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Diss Factsheets
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EC number: 943-794-2 | 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, other
- Remarks:
- other: In Vitro KeratinoSens
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study done to guideline and following the principles of GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 442d
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study following the principles of GLP.
- Type of study:
- other: KeratinoSens
Test material
- Reference substance name:
- Tetrahydro-3-pentyl-2H-pyran-4-yl acetate
- EC Number:
- 242-640-5
- EC Name:
- Tetrahydro-3-pentyl-2H-pyran-4-yl acetate
- Cas Number:
- 18871-14-2
- Molecular formula:
- C12H22O3
- IUPAC Name:
- 3-O-acetyl-1,5-anhydro-2,4-dideoxy-2-pentylpentitol
- Reference substance name:
- Nonane-1,3-diyl diacetate
- EC Number:
- 264-060-1
- EC Name:
- Nonane-1,3-diyl diacetate
- Cas Number:
- 63270-14-4
- Molecular formula:
- C13H24O4
- IUPAC Name:
- nonane-1,3-diyl diacetate
- Reference substance name:
- 1-(tetrahydrofuran-3-yl)hexyl acetate
- Molecular formula:
- C12H22O3
- IUPAC Name:
- 1-(tetrahydrofuran-3-yl)hexyl acetate
- Reference substance name:
- rel-(3R,4R)-3-pentyltetrahydro-2H-pyran-4-ol
- Cas Number:
- 24646-98-8
- Molecular formula:
- C10H20O2
- IUPAC Name:
- rel-(3R,4R)-3-pentyltetrahydro-2H-pyran-4-ol
- Reference substance name:
- 3-hydroxynonyl acetate
- Cas Number:
- 902270-36-4
- Molecular formula:
- C11H22O3
- IUPAC Name:
- 3-hydroxynonyl acetate
- Test material form:
- liquid
Constituent 1
Constituent 2
impurity 1
impurity 2
impurity 3
In vitro test system
- Details on the study design:
- The KeratinoSensTM assay is a cell-based assay with a reporter cell line to detect potential skin sensitizers by their ability to induce the Nrf2-response. This assay has been validated for a broad range of low-molecular weight chemicals and it was found to respond to skin sensitizers from a broad range of so called applicability domains, i.e. chemicals reacting with proteins by different mechanisms. It was validated by ECVAM and proposed to be used as part of an integrated approach for testing and assessment (IATA).
The test substance JASMONYL was dissolved in DMSO and tested according to the standard operating procedure of the KeratinoSensTM assay at 12 concentrations in three repetitions, each time in three replicates. After 48 h incubation time, luciferase induction and cellular viability at each
of the concentrations were determined.
In vivo test system
Test animals
- Species:
- other: in vitro
- Strain:
- other: human keratinocyte culture HaCaT.
- Sex:
- not specified
- Details on test animals and environmental conditions:
- In vitro test
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: In vitro test
Challenge
- Route:
- other: In vitro test
- No. of animals per dose:
- IN vitro test.
- Positive control substance(s):
- yes
- Remarks:
- Cinnamic aldehyde
Results and discussion
- Positive control results:
- Cinnamic aldehyde was run in all three repetitions. Here the detailed results for this positive control are reported in Table 8 and Figure 5. Cinnamic aldehyde needs to be positive for a run to be accepted (i.e. induction > 1.5 fold). This was the case in all three repetitions. The induction at 64 μM
and the EC 1.5 for cinnamic aldehyde were also calculated. The targets are: (i) Average induction in the three replicates for cinnamic aldehyde at 64 μM should be between 2 and 8, and (ii) the EC 1.5 value should be between 7 μM and 30 μM. At least one of these two numerical criteria must be met in order to accept a repetition. In the experiments performed here both criteria were fulfilled in all three repetitions. Thus all three repetitions were valid for the positive control.
In vitro / in chemico
Results
- Key result
- Remarks on result:
- no indication of skin sensitisation
- Other effects / acceptance of results:
- According to the prediction model of the KeratinoSens™ assay, the test substance is rated as non-sensitizer. This is also clearly supported by the analysis of the dose-response curve in Figure 4 with overall no induction of the luciferase reporter gene to be observed.
Any other information on results incl. tables
The result of the KeratinoSens™ assay should be used as part of an integrated approach for testing and assessment (IATA)[9]. A parallel test in the DPRA may indicate whether congruent results are obtained by both test methods. According to a detailed analysis on large set of substances, two congruent results in these two tests give a good prediction of the sensitizer hazard [5, 7, 18], in particular when comparing against human data, while an additional test in a dendritic cell line assessing expression of surface markers may be needed in case of discordant results. No induction of the luciferase above the threshold of 1.5 was noted in all three repetitions. According to the prediction model of the KeratinoSens™ assay, the test substance is rated as non-sensitizer. This is also clearly supported by the analysis of the dose-response curve in Figure 4 with overall no induction of the luciferase reporter gene to be observed.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- JASMONYL is considered a non-sensitizer according to the prediction model of the KeratinoSens™ assay.
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