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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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
Constituent 2
Reference substance name:
EDTA
IUPAC Name:
EDTA

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.