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: 256-062-6
CAS number: 43048-08-4
The objective of this study was to
evaluate the skin irritation potential of the test item using the Episkin
reconstructed human epidermis model.
The study design was based upon OECD
Test Guideline No. 439 and Commission Regulation (EC) No. 761/2009,
B.46. The study was conducted in compliance with Charles River
Laboratories Evreux 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 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% CO2in 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% (as
In the preliminary tests, the test
item was neither found to have direct MTT reducing properties, nor
In the main test, all acceptance
criteria were fulfilled, the study was therefore considered to be valid.
Following the 15-minute exposure and
the 42-hour recovery period, the relative mean viability of the tissues
treated with the test item was 122% with a Standard Deviation of 7%.
As the mean viability was > 50% after
the MTT reduction, the results met the criteria for a non-irritant
Under the experimental conditions of
this study, the test item is considered to be non-irritant to skin.
Accordingly, the classification of the test item should be No Category
(UN GHS and 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