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EC number: 232-650-8 | CAS number: 9002-07-7
A test for eye irritation in rabbits was performed with Pancreas Trypsin Novo 3.3 special, batch FTI 1164 in accordance with the Code of Federal Regulations 1979, title 16, § 1500.42.
The eyes of the six rabbits (three male and three females) were examined for defects 24 hours prior to the test. Just before instillation of the test substance the left eye of each rabbit was anaesthetized with two drops of 1% tetracain chloride. 0.1 g of Pancreas Trypsin Novo 3.3 special, batch FTI 1164 was placed in the left eye of each rabbit by gently pulling the lower lid away from the eye ball, and then introducing the test substance into the conjunctival sac. The lids were gently held together for one second. The right eye served as control.
The ocular reactions were recorded at 1, 24, 48, 72 hours and 7 days after instillation according to the specified guideline. Except for the examination at 1 hour, 1 drop of 1% fluorescein sodium was used.
Corneal reactions: Scattered areas of corneal opacity were seen at 1 and 24 hours in 2 and 4 rabbits respectively. No corneal opacity was noted at 48 hours.
Iris reactions: Congestion was seen at 24 hours in 2 rabbits. No iris reactions were noted at 48 hours.
Conjunctival reactions: Some hyperemic blood vessels or diffuse crimson color and swelling with lids about or more than half closed were seen at 1 hour in all the rabbits. At 24 hours the conjunctiva was diffuse crimson or beefy red in all the rabbits but no chemosis was seen. At day 7 only conjunctival reactions of score 1 were observed.
Besides the eye redness that carried a score of 1 for up to 7 days after treatment, all effects were fully reversible within 72 hours.
In conclusion, under the test conditions employed, Pancreas Trypsin Novo 3.3 special was regarded as Irritating to eyes, Category 2A.
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