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Diss Factsheets
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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study does not meet the requirements of 40 CFR Part 160, and differs in the following ways. 1. This study references, and is based upon, that portion of the present submission entitled Subchronic Toxicity Study -90-days, OPPTS870.3250. and this subchronic study does meet 40 CFR Part 160.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- - This study references, and is based upon, that portion of the present submission entitled Subchronic Toxicity Study -90-days, OPPTS870.3250.
- GLP compliance:
- yes
- Test type:
- other:
- Limit test:
- no
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]
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Details on dermal exposure:
- see executive summary
- Duration of exposure:
- 6 hours for 90 days
- Doses:
- 20, 200 and 2000 mg/kg/day
- No. of animals per sex per dose:
- 10 rats/sex
- Control animals:
- yes
- Details on study design:
- see executive summary
- Statistics:
- not applicable as no death occurred
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- see executive summary
- Clinical signs:
- see executive summary
- Gross pathology:
- see executive summary
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
The toxicity study of tetraacetylethylenediamine (TAED) when delivered by dermal application once daily for six hours to the skin
of Sprague Dawley rats for 90 days is submitted to fulfill the acute toxicity requirement Guideline OPPTS870.1200 (see reference
study, Subchronic dermal toxicity study - 90 - day, Guideline OPPTS870.3250, TherImmune Study No.1152 - 103 for
complete study, Chapter 7.5). All data requirements for the acute study are fulfilled in the subchronic study, including the maximum
dose that may be applied to the animals.
In this study, groups of 10 rats/sex received TAED at levels of 20, 200, or 2000 mg/kg/day and a group of 10 rats/sex received the vehicle, 1% carboxymethylcellulose. All groups received their doses once daily for six hours to the skin. Parameters evaluated were
mortality / morbundity; clinical observations / physical examinations; body weight and food consumption; ophthalmoscopic
examinations; hematology, coagulations, and chemistry; organweights; and necropsy and histopathology findings.
One control male, two 200mg/kg/day females,and one 2000 mg/kg/day female did not survive to termination. These deaths were considered to be the result of the wrapping procedure and not the result of TAED, since no clinical signs suggestive of TAED were
noted prior to death.
No treatment related findings were noted at the 0, 20, or 200 mg/kg/day dose levels in clinical observations, body weight and food
consumption, ophthalmologic findings, clinical pathology, gross necropsy and organ weights. The only treatment-related finding was found at the high dose, 2000 mg/kg/day, was a minimal centrilobular hypertrophy (cytomegaly) in 8 of 10 and 4 of 10 males and females, respectively. Minimal centrilobular hypertophy was not noted in the lower dosed rats that died on study or had gross lesions associated with the liver.
Based on the effects in this study, tetraacetylethyldiamine (TAED), when administered to Sprague-Dawley rats, dermally for
6 hours / day for 90 days, produced a no-effect level that would be equal to or greater than 200 mg/kg/day.
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