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EC number: 815-500-1 | CAS number: 1853175-99-1
- 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 July - 14 August 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study performed according to OECD Guideline 439.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- 26 July 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 24 August 2009
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 08 April 2015.
Test material
- Reference substance name:
- 2-(3,3-dimethylcyclohex-1-en-1-yl)-2,5,5-trimethyl-1,3-dioxane
- EC Number:
- 815-500-1
- Cas Number:
- 1853175-99-1
- Molecular formula:
- C15 H26 O2
- IUPAC Name:
- 2-(3,3-dimethylcyclohex-1-en-1-yl)-2,5,5-trimethyl-1,3-dioxane
- Test material form:
- liquid
- Details on test material:
- - Physical state: Liquid
- Storage condition of test material: room temperature, darkness.
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- Epi-200 Kit
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: reconstructed epidermis
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE:
Supplier: MatTek In Vitro Life Science Laboratories, Bratislava.
Date received: 14 August 2015
EpiSkinTM Tissues (0.38cm2) lot number: 21685
Maintenance Medium lot number: 1660120
Assay Medium lot number: 080615ZSD
EVALUATION OF DIRECT INTERACTION WITH MTT
- For correct interpretation of results it was necessary to assess the ability of the test item to directly reduce MTT. The direct interaction of MTT with the test item was checked by adding 30 µL of the test item to 1mL of the solution of MTT. No colour change could be observed in the present study. Therefore, there is no direct interaction between the test item and MTT
TREATMENT
- After approximately 18 hours incubation of the tissues, they were treated with the test item.
- 1 plate (3 tissues) was used as negative control; each tissue was treated with 30 μL DPBS buffer, a nylon mesh was added in order to ensure sufficient contact with the tissue sur-face.
- 1 plate was used as positive control; each tissue was treated with 30 μL SDS-solution, a nylon mesh was added in order to ensure sufficient contact with the tissue surface.
- 1 plate was used for treatment with the test item: 30 μL test item were applied, and a nylon mesh was added in order to ensure sufficient contact with the tissue surface.
Tissues were dosed in 1-min-intervals. After dosing the last tissue, all plates are trans-ferred into the incubator for 35 min at 37 ± 1°C and 5.0 ± 0.5% CO2. 60 min after the first application, the inserts were removed from the plates using sterile forceps and rinsed im-mediately in 1-min-intervals. After rinsing, each tissue was dried with a sterile cotton tip and then transferred into a new 6-well-plate with fresh assay medium (0.9 mL). Then, the tissues were set in the incubator for 24 h.
REMOVAL OF TEST MATERIAL AND CONTROLS
- For 3 incubated tissues, a new 6-well-plate with 0.9 mL assay medium in the upper row was prepared. The tissues were removed from the incubator and shaken for 10 min (500 rpm). Then the inserts were transferred into the new 6-well-plate and set into the in-cubator for 18 h for post-incubation.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- After a total incubation time of 42 h, a 24-well-plate was prepared with 300 μL freshly pre-pared MTT-reagent in each well. The tissues were blotted on the bottom and then trans-ferred into the 24-well-plate. Then the 24-well-plate was set into the incubator for 3 h at 37 ± 1°C and 5.0 ± 0.5% CO2.
- After 2 h, the inserts in which formazan had been produced were pierced with an injection needle, taking care that all colour was extracted. The inserts were then discarded and the content of each well was thoroughly mixed in order to achieve homogenisation.
- From each well, two replicates with 200 μL solution (each) were pipetted into a 96-well-plate which was read in a plate spectral photometer at 570 nm.
VIABILITY CALCULATION:
- Data from individual replicate tissues (OD values and calculated percent tissue viability data for the test item and controls), mean percent tissue viability and standard deviation for each individual test item and control were reported in Table 7.3.1/1. The results were expressed as a viability percentage compared with the negative control: viability % = (mean OD test item / mean OD negative control) * 100
ACCEPTABILITY OF THE ASSAY
- The absolute OD 570 nm of the negative control tissues in the MTT test is an indicator of tissue viability obtained after the shipping procedure and under specific conditions of the assay. Tissue viability is meeting the acceptance criterion if the mean OD of the two tissues is ≥ 0.8 and <=2.8.
The % Formazan production of positive control SDS is <=20% of negative control and the variation within replicates (RSD) 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): 30 µL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 60 minutes at 37 +/-1°C.
- Duration of post-treatment incubation (if applicable):
- 18 hours post-incubation period at 37°+/-1°C, 5 +/-0.5% CO2
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean
- Run / experiment:
- mean value
- Value:
- 100.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- MTT VIABILITY ASSAY RESULTS
- The test item is considered as not skin irritant.
- After the treatment, the relative absorbance values were increased to 100.9%. This value is well above the threshold for skin irritation (50%).The optical density of the negative control was well within the required acceptability criteri-on of 0.8 ≤ mean OD ≤ 2.8, OD was 1.8. The positive control induced a decrease in the relative absorbance as compared to the negative control to 3.3 % (required: ≤ 20%) for thus ensuring the validity of the test system. Variation within replicates was within the ac-cepted range for negative control, positive control and test item.
Any other information on results incl. tables
Table 7.3.1/&: Absorbance Values negative control, test item and positive control (OD at 570 nm):
Designation | Measurement | Negative Con-trol | Test susbtance | Positive Control |
Tissue 1 | 1 | 1.925 | 1.718 | 0.101 |
2 | 1.922 | 1.727 | 0.102 | |
Tissue 2 | 1 | 1.830 | 1.900 | 0.098 |
2 | 1.857 | 1.924 | 0.097 | |
Tissue 3 | 1 | 1.804 | 1.977 | 0.087 |
2 | 1.800 | 1.989 | 0.088 |
Table 7.3.1/2 Mean Absorbance Values
Designation | Negative Control | Test susbtance | Positive Control |
Mean – blank (tissue 1) | 1.888 | 1.687 | 0.066 |
Mean – blank (tissue 2) | 1.808 | 1.876 | 0.062 |
Mean – blank (tissue 3) | 1.766 | 1.947 | 0.052 |
Mean of the three tissues | 1.821 | 1.837 | 0.060 |
Relative standard deviation of the three tissues | 3.4% | 7.3% | 12.0% |
Table 7.3.1/3 % Formazan Production
Designation | Test susbtance | Positive Control |
% Formazan production (tissue 1) | 92.6% | 3.6% |
% Formazan production (tissue 2) | 103.0% | 3.4% |
% Formazan production (tissue 3) | 106.9% | 2.9% |
% Formazan production (mean) | 100.9% | 3.3% |
Table 7.3.1/4 Validity criteria and results
Criterion | Demanded | Found |
OD of negative control | ≥ 0.8 and ≤ 2.8 | 1.8 |
% Formazan production of positive control SDS | ≤ 20% of negative control | 3.3% |
Variation within replicates (RSD) | < 18% | 3.4% (negative control) 12.0% (positive control) 7.3% (test item) |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test material is not classified according to Regulation (EC) No. 1272/2008 (CLP).
- Executive summary:
An in vitro skin irritation test using the Reconstructed Human Epidermis (Episkin Standard model) was performed according to the OECD Guideline 439 and in compliance with GLP to predict the acute skin irritation potential of the test item.
The test item was applied at the dose of 30 µL, to 3 tissues of the Human skin model EpiDerm during 60 minutes, followed by a rinse with 25 mL of PBS and a 18 hours post-incubation period at 37+/-1°C, 5 +/-0.5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues.
The mean corrected percent viability of the treated tissues was 100.9%, versus 3.3% in the positive control (5% Sodium Dodecyl Sulfate).
Under the test conditions and in accordance with Regulation EC No. 1272/2008, the test item was considered as non-irritant to skin.
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