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EC number: 252-044-7
CAS number: 34455-00-0
The primary eye irritation/corrosion potential of the test article was
evaluated in New Zealand White Rabbits. The study was conducted in
compliance with OECD GLP (1997). The test method was based on OECD No.
405 (2002), EC No. 440/2008, EPA OPPTS 870.2400 (1998) and JMAFF
guidelines (2011). Single samples of approximately 64 mg of test article
(a volume of approximately 0.1 mL) were instilled in the conjunctival
sac of one of the eyes of each animal. The lids were held together for
about one second to prevent loss of the test substance. The remaining
untreated eye served as the control. The eyes were observed at 1, 24,
48, and 72 hours and 7 days after instillation. Immediately after the
24-hour observation, a solution of 2% fluorescein in water was instilled
in both eyes of each animal to quantitatively determine corneal
epithelial damage. Corneal opacity (maximum grade 1) and epithelial
damage (maximum 35% of the corneal area) that had resolved within 72
hours was observed in one animal. Slight dulling of the normal luster of
the cornea was noted in the other two animals on Day 1. Iridial
irritation (grade 1) was observed in all animals and resolved within 24
hours. Conjunctivae redness, chemosis, and discharge (maximum grade 2)
was seen in all animals but had resolved within 7 days. Individual
animal average corneal opacity scores (24-72 hours) were 0.7, 0.0, and
0.0. Individual animal average iritis scores (24-72 hours) were 0.0 in
all animals. Individual animal average conjunctival redness scores
(24-72 hours) were 2.0, 1.7, and 1.3. Individual animal average
conjunctival chemosis scores (24-72 hours) were 1.3, 0.3, and 0.7. Based
on the results of the study, the test article is a mild ocular irritant
and has no obligatory labeling requirements for eye irritation according
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