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EC number: 940-783-4
CAS number: -
An acute eye irritation study of the test
item was performed in New Zealand White rabbits.
The irritation effects of the test item were
evaluated according to the Draize method (OECD No.: 405, 2012). Rabbits
were treated with analgesic and anaesthetic as per the regulatory
guideline. Two animals were used to make the classification according to
the Sponsor request. The test item was placed into the conjunctival sac
of the left eye of each animal. The untreated right eye served as
control. A volume of 0.1 mL of the test item was administered as a
single dose. The eyes were examined at 1, 24, 48 and 72 hours after the
application. Initial Pain Reaction (IPR/PR) was not observed. First
animal (No: 00166) clinical observation At one hour after the
application: Conjunctival redness (score 2), chemosis (score 1) and
discharge (score 3) were found. At 24 hours after the application:
Conjunctival redness (score 1) was found. At 48 and 72 hours after the
application There were no clinical signs, and no conjunctival or corneal
effects observed. The effects were fully reversible therefore the animal
was euthanized. Second animal (No: 00159) clinical observation At one
hour after the application: Conjunctival redness (score 2), chemosis
(score 1) and discharge (score 3) were found. At 24 hours after the
application: Conjunctival redness (score 1) was found. At 48 and 72
hours after the application There were no clinical signs, and no
conjunctival or corneal effects observed. The effects were fully
reversible therefore the animal was euthanized. There were no clinical
sign of systemic toxicity observed in the animals during the study and
no mortality occurred. During the study, the control eye of each animal
was symptom-free. The body weights of the animal were considered to be
within the normal range of variability. The animal individual mean
scores (considering readings at 24, 48 and 72 hours after the treatment)
were as follows:
chemosis : 0.00, 0.00
discharge : 0.00, 0.00
redness : 0.33, 0.33
cornea opacity : 0.00, 0.00
iris : 0.00, 0.00
The test item, applied to rabbit eye mucosa,
caused conjunctival redness and transient discharge. The effects were
fully reversible within 48 hours. The substance is not classified as irritating
based on these results.
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