Registration Dossier
Registration Dossier
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EC number: 236-487-3 | CAS number: 13400-13-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Handbook data - No guideline reported
- Principles of method if other than guideline:
- Handbook data - No details on the guideline reported
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium fluoride
- EC Number:
- 231-667-8
- EC Name:
- Sodium fluoride
- Cas Number:
- 7681-49-4
- IUPAC Name:
- sodium fluoride
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- other: aqueous solution
- Amount / concentration applied:
- 2% of NaF in aqueous solution
Results and discussion
In vivo
Results
- Remarks on result:
- other: 2% aqueous solution to the eye caused corneal epithelial defects, necrotic areas in the conjunctiva; Injection subconjunctivally or into the anterior chamber caused corneal edema
- Irritant / corrosive response data:
- Application of a 2% aqueous solution to the eye caused corneal epithelial defects and necrotic areas in the conjunctiva. Injection subconjunctivally or into the anterior chamber caused corneal edema and a severe inflammatory reaction in the eye with hemorrhages in the iris.
Applicant's summary and conclusion
- Conclusions:
- Sodium fluoride has been tested on rabbit eyes in several different ways. Application of a 2% aqueous solution to the eye caused corneal epithelial defects and necrotic areas in the conjunctiva. Injection subconjunctivally or into the anterior chamber caused corneal edema and a severe inflammatory reaction in the eye with
hemorrhages in the iris. Note this reference is also quoted in the WHO EHC criteria (FLUORIDES (EHC 227, 2002)).
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