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EC number: 203-652-6
CAS number: 109-16-0
CLP EU GHS
(Regulation (EC) No 1272/2008) classification: sensitizing category 1B
(EC3 value > 2%) according to an LLNA OECD 429 (2014)
in vivo data in guinea pigs with several test methods.
suffient data to classify TREGDMA as weak skin sensitizer.
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)
vaild dermal sensitisation study according to OECD Guideline 429
(adopted July 2010) Triethyleneglycol dimethacrylate (purity: 99.68%) in
acetone:olive oil (4+1, v/v), groups of 5 female CBA/CaOlaHsd mice were
tested using the LLNA method with the individual approach.
Local Lymph Node Assay Triethyleneglycol dimethacrylate is a dermal
findings were observed during the study period. Only the highest
dose (100%) induced slight erythema on the ear skin on days 3 to 6
(Score 1). Animals treated with 25 and 50% of the test item did not show
any signs of local skin irritation.
weight of the animals, recorded prior to the first application and prior
to treatment with 3HTdR, was within the range commonly recorded for
animals of this strain and age. No
cases of mortality were observed.
INDICES (S.I.) of 1.40, 1.51 and 3.30 were determined with the test
substance at concentrations of 25%, 50% and 100% (w/v) in acetone:olive
oil (4+1, v/v), respectively. The positive control substance was α-Hexylcinnamaldehyde,
which gave an EC3 at 9.3 % (w/v). A result is regarded as positive when
the S.I. is ≥3.
these criteria, the test substance was found to be a sensitiser.
The EC3 was calculated to be 91.6 %.
study, Triethyleneglycol dimethacrylate is a dermal sensitiser.
GHS (Regulation (EC) No 1272/2008) classification: sensitizing category
1B (EC3 value > 2%)
of data in this dataset are disseminated by the European Union on a
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In a mouse local lymphnode assay, LLNA (MPA,
2014), TREGDMA formulated in acetone/olive oil (4+1 v/v), was assessed
for its possible skin sensitising potential using test item
concentrations of 25, 50 and 100 %. All treated animals survived the
scheduled study period and no signs of systemic toxicity were observed.
Only the highest dose of 100% induced slight erythema on the ear skin on
days 3 to 6 (Score 1). Animals treated with 25 and 50% of TREGDMA did
not show any signs of local skin irritation. The body weight of the
animals, recorded prior to the first application and prior to treatment
with 3HTdR, was within the range commonly recorded for this strain and
Stimulation Indices (S.
I.) of 1.40, 1.51 and 3.30
were determined with TREGDMA at concentrations of 25, 50 and 100%. The
test item TREGDMA was found to be a skin sensitiser with weak potency
due to the derived EC3 value of 91.6 % (w/v).
there are six publications (Klimisch score 2; reliable with
restrictions) available for the sensitising potential of TREGDMA:
Magnusson-Kligman (GPMT), Intradermal 5% soybean oil or soy bean oil/2-butanone 1:2; epicutaneous induction: 100%; challenge: 25% in petrolatum and 100%
Sensitising (9/20 and 3/20 +ve)
Magnusson-Kligman (GPMT), intradermal induction: 5%; epicutaneous induction: 100%; challenge: 1% and 5% in olive oil
Sensitising (6/20 and 15/20 +ve)
Cavelier et al. 1981
Magnusson-Kligman (GPMT), intradermal induction: 1% in AOO; epicutaneous induction: 50% in pet.; challenge: 1% in petrolatum
Not sensitising (1/15 +ve)
GPMT, intradermal induction: 1% in liq. paraffin; epicutaneous induction: 100%; challenge: 25% in liq. paraffin
Huntingdon 1973 for Loctite
Polak-Test; d0: 4 footpad injections, 1 nape injection (0.1 mL of 2 mg/mL emulsion); d7: open skin test (repeated weekly for up to 12 weeks)
Parker and Turk, 1983
Non-standard protocol, mix of repeated epicutaneous and intradermal induction, partly w. FCA; challenge w. 1 % and 98 %
available GPMT tests used intradermal induction procedures which are
considered to be less relevant for this substance as dermal penetration
of TREGDMA under normal use conditions is expected to be low.
sensitizing potential of TREGDMA is confirmed by the negative results
obtained in four studies with standard induction concentrations of 1 %.
Positive results were obtained in two studies with induction
concentrations as high as 5 %.
sensitisation is an immunological process consisting of an induction
phase and the subsequent immune reaction. Key steps in the induction
phase are penetration of the substance to the viable epidermis, protein
binding (haptenation), release of proinflammatory signals by
keratinocytes, activation and maturation of dentritic cells and
migration of dentritic cells to the draining lymph nodes (OECD, 2012).
penetration is a prerequisite for skin sensitisation. Based on a
reliable QSAR model for dermal absorption only low dermal penetration is
expected for TREGDMA:
absorption (steady-state flux) of TREGDMA has been estimated by
calculation using the principles defined in the Potts and Guy prediction
model. Based on a molecular weight of 286.32 g/mol and a log Kow of 2.3,
the predicted flux of TREGDMA is 4.989 μg/cm²/h.
The relative dermal absorption is expected to be low.
metabolism data show that the substance is rapidly metabolised by
unspecific carboxyl hydrolases with hydrolysis half-lives in the range
of minutes. The metabolites, methacrylic acid and triethylene glycol are
injection of the substance for induction as performed in the available
publications, however, bypasses the intact skin barrier and a large part
of the capacity of intact skin for ester hydrolysis. In a study with
lower alkyl methacrylates, Jones (2001) has demonstrated that intact
skin has a significant capacity for hydrolysis if methacrylate esters.
conclusion, the data available to the public so far do not take into
account the low dermal penetration potential of the substance.
relevant model to assess the skin sensitisation potential of TREGDMA is
the Local Lymph Node Assay as in this assay the skin is left intact.
Thus, a Local Lymph Node Assay was conducted. The results of the LLNA
test showed a weak positive reaction towards TREGDMA. In conclusion,
TREGDMA has to be classified as a dermal skin sensitiser.
There is no
information available for respiratory sensitisation. Therefore, there is
a data gap in this respect. However, the data gap cannot be fulfilled
with experimental data, since there is no internationally accepted
animal model for respiratory sensitisation. In case human data for
respiratory sensitisation emerges, this will be taken into account.
The Adverse Outcome Pathway for Skin Sensitisation Initiated by Covalent
Binding to Proteins Part 1: Scientific Evidence, Series on Testing and
Assessment No.168, ENV/JM/MONO(2012)10/PART1, available online:
Compliance to REACh requirements
he requirements are covered with reliable in vivo data,
performed with the substance itself and before in vitro testing
became current priority.
No cases of
respiratory allergy have been reported in the literature for TREGDMA.
There is no evidence in the literature that exposure to the
members of the Multifunctional Methacrylates (MfMA category) has been
associated with respiratory allergy.
There is no evidence in the literature that exposure to TREGDMA has been
associated with respiratory allergy.
Inhalation is no relevant route of exposure.
According to the CLP criteria, a
substance should be classified as sensitising when there are positive
results from appropriate animal tests (a response of at least 30 % of
the animals in an adjuvant-type test).
In a local lymphnode assay acc. OECD
guideline 429 with GLP at concentrations of 25, 50 and 100 % stimulation
indices of 1.40, 1.51, and 3.30 were determined as well as an EC3 value
of 91.6 % (w/v). Also TREGDMA showed positive response in two studies in
Guinea pig maximisation test (GPMT), non-GLP.
In conclusion, TREGDMA is considered
as weak sensitizing to skin.
classification of TREGDMA was reconsidered based on the positive outcome
of a Local Lymph Node Assay performed by MPA, 2014. Therefore TREGDMA
has to be classified as
a skin sensitiser (Skin Sensitiser Cat.: 1B; H317) according to
regulation CLP regulation 1272/2008/EC and UN-GHS.
on the available data there is no evidence that TREGDMA causes
respiratory sensitisation. Therefore, a classification for respiratory
sensitisation is considered as not justified.
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