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EC number: 915-008-8
CAS number: -
aim of the study was to evaluate the possible corrosive
effects of the test item after topical administration on in
reconstituted epidermis (epiCS®,
test item Reaction
mixture of CuDTPA and CuHEEDTA was
applied as supplied on a nylon mesh at the dose of 25 mg
then to 2 living and 4 killed Human skin model surfaces
previously moistened with 10 μL of distilled water during 3
minutes and 1 hour. The application was followed by a rinse
with 20 mL of DPBS. Cell viability was then measured by
enzymatic conversion of the vital dye MTT into a blue
formazan salt that was quantitatively measured after
extraction from tissues.
2 living and 4 killed Human skin model surfaces (epiCS®,
were treated in the same manner during both 3 minutes and 1
hour, but they were incubated in in MTT assay medium instead
of MTT solution in order to generate non-specific living and
killed colour controls.
The experimental protocol was established in accordance with the O.E.C.D.
Test Guideline No. 431 dated 29 July 2016 and the method
B.40bis of the Council regulation No. 440/2008.
minutes and 1 hour after the test item application, the mean
corrected percent viability of the epidermis skins treated
with the test item were 97.68%
(considered as 100%),
versus 17.98% and 0.33%, respectively, with the positive
control item (potassium hydroxide 8N).
accordance with the Regulation (EC) No. 1272/2008, the
results obtained under these experimental conditions enable
to conclude that the test item Reaction
mixture of CuDTPA and CuHEEDTAdoes
not have to be classified in Category 1 “Corrosive”.
hazard statement “H314: Causes severe skin burns and eye
damage” with the signal word “Danger” are not required.
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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