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EC number: 306-246-8 | CAS number: 96690-51-6
Mean absorption and tissue viability in the in vitro Skin irritation test with Soybean oil, epoxidized, Me ester, reaction products
0.675 / 0.581 / 0.673
*The test item values are corrected for the non-specific MTT reaction..
In this table the values are corrected for background absorption (0.043). Isopropanol was used to measure the background absorption.
The possible skin irritation potential of Soybean oil, epoxidized, Me ester, reaction products with propylene glycol was tested in vitro using a human skin model through topical application for 15 minutes. The study procedures described in this report were according to OECD TG 439 guideline and GLP principles. Skin tissue was treated by topical application of 25 μL undiluted test substance. After 42 hours post-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 (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) MTT at the end of treatment. The test item did interact with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT). In addition to the normal procedure, three killed tissues treated with test item and three killed untreated tissues were used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by Soybean oil, epoxidized, Me ester, reaction products was 4.69% of the negative control tissues. The net OD of the treated killed tissues was subtracted from the ODs of the test item treated viable tissues.
Skin irritation is expressed as the remaining cell viability after exposure to the test substance. Reliable negative and positive controls were included. The positive control had a mean cell viability of 5.9 % after 15 minutes exposure. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly. Under the conditions of this test, the relative mean tissue viability for the test item determined to be 94 %. This value is above the threshold for irritancy of ≤50%. Based on the results obtained, it can be concluded that Soybean oil, epoxidized, Me ester, reaction products with propylene glycol is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report and should not be classified according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations and according to the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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