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EC number: 807-840-4
CAS number: 64896-70-4
All data were recorded as and when obtained using forms identified by
the study number. Data were presented tabulated by animal number and
time, nature, severity and duration of effects.
Calculation of ocular primary irritation indices
Mean indices were calculated from results obtained for each rabbit by
direct examination at times 24 hours, 48 hours and 72 hours. The surface
area of corneal opacity and the lacrimation are not taken into account
in the calculation of mean index. For each parameter, mean of indices
for each rabbit for the three times is noted (Mean index per parameter,
per animal for the three times = Mi). The maximum theoretical score is 4
(chemosis), 3 (redness), 2 (iris lesions) and 4 (corneal lesions).
Criteria of classification :
Irritant property of the test item LAB 3822 (FAL 07/25) was evaluated
following a single ocular instillation in the rabbit in accordance with
general requirements of OECD Guideline No. 405 (April 24, 2002), method
B5 of Commission Directive No. 2004/73/EC (April 29, 2004) adapting to
technical progress for the 29th time Council Directive No. 67/548/EEC
and subsequent amendments enable full evaluation of the reversible or
irreversible nature of any effects seen.
Three animals were used for the study.
0.1 mL of LAB 3822 was introduced into the conjunctival sac of the left
eye of each of the three rabbits used. The untreated right eye served as
Any conjunctival, iris and corneal lesion was evaluated approximately
one hour, then on days D2, D3, D4, D5 and D8 after instillation of LAB
Results obtained were as follows:
Conjunctivae: 1 hour after instillation, a slight lacrimation was
observed in three animals.
1 hour after instillation and until D4, a redness (score 1 or 2) was
observed in three animals.
On D5, a redness (score 1) was seen in two animals.
No lesions of iris and cornea were seen in animals.
Table 1 Mean index (Mi) LAB 3822
Study Number 20070266STP
Under the experimental conditions adopted, LAB 3822 (FAL 07/25) was
found to be non irritant for the eye of the rabbit. Classification
according to Directive No. 67/548/EC and subsequent amendments: Symbol:
none is required. Indication of danger: non is appropriate. Risk phrase:
non is applicable.
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