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EC number: 915-650-9 | 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:
- 07 August 2017 - 14 August 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:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 20 July 2012
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde
- EC Number:
- 253-617-4
- EC Name:
- 4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde
- Cas Number:
- 37677-14-8
- Molecular formula:
- C13H20O
- IUPAC Name:
- 4-(4-methylpent-3-en-1-yl)cyclohex-3-ene-1-carbaldehyde
- Reference substance name:
- 3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde
- EC Number:
- 257-943-8
- EC Name:
- 3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde
- Cas Number:
- 52475-89-5
- Molecular formula:
- C13H20O
- IUPAC Name:
- 3-(4-methylpent-3-en-1-yl)cyclohex-3-ene-1-carbaldehyde
- Test material form:
- liquid
- Details on test material:
- Batch No. 0007470718
Purity: 99.3% (sum of the two main constituents)
Name of the test item (as cited in the study report): MYRAC ALD BHT
Physical state: colourless-slightly yellow liquid
Storage Conditions: room temperature
Expiry Date: 23 December 2017
Constituent 1
Constituent 2
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: epidermal keratinocytes
- Cell source:
- other: SkinEthic Laboratories, Lyon, France.
- Source strain:
- other: Not applicable
- Justification for test system used:
- In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimize the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN Small ModelTM, 0.38 cm^2
- Tissue batch number(s): 17-EKIN-032
- Pre-incubation: On the day of receipt the tissues were transferred to 12-well plates and preincubated with prewarmed Maintenance Medium for approximately 22 hours at 37°C. Maintenance medium and Assay medium were supplied by Skinethic Laboratories, Lyon, France.
- Before the start of the test, the substance was checked for possible colour interference and possible direct MTT reduction.
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 36.6-37.5 °C
- Humidity: 74-90%, containing 5.0 ± 0.5% CO2 in air
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 1 with phosphate buffered saline
- Observable damage in the tissue due to washing: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL in PBS
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
CELL VIABILITY MEASUREMENT:
After incubation in MTT, epidermis was separated from the collagen matrix and both parts were placed in prelabeled microtubes and extracted with 500 μL isopropanol (Merck, Darmstadt, Germany). Tubes were stored refrigerated and protected from light for 69.5 hours. The amount of extracted formazan was determined spectrophotometrically. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. Skin irritation potential of the test item was classified according to remaining cell viability following exposure of the test item.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: one experiment with two OD measurements for each replicate.
DECISION CRITERIA (see table 1 in 'any other information on materials and methods')
- A test substance is considered irritant in the skin irritation test if: The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test substance and 42 hours of post incubation is ≤ 50% of the mean viability of the negative controls.
- A test substance is considered non-irritant in the in vitro skin irritation test if: The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test substance and 42 hours of post incubation is > 50% of the mean viability of the negative controls.
ACCEPTABILITY CRITERIA:
- The absolute mean OD570 (optical density at 570 nm) of the three tissues of the negative control should reasonably be within the laboratory historical control data range and the Standard Deviation value (SD) of the % viability should be ≤18.
- The mean relative tissue viability of the positive control should be ≤ 50% relative to the negative control and the Standard Deviation value (SD) of the % viability should be ≤18.
- The SD calculated from individual % tissue viabilities of the three identically treated replicates should be ≤18. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Test material: 25 μL
Positive control: 25 μL, re-spread after 7 minutes contact time
Negative control: 25 μL - Duration of treatment / exposure:
- 15 minutes ± 0.5
- Duration of post-treatment incubation (if applicable):
- 42 hours and 3 hours with MTT
- Number of replicates:
- 3 tissues for the treatment group, the positive control group and the negative control group each.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of 3 replicates
- Value:
- 13
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Mean tissue viability: 4.8%
- Remarks on result:
- other: SD: 1.0%
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: the results of the positive control (mean tissue viability of 4.8% with a standard deviation of 2.3%) showed that the test system functioned properly.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, the absolute mean OD570 of the three tissues of the negative control were within the laboratory historical control data range and the Standard Deviation value (SD) of the % viability was 1.3.
- Acceptance criteria met for positive control: yes, the mean relative tissue viability of the positive control was 4.8% relative to the
negative control and the Standard Deviation value (SD) of the % viability was 2.3.
- Acceptance criteria met for variability between replicate measurements: yes, the SD calculated from individual % tissue viabilities of the three identically treated replicates was <3%
Any other information on results incl. tables
Mean OD570 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item:
Item |
OD570 of tissues |
Mean OD570 of triplicate tissues |
± SD of OD570 |
Relative mean viability (%) |
Negative Control Item |
1.222 |
1.234 |
0.016 |
100 |
1.227 |
||||
1.252 |
||||
Positive Control Item |
0.032 |
0.059 |
0.028 |
4.8 |
0.087 |
||||
0.059 |
||||
Test Item |
0.162 |
0.156 |
0.013 |
13 |
0.165 |
||||
0.142 |
SD = Standard deviation
*The mean viability of the negative control tissues is set at 100 %
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin irritant.
- Remarks:
- according to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the substance compared to the negative control tissues was 13%. Since the mean relative tissue viability for the test substance was below 50% it is considered to be irritant.
- Executive summary:
The possible skin irritation potential of the substance was tested in vitro using a human skin model through topical application for 15 minutes. The study procedures described in this report were according to OECD TG 439 guideline and GLP principles. Skin tissue was treated by topical application of 25 μL undiluted test substance. After a 42-hour incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) MTT at the end of treatment.
Skin irritation is expressed as the remaining cell viability after exposure to the test substance. Reliable negative and positive controls were included. The positive control had a mean cell viability of 4.8% after 15 minutes exposure. The standard deviation value of the percentage viability of three tissues treated identically was less than 3%, indicating that the test system functioned properly. The relative mean tissue viability obtained after 15 minutes treatment with the substance compared to the negative control tissue was 13%. Since the mean relative tissue viability for the substance was below 50% after 15 minutes treatment the substance is considered to be irritant.
Therefore, the substance has to be classified as a skin irritant according to CLP regulation (EC) n° 1272/2008.
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