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EC number: 947-751-9 | CAS number: -
An in vitro study was conducted to determine the corneal damage potential by the test substance, 'mono- and di- C16 PSE, K+ and C16-OH and isostearyl isostearate' (100%), using the Bovine Corneal Opacity and Permeability (BCOP) method according to OECD Guideline 437, in compliance with GLP. One valid experiment was performed with three replicates for negative control, positive control and the test substance. The undiluted test substance was applied in a way that as much as possible of the corneas surface was covered. Subsequently corneas were incubated for 240 minutes at 32 ± 1°C in BCOP corneal holder. At the end of the exposure period the test substance and control substances were removed from the anterior chamber and the cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete MEM. The anterior and posterior chambers were refilled with fresh complete MEM. A post treatment opacity reading was taken and each cornea was visually observed. Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium was replaced with 1 mL of sodium fluorescein solution (5 mg/mL) and corneas were incubated again at 32 ± 1°C for 90 minutes. After incubation 360 μL of medium representing each cornea was applied to a designated well on a 96-well plate and the optical density at 492 nm (OD492) was measured. The two endpoints opacity and permeability were combined in an empirically derived formula to generate an in vitro irritancy score (IVIS). The obtained in vitro irritancy scores for the test substance, negative control and positive control were 1 (which is well below the threshold for no classification for eye), 3.3, and 99.6, respectively. The study was considered to have met all the validity criteria. Under the study conditions, the test substance was determined to be non-corrosive or non-irritating to the eye (Harlan, 2012).
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