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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-227-5 | CAS number: 104-68-7
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Percutaneous Penetration of 2-Phenoxyethanol through Rat and Human Skin.
- Author:
- Roper, C.S. et al.
- Year:
- 1 997
- Bibliographic source:
- Food and Chemical Toxicology 35:1009-1016
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- yes
- Remarks:
- Data from a minimum of four replicates per test preparation are required. However, due to the limited supply of human skin, only three replicates were run.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-phenoxyethanol
- EC Number:
- 204-589-7
- EC Name:
- 2-phenoxyethanol
- Cas Number:
- 122-99-6
- Molecular formula:
- C8H10O2
- IUPAC Name:
- 2-phenoxyethanol
- Details on test material:
- - Name of test material (as cited in study report): 2-Phenoxy[1-14C]ethanol; synthesized by the Environmental Safety Laboratory, Unilever Research, Coleworth House, UK
- Radiochemical purity (if radiolabelling): > 99%
- Specific activity (if radiolabelling): 3.74mCi/mg
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- other: rat and human skin
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Male rats (28 - 35 days old) were received from the Comparative Biology Centre, The Medical School, University of Newcastle upon Tyne.
Human skin samples were obtained at operation (breast, leg and abdomen). No further details published.
Administration / exposure
- Type of coverage:
- other: uncovered and covered
- Vehicle:
- other: methanol
- Duration of exposure:
- E. g. sampling time:
Rat: Static diffusion cell: 0, 20, 40, 60 and 90 minutes, then hourly from 2 to 8 hr, and finally at 10, 12, and 24 hr.
Flow-through diffusion cell: hourly from 2 to 8 hr, and finally at 10, 12, and 24 hr.
Individual cells for determination of unabsorbed material (surface wash): 0, 1, 4, 8 and 24 hr.
Human: Studies with human skin were carries out in the flow-through diffusion cell in a similar manner to those with the rat skin. 2-Phenoxyethanol was applied to the skin surface (2560 nmol; 1.32 µCi) in 10 µl methanol. Receptor fluid was only collected to 6 hours post application and cells dismantled at 0, 1 and 6 hours to determine distribution. Human skin remains viable for longer periods of time in the flow-through system, but because of the limited supply of human skin from each donor only the early absorption profile was defined. - Doses:
- Volume applied: 10 µL/diffusion cell
Rat:
Static diffusion cell: 1556 nmol (0.81 µCi)
Flow-through diffusion cell: 5290 nmol (2.73 µCi)
Human:
Flow-through diffusion cell: 2560 nmol (1.32 µCi) - No. of animals per group:
- Rat: 7 rats (uncovered, static diffusion cell); 6 rats (covered, static diffusion cell); Unspecified numbers of rats (uncovered, flow-through diffusion cell)
Human: 3 donor skin samples - Control animals:
- no
- Details on study design:
- Size of test site: Static diffusion cell: 0.79 cm²; Flow-through diffusion cell: 0.64 cm²
- Details on in vitro test system (if applicable):
- Receptor fluid (static: 50% aqueous ethanol; flow-through: modified Earle’s medium (= MEM) with penicillin/streptomycin)
- surface wash
- stratum corneum
- residual skin
Individual cells were dismantled at 0, 1, 4, 8, and 24 hours for determination of unabsorbed material (surface wash), material associated with the stratum corneum (tape strippings) and material associated wit the epidermis and upper dermis. Separation of the surface wash, stratum corneum and residual skin was carried out: Each cell was washed six times with 2.5ml aliquots of 3% Teepol (v/v), the rinsings were pooled. Tissue swabs were used to dry the skin; these wee analysed by liquid scintillation counting together with the Teepol washing (= unabsorbed material). Radioactivity associated with the sides of the cell or the occlusive device (if used) was included as unabsorbed material. The swabbed skin was tape stripped with Scotch tape (3M) using five pieces (1.5 x 1.5 cm) per cell. The strippings, analysed by liquid scintillation counting, were deemed to be material associated with the stratum corneum. The remaining skin (epidermis and upper dermis) was mixed with 1 ml Biolute S (Zinsser Analytic) tissue solubilizer and incubated at 50°C for 3 hours an then analyzed by liquid scintillation counting.
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Total recovery:
- Static (24 h):
Total recovery was 67.6% (uncovered skin)
Total recovery was 102.6% (covered skin)
Flow-through (24 h):
Total recovery was 51.0% (uncovered skin)
Percutaneous absorptionopen allclose all
- Dose:
- static, uncovered
- Parameter:
- percentage
- Absorption:
- ca. 64 %
- Remarks on result:
- other: 24 h
- Remarks:
- rat; 64 ± 4%
- Dose:
- static, covered
- Parameter:
- percentage
- Absorption:
- ca. 99 %
- Remarks on result:
- other: 24 h
- Remarks:
- rat; 98.8 ± 7.0%
- Dose:
- flow-through, uncovered
- Parameter:
- percentage
- Absorption:
- ca. 43 %
- Remarks on result:
- other: 24 h
- Remarks:
- rat; 43 ± 3.7%
- Dose:
- flow-through, uncovered
- Parameter:
- percentage
- Absorption:
- ca. 59 %
- Remarks on result:
- other: 24 h
- Remarks:
- human; 59.3 ± 7.0%
Applicant's summary and conclusion
- Conclusions:
- 2-Phenoxyethanol was rapidly absorbed through rat skin mounted in both the static and flow-through diffusion cell with either aqueous ethanol or MEM as receptor fluid. The stratum corneum did not appear to be a good barrier to 2-phenoxyethanol penetration. Occlusion increased the permeability coefficient of 2-phenoxyethhanol in the static cell. The permeability profile and amount absorbed were similar for human and rat skin in the flow-through system with tissue culture medium. The mass balance recovery of 2-phenoxyethanol in the unocccluded studies was low; static diffusion 68% and flow-through diffusion cell 51% at 24 hr, due to the high evaporation, as confirmed by only 7.5% remaining on the aluminium foil at 24 hr. The losses from the skin decreased proportionally throughout the experiment due to the penetration of 2-phenoxyethanol into the skin and receptor fluid.
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.