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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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 to 16 February 2012
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
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): 2-(2-naphthoxy)ethanol
- Physical state: Light tan-coloured waxy solid
- Analytical purity: >98.5%
- Lot/batch No.: E00173-186
- Expiration date of the lot/batch: 31 July 2013
- Storage condition of test material: Ambient temperature, in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Margate
- Age at study initiation: Between 8 and 10 weeks old
- Weight at study initiation: 16.6 to 21.0 g
- Housing: In groups of 2 or 3
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C to 22°C
- Humidity (%): 48% to 70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: To: 01 to 13 February 2012
Study design: in vivo (LLNA)
- Vehicle:
- other: maize oil
- Concentration:
- 0%, 2.5%, 10% and 50%
- No. of animals per dose:
- 6 at 0% and 4 at each of 2.5%, 10% and 50%
- Details on study design:
- RANGE FINDING TESTS:
- Irritation and toxicity
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay: dermal application
- Criteria used to consider a positive response: Stimulation Indices greater than or equal to 3 in groups treated at either 2.5%, 10% or 50%
TREATMENT PREPARATION AND ADMINISTRATION: No preparation. Dermal administration to dorsum of the ears by micropipette - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Dixon’s Q-test for the detection of a single outlier was performed on disintegrations per minute values
Results and discussion
- Positive control results:
- Stimulation index = 8.09
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Control
- Parameter:
- SI
- Value:
- 1.25
- Test group / Remarks:
- Group 2 (2.5%)
- Parameter:
- SI
- Value:
- 1.15
- Test group / Remarks:
- Group 3 (10%)
- Parameter:
- SI
- Value:
- 1.59
- Test group / Remarks:
- Group 4 (50%)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Control group = 1533. Group 2 (2.5%) = 1916. Group 3 (10%) = 1766. Group 4 (50%) = 2440.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, since treatment with 2-(2-naphthoxy)ethanol at concentrations of up to 50% did not achieve a stimulation index of =3, it was considered that the test item does not have the potential to cause skin sensitisation.
This study is considered to be relevant, reliable and adequate for risk assessment and for classification purposes. - Executive summary:
The objective of this study was to determine the delayed contact hypersensitivity potential of 2-(2-naphthoxy)ethanol.
The study was performed using female CBA/Ca mice. A preliminary test was conducted by administering a 50% concentration of test item to two mice. Each mouse received an open application of 25 µL of test formulation onto the dorsum of each ear.
As a result of the findings from the preliminary test, formulation concentrations were selected for the main study. The study design for the main study was as follows:
Text Table1
Experimental DesignGroup Number
Treatment
Formulation Concentration (%)
Animal Numbers
1
Vehicle Control
0
1 to 6
2
2-(2-naphthoxy)ethanol
2.5
7 to 10
3
2-(2-naphthoxy)ethanol
10
11 to 14
4
2-(2-naphthoxy)ethanol
50
15 to 18
5
Hexylcinnamicaldehyde (HCA)
50
49 to 52
The selected vehicle was corn oil and the vehicle control group received only this. Each mouse received an open application of 25 µL of the appropriate formulation onto the dorsum of each ear for 3 consecutive days. Three days after the final application each animal received an intravenous injection of [methyl-3H] thymidine into the lateral tail vein. Approximately 5 h later the draining auricular lymph nodes were collected in order that incorporation of tritiated thymidine could be assessed by scintillation counting.
The stimulation indices (SI) for groups of mice that received 2-(2-naphthoxy)ethanol at concentrations of 2.5%, 10% or 50%, when compared with controls, were 1.25, 1.15 and 1.59, respectively. The group treated with HCA, a chemical known to induce skin sensitisation, recorded a stimulation index of 8.09. This is considered to demonstrate competent performance of the test procedures.
Under the conditions of the study, since treatment with 2-(2-naphthoxy)ethanol at concentrations of up to 50% did not achieve a stimulation index of =3, it was considered that the test item does not have the potential to cause skin sensitisation.
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.
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