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EC number: 601-409-2
CAS number: 116020-44-1
0.5 g of the test material was administered. After a single application
to the intact dorsal skin of a rabbit, for 4 hours under semiocclusive
conditions, erythema (scores 1 to 4) were observed from day 1 up to day
9 and edema (scores 1 to 2) were observed from day 2 up to day 5 of the
study. Furthermore brittle skin from day 6 up to day 9 and small scales
from day 10 up to day 17 of the study were seen at the site of
application. From day 18 up to the end of the experimental part
increased growth of hair was observed.
The purpose of this assay was to identify the skin irritation/corrosion
potential of the test material when applied to the intact skin of
previously shaven rabbits for a 4 hours period under semiocclusive
This study should provide a rational basis for risk assessment to the
irritating potential of the test item in man.
To test for primary skin irritation, 0.5 g of the test material was
mixed with some drops of liquid paraffin to ensure good contact with the
skin. Afterwards the test material was spread onto 6 cm2 patches and
applied to the intact skin of previously shaven rabbits for a 4 hours
period under semiocclusive conditions. The study was started as an
initial test with one animal. This animal showed signs of irritation
(well defined erythema, edema, brittle skin, and scales) and no more
animals were treated. The first examination of the treated skin sites
followed 1 hour after removal of the patches. Thereafter, examinations
were performed daily for further 21 days.
Only one rabbit was used for the study. No signs of pain were observed
after administration. Under the conditions of the present study erythema
(scores 1 to 3) were observed from day 1 up to day 5 and edema (scores 1
to 4) were observed from day 2 up to day 9 of the study. Furthermore
brittle skin from day 6 up to day 9 and small scales from day 10 up to
day 17 of the study were seen at the site of application. From day 18 up
to the end of the experimental part increased growth of hair was
The test material caused irritative effects at the site of application.
According to EU Regulation No. 1272/2008 and CLP the test material
should be regarded as an irritant to the skin.
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