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EC number: 208-010-9 | CAS number: 505-48-6
'Short Time Exposure In-Vitro Study Using SIRC Cell Line for Identification of Serious Eye Damage by Suberic Acid' was carried out in compliance with the Organization for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals, Section 4, No. 491 - Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, adopted by the council on 09 October 2017 and as per mutually agreed Study Plan.
Suberic Acid was evaluated for its irritancy potential based on its ability to induce cytotoxicity in Short Time Exposure (STE) Test method. The cytotoxic effect of test item on corneal epithelial cells is an important mode of action (MOA) leading to
corneal epithelium damage and eye irritation.
After extraction from cells, cell viability in the STE test method is assessed by the quantitative measurement of blue formazan salt produced by the living cells. It is due to enzymatic conversion of the vital dye MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5- diphenyltetrazolium bromide), also known as Thiazolyl Blue Tetrazolium Bromide. The obtained cell viability is compared to
the solvent control (relative viability) and used to estimate the potential eye hazard of test item.
The relative cell viability of each solvent control, medium control and test item expressed as a percentage.
Optical density of the medium control was found to be 0.47 which was higher than 0.3.
The relative cell viability obtained for solvent control (mineral oil) was 90.64%, which was greater than 80% relative to
The relative cell viability obtained for 0.01% sodium lauryl sulfate (Positive control) was 23.54%, i.e. between 21.1% and 62.3% according to laboratory historical data established by the method developer.
Standard deviations of the final cell viability derived from three experiments were 2.21 and 8.59 for both 5% and 0.05% concentrations of test item respectively, which is less than 15%.
Cell viability in both the concentrations i.e. 5% and 0.05% was 59.69% and 81.03% respectively, , which was less than 70%
for 5% test concentration and greater than 70% for 0.05% test concentration.
Under the given experimental conditions of this study, it is concluded that the test item is considered to fall under
‘No prediction can be made’ category of UN GHS classification.
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