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Diss Factsheets
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EC number: 946-058-9 | 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 irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April - June 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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:
- 3-butyltetrahydro-5-methyl-2H-pyran-4-yl acetate
- EC Number:
- 253-863-2
- EC Name:
- 3-butyltetrahydro-5-methyl-2H-pyran-4-yl acetate
- Cas Number:
- 38285-49-3
- Molecular formula:
- C12H22O3
- IUPAC Name:
- 3-O-acetyl-1,5-anhydro-2-butyl-2,4-dideoxy-4-methylpentitol
- Reference substance name:
- 3-pentyltetrahydro-2H-pyran-4-ol
- Cas Number:
- 24646-98-8
- Molecular formula:
- C10H20O2=
- IUPAC Name:
- 3-pentyltetrahydro-2H-pyran-4-ol
- Reference substance name:
- Likely acetylated constituents, MW 214
- Molecular formula:
- n/a
- IUPAC Name:
- Likely acetylated constituents, MW 214
- Reference substance name:
- Likely acetylated constituents
- Molecular formula:
- n/a
- IUPAC Name:
- Likely acetylated constituents
- Reference substance name:
- Unknown constituent, MW 172
- Molecular formula:
- n/a
- IUPAC Name:
- Unknown constituent, MW 172
- Test material form:
- liquid
- Details on test material:
- UVCB substance
Constituent 1
Constituent 2
impurity 1
impurity 2
impurity 3
impurity 4
- Specific details on test material used for the study:
- Batch no.: PE00138468
Expiry date: 20 February 2018
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The test system EPISKIN™is a reconstructed human epidermis (RhE) model, which in its overall design (the use of human derived epidermis keratinocytes as cell source and use of representative tissue and cytoarchitecture) closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e., the epidermis.
The principle of the RhE test method is based on the premise that chemicals are able to penetrate the stratum corneum and irritant chemicals are cytotoxic to the cells in the underlying layers. Cell viability is measured by dehydrogenase conversion of the vital dye MTT [3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue; CAS N. 298-93-1] into a blue formazan salt that is quantitatively measured after extraction from tissues. Irritant chemicals are identified by their ability to decrease cell viability below defined threshold levels. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Positive control item was 5% (w/v) sodium dodecyl sulphate (SDS) solution, obtained by 1:1 dilution in sterile water (Baxter, batch no. 15G2401) of a sterile commercial 10% (w/v) SDS solution in water (SIGMA, batch no. BCBP9757V).
Negative control item was D-PBS (GIBCO, batch no.1786985). - Amount/concentration applied:
- 20 µL per well
- Duration of treatment / exposure:
- An exposure time of 15±0.5 minutes was allowed in a ventilated cabinet at room temperature.
- Duration of post-treatment incubation (if applicable):
- At the end of the exposure, each tissue was rinsed with approximately 25mL of sterile D-PBS, filling and empting the tissue insert. The excess liquid was carefully removed and the sample transferred in new wells pre-filled with 2mL/well of maintenance medium.
A 42 ± 1 hour recovery period was allowed by incubation at 37°C, 5% CO2 and saturated humidity. - Number of replicates:
- 3 Negative control
3 Positive control
3 Test item (Jasmonyl LG).
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- 101
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The potential of the test item JASMONYL LG to be irritant to the skin was investigated through an in vitro skin irritation study, using a commercial reconstructed human epidermis (RhE) model named EPISKIN™.
The blank, negative and positive controls gave acceptable results and the study was accepted as valid.
The mean cell viability of the test item treated tissues, after the blank subtraction, was 101%.
Based on the results obtained, the test item JASMONYL LG is classified as not irritating to the skin (UN GHS No Category).
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