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EC number: 291-768-8 | CAS number: 90480-35-6
- 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:
- 01.12.2016-23.01.2017
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted July 28, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Mainzer Strasse 80, 65189 Wiesbaden, Germany
Test material
- Reference substance name:
- 2,6-Octadienal, 3,7-dimethyl-, acid-isomerized
- EC Number:
- 291-768-8
- EC Name:
- 2,6-Octadienal, 3,7-dimethyl-, acid-isomerized
- Cas Number:
- 90480-35-6
- IUPAC Name:
- 1-methyl-4-(propan-2-yl)benzene; ethanol
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: human-derived epidermal keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: human skin model EpiDerm™
- Tissue batch number: 23388
- Delivery date: 17 January 2017
- Date of initiation of testing: 17 January 2017 (preincubation phase)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1.5 °C, 5 ± 0.5% CO2
- Temperature of post-treatment incubation: 37 ± 1.5 °C, 5 ± 0.5 % CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: Rinsed with DPBS at least 15 times, after the rinsing the inserts were submerged in DPBS at least three times. Afterwards the inserts were once again rinsed with sterile DPBS from the inside and the outside.
- Observable damage in the tissue due to washing: No
- Modifications to validated SOP: No
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: (1 mg/mL)
- Incubation time: 3 hours
- Spectrophotometer: Versamax® Molecular Devices, Softmax Pro, version 4.7.1
- Wavelength: 570 nm
- Filter: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: Positive: 4.56%, range 2.76 - 6.77 %
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
the test item was considered to reduce MTT and an additional test with freeze-killed tissues was performed.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the mean tissue viability is ≤ 50 %.
- The test substance is considered to be non-irritant to skin if the mean tissue viability is > 50 %
Acceptability of the Assay
Criterion 1
Negative control: The absolute OD 570 nm of the negative control tissues in the MTT test is an indicator of tissue viability obtained after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is meeting the acceptance criterion if the mean OD570 of the negative control tissues is ≥ 0.8 and ≤ 2.8.
Criterion 2
Positive control: An assay is meeting the acceptance criterion if mean relative tissue viability of the positive control is ≤ 20%.
Criterion 3
Standard deviation: The SD of 3 identical replicates should be < 18%. OD values should not be below historically established boundaries. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- - Volume: 30 μL (47 μL/cm2 according to guideline) of undilted test item
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- approximately 43 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of three tissues
- Value:
- >= 37.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- The acceptance criteria were met.
Any other information on results incl. tables
Results after treatment with the test item and the controls
Dose Group |
Tissue No. |
Absorbance 570 nm Well 1 |
Absorbance 570 nm Well 2 |
Absorbance 570 nm Well 3 |
Mean Absorbance of 3 Wells |
Mean- Absorba nce of three wells blank corrected |
Mean Absorbance of 3 tissues after blank correction* |
Rel. Absorbance [%] Tissue 1, 2 + 3** |
Relative Standard Deviation [%] |
Mean Rel. Absorbance [% of Negative Control]** |
|
Blank
|
|
0.036 |
0.037 |
0.037 |
0.037 |
0.000 |
|
|
|
|
|
Negative Control |
1 |
1.757 |
1.682 |
1.699 |
1.713 |
1.676 |
1.533 |
109.3 |
8.1 |
100.0 |
|
2 |
1.540 |
1.486 |
1.463 |
1496 |
1.460 |
95.2 |
|||||
2 |
1.540 |
1.483 |
1.475 |
1.500 |
1.463 |
95.4 |
|||||
Positive Control |
1 |
0.077 |
0.075 |
0.076 |
0.076 |
0.039 |
0.042 |
2.6 |
8.2 |
2.7 |
|
2 |
0.078 |
0.077 |
0.076 |
0.077 |
0.040 |
2.6 |
|||||
2 |
0.082 |
0.082 |
0.083 |
0.082 |
0.046 |
3.0 |
|||||
Test Item |
1 |
0.729 |
0.703 |
0.691 |
0.707 |
0.671 |
0.574 |
43.8 |
15.9 |
37.4 |
|
2 |
0.617 |
0.595 |
0.584 |
0.598 |
0.562 |
36.6 |
|||||
2 |
0.541 |
0.524 |
0.515 |
0.526 |
0.490 |
31.9 |
* Mean of three replicate wells after blank correction
** relative absorbance per tissue [rounded values]:100× (absorbancetissue)/( mean absorbancenegative control)
*** relative absorbance per treatment group [rounded values]:100× (meanabsorbancetest item/positive control)/( mean absorbancenegative control)
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is irritant to skin according to EU CLP regulation.
- Executive summary:
This in vitro study was performed to assess the irritation potential of the test item by means of the Human Skin Model Test. The test was according to OECD 439 and GLP.
The test item passed the colour interference pre-test, but an additional test with freeze-killed tissues had to be performed due to the test item’s MTT-reducing property determined in the MTT interference pre-test.
30 μL of either the test item, the negative control (DPBS) or the positive control (5% SLS) were applied to triplicate tissue each. The test item and the positive and negative controls were washed off the skin tissues after 60 minutes treatment. After further incubation for approximately 43 hours the tissues were treated with the MTT solution for 3 hours following about 68 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.
After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for the 60 minutes treatment interval thus showing the quality of the tissues.
Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 2.7% thus ensuring the validity of the test system. The relative standard deviations between the % variability values of the test item, the positive and negative controls in the main test were below 16% (threshold of the "OECD Guideline for the Testing of Chemicals 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method”: < 18%), thus ensuring the validity of the study.
Compared to the relative absorbance value of the negative control the mean relative absorbance value was reduced to 37.4% after exposure of the skin tissues to the test item. Since this value is below the threshold for irritancy of ≤ 50%, a correction procedure using the correction factor determined in the additional test with freeze-killed tissues was not necessary.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is irritant to skin.
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