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EC number: 947-664-6 | 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2017 - February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date: 27 April 2017
Test material
- Reference substance name:
- (R*,R*)-α,4-dimethyl-α-(4-methyl-3-pentenyl)cyclohex-3-ene-1-methanol
- EC Number:
- 208-205-9
- EC Name:
- (R*,R*)-α,4-dimethyl-α-(4-methyl-3-pentenyl)cyclohex-3-ene-1-methanol
- Cas Number:
- 515-69-5
- Molecular formula:
- C15H26O
- IUPAC Name:
- 6-methyl-2-(4-methylcyclohex-3-en-1-yl)hept-5-en-2-ol
- Reference substance name:
- [3S-[3α,6α(R*)]-tetrahydro-2,2,6-trimethyl-6-(4-methyl-3-cyclohexen-1-yl)-2H-pyran-3-ol
- EC Number:
- 245-086-2
- EC Name:
- [3S-[3α,6α(R*)]-tetrahydro-2,2,6-trimethyl-6-(4-methyl-3-cyclohexen-1-yl)-2H-pyran-3-ol
- Cas Number:
- 22567-36-8
- Molecular formula:
- C15H26O2
- IUPAC Name:
- 2,2,6-trimethyl-6-(4-methylcyclohex-3-en-1-yl)tetrahydro-2H-pyran-3-ol
- Reference substance name:
- [2S-[2α,5β(R*)]]-tetrahydro-α,α,5-trimethyl-5-(4-methyl-3-cyclohexen-1-yl)furan-2-methanol
- EC Number:
- 247-509-6
- EC Name:
- [2S-[2α,5β(R*)]]-tetrahydro-α,α,5-trimethyl-5-(4-methyl-3-cyclohexen-1-yl)furan-2-methanol
- Cas Number:
- 26184-88-3
- Molecular formula:
- C15H26O2
- IUPAC Name:
- 2-[5-methyl-5-(4-methylcyclohex-3-en-1-yl)tetrahydrofuran-2-yl]propan-2-ol
- Reference substance name:
- 7,11-dimethyl-3-methylenedodeca-1,6,10-triene
- EC Number:
- 278-628-1
- EC Name:
- 7,11-dimethyl-3-methylenedodeca-1,6,10-triene
- Cas Number:
- 77129-48-7
- Molecular formula:
- C15H24
- IUPAC Name:
- 7,11-dimethyl-3-methylidenedodeca-1,6,10-triene
- Reference substance name:
- 7-ethyl-1,4-dimethylazulene
- EC Number:
- 208-449-6
- EC Name:
- 7-ethyl-1,4-dimethylazulene
- Cas Number:
- 529-05-5
- Molecular formula:
- C14H16
- IUPAC Name:
- 7-ethyl-1,4-dimethylazulene
- Reference substance name:
- [S-(R*,R*)]-dihydro-2,2,6-trimethyl-6-(4-methyl-3-cyclohexen-1-yl)-2H-pyran-3(4H)-one
- EC Number:
- 245-087-8
- EC Name:
- [S-(R*,R*)]-dihydro-2,2,6-trimethyl-6-(4-methyl-3-cyclohexen-1-yl)-2H-pyran-3(4H)-one
- Cas Number:
- 22567-38-0
- Molecular formula:
- C15H24O2
- IUPAC Name:
- 2,2,6-trimethyl-6-(4-methylcyclohex-3-en-1-yl)dihydro-2H-pyran-3(4H)-one
- Reference substance name:
- 2,6,10-trimethyldodeca-2,6,9,11-tetraene
- EC Number:
- 207-948-6
- EC Name:
- 2,6,10-trimethyldodeca-2,6,9,11-tetraene
- Cas Number:
- 502-61-4
- Molecular formula:
- C15H24
- IUPAC Name:
- (3E,6E)-3,7,11-trimethyldodeca-1,3,6,10-tetraene
- Reference substance name:
- (Z)-en-yn-dicycloether
- Cas Number:
- 4575-53-5
- Molecular formula:
- C13H14O2
- IUPAC Name:
- (Z)-en-yn-dicycloether
- Test material form:
- liquid
- Details on test material:
- Colour: deep blue
CAS No.: 8002-66-2
Storage: room temperature
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- the test material was used as supplied
In vitro test system
- Test system:
- human skin model
- Source species:
- other: reconstituted epidermis
- Cell type:
- other: reconstituted epidermis (epiCS®, CellSystems®)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: 0.60 cm2 reconstituted epidermis (epiCS®)
EXPOSURE
- The test item was applied, as supplied, at the dose of 50 µL to 2 living and 4 killed Human skin model surfaces during 3 minutes at room temperature and during 1 hour at 37°C ± 1°C, 5% ± 1% CO2.
Additionally, 2 living and 4 killed Human skin model surfaces (epiCS®, CellSystems®) were treated in the same manner during both 3 minutes and 1 hour, but they were incubated in MTT assay medium instead of MTT solution in order to generate non-specific living and killed colour controls.
- In the same experimental conditions, a positive control and a negative control were carried out.
REMOVAL OF TEST MATERIAL AND CONTROLS
- 3 minutes and 1 hour after the test item application, the human epidermis was washed 20 times with 20 mL of DPBS.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
The cell viability is quantified by measurement of the cellular mitochondrial dehydrogenases activity. These enzymes are responsible for the MTT [3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue; EINECS number 206-069-5, CAS number 298-93-1)] reduction into blue formazan in the viable cells. The skin sample is placed in MTT solution of appropriate concentration (e.g. 0.3 or 1 mg/mL) for 3 hours and 3 minutes between 36.4°C and 37.9°C. The precipitated blue formazan product is then extracted using a solvent (e.g. isopropanol), and the concentration of formazan is measured by determining the Optical Density (OD) at a wavelength between 540 and 600 nm (preferably 570 nm). The measured absorbances are proportional to the number of living cells.
The measurement of OD was performed using the ELx800 absorbance microplate reader supplied by BioTek and the validated software Gens ELISA V1.05.11 supplied by BioTek.
NUMBER OF REPLICATE TISSUES:
Duplicate skin tissues for test item, negative and positive controls
VIABILITY
Viability = (OD test item / OD negative control) x 100
As the test item is identified as producing both direct MTT reduction and colour interference:
True viability % = [(OD of living tissues exposed to test item - OD of killed tissues exposed to test item - OD of living tissues exposed to test item incubated with medium without MTT + OD of killed tissues exposed to test item incubated with medium without MTT) / OD of living tissues exposed to negative control] x 100
Results for test items producing non specific MTT reduction (%NSMTT) and/or non specific colour (%NSCliving) ≥ 50% of the negative control should be taken with caution.
For each tissue, OD values and calculated percentage cell viability data for the test item, positive and negative controls, should be reported in tabular form, including data from replicate repeat experiments as appropriate, mean and individual values. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Number of replicates:
- Duplicate skin tissues for test item, negative and positive controls
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean at 3 minutes
- Value:
- 128.16
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean at 1 hour
- Value:
- 100.07
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- VIABILITY
- 3 minutes and 1 hour after the test item application, the mean percent viability of the epidermis skins treated with the test item were 128.16% and 100.07%, respectively.
Any other information on results incl. tables
Table 7.3.1/1: Skin corrosion assay: Results at 3 minutes
|
Skin |
OD |
Mean OD / disc(#) |
Mean OD / product |
Viability % |
Meanviability % |
Viability difference between replicates % |
Negativecontrol |
1 |
0.524 0.591 0.618 |
0.578 |
0.570 |
101.40 |
100.00 |
2.8 |
2 |
0.608 0.558 0.521 |
0.562 |
98.60 |
||||
Positive control |
3 |
0.053 0.045 0.040 |
0.046 |
0.116 |
8.07 |
20.26 |
24.4 |
4 |
0.215 0.178 0.162 |
0.185 |
32.46 |
||||
Test item PH-17/0609 |
5 |
0.832 0.690 0.686 |
0.736 |
0.745 |
129.12 |
130.70 |
3.2 |
6 |
0.672 0.923 0.668 |
0.754 |
132.28 |
||||
Test item PH-17/0609NSMTT |
7 |
0.020 0.018 0.016 |
0.018 |
0.016 |
3.16 |
2.72 |
0.9 |
8 |
0.013 0.013 0.013 |
0.013 |
2.28 |
||||
Test item PH-17/0609 NSC livingcontrol |
11 |
0.004 0.004 0.004 |
0.004 |
0.004 |
0.70 |
0.70 |
0.0 |
12 |
0.005 0.004 0.003 |
0.004 |
0.70 |
||||
Test item PH-17/0609 NSC killedcontrol |
9 |
0.003 0.003 0.003 |
0.003 |
0.005 |
0.53 |
0.88 |
0.7 |
10 |
0.008 0.007 0.006 |
0.007 |
1.23 |
||||
Test item PH-17/0609 corrected |
|
128.16 |
|
Table 7.3.1/1: Skin corrosion assay: Results at 1 hour
|
Skin |
OD |
Mean OD / disc(#) |
Mean OD / product |
Viability % |
Mean viability % |
Viability difference between replicates % |
Negativecontrol |
1 (Plate 2) |
0.672 0.802 0.841 |
0.772 |
0.688 |
112.21 |
100.00 |
24.4 |
2 (Plate 2) |
0.603 0.622 0.587 |
0.604 |
87.79 |
||||
Positivecontrol |
3 (Plate 2) |
0.002 0.001 0.000 |
0.001 |
0.000 |
0.15 |
0.00 |
0.3 |
4 (Plate 2) |
-0.001 -0.001 -0.001 |
-0.001 |
-0.15 |
||||
Test itemPH-17/0609 |
5 (Plate 2) |
0.852 0.722 0.706 |
0.760 |
0.716 |
110.47 |
104.07 |
12.8 |
6 (Plate 2) |
0.720 0.648 0.647 |
0.672 |
97.67 |
||||
Test itemPH-17/0609NSMTT |
7 (Plate 2) |
0.012 0.009 0.009 |
0.010 |
0.020 |
1.45 |
2.83 |
2.8 |
8 (Plate 2) |
0.032 0.027 0.028 |
0.029 |
4.22 |
||||
Test itemPH-17/0609 NSC livingcontrol |
11 (Plate 2) |
0.009 0.008 0.008 |
0.009 |
0.010 |
1.31 |
1.38 |
0.1 |
12 (Plate 2) |
0.011 0.008 0.010 |
0.010 |
1.45 |
||||
Test itemPH-17/0609 NSC killedcontrol |
9 (Plate 2) |
0.000 0.000 0.000 |
0.000 |
0.002 |
0.00 |
0.22 |
0.4 |
10 (Plate 2) |
0.004 0.002 0.001 |
0.003 |
0.44 |
||||
Test itemPH-17/0609 corrected |
|
100.07 |
|
#: mean of 3 values
OD: optical density
Applicant's summary and conclusion
- Interpretation of results:
- other: test item does not have to be classified in Category 1 “Corrosive”
- Conclusions:
- Under the test conditions, in accordance with the Regulation (EC) No. 1272/2008, the results obtained enable to conclude that the test item does not have to be classified in Category 1 “Corrosive”. No hazard statement or signal word are required.
- Executive summary:
An in vitro skin corrosion study was performed according to OECD Guideline 431 and in compliance with GLP to evaluate the possible corrosive effects of the test item after topical administration on in vitro human reconstituted epidermis (epiCS®, CellSystems®).
The test item was applied as supplied, at the dose of 50 μL, to 2 living Human skin model surfaces (epiCS®, CellSystems®) during 3 minutes and 1 hour, followed by a rinse with 20 mL of DPBS. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues.
3 minutes and 1 hour after the test item application, the mean percent viability of the epidermis skins treated with the test item were 128.16% and 100.7% versus 20.26% and 0.00%, respectively, with the positive control item (potassium hydroxide 8N).
Under the test conditions, in accordance with the Regulation (EC) No. 1272/2008, the results obtained enable to conclude that the test item does not have to be classified in Category 1 “Corrosive”. No hazard statement or signal word are required.
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