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EC number: 246-788-1 | CAS number: 25279-09-8
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 February 2018 - 07 May 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
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,6-dimethyloct-7-en-2-yl formate
- EC Number:
- 246-788-1
- EC Name:
- 2,6-dimethyloct-7-en-2-yl formate
- Cas Number:
- 25279-09-8
- Molecular formula:
- C11H20O2
- IUPAC Name:
- 2,6-dimethyloct-7-en-2-ol
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- This study addresses the human health endpoint skin irritation. It makes use of reconstructed human epidermis (RhE) (obtained from human derived non-transformed epidermal keratinocytes) which closely mimics the histological, morphological, biochemical and physiological properties of the upper parts of the human skin, i.e., the epidermis. The use of reconstructed human epidermis (RhE) is also recommended by the OECD and other regulatory authorities. SkinEthicTM RHE model has been validated and is part of OECD validated reference methods (VRMs) and is also a recommended model for conducting in vitro skin irritation studies. The results of the study are believed to be of value in predicting the potential of inducing skin irritation by the test item in humans.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthicTM RHE model
- Tissue batch number(s): N°18-RHE-029
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: 37 ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: 25 times in a constant soft stream of 1 mL DPBS from 5-8 cm distance from the insert.
- Observable damage in the tissue due to washing: No.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 180 minutes
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
The test is considered to be irritant to skin, if the tissue viability after exposure and post-treatment incubation is less than or equal (≤) to 50%.
The test item is considered as non-irritant to skin, if the tissue viability after exposure and post-treatment incubation is more than (>) 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 16 ± 2 mg of test item/0.5 cm2
- Duration of treatment / exposure:
- 42 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:
- 1 (mean of 3 replicates)
- Value:
- 27.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No.
- Direct-MTT reduction: Test item did not produce direct MTT reduction when compared to concurrent negative control (Maintenance meduim).
- Colour interference with MTT: Difference in absorbance due to color interference was not observed between negative control (isopropanol) and dihydromyrcenyl formate. The test item did not form color in isopropanol, therefore results shows no interference in OD due to test item.
DEMONSTRATION OF TECHNICAL PROFICIENCY: JRF Study Number: 618-1-06-9641
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
The data met the acceptance criteria since the mean OD value of the 3 tissues was ≥ 1.2 at 570 ± 30 nm according to the historical database. The Standard Deviation value is considered as valid if it is ≤ 18%. The OD values (Corrected ODs) of negative controls in all tissues were between 1.221 to 1.273
- Acceptance criteria met for positive control:
The data met the acceptance criteria since the mean viability, expressed as % of the NC, was < 40 % and the Standard Deviation value is ≤ 18 %. Mean % viability of the positive control was 1.5%
- Acceptance criteria met for variability between replicate measurements:
Standard deviation of each intra-batch mean (3 Replicates/Tissue and 3 Tissue/Run) was < 18%.
- Range of historical values if different from the ones specified in the test guideline:
Optical Density at 570±30 nm
Exposure time: 42-minute exposure time
Negative Control (Dulbecco's phosphate-buffered saline):
Mean: 2.081
Standard deviation: 0.208
Minimum: 1.964
Maximum:2.776
Positive Control (Sodium dodecyl sulfate, 5% aqueous)
Mean: 0.028
Standard deviation: 0.007
Minimum: 0.021
Maximum: 0.053
Any other information on results incl. tables
Data summary of percent viability:
Treatment |
Tissue Replicate |
O.D. at 570 nm |
Blank Corrected O.D. |
Mean of Corrected O.D. |
Mean O.D. of Three Tissues |
% Viability/ Tissue |
Mean % Viability |
S.D. of % Viability |
C.V. of % Viability |
Corrosivity Class |
Negative Control (Dulbecco’s Phosphate Buffered Saline (DPBS)) |
1 |
1.274 |
1.231 |
1.238 |
1.238 |
100 |
100 |
0.01 |
0.81 |
NA |
1.282 |
1.239 |
|||||||||
1.287 |
1.244 |
|||||||||
2 |
1.280 |
1.237 |
1.231 |
|||||||
1.264 |
1.221 |
|||||||||
1.277 |
1.234 |
|||||||||
3 |
1.270 |
1.227 |
1.244 |
|||||||
1.276 |
1.233 |
|||||||||
1.316 |
1.273 |
|||||||||
Dihydromyrcenyl Formate |
1 |
0.361 |
0.319 |
0.336 |
0.342 |
27.1 |
27.6 |
0.61 |
2.21 |
Category 2 |
0.384 |
0.342 |
|||||||||
0.388 |
0.346 |
|||||||||
2 |
0.381 |
0.339 |
0.34 |
27.5 |
||||||
0.384 |
0.342 |
|||||||||
0.382 |
0.340 |
|||||||||
3 |
0.395 |
0.353 |
0.35 |
28.3 |
||||||
0.388 |
0.346 |
|||||||||
0.393 |
0.351 |
|||||||||
Positive control (Sodium dodecyl sulphate (5% aq.)) |
1 |
0.061 |
0.018 |
0.018 |
0.018 |
1.5 |
1.5 |
0 |
0.00 |
Category 2 |
0.061 |
0.018 |
|||||||||
0.060 |
0.017 |
|||||||||
2 |
0.062 |
0.019 |
0.019 |
1.5 |
||||||
0.062 |
0.019 |
|||||||||
0.061 |
0.018 |
|||||||||
3 |
0.061 |
0.018 |
0.018 |
1.5 |
||||||
0.061 |
0.018 |
|||||||||
0.061 |
0.018 |
Keys: O.D. = Optical Density, S.D. = Standard Deviation, C.V. = Coefficient of Variation, NA = Not Applicable
Note: For Negative control, SD and CV of % viability was calculated using corrected OD at 570 nm and for the test item and positive control SD and CV of % viability was calculated using % viability/tissue."
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The substance was determined to be irritating to the skin.
- Executive summary:
An in-vitro Skin Irritation test with Reconstructed Human Epidermis (RHE) Tissues was performed according to the OECD Guideline 439 (GLP study). Tissues were exposed to the negative control (Dulbecco’s Phosphate Buffered Saline (DPBS)), positive control (sodium dodecyl sulfate, 5% aqueous (SDS)) and test item in triplicate for 42 minutes at room temperature. The mean cell viability in tissues treated with the test item was 27.6% after 42 minutes exposure. A significant reduction in percent cell viability was observed in treated tissues when compared with the concurrent negative control. The Optical density (OD) values for the negative control replicates were between 1.221 to 1.273, against the guideline requirement of ≥ 0.8 and ≤ 3.0 (≥ 1.2 as per SkinEthic SOP). The OD of the blank was between 0.041 to 0.045 which met the guideline requirement of OD < 0.1. The positive control showed a 1.5% cell viability, against the acceptance criteria of <40% for the SkinEthic RHE model, compared to concurrent negative control. Variation between tissue replicates (i.e. CV% value) was 4.54% for the test item group, 0.00% for positive control and 0.81% for negative control against the guideline requirement of ≤ 18%, which demonstrate the efficiency of the test system, SkinEthicTM RHE model. All criteria for a valid study were met. Based on these results, the test item was determined to be irritating to the skin (category 2).
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