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Diss Factsheets
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EC number: 944-336-4 | 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:
- 04 - 06 Feb 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:
- 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:
- adopted 26 Jul 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- adopted 06 Jul 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Gyógyszerészeti és Egészségügyi Minőség- és Szervezetfejlesztési Intézet (National Institute for Quality- and Organizational Development in Healthcare and Medicines), Budapest, Hungary
Test material
- Reference substance name:
- Reaction product of 2,2'-oxydiethanol and 2-hydroxyethyl acrylate and 2-hydroxyethyl methacrylate and hexan-6-olide and trimethylhexa-1,6-diyl diisocyanate
- EC Number:
- 944-336-4
- Molecular formula:
- C21H34N2O8, C22H36N2O8, C23H38N2O8 as well as polymer content
- IUPAC Name:
- Reaction product of 2,2'-oxydiethanol and 2-hydroxyethyl acrylate and 2-hydroxyethyl methacrylate and hexan-6-olide and trimethylhexa-1,6-diyl diisocyanate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Episkin (EPISKIN SNC, Lyon, France)
- Tissue batch number: 15-EKIN-005
- Expiry date: 9 Feb 2015
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
- Temperature of post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The test substance was washed from the skin surface with phosphate buffered saline (PBS).
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 h ± 5 min
- Spectrophotometer: 96-well plate spectrometer
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the final product was assessed by undertaking an MTT cell viability test and a cytotoxicity test with sodium dodecyl sulphate.
- Morphology: Histological examination was performed to demonstrate a human epidermis-like structure. A well-differentiated epidermis consisting of a basal layer, several spinous and granular layers and a thick stratum corneum was observed.
- Contamination: All biological components of the epidermis and the kit culture medium have been tested for the presence of viruses, bacteria and mycoplasma.
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: A single experiment was conducted.
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the viability after 15 min exposure and 42 h post-incubation is less than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 10 µL
NEGATIVE CONTROL
- Amount applied: 10 µL
POSITIVE CONTROL
- Amount applied: 10 µL - Duration of treatment / exposure:
- 15 ± 0.5 min at room temperature
- Duration of post-treatment incubation (if applicable):
- 42 ± 1 h
- Number of replicates:
- in triplicates for each treatment and control group
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 3 tissues
- Run / experiment:
- 15 minutes exposure
- Value:
- 79
- 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:
- The test item showed slightly reduced cell viability in comparison to the negative control (mean value: 79%). However, all obtained test item viability results were above 50% when compared to the viability values obtained from the negative control. Therefore, the test item was considered to be non-irritant to skin.
Positive and negative controls showed the expected cell viability values within acceptable limits.
Any other information on results incl. tables
Table 3. MTT assay after 15 min exposure.
|
Negative control |
Positive control |
Test substance |
||||||
Tissue sample |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
OD570 |
0.854 |
0.862 |
0.835 |
0.212 |
0.110 |
0.192 |
0.639 |
0.622 |
0.759 |
OD570 (mean values of replicates) |
0.85 |
0.171 |
0.673 |
||||||
Viability (%) |
100 |
20 |
79 |
Possible direct MTT reduction with test substance:
No colour change was observed after 3 h of incubation. The test substance did not interact with the MTT, therefore additional controls and data calculations were not necessary. A false estimation of viability can be excluded.
Colouring potential of test substance:
The test substance showed no ability to become coloured in contact with water. The intrinsic colour of the test substance is light yellow and therefore considered to be not able to significantly stain the tissues and lead to a false estimate of the viability. Additional controls and data calculations were not necessary. A false estimation of the viability can be excluded.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- Based on the experimental findings and under the conditions of the test, the test substance has no skin irritating properties.
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