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EC number: 604-195-9
CAS number: 1406-66-2
Time after patch removal
Individual Skin Irritation Scores
Rabbit Number 39 (preliminary screen)
Rabbit Number 44
Rabbit Number 45
The purpose of this study was to evaluate the degree of irritation
produced by the test article, DL-a-Tocopherol,
when applied to the intact skin of the albino rabbit. The procedures
used were in accordance with those described in OECD Guideline for the
Testing of Chemicals, No. 404 (adopted 17th July 1992).
A 0.5 ml aliquot of the test article was spread evenly over a 2.5 cm
square of surgical lint and applied over a previously clipped area of
the dorsal skin of 3 albino rabbits. The test article was held in
contact with the skin, under a semi-occlusive patch assembly, for a 4
hour period. At the end of this period, the patches were removed and the
treated skin site on each animal gently cleansed with water. Reaction to
treatment, i.e. erythema and eschar as well as oedema formation was
assessed 1, 24, 48 and 72 hours and, for 2 animals, also 7 and 14 days
after patch removal.
There were no apparent signs of irritation at the treated skin site of
the animal used in the preliminary screen throughout the 72 hour
In 1 of the 2 remaining animals, erythema appeared to increase
throughout the initial observation period and at the 72 hour examination
it was noted to be moderate to severe. Barely perceptible oedema was
also visible 48 and 72 hours after patch removal at the treated skin
site of this animal. In a second animal, irritation was evident from 72
hours after patch removal and consisted of barely perceptible erythema
and oedema at the treated skin site. Signs of irritation were still
evident in both animals at day 7 but subsided completely by day 14.
The Primary Irritation Index for the three animals was calculated to be
Under the conditions of this study, the test article, DL-a-Tocopherol
as such, may be considered as a slight irritant to the skin of the
It can be assumed accordingly, that cutaneous exposure to DL-a-Tocopherol
such as may potentially give rise to an irritant skin reaction in humans.
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