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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
acute toxicity: oral
Type of information:
other: literature review
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Risk assesment prepered 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:
according to guideline
Guideline:
other: international guidelines
GLP compliance:
not specified
Limit test:
yes

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:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
5 female and 5 male rats (Wistar)

Administration / exposure

Vehicle:
water

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
other: no clinical signs
Gross pathology:
no deaths, no clinical signs and no autopsy findings

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In rats the acute oral toxicity is low, LD50 values is > 2,000 mg/kg
Executive summary:

In rats the acute oral toxicity is low. In two tests LD50 values of > 2,000 mg/kg were reported. There is no need for classification and labelling for acute oral toxicity.