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EC number: 289-214-5
CAS number: 86261-90-7
The test substance was soluble in acetonitrile.
The mean C-peptide depletion, caused by the test substance was
determined to be 58.3%.
The mean K-peptide depletion, caused by the test substance was
determined to be 5.5%.
Thus, the mean peptide depletion was calculated to be 31.9%.
No co-elution of test substance and peptides was noticed.
in an Guinea Pig Maximation Test according to OECD Guideline 406 (CIT
2003), the test substanc dissolved in 0.9% NaCl was assessed for its
skin sensitizing with a concentration of 5%. Thirty guinea pigs were
allocated to two groups: a control group of five males and five females
and a treated group of ten males and ten females. with an oedema and/or
crusts in 6/19 animals, was noted in 1/19, 5/19 and 12/19 animals,
respectively. At the 48-hour reading, a moderate or intense erythema,
together with an oedema,
dryness of the skin, crusts and/or a brownish area in 16/19 animals, was
recorded in 5/19 and 13/19 animals, respectively.
Under the experimental conditions the test item HYDROXYETHYL
IMIDAZOLIDONE METHACRYLATE (ureido methacrylate) induces delayed contact
hypersensitivity in 18/19 (95%) guinea pigs and should therefore be
considered as a sensitizer.
A combination of several in vitro methods addressing key steps
of the adverse outcome pathway (AOP) for skin sensitization  as
defined by OECD, has been conducted to assess the skin sensitizing
potential of ureido methacrylate
of keratinocytes(LuSens), and
of dendritic cells(MUSST).
The results of the individual studies are evaluated to predict
the presence or absence of skin sensitizing potential of ureido
The combination of test methods and the evaluation of their
results has been evaluated and published by Bauch et al., 2012.
Based on the performance standards of the OECD test guideline no. 429
(Local Lymph Node Assay, LLNA, OECD 2010), the evaluation based on
the DPRA, LuSens and MUSST methods yields an overall accuracy of 95%
compared to results in humans (for comparison: for the same data set
the LLNA yielded an overall accuracy of 86%).
A skin sensitizing (quantitative) potency assessment using the
reported results was not validated at the time of writing of this
Evaluation criteria for individual tests are:
Direct Peptide Reactivity Assay (DPRA)
Positiveif ≥6.38% mean peptide depletion
Negativeif <6.38% mean peptide depletion
Keratinocyte Activation Assay - LuSens
ARE-dependent luciferase activity
Positiveif ≥1.5-fold luciferase activity when viability is >70% of the vehicle control
Negativeif <1.5-fold luciferase activity
Dendritic Cell Line Activation Assay
Myeloid U937 Skin Sensitization Test (MUSST)
Positiveif ≥1.2-fold of CD86 when viability is >70% of the control
Negativeif <1.2-fold of CD86
Peptide Reactivity Assay: Positive
mean peptide depletion
cysteine peptide depletion; 5.5% Iysine peptide depletion)
Activation Assay (LuSens): Positive
independent experiments a luciferase activity induction above 1.5-fold
concentrations that did
not reduce cell viability below 70% was observed.
Cell Line Activation Assay Myeloid U937 Skin Sensitization Test(MUSST):
an induction of the expression of CD 86 above 1.2-fold
observed at sufficiently non-cytotoxic(cell
on the results of the in vitro tests applying the evaluation criteriaureido
predicted to be a skin sensitizer.
Adverse Outcome Pathway for Skin Sensitisation Initiated by Covalent
Binding to Proteins (2012) OECD ENVIRONMENT, HEALTH AND SAFETY
PUBLICATIONS: No.168; ENV/JM/MONO(2012)10
last accessed 05 Feb 2013
C Kolle SN, Ramirez T, Eltze T, Fabian E, Mehling A, Teubner W, van
Ravenzwaay B, Landsiedel R., 2012.Putting
the parts together: combining in vitro methods to test for skin
sensitizing potentials. Regul Toxicol Pharmacol. 63: 489-504.
2010: OECD GUIDELINE FOR THE TESTING OF CHEMICALS 429 Skin
Sensitization: Local Lymph Node Assay (adopted July 2010)
There is no information available on the potential for
Ureidomethacrylate to produce respiratory sensitisation in animals or
Based on the available data of ureido
methacrylate for skin sensitization, the substance has to be classified
as skin sensitisation (Xn, R43 according to Directive 67/548/EEC (DSD)
and skin sensitisation cat. 1B, H317 according to Regulation (EC) No
1272/2008 (CLP, GHS).
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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