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EC number: 213-537-2
CAS number: 971-15-3
OD = optical density
cOD = blanck corrected optical density
The objective of this study was to
evaluate the skin irritation potential of the test
item,Dipentamethylenethiuram hexasulfide,using the EpiskinTM reconstituted
human epidermis model.
The study design is based on
international guidelines (OECD Guideline No. 439 and Commission
Regulation (EC) No. 761/2009, B.46) and thestudy was conducted in
compliance with CIT’s standard operating procedures and the principles
of Good Laboratory Practice.
Preliminary tests were performed to
detect the ability of the test item to directly reduce MMT as well as
its coloring potential.
Following the preliminary tests, the
skin irritation potential of the test item was tested in one main test.
The test item, the negative and positive controls were applied topically
on triplicate tissues and incubated at room temperature during 15 (± 1)
minutes. At the end of the treatment period, each tissue was rinsed with
D-PBS and incubated for 42 (± 1) hours at 5% CO2 in a
humidified incubator. The cell viability was then assessed by means of
the colorimetric MTT reduction assay.
Relative viability values were
calculated for each tissue and expressed as percentages of the negative
control tissues viability which was set at 100% (reference viability).
In the preliminary test, thetest item
was found to not have direct MTT reducing properties since the
MTTsolution containing the test item did notturn blue/purple when
compared to the negative control.As a result, no additional controls
were performed on water-killed tissues in parallel to the main test.
The test item was found to not have a
coloring potential in the preliminary test since the water solution
containing the test item did not change color. As a result, no
additional controls were used in parallel to the main test.
All acceptance criteria for the
negative and positive controls were fulfilled. The study was therefore
considered as valid.
Following a 15-minute exposure and a
42-hour recovery period, the relative mean viability of the tissues
treated with the test item was 100.5%.
The test item is considered as
non-irritant to skin.
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