Registration Dossier
Registration Dossier
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EC number: 229-222-8 | CAS number: 6440-58-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5,5-dimethylhydantoin
- EC Number:
- 201-051-3
- EC Name:
- 5,5-dimethylhydantoin
- Cas Number:
- 77-71-4
- Molecular formula:
- C5H8N2O2
- IUPAC Name:
- 5,5-dimethylimidazolidine-2,4-dione
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- Not applicable
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 (3 males and 3 females)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since no cornea effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since no iris effect
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.89
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.5
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Three animals exhibited a mild positive response. All findings were reversible, as the severity of each reaction decreased with time
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DMH is not classified for eye irritancy
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