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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Tricyclo[8.2.2.24,7]hexadeca-4,6,10,12,13,15-hexaene, 5,11,13,15-tetramethyl-
- Cas Number:
- 205825-52-1
- Molecular formula:
- C20H24
- IUPAC Name:
- Tricyclo[8.2.2.24,7]hexadeca-4,6,10,12,13,15-hexaene, 5,11,13,15-tetramethyl-
- Test material form:
- solid: particulate/powder
Constituent 1
In chemico test system
- Details of test system:
- cysteine peptide, (Ac-RFAACAA-COOH)
- lysine peptide (Ac-RFAAKAACOOH)
- Details on the study design:
- Based on a molecular weight of 264.41 g/mol a 100 mM stock solution was prepared. The test item solutions were tested by incubating the samples with the peptides containing either cysteine or lysine for 24 ± 2 h at 25 ± 2.5 °C. Subsequently samples were analysed by HPLC.
All test item solutions were freshly prepared immediately prior to use.
For the 100 mM stock solution of the test item turbidity and precipitation was observed when diluted with the cysteine peptide solution. After the 24 h ± 2 h incubation period but prior to the HPLC analysis samples were inspected for precipitation, turbidity or phase separation. Precipitation was observed for
the samples of the test item (including the co-elution control). Samples were not centrifuged prior to
the HPLC analysis.
For the 100 mM stock solution of the test item turbidity and precipitation was observed when diluted
with the lysine peptide solution. After the 24 h ± 2 h incubation period but prior to the HPLC analysis
samples were inspected for precipitation, turbidity or phase separation. - Vehicle / solvent:
- acetonitrile
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- lysine depletion
- Value:
- 0.28 %
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- cysteine depletion
- Value:
- 0.28 %
Any other information on results incl. tables
Precipitation was observed for
the samples of the test item (including the co-elution control). Slight Turbidity was observed for the
samples of the positive control (excluding the co-elution control). Samples were not centrifuged prior
to the HPLC analysis. Since the acceptance criteria for the depletion range of the positive control were
fulfilled, the observed turbidity was regarded as not relevant.
Precipitation of the test item with both peptide peaks was observed. Therefore, the given peak areas
and corresponding peptide values can only be considered as an estimation of the peptide depletion.
The stock solution of the test item showed minimal reactivity towards the synthetic peptides. The mean
depletion of both peptides was 6.38% (0.28%). Since precipitation was observed, a test item
concentration of 100 mM as well as the full contact of peptide and test item is not guaranteed.
According to the evaluation criteria in the guideline, no firm conclusion on the lack of reactivity should be drawn from a negative result, if a test chemical is tested in concentration < 100 mM. Therefore, no
prediction can be made.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Due to the observed precipitation the prediction model does not apply and a prediction cannot be
made.
The data generated with this test should be considered in the context of integrated approached such as IATA, combining the result with other complementary information, e.g. derived from in vitro assays addressing other key events of the skin sensitisation AOP.
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