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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Version / remarks:
- 14 June 2021
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
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
- Specific details on test material used for the study:
- Name: L-Glutamic acid potassium salt monohydrate
Batch number: VG29748063 / Vendor Lot: SLCJ 1327
CAS number: 6382-01-0
Expiry date: 01 December 2022
Molecular weight: 203.23 g/mol
Purity: 100 %
Appearance: white powder
Storage: room temperature
Safety precautions: According to the SDS
In chemico test system
- Details on the study design:
- HPLC System Conditions
HPLC system: SHIMADZU LC2030 (Prominence-i LC-2030C)
Serial number: L21445402951AE
Detector: 220 nm – D2 lamp
Column: Zorbax SB-C18 (2.1 x 100 mm, 3.5 µm)
Serial number: USRY003976
Column temperature: 30°C
Sample temperature: 25°C
Injection volume: 7µL
System equilibration: 50% phase A and 50% phase B for 2 hours at 30°C and running the gradient twice before injecting the first sample
Run time: 20 min
Flow conditions: gradient flow
Mobile phases for HPLC:
Mobile Phase A – 0.100 % (v/v) trifluoroacetic acid in ultrapure water
Mobile Phase B – 0.085 % (v/v) trifluoroacetic acid in acetonitrile
1:10 ratio cysteine peptide0.5 mM peptide, 5 mM test item:
750 µL cysteine peptide stock solution
(or phosphate buffer for the co-elution control)
200 µL acetonitrile
50 µL 100mM test item solution
(or solvent for the reference controls A,B,C or
100 mM positive control solution for the positive control)
1:50 ratio lysine peptide 0.5 mM peptide, 25 mM test item:
750 µL lysine peptide stock solution (or ammonium acetate buffer for the co-elution control)
250 µL 100mM test item solution
(or solvent for the reference controls A,B,C or
100 mM positive control solution for the positive control)
The vials were capped, vortexed to mix and placed to the HPLC autosampler for 24 ± 2 h incubation at 22.5°C - 30°C in the dark. HPLC analysis of the batch of reaction samples started 24 ± 2 h hours after the test chemical was added to the peptide solution. The batches were consisted of 2 parts: one part with the A reference controls, the calibration standards and the co-elution controls. These samples could be run before the 24 ± 2 h incubation time ends and right before the other part started or right after the other part. The other part contained the B and C reference controls, the positive controls and the reaction samples and these samples were run right after the 24 ± 2 h incubation time ended. The total HPLC analysis time should be less than 30 hours.
Results and discussion
- Positive control results:
- Reference control A replicates were included in the HPLC run sequence to verify the HPLC system suitability prior analysis. The mean peptide concentration of A reference control sample replicates was 0.51 mM for the cysteine and 0.50 mM for the lysine peptide.
A standard calibration curve was generated for both cysteine and lysine peptides using serial dilutions from the peptide stock solutions. Calibration standard points were analyzed by linear regression.
Means of the peak areas versus the concentrations of both peptides showed good linearity with r2 = 0.9954 for cysteine peptide and r2 = 0.9999 for the lysine peptide, covering the concentration range from 0.534 mM to 0.0167 mM. All validity criteria were within acceptable limits and therefore the study can be considered valid.
In vitro / in chemico
Results
- Key result
- Run / experiment:
- other: 3
- Parameter:
- other: average percent peptide depletion
- Value:
- 1.63
- Vehicle controls validity:
- valid
- Remarks:
- ultrapure water
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these results and the cysteine 1:10 / lysine 1:50 prediction model, the test item “L-Glutamic acid potassium salt monohydrate” showed no or minimal reactivity towards the synthetic peptides; thus it is not a potential skin sensitizer under the experimental conditions of the in chemico Direct Peptide Reactivity Assay (DPRA) method according to OECD 442C.
- Executive summary:
In the course of this study the skin sensitization potential of the test item “L-Glutamic acid potassium salt monohydrate” was studied using the Direct Peptide Reactivity Assay (DPRA) in accordance with OECD 442C.
For the test item and the positive control substance, in order to derive a prediction two independent tests were evaluated, one with cysteine and one with lysine peptides. The results of two valid runs is used for the classification of the test item.
Peptide depletion resulting from the positive control cinnamaldehyde was within the expected percentage range both with cysteine and lysine peptides.
The mean back-calculated peptide concentrations of the reference control replicates were within the expected molarity concentration range and the CV % for the nine reference controls B and C in acetonitrile were also acceptable. Moreover, the mean back-calculated peptide concentrations of the three reference controls C in the ultrapure water replicates were within the expected molarity concentration range for cysteine and lysine peptides. For each peptide, all validity criteria were met, confirming the validity of the study.
The mean cysteine peptide depletion value was 3.26 % ± 3.82 % while the lysine peptide depletion valueof the test itemwas 0.00 % ± 0.11 %.
Based on these results and the cysteine 1:10 / lysine 1:50 prediction model, the test item “L-Glutamic acid potassium salt monohydrate” showed no or minimal reactivity towards the synthetic peptides; thus it is not a potential skin sensitizer under the experimental conditions of the in chemico Direct Peptide Reactivity Assay (DPRA) method according to OECD 442C.
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