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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Summaries of toxicological data
Author:
Yang, S.S. et al
Year:
1964
Bibliographic source:
Fd. Cosmet. Toxicol. 2, 763-767 (1964)

Materials and methods

Objective of study:
excretion
Principles of method if other than guideline:
Single doses of Na2EDTA were administered and the amount excreted in urine determined.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium dihydrogen ethylenediaminetetraacetate
EC Number:
205-358-3
EC Name:
Disodium dihydrogen ethylenediaminetetraacetate
Cas Number:
139-33-3
Molecular formula:
C10H14N2Na2O8
IUPAC Name:
disodium dihydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
Test material form:
solid
Radiolabelling:
not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on exposure:
no data
Duration and frequency of treatment / exposure:
no data
Doses / concentrationsopen allclose all
Dose / conc.:
47.5 other: mg/animal
Remarks:
corresponding to 237.5 mg/kg bw; assuming a body weight of 200 g
Dose / conc.:
95 other: mg/animal
Remarks:
corresponding to 475.0 mg/kg bw; assuming a body weight of 200 g
Dose / conc.:
142.5 other: mg/animal
Remarks:
corresponding to 712.5 mg/kg bw; assuming a body weight of 200 g
No. of animals per sex per dose / concentration:
no data
Control animals:
not specified
Details on study design:
no data
Details on dosing and sampling:
no data
Statistics:
no data

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
no data
Details on distribution in tissues:
no data
Details on excretion:
The amount of EDTA excreted in urine was directly proportional to the amount ingested. The peak urinary excretion was after 4 h. The authors concluded that due to the linear relationship EDTA is most likely absorbed by diffusion.

Metabolite characterisation studies

Details on metabolites:
no data

Applicant's summary and conclusion

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