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EC number: 941-461-6 | CAS number: 1231930-42-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Laboratory phase of the study: 21 October 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- no
Test material
- Reference substance name:
- 6-(2-chloro-5-fluoropyrimidin-4-yl)-4-fluoro-2-methyl-1-(propan-2-yl)-1H-1,3-benzodiazole
- EC Number:
- 941-461-6
- Cas Number:
- 1231930-42-9
- Molecular formula:
- C15H13CIF2N4
- IUPAC Name:
- 6-(2-chloro-5-fluoropyrimidin-4-yl)-4-fluoro-2-methyl-1-(propan-2-yl)-1H-1,3-benzodiazole
Constituent 1
- Specific details on test material used for the study:
- - Source and lot/batch No.of test material: RSO-H71422-082- Storage condition of test material: Room temperature
Test system
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- Test material was administered to the test system as a 20% (w/v) dilution in sterile, deionized water
- Duration of treatment / exposure:
- 4 hours at 32oC
- Duration of post- treatment incubation (in vitro):
- 90 minutes after the post-exposure opacity measurement
- Number of animals or in vitro replicates:
- Test material mixture (5 replicates), positive control (3 replicates) and negative control (3 replicates)
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS - Bovine eyes were obtained from a local abattoir in cooled Hanks' Balanced Salt Solution, containing Penicillin/Streptomycin (HBSS).QUALITY CHECK OF THE ISOLATED CORNEAS - Eyes were grossly examined for damage (opacity, scratches, pigmentation etc.) and those exhibiting defects were discarded.NUMBER OF REPLICATES - Test material mixture (5 replicates), positive control (3 replicates) and negative control (3 replicates)NEGATIVE CONTROL USED - Sterile, deionised waterPOSITIVE CONTROL USED - ImidazoleAPPLICATION DOSE AND EXPOSURE TIME - Test material was administered to the test system as a 20% (w/v) dilution in sterile, deionized water for a total of 4 hoursREMOVAL OF TEST SUBSTANCE- Number of washing steps after exposure period: At least three rinses with complete MEM solution (with phenol red) followed by final rinse with complete MEM solution (without phenol red)POST-EXPOSURE INCUBATION: post-exposure “expression” incubation time 90 minutes after opacity measurement is obtainedMETHODS FOR MEASURED ENDPOINTS:- Corneal opacity: Electro Design OP-KIT opacitometer- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a molecular Devices Vmax kinetic microplate reader (OD490)SCORING SYSTEM: In Vitro Irritancy Score (IVIS)Up to 4 = non-irritant>4-12 = slight irritant>12.1 to 25 = mild irritant25.1 to 55 = moderate irritant55.1 and above = severe irritant
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test material
- Value:
- ca. 7.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test material
- Value:
- ca. 99.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:The BCOP assay was accepted with the positive control (imidazole) caused an in vitro score that fell within two standard deviations of the historical mean
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Due to inconclusive data i.e. an in vitro score of 7.5 the EU CLP classification criteria are not met.
- Executive summary:
The Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy of the test material, LSN2833975 to isolated bovine corneas. Bovine corneas were mounted in special holders and exposed to the test material. An in vitro score was determined for the test material based on the induction of opacity and permeability (to fluorescein) in the isolated bovine corneas.
Due to inconclusive data i.e. an in vitro score of 7.5 the EU CLP classification criteria are not met.
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