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EC number: 229-745-1
CAS number: 6701-13-9
The objective of this study was to
evaluate the skin irritation potential of the test item,1,10-decanediyl
bis methacrylate, using the Episkin reconstructed human epidermis model.
The study design was based upon
international guidelines (OECD Guideline No. 439 and Commission
Regulation (EC) No. 761/2009, B.46).
Preliminary tests were performed to
detect the ability of the test item to directly reduce MTT as well as
its colouring potential.
Following the preliminary tests, the
skin irritation potential of the test item was tested in the main test.
The test item and both the negative and positive controls were applied
topically on triplicate tissues and incubated at room temperature for 15
minutes. At the end of the treatment period, each tissue was rinsed with
D-PBS and incubated for 42 hours at +37°C,
5% CO2 in a humidified incubator.
The cell viability was then assessed
by means of the colourimetric MTT reduction assay.
Relative viability values were
calculated for each tissue and expressed as a percentage of the mean
viability of the negative control tissues which was set at 100%
In addition, the concentration of the
inflammatory mediator IL-1a was evaluated in the culture medium retained
following the 42-hour recovery period. This quantification, based on an
ELISA assay, was performed since the mean relative viability of the test
item-treated tissues was > 50% following the MTT reduction assay.
In the preliminary tests, the test
item was found not to have direct MTT reducing properties or colouring
All acceptance criteria for the
negative and positive controls were fulfilled. The study was therefore
considered to be valid.
Following a 15 minutes exposure and 42
hours of recovery period, the relative mean viability of the tissues
treated with the test item was 109% with a standard deviation of 2%.
As the mean viability was > 50% after
the MTT reduction, the IL-1a concentration in culture media samples
retained from the three negative controls and the three test
item-treated tissues were analysed by ELISA.
The IL-1a concentration value of one
tissue was found Below the Limit of Quantification (< 5.00 pg/mL).
Consequently, the mean IL-1a concentration from the three test
item-treated tissues was not calculated. The IL-1a concentration values
of the two other test item-treated tissues were found < 60 pg/mL (5.04
and 20.0 pg/mL).
Therefore, the results met the
criteria for an in vitro classification as non-irritant to skin.
Under the experimental conditions of
this study, the test item 1,10-decanediyl bis methacrylate is considered
to be non-irritant to skin.
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