Registration Dossier
Registration Dossier
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EC number: 228-055-8 | CAS number: 6104-30-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: limited documentation, only 2 animals tested, only 50 µl applicated
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1967
Materials and methods
- Principles of method if other than guideline:
- The test substance was applied as a single instillation (50 µl) as powder, the substance was not washed out, only 2 rabbits were used
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N''-(isobutylidene)diurea
- EC Number:
- 228-055-8
- EC Name:
- N,N''-(isobutylidene)diurea
- Cas Number:
- 6104-30-9
- Molecular formula:
- C6H14N4O2
- IUPAC Name:
- N,N''-(2-methylpropane-1,1-diyl)diurea
- Details on test material:
- purity ca. 90-96% (0-3% urea, 2% potassium sulfate)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- no further data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: treated with talcum powder
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 microliter (50 mm3) - Duration of treatment / exposure:
- single instillation of the test substance as powder, the substance was not washed out
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: none, substance not washed out
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
Any other information on results incl. tables
Summary:
The treatment led to slight redness. All findings were reversible after 8 days of observation period. The control eyes which were treated with talcum powder did show the same reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean score observed for redness of the conjunctivae is 0.167 ( for 24, 48 and 72 hours) which is below 2.5.
These finding were reversible within 48 hours.
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