Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Limited documentation

Data source

Reference
Reference Type:
publication
Title:
Summaries of toxicological data
Author:
Yang SS, Chan MS
Year:
1964
Bibliographic source:
Fd. Cosmet. Toxicol. 2, 763-767

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

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
Details on test material:
no data
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