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EC number: 944-870-8
CAS number: -
Table 1: Results
2: Acceptability of the Quality Control Data of the Skin Model with
Reference to Historical Batch Data:
Negative control OD
> 0.8 and < 3.0
1.594 to 1.794
Table 3: Acceptability of the Positive and Negative Control stated by Episkin/SkinEthic Laboratories
Mean OD negative control
Mean viability positive control
SD of group-mean value
7.1% (positive control)
6.7% (negative control)
Table 4: Acceptability of the Positive and Negative Control based on Historical Data of the Testing Laboratory
Table 5: Test Item Data Acceptance Criteria:
6: Historical Data
The mean of
negative control and positive control of all performed experiments in
the testing laboratory is given in the following table.
Mean Viability [%]
Mean Absorption [OD570]
the historical data, acceptability ranges for the positive and negative
control were stated.
objective of the present study was to investigate the potential of the
test item to induce skin irritation in anin
skin model according to OECD TG 439. The
test item was applied topically to a human reconstructed skin model
followed by determination of the cell viability. Cell viability was
determined by enzymatic conversion of vital dye MTT into a blue formazan
salt and measurement of the formazan salt after extraction from tissues.
The percent reduction of cell viability in comparison to untreated
negative controls was used to predict the skin irritation potential. Triplicates
of the human skin RHE-model were treated with the test item, the
negative or the positive control for 42 minutes(±1
minute). 16 µL of either the negative control (DPBS-buffer) or the
positive control (5% aqueous solution of sodium dodecyl sulfate) were
applied to the tissues. Before application of 16 mg of the solid test
item, 10 µL of deionised water was spread to the epidermis surface to
improve the contact between the test item and the epidermis.
acceptability criteria after treatment with the negative control
(DPBS-buffer) and the positive control (5% aqueous solution of sodium
dodecyl sulfate) were met.
treatment with the test item, the tissue viability was 107.5% and, thus,
higher than 50%,i.e.according
to OECD 439 the test item is considered as non-irritant to skin (UN GHS:
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