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EC number: 690-995-3 | CAS number: 756-12-7
The acute ocular irritation potential of the test article was evaluated in three male rabbits. The study was conducted according to OECD 405 (2012) in compliance with OECD GLP principles. Each animal was treated by instillation of 0.1 mL of the test article, in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball while the other eye remained untreated to serve as a reference control. The lids were then gently held together for about one second to prevent loss of the test item. Observations were made 1, 24, 48 and 72 hours after instillation with fluorescein being utilized at the 24 hour observation to quantitatively determine corneal epithelial damage. Instillation of the test item resulted in irritation of the conjunctivae at the 1 hour examination, which consisted of redness (3/3 animals, scores of 1) and discharge (2/3 animals, scores of 1). The irritation had completely resolved by the 24 hour observation in all animals. No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein 24 hours after test item instillation revealed no corneal epithelial damage. No staining of (peri) ocular tissues by the test item was observed and no test item remnants were seen. Based on the results of the study, the test article is not an ocular irritant.
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