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EC number: 291-707-5 | CAS number: 90459-62-4
- 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:
- 05 April 2018 - 06 April 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:
- adopted 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octadecanoic acid, reaction products with diethylenetriamine, di-Me sulfate-quaternized
- EC Number:
- 291-707-5
- EC Name:
- Octadecanoic acid, reaction products with diethylenetriamine, di-Me sulfate-quaternized
- Cas Number:
- 90459-62-4
- Molecular formula:
- C24H55N3O6S
- IUPAC Name:
- bis(2-aminoethyl)amine octadecanoic acid dimethyl sulfate
- Test material form:
- solid
- Remarks:
- paste
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:
- unchanged (no vehicle)
- Remarks:
- wetted with water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm
- Tissue batch number(s): 25892
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37±1 °C, 5±1 % CO2 (1 h exposure), room temperature (3 min exposure)
- Temperature of post-treatment incubation (if applicable): 3 h
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: tissues were rinsed with sterile PBS (fill and empty insert 20 times in a constant soft stream of 1xPBS)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Wavelength: 540 nm
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.]
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg + 25 µL of distilled water
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL sterile distilled water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL glacial acetic acid - Duration of treatment / exposure:
- 3 min, 1 h
- Duration of post-treatment incubation (if applicable):
- 3 h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h exposure
- Value:
- 73.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 67.8
- 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
- Range of historical values if different from the ones specified in the test guideline:
positive control (glacial acetic acid): 3 min exposure 5.6±0.2, 1 h exposure: 4.3 ±0.1
negative control: 3 min exposure mean OD 2.081, 1 h exposure mean OD 1.445
Any other information on results incl. tables
SUMMARY OF Optical Density (OD) AND VIABILITY (%)
1 Hour Exposure
Treatment |
|
OD |
Viability (%) |
Classification |
Negative Control (Sterile distilled water) |
Mean |
1.423 |
100.0 |
NC |
±SD |
0.007 |
0.7 |
||
n |
2 |
2 |
||
Positive Control (Glacial acetic acid) |
Mean |
0.070 |
4.9 |
C (Category 1A) |
±SD |
0.005 |
0.5 |
||
n |
2 |
2 |
||
Test Item |
Mean |
1.049 |
73.8 |
NC |
±SD |
0.029 |
2.9 |
||
n |
2 |
2 |
3 Minutes Exposure
Treatment |
|
OD |
Viability (%) |
Classification |
Negative Control (Sterile distilled water) |
Mean |
1.454 |
100.00 |
NC |
±SD |
0.029 |
2.8 |
||
n |
2 |
2 |
||
Positive Control (Glacial acetic acid) |
Mean |
0.086 |
5.8 |
C (Category 1A) |
±SD |
0.006 |
0.6 |
||
n |
2 |
2 |
||
Test Item |
Mean |
0.985 |
67.8 |
NC |
±SD |
0.008 |
0.7 |
||
n |
2 |
2 |
NC = Non Corrosive; C = Corrosive; n = No. of tissues; SD = Standard Deviation.
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive
- Conclusions:
- Based on the results obtained under the laboratory testing conditions, the test item is categorized as non-corrosive to Reconstructed Human Epidermis (RhE) in accordance with 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.
- Executive summary:
The objective of study was to evaluate the in vitro skin corrosion potential of Octadecanoic acid, reaction products with diethylenetriamine, di-Me sulfate-quaternized by measurement of tissue viability on the Epidermal Model - Epiderm™ (EPI-200-SCT) as per the OECD Guideline 431, adopted on 29th July 2016.
The test item did not develop any colour when dissolved in distilled water/isopropanol and considered as non-reducer of MTT as no purple colour was developed when mixed and incubated with MTT solution.
After receipt of the tissues, visual inspection was done to verify the defects, as there were no tissue defects, air bubble and excess moisture observed all the tissue inserts were used for the study. Tissue inserts were transferred to upper row of 6 well plates prefilled with 0.9 mL of assay medium and incubated in CO2 incubator for 60 minutes.
Test items were exposed for 1 hour and 3 minutes separately. All the treatments were maintained in duplicates. For 3 minutes treatment, quantity of 50 µL of sterile distilled water (NC) was dispensed into the first insert atop the tissue. After 60 seconds the procedure was repeated with second tissue and continued for other tissues. Similar procedure was followed in the same manner until all the tissues were treated. Tissues were treated with 25 mg test item + 25 µL distilled waterand 50 µL of positive control (glacial acetic acid).
For 1 hour treatment, 25 mg test item + 25µL distilled water, 50 µL of negative control and 50 µL of positive control were dispensed directly atop Epiderm™ tissues at 1 minute intervals to facilitate rinsing after exposure. The tissues were incubated at standard culture conditions for 1 hour.
For the 3 minutes exposure, percentage viability of negative control, positive control and test item was 100±2.8, 5.9±0.6 and 67.8±0.7, 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 clearly represents the irritation potential of positive control.
For the 1 hour exposure, percentage viability of negative control, positive control and test item was 100±0.7, 4.9±0.5 and 73.8±2.9, 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.
Conclusion
Based on the results obtained under the laboratory testing conditions, Octadecanoic acid, reaction products with diethylenetriamine, di-Me sulfate-quaternized is categorized as non-corrosive 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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