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EC number: 277-753-9
CAS number: 74186-17-7
Appendix 1 Eye
Individual Scores for Eye Irritation
Rabbit Number and Sex
Area of Corneal Opacity
IPR=Initial pain reaction
Sf = Brown colored staining
of the fur around the treated eye
(continued) Eye Irritation Scores
Mean Values after 24, 48 and 72
Rabbit Numberand Sex
Number of available data points
Appendix 2 Individual Body
Weights and Body Weight Change
Individual Body Weight (kg)
Body Weight Change (kg)
The primary eye irritation potential
of Aluminium-Braun 1134 p was investigated according to a method
compatible with OECD test guideline No. 405 and Method B5. The test item
was applied by instillation of 0.1 mL into the right eye of each of two
young adult New Zealand White rabbits. Scoring of irritation effects was
performed approximately 1, 24, 48 and 72 hours after test item
The mean score was calculated
separately for each animal across three scoring times (24, 48 and
72 hours after instillation) for corneal opacity, iritis, redness and
chemosis of the conjunctivae. The individual mean scores for corneal
opacity and iritis was 0.0 for both animals. The individual mean scores
for the conjunctivae were 0.7 for reddening for both animals and 0.0 or
0.3 for chemosis.
The instillation of Aluminium-Braun
1134 p into the eye resulted in conjunctival irritation. These effects
were reversible and were no longer evident 72 hours after treatment in
both animals (end of the observation period). No abnormal findings were
observed in the cornea of any animal at any of the examinations. No
corrosion was observed at any of the measuring intervals. No clinical
signs of toxicity were observed.
Thus, the test item did not induce
significant or irreversible damage to the rabbit eye.
According to the findings in this
study, Aluminium-Braun 1134 p does notmeet the criteria for
classification according to Regulation (EC) No. 1272/2008 of the
European Parliament and of the Council of 16 December 2008.
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