Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 227-105-6 | CAS number: 5657-17-0
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of 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 reported study
Data source
Reference
- Reference Type:
- publication
- Title:
- Summaries of toxicological data
- Author:
- Yang SS et al.
- Year:
- 1 964
- Bibliographic source:
- Fd Cosmet Toxicol 2, 763-767
Materials and methods
- Objective of study:
- excretion
- Principles of method if other than guideline:
- At regular intervals up to 32 h after a single dose of 95 mg Na2EDTA the gastrointestinal tract was removed and the stomach, small intestine and colon subjected to thorough washing before determining the EDTA concentrations of each of these sections.
- GLP compliance:
- no
Test material
- 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
Constituent 1
- Radiolabelling:
- not specified
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- no data
- Duration and frequency of treatment / exposure:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
95 mg/ animal ca. 475 mg/kg bw
- 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:
- All EDTA had passed through the stomach within 12 h and 93% of the dose was recovered in the colon after 32 h, which demonstrated a poor absorption from GI tract.
- Details on distribution in tissues:
- The contents of the small intestine and urine reached a maximum about 4 h after dosage.
- Details on excretion:
- Urinary excretion over the period of 32 h cumulated to 6% of the dose.
Metabolite characterisation studies
- Details on metabolites:
- no data
Any other information on results incl. tables
- When adults received daily doses of 95 mg Na2EDTA for 7 days the percentage of daily excretion in urine and feces was similar.
Applicant's summary and conclusion
- Conclusions:
- All EDTA had passed through the stomach within 12 h and 93% of the dose was recovered in the colon after 32 h, which demonstrated a poor absorption from GI tract.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
