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EC number: 203-770-8 | CAS number: 110-46-3
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.
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