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EC number: 943-519-6 | CAS number: -
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean. The negative control has to show an IVIS ≤ 3.
The validity criteria and findings are given in the following table:
Values for negative and positive controls were within the range of historical data of the test facility. Therefore, the test system was acceptable.
COMPARISON WITH HISTORICAL DATA:
In the following table, the means of the negative control and positive control of all experiments which were performed with this positive control up to 16. Jun. 2015 are stated and compared with the values which were found in this study.
This in vitro study was performed to assess corneal damage potential of 2,5- bis[(glycidyloxy)phenyl]octahydro-4,7-methano-5h-indene (TK30250) by quantitative measurements of changes in opacity and permeability in a bovine cornea.
The test item 2,5-bis[(glycidyloxy)phenyl]octahydro-4,7-methano-5h-indene (TK30250) was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 h and whose opacity had been determined.
The test item was incubated on the cornea for 4 h at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.
The test item was tested pure.
Under the conditions of this test, the test item 2,5-bis[(glycidyloxy)phenyl]octahydro-4,7- methano-5h-indene (TK30250) showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is -0.61.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
The negative control (physiological sodium chloride solution) and the positive control (20% imidazole solution) have met the validity criteria.
Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (in vitro irritancy score) is 1.43.
20% Imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and falls within two standard deviations of the current historical mean. The calculated IVIS (in vitro irritancy score) is 62.88.
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.
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