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EC number: 434-630-6 | CAS number: 60372-77-2
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- January 12, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: No specific test guideline was reported; however, a scientifically defensible investigation approach was used to conduct the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 434-630-6
- EC Name:
- -
- Cas Number:
- 60372-77-2
- Molecular formula:
- Hill formula: C20H41N4O3Cl
- IUPAC Name:
- ethyl N2-dodecanoyl-l-argininate hydrochloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: Nα-Lauroyl-L-arginine ethyl ester monohydrochloride
- Substance type: White powder
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Validation of an Liquid Chromatography-MS/MS (13C-LAE,13C-LAS and 13C-arginine) method for the measurement of LAE and two metabolites in human plasma. Full validation consisted of analysis of 2 calibration curves, QC samples (prepared at 1, 3, 15 and 180 ng/ml for C-LAE and C-LAS, prepared at 20, 60, 250 and 900 ng/ml for C-arginine) and analysed on 3 separate occasions to assess precision and accuracy, specificity checks in 6 sources of blank plasma, matrix effects, recovery of analytes and internal standard through extraction, dilution of over-range samples and stability of analytes in plasma and standard solution. In conclusion, an LC-MS/MS method for the measurement of 13C-LAE, 13C-LAS and 13C-arginine in human plasma has been successfully validated for use.
- Executive summary:
With the purpose of validating Liquid Chromatography-MS/MS method for the measurement of LAE and two metabolites in human plasma the current study was performed.
Validation consisted of analysis of 2 calibration curves, QC samples (prepared at 1, 3, 15 and 180 ng/ml for 13C-LAE and 13C-LAS, prepared at 20, 60, 250 and 900 ng/ml for 13C-arginine) and analysed on 3 separate occasions to assess precision and accuracy, specificity checks in 6 sources of blank plasma, matrix effects, recovery of analytes and internal standard through extraction, dilution of over-range samples and stability of analytes in plasma and standard solution. In conclusion, an LC-MS/MS method for the measurement of 13C-LAE, 13C-LAS and 13C-arginine in human plasma has been successfully validated for use.
Acceptable linearity, precision, accuracy and specificity were observed over the concentration range 1 to 200 ng/ml for 13C-LAE and 13C-LAS and over 20 to 1000 ng/ml for 13C-arginine.
The low limit of quantification was 1 ng/ml for 13C-LAE, 1 ng/ml for 13C-LAS and 20 ng/ml for 13C -arginine based upon a plasma volume of 400 µl.
The recovery of all three analytes and their internal standards from plasma was consistent over the calibration range.
There were no interfering peaks from human plasma that affected the measurement of any analyte or internal standard. A peak was presentat the retention time of N-methyl-L-arginine in the chromatograms of blank plasma extracts, but was considered to be insignificant compared to the level of the spiked internal standard.
The effect of the variability of the matrix from different humans onthe reliability of the method was shown to be negligible.
Plasma samples containing concentrations of an analyte in excess of the validated range could be measured precisely and accurately after a 10-fold dilution with blank plasma to enablemeasurement up to a maximum concentration of 2000 ng/ml for 13C-LAE and 13C-LAS and10000 ng/ml for 13C-arginine using this method.
The analytes (13C-LAE,13C-LAS and 13C-arginine) were shown to be stable in plasma whilst on ice (c.a.0°C) for 2 hours, at nominally -70°C for 31 days and following 3 freeze/thaw cycles. The analytes were also stable in extracted samples at c.a. 22°C (room temperature) for 7 days and atc.a.+4°C for 6 days.
In conclusion, an LC-MS/MSmethod for the measurement of 13C-LAE,13C-LAS and 13C-arginine in human plasma has been successfully validated for use.
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