Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 946-427-4 | 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:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[[1-(chloromethyl)-2-[[4-(oxiran-2-ylmethoxymethyl)cyclohexyl]methoxy]ethoxy]methyl]oxirane
- Molecular formula:
- C17H29ClO5
- IUPAC Name:
- 2-[[1-(chloromethyl)-2-[[4-(oxiran-2-ylmethoxymethyl)cyclohexyl]methoxy]ethoxy]methyl]oxirane
- Reference substance name:
- cis-1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane
- Cas Number:
- 1197197-64-0
- Molecular formula:
- C14H26O4
- IUPAC Name:
- cis-1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane
- Reference substance name:
- trans-1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane
- Cas Number:
- 158307-92-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- trans-1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane
- Reference substance name:
- [4-(oxiran-2-ylmethoxymethyl)cyclohexyl]methanol
- Molecular formula:
- C11H20O3
- IUPAC Name:
- [4-(oxiran-2-ylmethoxymethyl)cyclohexyl]methanol
- Reference substance name:
- [4-[[3-chloro-2-(oxiran-2-ylmethoxy)propoxy]methyl]cyclohexyl]methanol
- Molecular formula:
- C14H25ClO4
- IUPAC Name:
- [4-[[3-chloro-2-(oxiran-2-ylmethoxy)propoxy]methyl]cyclohexyl]methanol
- Reference substance name:
- 2-[[3-chloro-2-[[4-[[3-chloro-2-(oxiran-2-ylmethoxy)propoxy]methyl]cyclohexyl]methoxy]propoxy]methyl]oxirane
- Molecular formula:
- C20H34Cl2O6
- IUPAC Name:
- 2-[[3-chloro-2-[[4-[[3-chloro-2-(oxiran-2-ylmethoxy)propoxy]methyl]cyclohexyl]methoxy]propoxy]methyl]oxirane
Constituent 1
Constituent 2
Constituent 3
impurity 1
impurity 2
impurity 3
impurity 4
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company
- Expiration date of the lot/batch: 26 May 2022
- Purity test date:
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
OTHER SPECIFICS:
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Multiple adult donors.
- Details on animal used as source of test system:
- SOURCE ANIMAL
- Source: Adult human donors
- Sex: No data - Justification for test system used:
- Recommended by OECD Guideline 439.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SKIN DISC PREPARATION
- Procedure used:
- Quality control for skin discs: Electrical resistance obtained with two of the isolated skin discs was [complete, e.g. 10 kΩ]
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature
- Temperature of post-treatment incubation (if applicable): 37 C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: Not specified
- Observable damage in the tissue due to washing: Not specified
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: TECAN Infinite M200 Pro Plate Reader
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3 per test article or control
PREDICTION MODEL / DECISION CRITERIA
A test item 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 item and 42 hours of post incubation is ≤ 50% of the mean viability of the negativecontrols.
A test item 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 item and 42 hours of post incubation is > 50% of the mean viability of the negative controls.
The in vitro skin irritation test is considered acceptable if it meets the following criteria:
a) 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 less than or equal to 18.
b) The mean relative tissue viability of the positive control should be less than or equal to 40% relative to the negative control and the Standard Deviation value (SD) of the % viability should be less than or equal to 18.
c) The SD calculated from individual % tissue viabilities of the three identically treated replicates should be less than or equal to 18. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 uL
VEHICLE: None
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): Phosphate buffered saline
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 5% (aq) Sodium dodecyl sulfate (SDS, Sigma-Aldrich Chemie GmbH, Steinheim, Germany) [CAS Number 151-21-3] in PBS
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3 per test article or control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Assay 1
- Value:
- ca. 46
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: See 'Remarks'
- Remarks:
- The standard deviation value of the percentage viability was 44% and the results of the individual tissues were in 2 different categories (96%, 26% and 15%). To gain more information the assay was repeated.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Assay 2
- Value:
- ca. 73
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: See 'Remarks'
- Remarks:
- The standard deviation was 41% and the results of the individual tissues were in 2 different categories (31%, 113% and 75%)
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None
- Direct-MTT reduction: None
- Colour interference with MTT: None
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: No, the standard deviation was greater than 40% for both assays.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on the results of the study, test article is equivocal in the in vitro skin irritation test under the experimental conditions described. The test was concluded to be valid, however the test item is not suitable for the assay. In the absence of a conclusive finding for skin irritation, a Skin 2 classification is assigned.
- Executive summary:
The dermal irritation potential of the test article was evaluated in an in vitro reconstructed epidermal model. The study was conducted in compliance with OECD GLP (1997) according to OECD Test Guideline 439 (2015). The undiluted test article (25 uL) was applied to the tissues (n=3) and the tissues were incubated for 15 minutes at room temperature. Positive (5% Sodium dodecyl sulfate (SDS) in phosphate buffered saline (PBS)) and negative (PBS) controls were tested in parallel. Following exposure, the tissues were washed to removed the test article and controls and incubated for 42 hours at 37 C. Following the post-exposure incubation, tissue viability was determined using the MTT assay. Test article tissue viability was compared to negative control tissues. In the fist assay, the mean test article-treated tissue viability was 46%. The standard deviation value of the percentage viability was 44% and the results of the individual tissues were in 2 different categories (96%, 26% and 15%). To gain more information the assay was repeated. In the second assay, the mean test article-treated tissue viability was 73%. However, the standard deviation was 41% and the individual results were again divided over two categories (31%, 113% and 75%). Based on the results of the study, test article is equivocal in the in vitro skin irritation test under the experimental conditions described. The test was concluded to be valid, however the test item is not suitable for the assay. In the absence of a conclusive finding for skin irritation, a Skin 2 classification is assigned.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Kuigi ECHA veebilehe paljud osad on sinu keeles olemas, on see leht osaliselt inglise keeles. Lisateave ECHA mitmekeelsuse kohta.
Tere tulemast Euroopa Kemikaaliameti (ECHA) veebilehele! Internet Explorer 7 (ja varasemad versioonid) ei toeta täielikult seda veebilehte. Uuendage oma Internet Exploreri versiooni.
Sellel veebilehel kasutatakse küpsiseid, et tagada lehe parim kasutus.
Lisateave küpsiste kohta.