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Diss Factsheets
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EC number: 226-546-1 | CAS number: 5422-34-4
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 29 Aug - 29 Nov 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Version / remarks:
- 5 Feb 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- N-2-hydroxyethyllactamide
- EC Number:
- 226-546-1
- EC Name:
- N-2-hydroxyethyllactamide
- Cas Number:
- 5422-34-4
- Molecular formula:
- C5H11NO3
- IUPAC Name:
- N-2-hydroxyethyllactamide
Constituent 1
In chemico test system
- Details on the study design:
- Skin sensitisation (In chemico test system) - Details on study design: DPRA
TEST SYSTEM
Synthetic peptides: Cysteine- (C-) containing peptide: Ac-RFAACAA-COOH (MW=751.9 g/mol), Lysine- (K-) containing peptide: Ac-RFAAKAA-COOH (MW=776.2 g/mol); containing phenylalanine to aid in detection
Supplier: GenScript, Piscataway, USA; RS Synthesis, Loisville, USA
VEHICLE CONTROL
- Substance: Acetonitrile
TEST CONCENTRATIONS:
The test substance was prepared at a 100 mM concentration. The C-containing peptide was incubated with the test substance in a ratio of 1:10 (0.5 mM peptide, 5 mM test substance) and the K-containing peptide in a ratio of 1:50 (0.5 mM peptide, 25 mM test substance)
CONTROLS
Negative control: Acetonitrile as vehicle control
Positive control: Ethylene glycol dimethacrylate (EGDMA, CAS 97-90-5), 50 mM in acetonitrile
Co-elution control: Sample prepared of the respective peptide buffer and the test substance but without peptide
NUMBER OF REPLICATES: Triplicates with each peptide
MEASUREMENT HLPC
- Column: ZORBAX SB-C18 2.1 x 100 mm, 3.5 μm with guard column SecurityGuard Ultra Cartridges, UHPLC C18 for 4.6 mm ID (Phenomenex)
- Mobile Phase: A: H2O/ACN/TFA 950/50/1 V/V/V; B: ACN/H2O/TFA 950/50/0.85 V/V/V
- Flow: 0.50 mL/min
- Gradient: time [min]: 0, 8, 8.1, 10, 10.1 and 16 min; %B: 5, 20, 90, 90, 5 and 5
- Wavelength: 220 and 258 nm
- Injection volume: 2 µL
- Software: Dionex Chromeleon
- Calibation samples: 0.534, 0.267, 0.134, 0.067, 0.033 and 0.017 mM peptide
ACCEPTANCE CRITERIA
The standard calibration curve should have an r² > 0.99.
The negative control (vehicle control) samples of sets A and C should be 0.50 mM ± 0.05 mM.
The CV of the nine vehicle controls B and C should be < 15%.
Since the mean peptide depletion for each peptide is determined from the mean of three single samples, the variability between these samples should be acceptably low (SD < 14.9% for % cysteine depletion and < 11.6% for % lysine depletion).
In addition the positive control should cause depletion of both peptides comparable to historic data.
Results and discussion
In vitro / in chemico
Results
- Key result
- Run / experiment:
- other: 24 ± 2 h incubation
- Parameter:
- other: Mean of cysteine- and lysine-depletion [%]
- Remarks:
- Direct Peptide Reactivity Test (DPRA)
- Value:
- 0.78
- Vehicle controls validity:
- valid
- Remarks:
- 0.00
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- 36.63
- Remarks on result:
- no indication of skin sensitisation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
Any other information on results incl. tables
Table 5: Results of DRAP: Reaction with cysteine-peptide
Reaction with cysteine-peptide | peptide concentration [mM] | peptide depletion [%] | ||||||||
sample 1 | sample 2 | sample 3 | mean | SD | sample 1 | sample 2 | sample 3 | mean | SD | |
Vehicle control | 0.486 | 0.482 | 0.497 | 0.488 | 0.008 | 0.44 | 1.33 | -1.76 | 0.00 | 1.59 |
Test substance | 0.481 | 0.483 | 0.478 | 0.481 | 0.003 | 1.50 | 1.04 | 2.13 | 1.56 | 0.55 |
Positive control | 0.240 | 0.221 | 0.219 | 0.227 | 0.012 | 50.77 | 54.65 | 55.13 | 53.52 | 2.39 |
Table 6: Results of DRAP: Reaction with cysteine-peptide
Reaction with lysine-peptide | peptide concentration [mM] | peptide depletion [%] | ||||||||
sample 1 | sample 2 | sample 3 | mean | SD | sample 1 | sample 2 | sample 3 | mean | SD | |
Vehicle control | 0.533 | 0.536 | 0.535 | 0.535 | 0.001 | 0.29 | -0.22 | -0.07 | 0.00 | 0.26 |
Test substance | 0.537 | 0.550 | 0.538 | 0.542 | 0.007 | -0.52 | -2.94 | -0.71 | -1.39 | 1.35 |
Positive control | 0.420 | 0.436 | 0.431 | 0.429 | 0.009 | 21.52 | 18.38 | 19.30 | 19.74 | 1.61 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not skin sensitising based on the key event "direct peptide binding assay"
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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