Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 237-136-7
CAS number: 13653-62-8
The objective of this study was to
evaluate the skin irritation potential of the test item using the EpiskinTM
reconstructed human epidermis model. The study design was based
upon international guidelines (OECD Guideline No. 439 and Commission
Regulation (EC) No. 761/2009, B.46). The study was conducted in
compliance with CiToxLAB France 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 MTT as well as
its colouring potential. Following the preliminary tests, the skin
irritation potential of the test item was tested in the main test. The
test item and both the negative and positive controls were applied
topically on triplicate tissues and incubated at room temperature for 15
minutes. At the end of the treatment period, each tissue was rinsed with
D-PBS and incubated for 42 hours at +37°C, 5% CO2 in a
humidified incubator. The cell viability was then assessed by means of
the colourimetric MTT reduction assay. Relative viability values were
calculated for each tissue and expressed as a percentage of the mean
viability of the negative control tissues which was set at 100%
(reference viability). In addition, the concentration of the
inflammatory mediator IL-1a was evaluated in the culture medium retained
following the 42-hour recovery period. This quantification, based on an
ELISA assay, was performed since the mean relative viability of the test
item-treated tissues was > 50% following the MTT reduction assay.
In the preliminary tests, the test
item was found not to have direct MTT reducing properties or colouring
potential. All acceptance criteria for the negative and positive
controls were fulfilled. The study was therefore considered to be valid.
Following a 15 minutes exposure and 42 hours of recovery period, the
relative mean viability of the tissues treated with the test item was
78% with a standard deviation of 7%. As the mean viability was > 50%
after the MTT reduction, the IL-1a concentrations in culture media
samples retained from the three negative controls and the three test
item-treated tissues were analyzed by ELISA. The mean IL-1a
concentration for test item-treated tissues was 104 pg/mL. Due tothis
value being above the limit of 60 pg/mL, the results met the criteria
for an in vitro classification as irritant to skin.
Under the experimental conditions of
this study, the test item is considered to be irritant to skin; however,
it is not possible to discriminate the classification between Category 1
(H314) and Category 2 (H315) (Regulation (EC) No. 1272/2008).
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again