposuregroups.The
vehcle (solvent) controls gave frequencies of cells with aberrations
within the range expected for theCHL
cell line. All the positive control chemicals induced highly significant
increases in the frequency ofcells
with aberrations indicating the satisfactory performance of the test and
of the activity of themetabolizing
system. The test material did not induce any significant increases in
the frequency of cellswith
aberrations in any of the exposure groups. The test material was shown
to be non-toxic to CHL cells invitro
and the maximum recommended dose level of 10rnMwas
used in all cases.
TA1535, TA1537, TA98 and TA100 andEscherichia
treated with the test item using both the Ames plate incorporation andpre-incubation
methods at up to eight dose levels, in triplicate, both with and without
of a rat liver homogenate metabolizing system (10% liver S9 in standard
maximum dose level of the test item in the first experiment was selected
as the maximumrecommended
dose level of 5000 µg/plate. There was no visible reduction in the
bacterial background lawn at any dose level, either in the presence or
activation (S9-mix), in the first mutation test (plate incorporation
the same maximum dose level was used in the second mutation test.
employing pre-incubation methodology in the second mutation test, a
the growth of the bacterial background lawns of all of theSalmonellastrains
was noted at5000
µg/plate in both the presence and absence of metabolic activation
(S9-mix). No toxicitywas
the second mutation test at any test itemdose
level in either the presence or absence of S9-mix. No test item
precipitate was observedon
the plates at any of the doses tested in either the presence or absence
were no toxicologically significant increases in the frequency of
revertant colonies recorded
for any of the bacterial strains, with any dose of the test item, either
with or withoutmetabolic
activation (S9-mix) in Experiment 1 (plate incorporation method) or Experiment
2 (pre-incubation method).
small, statistically significant increase in
TA1535 revertant colony frequency was observed in the presence of S9-mix
µg/plate in the first mutation test. This increase was considered to be
of no biologicalrelevance
because there was no evidence of a dose-response relationship or
No indications of a clastogenic effect of 3-(dimethylamino)propylurea
were found after a sinde oral treatment of 5000 mg/kg.
Based on the presence of approximately 15% of
1,3-bis[3-(dimethylamino)propyl]urea.(bisDMAPAU) in the test item, and
according to the attached read-across justification this result is also
deemed valid for 1,3-bis[3-(dimethylamino)propyl]urea (bisDMAPU).
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