Registration Dossier
Registration Dossier
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EC number: 205-381-9 | CAS number: 139-89-9
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:
- other: Documentation insufficient for assessment For read-across justification refer to section 13.
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:
- 48 h after administration of Na2EDTA and Na2CaEDTA the percentage of administered dose in feces and urine was 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
- Details on test material:
- Test substance: Ethylenediaminetetraacetate, disodium (Na2-EDTA)
Purity/content: no data
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- - weanlings and adults were tested
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- single exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
- equivalent to 1% EDTA in diet (corresponding to 600 mg/kg bw, conversion according to EU risk assessment)
- No. of animals per sex per dose / concentration:
- no data
- Control animals:
- no
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- within 48 h:
WEANLINGS
Na2EDTA: 8.5% in urine; 88.6% in feces
ADULTS
Na2EDTA: 5.3% in urine; 89.9% in feces
Na2CaEDTA: 4.6% in urine, 88.5% in feces
3% of the EDTA was removed from the surface of metabolism cage and 5% from intubation syringe
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
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