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EC number: 250-796-0 | CAS number: 31774-90-0
- 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
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
- Biodegradation
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- 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
Endpoint summary
Administrative data
Description of key information
Skin irriation: In an in vitro skin irritation study under the given conditions the test item showed no irritant effects. The test item is therefore classified as non-irritant in accordance with UN GHS No Category.
Eye irritation: The eye irritancy potential of the test item was investigated in the bovine corneal opacity and permeability assay. The following mean in vitro irritation score was calculated to 2.29. Therefore the test item was classified into UN GHS No Category.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name: Ethyltris(2-hydroxyethyl)ammonium ethyl sulphate
Product Description: Triethanolamine DES Quat
CAS No.: 31774-90-0
Physical state: colourless to yellow viscous liquid at 20 °C
Batch No.: PFS-755-175
Re-certification date of batch: 21 April 2018
Purity: 100 % (UVCB, water content 0.33 % (w/w))
pH, 5% in water 7.85
Acid Value , mg KOH/g 38.45
Moisture, % 0.33
Total Amine, mg/g 33.10
Viscosity,cps, #4@60,25C 1580
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light - Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: normal human epidermal keratinocytes (NHEK)
- Cell source:
- other: certificate of analysis of supplier available
- Source strain:
- not specified
- Details on animal used as source of test system:
- not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test item was applied undiluted. 30 µL (47 µL/cm2) of the test item was dispensed directly atop the EpiDerm tissue. The test item was gently spread to match size of the tissue using a bulb-headed Pasteur pipette.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test item was applied undiluted. 30 µL (47 µL/cm2) of the test item was dispensed directly atop the EpiDerm tissue. The test item was gently spread to match size of the tissue using a bulb-headed Pasteur pipette.
- Duration of treatment / exposure:
- In the present study the test item was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay.
- Duration of post-treatment incubation (if applicable):
- In the present study the test item was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay.
- Number of replicates:
- 3 replicate tissues per group
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean relative tissue viability [%]
- Value:
- 85
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this in vitro skin irritation study under the given conditions the test item showed no irritant effects. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
- Executive summary:
In this in vitro skin irritation study (OECD 439) under the given conditions the test item showed no irritant effects. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
Reference
Pre-Experiments
The mixture of 30 µL test item per 1 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%. The mixture of 30 µL of the test item per 300 µL aqua dest. and per 300 µL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSC equalled 0%.
Results
Table 1: Result of the Test Item
Name | NC | PC | Test item | ||||||
Tissue | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
absolute OD570 | 1.923 1.901 |
2.198 2.146 |
2.195 2.236 |
0.100 0.099 |
0.125 0.128 |
0.132 0.131 |
1.691 1.634 |
2.015 1.933 |
1.751 1.726 |
OD570 (blank-corrected) | 1.882 1.860 |
2.156 2.195 |
2.154 2.195 |
0.059 0.058 |
0.084 0.087 |
0.091 0.090 |
1.650 1.593 |
1.974 1.892 |
1.710 1.685 |
mean OD570 of the duplicates (blank-corrected) |
1.871 | 2.131 | 2.174 | 0.059 | 0.085 | 0.090 | 1.621 | 1.933 | 1.697 |
total mean OD570 of 3 replicate tissues (blank-corrected) |
2.059* | 0.078 | 1.751 | ||||||
relative tissue viability [%] | 90.9 | 103.5 | 105.6 | 2.8 | 4.1 | 4.4 | 78.8 | 93.9 | 82.5 |
SD OD570 | 0.164 | 0.017 | 0.163 | ||||||
mean relative tissue viability [%] | 100.0 | 3.8** | 85.0 | ||||||
SD tissue viability [%]*** |
8.0 | 0.8 | 7.9 | ||||||
CV [% viabilities] | 8.0 | 21.8 | 9.3 |
* Blank-corrected mean OD570 nm of the negative control corresponds to 100% absolute tissue viability.
** Mean relative tissue viability of the three positive control tissues is <= 20%.
*** Standard deviation (SD) obtained from the three concurrently tested tissues is ≤ 18%
Discussion
The potential of the test item to induce skin irritation was analysed by using the three-dimensional human epidermis model EpiDerm comprising a reconstructed epidermis with a functional stratum corneum. In the present study the test item was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay. Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS. The test item showed no non-specific reduction of MTT compared to the solvent. Therefore, NSMTT equalled 0%. The mixture of 30 µL of the test item per 300 µL aqua dest. and per 300 µL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSCliving equalled 0%.The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (85.0%) after 60 min treatment and 42 h post-incubation. The controls confirmed the validity of the study. The mean absolute OD570 of the three negative control tissues was >= 0.8 and ≤ 2.8. The mean relative tissue viability (% negative control) of the positive control was <= 20% (3.8%). Standard deviation of viability of replicate tissues of all dose groups was ≤ 18% (0.8% - 8.0%).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name: Ethyltris(2-hydroxyethyl)ammonium ethyl sulphate
Product Description: Triethanolamine DES Quat
CAS No.: 31774-90-0
Physical state: colourless to yellow viscous liquid at 20 °C
Batch No.: PFS-755-175
Re-certification date of batch: 21 April 2018
Purity: 100 % (UVCB, water content 0.33 % (w/w))
pH, 5% in water 7.85
Acid Value , mg KOH/g 38.45
Moisture, % 0.33
Total Amine, mg/g 33.10
Viscosity,cps, #4@60,25C 1580
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light - Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Preparation of the Corneas
The assay uses isolated corneas obtained as a by-product from animals freshly slaughtered at the abattoir A. Moksel AG, Buchloe, Germany. On the test day, fresh eyes were collected from the slaughterhouse and were transported in HBSS containing Pen/Strep on ice to the laboratories. Immediately after arrival of the eyes, cornea preparation was initiated. The eyes were carefully examined for defects and any defective eyes were discarded.
The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS. Before the corneas were mounted in corneal holders (Duratec GmbH) with the endothelial side against the O-ring of the posterior chamber, they had been visually examined for defects and any defective cornea had been discarded. The anterior chamber was then positioned on top of the cornea and tightened with screws. The chambers of the corneal holder were then filled with RPMI (without phenol red) containing 1% FBS and 2 mM L-glutamine (complete RPMI). The posterior chamber was always filled first. The corneas were incubated for one hour at 32 +- 1 °C.
Test Groups:
- 3 corneas for the test item
- 3 corneas as negative controls treated with physiological saline 0.9% NaCl
- 3 corneas as positive controls treated with ethanol 100% - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µL of the test substance or the control substance was introduced into the anterior chamber. As the viscosity of the test item was relatively high, it was applied directly onto the cornea by removing the window-locking ring and glass window prior to treatment. After 10 minutes incubation at 32 +- 1 °C either the test substance or the control substance was removed and the epithelium washed at least three times with MEM (containing phenol red). Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI (without phenol red).
- Duration of treatment / exposure:
- After the equilibration period, the medium was removed from both chambers and replaced with fresh complete RPMI. An initial measurement was performed on each of the corneas using the opacitometer. Three corneas with illuminance readings approximately equivalent to the median illuminance of all corneas were selected as negative-control corneas. The illuminance of each cornea was read and recorded. Only corneas that had an initial illuminance reading I > I0/1.1651 lux were used for the assay. The medium was removed from the anterior chamber and replaced with the test item or control. 750 µL of the test substance or the control substance was introduced into the anterior chamber. As the viscosity of the test item was relatively high, it was applied directly onto the cornea by removing the window-locking ring and glass window prior to treatment. After 10 minutes incubation at 32 +- 1 °C either the test substance or the control substance was removed and the epithelium washed at least three times with MEM (containing phenol red). Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI (without phenol red). The anterior chamber expect of cornea no. 8 was refilled with complete RPMI and an illuminance measurement was performed after 2 hours incubation at 32 +- 1 °C. Also, each cornea was observed visually and pertinent observations were recorded.
- Duration of post- treatment incubation (in vitro):
- After the illuminance measurement was performed, the medium was removed from both chambers of the holder. The posterior chamber was refilled with fresh complete RPMI. 1 mL of a 4 mg/mL sodium fluorescein solution was added to the anterior chamber and the corneas were incubated for 90 minutes at 32 +- 1 °C. Then the medium from the posterior chamber was removed and its optical density at 490 nm (OD490) was determined, using a spectrophotometer.
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 2.29
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Validity
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the evaluation criteria the test item is classified into UN GHS No Category.
- Executive summary:
The eye irritancy potential of the test item was investigated in the bovine corneal opacity and permeability assay. The following mean in vitro irritation score was calculated to 2.29.
Therefore the test item was classified into UN GHS No Category.
Reference
Results
The eye irritancy potential of the test item was investigated in the bovine corneal opacity and permeability assay. The test item was tested as provided by the sponsor. None of the 3 corneas treated with the test item showed any opacity of the tissue. The anterior chamber of cornea no. 8 was not refilled with complete RPMI between the first and second measurement of the opacity. Certainly the scores of the opacity measurement as well of the permeability measurement of cornea no. 8 are comparable with the scores of the other corneas. The following mean in vitro irritation score was calculated: 2.29
Therefore the test item was classified into UN GHS No Category.
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.
Table 1: In Vitro Irritation Score
Cornea No. | Test item | Corrected opacity | Corrected OD490 value | IVIS |
1 | Negative control | 0.07 | 0.027 | - |
2 | Negative control | -1.55 | 0.018 | - |
3 | Negative control | -0.37 | 0.002 | - |
MV | Negative control | -0.61 | 0.016 | -0.38 |
4 | Positive control | 27.88 | 1.227 | - |
5 | Positive control | 26.10 | 1.829 | - |
6 | Positive control | 27.04 | 2.249 | - |
MV | Positive control | 27.01 | 1.769 | 53.54 |
7 | Test item | 1.86 | -0.005 | - |
8 | Test item | 1.64 | -0.007 | - |
9 | Test item | 3.58 | -0.003 | - |
MV | Test item | 2.36 | -0.005 | 2.29 |
MV = mean value
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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