Registration Dossier
Registration Dossier
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EC number: 200-449-4 | CAS number: 60-00-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: literature review
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data prepared by Eureopean Chemical Bureau.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- European Union Risk Assessment Report CAS 60-00-4 CE 200-449-4 edetic acid (EDTA)
- Author:
- Europaen chemical Bureau Institute of Health and Consumer Protection
- Year:
- 2 004
- Bibliographic source:
- Europaen chemical Bureau Institute of Health and Consumer Protection
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 50 mg of solid edetic acid (no data on purity) was instilled to the eye of one rabbit.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Edetic acid
- EC Number:
- 200-449-4
- EC Name:
- Edetic acid
- Cas Number:
- 60-00-4
- Molecular formula:
- C10H16N2O8
- IUPAC Name:
- 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetic acid
- Reference substance name:
- EDTA
- IUPAC Name:
- EDTA
- Test material form:
- other: solid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 50 mg
- Observation period (in vivo):
- 1h, 24h, 8 days
- Number of animals or in vitro replicates:
- 1 animal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- Mild irritation, strong oedema, mild opacity and blood formation
- Time point:
- other: 1h
- Remarks on result:
- other: Irritation scores are not mentioned.
- Irritation parameter:
- overall irritation score
- Remarks:
- strong irritation, mild oedema and strong opacity
- Time point:
- other: 24h
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Irritation scores are not mentioned
- Irritant / corrosive response data:
- Mild irritation, strong oedema, mild opacity and blood formation were observed at one hour. At 24 hours there was a strong irritation, mild oedema and strong opacity. Irritation scores are not mentioned. At 8 days there were no findings.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- EDTA is irritaiting for eyes.
- Executive summary:
Instillation of 50 mg of solid edetic acid to the rabbit eye resulted in strong but reversible irritant effects that led to a classification as Eye Irrit. 2 and labelling as H319 Causes serious eye irritation.
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