Registration Dossier
Registration Dossier
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EC number: 269-056-3 | CAS number: 68186-94-7 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77494.
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: short report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Due to the age of the study, deficiencies in study conduct and reporting.
- Principles of method if other than guideline:
- application into conjunctival sac, post observation period: 7 days
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Manganese ferrite black spinel
- EC Number:
- 269-056-3
- EC Name:
- Manganese ferrite black spinel
- Cas Number:
- 68186-94-7
- Molecular formula:
- (Fe,Mn)3O4
- IUPAC Name:
- diiron(3+) dimanganese(3+) manganese(2+) λ²-iron(2+) octaoxidandiide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3- 4 kg
- Housing: individual
- male and female
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg/ animal - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 h not determined; after 24 h and 48 h and on days 5, 6, and 7 no effects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to eye and does not require classification and labelling.
- Executive summary:
Application of test substance into conjunctival sac, post observation period: 7 days
Result: not irritating
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