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EC number: 289-214-5
CAS number: 86261-90-7
Valid experimental data were available to
assess the genetic toxicity in vitro of ureido methylacrylate.
Gene mutation in bacteria
The ability to induce reverse mutations at
the histidine locus in four strains of Salmonella typhimurium (TA98,
TA100, TA1535 and TA1537), and at the tryptophan locus in Escherichia
coli tester strain WP2uvrA, in the presence or absence of an exogenous
metabolic activation system (S9) containing mammalian microsomal enzymes
was examined for ureido methacrylate (Covance Lab, 2002). A dose range
finding assay was conducted on the test article using tester strains TA
l00 and WP2uvrA (one plate per dose). Ten doses of test article, from
6.67 to 5000 μg/plate, were evaluated in the presence and absence of S9.
Apparently normal growth was observed in both tester strains, and the
test article was found to be freely soluble, at all doses evaluated with
and without S9.
Based upon these results, ureido
methacrylate was evaluated in the initial mutagenicity assay, in all
five tester strains, at doses of 33.3, 100,333, 1000, 3330 and 5000
μg/plate with and without S9. All doses of the test article, as well as
the concurrent positive and vehicle controls, were evaluated using three
plates per dose. Apparently normal growth again was observed in all five
tester strains, and the test article again was freely soluble, at all
doses evaluated with and without S9. Revertant frequencies for all doses
ureido methacrylate, in all tester strains
with and without S9, approximated those observed in the concurrent
vehicle control cultures.
The test article was re-evaluated in an
independent confirmatory experiment under identical conditions, and
similar results were observed. Apparently normal growth again was
observed in all five tester strains, and the test article again was
freely soluble, at all doses evaluated with and without S9. Increases in
revertant frequencies, to approximately 2.0- to 2.7-fold control values,
were observed in tester strain WP2uvrA at doses of 33.3 to 333 μg/plate
without S9. However, these increases did not appear to be dose
dependent, and all observed values were within acceptable negative
control ranges. Revertant frequencies for all doses of ureido
metharclate, in all other tester strainlS9 combinations, approximated
control values. Thus, the slight increases observed in tester
strainWP2uvrA without S9 in the confirmatory assay are considered to be
a statistical aberration due to random fluctuation of the spontaneous
revertant frequency. All positive and negative control values in both
assays were within acceptable ranges, and all criteria for a valid study
These results indicate that ureido
methacrylate was negative in the Salmonella-Escherichia
coli/Mammalian-Microsome Reverse Mutation Assay with a Confirmatory
Assay under the conditions, and according to the criteria, of the test
A further high quality Ames test was
performed as preincubation assay with Salmonella typhimurium TA1535, TA
1537, TA 98 and TA 100 and TA 102 with and without metabolic activation
(Rohm & Haas 2001). Again, ureido methacrylate (purity unknown) showed
no mutagenic potential.
Another high quality Ames test was performed
as preincubation and plate incorporation assay with Salmonella
typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 with and without
metabolic activation (RTC 2001). The test item ureido methacrylate (50
%) was examined for mutagenic activity by assaying for reverse mutation
to histidine prototrophy in the prokaryotic organism Salmonella
typhimurium. The tested concentrations were 5000, 2500, 1250, 625, and
313 µg/plate, based on active ingredient. Also in this test, ureido
methacrylate showed no mutagenic potential.
The assay was performed in two
independent experiments, using two parallel cultures each. The first
main experiment was performed with and without liver microsomal
activation and a treatment period of 4 hours.The second experiment was
performed with a treatment time of 4 hours with and 24 hours without
metabolic activation. The test concentrations was 250, 500, 1000, 2000
and 4000 µg/ml. The highest concentration of 4000 µg/mL was equal to
approximately 10 mM. The test item was dissolved in water. No
relevant toxic effects occurred up to the maximum concentration with and
without metabolic activation following 4 hour treatment. After 24 hour
treatment without metabolic activation minor cytotoxic effects were
noted at the highest analysable concentration of 2000 µg/mL. At the next
higher concentration of 4000 µg/mL exceedingly severe cytotoxic effects
Ureidomethacrylate 50 % in water is
considered to be non-mutagenic in this HPRT assay.
Cytogenicity in vivo
Ureido methacrylate was evaluated for its
potential to induce chromosomal damage in vivo, as assessed by the
micronucleus assay with mouse bone marrow cells. Adult CD-1 male and
female mice (5 male and 5 female animals per group, except for the high
dose group, which had 2 additional animals per time point) received a
single oral dose of the test article at concentrations of 200, 1000 or
2000 mg/kg bw. Control animals received a single oral dose of distilled
water (vehicle control), or an intraperitoneal injection of 2.0 mg/kg bw
mitomycin-C (positive control) (MMC). Animals from test article and
vehicle control groups were euthanized at 24 or 48 hours after
treatment. Animals from the positive control group were euthanized 24
hours after treatment. Bone marrow slides were prepared and the
frequency of micronucleated polychromatic erythrocytes was measured as
an indicator of cytogenetic damage. For each animal, a total of at least
2000 polychromatic erythrocytes were scored for the presence or absence
of micronuclei. In addition, the polychromatic erythrocyte1
normochromatic erythrocyte (PCENCE) ratio was measured to evaluate the
cytotoxicity of the test agent.
The test article did not induce an increase
in the frequency of micronucleated polychromatic erythrocytes in bone
marrow cells of male or female mice when compared to the vehicle
controls. An increase in the frequency of micronucleated polychromatic
erythrocytes was observed in the bone marrow cells of male and female
mice treated with 2.0 mg/kg bw of the positive control, MMC. When
compared to the vehicle controls, the increase was greater than
two-fold, indicating that the assay was sufficiently sensitive to detect
induced cytogenetic damage. Under the conditions of this study, ureido
methacrylate was not mutagenic in the micronucleus assay in CD-1 mouse
bone marrow cells.
Based on the available data, there is no
indication for a mutagenic potential of the test substance. Thus, no
classification is warranted according to 67/548/EEC and Regulation (EC)
No 1272/2008 (GHS, CLP), respectively.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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