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EC number: 203-004-2
CAS number: 102-08-9
The objective of this study was to
evaluate the potential corrosive and irritant properties of the test
item following dermal application on rabbits.
The test item was first applied for
periods of 3 minutes, 1 hour and 4 hours to a single female New Zealand
After the 4-hour application, since
the mean value from grading at 24, 48 and 72 hours after patch removal
is < 2.3 for erythema and for edema, the test item was applied on the
skin of two other animals for 4 hours.
A dosage-volume of 500 mg/flank was
The test item was placed on a gauze
pad, moistened with drinking water treated by reverses osmosis, which
was then applied to a skin area of approximately 6 cm2. The gauze pad
was held in place by a non-irritation semi-occlusive dressing and a
restraining bandage. After required period of contact with the skin, the
dressing was removed.
Each animal was observed once a day
for mortality and clinical signs. For each exposure period, cutaneous
reactions were evaluated approximately 1 hour, 24, 48 and 72 hours after
removal of the dressing and then daily until the end of the observation
period. The mean values of the scores for erythema and edema were
calculated for each animal. Body weight was recorded at the beginning
and the end of the observation period.
On completion of the observation
period, the animals were used subsequently for the evaluation of the
ocular irritation potential of the same test item.
No unscheduled deaths occurred and no
clinical signs were noted during the study.The body weight of the
animals was unaffected.
After 3-minute and 1-hour exposures
(one animal), a very slight erythema was noted from day 1 to day 3.
After a 4-hour exposure (three
animals), a very slight erythema was noted from day 1 to day 2
(2/3 animals) or 3 (1/3 animals).
Mean scores calculated for each animal
over 24, 48 and 72 hours were as follows:
0.7, 0.3, 0.3; showing no significant inflammation,
0.0, 0.0; 0.0; showing no significant inflammation.
In conclusion, the test item is not
classified as irritating to skin according to the criteria of CLP
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