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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | CAS number: -
- 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 chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01.05.2018 - 04.05.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- In 2012 the OECD published an Adverse Outcome Pathway (AOP), which describes the biological mechanisms of skin sensitisation initiated by the covalent
binding of substances to skin proteins.The key events of this skin sensitisation pathway are:
1. covalent binding of the electrophilic substance to skin proteins
2. release of pro-inflammatory cytokines and induction of cyto-protective pathways in kerationocytes
3. activation and maturation of dendritic cells and their migration to the local lymph nodes
4. presentation of the chemical allergen by the dendritic cells to naive T-cells, which leads to their differentiation and proliferation into allergen-specific memory
T-Cells.
DPRA addresses the first key event of the AOP
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In chemico test system
- Details on the study design:
- The study was performed according to the OECD Guideline 442C and the Protocol N° 154 from ECVAM DB ALM.
The principle is based on chemical reactivity of the test item with proteins. The interaction between the molecule and lysine or cysteine rich peptides is detected with a high performance liquid chromatography (HPLC). The remaining concentration of peptides is measured after 24 hours of incubation with the test item at 25°C. It is measured with the UV detector of the HPLC system, after gradient elution,at 220 nm. The depletion rates of lysine and cysteine peptides are then used to distinguish the skin sensitizer and non-sensitizer.
The following table allows a determination of reactivity: the 6.38% threshold is used in order to differentiate between non-sensitizers and sensitizers.
Mean of cysteine and lysine% depletion Reactivity Class DPRA Prediction
0.00 % ≤ mean% depletion ≤ 6.38 % No or minimal reactivity Negative
6.38 % < mean% depletion ≤ 22.62 % Low reactivity Positive
22.62 % < mean% depletion ≤ 42.47 % Moderate reactivity Positive
42.47 % < mean% depletion ≤ 100 % High reactivity Positive
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Parameter:
- other: Mean Depletion in Lysine Peptide %
- Value:
- 0.39
- Parameter:
- other: Mean Depletion in Cysteine Peptide %
- Value:
- 4.4
- Key result
- Parameter:
- other: Calculated mean percentage of depletion of Lysine and Cysteine
- Value:
- 2.4
Any other information on results incl. tables
Depletion in Lysine Peptide % | Depletion in Cysteine Peptide % | |
Repetition 1 | 0 | 4.04 |
Repetition 2 | 0 | 4.44 |
Repetition 3 | 1.18 | 4.72 |
MEAN | 0.39 | 4.40 |
Applicant's summary and conclusion
- Interpretation of results:
- other: DPRA is considered scientifically valid to be used as part of an integrated approach.
- Conclusions:
- The sensitivity of the test item is determined by calculating the mean percentage of depletion of Lysine and Cysteine.
The test item Oleic acid. compound with dicyclohexylamine shows mean depletion of 0.39 % for Lysine and 4.40 % for Cysteine, i.e. an overall average of 2.40 % reflecting no or minimal reactivity and therefore a negative prediction of DPRA.
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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