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EC number: 304-037-6 | CAS number: 94233-07-5
This report describes the ability of EDTA-MnNa2 to induce skin irritation on a human three dimensional epidermal model (EPISKIN Standard model (EPISKIN-SMTM)). The possible skin irritation potential of EDTA-MnNa2 was tested through topical application for 15 minutes. The study procedures described in this report were based on the most recent OECD and EC guidelines. Batch CFC 9380 of EDTA-MnNa2 is an off-white powder. Skin tissue was moistened with 5 µl of Milli-Q water and at least 10 mg of EDTA-MnNa2 was applied directly on top of the skin tissue for 15 minutes. After a 42 hour incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with EDTA-MnNa2 compared to the negative control tissues was 72%. Since the mean relative tissue viability for EDTA-MnNa2 was above 50% after 15 minutes treatment EDTA-MnNa2 is considered to be non-irritant. The positive control had a mean cell viability after 15 minutes exposure of 9%. The absolute mean OD570(optical density at 570 nm) of the negative control tissues was according to the acceptability criteria of the assay. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly. It was concluded that this test is valid and that EDTA-MnNa2 is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
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