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EC number: 266-795-3 | CAS number: 67633-94-7
- 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:
- 24-30 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- In accordance with GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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:
- 2015
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2009
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-benzyl-4,4,6-trimethyl-1,3-dioxane
- EC Number:
- 266-795-3
- EC Name:
- 2-benzyl-4,4,6-trimethyl-1,3-dioxane
- Cas Number:
- 67633-94-7
- Molecular formula:
- C14H20O2
- IUPAC Name:
- 2-benzyl-4,4,6-trimethyl-1,3-dioxane
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: human
- Cell type:
- other: epidermal keratinocytes
- Cell source:
- other: SkinEthic Laboratories, Lyon, France
- Source strain:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN TM
- Tissue batch number(s): 16-EKIN-021
- Delivery date: 24 May 2016
- Date of initiation of testing: 24 May 2016
PRE-TEST PROCEDURE
- Pre-incubation: On day of receipt the tissues were transferred into a 12-wells plate filled with maintenance medium. A different 12-wells plate was used for the test and each control item were. The tissue were incubated at 37°C, 5% CO2 in air overnight.
- Test item colour interference: To assess colour interference, 10 μL of Peomosa (mono-constituent) was added to 90 μL sterile water. The mixture was mixed for approximately 15 minutes. At the end of the shaking period a colour check was performed.
- Test item MTT reduction: To assess the ability of the test item to reduce MTT, 10 μL of the test item was added to 2 mL MTT solution (0.3 mg/mL in PBS). The mixture was incubated for 3 hours at 37°C, 5% CO2 in air. Untreateed MTT solution was used as a control. At the end of the incubation period a colour check was performed.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure/ post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Tissues were washed with phosphate buffered saline to remove residual test item.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/ml in PBS
- Incubation time: 3 hours at 37 °C
- Spectrophotometer: not specified
- Wavelength: 562 nm (without reference fildeter)
NUMBER OF REPLICATE TISSUES: 3
DECISION CRITERIA
- 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 incubat
ion 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.
ACCEPTANCE CRITERIA
- Positive Control: The assay establishes the acceptance criterion for an acceptable test if the relative mean tissue viability for the positive control treated tissues is ≤40% relative to the negative control treated
tissues, and the standard deviation (SD) value of the percentage viability is ≤18%.
- Negative Control: The assay establishes the acceptance criterion for an acceptable test if the mean OD562 for the negative control treated tissues is ≥0.6 and ≤1.5, and the SD value of the percentage viability is ≤18%.
- Test Item: The assay establishes the acceptance criterion for an acceptable test if the standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues is ≤18%. - 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
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 μL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 μL
- Concentration (if solution): 5% (w/v) - 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:
- % tissue viability
- Run / experiment:
- Relative mean tissue viability compared to the negative control tissues (100%)
- Value:
- 26.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 4.9
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct-MTT reduction: No colour changes observed
- Colour interference with MTT: Not colour changes observed
DEMONSTRATION OF TECHNICAL PROFICIENCY: No data
ACCEPTANCE OF RESULTS:
-The relative mean tissue viability for the positive control treated tissues was 4.9% relative to the negative control treated tissues and the standard deviation value of the viability was 0.9%. The positive control acceptance criteria were therefore satisfied.
-The mean OD562 for the negative control treated tissues was 1.293 and the standard deviation value of the viability was 3.5%. The negative control acceptance criteria were therefore satisfied.
-The standard deviation calculated from individual tissue viabilities of the three identically test item treated tissues was 1.0%. The test item acceptance criterion was therefore satisfied.
Any other information on results incl. tables
Mean OD562 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item | OD562 of tissues |
Mean OD562 of triplicate tissues |
± SD of OD562 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative Control Item | 1.265 / 1.345 /1.269 | 1.293 | 0.045 | 97.8 / 104.0 / 98.1 | 100∗ | 3.5 |
Positive Control Item | 0.076 / 0.058 / 0.055 | 0.063 | 0.011 | 5.9 / 4.5 /4.3 | 4.9 | 0.9 |
Test Item | 0.365 / 0.333 / 0.355 | 0.348 | 0.013 | 27.5 / 25.8 / 27.5 | 26.9 | 1.0 |
OD = Optical Density
SD = Standard deviation
∗ = The mean viability of the negative control tissues is set at 100%
⊕ = The control groups were shared with Envigo - Shardlow study number TW67BS, MS48XJ, FC59GT, LL32QY, RS46VL, JD61DM and NL15CD.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 (skin irritant)
- Remarks:
- based on CLP criteria (EC 1272/2008 and its amendments)
- Conclusions:
- Under the conditions of this test, the relative mean tissue viability for the test item determined to be 26.9%. This value is below the threshold for irritancy of ≤50%. Based on the results obtained, it can be concluded that Reseda body is an irritant to skin (Category 2 according to the CLP Regulation).
- Executive summary:
The possible skin irritation potential of Reseda body 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 10 μL undiluted test substance. After 42 hours 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 4.9% after 15 minutes exposure. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly. Under the conditions of this test, the relative mean tissue viability for the test item determined to be 26.9%. This value is below the threshold for irritancy of ≤50%.
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