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EC number: 615-231-8 | CAS number: 70983-58-3
- 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:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Council Regulation 440/2008, Method B.40 BIS: “In Vitro Skin Corrosion: Human Skin Model Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized
- EC Number:
- 615-231-8
- Cas Number:
- 70983-58-3
- Molecular formula:
- UVCB
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized
- Test material form:
- liquid: viscous
- Details on test material:
- Name: Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized
Product Description: C10-16-alkyletherpropylamine, ethoxylated, DES Quat
CAS No.: 70983-58-3
Physical state: yellowish to amber viscous liquid at 20 °C
Batch No.: PFS-755-173
Re-certification date of batch: 19 April 2018
Purity: 100 % (UVCB)
Color, Gardner 8.8
pH, 5% in water 5.76
Acid Value , mg KOH/g 20.1
Moisture, % 0.127
Total Amine, mg/g 11.18
Viscosity,cps, #4@60,25C 3280
Appearance @25C pass
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light
Constituent 1
- Specific details on test material used for the study:
- Name: Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized
Product Description: C10-16-alkyletherpropylamine, ethoxylated, DES Quat
CAS No.: 70983-58-3
Physical state: yellowish to amber viscous liquid at 20 °C
Batch No.: PFS-755-173
Re-certification date of batch: 19 April 2018
Purity: 100 % (UVCB)
Color, Gardner 8.8
pH, 5% in water 5.76
Acid Value , mg KOH/g 20.1
Moisture, % 0.127
Total Amine, mg/g 11.18
Viscosity,cps, #4@60,25C 3280
Appearance @25C pass
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test was carried out with the reconstituted three-dimensional human skin model EpiDerm (MatTek). This skin model consists of normal (non-cancerous), human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts. The EpiDerm skin model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous, granular and cornified layers analogous to those found in vivo.
The test meets acceptance criteria if:
- mean OD570 nm of the two negative control tissues of the 3 min and 60 min treatment period is between 0.8 and 2.8,
- mean relative tissue viability of the two positive control tissues of the 60 min treatment period is < 15%,
- coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is <= 30%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test item was applied undiluted. Firstly, 100 µL aqua dest. was applied topically on the tissue surface. Then, 50 µL of the test item was dispensed directly atop the EpiDerm tissue.
Dose Groups
Negative control: 50 µL distilled water
Positive control: 50 µL 8 N KOH
Test Item: 50 µL (undiluted) - Duration of treatment / exposure:
- The test was performed on a total of 4 tissues per dose group, 2 replicates for each treatment period (3 min and 60 min exposure time).
- Duration of post-treatment incubation (if applicable):
- 3 min and 60 min experiment: after the 3 h MTT incubation period the MTT solution was aspirated. The wells were refilled with PBS and the PBS was aspirated. The rinsing was repeated twice and the tissues were dried. Then the inserts were transferred into 12-well “extraction plates“. 2 mL of isopropanol were pipetted into each insert, thus the insert was covered from both sides. The extraction plates were sealed in zip-bags to inhibit isopropanol evaporation. Extraction was carried out either over night without shaking at room temperature or, alternatively, at least 2 h with shaking at room temperature.
After the extraction period the inserts were pierced with an injection needle to allow the extracts to run through the tissues into the corresponding wells. Then the inserts were discarded and the extraction plates were placed on a shaker for 15 min.
Per each tissue 3 x 200 µL aliquots of the extract were transferred into a 96-well plate and OD was measured at 570 nm without reference wavelength in a plate spectrophotometer using isopropanol as a blank. - Number of replicates:
- The test was performed on a total of 4 tissues per dose group.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min experiment - mean of 2 tissues
- Value:
- 61.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min experiment - mean of 2 tissues
- Value:
- 47.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- 3 min experiment: After 3 min of application, the first insert was removed from the 6-well plate with forceps. Using a wash bottle, the tissue was gently rinsed about 20 times with PBS (phosphate buffered saline) to remove any residual test item. Since the test item could not be removed completely from the tissue surface by rinsing, a Q-tip was used to remove the sticky test item and additional rinsing steps with PBS were performed. However, it was not possible to remove the test item completely. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper.
60 min experiment: after 60 min application, the first insert was removed from the 6-well plate with forceps. Using a wash bottle, the tissue was gently rinsed about 20 times with PBS to remove any residual test item. Since the test item could not be removed completely from the tissue surface by rinsing, a Q-tip was used to remove the sticky test item and additional rinsing steps with PBS were performed. However, it was not possible to remove the test item completely. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper.
Test Acceptance Criteria:
The test item could not be removed completely from the tissue surface after 3 min and 60 min treatment. Therefore, in consultation with the sponsor, 100 µL aqua dest was applied to the tissue surface before application of the test item and additional rinsing steps and manual removal by using a Q-tip were included. However, residuals of the test item were still visible. After 60 min treatment, viability of the two tissues treated identically with the test item showed high variability, exceeding the 30% threshold (32.7%). This is accepted regarding the stickiness of the test item. Under these exaggerated treatment conditions, the test item showed no corrosive effects. The mean relative tissue viability (% negative control) was >= 50% (61.6%) after 3 min treatment and >= 15% (47.9%) after 60 min treatment. The worst case value of the two tissues of the 60 min part of the experiment was 36.8% tissue viability, which indicates no corrosive effect.
The controls confirmed the validity of the study. The mean OD570 of the two negative control tissues was >= 0.8 and ≤ 2.8 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was < 15% (8.7%) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100% viability) of replicate tissues of the control groups was >= 30% (0.2% - 4.0%).
All other test acceptance criteria were fulfilled except CV [%] in the range of 20 – 100% viability exceeded for test material (60 min experiment only).
Any other information on results incl. tables
Pre-Experiments
The mixture of 50 µL test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%.
The mixture of 50 µL test item per 300 µL Aqua dest. and per 90 µL isopropanol showed no colouring as compared to the solvent. Therefore NSC equalled 0%.
Results and discussion
The potential of the test item to induce skin corrosion was analysed by using the three-dimensional human skin 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 3 min and 60 min followed by immediate determination of cytotoxic effects via MTT reduction assay.
Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after both treatment periods had been compared to the corresponding negative control tissues.
The test item shows no non-specific MTT-reducing or colouring potential, therefore no additional controls were necessary.
The test item could not be removed completely from the tissue surface after 3 min and 60 min treatment. Therefore, in consultation with the sponsor, 100 µL aqua dest was applied to the tissue surface before application of the test item and additional rinsing steps and manual removal by using a Q-tip were included. However, residuals of the test item were still visible. After 60 min treatment, viability of the two tissues treated identically with the test item showed high variability, exceeding the 30% threshold (32.7%). This is accepted regarding the stickiness of the test item. Under these exaggerated treatment conditions, the test item showed no corrosive effects. The mean relative tissue viability (% negative control) was >= 50% (61.6%) after 3 min treatment and >= 15% (47.9%) after 60 min treatment. The worst case value of the two tissues of the 60 min part of the experiment was 36.8% tissue viability, which indicates no corrosive effect.
The controls confirmed the validity of the study. The mean OD570 of the two negative control tissues was >= 0.8 and ≤ 2.8 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was < 15% (8.7%) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100% viability) of replicate tissues of the control groups was <= 30% (0.2% - 4.0%).
Table 1: Results of 3 min Experiment
Name | Negative control | Test item | Positive control | |||
Tissue | 1 | 2 | 1 | 2 | 1 | 2 |
Absolute OD570 | 1.244 1.244 1.260 |
1.301 1.311 1.345 |
0.730 0.797 0.793 |
0.829 0.852 0.856 |
0.188 0.197 0.198 |
0.261 0.261 0.274 |
OD570 - Blank Corrected | 1.198 1.197 1.214 |
1.255 1.264 1.299 |
0.684 0.750 0.746 |
0.783 0.805 0.810 |
0.142 0.150 0.152 |
0.215 0.214 0.228 |
Mean OD570 of 3 Aliquots (blank corrected) | 1.203 | 1.273 | 0.727 | 0.799 | 0.148 | 0.219 |
SD OD570 of 3 Aliquots | 0.010 | 0.033 | 0.042 | 0.028 | 0.026 | 0.026 |
Total Mean OD570 of 2 Replicate Tissues (Blank Corrected) | 1.238* | 0.763 | 0.184 | |||
SD OD570 of 2 Replicate Tissues | 0.049 | 0.051 | 0.050 | |||
Mean Relative Tissue Viability [%] |
100.0 | 61.6 | 14.8 | |||
Coefficient Of Variation [%]*** | 4.0 | 6.7 | 27.3 |
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is <= 30%.
Table: Results of 60 min Experiment
Name | Negative control | Test item | Positive control | |||
Tissue | 1 | 2 | 1 | 2 | 1 | 2 |
Absolute OD570 | 1.390 1.439 1.431 |
1.420 1.429 1.423 |
0.867 0.846 0.860 |
0.546 0.546 0.568 |
0.154 0.159 0.157 |
0.172 0.179 0.175 |
OD570 - Blank Corrected | 1.344 1.393 1.385 |
1.374 1.383 1.377 |
0.820 0.799 0.814 |
0.499 0.499 0.521 |
0.108 0.113 0.110 |
0.125 0.133 0.128 |
Mean OD570 of 3 Aliquots (blank corrected) | 1.374 | 1.378 | 0.811 | 0.507 | 0.110 | 0.129 |
SD OD570 of 3 Aliquots | 0.026 | 0.026 | 0.027 | 0.028 | 0.025 | 0.026 |
Total Mean OD570 of 2 Replicate Tissues (Blank Corrected) | 1.376* | 0.669 | 0.120 | |||
SD OD570 of 2 Replicate Tissues | 0.003 | 0.215 | 0.013 | |||
Mean Relative Tissue Viability [%] |
100.0 | 47.9 | 8.7** | |||
Coefficient Of Variation [%]*** | 0.2 | 32.7 | 10.9 |
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
** mean relative tissue viability of the 60 min positive control < 15%.
*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is <= 30%. This criterion failed for the test item treated tissues.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
- Executive summary:
In the present Klimisch 1 OECD 431 GLP study the test item was applied topically to the EpiDerm tissue for 3 min and 60 min followed by immediate determination of cytotoxic effects via MTT reduction assay. Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after both treatment periods had been compared to the corresponding negative control tissues. In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
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