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EC number: 216-600-2
CAS number: 1623-05-8
The primary eye irritation potential of the test article (liquid,
batch 10B1001) was evaluated in New Zealand White Rabbits. This study
was performed in accordance with OECD GLP (1999). The study design was
based on OECD 405 (1987) and Directive 92/69/EEC guideline B.5 (1992).
Approximately 24 hours prior to the study the eyes of all animals were
examined using a fluorescein solution. Animals without ocular
abnormalities were selected for this study. The test material (0.1 mL)
was administered as received to the conjunctival sac of the left eye of
three rabbits. The contralateral eye served as the control. The treated
eyes were washed with 37 C saline at 24 hours post-dose. The eyes were
examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48
and 72 hours and 7 and 14 days post-dose using the Draize technique.
Sodium fluorescein dye procedures were used at 24 and 72 hours and at 7
and 14 days after dosing to improve the evaluation of the cornea. Mean
values (over 24, 48 and 72 hours) for each animal: corneal opacity (0.0,
1.0, 1.0); iritis (0.0, 0.67, 0.67); conjunctival redness (0.33, 2.67,
2.67); and conjunctival chemosis (0.0, 1.67, 1.67). Conjunctival redness
persisted through Day 7. The animals were normal at 14 days after
dosing. Based on the results of this study, the test article is a severe
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