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EC number: 915-384-3
CAS number: -
A study was conducted to determine the potential eye irritation or corrosion properties of the test substance, C8-10 MIPA, according to OECD Guideline 437, in compliance with GLP. In this in vitro method, damage by the test substance is assessed by quantitative measurements of changes in corneal opacity and permeability. Corneas obtained from freshly slaughtered calves were mounted in corneal holders. Both chambers of the corneal holder were filled with complemented MEM culture media (cMEM) and pre-incubated for 1 hour and 5 minutes (± 5 minutes) at 32°C. A single experiment was performed using three corneas for each treated series (test substance, positive control and vehicle control). Before the treatment, a first opacity measurement was performed on each cornea using an opacitometer. The test substance was applied at the concentration of 10% (w/v) in the vehicle (0.9% NaCl), in a single experiment using a treatment time of 10 minutes and using the closed chamber treatment method. Vehicle and positive controls were treated concurrently. At the completion of the treatment period the epithelia were rinsed and the corneas were then incubated for 2 hours (± 10 minutes) at +32 °C before a second opacity measurement was performed. After the second opacity measurement, the medium of the anterior chamber was removed and filled with a fluorescein solution. The holders were then incubated vertically for 90 minutes (± 5 minutes) at 32 °C. At the end of the incubation period, the Optical Density of the solution from the posterior chamber of each holder was measured in order to determine the permeability of the cornea. Each cornea was then observed for opaque spots and other irregularities. Fluorescein fixation was observed on the corneas treated with the test substance. All acceptance criteria were fulfilled. The study was therefore considered as valid. Under the study conditions, the obtained mean In Vitro Irritancy Score (IVIS) was 3, with individual IVIS of 5, 1 and 4 for each cornea. The mean IVIS indicates the test substance is not irritant to the eye. However, as two out of three corneas gave a prediction different from the mean of all three, results were considered borderline and no conclusion can be made (Gerbeix, 2018).
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