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EC number: 240-162-1 | CAS number: 16024-58-1
- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Version / remarks:
- 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- [2-(2-methoxyethoxy)ethoxy]acetic acid
- EC Number:
- 240-162-1
- EC Name:
- [2-(2-methoxyethoxy)ethoxy]acetic acid
- Cas Number:
- 16024-58-1
- Molecular formula:
- C7H14O5
- IUPAC Name:
- 2-[2-(2-methoxyethoxy)ethoxy]acetic acid
- Test material form:
- other: liquid: Clear colourless
Constituent 1
In chemico test system
- Details on the study design:
- Instruments and Devices
Usual laboratory equipment and the following instruments were used in this study:
- Analytical and precison scales
- Volumetric measurement tools
- pH-meter
- Standard laboratory glassware
- Incubation chamber capable of holding 25 ± 2.5 °C
HPLC system:
Designation: HPLC_4
Components:
Degasser G1322A
Quaternary pump G1311A
Autosampler G1313A
Column compartment G1316A
UV/VIS-Detector DAD G1315A
Manufacturer: Agilent Technologies
Software: CHROMELEON 6.80 SR15b Build 4981
An ACE Excel SuperC18 150x3 mm column with 3 μm particles was used. This column was used instead the Agilent Zorbax SB-C18 column recommended in the OECD 442C guideline because it delivers substantially better peak shape for the peptides.
Peptides with ≥ 95 % purity, syntheseized by Genecust, Dudelange, Luxemburg, were used.
Sequence Cys-Peptide (Cysteine): Ac-RFAACAA-COOH (MW = 751.9 g/mol)
Sequence Lys-Peptide (Lysine): Ac-RFAAKAA-COOH (MW = 776.2 g/mol)
Chemicals
- Water for chromatography
- Demineralized water
- Acetonitrile for chromatography
- Trifluoroacetic acid
- Isopropanol
- Acetone
- Dimethylsulfoxide
Positive control
Positive controls are treated identically as the test item. The following positive controls were used:
- Cinnamaldehyde (CAS 104-55-2, food grade ≥95 %) used as 100 mM solution in acetonitrile for the cysteine peptide, Depletion range 60.8 – 100 %
- 2,3-Butanedione (CAS 431-03-8, >97 %) will be used as 100 mM solution in acetonitrile for the lysine peptide, Depletion range 10 – 45 %
As cinnamaldehyde mixed with the lysine peptide turned turbid in all experiments performed during the implementation phase, it was considered unsuitable as positive control. Instead, the proficiency chemical 2,3-Butanedione is used as positive control showing midrange depletion for the lysine peptide.
Solvent controls
For both peptides, four sets of solvent controls using acetonitrile instead of test item stock solution are prepared in triplicate (Sets A, B1, B2 and C, total 12 samples per peptide). Set A is analysed together with the peptide calibration standards, sets B1, B2 and C are incubated with the samples. Sets B1 and B2 are analysed at the start and end of the analysis sequence and are used as stability control for the peptide over the total analysis time. Set C is analysed together with the samples and is used for calculation of the peptide depletion.
Acceptance criteria
- The standard calibration curve should have an r² > 0.99
- The measured values of solvent control samples of sets A and C should be 0.5 ± 0.05 mM
- The variation coefficient (relative standard deviation, RSD) of measured values of the nine samples from sets B1, B2 and C should be < 15 %
- The mean peptide depletion value for the positive control cinnamic aldehyde should be 60.8 % - 100 % for the Cys-Peptide and 40.2 % - 69.0 % for the lysine peptide with a maximum standard deviation (SD) of < 14.9 % for the Cys-Peptide and < 11.6 % for the Lys-Peptide. If one of the acceptance criteria is not fulfilled, the test is repeated. If the result is unambiguous even though one of the criteria is not met, the test may be considered valid by the study director, but justification must be given.
If the mean percent depletion falls in the range of 3% to 10% for the cysteine 1:10/lysine 1:50 prediction model or the cysteine percent depletion falls in the range of 9% to 17% for the cysteine 1:10 prediction model, a second run should be considered, as well as a third one in case of discordant results between the first two runs.
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: mean of three runs
- Parameter:
- other: mean peptide depletion of both peptides (%)
- Value:
- 1.88
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Run / experiment:
- other: mean of three runs
- Parameter:
- other: Cys-Peptide depletion [%]
- Value:
- 3.62
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Run / experiment:
- other: mean of three runs
- Parameter:
- other: Lys-Ppetide depletion [%]
- Value:
- 0.14
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
Eight out of ten proficiency chemicals listed in the guideline were tested successfully. The results confirmed the classification reported in the OECD guideline (LAUS reference study 201704R875).
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for solvent control: yes
- Acceptance criteria met for positive control: yes
Applicant's summary and conclusion
- Interpretation of results:
- other: study cannot be used for classification alone
- Conclusions:
- The test item shows only minimal reactivity towards cysteine and lysine containing peptides and therefore no potential to cause skin sensitization.
- Executive summary:
This study was performed in order to estimate the skin sensitisation potential of the test item using a peptide model. The direct peptide reactivity assay (DPRA) is an in chemico assay to quantify the reactivity of the test item towards cysteine and lysine containing peptides. This reactivity is related to the skin sensitisation potential. To quantify the sensitisation potential, the depletion of the cysteine and lysine containing peptides caused by known amounts of the test item is measured using HPLC. The assay is used for supporting the discrimination between skin sensitizers (i.e. UN GHS Category 1) and non-sensitizers in accordance with the UN GHS. A categorization in the sub-categories 1 A and 1 B is not possible. In this assay, the test item as well as the positive control (2,3-Butanedione) and the solvent control were tested in triplicate. 2,3-Butanedione shows a midrange depletion for the lysine peptide. As a result for the test item, the mean peptide depletion percentage was 3.62 for the Cys-Pepetide and 0.14 for the Lys-Peptide. The mean percentage of depletion of both peptides was 1.88, therefore predicting only minimal reactivity towards cysteine and lysine containing peptides and no potential to cause skin sensitization based on this reactivity.
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