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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- 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 with 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
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 85-3 (Dermal Penetration)
- 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
- Remarks:
- C14- Labeled EGHE
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, denver ,PA
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 2 - 3 kgs
- Housing: Open rack-type metabolism cages
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum):Ad libitum
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light):12 hour photoperiod
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 48 hour experimental period
- Doses:
- Percutaneous Male-10mg/kg
Percutaneous Female-10mg/kg - No. of animals per group:
- 5 animals per group
- Control animals:
- no
- Details on study design:
- APPLICATION OF DOSE: 10mg/kg EGHE to male and female rabbits.
TEST SITE
- Preparation of test site: The dose material was applied to the skin using a syringe and needle
- Area of exposure: Occluded with polyethylene sheeting held in place woth waterproof surgical tape and covered with stretch adhesive bandage tape.
SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: yes:
SAMPLE COLLECTION
- Collection of blood: 1,2,4,8,12,24,30,36 and 48 hours
- Collection of urine and faeces: Done
- Details on in vitro test system (if applicable):
- not applicable
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- no effects
- Absorption in different matrices:
- Refer to attachment
- Total recovery:
- Refer to attachment
- Conversion factor human vs. animal skin:
- not applicable
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- The results in rabbits indicates that EGHE (Ethylene glycol hexyl ether) 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:
New Zealand White rabbits were used to access Skin Penetration and Pharmacokinetics of Ethylene Glycol Monohexyl Ether (EGHE). 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 C02and organic volatile fractions could not be assessed; however, over 90% of the dose was recovered in the intravenous studies. After cutaneous dosing of 10 mg/kg EGHE to male and female rabbits, about 75% of the dose was recovered; the remainder of the dose may have been lost because the organic volatile fraction could not be collected. No sex differences in the disposition of EGHE were observed. EGHE penetrated the skin rapidly, and the radioactivity was widely distributed. Most of the radioactivity was eliminated in the urine (55-65%) with minimal recovery in feces. The cutaneous bioavailability, based on total radioactivity, was greater than 65%; however, EGHE was extensively metabolized so that it accounted for less than 10% of the total radioactivity by 1 hour post-dosing. In nearly all urine fractions no EGHE was detected, but up to nine metabolite peaks were found.
No marked accumulation of EGHE was observed in a variety of tissues and organs that were analyzed.
The results in and 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.