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Diss Factsheets
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EC number: 944-067-2 | 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:
- November 23, 2016 - January 13, 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- July 28, 2015
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 2,4-dimethyl-3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-ol and 3,4-dimethyl-3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-ol
- EC Number:
- 944-067-2
- Molecular formula:
- C12H18O
- IUPAC Name:
- Reaction mass of 2,4-dimethyl-3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-ol and 3,4-dimethyl-3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-ol
- Test material form:
- liquid
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Normal Human-Derived Epidermal Keratinocytes
- Cell source:
- other: SkinEthic Laboratories (69007 Lyon, France)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkin
- Tissue batch number(s): 17-EKIN-002
- Delivery date: January 10, 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: not specified
- Temperature of post-treatment incubation: 37 ± 1.5 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: rinsed with PBS until all test material was removed
- Observable damage in the tissue due to washing: not specified
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3h
- Spectrophotometer: Versamax® Molecular Devices, 85737 Ismaning, Germany, version 4.7.1
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: Historical neg control OD= 0.61-1.52, Current negative control OD = 1.053
NUMBER OF REPLICATE TISSUES: 3
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 viability after 15 minutes exposure is less than or equal to 50%
- The test substance is considered to be non-irritant to skin if the viability after 15 minutes exposure is greater than 50% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL
- Concentration (if solution): undiluted
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL
- Concentration (if solution): undiluted
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL
- Concentration (if solution): 5% SLS solution in deionised water - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: Mean relative tissue viability (%)
- Value:
- 6
- 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:
- - OTHER EFFECTS:
- Visible damage on test system: not specified
- Direct-MTT reduction: none
- Colour interference: none
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, after treatment with the negative control the mean absorbance value of the triplicate tissues was 1.053 which was well within the required acceptability criterion of mean OD >= 0.6 till ≤ 1.5 thus showing the quality of the tissues.
- Acceptance criteria met for positive control: yes, treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 8.1% (<40%) thus ensuring the validity of the test system.
- Acceptance criteria met for variability between replicate measurements: yes, the rel. standard deviations between tissues of the same treatment group were below 16% (<18%), thus ensuring the validity of the study.
- Range of historical values if different from the ones specified in the test guideline:
Data of 232 studies performed from October 2007 until May 2014
Positive Control
Mean Viability: 19.30%
Rel. Standard Deviation: 10.00%
Range of Viabilities: 1.70% - 35.40%
Negative Control
Mean OD: 1.01
Rel. Standard Deviation: 0.22
Range of ODs: 0.61 – 1.52
Data of 12 studies performed from July 2015 to January 2017
Positive Control
Mean Viability: 15.83%
Rel. Standard Deviation: 11.88%
Range of Viabilities: 4.25% - 32.7%
Negative Control
Mean OD: 0.80
Rel. Standard Deviation: 0.22
Range of ODs: 0.61 – 1.09
Any other information on results incl. tables
The test for colour interference and direct MTT reduction was found to be negative, as 1) the colour of the test item/water mixture did not change during the incubation period compared with the colour of the pure test item and 2) the colour of a test solution containing test substance and MTT did not turn blue/purple after incubation.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Irritant Category 2
- Remarks:
- based on EU CLP (EC 1272/2008 and its updates)
- Conclusions:
- Under the conditions of this test, the relative mean tissue viability for the test item was determined to be 6%. This value is below the threshold for irritancy of ≤50%. Therefore, the test substance is considered to be a skin irritant.
- Executive summary:
This in vitro skin irritation study to assess the irritation potential of Dimeth Cyclormol by means of the Human Skin Model Test, was performed in line with OECD439 and GLP principles. The test item did not directly reduce MTT, and did not cause colour interference. Triplicate tissues of the human skin model EpiSkin™ were treated with the test item, the negative or the positive control for 15 minutes. After washing, and further incubation for approximately 42 hours, tissue viability was determined by measuring MTT reduction. The viability and OD values of respectively the positive and negative control tissues were considered valid. After treatment with the test item the mean relative viability decreased to 6.0%. The value is below the threshold for irritancy of ≤ 50%. Therefore, the test item is considered a skin irritant.
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