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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:
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:
1964
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
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: Ethylenediaminetetraacetate, disodium (Na2-EDTA)
Purity/content: no data
Radiolabelling:
no

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals 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:
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