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EC number: - | 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:
- 03 November 2020 - 11 December 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid: viscous
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm, lot 34108
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 300 µL 1 mg/mL
- Incubation time: 3 hour ± 5 minutes
- Spectrophotometer: Versamax® Molecular Devices
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
positive control: Mean OD 0.07, range: 0.03 – 0.11
Mean Tissue Viability [%] 3.93, range: 2.24% - 6.19 %
negative control: Mean OD 1.71, range: 1.28 - 2
(Data of 60 sets of controls performed from August 2015 until May 2020 and shared between 226 studies.)
NUMBER OF REPLICATE TISSUES:
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
1) The Color Interference – Test
Colored test items or test items which become colored after application to the tissues may interfere with the photometric MTT measurement if the colorant binds to the tissue and is extracted together with MTT. Therefore, each test item had to be checked for its colorant properties.
Therefore, 30 μL of the test item was added to 300 μl of deionised water and mixed. 330 μl of deionised water was used as control (blank). Both were incubated for 60 min under standard conditions.
In parallel, 30 μL of the test item was added to 2 mL of isopropanol and mixed. A control (2 mL of isopropanol, blank) was run concurrently. Both were incubated for 1 hour at room temperature.
Since the test item was not soluble in water the suspension was centrifuged.
After incubation the change of color was determined by the unaided eye.
2) The MTT Interference – Test
To test if a test item directly reduces MTT, 1 ml of a MTT solution (1 mg/mL) including 30 μL of the test item was incubated for 1 hour at standard conditions. Untreated MTT/DMEM solution (1 mg/mL) was used as negative control.
After incubation the change of color was determined by the unaided eye.
Since the test item/ water or test item/ isopropanol solutions changed color significantly in the first pre-experiment it was presumed to have the potential to stain the tissues. Two additional controls in duplicates run with the main experiment – additional viable tissues (colored controls = CC)
• Deionised water treated tissues (NC_CC)
• Test item treated tissues (TI_CC)
These four tissues were incubated in medium without MTT solution in the MTT assay. At the end, Data Correction Procedure I was performed.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
The test item is identified as requiring classification and labelling according to UN GHS/ EU CLP “Category 2” or “Category 1”, if the tissue viability after exposure and post-incubation is ≤ 50%. Since this assay covered by this OECD 439 cannot resolve between UN GHS Categories 1 and 2 further information on skin corrosion will be required to decide on its final classification. In case the test item is found to be non-corrosive the test item is considered to be irritant to skin in accordance with UN GHS Category 2.
The test item is identified as non-irritant to skin in accordance with UN GHS / EU CLP “No Category” if the tissue viability after exposure and post-treatment incubation is more than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- DPBS Rinse Solution
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 77.3
- Vehicle controls validity:
- not applicable
- 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: yes; respective controls were included
DEMONSTRATION OF TECHNICAL PROFICIENCY: the controls gave the appropriate response
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
Treatment Group |
Tissue No. |
OD 570 nm |
Mean OD of |
Mean OD of 3 Wells blank corrected |
Mean OD of 3 tissues |
Rel. Viability [%] Tissue |
Standard Deviation |
Mean Rel. Viability [%] |
||
Well 1 |
Well 2 |
Well 3 |
||||||||
Blank |
|
0.039 |
0.039 |
0.039 |
0.039 |
|
||||
Negative Control |
1 |
2.015 |
1.945 |
1.958 |
1.973 |
1.934 |
1.876 |
103.125 |
0.053 |
100.0 |
2 |
1.950 |
1.870 |
1.877 |
1.899 |
1.860 |
99.188 |
||||
3 |
1.890 |
1.855 |
1.868 |
1.871 |
1.832 |
97.687 |
||||
Positive Control |
1 |
0.160 |
0.149 |
0.140 |
0.150 |
0.111 |
0.088 |
5.909 |
0.020 |
4.69 |
2 |
0.121 |
0.117 |
0.116 |
0.118 |
0.079 |
4.223 |
||||
3 |
0.114 |
0.110 |
0.114 |
0.113 |
0.074 |
3.944 |
||||
Test Item |
1 |
1.707 |
1.678 |
1.681 |
1.689 |
1.650 |
1.457 |
87.983 |
0.183 |
77.30* |
2 |
1.480 |
1.465 |
1.476 |
1.473 |
1.435 |
76.490 |
||||
3 |
1.314 |
1.319 |
1.340 |
1.324 |
1.286 |
68.551 |
||||
NC_CC |
1 |
0.049 |
0.050 |
0.049 |
0.049 |
0.011 |
0.008 |
0.569 |
0.003 |
0.45 |
2 |
0.045 |
0.045 |
0.044 |
0.045 |
0.006 |
0.322 |
||||
TI_CC |
1 |
0.044 |
0.045 |
0.044 |
0.044 |
0.005 |
0.007 |
0.291 |
0.002 |
0.38 |
2 |
0.047 |
0.048 |
0.048 |
0.047 |
0.009 |
0.466 |
NC_CC Negative
Control Colored Control
TI_CC Test
Item treated Colored Control
* Corrected viability (%) = TI viability – TI_CC viability
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, Esterification products of triglycerides, C18 (unsaturated) with triethanolamine, dimethyl sulphate-quaternized is non-irritant to skin according to UN GHS and EU CLP regulation.
- Executive summary:
Thisin vitrostudy was performed to assess the irritation potential of Esterification products of triglycerides, C18 (unsaturated) with triethanolamine, dimethyl sulphate-quaternized by means of the Human Skin Model Test in accordance with OECD TG 439.
The test item did not prove to be a MTT reducer in the MTT interference pre-experiment. It changed color when mixed with deionised water. Therefore, additional tests with viable tissues (without MTT addition) had to be performed.
Three tissues each of the human skin model EpiDerm™ were treated with the test item, the negative control (DPBS) or the positive control (5% SDS) for 60 minutes.
After treatment with the negative control the absorbance values were well within the required range of the acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for the 60 minutes treatment interval, thus assuring the quality of the tissues.
Treatment with the positive control induced a sufficient decrease well below 20% in the viability as compared to the negative control for the 60 minutes treatment interval, thus assuring the validity of the test system.
After treatment with the test item Esterification products of triglycerides, C18 (unsaturated) with triethanolamine, dimethyl sulphate-quaternized the mean relative viability value was 77.30% compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
In conclusion, it can be stated that in this study and under the experimental conditions reported, Esterification products of triglycerides, C18 (unsaturated) with triethanolamine, dimethyl sulphate-quaternized is non-irritant to skin.
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.
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