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EC number: 263-179-6 | CAS number: 61791-46-6
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 05 April - 23 May, 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29 July 201
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides
- EC Number:
- 263-179-6
- EC Name:
- Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides
- Cas Number:
- 61791-46-6
- Molecular formula:
- n.a
- IUPAC Name:
- Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides
- Test material form:
- semi-solid (amorphous): gel
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The Reconstructed Human Epidermal Model EpiDerm™ (EPI-200-SCT) was selected as test system to assess the skin corrosion potential of the test item as it represents a recommended in vitro test system according to OECD Guideline No. 431.
- Vehicle:
- water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Reconstructed Human Epidermal Model - EpiDerm™ (EPI-200-SCT)
- Tissue lot number: 25892
- Date of initiation of testing: 05-04-2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during exposure:
3 min: Room temersture
1 h: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After completion of 1 hour period of test item exposure, the tissues were rinsed with sterile PBS (fill and empty insert 20 times in a constant soft stream of PBS) to remove any residual test item/NC/PC.
- Observable damage in the tissue due to washing: No
- Modifications to validated SOP: No
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: 96-well plate reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
see: " Any other information on materials and methods"
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
A test item is considered to be “corrosive” to skin in accordance with UN GHS Category 1, if;
Step 1
The tissue viability after 3 minutes exposure is < 50%.
The tissue viability after 3 minutes exposure is ≥ 50% and < 15% after 1 hour exposure.
The test item is considered as non-corrosive to skin in accordance with UN GHS No Category, if the tissue viability after 3 minutes exposure is ≥ 50% and ≥1 5% after 1 hour incubation exposure.
Step 2
A test item identified as being corrosive in step 1 is further subcategorised in accordance with UN GHS based on the following:
The tissue viability after 3 minutes exposure is < 25%: optional subcategory 1A.
The tissue viability after 3 minutes exposure is ≥ 25 %: a combination of optional Sub-Categories 1B-and-1C. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 25 mg + 25 µL water
NEGATIVE CONTROL
- Amount applied: 50 µL
POSITIVE CONTROL
- Amount applied: 50 µL - Duration of treatment / exposure:
- 3 min or 1 h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min treatment
- Value:
- 96.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h treatment
- Value:
- 79.6
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: No
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: Yes
Any other information on results incl. tables
Table 2: Summary of the 3 min treatment
Treatment |
|
OD |
Viability (%) |
Classification |
Negative Control (Sterile water) |
Mean |
1.748 |
100.0 |
NC |
±SD |
0.046 |
3.8 |
||
n |
2 |
2 |
||
Positive Control (Glacial acetic acid) |
Mean |
0.027 |
1.6 |
C (Category 1A) |
±SD |
0.003 |
0.3 |
||
n |
2 |
2 |
||
Test Item (Humectol LYS Mod ) |
Mean |
1.656 |
96.5 |
NC |
±SD |
0.183 |
15.1 |
||
n |
2 |
2 |
Table 3: Summary of the 1 h treatment
Treatment |
|
OD |
Viability (%) |
Classification |
Negative Control (Sterile water) |
Mean |
1.871 |
100.00 |
NC |
±SD |
0.024 |
1.8 |
||
n |
2 |
2 |
||
Positive Control (Glacial acetic acid) |
Mean |
0.025 |
1.3 |
C (Category 1A) |
±SD |
0.005 |
0.4 |
||
n |
2 |
2 |
||
Test Item (Humectol LYS Mod ) |
Mean |
1.490 |
79.6 |
NC |
±SD |
0.268 |
20.2 |
||
n |
2 |
2 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vitro skin corrosion assay (RhE) according to OECD guideline 431, the thest item did not show skin corrosive properties.
- Executive summary:
The skin corrosive potential of the test item was evaluated in an in vitro skin corrosion assay (RhE) according to OECD guideline 431. In an pre-test the test item did not develope any colour when dissolved in distilled water/isopropanol and was considered as non-reducer of MTT as no purple colour was developed when mixed and incubated with MTT solution.
Test items were exposed for 1 hour and 3 minutes separately. All the treatments were maintained in duplicates. For 3 minutes and 1 h treatment, 50 µL of sterile distilled water (NC) was dispensed into the inserts atop the tissue. Tissues were treated with 25 mg test item + 25 µL distilled water or 50 µL of positive control (glacial acetic acid). Tissues were incubated for 3 min at room temperature or 1 h at 37 °C. At the end of treatment time tissue inserts were rinsed with sterile PBS. In an MTT assay, the viability of the tissues was calculated. The optical density of the extracted formazan was measured in 96-well plate spectrophotometer at 570 nm.
For 3 minutes exposure, percentage viability of negative control, positive control and test item was 100 ± 3.8%, 1.6 ± 0.3% or 96.5 ± 15.1%, respectively. As the percentage viability of test item was greater than 50% of negative control, the test item is considered as non-corrosive, whereas the percentage viability of positive control (PC) is less than 50% of negative control and clearly represents the irritation potential of positive control. For 1 hour exposure, percentage viability of negative control, positive control and test item was 100 ± 1.8, 1.3 ± 0.4 and 79.6 ± 20.2 respectively. As the percentage viability of test item was greater than 15% of negative control, the test item is considered as non-corrosive, whereas the percentage viability of positive control (PC) is less than 50% of negative control clearly represents the irritation potential of positive control.
Based on the results obtained under the laboratory testing conditions, the test item is categorized as non-corrosive to reconstructed human epidermis (RhE) (UN GHS No category), as the mean percentage tissue viability was greater than 50% after 3 minutes exposure and greater than 15% after 1 hour exposure of the negative control.
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