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Diss Factsheets
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EC number: 947-953-7 | 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:
- 2017-01-16 to 2017-01-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- Reaction mass of Reaction product of 1-chloro-3-{[1-chloro-3-(dodecyloxy)propan-2-yl]oxy}propan-2-ol with methyl diethanolamine and [3-(dodecyloxy)-2-hydroxypropyl]bis(2-hydroxyethyl)methylammonium chloride
- IUPAC Name:
- Reaction mass of Reaction product of 1-chloro-3-{[1-chloro-3-(dodecyloxy)propan-2-yl]oxy}propan-2-ol with methyl diethanolamine and [3-(dodecyloxy)-2-hydroxypropyl]bis(2-hydroxyethyl)methylammonium chloride
- Test material form:
- other: solid, very viscous yellow paste
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: human-derived epidermal keratinocytes
- Source strain:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- - Source: MatTek Corporation (82105 Bratislava, Slovakia).
- The EpiDerm™ tissue: normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
- Surface: 0.63 cm.
- Pre-incubation: 60 minutes in the incubator (37 ± 1 °C, 5 ± 0.5% CO2) in the upper wells. Then transferred from upper wells into the lower wells for about 19 hours (37 ± 1 °C, 5 ± 0.5% CO2). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- - per replicate: 25.2, 25.8 and 24.5 mg, respectively
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 23.5 h
- Number of replicates:
- 3
Test system
- Details on study design:
- Details of the test procedure used
- EpiDerm™ tissue of human-derived epidermal keratinocytes was used (EPI-212-SIT)
- Conditions of exposure: 37 ± 1 °C, 5 ± 0.5% CO2
- Washing: inserts gently rinsed with DPBS
- Number of tissue replicates used per test chemical and controls: 2
- MTT assay: incubation with 0.3 mL of MTT solution for 60 minutes at 37 ± 1 °C, 5 ± 0.5% CO2)
- Data evaluation: the following was calculated: The mean OD of the three negative control tissues was calculated after blank correction. The mean of the photometric absorbance of the negative control is set to 100%. For each individual tissue treated with the test item or the positive control the individual relative tissue viability is calculated according to the following formula: Relative viability(%) = (mean OD test item / positive control / mean OD negative control) x 100. For the test item and the positive control themean relative viability ± rel. standard deviation of the three individual tissues was calculated
- Description of evaluation criteria: For the current test, an irritation potential of the test item of H315, GHS Cat 2 according to UN GHS (published 2003, last (6th) revision 2015) is recommended if the mean relative tissue viability of three individual tissues is reduced ≤ 50% of the negative control.
- Historical data positive control: Mean Viability:5.1%; Rel. Standard Deviation: 3.4%; Range of Viabilities: 2.0 - 17.1%.
- Historical data negative control: Mean Absorption: 1.854%; Rel. Standard Deviation: 0.336%; Range of Absorbance: 0.476 - 2.471
- Acceptability of the Assay: the results are acceptable if (1) tissue viability is meeting the acceptance criterion, i.e. if the mean OD570 of the negative control tissues is ≥ 0.8 and ≤ 2.8 (negative control). If (2) the relative tissue viability of the positive control is ≤ 20% (positive control). If (3) the SD of 3
identical replicates is < 18%. OD values should not be below historically established boundaries.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Single test with three tissues
- Value:
- < 5.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- The acceptance criteria were met.
Any other information on results incl. tables
The mean absorbance values measured for the 3 tissues (mean - blank) is presented below:
Sample | Negative control |
Positive control | Test item |
Tissue 1 | 2.023 | 0.040 | 0.120 |
Tissue 2 | 2.044 | 0.033 | 0.111 |
Tissue 3 | 2.047 | 0.040 | 0.119 |
Mean of 3 tissues |
2.038 | 0.038 | 0.117 |
This resulted in following % viability:
Sample | Positive control | Test item |
Tissue 1 | 2.0% | 5.9% |
Tissue 2 | 1.6% | 5.4% |
Tissue 3 | 2.0% | 5.8% |
Mean of 3 tissues | 1.8% | 5.7% |
SD of mean viability | 0.2% | 0.2% |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test item is considered as irritant to skin in the Reconstructed Human Epidermis (RhE) Test Method.
- Executive summary:
In an in vitro study the skin irritation potential of the test item was assessed with the Reconstructed Human Epidermis (RhE) Test Method according to EU-Method B.46 resp. OECD 439 and GLP. In this study the test item was applied on top of a human reconstructed epidermis model. The cell viability was measured by dehydrogenase conversion of MTT [3-(4,5-dimethylthiazole-2-yl)-2,5-diphenyl-tetrazoliumbromide] into a blue formazan salt that was quantitatively measured (as optical density (OD)) after extraction from the tissues.
In the pre-tests, neither direct MTT reduction by the test item, nor a possible binding capacity of the test item could be observed. Therefore, no additional tests were necessary.
In the main test, three tissues of the human skin model EpiDermTM were treated with the test substance, the negative control (DPBS), or the positive control (5% SDS) for 60 minutes. The test item, the negative control, and the positive control were applied directly on top of each tissue and spread to match the tissue size (0.63 cm2).
After treatment with the negative control, the absorbance value (OD was 2.0) was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, thus showing the quality of the tissues. The positive control induced a decrease to 1.8% of the relative absorbance compared to the negative control, indicating clear irritating effects, and thus ensuring the validity of the test system. The variation within the tissue replicates was below the threshold of the OECD TG (<18%), thus ensuring the validity of the study.
After the treatment with the test item, the mean relative absorbance value was reduced to 5.7 % compared to the negative control. This value is below the threshold for skin irritancy of 50% and therefore the test item is considered to possess skin irritant potential.
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