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EC number: 238-620-0 | CAS number: 14576-08-0
- 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:
- 20 April, 2015 - 22 May, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- (2013)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- (2012)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(1-methoxy-1-methylethyl)-1-methylcyclohexene
- EC Number:
- 238-620-0
- EC Name:
- 4-(1-methoxy-1-methylethyl)-1-methylcyclohexene
- Cas Number:
- 14576-08-0
- Molecular formula:
- C11H20O
- IUPAC Name:
- 4-(2-methoxypropan-2-yl)-1-methylcyclohex-1-ene
- Test material form:
- liquid
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN Small ModelTM
- Supplier : SkinEthic Laboratories, Lyon, France
- EpiSkinTM Tissues (0.38cm2) lot number: 15-EKIN-020 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Test material
- Applied volume: 25 μL into 12-well plates on top of the skin tissues - Duration of treatment / exposure:
- 15 min
- 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:
- mean compared to the negative control
- Value:
- 7.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with Orange Flower Ether compared to the negative control tissues was 7.2%. Since the mean relative tissue viability for Orange Flower Ether was below 50% it is considered to be irritant.
Any other information on results incl. tables
Direct MTT Reduction
Orange Flower Ether was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test substance to MTT medium. Because no colour changes were observed it was concluded that Orange Flower Ether did not interact with the MTT endpoint.
Test Item, Positive Control Item and Negative Control Item
The relative mean viability of the test item treated tissues was 7.2 % after a 15 -minute exposure period and 42 hours post-exposure incubation period.
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 24% relative to the negative control treated tissues.The positive control acceptance criterion was therefore satisfied.
The mean OD570 for the negative control treated tissues was 0.957 and the standard deviation was 0.023. The negative control acceptance criterion was therefore satisfied. The standard deviation value of the percentage viability of three tissues treated identically was less than 5%, indicating that the test system functioned properly.
Mean OD570 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
OD570 of tissues |
Mean OD562 of triplicate tissues |
± SD of OD570 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
Negative Control Item |
0.983 |
0.957 |
0.023 |
100 |
|
0.946 |
|||||
0.940 |
|||||
Positive Control Item |
0.271 |
0.226 |
0.057 |
28 |
24 |
0.245 |
26 |
||||
0.162 |
17 |
||||
Test Item |
0.060 |
0.069 |
0.010 |
6.1 |
7.2 |
0.066 |
7.0 |
||||
0.080 |
8.5 |
SD = Standard deviation
*The mean viability of the negative control tissues is set at 100 %
Applicant's summary and conclusion
- Interpretation of results:
- other: Criteria for Cat 2 are met
- Remarks:
- in accordance with EU CLP (1272/2008 and its updates)
- Conclusions:
- The relative mean tissue viability after 15 minutes treatment with Orange Flower Ether compared to the negative control tissue was 7.2%. Since the mean relative tissue viability for the substance was below 50% after 15 minutes treatment, the substance is considered to be irritant. The substance needs to be classified as Cat 2 and Cat 2A for EU CLP and GHS, respectively.
- Executive summary:
- The skin irritation potential of the test substance was tested through topical application for 15 minutes. The study procedures described in this report were according to OECD TG 439 guideline and GLP principles. Skin tissue was treated by topical application of 25 µL undiluted test substance. After 42 hours 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. The positive control had a mean cell viability of 24% after 15 minutes exposure. The standard deviation value of the percentage viability of three tissues treated identically was less than 5%, indicating that the test system functioned properly. The relative mean tissue viability obtained after 15 minutes treatment with the substance compared to the negative control tissue was 7.2%. Since the mean relative tissue viability for the test substance was below 50% after 15 minutes treatment the substance is considered to be irritant. Based on these results the substance needs to be classified as Cat 2 and Cat 2A for EU CLP and GHS, respectively.
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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