Registration Dossier

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:
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.