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EC number: 205-581-6 | CAS number: 143-06-6
- 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:
- 2016-11-11 to 2017-01-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- Deviation was not considered to have affected the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (6-aminohexyl)carbamic acid
- EC Number:
- 205-581-6
- EC Name:
- (6-aminohexyl)carbamic acid
- Cas Number:
- 143-06-6
- Molecular formula:
- C7H16N2O2
- IUPAC Name:
- (6-aminohexyl)carbamic acid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: stable
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: SkinEthic Laboratories (4, A. Fleming – 69366 Lyon – France)
- Source strain:
- not specified
- Justification for test system used:
- In vitro study - The purpose of the study was to assess the potential skin irritancy of the test material as measured by its ability to induce cell death in a commercial reconstructed human epidermis (RhE)model, EPISKIN™.
The test system EPISKIN™ is a reconstructed human epidermis (RhE) model, which in its overall design (the use of human derived epidermis keratinocytes as cell source and use of representative tissue and cytoarchitecture) closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e., the epidermis. - Vehicle:
- not specified
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE - MTT Method
- Model used: EPISKIN™ - 0.38 cm2
- Supplier: SkinEthic Laboratories (4, A. Fleming – 69366 Lyon – France)
- Tissue batch number(s): 16-EKIN-049, 17-EKIN-004
- Delivery date: 06 Dec 2016 and 24 Jan 2017
- Date of initiation of testing: 11 November 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): room temperature
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: At the end of the exposure, each tissue was rinsed with approximately 25 mL of sterile D-PBS, filling and empting the tissue insert. The excess liquid was carefully removed and the sample transferred in new wells pre-filled with 2 mL/well of maintenance medium.
- Observable damage in the tissue due to washing: no damage
- Modifications to validated SOP: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 2 mL/well of MTT ready-to-use solution.
- Incubation time: 3hr
- Wavelength: spectral analysis at 595 nm
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 15 ± 0.5 minutes exposure is less than 50%
- The test substance is considered to be non-corrosive to skin if the viability after 15 ± 0.5 minutes exposure is greater than or equal to 50% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- NEGATIVE CONTROL (Live Tissue)
- Amount(s) applied (volume or weight): 20 µL
POSITIVE CONTROL (Live Tissue)
- Amount(s) applied (volume or weight): 20 µL
TEST MATERIAL (Live Tissue)
- Amount(s) applied (volume or weight with unit): 20 mg
TEST MATERIAL (Without MTT Live Tissue)
- Amount(s) applied (volume or weight with unit): 20 mg
TEST MATERIAL (Killed Tissue)
- Amount(s) applied (volume or weight with unit): 20 mg
NEGATIVE CONTROL (Killed Tissue)
- Amount(s) applied (volume or weight): 20 µL
TEST MATERIAL (Without MTT (Killed Tissue)
- Amount(s) applied (volume or weight with unit): 20 mg - Duration of treatment / exposure:
- An exposure time of 15 ±0.5 minutes was allowed in a ventilated cabinet at room temperature.
- Duration of post-treatment incubation (if applicable):
- A 42 ± 1 hour recovery period was allowed by incubation at 37 °C, 5% CO2 and saturated humidity.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Test Material
- Run / experiment:
- 2
- Value:
- ca. 98
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Preliminary test
Before the Main Assay, a preliminary test was carried out to evaluate the compatibility of the test item with the test system.
In a first step, the test item was assayed for the ability of reducing MTT per se. A grey purple solution was observed at the end of the incubation period, indicating that the test item could direct interact with MTT.
In a second step, the test item was assayed for the ability of colouring water per se and spectral analysis of the test item in water, to evaluate the ability of the test chemical to absorb light at 595 nm, was performed. A colourless solution was
observed; however, the value obtained for the Optical Density (OD) was 0.217, indicating that the test item has a potential interfering ability. Based on the results obtained, additional controls were added in the Main Assay for the evaluation of Non Specific Colouring potential (NSCliving) and Non Specific MTT reduction (NSMTT). Since the test item was able both to stain tissue and reduce MTT, to avoid a possible double correction for colour interference, a third control for Non Specific Colour in killed tissue (NSCkilled) was performed.
- OTHER EFFECTS:
- Direct-MTT reduction: In the preliminary test, a grey purple solution was observed at the end of the incubation period, indicating that the test item coulddirect interact with MTT.
- Colour interference with MTT: no relevant colouring ability of the test item was noted
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes (The negative control gave the expected baseline value (Optical Density values of the three replicates higher than 0.6) and variability (Standard Deviation of the % viability lower or equal to 18), in agreement with guideline indications).
- Acceptance criteria met for positive control: The positive control caused the expected cell death (mean viability ≤40%) and variability(SD of % viability lower than 18).
- Acceptance criteria met for variability between replicate measurements: yes (Acceptable intra-replicate variability was obtained (SD of % viability = 4.5 lower than 18)
Any other information on results incl. tables
Table 2. Preliminary Test – Results - Direct MTT reduction test (Step 1) |
||||
Test Item (mg) |
MTT ready to use solution (mL) |
Container |
Incubation condition |
Colour Observation |
20.0 |
2.0 |
Well |
3 h at 37°C 100% nominal humidity 5% CO2 |
Grey purple colour (possible interaction) |
Table 3. Preliminary Test – Results - Colouring potential test (Step 2) |
||||
Test Item (mg) |
Water (µL) |
Container |
Incubation condition |
Observation |
20 |
180 |
Eppendorf Tube |
15’, ambient condition, in agitation |
Colourless solution; spectrophotometer analysis: OD=0.217 (possible interaction) |
Table 4. Main Assay - Results |
||||||
Sample |
|
Optical Density (OD) |
Viability (%) (mean) |
NSMTTkilled (%) |
NSCkilled (%) |
NSCliving(%) |
Run 1 |
|
|||||
Negative control (live tissue) |
Mean |
0.6 |
100 |
- |
- |
- |
SD |
0.04 |
6.7 |
- |
- |
- |
|
CV% |
6.7 |
6.7 |
- |
- |
- |
|
|
||||||
Negative control (killed tissues) |
Mean |
0.0 |
- |
- |
- |
- |
SD |
0.00 |
- |
- |
- |
- |
|
CV% |
10.4 |
- |
- |
- |
- |
|
|
||||||
Test Item (killed tissues) |
Mean |
0.0 |
- |
-1 |
- |
- |
SD |
0.02 |
- |
2.83 |
- |
- |
|
CV% |
48.7 |
- |
-392.8 |
- |
- |
|
|
||||||
Test Item (killed tissues without MTT) |
Mean |
0.0 |
- |
- |
1 |
- |
SD |
0.00 |
- |
- |
0.1 |
- |
|
CV% |
4.7 |
- |
- |
4.7 |
- |
|
Run 2 |
|
|||||
Negative control |
Mean |
0.9 |
100 |
- |
- |
|
SD |
0.04 |
4.2 |
- |
- |
|
|
CV% |
4.2 |
4.2 |
- |
- |
|
|
|
||||||
Positive control |
Mean |
0.0 |
4 |
|
|
|
SD |
0.01 |
0.6 |
|
|
|
|
CV% |
16.1 |
16.1 |
|
|
|
|
|
||||||
Test Item |
Mean |
0.8 |
98 |
|
|
|
SD |
0.04 |
4.5 |
|
|
|
|
CV% |
4.6 |
4.6 |
|
|
|
|
|
||||||
Test Item (without MTT) |
Mean |
0.0 |
- |
- |
- |
0 |
SD |
0.00 |
- |
- |
- |
0.1 |
|
CV% |
18.4 |
- |
- |
- |
18.4 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to the CLP Regulation
- Remarks:
- not irritating to the skin.
- Conclusions:
- Based on the results observed, the test material does not meet the GHS classification criteria for skin irritation.
- Executive summary:
In a key Guideline (OECD 439) in vitro skin irritation study, the potential of the test material to be irritant to the skin was investigated using a commercial reconstructed human epidermis (RhE) model named EPISKIN™. The test material, as well as controls, were tested for their ability to impair cell viability after an exposure period of 15 minutes followed by a 42 ± 1 hour recovery period.
A preliminary test was carried out to evaluate the compatibility of the test material with the test system. In the first step, the test material was assayed for to evaluate its ability to reduce MTT ([3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue; CAS N. 298-93-1). A grey purple solution was observed at the end of the incubation period, indicating that the test material could directly interact with MTT. In the second step, the test material was assayed for the ability of colouring water and spectral analysis of the test material in water, to evaluate the ability of the test chemical to absorb light at 595 nm, was performed. A colourless solution was observed, however the value obtained for the Optical Density (OD) was 0.217, indicating that the test material has a potential interfering ability. Based on these results, additional controls were added in the Main Assay.
In the Main Assay, the test material was applied as supplied in three replicates at the treatment level of 20 mg/epidermis unit, each measuring 0.38 cm2(treatment level: 53 mg/cm2). Positive and negative controls [a 5% (w/v) sodium dodecyl
sulphate solution in water and Dulbecco’s phosphate buffered saline (D-PBS), respectively] were concurrently tested, in the same number of replicates and test conditions at the treatment level of 20μL/epidermis unit. To verify if the test material results had to be corrected, the non-specific colour (NSCliving) was evaluated using two alive treated tissues without MTT staining and compared with the D-PBS control. Moreover, non-specific MTT reduction (NSMTT) was evaluated using two killed tissues and compared with negative control performed with alive tissues. Since the test material was able both to stain tissue and reduce MTT, to avoid a possible double correction for colour interference, a third control for Non Specific Colour in killed tissue (NSCkilled) was performed.
Data presented for the alive tissues treated with the test material were obtained in a repeated experiment (second run). In the first run, probably due to a microbial contamination in two epidermis units, unacceptable variability within replicate tissues
stained with MTT was observed. Since the non-specific colour (NSCliving) control needs to be performed concurrently to the testing of the coloured test chemical, this control was also repeated. In each run, the negative control gave the expected baseline value (Optical Density values of the three replicates higher than 0.6) and variability [Standard Deviation (SD) of % viability lower or equal to 18], in agreement with the guideline indications. According to the method, the negative control mean value is considered the baseline value of the experiment and thus represents 100% of cell viability.
The positive control caused expected cell death (mean viability ≤40%) and variability (SD of % viability lower than 18). Based on the stated criteria, the assay was regarded as valid. Following treatment of alive tissue without MTT, no relevant colouring
ability of the test material was noted; no relevant interaction was recorded between the test material and MTT. Based on these results, only the OD-blank background subtraction was performed. In the second run, the test material did not induce cell death in any replicate, the mean cell viability after the blank subtraction was 98%, when compared to the negative control. Intra-replicate variability was acceptable with a SD of % viability value equal to 4.5 (lower than 18,as stated in the Study Protocol).
Based on the results observed, the test material is considered as not irritating to the skin.
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