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EC number: 814-113-5 | CAS number: 253454-23-8
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 April 2016 - 27 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- Updated guideline adopted July 28, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek test protocol “In vitro EpiDerm(TM) Skin Corrosion Test (EPI-200-SCT)”
- Version / remarks:
- 07 November 2014
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dd 14 September 2015
Test material
- Reference substance name:
- rel-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- EC Number:
- 814-113-5
- Cas Number:
- 253454-23-8
- Molecular formula:
- C15H30O
- IUPAC Name:
- rel-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Hysandol called Timberol in the test report may be a multi of the cis and trans-isomer, while Hysandol is a mono-trans isomer. The cis isomer is expected to have the same results for this endpoint because it is stereo isomer.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: epidermal keratinocytes
- Cell source:
- other: MatTek Corporation (Bratislava, Slovakia)
- Source strain:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ tissue
- Tissue batch number(s): 23338
- Delivery date: 24 May 2016
- Date of initiation of testing: 24 May 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 minutes exposure: at room temperature, 60 minute exposure: 37 ± 1.5 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 20 times using a wash bottle containing DPBS
- Observable damage in the tissue due to washing: no
TEST FOR DIRECT MTT REDUCTION AND COLOUR INTERFERENCE
The substance was checked for possible interference with the MTT endpoint before the start of the study. 50 μL of the test item was added to 0.3 mL of deionised water (transparent glass test-tube). The mixture was incubated in the incubator (37 ± 1.5 °C, 5 ± 0.5 % CO2) for 60 min. At the end of the exposure time, the mixture was shaken and the presence and intensity of the staining (if any) was evaluated. The test item did not dye water when mixed with it.
To test if an item directly reduces MTT, 50 μL of the test item were added to 1 ml of a MTT/DMEM solution (1 mg/mL) and were incubated in the incubator (37 ± 1.5 °C, 5 ± 0.5 CO2) for 60 minutes. Untreated MTT/DMEM solution (1 mg/mL) medium was used as control. The test item did not prove to be a MTT reducer.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Microplate reader: Versamax®, Molecular Devices, SoftMax Pro Enterprise (version 4.7.1)
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2 exposure times
EVALUATION
The mean OD of the duplicate negative control tissues was calculated after blank correction. This value corresponds to 100% tissue viability in the current test. For each individual tissue treated with the test item or the positive control the individual relative tissue viability is calculated according to the following formula:
Relative viability (%)= [mean OD(test item/positive control)/mean ODnegative control] *100
PREDICTION MODEL / DECISION CRITERIA: see Table 1
ACCEPTABILITY CRITERIA:
1. The mean OD of the tissue replicates treated with the negative control should be ≥ 0.8 and ≤ 2.8 for every exposure time
2. The mean viability of the tissue replicates treated with the positive control for 1 hour, should be <15% compared to the negative control
3. The Coefficient of Variation (CV) in the range 20 – 100% viability between tissue replicates should be ≤ 30% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 μL (79.4 μL/cm^2)
- Duration of treatment / exposure:
- 3 +/- 0.5 minutes and 60 +/- 0.5 minutes
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes exposure / mean of 2 replicates
- Value:
- 97.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100
- Positive controls validity:
- valid
- Remarks:
- 16.2
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes exposure / mean of 2 replicates
- Value:
- 105.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100
- Positive controls validity:
- valid
- Remarks:
- 10.7
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, the mean OD of the tissue replicates treated with the negative control is ≥ 0.8 and ≤ 2.8 for every exposure time (values between 1.627 and 1.755)
- Acceptance criteria met for positive control: yes, the mean viability of the tissue replicates treated with the positive control for 1 hour, is <15% (10.7%) compared to the negative control
- Acceptance criteria met for variability between replicate measurements: yes, the Coefficient of Variation (CV) in the range 20 – 100% viability between tissue replicates is ≤ 30% (values between 0.2% and 5.8%)
Any other information on results incl. tables
Mean OD570 values and viabilities for the negative control, positive control and test item are given below:
Item |
Exposure Period (minutes) |
Individual OD570 of Individual tissues |
Mean OD570 of duplicate tissues (tvt) |
Water-Killed Tissues |
True Viability |
Relative mean viability (%) |
||
tkt |
ukt |
tkt-ukt |
||||||
Negative Control Item |
60 |
1.634 |
0.818 |
|
|
|
|
100* |
1.639 |
||||||||
Positive Control Item |
0.219 |
0.027 |
|
|
|
|
10.7 |
|
0.186 |
||||||||
Test Item |
3 |
1.587 |
1.611 |
97.7 |
||||
1.635 |
||||||||
60 |
1.780 |
1.710 |
105.4 |
|||||
1.640 |
||||||||
*= The mean viability of the negative control tissues is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- other: Not corrosive to the skin
- Remarks:
- In accordance with EU CLP (EC No. 1272/2008 and its amendments).
- Conclusions:
- The results of an in vitro skin corrosion test showed that the substance was not corrosive to the skin (tissue viability after 3 minutes exposure: 97.7% and tissue viability after 60 minutes exposure: 105.4%).
- Executive summary:
The substance was tested in duplicate in an in vitro skin corrosion test according to OECD TG 431 test guideline and GLP principles. Tissues were exposed to the substance, a negative control (deionised water) and a positive control (8.0 N KOH) for 3 minutes and 60 minutes. The substance was tested for direct MTT reduction and colour interference and both results were negative. Acceptability criteria for the negative control, positive control and variability between measurements were met. The cell viability of the tissues exposed to the substance were 97.4% and 105.4% for 3 minutes and 60 minutes exposure, respectively. Both values did not exceed thereshold for corrosivity (50% after 3 minutes exposure and 15% after 60 minutes exposure), therefore the substance is considered not to be corrosive.
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