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Diss Factsheets
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EC number: 940-702-2 | CAS number: -
- 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:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (3R)-3-[(1R)-4-methylcyclohex-3-en-1-yl]butan-1-ol; (3S)-3-[(1R)-4-methylcyclohex-3-en-1-yl]butan-1-ol
- EC Number:
- 940-702-2
- Molecular formula:
- C11H20O
- IUPAC Name:
- (3R)-3-[(1R)-4-methylcyclohex-3-en-1-yl]butan-1-ol; (3S)-3-[(1R)-4-methylcyclohex-3-en-1-yl]butan-1-ol
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: liquid
- Storage condition of test material: room temperature in the dark under nitrogen
Constituent 1
Test animals
- Species:
- other: EPISKIN MODEL KIT
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- The EPISKINTM model is a three-dimensional reconstructed human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. A highly differentiated and stratified epidermis model is obtained after a 13-Day culture period comprising of the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
Incubations were at 37°C and 5% CO2.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative group treated with DPBS; Positive group treated with SDS (5% w/v).
- Amount / concentration applied:
- 10 micolitre of test material was applied unchanged (no vehicle).
- Duration of treatment / exposure:
- 15 minutes
- Number of animals:
- For each test group, triplicate tissues were used.
- Details on study design:
- TEST SITE
- Area of exposure: 10 μl of the undiluted test substance was added on top of the skin tissues.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 15 minutes.
SCORING SYSTEM: Skin irritation is expressed as the remaining cell viability after exposure to the test substance.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: Mean tissue viability
- Value:
- 9.6
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 minutes. Reversibility: no data. Remarks: Score in terms of percentage of negative control group. (migrated information)
In vivo
- Other effects:
- The MTT solution containing the test item did not turn blue which indicated that the test item did not directly reduce MTT.
Any other information on results incl. tables
Table 1. Mean OD540 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item | OD540of tissues | Mean OD540of triplicate tissues | ± SD of OD540 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative control | 0.748 | 0.751 | 0.027 | 99.6 | 100 | 3.6 |
0.725 | 96.5 | |||||
0.779 | 103.7 | |||||
Positive control | 0.092 | 0.066 | 0.023 | 12.3 | 8.8 | 3.1 |
0.048 | 6.4 | |||||
0.057 | 7.6 | |||||
Test material | 0.07 | 0.072 | 0.002 | 9.3 | 9.6 | 0.3 |
0.073 | 9.7 | |||||
0.074 | 9.9 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material is considered to be irritating to skin.
- Executive summary:
The study was performed to assess the skin irritation potential of the test material to a human three dimensional epidermal model. The study was performed under GLP and followed the OECD guideline 439. Tissues were treated with the test material for 15 minutes and then washed with phosphate buffered saline to remove residual test material. Subsequently the skin tissues were incubated for 42 hours at 37°C in maintenance medium. After incubation, cell culture inserts were dried carefully to remove excess medium and were transferred into a 12-wells plate prefilled with 2 ml MTT-medium (0.3 mg/ml). The tissues were incubated for 3 h at 37°C. The amount of extracted formazan was determined spectrophotometrically at 540 nm. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. The relative mean tissue viability obtained after 15 minutes treatment with the test substance compared to the negative control tissues was 9.6%. Since the mean relative tissue viability for the test substance was below or equal to 50% after 15 minutes treatment it is considered to be a skin irritant.
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