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EC number: 222-793-4 | CAS number: 3615-41-6
- 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: in vitro
- 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:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- 6-deoxy-L-mannose
- EC Number:
- 222-793-4
- EC Name:
- 6-deoxy-L-mannose
- Cas Number:
- 3615-41-6
- Molecular formula:
- C6H12O5
- IUPAC Name:
- 6-deoxy-L-mannose
- Test material form:
- other: crystalline powder
- Details on test material:
- - Purity: 98%
Constituent 1
In chemico test system
- Details on the study design:
- The test article was incubated concurrently in two separate buffers, one with cysteine (Ac-RFAACAA-COOH) and one with lysine (Ac-RFAAKAA-COOH). Reactive chemicals bind one or both of the peptides thereby reducing their free concentration levels. The disappearance of each peptide is measured by HPLC/UV. This method does not require any biological material such as enzymes in order for this reaction to take place. It is important to note that the cysteine peptide captures soft electrophiles, while the lysine peptide captures hard electrophiles. This makes the DPRA assay a good choice to screen for reactive chemicals which are associated with allergic contact dermatitis.
L-Rhamnose was prepared at a stock concentration of 100 mM in water and added to the peptide reactions. 2,3-butanedione, the positive control material, was prepared in acetonitrile to yield a final concentration of 100 mM.
The cysteine peptide was prepared at 0.667 mM in Cysteine Reaction buffer and the lysine peptide was prepared at 0.667 mM in Lysine Reaction buffer. The reaction mix for cysteine peptide had a 1:10 test peptide to reference article ratio (0.5 mM cysteine to 5 mM reference article). The reaction mix for lysine peptide had a 1:50 peptide to reference article ratio (0.5 mM lysine to 25 mM reference article). Reactions for test and reference articles were run in triplicate. Vehicle control reactions were also made with acetonitrile or water containing no reference or test articles.
Reference control reactions were prepared by mixing 2.5 mL of acetonitrile with 7.5 mL of the respective buffer. Aliquots of 1 mL were added to 9 glass vials for each peptide and placed at the beginning middle and end of the samples. These reactions were used to ensure the consistency of peptide detection during the run.
A standard curve was prepared for both peptides by adding 400 µL of acetonitrile to 1600 µL of 0.667 mM peptide to make a 0.534 mM standard. This 0.534 mM standard was serial diluted in 20% acetonitrile/buffer to make a 6 point standard curve. A zero peptide standard was also included in the standard curve.
After 24 ± 2 hours incubation DPRA samples were assayed for peptide depletion via HPLC/UV.(HPLC with gradient elution and UV detections at 220 nm using a Waters Alliance 2795 HPLC equipped with a 2996 Photodiode Array). Prior to sample analysis the suitability of the HPLC/UV system was verified by running the standard curve and a triplicate set of reference controls. Samples were run on an Agilent Zorbax SB-C-18 column. Sample analysis was initiated within 24 ±2 hours of the reaction start. The results were acquired with the MassLynx data system and quantified via the QuanLynx application. Samples were injected once.
After determination of peptide remaining in the analysis, percent depletion relative to vehicle controls was calculated relative to no test article (vehicle control) samples. Peptide reactivity was reported as percent depletion and was calculated using the following formula:
% Depletion = (1-(test compound area/ vehicle control area)) x 100
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Parameter:
- other: % CYS depletion
- Value:
- 0
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Parameter:
- other: & Lys depletion
- Value:
- 0
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Parameter:
- other: % DPRA depletion
- Value:
- 0
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
For this test: low, moderate, and high reactivity were considered positive, while minimal reactivity was considered negative. See results in the table below.
It should be noted that some co-elution of mannose test material with peptide was observed with the lysine peptide. The co-elution was found to be consistent across all the replicates, and consisted of small “shoulders” on the main peptide peak. The peak integration used to calculate the depletion was the one initially predicted by the computer. Modification of the peak by the analytical scientist showed that removing the “shoulder” from the main peptide peak area did not greatly change the depletion. This indicated the co-elution did not significantly increase the signal. No co-elution issues were observed with the cysteine peptide.
Material |
%Cys Dep |
SD |
%Lys Dep |
SD |
%Dep DPRA |
Reactivity Class |
Sensitizer |
2,3-butanedione |
79.7 |
1.3 |
27.8 |
2.8 |
53.8 |
High |
Positive |
L-Rhamnose |
0.0 |
5.1 |
0.0 |
5.0 |
0.0 |
Minimal |
Negative |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- L-Rhamnose showed minimal reactivity in the DPRA test and therefore is considered to be negative for skin sensitisation.
- Executive summary:
L-Rhamnose was tested in the OECD guideline study 442C, In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA). The overall DPRA depletion for L-Rhamnose was 0.0%. It should be noted that some co-elution of test material with peptide was observed with the lysine peptide reactions. The co-elution was found to be consistent across all the replicates, and consisted of small “shoulders” on the main peptide peak. The peak integration used to calculate the depletion was the one initially predicted by the computer. Modification of the peak by the analytical scientist showed that removing the “shoulders” from the main peptide peak area did not greatly change the depletion. This indicated the co-elution did not significantly increase the signal. No co-elution issues were observed with the cysteine peptide. L-Rhamnose was negative for sensitization potential with minimal to no reactivity with either peptide.
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