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Diss Factsheets
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EC number: 423-630-1 | CAS number: 62435-71-6
- 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:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Assessment made on result of testing to support registration of this substance and using test data from key metabolites
See report attached
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment made on result of testing to support registration of this substance and using test data from key metabolites
- GLP compliance:
- not specified
Test material
- Reference substance name:
- -
- EC Number:
- 423-630-1
- EC Name:
- -
- Cas Number:
- 62435-71-6
- Molecular formula:
- C7H14O2
- IUPAC Name:
- 2-(ethoxymethyl)oxolane
- Test material form:
- liquid
1
- Radiolabelling:
- no
Test animals
- Species:
- other: Not applicable
Administration / exposure
- Route of administration:
- not specified
Results and discussion
- Preliminary studies:
- The substance is soluble in water and is considered rapidly biodegradable (although along with other ethers and glycols, the results will depend on the type of method performed). A hydrolysis study has been performed and although apparently stable under environmental conditions, ethers will hydrolyse under gastric conditions to corresponding alcohols and aldehydes.
In view of the metabolic route being to tetrahydrofurfuryl alcohol (plus acetylaldehyde) and then on to hydroxybutanoic acid, date from these metabolites can be used to assess the potential toxicity of the ether.
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Yes, oral
- Type:
- distribution
- Results:
- Yes, target organs identified
- Type:
- metabolism
- Results:
- Yes, key metabolites estimated
- Type:
- excretion
- Results:
- No evidence of excretion, but metabolism is to substances found in nature
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- There was evidence of systemic effects reported for oral toxicity studies, with the repeat oral study and reproduction toxicity screening tests showing adverse effects at higher dose levels. Effects for both the ethyl ether and the alcohol include effects on liver function and organ weights, including testes.
There is no evidence of absorption following dermal or inhalation exposure, but in view of the low molecular weight, polarity and similarity to other ethers and alcohols, dermal absorption is considered likely. - Details on distribution in tissues:
- The impact on organs following oral ingestion and changes in chemistry parameters confirms distribution to key organs, even though some of the reported changes are possibly adaptive (ie metabolic processes) and not toxic adverse effects.
The low molecular weight and solubility in biological media would suggest transport of the substance and primary metabolites.
- Details on excretion:
- There is limited evidence that furans and linear ethers are directly excreted, but in view of the potentially rapid metabolism to substances found naturally in the body, it is not expected that there will be excretion of the substance itself.
The ultimate metabolisms is to water and carbon dioxide that are excreted as part of natural biological systems.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Furans and linear ethers are well document for metabolic processes in biotic and in acidic media. The route of metabolism is illustrated below.
This route of degradation is the basis for validating the read-across between the ethyl ether and alcohol. Although the impact of acetaldehyde cannot be ignored, the reaction kinetics is thought to result in further degradation to acetate at a sufficiently high rate to ensure low levels of acetaldehyde. However, the slight, but significant, mutagenic potential from in-vitro gene mutation testing is consistent with low levels of acetaldehyde and furan.
In human metabolism, acetaldehyde forms naturally as part of the metabolism of ethanol.
Applicant's summary and conclusion
- Conclusions:
- Considered to be readily adsorbed and metabolised to alcohols, aldhehydes and acid salts.
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