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EC number: 203-770-8
CAS number: 463-04-7
The aim was to evaluate the possible irritating effects of the test item
ISOAMYL NITRITE after topical application on in vitro human
reconstructed epidermis (SkinEthic RHE® model).
The test item ISOAMYL NITRITE was applied as supplied, at the dose of 16
μL to 3 living Reconstructed Human epidermis (SkinEthic RHE® model)
during 42 minutes. The application was followed by a rinse with 25 mL of
DPBS and a 41 hours and 40 minutes post-incubation period at 37°C, 5%
CO2. 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.
The experimental protocol was established in accordance with O.E.C.D.
Test Guideline No. 439 adopted 28 July 2015 and the Test method B.46 of
Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220) -
ATP Council regulation No. 440/2008 of 30 May 2008 (E.U. Journal L142).
An opaque beige coloration was noted on all Reconstructed Human
epidermis after the rinse.
The mean percent viability of the treated tissues was 0.9%, versus 1.5%
in the positive control (5% Sodium Dodecyl Sulfate).
In accordance with the Regulation EC No. 1272/2008 and considering the
results obtained during the in vitro skin corrosion study (study No.
HSMC-PH-18/0023, test item classified as corrosive 1B/1C), the test item
ISOAMYL NITRITE has to be classified in Category 1 “Corrosive”. The
hazard statement “H314: Causes severe skin burns and eye damage” with
the signal word “Danger” is 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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