Registration Dossier
Registration Dossier
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EC number: 942-217-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,4,6(1H,3H,5H)-Pyrimidinetrione, 5,5'-(1,2-diazenediyl)bis-
- Cas Number:
- 25157-64-6
- Molecular formula:
- C8H6N6O6
- IUPAC Name:
- 2,4,6(1H,3H,5H)-Pyrimidinetrione, 5,5'-(1,2-diazenediyl)bis-
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- other: cattle eye
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Eyes from adult cattle were obtained from a local abattoir as a by-product from freshlyslaughtered animals. The eyes were excised by an abattoir employee and placed inHanks’ Balanced Salt Solution (HBSS), supplemented with Penicillin/Streptomycin, andtransported to the laboratory on ice packs.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 240 min
- Number of animals or in vitro replicates:
- 0
Results and discussion
In vivo
Results
- Irritation parameter:
- other: in vitro irritancy Score
- Basis:
- other:
- Time point:
- other: 240 minutes
- Score:
- 5.2
- Reversibility:
- other: not relevant
Any other information on results incl. tables
Results
Treatment In Vitro Irritancy Score
Test Item 5.2
Negative Control 6.1
Positive Control 92.1
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The test item was considered not to be an ocular corrosive or severe irritant.
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