Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
weight of evidence
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Partitioning of Renal Zinc between Metallothionein and Ethylenediaminetetraacetic Acid (EDTA) after Treatment of Rats with Ca(Na)2EDTA
Author:
Miller, C.R. et al
Year:
1986
Bibliographic source:
Toxicology and Applied Pharmacology 84, 584-592 (1986)

Materials and methods

Objective of study:
excretion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats were injected with a single dose of [14C]EDTA. The concentration of EDTA in urine and kidney homogenates was determined at several time points.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium calcium edetate
EC Number:
200-529-9
EC Name:
Sodium calcium edetate
Cas Number:
62-33-9
Molecular formula:
C10H12CaN2O8.2Na
IUPAC Name:
calcium disodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
Specific details on test material used for the study:
Specific activity (if radiolabelling): 5 µCi/100 mg
Radiolabelling:
yes
Remarks:
14C

Test animals

Species:
rat
Strain:
other: Charles River
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 200 - 300 g
- Individual metabolism cages: yes
- Diet: NIH-31 rat food ad libitum
- Water: tap water ad libitum

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Duration and frequency of treatment / exposure:
single treatment
Doses / concentrations
Dose / conc.:
400 mg/kg bw (total dose)
No. of animals per sex per dose / concentration:
18
Control animals:
other: yes, 0.9% saline treated animals
Details on study design:
18 rats were each injected with a single dose of [14C]EDTA and placed in plastic metabolic cages for urine collection. Six were killed at 16, 22, or 28 hr after the injection. One control rat was killed at each time point. Kidneys were removed, weighed and homogenized. Radioactivity in the urine and kidney homogenates was measured by scintillation counting in order to calculate EDTA concentrations.
Details on dosing and sampling:
PHARMACOKINETIC STUDY
- Body fluids sampled: Urine
- Tissues sampled: Kidneys
- Time and frequency of sampling: urine: 16, 22, 28 h
- Method type for identification: Liquid scintillation counting
Statistics:
Student's t-test, ANOVA and Dunnett's test

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on distribution in tissues:
- During the 22 h period, the renal EDTA concentration was about 80 µg/g kidney homogenate. This equals to 0.1-0.2% of the EDTA injected.
Details on excretion:
- By 22 hr, 80% + / - 3% of the injected dose had been collected in the urine. This amount stayed approximately the same until 28 h after application.

Metabolite characterisation studies

Metabolites identified:
not measured

Applicant's summary and conclusion

Conclusions:
Interpretation of results: no bioaccumulation potential based on study results