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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles

Data source

Reference
Reference Type:
publication
Title:
The metabolism of 14C-Labeled ethylenediaminetetraacetic acid in human beings
Author:
Foreman H, Trujillo TT
Year:
1954
Bibliographic source:
J. Lab. Clin. Med. 43, 566-571

Materials and methods

Endpoint addressed:
basic toxicokinetics
dermal absorption
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Sodium calcium edetate
EC Number:
200-529-9
EC Name:
Sodium calcium edetate
Cas Number:
62-33-9
IUPAC Name:
calcium disodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
Details on test material:
- Name of test material (as cited in study report): CaNa2EDTA
- Specific activity (of the radialabelled form): 2.5 x 10^7 d/min

Method

Ethical approval:
not specified
Details on study design:
- 3 young healthy adult male were used in each application group
Details on exposure:
INTRAVENOUS ADMINISTRATION
- Dose preparation:
2.2 mg of 14C-CaNa2EDTA was mixed with 2 g of unlabelled CaNa2EDTAin a total of 10.5 ml water
- Application:
injections were given over a 2-3 min period
- Sample taking:
blood samples: up to 6 h regularly exact time points not stated; urine: over a 24 h period as voided until radioactivity had fallen below detection levels; in one case spinal fluid
- Additional measurements:
blood pressure and electrocardiogram tracings were made every 15 min, starting 1/2 h before the administration and continuing for 1 h after

INTRAMUSCULAR ADMINISTRATION
- Dose preparation:
2.2 mg of 14C-CaNa2EDTA was mixed with 2 g of unlabelled CaNa2EDTA and 2 ml of a 1% procaine solution, all made up to 10 ml with water
- Application:
Injections were made into the buttocks, 5 ml each side
- Sample taking:
blood samples: up to 6 h regularly exact time points not stated ; urine: over a 24 h period as voided until radioactivity had fallen below detection levels

ORAL ADMINISTRATION
- Dose preparation:
1.5 mg of 14C-labelled CaNa2EDTA was dissolved in 1/2 ml water given in a gelatin capsule
- Sample taking:
Urine and feces were collected for the study (sample takings not specified); blood was collected in the first study only

SKIN ABSORPTION
- Dose preparation:
2 mg 14C-labelled CaNa2EDTA and 1 g unlabelled CaNa2EDTA were prepared in a thin paste of Aquaphor. In one study Na salt of EDTA was used instead of Ca salt.
-Application:
The past was spread over an area of 100 cm2 on a sheet of thin latex and taped firmly to the lateral chest wall. It was kept there for 24 h
-Sample taking:
Urine samples were taken

Results and discussion

Results:
INTRAVENOUS ADMINISTRATION
- Recovery in urine: 98.1 + /- 4.6%
- 50% was excreted within 1 h, 90% within 7 h
- Half-life blood clearance: 1 h 5 min
-Activity in spinal fluid 1 h after injection: 1/20 of the plasma
INTRAMUSCULAR ADMINISTRATION
- Recovery in urine: 98.8 + / - 1.6%
- 50% was excreted within 2.5 h, 90% within 7 h
- Half-life blood clearance: 1.5 h
ORAL ADMINISTRATION
- TS is poorly absorbed
- no TS could be detected in the blood
- 91 + / - 2% are excreted via feaces, 4.2 + / - 2 % via urine
- TS is excreted within 72 h
SKIN ABSORPTION
- The maximum activity detected in urine was 0.001%

Any other information on results incl. tables

- The study indicates that CaNa2EDTA passes through the body unchanged and is excreted via the kidney by both glomerular filtration and tubular excretion.

- The turnover time from the blood is approximately 1 h after iv administration.

- It is poorly absorbed from the GI-tract

- It does not penetrate the skin

Applicant's summary and conclusion