Registration Dossier
Registration Dossier
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EC number: 465-070-0 | CAS number: 518048-03-8
Eye irritation
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:
- 2 004
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
- Reference substance name:
- -
- EC Number:
- 465-070-0
- EC Name:
- -
- Cas Number:
- 518048-03-8
- Molecular formula:
- C16H19FN403
- IUPAC Name:
- 2-(2-aminopropan-2-yl)-N-[(4-fluorophenyl)methyl]-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide
- Details on test material:
- L-000900405-000M004
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
