Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
October 2004
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: An In-Vitro Assay of Occular Irritancy (1992) -P.Gautheron; M.Dukic; D.Alix; J.F. Sina - Fundamental and Applied Toxicology 18, 442-449
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
465-070-0
EC Name:
-
Cas Number:
518048-03-8
Molecular formula:
C16H19FN403
IUPAC Name:
2-(1-amino-1-methylethyl)-N-(4-fluorobenzyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide
Details on test material:
L-000900405-000M004

Test animals / tissue source

Species:
other: bovine
Details on test animals or tissues and environmental conditions:
The corneas were placed in a refrigerated container of fresh Hank's Balanced Salt Solution.
The dissected corneas were mounted in specially designed holders which were separated into anterior and posterior chambers and filled separately. Each cornea was mounted allowing the epithelium of the cornea to project into the anterior chamber. The posterior chamber was filled with minimal Essential Media supplemented with 1% fetal bovine serum (MEM), insuring contact of the endothelium with the MEM . The anterior chamber was filled with MEM, insuring contact of epithelium with the MEM. Each cornea was visually inspected again to insure there were no defect. The entire holder with cornea was then submerged in a 32°C water bath and allowed to equilibrate for at least one hour, but no longer than 2 hours. Following the equilibration, the holders containing the corneas were removed from the water bath. The MEM was removed from both chambers and the chambers refilled with fresh MEM.

Test system

Amount / concentration applied:
2.0 g of test article was mixed with MEM to a total volume of 10 ml (20%).
0.75 ml of the test article mixture was applied to the epithelium of each of five treated corneas.
Duration of treatment / exposure:
4 hours
Number of animals or in vitro replicates:
5 bovine eyes

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 hours
Score:
0.48
Remarks on result:
other: corrected mean opacity score
Irritant / corrosive response data:
Classification : mild irritant

Applicant's summary and conclusion