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Diss Factsheets
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EC number: 247-361-2 | CAS number: 25952-53-8
- 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 vitro / ex vivo
- Type of information:
- other: In accordance with REACH Annex VIII (8.8) an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.
- Adequacy of study:
- key study
- Study period:
- The assessment was conducted in july 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Relevant studies were reviewed by a qualified toxicologist with a view to fulfilling the requirements of Annex VIII (8.8).
Data source
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In accordance with REACH Annex VIII (8.8) an assessment of toxicokinetic behaviour has been conducted to the extent that can be derived from the relevant available information.The assessment is based on the Guidance on information requirements and chemical safety assessment R.7c:
Endpoint specific guidance (ECHA, November 2014)
Test material
- Reference substance name:
- N'-(ethylcarbonimidoyl)-N,N-dimethylpropane-1,3-diamine monohydrochloride
- EC Number:
- 247-361-2
- EC Name:
- N'-(ethylcarbonimidoyl)-N,N-dimethylpropane-1,3-diamine monohydrochloride
- Cas Number:
- 25952-53-8
- Molecular formula:
- C8H17N3.ClH
- IUPAC Name:
- N-[3-(dimethylamino)propyl]-N'-ethylcarbodiimide hydrochloride
- Test material form:
- solid
Constituent 1
- Radiolabelling:
- no
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- EDAC is known to be unstable in pH ranges outside of neutral pH 7. The main known metabolite of EDAC is EDAU
Any other information on results incl. tables
EDAC is a white to to off white powder. EDAC is very hydrolytic and unstable with the ½ life of 1.5 hrs at pH7 where it is converted into the metabolite 1-ethyl-3-(3-dimethylaminopropyl) urea. Physico-chemical properties such as log Kow and vapour pressure imply the risk of particle inhalation would be minimal. However, based on the water solubility and particle size any vapour could potentially be absorbed. Furthermore, the supporting toxicological information suggests any inadvertent inhalation may lead to an elevation in systemic toxicity as acute dermal and oral effects were detected and the substance is considered to be STOT RE 2. EDAC was identified to be a kin and ocular irritant; the in vitro genotoxicity panel indicates that there are limited concerns for genotoxicity, with negative effects seen in the in-vivo studies.
The results from a single dermal dose toxicity study (irritation) in conjunction with the molecular weight indicate that absorption occurs via the dermis with the LD50 value of between 200-1000mg/kg. Acute oral toxicity results showed the LD50 to be 500 mg/kg body weight, and the Oral (Gavage) Repeated Dose Toxicity Study in the rat resulted in any adverse toxicological findings at the highest dose tested of 300mg/kg/day, based upon these findings, absorption form the Gastrointestinal tract and dermis can be anticipated.
Absorption
The general physico-chemical properties of EDAC including the molecular weight and log Pow and toxicological findings would indicate that significant absorption is possible of the metabolite EDAU.
Distribution
Information relating to the distribution of EDAU is limited; however, the chemical characteristics and findings from the Oral (Gavage) Repeated Dose Toxicity Study implies systemic distribution would most likely occur via the serum following oral administration and gastric absorption.
Metabolism
There is limited evidence of test item or metabolite influenced hepatic metabolism from the Oral (Gavage) Repeated Dose Toxicity Study.
Excretion
The most plausible route of clearance for relatively highly soluble chemicals would be by transfer of test material and/or metabolites from the plasma leading to clearance of any metabolic breakdown products primarily via the urine.
Applicant's summary and conclusion
- Conclusions:
- The available information demonstrates that absorption of substance from the gastrointestinal tract following oral ingestion occurs given the test items physico-chemical characteristics.
These characteristics together with the observed systemic toxicity and acute dermal toxicity also indicate absorption via dermal exposure of test item occurs in addition to oral adsorption. Absorption via the inhalation route is not expected to occur based on the very low vapour pressure.
The substance is not expected to bioacumulate based on the log Kow value of -2.98
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