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EC number: 256-367-4 | CAS number: 49553-76-6
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 28 Oct 2011 - 11 Jan 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
- Principles of method if other than guideline:
- The Direct Peptide Reactivity Assay (DPRA) is an in vitro alternative method currently under evaluation of ECVAM and based on the publications of Gerberick et al. (2004 and 2007), Bauch et al. (2010) and Maxwell et al. (2011). The principle of this method is to determine the reactivity of a test substance towards synthetic cysteine (C)- or lysine (K)-containing peptides in order to assess its skin sensitisation potential. For this purpose, the test substance is incubated with synthetic peptides for approximately 24 h at room temperature and the remaining concentration of non-depleted peptides is analysed by high performance liquid chromatography with gradient elution and UV detection at 220 nm.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
- Type of study:
- other: Direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Glycerides, C14-18 mono- and di-
- EC Number:
- 266-952-6
- EC Name:
- Glycerides, C14-18 mono- and di-
- Cas Number:
- 67701-33-1
- IUPAC Name:
- 67701-33-1
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Chemical class: monodiglyceride
- Analytical purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- other: not applicable
- Strain:
- other: not applicable
Results and discussion
Any other information on results incl. tables
Table 1. REACTION WITH CYSTEIN-CONTAINING PEPTIDE
Reaction with cysteine-peptide |
Peak area [mAU*s] |
Peptide concentration [mM] |
||||||
Sample 1 |
Sample 2 |
Sample 3 |
Sample 1 |
Sample 2 |
Sample 3 |
Mean value |
SD |
|
NC 1: acetone |
728.2 |
704.1 |
673.0 |
0.474 |
0.459 |
0.438 |
0.457 |
0.02 |
Test substance |
679.1 |
718.7 |
703.8 |
0.442 |
0.468 |
0.458 |
0.456 |
0.01 |
NC 2: acetonitrile |
707.2 |
695.5 |
675.5 |
0.461 |
0.453 |
0.440 |
0.451 |
0.01 |
PC: p-benzoquinone* |
11.4 |
11.8 |
17.8 |
0.007 |
0.007 |
0.011 |
0.008 |
0.00 |
Reaction with cysteine-peptide |
Peptide depletion [%] |
||||
Sample 1 |
Sample 2 |
Sample 3 |
Mean value |
SD |
|
NC 1: acetone |
-3.8 |
-0.3 |
4.1 |
0.0 |
3.9 |
Test substance |
3.2 |
-2.4 |
-0.3 |
0.2 |
2.9 |
NC 2: acetonitrile |
-2.1 |
-0.4 |
2.5 |
0.0 |
2.3 |
PC: p-benzoquinone* |
98.5 |
98.4 |
97.5 |
98.1 |
0.5 |
NC: Negative control
PC: Positive control
*The calculation of peptide depletion of the PC was made relative to NC 2 as the PC was solved in acetonitrile.
Table 2. REACTION WITH LYSINE-CONTAINING PEPTIDE
Reaction with lysine-peptide |
Peak area [mAU*s] |
Peptide concentration [mM] |
||||||
Sample 1 |
Sample 2 |
Sample 3 |
Sample 1 |
Sample 2 |
Sample 3 |
Mean value |
SD |
|
NC 1: acetone |
575.2 |
635.5 |
588.3 |
0.448 |
0.495 |
0.458 |
0.467 |
0.02 |
Test substance |
593.6 |
625.8 |
598.6 |
0.462 |
0.487 |
0.466 |
0.472 |
0.01 |
NC 2: acetonitrile |
** 648.4 |
645.1 643.6 |
645.2 644.1 |
- 0.505 |
0.502 0.501 |
0.502 0.502 |
0.503 |
0.00 |
PC: p-benzoquinone* |
0.0 |
0.0 |
0.0 |
0.000 |
0.000 |
0.000 |
0.000 |
0.00 |
Reaction with lysine-peptide |
Peptide depletion [%] |
||||
Sample 1 |
Sample 2 |
Sample 3 |
Mean value |
SD |
|
NC 1: acetone |
4.1 |
-6.0 |
1.9 |
0.0 |
5.3 |
Test substance |
1.0 |
-4.4 |
0.2 |
-1.1 |
2.9 |
NC 2: acetonitrile |
- -0.5 |
0.0 0.3 |
0.0 0.2 |
0.0 |
0.3 |
PC: p-benzoquinone* |
100 |
100 |
100 |
100 |
0.0 |
NC: Negative control
PC: Positive control
*The calculation of peptide depletion of the PC was made relative to NC 2 as the PC was solved in acetonitrile.
**The value is considered to be a measurement error and thus not used for calculations. Hence, two measurements were performed for each of the 3 NC-samples. The remaining 5 values were used for calculations.
Table 3. MEAN PEPTIDE DEPLETION
|
Cysteine-containing peptide |
Lysine-containing peptide |
Mean of both depletions[%] |
||
Mean depletion [%] |
SD |
Mean depletion [%] |
SD |
||
PC: p-benzoquinone* |
98.1 |
0.5 |
100 |
0.0 |
99.1 |
Test substance |
0.2 |
2.9 |
-1.1 |
2.9 |
0.1 |
Based on the observed results and applying the prediction model according to Gerberick et al. (2007), it was concluded that the test substance showed a minimal chemical reactivity in the DPRA under the test conditions chosen.
Applicant's summary and conclusion
- Interpretation of results:
- other: inconclusive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test material showed a minimal chemical reactivity in the DPRA. The results of this in vitro test are, however, not sufficient for the purpose of classification and labelling according to CLP and DSD.
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