Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: literature review
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Risk assessment prepared by European Chemical Bureau.

Data source

Reference
Reference Type:
review article or handbook
Title:
European Risk Assessment Report CAS 60-00-4 EC 200-449-4 edetic acid (EDTA)
Author:
European Chemical Bureau Institute of Health and Consumer Protection
Year:
2004
Bibliographic source:
European Chemical Bureau Institute of Health and Consumer Protection

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The principle of test was accepted by European Chemical Bureau Institute of Heath and Consumer Protection.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit

Test system

Type of coverage:
not specified
Vehicle:
water
Amount / concentration applied:
50% aqueous preparation of edetic acid (no data on purity).
Duration of treatment / exposure:
1, 5 or 15 minutes or 20 hours on the back or for 20 hours on the ear
Observation period:
24 h
Number of animals:
2

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks:
At 24 hours the ear showed a mild irritation after a 20-hour exposure time
Basis:
animal #1
Time point:
other: 24h
Remarks on result:
other: Irritation scores are not mentioned.
Other effects:
There were no other findings.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A 50% aqueous preparation of edetic acid (no data on purity) resulted in a mild irritation of the skin after a 20-hour exposure time. It can be concluded that these findings do not warrant a classification and labelling for skin irritation.
Executive summary:

One rabbit was exposed for either 1, 5 or 15 minutes or 20 hours on the back or for 20 hours on the ear to a 50% aqueous preparation of edetic acid (no data on purity). At 24 hours the ear showed a mild irritation after a 20-hour exposure time. There were no other findings.