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EC number: 200-889-7
CAS number: 75-65-0
The maximum average irritation score in unwashed eyes was 41.0/110 at 24
hours. Group average scores at 24-hr were: cornea 24.0/80; iris 5.0/10;
conjunctiva 12.0/20. All six animals exhibited corneal opacity ≥1 at
the 24, 48 and 72-hour observation period. By day 7,
one male and two females were normal. Total individual scores for the
two other males were also 0/110 on day 7 but 5-10% of the treated area
tested positive with fluorescein. On day 10, corneal effects were again
observed in these same two males with scores of 25/80 and 5/80. In the
remaining female, the total individual score was 2.5/110 on day 7, based
on scores of 2.5, 0 and 0 for cornea, iris and conjunctiva,
respectively. All unwashed eyes were normal by day 16. In all test
animals, a positive response of corneal opacity ≥1 and conjunctival
redness ≥2 calculated as the mean scores following grading at 24, 48,
and 72 hours after instillation of the test material was observed.
The maximum average irritation score in washed eyes was 30.3/110 at 72
hours. Group average scores at 72-hr were: cornea 17.1/80; iris 4.2/10;
conjunctiva 9.0/20. One male was normal by day 7. Although both females
were judged normal on day 22, one animal again exhibited corneal effects
on day 25 (total corneal score 6.3) and which continued to study
termination on day 34 (total corneal score 2.5). The total corneal
scores for this animal were lower at the four preceding observation
periods (day 13 – 5.0, day 16 – 5.0, day 19 – 2.5, day 22 – 0) so the
relevance of this effect is unknown.
In a primary eye irritation study, 0.1 mL of Arconol (a product
containing predominantly tertiary butyl alcohol [91% minimum] and low
levels of acetone, water, other organics, and butanes) was instilled
into the eyes of young adult New Zealand Albino rabbits (4 males, 5
females). Of these, 3 had their eyes washed after treatment and 6 were
unwashed. Animals were observed for 16 days (unwashed eyes) or 34 days
(washed eyes). Irritation was scored by the method of Draize.
For all six animals in the unwashed group, a positive response of
corneal opacity ≥1 and conjunctival redness ≥2 calculated as the mean
scores following grading at 24, 48 and 72 hours after instillation of
the test material was observed. All effects in unwashed eyes were fully
reversible in 16 days. For all three animals in the washed group, a
positive response of corneal opacity ≥1 was observed. All animals were
normal on day 22. Corneal effects were again observed in a single
animal in the washed group on day 25 and these effects continued until
study termination on day 34. Since the score for corneal effects (6.3)
on day 25 was higher than the scores on day 13 (5.0), day 16 (5.0), day
19 (2.5) and day 22 (0), no conclusion can be drawn about the
significance of the effects observed in this single animal. In this
study, Arconol containing ≥91% tertiary butyl alcohol was an eye
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