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EC number: 243-094-0 | CAS number: 19473-49-5
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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:
- OECD Guidelines for the Testing of Chemicals, No.431 (18 June 2019) “In Vitro Skin Corrosion:
Reconstructed Human Epidermis (RhE) Test Method”
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-potassium hydrogen L-glutamate
- EC Number:
- 243-094-0
- EC Name:
- 5-potassium hydrogen L-glutamate
- Cas Number:
- 19473-49-5
- Molecular formula:
- C5H9NO4.K
- IUPAC Name:
- potassium 5-oxido-5-oxo-L-norvaline
- Test material form:
- solid
1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: EpiDerm (Source: MatTek Corporation, USA) is a three-dimensional human epidermis model.
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- 3.3.1. Human skin
EpiDerm (Source: MatTek Corporation, USA) is a three-dimensional human epidermis model.
It consists of normal, human-derived epidermal keratinocytes (NHEK) which have been cultured
to form a multilayered, highly differentiated model of the human epidermis. The NHEK, which
are cultured on specially prepared cell culture inserts using serum free medium, attain levels of
differentiation. Ultrastructurally, the EpiDerm Skin Model closely parallels human skin, thus
providing a useful in vitro means to assess dermal irritancy and toxicology [5].
The EpiDerm Skin Model exhibits in vivo-like morphological and growth characteristics which
are uniform and highly reproducible. EpiDerm consists of organized basal, spinous, granular and
cornified layers analogous to those found in vivo. EpiDerm is mitotically and metabolically
active. Markers of mature epidermis specific differentiation such as profilaggrin, the K1/K10
cytokeratin pair, involucrin, and type I epidermal transglutaminase have been localized in the
model. Ultrastructural analysis has revealed the presence of keratohyalin granules, tonofilament
bundles, desmosomes, and a multi-layered stratum corneum containing intercellular lamellar
lipid layers arranged in patterns characteristic of in vivo epidermis [5].
Its use for skin corrosivity testing involves topical application of test materials to the surface of
the epidermis, and the subsequent assessment of their effects on cell viability. - Justification for test system used:
- 3.3.2. Justification for selection of the test system
The EpiDerm model is one of the five RhE test methods recommended by the OECD 431
guideline. The test has been validated for in vitro corrosivity testing in an international trial
[6, 7]; it was considered to be suitable for this study. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- 3.3.3. Number of replicate wells
In this assay, two replicates per time point were used. Two negative controls and two positive
controls were run additionally. Each test item was tested for a 3-minute and a 60-minute
exposure.
3.3.4. Quality Control
EpiDerm kits are manufactured according to defined quality assurance procedures (certified ISO
9001). 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 was
assessed by undertaking a MTT cell viability test, and a cytotoxicity test with 1% Triton X-100
Solution.
These quality control experiments were conducted at MatTek (supplier of the EpiDerm test kits
used in the present study) and are documented in Appendix 3.
3.3.5. Kit Contents
One EPI-200-SCT Kit and one MTT-100 Assay Kit was used for the test item.
Name: EpiDerm™ tissues (EPI-200 ver. 2.0)
Supplier: MatTek Corporation
Lot number: 34164
Name: Assay Medium (EPI-100-ASY) *
Batch number: 060321LHB
Expiry date: 17 June 2021
* Also used as Maintenance Medium in the test. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg of the test item was applied evenly to the epidermal surface with a spoon, and 25 µL of distilled water was pipetted onto it to wet the test item in order to ensure a good contact with the skin surface.
- Duration of treatment / exposure:
- 3-minute exposure: After the 1-hour pre-incubation, each tissue was treated with an exposure
time of 3 minutes at room temperature.
60-minute exposure: After the 1-hour pre-incubation, the “Maintenance Medium” was replaced
with fresh medium (0.9 mL per well). Each tissue was treated with an exposure time of
60 minutes. The tissues were placed at 37 °C in an incubator with 5% CO2, in a ≥95%
humidified atmosphere for the exposure time. - Duration of post-treatment incubation (if applicable):
- The viability of each
tissue was assessed by incubating the tissues for 3 hours with MTT solution. The precipitated
formazan crystals were then extracted with isopropanol and then quantified with a
spectrophotometer at 570±10 nm. - Number of replicates:
- Two tissues per exposure time were treated with the test item for 3 minutes or 60 minutes.
Exposure to test material was terminated by rinsing with DPBS solution.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- >= 73.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure
- Value:
- >= 74.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
As no colour change was observed after one hour of incubation of
the test item in MTT solution,
it is considered that the test material did not interact with MTT.
Therefore, additional controls
and data calculations were not necessary to exclude the false estimation
of viability.
In the lack of intrinsic colour or colouring potential, no additional
controls and data calculations
were necessary to exclude the false estimation of viability.
VIABILITY RESULTS
The results of the optical density (OD) measured at 570 nm of each
sample and the calculated
relative viability % values are presented below. The mean OD value for
the test item treated skin
tissues showed 73.5% and 74.1% relative viability compared to the
negative control, after the 3
minutes and the 60 minutes exposure, respectively. Positive control OD
values were within the
historical control range therefore all validity criteria met according
to OECD 431.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, in this in vitro EpiDerm™ model test with L-Glutamic acid potassium salt monohydrate, the results indicate that the test item is not corrosive to the skin.
- Executive summary:
An in vitro skin corrosivity test with the test item was performed in a reconstructed human
epidermis model. EpiDerm™ is designed to predict and classify the corrosive potential of
chemicals by measuring its cytotoxic effect as reflected in the MTT [3-(4,5-Dimethylthiazol-
2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue; CAS number 298-93-1] assay. The
corrosivity of the test item was evaluated according to the OECD No. 431 guideline.
Two tissues per exposure time were treated with the test item for 3 minutes or 60 minutes.
Exposure to test material was terminated by rinsing with DPBS solution. The viability of each
tissue was assessed by incubating the tissues for 3 hours with MTT solution. The precipitated
formazan crystals were then extracted with isopropanol and then quantified with a
spectrophotometer at 570±10 nm.
Distilled water and 8N Potassium hydroxide solution treated tissues were used as negative and
positive controls, respectively (two tissues per exposure time). For each treated tissue, cell
viability was expressed as a % relative to the concurrent negative control.
Following exposure with the test item, the mean cell viability was 73.5% after the
3-minute exposure, and 74.1% after the 60-minute exposure, compared to the concurrent
negative control. This is above the thresholds of 50% after 3-min exposure, and higher than 15%
after 60-min exposure, therefore the test item was considered as being Non-corrosive according
to the UN GHS/EU CLP Classification. The experiment met all the validity criteria, therefore the
study was considered to be valid.
In conclusion, in this in vitro EpiDerm™ model test with L-Glutamic acid potassium salt
monohydrate, the results indicate that the test item is not corrosive to the skin.
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