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EC number: 941-129-0 | CAS number: 1407974-32-6
- 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
- Remarks:
- other: in vitro DPRA
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 February 2014 to 19 February 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to draft OECD test guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draft OECD 13Nov2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: DPRA
Test material
- Reference substance name:
- D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates
- EC Number:
- 941-129-0
- Cas Number:
- 1407974-32-6
- Molecular formula:
- C15H28O7 - C25H46O7
- IUPAC Name:
- D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates
- Test material form:
- other: yellowish thick liquid
- Details on test material:
- - Physical state: yellowish thick liquid
- Purity: 100%
- Expiration date of the lot/batch: 01 December 2014
- Storage condition of test material: room temperature and protected from light
Constituent 1
Results and discussion
- Positive control results:
- The positive control substance induced a mean depletion rate of 60.47%.
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Cysteine peptide depletion
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Lysine peptide depletion
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Acceptance criteria were as per the draft OECD guideline.
Classification criteria for direct peptide reactivity were as per the draft OECD guideline.
Results for the test item and the positive control are presented in attached Tables 1 and 2, respectively. The peak areas for calibration curve samples are presented in attached Tables 3.1 and 3.2, the peptide concentrations and peak areas in reference control samples are presented in attached Tables 4.1 and 4.2. Representative chromatograms of the co-elution, reference control C and test item samples are presented for each peptide in attached Figures 1 to 6. The acceptance criteria for the calibration curve samples, the reference and positive controls as well as for the study samples were satisfied. The study was therefore considered to be valid. Analysis of the chromatograms of the co-elution samples (Figures 1 and 4) indicated that the test item did not co-elute with either the lysine or the cysteine peptides. As a result, the mean percent depletion values were calculated for each peptide using the formula described in § Data analysis and calculation. For both cysteine and lysine peptides, the mean depletion values were set to 0% since the individual percent depletion values were negative. The mean of the percent cysteine and percentage lysine depletions was therefore equal to 0%. Accordingly, the test item was considered to have no/minimal peptide reactivity.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other:
- Conclusions:
- Under the experimental conditions of this study, the test item, has 0% peptide reactivity.
- Executive summary:
Introduction
The objective of the Direct Peptide Reactivity Assay (DPRA) was to evaluate the reactivity of the test item to synthetic cysteine and lysine peptides for skin sensitization assessment.
Methods
The reactivity of the test item was evaluated in chemico by monitoring peptide depletion following a 24-hour contact between the test item and synthetic cysteine and lysine peptides. The method consisted of the incubation of a diluted solution of cysteine or lysine with the test item for 24 hours. At the end of the incubation, the concentrations of residual peptides were evaluated by HPLC with Ultra-Violet detection at 220 nm. Peptide reactivity was reported as percent depletion based on the amount of peptide remaining in the sample relative to the average amount measured in the relevant reference control.
Results
Solubility assay
The test item was found soluble at 50 mg/mL in water obtained by reverse osmosis. Therefore, water obtained by reverse osmosis was selected as vehicle.
Direct Peptide Reactivity Assay
The acceptance criteria for the calibration curve samples, the reference and positive controls as well as for the study samples were satisfied. The study was therefore considered to be valid. Analysis of the chromatograms of the co-elution samples indicated that the test item did not co-elute with either the lysine or the cysteine peptides. As a result, the mean percent depletion values were calculated. For both cysteine and lysine peptides, the mean depletion values were set to 0% since the individual percent depletion values were negative. The mean of the percent cysteine and percent lysine depletions was therefore 0%. Accordingly, the test item was considered to have no/minimal peptide reactivity.
Conclusion
Under the experimental conditions of this study, the test item, has 0% peptide reactivity
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