Registration Dossier
Registration Dossier
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EC number: 420-960-8 | CAS number: 77214-82-5 JOF 2822 5F; JOF 2822 5FL; JOF 4443
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Iron (III) tris(4-methylbenzenesulfonate)
- EC Number:
- 420-960-8
- EC Name:
- Iron (III) tris(4-methylbenzenesulfonate)
- Cas Number:
- 77214-82-5
- Molecular formula:
- C21 H21 Fe O9 S3
- IUPAC Name:
- iron(3+) tris(4-methylbenzene-1-sulfonate)
- Test material form:
- solid: pellets
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- 50 mg
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.7
- Remarks on result:
- other: Max. value at end of observation period: 1 (related to all animals)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Remarks on result:
- other: Max. value at end of observation period: 1 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 2
- Remarks on result:
- other: Max. value at end of observation period: 1 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 2
- Remarks on result:
- other: Max. value at end of observation period: 1 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2.3
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: Max. value at end of observation period: 4 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Remarks on result:
- other: Max. value at end of observation period: 4 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 3.3
- Max. score:
- 4
- Remarks on result:
- other: Max. value at end of observation period: 4 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Remarks on result:
- other: Max. value at end of observation period: 1 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. value at end of observation period: 1 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Remarks on result:
- other: Max. value at end of observation period: 1 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes not fully reversible within 21 days
- Other effects:
- Destruction of tissue of the mucousa skin membrane, visible by a white-yellow discolouration of the conjunctiva in all three animals. In one animal the lower part of the froint eye chamber was filled with milky content.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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