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EC number: 947-476-4
CAS number: -
after 240 Minutes Incubation Time
This in vitro study was performed to assess
thecorneal damage potentialofDiamine-Fatty Acids mixture salt by means
of the BCOP assay usingfresh bovine corneae.
After a first opacity measurement of the
fresh bovine corneae (t0), the 20% (w/v)suspensionin saline (0.9% (w/v)
NaCl in deionised water) of the test item Diamine-Fatty Acids mixture
salt, the positive, and the negative controls were applied to corneae
fixed in an incubation chamber in horizontal position and incubated for
240 minutes at 32 ± 1 °C. The posterior chamber containedincubation
medium. After the incubation phase the test item, the positive, and the
negative controls were each rinsed from the corneae andopacity was
measured again (t240).
After the opacity measurements permeability
of the corneae was determined by measuring spectrophotometrically the
transfer of sodium fluorescein after incubation in a horizontal position
for 90 minutes at 32 ± 1 °C.
With the negative control (physiological
saline) neither an increase of opacity nor permeability of the corneae
could be observed.
The positive control (10% (w/v) Benzalkonium
chloride in saline) showed clear opacity and distinctive permeability of
the corneae corresponding to a classification as serious eye damage
(CLP/EPA/GHS (Cat 1)).
Relative to the negative control, the test
item Diamine-Fatty Acids mixture salt caused an increase of the corneal
opacity and permeability compared with the values caused by the negative
control. The calculated meanin vitroirritancy score was 40.21.According
to OECD 437 the test item is not classified as serious eye damaging
(CLP/EPA/GHS (Cat 1), but the test item’s hazard for eye damaging cannot
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