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EC number: 233-732-6 | CAS number: 10339-55-6
- 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:
- 09/06/2010 - 26/08/2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD: Draft Proposal for a New Guideline on In Vitro Skin Irritation: Human Skin Model Test of 06-Jun-2008 and OECD Guideline for Testing of Chemicals No. 404, April 24, 2002 (Acute Dermal Irritation/Corrosion)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD: Draft Proposal for a New Guideline on In Vitro Skin Irritation: Human Skin Model Test of 06-Jun-2008; therefore OECD 439, In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
- Qualifier:
- according to guideline
- Guideline:
- other: BfR: EpiDermTM Skin Irritation Test: Standard Operating Procedure. SOP Version 7.0 of October 2007
- Qualifier:
- according to guideline
- Guideline:
- other: Spielmann et al 2007, ATLA 35: 559-601
- Principles of method if other than guideline:
- In addition the study follows the test strategy for determination of a corrosive/irritation property as given in the following guideline: OECD Guideline for Testing of Chemicals No. 404, April 24, 2002 (Acute Dermal Irritation/Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,7-dimethylnona-1,6-dien-3-ol
- EC Number:
- 233-732-6
- EC Name:
- 3,7-dimethylnona-1,6-dien-3-ol
- Cas Number:
- 10339-55-6
- Molecular formula:
- C11H20O
- IUPAC Name:
- 3,7-dimethylnona-1,6-dien-3-ol
- Details on test material:
- - Name of test material (as cited in study report): Ethyllinalool
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor.
- Other: The test substance was homogeneous by visual inspection.
- Physical state: liquid
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: Epi-200, MatTek Corporation, Ashland MA, USA
- Details on test animals or test system and environmental conditions:
- No remarks
Test system
- Type of coverage:
- other: nylon meshto spread the liquid material on the tissue.
- Preparation of test site:
- other: Three dimensional human epidermis model, EpiDerm TM
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control tissues have been used with: PBS, sterile (negative control) or 5% (w/v) sodium dodecyl sulfate in highly de-ionized water, sterile (positive control)
- Amount / concentration applied:
- Test substance was applied undiluted
- Duration of treatment / exposure:
- 1 hour
- Observation period:
- 42 hours post incubation
- Number of animals:
- not applicable
- Details on study design:
- The potential of Ethyllinalool to cause dermal irritation was assessed by a single topical application of 30 µL of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm TM). The tissues were purchased from MatTek Corporation, Ashland MA, USA. The test substance was spread onto 3 EpiDerm TM tissue samples (0.6 cm2 surface). Control tissues (#3 per control) were concurrently exposed to the negative control PBS and the positive control 5% SDS. For both, 30 µL were spread on the tissues. The tissues were incubated with the test substance and the controls for 1 hour followed by a 42-hours post-incubation period. After the postincubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol for at least 2 hours at room temperature on a plate shaker. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 6 microtiter wells filled with isopropanol for each microtiter plate.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Viability (% of negative control)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Remarks: Negative control. (migrated information)
- Irritation / corrosion parameter:
- other: other: Viability (% of negative control)
- Value:
- 7
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Remarks: Test substance. (migrated information)
- Irritation / corrosion parameter:
- other: other: Viability (% of negative control)
- Value:
- 7
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Remarks: Positive control. (migrated information)
In vivo
- Irritant / corrosive response data:
- No remarks
- Other effects:
- No remarks
Any other information on results incl. tables
Irritant potential of the test materials is predicted from the mean relative tissue viabilities compared to the negative control tissues concurrently treated with sterile PBS. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%.
Mean tissue viability (% of negative control) ---> Prediction
= 50 ---> irritant
= 50 ---> non-irritant
Historical control values of negative and positive controls have been gathered over an appropriate time period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It was concluded, that Ethyllinalool shows a skin irritation potential in the EpiDerm skin irritation test under the test conditions chosen. Based on the criteria laid down in Regulation 1272/2008/EC, undiluted Ethyllinalool is considered a skin irritant (category 2).
- Executive summary:
It was concluded, that Ethyllinalool shows a skin irritation potential in the EpiDerm skin irritation test under the test conditions chosen. Based on the criteria laid down in Regulation 1272/2008/EC, undiluted Ethyllinalool is considered a skin irritant (category 2).
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