Registration Dossier

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:
2004
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: solid

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.