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EC number: 943-519-6 | CAS number: 2149603-92-7
- 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:
- Start of experimental phase: 29 June 2015 and End of experimental phase: 31 August 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2'-{octahydro-1H-4,7-methanoindene-2,5-diylbis[(2,1-phenylene)oxymethylene]}bis(oxirane)
- EC Number:
- 943-519-6
- Cas Number:
- 2149603-92-7
- Molecular formula:
- C28H32O4
- IUPAC Name:
- 2,2'-{octahydro-1H-4,7-methanoindene-2,5-diylbis[(2,1-phenylene)oxymethylene]}bis(oxirane)
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- other: Commercial reconstructed human epidermis (RhE) model named EPISKIN™.
- Strain:
- other: Not applicable
- Details on test animals or test system and environmental conditions:
- - Supplier: SkinEthic Laboratories (4, A. Fleming – 69007 Lyon – France).
- Batch number: 15-EKIN-034 (alive tissue)
- Arrived at RTC: on 25 August 2015
Functional controls:
- Quality controls: histology scoring, magnitude of viability and barrier function (IC50 determination).
- Biological safety: absence of HIV1 and 2, Hepatitis B and C antigens, absence of bacteria, fungi and mycoplasma.
Test system
- Type of coverage:
- other: Not applicable
- Preparation of test site:
- other: Not applicable
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The epidermis surfaces were moistened with 10 microL. sterile water before application of the test item.
- Controls:
- other: Positive control (SDS: Sodium Dodecyl Sulphate) diluted at the final concentration of 5% (v/v) in sterile water for injection and negative control is D-PBS.
- Amount / concentration applied:
- 20 mg/epidermis unit, each measuring 0.38 cm2 (treatment level: 53 mg/cm2)
- Duration of treatment / exposure:
- - An exposure time of 15 +/- 0.5 minutes was allowed in a ventilated cabinet at room temperature for the test item.
- Negative and postive control treatments were carried out staggering samples of approximately 1 minute +/- 0.5 minute, while test item treatments were performed staggering samples of approximately 2 minutes +/- 0.5 minute. - Observation period:
- - A 42 1 hour recovery period was allowed by incubation at 37°C, 5% CO2 and saturated humidity.
- Number of animals:
- Not applicable
- Details on study design:
- TEST SITE
- % coverage:20 mg/epidermis unit, each measuring 0.38 cm2
- Replicate: 3 replicates for positive,3 for negative control and 3 for the test item.
REMOVAL OF TEST SUBSTANCE
At the end of the exposure, tissue samples were rinsed with approximately 25 mL of sterile D-PBS filling and empting the tissue insert; only one treated sample was rinsed twice and the test item was mechanically removed by using sterile tweezers.
The excess liquid was carefully removed and the samples transferred into new wells pre-filled with 2 mL/well of maintenance medium.
SCORING SYSTEM:
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: Mean cell viability
- Value:
- 93.5
- Remarks on result:
- other:
- Remarks:
- Time point: 15 minutes exposure and 42 hours recovery period. Max. score: 100.0. Remarks: Mean cell viability in %. Acceptable intra-replicate variability was obtained (SD of % viability = 15.4% lower than 18.). (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The potential of the test item to be irritant to the skin was investigated through an in vitro skin irritation study, using a commercial reconstructed
human epidermis (RhE) model named EPISKIN™. The negative and positive controls gave the expected results and the study was accepted as valid.
The mean cell viability of the test item treated tissues was 93.5%. Based on the results obtained, the test item is classified as not irritant to the skin. - Executive summary:
The potential of the test item to be irritant to the skin was investigated through an in vitro skin irritation study using a commercial reconstructed human epidermis (RhE) model named EPISKIN™. The experimental procedures are based on the OECD Guideline for testing of chemicals no. 439. The test item, as well as controls, were tested for their ability to impair cell viability after an exposure period of 15 minutes followed by a 42 +/- 1 hour recovery period. The final endpoint of the assay is the colorimetric measurement of MTT reduction (blue formazan salt) in the test system being this reaction an index of cell viability. The test item was tested as supplied
by the Sponsor.
Before the Main Assay, a preliminary test was carried out to evaluate the compatibility of the test item with the test system. In a first step, the test item was assayed for the ability of reducing MTT per se; a colourless suspension, with yellow precipitate, was observed at the end of the incubation period, indicating that the test item could not interact with MTT. In a second step, the test item was assayed for the ability of colouring water per se; a colourless suspension, without precipitate but with the presence of two different phases, was observed, which indicates that the test item does not have a colouring ability. Based on these results, no additional controls were
added in the Main Assay.
In the Main Assay, the test item was applied as supplied in three replicates at the treatment level of 20 mg/epidermis unit, each measuring 0.38 cm2 (treatment level: 53 mg/cm2). Positive and negative controls [a 5% (v/v) sodium dodecyl sulphate solution in water and Dulbecco’s phosphate buffered saline (D-PBS), respectively] were concurrently tested, in the same number of replicates and test conditions at the treatment level of 20 μL/epidermis unit.
The negative control gave the expected baseline value (Optical Density values of the three replicates higher than 0.6) and variability [Standard Deviation (SD) of % viability lower or equal to 18], in agreement with the guideline indications. According to the method, the mean value is considered the baseline value of the experiment and thus represents 100% of cell viability. The positive control caused the expected cell death (6.2% of cell viability when compared to the negative control) and variability (SD of % viability
equal to 4.3). Based on the stated criteria (mean viability <= 40% and SD of % viability <=1 8), the assay was regarded as valid.
Only the OD-blank background subtraction was performed for the evaluation of irritant properties of the test item. The test item did not induce cell death in any replicate with a mean cell viability of 93.5%, when compared to the negative control.
Based on the results obtained, the test item is classified as not irritant to the skin.
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