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Toxicological information

Basic toxicokinetics

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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:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Inconsistent results

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:
No data
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Disodium dihydrogen ethylenediaminetetraacetate
EC Number:
205-358-3
EC Name:
Disodium dihydrogen ethylenediaminetetraacetate
Cas Number:
139-33-3
IUPAC Name:
disodium dihydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
Details on test material:
no data
Radiolabelling:
not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
not specified

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Details on exposure:
no data
Duration and frequency of treatment / exposure:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
300, 600, 3000 mg/kg bw/day (original data 0.5; 1.0; 5.0% of the diet, conversion according to EU risk assessment)
No. of animals per sex per dose / concentration:
no data
Control animals:
not specified
Details on study design:
no data
Details on dosing and sampling:
no data
Statistics:
no data

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
no data
Details on distribution in tissues:
no data
Details on excretion:
- 82.2% of the ingested 0.5% in diet dose was excreted in urine and feces thereof 99.4% were recovered from feces and 0.6% in urine.
- 44.5% of the ingested 1.0% in diet dose was excreted in urine and feces thereof 98.2% were recovered from feces and 1.8% in urine.
- 45.4% of the ingested 5.0% in diet dose was excreted in urine and feces thereof 97.5% were recovered from feces and 2.5% in urine.

Metabolite characterisation studies

Details on metabolites:
no data

Applicant's summary and conclusion