Registration Dossier
Registration Dossier
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EC number: 424-250-9 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Yellow MGi 1301
- IUPAC Name:
- Yellow MGi 1301
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- no rinse
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, as well as 7, 14 and 21 days after administration.
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 25
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 26, 27
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 25
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 26, 27
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal: 25, 26, 27
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
Any other information on results incl. tables
Irreversible orange staining of the conjunctivae and sclera of the treated eyes by the test article was observed.
No corrosion was observed at any of the measuring intervals.
Applicant's summary and conclusion
- Interpretation of results:
- other: cat. 1 causes serious eye damage (H318) within the CLP Regulation (EC 1272/2008)
- Conclusions:
- Staining of conjunctivae and sclera was not reversible within the 21-days observation period.
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