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EC number: 202-597-5
CAS number: 97-63-2
Skin sensitisation: weakly sensitising. CLP EU GHS (Regulation (EC) No
1272/2008) classification: sensitizing category 1B (LLNA EC3 value > 2%)
Respiratory sensitization: No experimental studies on respiratory
sensitisation of EMA in animals have been reported in the literature,
but also no clinical reports implicating EMA with the development of
asthma have been published. In the absence of any positive indication,
EMA is regarded as non-sensitising for the respiratory tract.
Vehicle: acetone/olive oil (4+1 v/v)
Test item concentration
DPM values measured
DPM-BG per animal(2 lymph nodes)a)
1 = Control
a) = values corrected for mean background value (BGI
b) = Stimulation
Indices relative to the mean of the control group (Group 1)
Vehicle: acetone : olive oil (4 +1 v/v)
Test item concentration % (w/v)
mean DPM per animal (2 lymph nodes)a)
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
CG1= Control Group
2-4 = Test Group
S.I. = Stimulation Index
a) = Mean DPM/animal was determined by dividing
the sum of the measured values from lymph nodes of all animals within a
group by the number of animals in that group (5 animals)
The EC3 value was calculated, to be 82.6% (w/v).
No deaths occurred during the study period.
No systemic findings were observed during the study period. On day 3 and
4 the treated animals showed an erythema of the ear skin (Score 1) and
animals treated with a test concentration of 100% showed an erythema of
the ear skin (Score 1) from day 3 up to day 6.
The body weight of the animals, recorded prior
to the first application and prior to treatment with3HTdR,
was within the range commonly recorded for animals of this strain and
The individual body weight values are included in the following
Initial Weight (g)
weight prior to treatment with3HTdR (g)
In a dermal sensitization study
with Ethyl methacrylate (99.81%) dissolved in acetone : olive
oil (4 +1 v/v) as a vehicle, 20 (5 per dose group) 9 - 10 week old
female CBA/CaOlaHsd mice were
tested using the method of OECD 429 (Local Lymph node Assay).
Ethyl methacrylate, three groups each of five
female mice were treated daily with the test item at concentrations of
25, 50, and 100% (w/v) in acetone:olive oil (4+1 v/v) by topical
application to the dorsum of each ear lobe (left and right) for three
consecutive days. A control group of five mice was treated with the
vehicle (acetone:olive oil (4+1 v/v)) only. Five days after the first
topical application the mice were injected intravenously into a tail
vein with radio-labelled thymidine (3H-methyl thymidine).
Approximately five hours after intravenous injection, the mice were
sacrificed, the draining auricular lymph nodes excised and pooled per
animal. Single cell suspensions of lymph node cells were prepared from
pooled lymph nodes, which were subsequently washed and incubated with
trichloroacetic acid overnight. The proliferative capacity of pooled
lymph node cells was determined by the incorporation of3H-methyl
thymidine measured in a beta-scintillation counter.
validation-/positive control experiment was performed with alpha-Hexyl
cinnamic aldehyde dissolved in acetone/olive oil (4 +1 v/v). In
the course of the study no cases of mortality and
no signs of systemic toxicity were observed.
On day 3 and 4 the treated animals showed an erythema of the ear skin
(Score 1) and animals treated with a test concentration of 100% showed
an erythema of the ear skin (Score 1) from day 3 up to day 6.
A test item is regarded as a sensitiser in the LLNA if the
exposure to one or more test concentration resulted in 3-fold or
greater increase in incorporation of3HTdR compared with
concurrent controls, as indicated by the Stimulation Index (S.I.). The
estimated concentration of test item required to produce a S.I. of 3
is referred to as the EC3 value. In this study Stimulation Indices of
0.93, 1.41, and 3.85 were determined with the test item at
concentrations of 25, 50, and 100% in acetone:olive oil (4+1 v/v). A
clear dose response was observed. The EC3 value was calculated, to be
Therefore, Ethyl methacrylate was a skin sensitiser when
tested in this fully valid Local Lymph Node Assay according to OECD TG
CLP EU GHS (Regulation (EC) No 1272/2008) classification: sensitizing
category 1B (EC3 value > 2%)
NOTE: Any of data in this dataset are
disseminated by the European Union on a right-to-know basis and this is
not a publication in the same sense as a book or an article in a
journal. The right of ownership in any part of this information is
reserved by the data owner(s). The use of this information for any
other, e.g. commercial purpose is strictly reserved to the data owners
and those persons or legal entities having paid the respective access
fee for the intended purpose.
EMA is an extremely weak skin sensitiser in animals
giving equivocal or negative results in the limited number of
intradermal animal tests and this is consistent with a low incidence in
clinical patch tests in humans. By analogy to MMA, for which a higher
prevalence of contact allergy has been reported in humans and for which
it has been shown has a weak potency for induction potency in LLNA
et al., 2006), it may be concluded that EMA is a weak skin sensitiser. EMA,
like other methacrylate esters, can cross-react with other
In a recent mouse local
lymphnode assay (LLNA) (MPA, 2013) Ethyl methacrylate formulated in
acetone/olive oil (4+1 v/v) was assessed for its possible skin
sensitising potential. For this purpose a LLNA assay was performed using
test item concentrations of 25,
50 and 100% (w/v). All treated animals survived the scheduled study
period and no signs of systemic toxicity were observed.
On day 3 and 4 the treated animals showed an erythema
of the ear skin (Score 1) and animals treated with a test
concentration of 100% showed an erythema of the ear skin (Score 1)
from day 3 up to day 6.
In this study Stimulation Indices of 0.93, 1.41,
and 3.85 were determined with the test item at concentrations of 25,
50, and 100% (w/v) in acetone:olive oil (4+1 v/v). A clear dose
response was observed. The EC3 value was calculated, to be 82.6%
The test item Ethyl
methacrylate was found to be a skin sensitiser, the EC3 value of 82.6 %
(w/v) was derived. In this study Ethyl methacrylate is a skin sensitizer
of weak potency. (MPA, 2013)
Contact allergy to MMA is relatively common reported in the
literature although closer examination of the prevalence data indicate
that it is not a strong sensitizer in humans (Kimber
and Pemberton, 2014). This is consistent with a weak induction potency
in LLNA studies (Betts et al.,
2006). Weak sensitisation potential was also demonstrated
for the other members of the category in the LLNA. Preliminary data from
in vitro screens confirms allergenic potential but likely due to the
complexity of the ADME and reactivity processes that occur within
viable, intact skin these appear not to be predictive of in vivo
potency. Kimber and Pemberton concluded that “MMA and other
Lower Alkyl Methacrylate esters are contact allergens, but that none of
these chemicals has any more than weak skin sensitising potency.”
no clinical case studies in the literature linking exposure to EMA and
the development of respiratory allergy/asthma
closely related methyl ester MMA, the EuRA in 2002, and
later SCOEL in 2005, concluded that there have been a small number of
cases reported of asthmatic reactions in people occupationally exposed
to MMA in the literature but as MMA is a respiratory irritant that there
is no convincing evidence that methyl methacrylate caused the
acquisition of asthma in these individuals. There has been no
information published since these reviews to contradict this decision.
There is no evidence in the literature that exposure to MAA or the other
esters within the category has caused respiratory allergy.
EMA give equivocal results in adjuvant studies in guinea pigs. In a
recent LLNA assay Ethyl methacrylate was determined to be a
weak skin sensitiser when tested in this fully valid Local Lymph
Node Assay according to OECD TG 429 (MPA, 2013).
CLP EU GHS (Regulation (EC) No 1272/2008) classification:
sensitizing category 1B (EC3 value > 2%)
It is an extremely weak sensitizer in animals. No experimental studies
on respiratory sensitization have been reported.
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