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EC number: 234-123-8 | CAS number: 10543-57-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Rationale for reliability incl. deficiencies:
- other: There is only a summary of the study available.
Data source
Reference
- Reference Type:
- grey literature
- Title:
- HERA-draft: Tetraacetylethylenediamine (TAED)
- Author:
- HERA members
- Year:
- 2 002
- Bibliographic source:
- http://www.heraproject.com/RiskAssessment.cfm?SUBID=2
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The fates of tetra acetyl [14C]ethylene diamine (TA[14C]ED) and [1-14C]tetra acetyl ethylene diamine ([14C]TAED) were followed in groups in rats after oral intubation. The nature of the radio-labelled compounds in urine and feces was studied and 14C levels were monitored in tissues, carcass remains, urine and feces. A further group of rats was intubated with [14C]TAED and killed at 1, 2, 4, 7 and 24 hours to monitor the rate of absorption from the intestine and uptake by the liver, adrenal and kidney tissues.
- GLP compliance:
- no
- Remarks:
- , study was conducted prior to the implementation of GLP
Test material
- Reference substance name:
- N,N'-ethylenebis[N-acetylacetamide]
- EC Number:
- 234-123-8
- EC Name:
- N,N'-ethylenebis[N-acetylacetamide]
- Cas Number:
- 10543-57-4
- Molecular formula:
- C10H16N2O4
- IUPAC Name:
- N,N'-ethylenebis[N-acetylacetamide]
- Details on test material:
- - Other: tetra acetyl [14C]ethylene diamine (TA[14C]ED) and [1-14C]tetra acetyl ethylene diamine ([14C]TAED) were used
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not given
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: dietary slurry
- Details on exposure:
-
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml dietary slurry containing 5 mg TA[14C]ED or 4.6 mg [14C]TAED per animal
no further information given - Duration and frequency of treatment / exposure:
- once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5 mg TA[14C]ED or 4.6 mg [14C]TAED per rat
- No. of animals per sex per dose / concentration:
- 3
- Control animals:
- not specified
- Positive control reference chemical:
- none
- Details on study design:
- The fates of tetra acetyl [14C]ethylene diamine (TA[14C]ED) and [1-14C]tetra acetyl ethylene diamine ([14C]TAED) were followed in groups of 3 male and 3 female Wistar rats after oral intubation with 0.5 ml dietary slurry containing 5 mg TA[14C]ED or 4.6 mg [14C]TAED. The nature of the radio-labelled compounds in urine and feces was studied and 14C levels were monitored in tissues, carcass remains, urine and feces. A further group of rats was intubated with [14C]TAED and killed at 1, 2, 4, 7 and 24 hours to monitor the rate of absorption from the intestine and uptake by the liver, adrenal and kidney tissues.
- Details on dosing and sampling:
- see above (details on study design)
- Statistics:
- none
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Rapidly and quantitatively absorbed form the intestine (already > 50% at one hour after dosing).
- Type:
- distribution
- Results:
- Tissue levels of 14C were at their highest at 2 hours after dosing. Subsequently levels fell rapidly except in the adrenal gland where 14C levels rose during the 7 hours after dosing and declined thereafter.
- Type:
- excretion
- Results:
- Rapidly excreted predominately via urine. More than 90% of the urinary 14C was excreted within 24 hours of dosing.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Chromatographic analysis showed only traces of TAED in the urine. Most of the 14C was excreted as triacetyl ethylene diamine (TriAED) and diacetyl ethylene diamine (DAED). Mono acetyl ethylene diamine (MAED) and ethylene diamine were not found.
Any other information on results incl. tables
2 days after [14C]TAED administration: 67.3% (urine), 2.8% (feces), 17.9% (expired air), 3.1% (carcass); total: 91.1%
4 days after TA[14C]ED administration: 97.7% (urine), 3.4% (feces), 0.4% (expired air), 1.0% (carcass); total: 102.5%
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
There was no sex difference in the absorption, metabolism and excretion of TA[14C]ED and [14C]TAED.
The results show that TAED was rapidly absorbed from the rat intestine and was largely metabolized and excreted in the urine within 24 hours. Differences in the levels of 14C recovered as expired CO2 reflect the different metabolic fates of the acetyl and ethylene diamine moieties. The 14C compounds identified in the urine, TirAED and DAED, indicate that deacetylation was the main metabolic route for TAED in the rat.
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