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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-018-4 | CAS number: 10022-28-3
- 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:
- 24 May - 30 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- In accordance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Adopted 28 July 2015
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2009
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,1-dimethoxyoctane
- EC Number:
- 233-018-4
- EC Name:
- 1,1-dimethoxyoctane
- Cas Number:
- 10022-28-3
- Molecular formula:
- C10H22O2
- IUPAC Name:
- 1,1-dimethoxyoctane
1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: human
- Cell type:
- other: epidermal keratinocytes
- Cell source:
- other: SkinEthic Laboratories, Lyon, France
- Source strain:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN TM
- Tissue batch number(s): 16-EKIN-021
- Production date/ Shipping date: no data
- Delivery date: 24 May 2016
- Date of initiation of testing: 24 May 2016
PRE-TEST PROCEDURE
- Pre-incubation: On day of receipt the tissues were transferred into a 12-wells plate filled with maintenance medium. A different 12-wells plate was used for the test item and each control item. The tissue were incubated at 37°C, 5% CO2 in air overnight.
- Test item colour interference: To assess colour interference, 10 μL of test substance was added to 90 μL sterile water. The mixture was mixed for approximately 15 minutes. At the end of the shaking period a colour check was performed.
- Test item MTT reduction: To assess the ability of the test item to directly reduce MTT, 10 μL of the test item was added to 2 mL MTT solution (0.3 mg/mL in assay medium). The mixture was incubated in the dark for 3 hours at 37°C, 5% CO2 in air. Untreated MTT solution was used as a control. At the end of the incubation period a colour check was performed.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment: room temperature for 15 minutes, post-treatment incubation: 37 °C for 42 hours
REMOVAL OF TEST MATERIAL AND CONTROLS
-Tissues were washed with DPBS with Ca++ and Mg++ to remove residual test item.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL in assay medium
- Incubation time: 3 hours at 37 °C, 5% CO2 in air
- Spectrophotometer: Anthos 2001 microplate reader
- Wavelength: 562 nm (without reference filter)
NUMBER OF REPLICATE TISSUES: 3
DECISION CRITERIA
- A test substance is considered irritant in the skin irritation test if: The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test substance and 42 hours of post-exposure incubation is ≤ 50% of the mean viability of the negative controls.
- A test substance is considered non-irritant in the in vitro skin irritation test if: The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test substance and 42 hours of post-exposure incubation is > 50% of the mean viability of the negative controls.
ACCEPTANCE CRITERIA
- Positive Control: The assay establishes the acceptance criterion for an acceptable test if the relative mean tissue viability for the positive control treated tissues is ≤40% relative to the negative control treated tissues, and the standard deviation (SD) value of the percentage viability is ≤18%.
- Negative Control: The assay establishes the acceptance criterion for an acceptable test if the mean OD562 for the negative control treated tissues is ≥0.6 and ≤1.5, and the SD value of the percentage viability is ≤18%.
- Test Item: The assay establishes the acceptance criterion for an acceptable test if the standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues is ≤18%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 μL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 μL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 μL
- Concentration (if solution): 5% (w/v) - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Relative mean tissue viability compared to the negative control tissues (100%)
- Value:
- 5.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct-MTT reduction: The MTT solution containing the test item did not turn blue or purple which indicated that the test item did not directly reduce MTT.
- Colour interference with MTT: The solution containing the test item was colorless. It was therefore unnecessary to run color correction tissues.
ACCEPTANCE OF RESULTS:
The relative mean tissue viability for the positive control treated tissues was 4.9% relative to the negative control treated tissues and the standard deviation value of the viability was 0.9%. The positive control acceptance criteria were therefore satisfied.
The mean OD562 for the negative control treated tissues was 1.293 and the standard deviation value of the viability was 3.5%. The negative control acceptance criteria were therefore satisfied.
The standard deviation calculated from individual tissue viabilities of the three identically test item treated tissues was 1.3%. The test item acceptance criterion was therefore satisfied.
Any other information on results incl. tables
Mean OD562 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item:
Item |
OD562of tissues |
Mean OD562 of triplicate tissues |
± SD of OD562 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative Control Item ⊕ |
1.265 |
1.293 |
0.045 |
97.8 |
100* |
3.5 |
1.345 |
104.0 |
|||||
1.269 |
98.1 |
|||||
Positive Control Item ⊕ |
0.076 |
0.063 |
0.011 |
5.9 |
4.9 |
0.9 |
0.058 |
4.5 |
|||||
0.055 |
4.3 |
|||||
Test Item |
0.062 |
0.077 |
0.017 |
4.8 |
5.9 |
1.3 |
0.096 |
7.4 |
|||||
0.072 |
5.6 |
OD = Optical Density
SD = Standard deviation
* = The mean viability of the negative control tissues is set at 100%
⊕ = The control groups were shared with Envigo - Shardlow study number TW67BS, MS48XJ, FC59GT, YB24MH, RS46VL, JD61DM and NL15CD.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin irritant, Category 2
- Remarks:
- according to EU CLP criteria (1272/2008) and its amendments.
- Conclusions:
- Under the conditions of this test, the relative mean tissue viability for the test item treated tissues was determined to be 5.9%. This value is below the threshold for irritancy of ≤50%. Based on the results obtained, the test substance is considered to be irritating to the skin, Category 2 according to GHS.
- Executive summary:
The possible skin irritation potential of the substance was tested in vitro, using a reconstructed human epidermis model, according to OECD TG 439 guideline and GLP principles. Skin tissues were treated by topical application of 10 μL undiluted test substance for 15 minutes. After a 42 hours post-exposure incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) MTT at the end of treatment. Skin irritation is expressed as the remaining cell viability after exposure to the test substance. Reliable negative and positive controls were included. The positive control had a relative mean tissue viability of 4.9% after 15 minutes exposure. The standard deviation value of the percentage viability of three tissues treated identically was less than 18% for test item, positive control and negative control treated tissues, indicating that the test system functioned properly. Under the conditions of this test, the relative mean tissue viability for the test item treated tissues is determined to be 5.9%. This value is below the threshold for irritancy of ≤50%. Based on the results obtained, the test substance is considered to be irritating to the skin.
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.