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EC number: 940-783-4
CAS number: -
The reconstructed human epidermis model
EPISKIN-SM is designed to predict and classify the skin irritant
potential of chemicals, by measuring its cytotoxic effect, as reflected
in the MTT assay, on the EPISKIN reconstituted human epidermis. This
method is approved by international regulatory agencies as a replacement
for the identification of irritants / corrosives in the in vivo Rabbit
skin assay (OECD 404).
Disks of EPISKIN (three units / chemical)
were treated with PREPOLYMER D and incubated for 15 minutes at room
temperature. Exposure of test material was terminated by rinsing with
PBS. Epidermis units were then incubated at 37°C for 42 hours in an
incubator with 5% CO2. The viability of the epidermis on each disk was
assessed by incubating the tissues for 3 hours with MTT solution at 37°C
in 5% CO2 protected from light. The formazan extract in acidified
isopropanol was then spectrophotometrically evaluated for optical
density (OD) and quantified.
SDS 5% and PBS treated epidermis were used
as positive and negative controls, respectively. An additional disk was
used to provide an estimate of colour contribution from the test item.
For each treated tissue viability was expressed as a % relative to
negative control. If the mean relative viability after 15 minutes
exposure and 42 hours post incubation is less or equal (≤) to 50% of the
negative control, the test substance is considered to be irritant to
Following exposure with PREPOLYMER D, the
mean cell viability was 105% compared to the negative control and
therefore non- irritant. All validity criteria were within acceptable
limits and therefore the study can be considered as valid.
In this in vitro skin irritation test in the
EPISKIN model with PREPOLYMER D the results indicated that the test item
is Non Irritant (NI).
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