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EC number: 240-521-2
CAS number: 16470-24-9
The test was performed on 3 male and 3
female New Zealand White rabbits. The test material in an amount of 0.1
g was inserted into
the conjunctival sac of the left eye of
the rabbits and the lids were gently closed for a few seconds. The right
eye was not treated and served as an untreated control. In 3 of the 6
rabbits approximately 30 seconds after treatment the treated eye was
The eye irritation was appraised with a
slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual
Under the conditions of this experiment
the test material was found to cause a minimal irritation when applied
to the rabbit eye mucosa.
The primary irritation index was found to
be: unrinsed eyes = 0.4; rinsed eyes = 0.1.
Animal No. 147 died at day 7. No symptoms
had been observed previously.
The criteria for the evaluation of the eye
irritation potential followed in the test are different from those
reported into the OECD guideline. The scoring system used for the corea
opacity and degree of density, for the iris and conjunctivae redness and
chemosis is the same of that reported into the OECD, but the timing for
the removal of the substance are very different (30 seconds in the
current study and 1 hours in the OECD). Nevertheless, because the raw
tables are included into the study report, it is possible to re-evaluate
the results according to the CLP Regulation (EC 1272/2008).
The mean values from gradings at 24, 48
and 72 hours for both rinsed and unrinsed eyes were lower than 1 for
corneal opacity, lower than 1 for irtitis, lower than 2 for both
conjunctival redness and oedema, in all animals.
Therefore the substance does not meet the
criteria to be classified as eye irritating.
In conclusion, the test item can be
classified as NON irritating, according to the CLP (EC 1272/2008)
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