Registration Dossier
Registration Dossier
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EC number: 200-529-9 | CAS number: 62-33-9
Basic toxicokinetics
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:
- 1 964
- 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
- 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
Constituent 1
- 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
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