Registration Dossier
Registration Dossier
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EC number: 206-860-5 | CAS number: 387-45-1
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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1984
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-chloro-6-fluorobenzoic acid
- EC Number:
- 207-105-2
- EC Name:
- 2-chloro-6-fluorobenzoic acid
- Cas Number:
- 434-75-3
- Molecular formula:
- C7H4ClFO2
- IUPAC Name:
- 2-chloro-6-fluorobenzoic acid
- Reference substance name:
- 2-chloro-6-fluorobenzaldehyde
- EC Number:
- 206-860-5
- EC Name:
- 2-chloro-6-fluorobenzaldehyde
- Cas Number:
- 387-45-1
- Molecular formula:
- C7H4ClFO
- IUPAC Name:
- 2-chloro-6-fluorobenzaldehyde
- Test material form:
- solid: crystalline
impurity 1
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h + 7 d post observation period
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.33
- Max. score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.33
- Max. score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal:
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.33
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.33
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.33
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.33
- Max. score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.33
- Max. score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.33
- Max. score:
- 3
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to regulation EU 1272/2008 the criteria for a classification as eye irritant are not met.
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