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EC number: 201-545-9
CAS number: 84-61-7
potential of the test item DICYCLOHEXYLPHTHALATE (batch: 031-12) to be
irritant to the
skin was investigated through anin vitroskin irritation study
using a commercial reconstructed
human epidermis (RhE) model named EPISKINTM.
The test item, as well as
controls, were tested for their ability to impair cell viability after
an exposure period of 15 minutes
followed by a 42 hour recovery period. The final endpoint of the assay
is the colorimetric measurement of MTT reduction (blue formazan salt) in
the test system being this
reaction an index of cell viability.
Main Assay, a preliminary test was carried out to assay the
compatibility of the test item
with the test system. In particular, the test item was assayed for the
ability of reducing MTT and of
colouring waterper se. No
interaction was recorded between the test item and MTT in test
conditions similar to those of the
Main Assay. Moreover, no colouring potential of the test item in contact
with water was recorded. Thus, no
additional control was added in the main phase for the evaluation of non specific
coloration which may influence evaluation of results.
Main Assay, the test item was applied as supplied in three replicates at
the treatment level of
20 mg/epidermisunit each measuring 0.38 cm2(treatment
level: 53 mg/cm2).
Positive and negative controls [a
5% (w/v) sodium dodecyl sulphate solution in water and Dulbecco’s
phosphate buffered saline (D-PBS)] were concurrently tested, in the same
number of replicates and test
conditions at the treatment level of 20 μL/epidermis unit.The
negative control gave the expected baseline value and variability, in
agreement with the guideline
indications. According to the method, the mean value is considered the
baseline value of the experiment
and thus represents 100% of cell viability. The
positive control caused the expected cell death (2.9% of cell viability
when compared to the negative
control) and variability (CV% equal to 12.2).
the assay was regarded as valid.
test item did not induce cell death, with a mean cell viability of 92.2%
when compared to the negative control. The intra-replicate variability
was slightly higher than expected (20.1% instead of < 18%). However,
since the test item did not clearly induce cell death and the relative
cell viability was much higher than the cut-off value (50%) in each of
the three replicates, the result was accepted as valid.
According to the established
criteria (cell viability less than 50%), the test item is considered to
have no irritant effect on the skin under the reported experimental
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