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EC number: 609-462-3
CAS number: 376653-37-1
Density (OD) and the calculated relative viability % of the samples
Optical Density (OD)
Viability (% RV)
Phosphate buffered saline
5% (w/v) SDS solution
blank value was 0.047
density means the mean value of the duplicate wells for each sample
(rounded to three decimal places).
An in vitro skin irritation
test of BAL0001024 test item was performed in a reconstructed human
epidermis model. EPISKINTM(SM) is designed to predict and
classify the irritation potential of chemicals by measuring its
cytotoxic effect as reflected in the MTT
(3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay.
The irritation potential of the test item was evaluated according to the
OECD No. 439 guideline.
Disks of EPISKINTM(SM)
(three units) were treated with the test item and incubated for
15 minutes at room temperature. Exposure to the test item was terminated
by rinsing with Phosphate Buffered Saline (PBS). The epidermis units
were then incubated at 37 °C for 42 hours in an incubator with 5% CO2 in
a >95% humidified atmosphere. The viability of each disk was assessed by
incubating the tissues for 3 hours with MTT solution at 37 °C in an
incubator with 5% CO2in a >95% humidified atmosphere
protected from light. The precipitated formazan crystals, the
concentration of which indicates cell viability, were then extracted
using acidified isopropanol and quantified spectrophotometrically.
PBS and 5% (w/v) Sodium
Dodecyl Sulphate (SDS) solution treated epidermis were used as negative
and positive controls, respectively (three units / control). For each
treated tissue, the cell viability was expressed as a % relative to the
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 item is considered to be irritant to skin.
Following exposure with
BAL0001024, the mean cell viability was 89.5% compared to the negative
control. This is above the threshold of 50%, therefore the test item was
considered as being non-irritant to skin. The experiment met the
validity criteria, therefore the study was considered to be valid.
Based on the results of a
corrosivity test (performed by Citoxlab Hungary Ltd., study code:
17/220-039B) the test item is non-corrosive.
In conclusion, in this in
vitro EPISKINTM (SM) model test with BAL0001024 (Batch number: 012), the
results indicate that the test item is non-irritant to skin (No
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