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EC number: 700-938-7 | CAS number: 72716-26-8
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 May 2012 to 11 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- potassium (2S)-4-carboxy-2-tetradecanamidobutanoate
- EC Number:
- 700-938-7
- Cas Number:
- 72716-26-8
- Molecular formula:
- C19H34NO5K
- IUPAC Name:
- potassium (2S)-4-carboxy-2-tetradecanamidobutanoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Substance type: white to pale yellow powder, a slightly characteristic odour.
- Storage condition of test material: room temperature
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- Skin Samples
- Model: EPISKIN-SM.
- Source: SkinEthic, France, Batch No.:12-EKIN-015, Expiry Date: 14 April 2012.
- Quality control: All biological components of the epidermis and the kit culture medium have been tested for the presence of viruses, bacteria and mycoplasma. The quality of the final product is assessed by undertaking an MTT cell viability test and a cytotoxicity test with sodium dodecylsulphate (SDS). The EPISKIN kit received was checked for pH and to verity that the kit had not been exposed to temperatures above 40 °C during transport; the kit was found to be in good order.
- Storage: The EPISKIN kit was kept in their packaging at 37 °C and the assay medium supplied with the kit was stored at 2-8°C until test initiation.
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg. - Duration of treatment / exposure:
- 15 minutes
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 88
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- CELL VIABILITY
- The viability results of the test material treated disks was 88 % of the negative control, since this is > 50 % of the negative control the test material is considered to be a non-irritant.
VALIDITY OF THE TEST
The mean OD value of the three negative control tissues was 0.756. The positive control result showed a mean of 6.9 % viability. Each standard deviation value (SD) of the % viability was below 18. All validity criteria were within acceptable limits and therefore the study can be considered as valid.
INDICATOR FOR POTENTIAL FALSE VIABILITY
> Possible direct MTT reduction with the test material: No colour change was observed after three hours of incubation of the test item in MTT solution. The test material did not interact with the MTT, therefore additional controls and data calculations were not necessary. A false estimation of viability due the MTT interaction can be precluded.
> Colouring potential of the test material: As the test material is coloured, one additional chemical-treated tissue was used for the non specific OD evaluation. Optical Density (measured at 540 nm) of this tissue was determined as 0.034, Non Specific Colour % was calculated as 4.5 %, below the threshold of 50 %. Therefore additional data calculation was not necessary.
Any other information on results incl. tables
Table 1: Optical Density (OD) and the Calculated % Viability
Substance |
Optical Density (OD) |
Viability (%) |
|
Negative Control |
1 |
0.820 |
108 |
2 |
0.659 |
87 |
|
3 |
0.788 |
104 |
|
Mean |
0.756 |
100 |
|
(SD) |
|
11.15 |
|
Positive Control |
1 |
0.040 |
5.3 |
2 |
0.079 |
10 |
|
3 |
0.041 |
5.4 |
|
Mean |
0.053 |
6.9 |
|
(SD) |
|
2.69 |
|
Test Material |
1 |
0.721 |
95 |
2 |
0.536 |
71 |
|
3 |
0.746 |
99 |
|
Mean |
0.668 |
88 |
|
(SD) |
|
15.14 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating according to EU criteria
- Conclusions:
- Under the conditions of the test, the results indicate that the test material is not a skin irritant.
- Executive summary:
The potential for the test material to cause skin irritation was predicted in vitro using the EPISKIN Model in a study conducted under GLP conditions and in line with OECD 439 and EU Method B.46. The test material was applied topically to the surface of the skin for 15 minutes, which was terminated by rinsing with PBS 1 x solution (0.9 %). Epidermis units were then incubated at 37 °C for 42 hours in an incubator with 5 % CO2. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37 °C in 5 % CO2 protected from light. The formazan extract in acidified isopropanol was then spectrophotometrically evaluated for optical density (OD) and quantified. Positive and negative controls were run concurrently and tissue viability was expressed as a % relative to the negative control.
Under the conditions of the study, exposure to the test material resulted in a mean relative cell viability of 88 %. Since the cell viability was determined to be > 50 % of the negative control the test material was considered to be non-irritating.
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