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Diss Factsheets
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EC number: 202-228-8 | CAS number: 93-20-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 January 2012 to 09 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with current guideline and GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Principles of method if other than guideline:
- N/A
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-(2-naphthyloxy)ethanol
- EC Number:
- 202-228-8
- EC Name:
- 2-(2-naphthyloxy)ethanol
- Cas Number:
- 93-20-9
- Molecular formula:
- C12H12O2
- IUPAC Name:
- 2-(2-naphthyloxy)ethanol
- Details on test material:
- - Name of test material (as cited in study report): Naphthoxyethanol
- Lot/batch No.: E00173-186
- Physical state: solid
- Analytical purity: 98.5%
- Expiration date of the lot/batch: 31 July 2013
Constituent 1
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- OECD TG 439
- Value:
- > 50
- Remarks on result:
- other:
- Remarks:
- Exposure to Naphthoxyethanol resulted in a mean EpiSkin® viability of 91.77% ±2.70% ofthe negative control value.
Any other information on results incl. tables
MTT Direct Reduction Test (Preliminary Assay)
The test was scored by visual assessment of the formation of purple-coloured formazan. The positive control eugenol reduced the MTT solution to purple-coloured formazan. The negative controlwater did not reduce MTT to formazan after 3 h incubation. The test item,Naphthoxyethanol, did not reduce MTT to formazan after 3 h incubation.
EpiSkin® Irritation Test
Percentage Viability of EpiSkin® Tissues After ca 42h Recovery Time
Treatment |
Mean viability per tissue (%) |
Mean viability per test item (%) |
SD (%) |
2-Naphthoxyethanol |
94.54 |
91.77 |
2.70 |
89.16 |
|||
91.60 |
|||
Aqueous SDS Solution (5%, w/v) (Positive Control) |
6.20 |
10.52 |
3.91 |
13.83 |
|||
11.54 |
|||
PBS Solution (Negative Control) |
95.36 |
100.00 |
4.87 |
99.58 |
|||
105.07 |
The negative control results were similar for the three viable EpiSkin® units dosed with Dulbecco’s PBS. Exposure to Dulbecco’s PBS resulted in a mean EpiSkin® viability of 100.00% ±4.87%.
The positive control results were similar for the three viable EpiSkin® units dosed with aqueous SDS solution (5%, w/v). Exposure to aqueous SDS solution (5%, w/v) resulted in amean EpiSkin® viability of 10.52% ±3.91%.
The results were similar for the three viable EpiSkin® units dosed with Naphthoxyethanol.Exposure to Naphthoxyethanol resulted in a mean EpiSkin® viability of 91.77% ±2.70% ofthe negative control value.
The test item was considered to be irritant to skin in accordance with GHS category 2 if the tissue viability after exposure and post-treatment incubation was less than or equal (=) to 50%.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Naphthoxyethanol was demonstrated to be non-irritant when tested in the EpiSkin® in vitro irritation assay.
- Executive summary:
Evaluation of skin irritation is part of the Human Health Hazard Assessment required for registration of a chemical. In this study, the irritation potential of Naphthoxyethanol was evaluated using the SkinEthic EpiSkin in vitro irritation assay. Prior to the conduct of the irritation assay, a preliminary test was conducted to assess the intrinsic ability of the test item to reduce methylthiazoldiphenyl-tetrazolium bromide (MTT) to formazan. Naphthoxyethanol did not reduce MTT to formazan. The dermal irritation potential was assessed by applying 10 mg ± 2 mg of the solid Naphthoxyethanol to the exposed surface of three EpiSkin reconstructed human epidermis (RhE) units for 15 min. Prior to applying the test item, the EpiSkin surface was pre-moistened with sterile, ultra-pure water (5 µL). The surface area of the EpiSkin was 0.38 cm2, therefore the application rate was ca 26.3 mg/cm2. After the 15 min exposure period, the test item was washed from the surface of the EpiSkin using Dulbecco’s phosphate-buffered saline (PBS). The EpiSkin was then incubated for a recovery period of ca 42 h in a humidified incubator, set to maintain temperature and CO2 levels of 37°C and 5%, respectively. Following incubation, the EpiSkin units were transferred to assay medium containing MTT (0.3 mg/mL) and returned to the incubator for 3 h. Biopsies of the EpiSkin membranes were removed, added to acidified isopropanol, and refrigerated for ca 69 h in order to extract the
formazan. The formazan production (cell viability) was assessed by measuring the optical density of the extracts at a wavelength of 550 nm. Three replicates of the positive control, aqueous sodium dodecyl sulphate (SDS) solution (5%, w/v) (10 µL), and the negative control, PBS (10 µL) were tested in parallel to demonstrate the efficacy of the assay. The viability of each individual EpiSkin tissue was calculated as a percentage of the mean negative control viability (defined as 100%). Exposure to Naphthoxyethanol resulted in a mean EpiSkin viability of 91.77% ± 2.70% of the negative control value. Exposure to the positive control, aqueous SDS solution (5%, w/v), resulted in a mean EpiSkin viability of 10.52% ± 3.91% of the negative control value. In conclusion, Naphthoxyethanol was demonstrated to be non-irritant when tested in the EpiSkin in vitro irritation assay.
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