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EC number: 947-946-9
CAS number: -
MTT solution containing the test item turned purple which indicated that
the test item directly reduced MTT.
of Color Interference with the MTT Endpoint
solution containing the test item was a dark green color, therefore
additional color correction tissues were incorporated into the testing
results obtained showed that negligible color interference occurred. It
was considered unnecessary to use the results of the color correction
tissues for quantitative correction of results.
Item, Positive Control Item and Negative Control Item
relative mean viability of the test item treated tissues was 23.8%
(≤50%) after a 15 Minute exposure period and 42 Hour post exposure
relative mean viability for the positive control was 19.7% relative to
the negative control treated tissues and the standard deviation value of
the viability was 6.7% (≤18%). The
positive control acceptance criteria were therefore satisfied. The
mean OD570 for the negative control treated tissues was 0.874, within
the range of 0.6 - 1.5 and the standard deviation value of the viability
was 2.1% (≤18%). The
negative control acceptance criteria were therefore satisfied. The
standard deviation calculated from individual tissue viabilities of the
three identically test item treated tissues were 2.8% (≤18%). The
test item acceptance criterion was therefore satisfied.
Viabilities of the EPISKIN™ Tissues
OD570(Mean ± SD)
Relative Tissue Viability(Mean ± SD)
0.208 ± 0.024
DPBS (Negative Control)
0.5% SDS (Positive Control)
0.172 ± 0.058
purpose of this test was to evaluate the skin irritation potential of
the test item using the EPISKINTMreconstructed human
epidermis model after a treatment period of 15 minutes followed by a
post exposure incubation period of 42 hours. Tissue viability is
measured by enzymatic reduction of the yellow MTT tetrazolium salt (3
[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a
blue/purple formazan salt in the test item treated tissues relative to
the negative controls.
tissues were treated with the test item for 15 minutes. At the end of
the exposure period each tissue was rinsed before incubating for 42
hours. The test item was found to directly reduce MTT; therefore,
additional non-viable tissues were incorporated into the testing for
correction purposes. The test item was also found to have the potential
to cause color interference with the MTT endpoint therefore additional
tissues were incorporated into the testing to correct for this. A third
set of controls was included, comprising water killed tissues, to
prevent a double correction from a colored test item that also reduces
MTT. At the end of the post exposure incubation period the maintenance
medium from beneath each tissue was transferred to pre labeled micro
tubes and stored in a freezer for possible inflammatory mediator IL-1α
determination. After MTT-loading a total biopsy of each epidermis was
made and placed into micro tubes containing acidified isopropanol for
extraction of formazan crystals. At the end of the formazan extraction
period each tube was mixed thoroughly and duplicate 200 µL samples were
transferred to the appropriate wells of a pre labeled 96 well plate. The
optical density was measured at 570 nm. Data was presented in the form
of percentage viability (MTT reduction in the test item or positive
control treated tissues relative to negative control tissues). The
relative mean viability of the test item treated tissues was 23.8% after
the 15 minute exposure period and 42 hours post exposure incubation
period. The quality criteria required for acceptance of results in the
test were satisfied.
the conditions of the study, the relative mean tissue viability of the
test item was 23.8%, less than 50%, and therefore, the test item
demonstrated the ability to cause a positive response as skin
irritant. However this study does not allow the conclusion on whether
the test item is Category 1 or Category 2 of Regulation (EC) No.
1272/2008 Classification, Labelling and Packaging of Substances and
Mixtures (EU CLP), and United Nations Globally Harmonized System of
Classification and Labelling of Chemicals (UN GHS).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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