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EC number: 417-790-1
CAS number: 78418-01-6
Individual and mean scores for cornea, iris and conjunctivae
Rabbit number & sex
Time after treatment
In an eye irritation study conducted
according to the OECD Guideline 405 and in compliance with GLP, 3
healthy (two males and one female) adult rabbits of the New Zealand
White strain were exposed to 65 mg of undiluted ER 195 in their right
eye while the other eye corresponded to the control. The eyes were
examined unwashed and the changes were observed at 24, 48 and 72 h after
dosing and graded according to Kay J. H. and Calandra J. C. (1962).
Diffuse corneal opacity, iridial
inflammation and moderate or severe conjunctival irritation were noted
in all treated eyes one hour after treatment and in two treated eyes at
subsequent 24, 48 and 72-hour observations.
In one animal, the corneal opacity in the
treated eye increased and areas of opalescent corneal opacity with
iridial inflammation and moderate to severe conjunctival irritation were
noted in this treated eye at the 48 and 72-hour observation. Other
adverse effects noted on the nictitating and/or conjunctival membranes
of this treated eye were pale appearance, small green-coloured or white
areas and areas of haemorrhage. A blood stained discharge was also
noted. For humane reasons this animal was killed after the 72-hour
In another animal, diffuse corneal opacity,
iridial inflammation and minimal conjunctival irritation persisted in
the treated eye on day seven. No corneal opacity, iridial inflammation
or conjunctival irritation was noted on day fourteen. Circumcorneal
vascularisation and convoluted eyelids were also apparent during this
period. The nictitating membrane was also pale in appearance.
The corneal opacity in the eye of the third
treated animal increased and opalescent corneal opacity with pannus
formation, indicative of irreversible ocular damage, had developed on
day fourteen. The iridial inflammation could not be assessed at this
time; minimal conjunctival irritation with convoluted eyelids were also
noted. For humane reasons this animal was killed on day fourteen.
Mean individual scores at 24, 48 and 72 h
after exposure for the 3 animals were 1, 1, 2.7 for cornea score, 1, 1,
1 for iris score, 2.7, 2.7, 2.3 for conjunctivae score and 2.7, 2.7, 3
for chemosis score.
Under these test conditions, ER 195, was
found to be at least severe irritant to the rabbit eye and should be
classified R41 according to the criteria of Annex VI to the Directive
67/548/EEC and category 1 according to CLP Regulation (EC) N°
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