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EC number: 206-788-4
CAS number: 375-50-8
corneal irritation and damage potential of the test article (clear and
colourless liquid, Purity 99.64%, Lot 12912) was tested in the Bovine
Corneal Opacity and Permeability test (BCOP test). The study was
performed in compliance with OECD GLP (98) 17 (1997). The test method
was based on OECD no. 437 (2009), EC No. 440/2008 B. 47 (2010), OTWG-
ICCVAM-NICEATM (2006), INVITTOX 127 (2006), and Gautheron, P. et al. 18:
were prepared in cell culture medium and incubated at 32°C for at least
1 hour prior to exposure. Corneas (3/group) were treated with 0.75 mL of
undiluted test material and incubated in a horizontal position for 10
minutes at 32°C. A positive control (10% w/v Benzalkonium Chloride) and
a negative control (physiological saline) were tested in parallel with
the test material. At the end of the exposure period, the corneas were
rinsed and incubated in fresh cell culture medium for 120 ± 10 minutes
at 32 C. Opacity was evaluated using an opacitometer after the 2 hour
post-exposure incubation. Following opacity readings, the cell culture
medium was replaced with Na-fluorescein medium and incubated for
approximately 90 minutes at 32°C. Following the 90 minute Na-fluorescein
exposure, permeability was measured. The mean in
score (IVIS) was calculated and the scores were classified according to
protocol defined categories.
the test article, the mean IVIS = 3.9 after 10 minutes. The mean opacity
score was 4 (range 3 to 5) and the mean permeability score was 0.-0.004
(range -0.012 to 0.001). Controls performed as expected. No pH effect of
the test substance was observed on the rinsing medium.
on the results of the test (IVIS=3.9), the test substance is not
Category 1, and it is not “no category.”
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