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EC number: 202-500-6
CAS number: 96-33-3
Methyl acrylate is a chemical intermediate,
manufactured and processed within closed systems. The primary routes of
industrial exposure to methyl acrylate are skin contact and inhalation.
In an industrial setting, ingestion is not an anticipated route of
Long-tern exposure systemic DNELs were not
calculated because of the lack of long-term systemic effects. Dose-level
selection for long-term studies was limited by severity of local effects
on the upper respiratory tract.
EU Scientific Committee on Occupational Exposure Limits (SCOEL)
Commission on 'health-based' OELs. An OEL of this type may be
established in those cases where a review of the total available
scientific database leads to the conclusion that it is possible to
identify a clear threshold dose below which exposure to the chemical in
question is not expected to lead to adverse effects. The European
Commission uses the scientific advice from SCOEL to make proposals for
occupational exposure limits. Limits based solely on scientific
considerations are considered as adaptations to technical progress, and
are incorporated in proposals for Commission directives within the
framework of the chemical agents directive and are indicative.
September 2004 the EU Scientific Committee on Occupational Exposure
Limits (SCOEL) recommended an 8 hour OEL (TWA) of 5 ppm (18 mg/m3)
for methyl acrylate. This
reommended OEL is taken as DNEL, it is based on actual and well
information and evaluation of health effects, in which the approach how
it is derived is scientifically justified and is therefore in accordance
with ECHA Guidance on information requirments and chemical safety
assessment, Chapter R.8: Characterisation of dose
(concentration)-response for human health (May 2008).
are no human data available which are adequate for proposing
occupational exposure limits.
study of Reininghaus et al. (1991), establishing a LOAEL of 15
ppm (54 mg/m3), for slight irritation of the olfactory
epithelium in rats, was considered to be the best available basis for
proposing occupational exposure limits.
this well-conducted 2 year study Sprague-Dawley rats (86 rats per sex
and group) developed no systemic effects at concentrations of 15, 45 and
135 ppm Methylacrylate (54, 161 or 483 mg/m3). In the cornea
a dose-related increase in neovascularization and parenchymal cloudiness
was observed in
male and female animals. However, little importance can be attached to
this finding because it is a result of anatomical and geriatric features
of the rat which are not found in man. The rat eye is spherical and the
cornea highly domed so that external factors have more effect on the rat
than on the human eye. The lacrimal glands of some strains including the
Sprague-Dawley rat, are often subject to age-related changes. This is
also to be seen in the author's own historical data for the Wistar rat.
The changes lead to inadequate lacrimation which means that the cornea
of such animals is no longer adequately protected. Any additional
adverse external influences, such as the irritation caused by methyl
acrylate, can then result in (dose dependent) corneal changes.
Furthermore, the neovascularization of the cornea in rats exposed to
methyl acrylate is known to be a reversible non-specific reaction to
chronic irritation. Thus the alterations in the lacrimal glands and
cornea which developed in rats under the conditions described above are
not to be expected in man. Corneal damage has not been reported in
workers in factories producing methyl acrylate (DFG 1993). The critical
effect was irritation of the nasal mucosa. Dose-related changes occurred
in the nasal mucosa at the level of the dorsal lamella of the second
endoturbinate. At the lowest concentration tested (15 ppm, 54 mg/m3)
slight atrophy of the neurogenic part of the olfactory epithelium was
observed in a
few male rats. At 45 and 135 ppm, almost all exposed rats developed a
partial loss of the columnar cell layer, with an accompanying stratified
reserve-cell hyperplasia . No treatment-related changes were detected in
the posterior nasal cavity, which is mainly lined with olfactory
epithelium. No irritative changes were observed in the larynx, trachea
or lungs of the exposed rats. The LOAEL of this study for basal-cell
hyperplasia (critical effect) is 15 ppm with a very steep
concentration-response-curve at higher concentrations (Reininghaus et
al., 1991). Calculation of a benchmark dose (BenchMark dose Software
from US EPA, Version 1.3.2, dichotomous logistic model with 0.95
confidence level) gave a BMDL of 14 ppm. In contrast to methylacrylate,
the concentration-response-curve for butylacrylate was flat, resulting
in a BMDL of 6 ppm, which is in accordance with the 8-h TWA of 2 ppm.
view of the mild nature of this localized lesion, observed in a
well-conducted study and
very steep concentration-response-curve beyond 15 ppm, the Scientific
Committee of Occupational Exposure Limits considered an uncertainty
factor of 2 appropriate to allow for the absence of a NOAEL and of human
data. This is in accordance with the calculated BMDL of 14 ppm. Taking
into account the preferred value approach, the recommended 8-hour TWA is
5 ppm (18 mg/m3). A short term exposure limit (STEL) (15 mins) of 10 ppm
(36 mg/m3) was proposed to limit peaks of exposure which
could result in irritation.
addition, a qualitative risk assessment approach was conducted for
dermal local acute and long term exposure based upon skin sensitization
as a hazard in accordance with the Guidance on information requirements
and chemical safety assessment, Chapter R.8 (ECHA, Nov 2012). A medium
hazard conclusion was based on the EC3 value of 19.6%
indicative of a sensitizer of weak potency.
end-use consumer products contain only trace levels of acrylic acid and
esters (as a result of polymerization), consumer exposure to acrylate
monomers is likely to be low (SRI, 2001).
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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