Registration Dossier
Registration Dossier
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EC number: 200-573-9 | CAS number: 64-02-8
Basic toxicokinetics
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:
- 1 964
- 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
- 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
Constituent 1
- 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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