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EC number: 239-311-3
CAS number: 15267-95-5
Skin irritation/corrosion (OECD 404): not irritatingEye irritation (OECD 405): not irritating
In the available key study (BSL BIOSERVICE,
2011a) the test item was tested for its skin irritating properties
according to the OECD TG 404 and in compliance with GLP. 3 female New
Zealand White rabbits were semiocclusively treated with 0.5 ml of the
test material on the shaved dorsal area of the trunk for 4 hours. No
irritant effects were noted during the 72 h observation period. No
deaths occurred, and no signs of systemic toxicity were reported.
Moreover, the body weight was not affected by the treatment. In
conclusion, the test material was considered to be not irritating to the
rabbits' skin under the conditions of the test.
In the available key study (Harlan, 2012c)
the test item was investigated for eye irritation according to the OECD
TG 405, and in compliance with GLP. The test item was applied by
instillation of 0.1 ml into the left eye of each of three young adult
New Zealand White rabbits. Scoring of irritation effects was performed
approximately 1, 24, 48 and 72 hours post treatment. No abnormal
findings were observed in the cornea or for the iris light reflex of any
animals at any of the measurement intervals. Slight redness of the
conjunctivae was noted in one animal at 1 and 24 hours after treatment.
Thereafter, all animals were negative. The mean score was calculated
separately for each animal across three scoring times (24, 48, and 72
hours after instillation) for corneal opacity, iris light reflex,
redness and chemosis of the conjunctivae, respectively. The individual
mean scores for corneal opacity and iris light reflex were 0.0 for all
three animals. The individual mean scores for the conjunctivae were 0.0
in two animals and 0.33 in one animal for reddening and all 0.0 for
chemosis. No deaths occurred, no signs of systemic toxicity were
reported, and the body weight was not affected by the treatment. Hence,
the test item was considered to be not irritating to the rabbits' eye
under the conditions of the test.
The available data are reliable and suitable
for classification. Based on these data classification for skin
irritation and eye irritation according to EC/1272/2008 is not warranted.
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