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EC number: 944-170-2
CAS number: -
Maximum mean score for:
NaOH (positive control)
= no effect; II = slight effect; III = moderate effect; IV = severe
Index = maximum mean corneal swelling + maximum mean opacity (x 20) +
mean fluorescein score (x 20)
NC = not classified; Category 2 = Irritating to eyes; Category 1 =
irreversible effects on the eye/serious damage to the eye. Regulation
(EC) No 1272/2808 of the European Parliament and of the Council of 16
December 2008 on classification, labelling and packaging of substances
and mixtures, amending and repealing Directives 67/548/EEC and
1999/45/EC, and amending Regulation (EC) No 1907/2806.
NC = not classified; Category 2B = mild irritant, causes eye irritation;
Category 2A = irritant, causes eye irritation; Category 1 = irreversible
effects on the eye/serious damage to the eye. United Nations-Economic
Commission for Europe (UN/ECE) (2003). Globally Harmonised System of
Classification and Labelling of Chemicals (GHS).UN,
New York and Geneva, 2007.
small lump of the test substance adhered to the cornea of one eye. After
ca 5 minutes it was rinsed off by the saline drip
iris constriction and severe loosening of epithelium
Disorder of fibers
outer region (adjacent to epithelium)
inner region (adjacent to endothelium)
Saline (negative control)
= not observed; P = present; ½ = very slight; 1 = slight; 2 = moderate;
3 = severe; † = scored in the top/mid/low section of the epithelium; ‡ =
majority of the nuclei of the stroma (inner region) not visible
an Isolated Chicken Eye (ICE) test according to OECD Guideline 438
(adopted 26 July 2013), the eye irritation potential of C8-10
addition, the test included a negative control (saline) and a positive
control (NaOH). Chicken eyes were obtained from slaughter animals used
for human consumption.
isolated chicken eyes were exposed to a single application of 30 mg for
10 seconds followed by a 20 mL saline rinse. Three main parameters were
measured to disclose possible adverse eye effects: corneal thickness
(expressed as corneal swelling), corneal opacity and fluorescein
retention of damaged epithelial cells. In addition, histopathology of
the corneas was performed.
administration of the test item, a small lump of the test substance
adhered to the cornea of one eye. After ca 5 minutes it was rinsed off
by the saline drip.
test item caused
slight corneal swelling (14%), moderate or severe opacity (2.3) and
moderate or moderate to severe fluorescein retention (2.2).
one cornea with the prolonged exposure tothe
test item showed severe opacity and moderate to severefluorescein
negative control eye did not show any corneal effect and demonstrated
that the general conditions during the tests were adequate.
positive control NaOH caused severe corneal effects and demonstrated the
ICE test valid to detect severe eye irritants.
examination of the corneas treated with C8-10 Alkylamidopropyl
very slight erosion of the epithelium.
examination of the corneas treated with the negative control (saline)
did not reveal any abnormalities. The positive control NaOH caused
severe erosion of the epithelium, the majority of the nuclei of the
stroma (inner region) not visible and necrosis of the endothelium.
the classification criteria of the ICE, C8-10 Alkylamidopropyl
classifed as Category
“Irritating to eyes”.
is recognized that the prediction models adopted in the OECD Test
Guideline 438 are for identifying i) chemicals inducing serious eye
damage and ii) chemicals not requiring classification for eye irritation
or serious eye damage. However, further support for identification
a Category 2 irritant is derived from histopathology examination within
this ICE test.
effects observed in one cornea treated withthe
test item demonstrates thatprolonged
contact (mimicking exposure conditions of the Draize eye irritation test
in rabbits) will dramatically increase the corneal effects.
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