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EC number: 947-925-4 | 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 24, 2018 to February 01, 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- {3-[(1-carboxy-2-hydroxyethyl)amino]-2-hydroxypropyl}(dodecyl)dimethylazanium {3-[(1-carboxyethyl)amino]-2-hydroxypropyl}(dodecyl)dimethylazanium {3-[(carboxymethyl)amino]-2-hydroxypropyl}(dodecyl)dimethylazanium trichloride
- EC Number:
- 947-925-4
- Molecular formula:
- Molecular formula of major active constituents: C20H43CL1N2O3 (representative molecular formula for C12 alkyl chain Quaternised alanine) C19H41CL1N2O3 (representative molecular formula for C12 alkyl chain Quaternised glycine) C20H43Cl1N2O4 (representative molecular formula of C12 alkyl chain quaternised serine)
- IUPAC Name:
- {3-[(1-carboxy-2-hydroxyethyl)amino]-2-hydroxypropyl}(dodecyl)dimethylazanium {3-[(1-carboxyethyl)amino]-2-hydroxypropyl}(dodecyl)dimethylazanium {3-[(carboxymethyl)amino]-2-hydroxypropyl}(dodecyl)dimethylazanium trichloride
- Test material form:
- other: Paste
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- The reconstructed human epidermal model EpidermTM (EPI-200 MatTek Corporation)
- Source species:
- human
- Cell type:
- other: normal human-derived epidermal keratinocytes
- Justification for test system used:
- The EpiDermTM skin model and assay for skin corrosion testing is endorsed by OECD TG 431.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Test system
The reconstructed human epidermal model EpidermTM (EPI-200 MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differential model of the human epidermis. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.
Characterisation of the test system
MatTek’s EpiDermTM model has been extensively characterised for multiple parameters including morphology, tissue viability, skin barrier function and sterility. QC results for the specific lot of models received (Lot# 25876) were checked in-house for MatTek acceptance ranges with the following outcome:
- Morphology - PASS
- Tissue viability - PASS
- Skin barrier function (ET50 value for 1 % Triton X-100) where ET50 is the time taken for 1 % Triton X-100 to reduce the viability of the skin model to 50 % relative to the negative control) - PASS
- Sterility testing showed no contamination during long term antibiotic and antimycotic free culture - PASS - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Single topical application of 15 μL sterile water plus neat test substance
50 μL reference substances - Duration of treatment / exposure:
- 3 and 60 minutes at 37°C, 5 % CO2, 95 % RH
- Number of replicates:
- 3 replicates each for test substance, negative and positive controls
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- ca. 95.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: non-corrosive
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- ca. 53.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: non-corrosive
- Other effects / acceptance of results:
- Prior to the assay, the test substance was checked for interference (water coloration or MTT interference) and found not to interfere.
Any other information on results incl. tables
Results
Table 1: Cell viability measurements after 3 minutes of application
Name |
Tissue n° |
3 min endpoint |
|||||||
Aliq. 1 |
Aliq. 2 |
mean |
OD Mean |
viability |
Mean |
SD |
CV |
||
[%] |
[%] |
[%] |
[%] |
||||||
NC |
1 |
1.642 |
1.604 |
1.623 |
1.561 |
104.0 |
100.0 |
3.4 |
3.4 |
2 |
1.536 |
1.516 |
1.526 |
|
97.7 |
|
|
|
|
3 |
1.554 |
1.516 |
1.535 |
|
98.3 |
|
|
|
|
PC |
1 |
0.374 |
0.356 |
0.365 |
0.379 |
23.4 |
24.3 |
0.8 |
3.3 |
2 |
0.388 |
0.382 |
0.385 |
|
24.6 |
|
|
|
|
3 |
0.390 |
0.385 |
0.387 |
|
24.8 |
|
|
|
|
TA2 |
1 |
1.496 |
1.459 |
1.477 |
1.486 |
94.6 |
95.2 |
0.6 |
0.6 |
2 |
1.509 |
1.483 |
1.496 |
|
95.8 |
|
|
|
|
3 |
1.478 |
1.491 |
1.484 |
|
95.1 |
|
|
|
NC: negative control (H2O), PC: Positive control (KOH 8N), TA2: Test substance
Table 2: Cell viability measurements after 1 h of application
Name |
Tissue n° |
1h endpoint |
|
||||||
Aliq. 1 |
Aliq. 2 |
mean |
OD Mean |
viability |
Mean |
SD |
CV |
||
[%] |
[%] |
[%] |
[%] |
||||||
NC |
1 |
1.565 |
1.551 |
1.558 |
1.548 |
100.7 |
100.0 |
3.9 |
3.9 |
2 |
1.492 |
1.473 |
1.483 |
|
95.8 |
|
|
|
|
3 |
1.617 |
1.586 |
1.602 |
|
103.5 |
|
|
|
|
PC |
1 |
0.062 |
0.052 |
0.057 |
0.048 |
3.7 |
3.1 |
0.7 |
21.7 |
2 |
0.035 |
0.038 |
0.037 |
|
2.4 |
|
|
|
|
3 |
0.047 |
0.054 |
0.051 |
|
3.3 |
|
|
|
|
TA2 |
1 |
0.969 |
0.954 |
0.962 |
0.830 |
62.1 |
53.6* |
12.1 |
22.5 |
2 |
|
|
|
|
|
|
|
|
|
3 |
0.692 |
0.702 |
0.697 |
|
45.1 |
|
|
|
*corrected value in (one outlier removed for TA2, i.e., second tissue readings)
NC: negative control (H2O), PC: Positive control (KOH 8N), TA2: Test substance
Table 3: Mean and SD of cell viability measurements after 3 minutes and 1 h application
|
3 min |
1 h |
||||
Mean of viability [%] |
SD of viability |
CV(%) |
Mean of viability [%] |
SD of viability |
CV(%) |
|
NC |
100.0 |
3.4 |
3.4 |
100.0 |
3.9 |
3.9 |
PC |
24.3 |
0.8 |
3.3 |
3.1 |
0.7 |
21.7 |
TA2 |
95.2 |
0.6 |
0.6 |
53.6 |
12.1 |
22.5 |
NC: negative control (H2O), PC: Positive control (KOH 8N), TA2: Test substance.
Table 4: Results Summary
Test substance |
Test substance ID |
Viability after 3 minutes application (% to negative control) |
Viability ≥ 50% after 3 min (Yes/No) |
Viability after 1h application (% to negative control) |
Viability ≥ 15% after 1h (Yes/No) |
Corrosive (C)/Non corrosive(NC) |
Test substance |
TA2 |
95 .2% |
Yes |
53.6% |
Yes |
NC |
The test substance did not reduce the viability below 50% after 3 min nor below 15% after 1h and should be considered as non-corrosive. Note that the final results are presented here (without outliers).
Acceptance criteria
|
|
Actual values |
Pass/Failed |
||||||||||||
Acceptance criterion 1 |
The mean OD570of the negative control tissues must be ≥0.8.
|
3 min: 1.561 1h: 1.548
|
Pass |
||||||||||||
Acceptance criterion 2 |
The mean of the positive control relative percentage viability, after 1 hour exposuremust be < 15% of the mean of the negative control.
|
3.1% |
Pass |
||||||||||||
Acceptance criterion 3 |
In the range between 20% and 100% viability, the coefficient of variation (CV) is an additional acceptance criterion.It should not exceed 0.3(i.e 30%).
|
|
Pass |
Interpretation of results and skin corrosion Prediction Model
The cut-off values for the prediction of human skin corrosion are as follows:
Step 1
A test substance is classified "corrosive", if the relative tissue viability after3 mintreatment with a test material is decreased below 50%.
In addition, those materials classified "non-corrosive" after3 min(viability ≥ 50%) are classified "corrosive" if the relative tissue viability after1 htreatment with a test material is decreased below 15%.
Mean tissue viability(expressed as % of negative control) |
Prediction |
3 min < 50% |
corrosive |
3 min ≥ 50%and1 h: < 15% |
corrosive |
3 min ≥ 50%and1 h: ≥ 15% |
non-corrosive |
Step 2 (if test substance is classified as corrosive in step 1)
A test substance is classified "corrosive, optional Sub-Category 1A", if the relative tissue viability after3 mintreatment with a test material is decreased below 25%.
A test substance is classified "corrosive, optional Sub-Category 1B/1C", if the relative tissue viability after3 mintreatment with a test material is ≥25%.
Mean tissue viability(expressed as % of negative control) |
Prediction |
3 min < 25% |
Corrosive, optional Sub-category 1A |
3 min ≥ 25% |
Corrosive, optional Sub-categories 1B and 1C |
Conclusion for test substance
Test substance evaluated for skin corrosion following OECD guideline TG 431 and using EpiDermTM tissue model was non-corrosive.
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive based on CLP criteria
- Conclusions:
- Under the study conditions, the test substance was determined to be non-corrosive to the skin.
- Executive summary:
An in vitro study was conducted to determine the skin corrosion potential of the test substance, 'Cocodimonium hydroxypropyl hydrolysed silk' (active: 51%), using Reconstructed Human Epidermis (RHE) cells, according to OECD Guideline 431, in compliance with GLP. EpiDermTM tissues were kept overnight at 4°C. On Day 1, the tissues were pre-incubated for 1 h at 37°C, 5% CO2, 95% RH. After incubation, tissues were exposure to test (15 μL water plus neat test substance) and reference substances (50 μL sterile water as negative control and 50 μL Potassium hydroxide as positive control) in triplicates for 3 and 60 minutes. After 3 minutes and 1 h treatment, the test substance and the reference substances were rinsed off from the tissues. Cell viability of the tissues was evaluated by addition of MTT on Day 2 and final MTT assay testing and measurements were performed. Results were compared to negative control. All validity criteria for the performed test were met. After 3 minutes and 1 h treatment, the mean viability values obtained with the test substance were determined to be 95.2% and 53.6%, respectively, which is well above the corrosive limits of 50 and 15% respectively. Under the study conditions, the test substance was determined to be non-corrosive to the skin (XCellR8, 2018).
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