Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-951-1 | CAS number: 112-25-4
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted as per compliance to Good Laboratory Practices TSCA Standards; Federal Register 48(230): 5397-53944, November 29, 1983.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
- Objective of study:
- other: pharmacokinetics
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.8320 (Oral/dermal pharmacokinetics)
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-hexyloxyethanol
- EC Number:
- 203-951-1
- EC Name:
- 2-hexyloxyethanol
- Cas Number:
- 112-25-4
- Molecular formula:
- C6H13OCH2CH2OH
- IUPAC Name:
- 2-hexyloxyethanol
- Details on test material:
- - Name of test material (as cited in study report): Ethylene Glycol Monohexyl Ether (EGHE)
- Physical state: clear liquid
- Analytical purity: 98.5% by gas chromatography
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Isomers composition: not specified
- Purity test date: not specified
- Lot/batch No.: S-020773/BRRC No. 50-383
- Expiration date of the lot/batch: not specified
- Radiochemical purity (if radiolabelling): 97.2% by thin layer chromatography and 99% by gas chromatography
- Specific activity (if radiolabelling): 2.1 mCi/mmole, which is equivalent to 31.88 x 10(6) DPM/mg.
- Locations of the label (if radiolabelling): 14C-labelled EGHE was synthesized by DuPont/New England Nuclear Products, Boston, MA
- Expiration date of radiochemical substance (if radiolabelling): not specified
- Stability under test conditions: stated to be stable in the Material Safety Data Sheet; stability studies at BRRC showed EGHE to be stable in physiological saline solution
- Storage condition of test material: The chemical was stored at ambient temperatures throughout the course of the study
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton-Dutchland
- Age at study initiation: 9-10 weeks of age
- Weight at study initiation: 2-3 kg
- Fasting period before study: not specified
- Housing: individually housed in Roth-type metabolism cages
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): standard conditions
- Humidity (%): standard conditions
- Air changes (per hr): standard conditions
- Photoperiod (hrs dark / hrs light): 12-hour light/darkcycle
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- physiological saline
- Details on exposure:
- In the intravenous studies, EGHE and 14C-EGHE were diluted in 0.9% (w/v) NaCl in water. The dose solution was delivered gravimetrically to each animal in a study. In intravenous studies, the dose solution was delivered using a syringe with a sawed-off needle into an indwelling cannula over a period of 2 minutes. The dose volume was followed by the same volume of 0.9% NaCl to clear the cannula, then the cannula was plugged.
- Duration and frequency of treatment / exposure:
- single
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10 and 1 mg/kg
- No. of animals per sex per dose / concentration:
- 6 animals
- Control animals:
- not specified
- Positive control reference chemical:
- not applicable
- Details on study design:
- - Dose selection rationale: based on acute and probe study
- Rationale for animal assignment: random - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, plasma, blood, cage washes
- Time and frequency of sampling: Urine was collected on dry ice in 6- to 12-hr intervals and feces in 24-hr intervals. Urine samples were assayed immediately for 14c and the remaining volumes were stored at approximately -80°C until chemical analysis was conducted by HPLC. Feces were frozen at approximately -20°C until analyzed. Expired 14CO2, was collected at 12-hour intervals and stored at approximately -20°C until analyzed for 14C
- Statistics:
- The pharmacokinetic description of the fate of absorbed l4C-EGHE w as derived using best-fit parameter estimates for the plasma. The parameters
estimated included: rate constant of absorption, ka; rate constant of elimination, ke; volume of distribution, Vd; half-lives (t1/2) of absorption and elimination and area under the plasma concentration (AUC) versus time.
Results and discussion
- Preliminary studies:
- not applicable
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- no data
- Details on distribution in tissues:
- no data
- Details on excretion:
- The disposition of radioactivity following 10 and 0.1 mg/kg doses of EGHE/14C-EGHE to male NZW rabbits was that the total recovery of dose in excreta fractions, carcass and the cage wash was approximately 95 to 100% in the two dose groups.
A majority of the dose was eliminated in the urine (approximately 80%) while less than 2% was eliminated in the feces (largely in the first day of exposure).
There were no marked difference in rates or extents of urinary elimination observed between the two dose groups. In general, most of the dose recovered in the urine was eliminated in the first 24 hours after dosing, after which little additional urinary elimination of the dose occurred.
Toxicokinetic parametersopen allclose all
- Test no.:
- #1
- Toxicokinetic parameters:
- Cmax: (10 mg/kg): 42.491 µg/g
- Test no.:
- #1
- Toxicokinetic parameters:
- Tmax: (10 mg/kg): 0 minutes
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: (10 mg/kg): Half-life of distribution: 40.232 min
- Test no.:
- #1
- Toxicokinetic parameters:
- AUC: (10 mg/kg): AUC(48): 3598.5 µg/g.min
- Test no.:
- #1
- Toxicokinetic parameters:
- AUC: (10 mg/kg): AUC(∞): 4241.3 µg/g.min
- Test no.:
- #1
- Toxicokinetic parameters:
- other: (10 mg/kg): Distribution rate constant k(d): 0.017229 min(-1)
- Test no.:
- #1
- Toxicokinetic parameters:
- other: (10 mg/kg): Elimination rate constant k(e): 0.00036001 min (-1)
- Test no.:
- #1
- Toxicokinetic parameters:
- other: (10 mg/kg): Apparent volume of distribution Vd: 32610 ml
- Test no.:
- #1
- Toxicokinetic parameters:
- other: (10 mg/kg): Systemic clearance Cl(tot): 11.74 ml/min
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 2nd: (10 mg/kg): Half-life of elimination: 1925.4 min
- Test no.:
- #2
- Toxicokinetic parameters:
- Cmax: (1.0 mg/kg): 5.0998 µg/g
- Test no.:
- #2
- Toxicokinetic parameters:
- Tmax: (1.0 mg/kg): 0 minutes
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 1st: (1.0 mg/kg): Half-life of distribution: 16.917 min
- Test no.:
- #2
- Toxicokinetic parameters:
- AUC: (1.0 mg/kg): AUC(48): 288.73 µg/g.min
- Test no.:
- #2
- Toxicokinetic parameters:
- AUC: (1.0 mg/kg): AUC(∞): 357.38 µg/g.min
- Test no.:
- #2
- Toxicokinetic parameters:
- other: (1.0 mg/kg): Distribution rate constant k(d): 0.040973 min(-1)
- Test no.:
- #2
- Toxicokinetic parameters:
- other: (1.0 mg/kg): Elimination rate constant k(e): 0.00029278 min (-1)
- Test no.:
- #2
- Toxicokinetic parameters:
- other: (1.0 mg/kg): Apparent volume of distribution Vd: 43640 ml
- Test no.:
- #2
- Toxicokinetic parameters:
- other: (1.0 mg/kg): Systemic clearance Cl(tot): 12.777 ml/min
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 2nd: (1.0 mg/kg): Half-life of elimination: 2367.5 min
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- 3-9 peaks were observed, none of which corresponded to EGHE. These peaks were probably considered metabolites of EGHE, of which at least three of which appear to be major urinary metabolites.
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: low bioaccumulation potential based on study results
Under the conditions of the study, the results in rabbits indicate that while EGHE has a large potential for systemic absorption, it is rapidly and extensively eliminated from the plasma by metabolic conversion to multiple metabolite species. - Executive summary:
The absorption, distribution, metabolism and elimination of ethylene glycol monohexyl ether (EGHE) following single intravenous dose was investigated in rabbits. In New Zealand White rabbits, intravenous doses of 10 and 1 mg/kg EGHE given to male rabbits were metabolized rapidly, so that EGHE levels were less than 1% of the total plasma radioactivity by 1 hour post-dosing. About 80% of the radioactivity was recovered in the urine, with less than 2% in the feces. Because the rabbits were housed in open metabolism cages, the recoveries of radioactivity in CO2 and organic volatile fractions could not be assessed; however, over 90% of the dose was recovered in the intravenous studies. The results in rabbits indicate that, while EGHE has a large potential for systemic absorption, it is rapidly and extensively eliminated from the plasma by metabolic conversion to multiple metabolite species.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.