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CAS number: -
No statistical analysis was performed
NECROPSY: No necropsy was performed on the animals sacrificed at termination of observation. The surviving animals were killed by intravenous injection of Pentobarbitone into the ear vein at a dose of at least 1 mL/kg body weight and discarded.
The primary eye irritation potential of FP-100 was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00, 0.00 and 0.33 for reddening and 0.00 for chemosis for each of the three animals.
The instillation of FP-100 into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae. These effects were reversible and were no longer evident 48 to 72 hours after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.
Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06, 2001), FP-100 is considered to be “not irritating” to the rabbit eye.
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