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EC number: 247-665-5
CAS number: 26401-86-5
Table 2: Summary of Results
Maximum mean score for:
(General, GHS and EC/GHS)
Saline (negative control)6
1 I = no effect; II = slight effect; III = moderate effect; IV =
2 Irritation Index = maximum mean corneal swelling + maximum mean
opacity (x 20) + mean fluorescein score (x 20).
3 2B = mild irritant; 2A = irritant; 1 = serious eye damage.
United Nations-Economic Commission for(UN/ECE) (2003). Globally
Harmonised System of Classification and Labelling of Chemicals (GHS).
4 Blistering of epithelium.
5 Individual values based on one eye.
6 n.a. = not applicable
EC/GHS‑CLASSIFICATION (CLP) OF EYE
IRRITANTS; EXTRAPOLATION FROM IN VITRO RESULTS TO IN VIVO CLASSIFICATION.
Extrapolation from thein vitroirritancy
results to the EC/GHS classification will be carried out using
scientific judgement, re-dividing the original four irritancy classes to
three. The combinations of the three categories that are allowed for
each of the three classifications are mentioned in the scheme below.
NC/NI = not classified/not irritating
3 x I
x I, 1 x II
x II, 1 x I3
EC/GHS Category 24:
3 x II
Irritating to eyes
2 x II, 1 x III
x I, 1 x II, 1
3 x III
x III, 1 x II
x III, 1 x I
x I, 1 x IV¹
x II, 1 x IV¹
x III, 1 x IV2
x II, 1 x III,
1 x IV¹
EC/GHS Category 14:
3 x IV
Irreversible effects on the eye/
2 x IV, 1
serious damage to eyes
2 x IV, 1
x IV, 1 x I¹
corneal opacity score 3
opacity score 4
loosening of epithelium
¹ Combinations of categories less likely
combination of 2 x III, and 1 x IV can be considered as a borderline
case between irritating and severely irritating.
combination of 2 x II, and 1 x I can be considered as a borderline case
between not irritating and Category 2.
(EC) No 1272/2008 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 1907/2006.
The test material was evaluated neat in the Isolated Chicken Eye (ICE)
test, according to the standardised OECD guideline no. 438, under GLP
Chicken eyes were obtained from slaughter animals used for human
consumption. The isolated chicken eyes were exposed to a single
application of the test material for 10 seconds using an application
volume of 30 µL. Benzalkonium chloride (BAC) 5 % was used as the
positive control and physiological saline as the negative control. 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.
The negative control eye showed no corneal effects. The positive control
caused moderate swelling, severe opacity and severe fluorescein
retention. The calculated Irritation Index for the positive control was
149. The test material caused very slight swelling, very slight opacity
and very slight fluorescein retention. The calculated Irritation Index
Under the conditions of this study the test material was not irritating
to the eye.
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